Women's Health

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Many women with symptoms of menopause are turning to cannabis for help, researchers have found, despite a lack of evidence that the drug works for these issues. 

In a survey of perimenopausal and menopausal women who said they’ve used cannabis, nearly 80% said they use medical marijuana to alleviate symptoms such as sleep disturbances, hot flashes, and mood swings. 

“Increasingly, we see greater numbers of individuals exploiting the use of cannabis and cannabinoids for lots of conditions. We realized there was no long-term data on how women were treating themselves for conditions like menopause,” said Staci Gruber, PhD, director of the Marijuana Investigations for Neuroscientific Discovery (MIND) program at McLean Hospital, an affiliate of Harvard Medical School, Boston, who led the study.

Dr. Gruber and her colleagues surveyed 131 perimenopausal and 127 postmenopausal women about their use of cannabis, identifying them through targeted advertising and social media platforms such as Twitter, Facebook, and Reddit.

The survey, published in Menopause, found 83.5% reported habitual cannabis use and 86% said they were current users. Around half of the women reported mixed medical/recreational use; 30.8% reported recreational use only and 17.7% said they only used medical forms of the drug.

The three most common modes of cannabis use were smoking a joint, bowl, or bong (84.3%); using edibles (78.3%);, and vaping oils (52.6%).

The researchers found that women in perimenopause reported markedly worse symptoms than did those in menopause, and these women tended to use a wider variety of cannabis products.

Dr. Gruber said clinicians should be asking their menopausal patients if they use cannabis to alleviate their symptoms. 

Stephanie Faubion, MD, MBA, a women’s health expert at Mayo Clinic in Rochester, Minn., and Jacksonville, Fla., said the looming question is whether cannabis in fact works in these patients. 

“What we need is to figure out whether it works for women, and that hasn’t been studied yet,” she said. 

Dr. Faubion, medical director for the North American Menopause Society, said the society is now conducting a review of worldwide data on nonhormonal treatments for symptoms of menopause. The report, which will examine the most current research on the effects of cannabis, hypnosis, diet, exercise, acupuncture, yoga, and meditation, will be released in 2023, she said.

Dr. Gruber said she hopes her group’s research will open the doors to more detailed explorations of how strains of cannabis and their levels of cannabidiol, a chemical compound in cannabis plants, and tetrahydrocannabinol, the main psychoactive component in cannabis, affect the symptoms women experience from menopause. Clinical trials for products aimed at specific symptoms also will be important, she added.

“We have a paucity of data from primary care clinicians,” Dr. Gruber said. “We, as researchers and clinicians, should be providing women with the research to make informed choices.”

The study was supported by private donations to the MIND program at McLean Hospital. No funding sources were involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Dr. Gruber reported grants from the National Institute on Drug Abuse, Foria/Praxis Ventures, and Charlotte’s Web. She reported personal fees from the Coalition for Cannabis Policy, Education and Regulation; Beth Israel Deaconess; Fenway Health; Greenwich Biosciences Cannabis Education Working Group; and National Academy of Neuropsychology outside the submitted work. Dr. Faubion reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Each week, Kim Puterbaugh, MD, sees several pregnant patients at a Cleveland hospital who are experiencing complications involving bleeding or infection. The ob.gyn. has to make quick decisions about how to treat them, including whether to remove the dead or dying fetus to protect the health and life of the mother. Leaving in place a fetus that has no chance of survival dramatically increases the chance of maternal infection and permanent injury.

But now her medical decisions are complicated by Ohio’s new abortion law, which generally prohibits abortions after 6 weeks of pregnancy if cardiac activity is detected in the embryo or fetus – which can persist for hours or days even if a pregnancy has no chance of progressing. Given the new law, University Hospitals Cleveland Medical Center has streamlined its system of having an administrator and legal team on call for Dr. Puterbaugh and other physicians if anyone questions whether the planned treatment is allowed under the law.

Since the Supreme Court erased the constitutional right to abortion in June, Dr. Puterbaugh said these cases put her and doctors like her in an impossible position – squeezing doctors between antiabortion laws in Ohio and other states and the federal Emergency Medical Treatment & Labor Act. That 1986 law requires hospitals and physicians to provide screening and stabilizing treatment – including abortion, if necessary – in emergency situations.

“It’s a challenge to balance both those two things,” said Dr. Puterbaugh, president of the Society of OB/GYN Hospitalists. “But it’s not really a challenge to me because, in my mind, the life and health of the mother always comes first.”

The Biden administration argues that EMTALA trumps state abortion bans in emergency situations. On Aug. 2, the Department of Justice filed a federal lawsuit challenging an Idaho law that bans abortion in nearly all circumstances. The suit claims the law would make it a criminal offense for medical providers to comply with EMTALA’s requirement to provide abortion, if needed, for women experiencing emergency pregnancy complications.

In a July policy guidance and letter, the Department of Health & Human Services reaffirmed that EMTALA requires hospitals and physicians to offer life- or health-saving medical services, including abortion, in emergency situations. The letter refers to situations such as ectopic pregnancies, severe blood pressure spikes known as preeclampsia, and premature ruptures of the membrane causing a woman’s water to break before her pregnancy is viable.

The guidance stressed that this federal requirement supersedes any state laws that bar abortion, and that hospitals and physicians who don’t comply with the federal mandate could face civil fines and termination from the Medicare and Medicaid programs.

There are no known reports so far of EMTALA investigations arising from denial of emergency care in pregnancy situations.

But elected officials in states that have sharply restricted abortion disagree with the federal judgment. Texas Attorney General Ken Paxton sued the Biden administration in July to prevent the federal government from using the EMTALA law to require abortions in emergency cases. The suit claims that EMTALA doesn’t specifically mandate particular medical procedures such as abortion.

Abortion foes argue that state antiabortion laws already include adequate exceptions when a pregnant woman’s life or health is in danger. John Seago, president of Texas Right to Life, said one of Texas’ laws specifies that treatment for ectopic pregnancies or miscarriages is not prohibited. In addition, the law defines a medical emergency allowing abortion as a condition in which a woman is at serious risk of a “substantial impairment of a major bodily function.”

Mr. Seago blamed the news media and medical associations for deliberately sowing confusion about the laws. “The law is very clear,” he said.

Legal wrangling aside, in practice, physicians and hospital lawyers say much depends on the interpretation of vaguely worded exceptions in state abortion bans, and that’s further complicated by the existence of contradictory laws, such as those banning abortion based on cardiac activity. And medical providers don’t want to risk criminal prosecution, fines, and loss of licensure if someone accuses them of violating these confusing laws.

Louise Joy, an attorney in Austin, Tex., who represents hospitals and other health care providers, said her clients perhaps are being overly cautious, but that’s not surprising. “I try to encourage them to do the right thing, but I can’t assure them they’ll be risk free.”

A lot hinges on when a pregnancy-ending complication is deemed an emergency, a moment that is hard to define. Some Missouri women have come to the hospital ED with mild cramping and bleeding and were found to have an ectopic pregnancy that hadn’t ruptured yet, colleagues have told Alison Haddock, MD, a Houston emergency physician who chairs the board of the American College of Emergency Physicians. The standard treatment is to provide the drug methotrexate, which can terminate a pregnancy.

“You’re stable until it ruptures, then it becomes unstable,” she said. “But how unstable do you need to be? The woman’s life is not clearly at risk yet. It’s not clear if EMTALA applies. There will be a lot of gray areas that make it really tough for emergency physicians who want to do what’s right for patients without violating any laws.”

Physicians and hospital attorneys are hoping for clearer federal guidance and guarantees of protection from state prosecutors who might oppose their medical judgment on political grounds.

“This is when we need the federal government to step up and say: ‘Doctors, you must provide the standard of care, and we will prevent the prosecution of anyone who is following appropriate medical practices and doing the right thing for patients,” Ms. Joy said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Pain is classified as chronic when it lasts or recurs for more than 3-6 months (“Classification of chronic pain” 2nd ed. Seattle: IASP Press, 1994). This universally accepted definition does not distinguish between physical and emotional pain. Categorically, pain is pain. Two prevalent chronic gynecologic diseases are closely related medically and emotionally. Forty percent to 50% of women with endometriosis have infertility; 30%-50% of women with infertility are found to have coexisting endometriosis. The approach to both is, typically, symptomatic treatment. In this month’s column, I examine the relationship between these ailments and how we can advise women on management.

Endometriosis is simply defined as the displacement of normal endometrial glands and stroma from their natural anatomical location to elsewhere in the body. With the recent identification of the disease in the spleen, endometriosis has been found in every organ system. Endometriosis is identified in 6%-10% of the general female population. The prevalence ranges from 2% to 11% among asymptomatic women and from 5% to 21% in women hospitalized for pelvic pain (Best Pract Res Clin Obstet Gynaecol. 2018;51:1-15). Compared with fertile women, infertile women are six to eight times more likely to have endometriosis (Fertil Steril. 2012;98:591-8).

Retrograde menstruation is the presumed theory for the origins of endometriosis, that is, the reflux of menstrual debris containing active endometrial cells through the fallopian tubes into the peritoneal cavity (Am J Obstet Gynecol. 1927;14:422-69). Because of the varied etiologies of the most common symptoms of endometriosis, dysmenorrhea, dyspareunia, dyschezia, and infertility, women visit, on average, seven physicians before being diagnosed (Fertil Steril. 2011;96:366). The delay in promptly identifying endometriosis is further impaired by the lack of specific biomarkers, awareness, and inadequate evaluation (N Engl J Med. 2020;382:1244-56).

The 2008 U.S. health care costs for endometriosis were approximately $4,000 per affected woman, analogous to the costs for other chronic conditions such as type 2 diabetes, Crohn’s disease, and rheumatoid arthritis (Hum Reprod. 2012;27:1292-9). The management of symptoms further increases the financial burden because of the effect of the disease on physical, mental, sexual, and social well-being, as well as productivity (Health Qual Life Outcomes. 2019;17:123).

We have known the paradoxical relationship between the stage of endometriosis and symptoms: Women with low-stage disease may present with severe pain and/or infertility but those with advanced-stage disease may be asymptomatic. Endometriotic cells and tissue elicit a localized immune and inflammatory response with the production of cytokines, chemokines, and prostaglandins. Given the usual intra-abdominal location and the small size of implants, endometriosis requires a surgical diagnosis, ideally with histopathology for confirmation. However, imaging – transvaginal ultrasound or MRI – has more than 90% sensitivity and specificity for identifying endometriomas (Cochrane Database Syst Rev. 2016;2[2]:CD009591).

The effect of endometriosis on fertility, particularly in women with minimal to mild stages, is not clear, and many studies have been retrospective. Tubal factor infertility can be a result of endometriosis. Per the 2020 Cochrane Database Systemic Reviews (2020 Oct;2020[10]:CD011031), “Compared to diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis; no data were reported on live birth. There is moderate-quality evidence that laparoscopic surgery increases viable intrauterine pregnancy rates confirmed by ultrasound compared to diagnostic laparoscopy only.” In women undergoing IVF, more advanced stages of endometriosis have reduced pregnancy outcomes as shown in recent meta-analyses (Obstet Gynecol. 2015;125:79-88).

The revised ASRM (rASRM) surgical staging classification of endometriosis has been widely used to describe the degree, although it poorly correlates with fertility potential (Fertil Steril. 2012;98:591-8). Women diagnosed with endometriosis may benefit from the Endometriosis Fertility Index (EFI), published in 2010 as a useful scoring system to predict postoperative non-IVF pregnancy rates (both by natural means and intrauterine insemination) based on patient characteristics, rASRM staging and “least function” score of the adnexa (Fertil Steril. 2010;94:1609-15).

Compared with diagnostic laparoscopy only, it is uncertain whether laparoscopic surgery reduces overall pain associated with minimal to severe endometriosis. “Further research is needed considering the management of different subtypes of endometriosis and comparing laparoscopic interventions with lifestyle and medical interventions (Cochrane Database Syst Rev. 2020 Oct;2020[10]:CD011031).”

The treatment of endometriosis is directly related to the desire for and timing of fertility since therapy is often contraceptive, as opposed to surgery. Because endometriosis is exacerbated by estradiol, the mainstay of medical therapy is initially combined hormonal or progestin-only contraception as a means of reducing pelvic pain by reducing estradiol production and action, respectively. GnRH-agonist suppression of follicle stimulation hormone and luteinizing hormone remains the standard for inactivating endogenous estradiol. In 2018, the U.S. Food and Drug Administration approved elagolix for the treatment of pain associated with endometriosis – the first pill specifically approved for endometriosis pain relief. An off-label approach for women is letrozole, the aromatase inhibitor, to reduce circulating estradiol levels. Unfortunately, estradiol suppression cannot be used solely long term without add-back therapy, because of the risk of bone loss and vasomotor symptoms.

Excision of endometriomas adversely affects ovarian follicular reserve (as indicated by lower levels of anti-müllerian hormone and reduced ovarian antral follicle counts on ultrasound). For women who want to preserve their fertility, the potential benefits of surgery should be weighed against these negative effects. Surgical treatment of endometriosis in women without other identifiable infertility factors may improve rates of spontaneous pregnancy. In women with moderate to severe endometriosis, intrauterine insemination with ovarian stimulation may be of value, particularly with preceding GnRH-agonist therapy (J Endometr Pelvic Pain Disord. 2018;10[3]:158-73).

Despite the reduction in IVF outcomes in women with moderate to severe endometriosis, it remains unclear whether surgery improves the likelihood of pregnancy with IVF as does the concurrent use of prolonged GnRH agonist during IVF stimulation. (Fertil Steril. 2012;98:591-8).

Summary

• Medical therapy alone does not appear to improve fertility in endometriosis.
• Surgical treatment of endometriosis improves natural fertility, particularly in lower-stage endometriosis.
• EFI is a useful tool to predict postoperative natural fertility and assess the need for IVF.
• Despite advanced endometriosis reducing IVF outcomes, surgery or medical pretreatment to increase IVF success remains unproven.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.

Hormone therapy remains a topic for debate, but a constant in the 2 decades since the Women’s Health Initiative has been the demonstrated effectiveness for relief of vasomotor symptoms and reduction of fracture risk in menopausal women, according to the latest hormone therapy position statement of the North American Menopause Society.

“Healthcare professionals caring for menopausal women should understand the basic concepts of relative risk and absolute risk,” wrote Stephanie S. Faubion, MD, director of the Mayo Clinic Center for Women’s Health and medical director of NAMS, and members of the NAMS 2022 Hormone Therapy Position Statement Advisory Panel in Menopause.

The authors noted that the risks of hormone therapy vary considerably based on type, dose, duration, route of administration, timing of the start of therapy, and whether or not a progestogen is included.

The 2022 statement was commissioned to review new literature and identify the strength of recommendations and quality of evidence since the previous statement in 2017.

The current statement represents not so much a practice-changing update, “but rather that the literature has filled out in some areas,” Dr. Faubion said in an interview. “The recommendations overall haven’t changed,” she said. “The position statement reiterates that hormone therapy, which is significantly underutilized, remains a safe and effective treatment for menopause symptoms, which remain undertreated, with the benefits outweighing the risks for most healthy women who are within 10 years of menopause onset and under the age of 60 years,” she emphasized. “Individualizing therapy is key to maximizing benefits and minimizing risks,” she added.

Overall, the authors confirmed that hormone therapy remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM), and has been shown to prevent bone loss and fracture. The risks of hormone therapy differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

Risks and benefits should be stratified by age and time since the start of menopause, according to the statement.

For women younger than 60 years or within 10 years of the onset of menopause who have no contraindications, the potential benefits outweigh the risks in most cases for use of hormone therapy to manage vasomotor symptoms and to help prevent bone loss and reduce fracture risk.

For women who begin hormone therapy more than 10 or 20 years from the start of menopause, or who are aged 60 years and older, the risk-benefit ratio may be less favorable because of the increased absolute risk of coronary heart disease, stroke, venous thromboembolism, and dementia. However, strategies such as lower doses and transdermal administration may reduce this risk, according to the statement.

The authors continue to recommend that longer durations of hormone therapy be for documented indications, such as VMS relief, and that patients on longer duration of therapy be reassessed periodically as part of a shared decision-making process. Women with persistent VMS or quality of life issues, or those at risk for osteoporosis, may continue hormone therapy beyond age 60 or 65 years after appropriate evaluation and risk-benefit counseling.

Women with ongoing GSM without indications for systemic therapy whose GSM persists after over-the-counter therapies may try low-dose vaginal estrogen or other nonestrogen therapies regardless of age and for an extended duration if needed, according to the statement.
 

Challenges, research gaps, and goals

“Barriers to the use of hormone therapy include lack of access to high quality care,” Dr. Faubion said in an interview. The NAMS website, menopause.org, features an option to search for a NAMS-certified provider by ZIP code, she noted.

“Coverage of hormone therapy is highly variable and depends on the insurance company, but most women have access to one form or another with insurance coverage,” she said. “We need to continue to advocate for adequate coverage of menopause symptom treatments, including hormone therapy, so that women’s symptoms – which can significantly affect quality of life – are adequately managed.

“Additional research is needed on the thrombotic risk (venous thromboembolism, pulmonary embolism, and stroke) of oral versus transdermal therapies (including different formulations, doses, and durations of therapy),” Dr. Faubion told this news organization. “More clinical trial data are needed to confirm or refute the potential beneficial effects of hormone therapy on coronary heart disease and all-cause mortality when initiated in perimenopause or early postmenopause,” she said.

Other areas for research include “the breast effects of different estrogen preparations, including the role for selective estrogen receptor modulator (SERM) and tissue selective estrogen complex therapies, optimal progestogen or SERM regimens to prevent endometrial hyperplasia, the relationship between vasomotor symptoms and the risk for heart disease and cognitive changes, and the risks of premature ovarian insufficiency,” Dr. Faubion emphasized.

Looking ahead, “Studies are needed on the effects of longer use of low-dose vaginal estrogen therapy after breast or endometrial cancer, extended use of hormone therapy in women who are early initiators, improved tools to personalize or individualize benefits and risks of hormone therapy, and the role of aging and genetics,” said Dr. Faubion. Other areas for further research include “the long-term benefits and risks on women’s health of lifestyle modification or complementary or nonhormone therapies, if chosen in addition to or over hormone therapy for vasomotor symptoms, bone health, and cardiovascular disease risk reduction,” she added.

The complete statement was published in Menopause: The Journal of the North American Menopause Society.

The position statement received no outside funding. The authors had no financial conflicts to disclose.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO, CALIF. – Californians will decide in November whether to lock the right to abortion into the state constitution.

If they vote “yes” on Proposition 1, they will also lock in a right that has gotten less attention: The right to birth control.

Should the measure succeed, California would become one of the first states – if not the first – to create explicit constitutional rights to both abortion and contraception.

The lawmakers and activists behind the constitutional amendment said they hope to score a one-two punch: Protect abortion in California after the U.S. Supreme Court ended the federal constitutional right to abortion under Roe v. Wade, and get ahead of what they see as the next front in the reproductive rights fight: Birth control.

“The United States Supreme Court said that the privacy and liberty protections in the United States Constitution did not extend to abortion,” said UCLA law professor Cary Franklin, an expert in constitutional law and reproductive rights who has testified before the California legislature in support of the amendment. “If they said ‘no’ on abortion, they’re probably going to say ‘no’ on birth control because that has a similar history.”

In June, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization ended the federal right to abortion and left states to regulate the service. In his concurring opinion, Justice Clarence Thomas said the court should revisit other cases that have created protections for Americans based on an implicit right to privacy in the U.S. Constitution, such as the 1965 case Griswold v. Connecticut, which established a federal right to contraception for married people, and which was later extended to unmarried people.

Some congressional Democrats are now trying to codify the right to contraception in federal law. In July, the U.S. House of Representatives passed the Right to Contraception Act, which would give patients the right to access and use contraception and providers the right to furnish it. But the bill has little chance of success in the U.S. Senate, where Republicans have already blocked it once.

Protecting access to contraception is popular with voters. A national poll from Morning Consult and Politico conducted in late July found that 75% of registered voters support a federal law that protects a right to birth control access.

California isn’t the only state where voters are considering reproductive rights in their constitutions.

On Aug. 2, Kansas voters decisively rejected a constitutional amendment that would have allowed state lawmakers to ban or dramatically restrict abortion. It failed by nearly 18 percentage points.

Kentucky voters will face a similar decision in November with a proposed constitutional amendment that would declare that the state’s constitutional right to privacy does not cover abortion.

Vermont is going in the opposite direction. Voters there will weigh a ballot measure in November that would add a right to “personal reproductive autonomy” to the state constitution, though it does not explicitly mention abortion or contraception. In Michigan, a proposed constitutional amendment that would guarantee a right to both abortion and contraception is expected to qualify for the November ballot.

In California, Proposition 1 would prevent the state from denying or interfering with “an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

The proposed constitutional amendment doesn’t go into detail about what enshrining the right to contraception in the state constitution would mean.

California already has some of the strongest contraceptive-access laws in the country – and lawmakers are considering more proposals this year. For instance, state-regulated health plans must cover all Food and Drug Administration–approved contraception; pharmacists must dispense emergency contraception to anyone with a prescription, regardless of age; and pharmacists can prescribe birth control pills on the spot. State courts have also interpreted California’s constitution to include a right to privacy that covers reproductive health decisions.

The amendment, if adopted, could provide a new legal pathway for people to sue when they’re denied contraceptives, said Michele Goodwin, chancellor’s professor of law at the University of California, Irvine.

If a pharmacist refused to fill a birth control prescription or a cashier declined to ring up condoms, she said, customers could make a case that their rights had been violated.

Making the rights to abortion and contraception explicit in the state constitution – instead of relying on a right to privacy – would also protect against shifting political winds, said state Senate leader Toni Atkins (D–San Diego), who was the director of a women’s health clinic in the 1980s. Although California’s lawmakers and executive officers are solid supporters of abortion rights, she said, the composition of the legislature and courts’ interpretation of laws could change.

“I want to know for sure that that right is protected,” Ms. Atkins said at a legislative hearing in June. “We are protecting ourselves from future courts and future politicians.”

The amendment would solidify California’s role as a reproductive rights sanctuary as much of the country chips away at birth control availability, Ms. Goodwin added.

Experts said two forms of birth control that are vulnerable to restrictions in other states are intrauterine devices, or IUDs, and emergency contraception such as Plan B. These methods are often incorrectly conflated with abortion pills, which end a pregnancy instead of preventing it.

Nine states have laws that restrict emergency contraception – for example, by allowing pharmacies to refuse to dispense it or excluding it from state family planning programs – according to the Guttmacher Institute, a research organization that supports abortion rights. In Alabama and Louisiana this year, abortion opponents introduced legislation that would restrict or ban abortion, and would also apply to emergency contraception.

“We’re seeing an erosion of abortion access that is playing out in statehouses across the country that have and will continue to target contraceptive care as well,” said Audrey Sandusky, senior director of policy and communications for the National Family Planning and Reproductive Health Association.

Susan Arnall, vice president of California’s Right to Life League, said the proposed amendment is symbolic and merely echoes current laws. Ms. Arnall said the campaign is mostly about Democratic politicians trying to score political points.

“It just allows the pro-abort legislators to trumpet and give them talking points about how they’re doing something about the overturn of Roe v. Wade,” she said. “It is political virtue signaling. I don’t think it does much of anything else.”

Ms. Goodwin argues that the measure’s symbolism is significant and overdue. She pointed to the Civil War era, when enslaved people in Southern states could look to free states for spiritual hope and material help. “Symbolically, what that meant is a kind of beacon of hope, that those places did exist, where one’s humanity could be regarded,” Ms. Goodwin said.

But California’s reputation as a haven for contraceptive availability may not be fully warranted, said Dima Qato, PharmD, PhD, an associate professor at the University of Southern California School of Pharmacy. In her 2020 study of contraceptive access in Los Angeles County, which has some of the highest rates of teen and unintended pregnancy in the country, Dr. Qato found that only 10% of pharmacies surveyed offered pharmacist-prescribed birth control. Pharmacies in low-income and minority communities were the least likely to offer the service, Dr. Qato said, worsening disparities instead of solving them.

Dr. Qato supports the constitutional amendment but said California should focus on improving and enforcing the laws it already has.

“We don’t need more laws when we don’t address the root cause of a lack of effectiveness of these laws in these communities,” she said. “Lack of enforcement and accountability disproportionately impacts communities of color.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Rachel Bluth is a correspondent for California Healthline. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A new study from the Centers for Disease Control and Prevention found that a surprising proportion of cases of carbapenem-resistant Enterobacterales (CRE) are found in isolates from patients in the community (CA-CRE). They had previously been thought to be health care–associated infections (HCA-CRE).

Traditionally, CRE has been thought of as a nosocomial infection, acquired in a hospital or other health care facility (nursing home, long-term acute care hospital, dialysis center, etc.). This is the first population-level study to show otherwise, with fully 10% of the CRE isolates found to be community acquired.

CREs are a group of multidrug-resistant bacteria considered an urgent health threat by the CDC because they can rapidly spread between patients, especially those who are most seriously ill and vulnerable, and because they are so difficult to treat. These patients often require treatment with toxic antibiotics, such as colistin, and carry a high mortality rate – up to 50% in some studies.

Overall, 30% of CREs carry a carbapenemase – an enzyme that can make them resistant to carbapenem antibiotics. The genes for this are readily transferable between bacteria and help account for their spread in hospitals.

But in this study, published in the American Journal of Infection Control, of the 12 isolates that underwent whole-genome sequencing, 42% of the CA-CRE isolates carried the carbapenemase gene. Lead author Sandra Bulens, MPH, a health scientist in the CDC’s division of health care quality promotion, said in an interview, “The findings highlight the potential for CP-CRE to move from health care settings into the community. The fact that 5 of the 12 isolates harbored a carbapenemase gene introduces new challenges for controlling spread of CP-CRE.”

CDC researchers analyzed data from eight U.S. metropolitan areas between 2012 and 2015 as part of the CDC’s Emerging Infections Program (EIP) health care–associated infections – community interface activity, which conducts surveillance for CRE and other drug-resistant gram-negative bacteria. Cases of CA-CRE were compared with HCA-CRE, with 1499 cases in 1,194 case-patients being analyzed. Though Klebsiella pneumoniae was the most common isolate, there were some differences between metropolitan areas.

The incidence of CRE cases per 100,000 population was 2.96 (95% confidence interval, 2.81-3.11) overall and 0.29 (95% CI, 0.25-0.25) for CA-CRE. Most CA-CRE cases were in White persons (73%) and women (84%). Urine cultures were the source of 98% of all CA-CRE cases, compared with 86% of HCA-CRE cases (P < .001). Though small numbers, the numbers of patients with CA-CRE without apparent underlying medical condition (n = 51; 37%) was greater when compared with patients with HCA-CRE (n = 36; 3%; P < .001).

Asked for independent comment, Lance Price, PhD, of George Washington University and the founding director of GW’s Antibiotic Resistance Action Center, Washington, said, “what’s striking about these data is that: ‘Who is the front line, at least in the United States for CRE?’ It’s women, older women. ... At some point, we have to frame drug resistance as a women’s health issue.”

Dr. Price noted that the 10% of patients with CA-CRE acquired it in the community. “I would argue that probably none of them had any idea, because there’s this silent community epidemic,” he said. “It’s asymptomatic carriage and transmission in the community. Somebody can be this walking reservoir of these really dangerous bacteria and have no idea.”

This is an increasingly serious problem for women, Dr. Price said, because, “with a community-acquired bladder infection, you’re going to call your doctor or go to an urgent care, and they’re not going to test you. They’re going to guess what you have, and they’re going to prescribe an antibiotic, and that antibiotic is going to fail. So then your bladder infection continues, and then you wait a few more days, and you start to get flank pain and kidney infection. ... If you start getting a fever, they might admit you. They are going to start treating you immediately, and they might miss it because you’ve got this organism that’s resistant to all the best antibiotics. ... The gateway to the blood is the UTI.”

Because of such empiric treatment and increasing resistance, the risk for treatment failure is quite high, especially for older women. Ms. Bulens, however, said that, “[although] 10% of CRE were in persons without health care risk factors, the proportion of all UTIs in this population that are CRE is going to be very, very small.”

This study involved cultures from 2012 to 2015. Before the pandemic, from 2012 to 2017, U.S. deaths from antibiotic resistance fell by 18% overall and by 30% in hospitals.

But in the first year of the COVID-19 pandemic, there was a 15% increase in infections and deaths from antibiotic-resistant (AMR), hospital-acquired bacteria. In 2020, 29,400 patients died from AMR infections. There was a 78% increase in carbapenem-resistant Acinetobacter baumannii health care–associated infections, a 35% increase in carbapenem-resistant Enterobacterales, and 32% increases in both multidrug-resistant Pseudomonas aeruginosa and extended-spectrum beta-lactamase–producing Enterobacterales. Aside from gram-negative bacteria, methicillin-resistant Staphylococcus aureus rose 13%, and Candida auris rose 60%. But owing to limited surveillance, recent sound figures are lacking.

Ms. Bulens and Dr. Price reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study from the Centers for Disease Control and Prevention found that a surprising proportion of cases of carbapenem-resistant Enterobacterales (CRE) are found in isolates from patients in the community (CA-CRE). They had previously been thought to be health care–associated infections (HCA-CRE).

Traditionally, CRE has been thought of as a nosocomial infection, acquired in a hospital or other health care facility (nursing home, long-term acute care hospital, dialysis center, etc.). This is the first population-level study to show otherwise, with fully 10% of the CRE isolates found to be community acquired.

CREs are a group of multidrug-resistant bacteria considered an urgent health threat by the CDC because they can rapidly spread between patients, especially those who are most seriously ill and vulnerable, and because they are so difficult to treat. These patients often require treatment with toxic antibiotics, such as colistin, and carry a high mortality rate – up to 50% in some studies.

Overall, 30% of CREs carry a carbapenemase – an enzyme that can make them resistant to carbapenem antibiotics. The genes for this are readily transferable between bacteria and help account for their spread in hospitals.

But in this study, published in the American Journal of Infection Control, of the 12 isolates that underwent whole-genome sequencing, 42% of the CA-CRE isolates carried the carbapenemase gene. Lead author Sandra Bulens, MPH, a health scientist in the CDC’s division of health care quality promotion, said in an interview, “The findings highlight the potential for CP-CRE to move from health care settings into the community. The fact that 5 of the 12 isolates harbored a carbapenemase gene introduces new challenges for controlling spread of CP-CRE.”

CDC researchers analyzed data from eight U.S. metropolitan areas between 2012 and 2015 as part of the CDC’s Emerging Infections Program (EIP) health care–associated infections – community interface activity, which conducts surveillance for CRE and other drug-resistant gram-negative bacteria. Cases of CA-CRE were compared with HCA-CRE, with 1499 cases in 1,194 case-patients being analyzed. Though Klebsiella pneumoniae was the most common isolate, there were some differences between metropolitan areas.

The incidence of CRE cases per 100,000 population was 2.96 (95% confidence interval, 2.81-3.11) overall and 0.29 (95% CI, 0.25-0.25) for CA-CRE. Most CA-CRE cases were in White persons (73%) and women (84%). Urine cultures were the source of 98% of all CA-CRE cases, compared with 86% of HCA-CRE cases (P < .001). Though small numbers, the numbers of patients with CA-CRE without apparent underlying medical condition (n = 51; 37%) was greater when compared with patients with HCA-CRE (n = 36; 3%; P < .001).

Asked for independent comment, Lance Price, PhD, of George Washington University and the founding director of GW’s Antibiotic Resistance Action Center, Washington, said, “what’s striking about these data is that: ‘Who is the front line, at least in the United States for CRE?’ It’s women, older women. ... At some point, we have to frame drug resistance as a women’s health issue.”

Dr. Price noted that the 10% of patients with CA-CRE acquired it in the community. “I would argue that probably none of them had any idea, because there’s this silent community epidemic,” he said. “It’s asymptomatic carriage and transmission in the community. Somebody can be this walking reservoir of these really dangerous bacteria and have no idea.”

This is an increasingly serious problem for women, Dr. Price said, because, “with a community-acquired bladder infection, you’re going to call your doctor or go to an urgent care, and they’re not going to test you. They’re going to guess what you have, and they’re going to prescribe an antibiotic, and that antibiotic is going to fail. So then your bladder infection continues, and then you wait a few more days, and you start to get flank pain and kidney infection. ... If you start getting a fever, they might admit you. They are going to start treating you immediately, and they might miss it because you’ve got this organism that’s resistant to all the best antibiotics. ... The gateway to the blood is the UTI.”

Because of such empiric treatment and increasing resistance, the risk for treatment failure is quite high, especially for older women. Ms. Bulens, however, said that, “[although] 10% of CRE were in persons without health care risk factors, the proportion of all UTIs in this population that are CRE is going to be very, very small.”

This study involved cultures from 2012 to 2015. Before the pandemic, from 2012 to 2017, U.S. deaths from antibiotic resistance fell by 18% overall and by 30% in hospitals.

But in the first year of the COVID-19 pandemic, there was a 15% increase in infections and deaths from antibiotic-resistant (AMR), hospital-acquired bacteria. In 2020, 29,400 patients died from AMR infections. There was a 78% increase in carbapenem-resistant Acinetobacter baumannii health care–associated infections, a 35% increase in carbapenem-resistant Enterobacterales, and 32% increases in both multidrug-resistant Pseudomonas aeruginosa and extended-spectrum beta-lactamase–producing Enterobacterales. Aside from gram-negative bacteria, methicillin-resistant Staphylococcus aureus rose 13%, and Candida auris rose 60%. But owing to limited surveillance, recent sound figures are lacking.

Ms. Bulens and Dr. Price reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study from the Centers for Disease Control and Prevention found that a surprising proportion of cases of carbapenem-resistant Enterobacterales (CRE) are found in isolates from patients in the community (CA-CRE). They had previously been thought to be health care–associated infections (HCA-CRE).

Traditionally, CRE has been thought of as a nosocomial infection, acquired in a hospital or other health care facility (nursing home, long-term acute care hospital, dialysis center, etc.). This is the first population-level study to show otherwise, with fully 10% of the CRE isolates found to be community acquired.

CREs are a group of multidrug-resistant bacteria considered an urgent health threat by the CDC because they can rapidly spread between patients, especially those who are most seriously ill and vulnerable, and because they are so difficult to treat. These patients often require treatment with toxic antibiotics, such as colistin, and carry a high mortality rate – up to 50% in some studies.

Overall, 30% of CREs carry a carbapenemase – an enzyme that can make them resistant to carbapenem antibiotics. The genes for this are readily transferable between bacteria and help account for their spread in hospitals.

But in this study, published in the American Journal of Infection Control, of the 12 isolates that underwent whole-genome sequencing, 42% of the CA-CRE isolates carried the carbapenemase gene. Lead author Sandra Bulens, MPH, a health scientist in the CDC’s division of health care quality promotion, said in an interview, “The findings highlight the potential for CP-CRE to move from health care settings into the community. The fact that 5 of the 12 isolates harbored a carbapenemase gene introduces new challenges for controlling spread of CP-CRE.”

CDC researchers analyzed data from eight U.S. metropolitan areas between 2012 and 2015 as part of the CDC’s Emerging Infections Program (EIP) health care–associated infections – community interface activity, which conducts surveillance for CRE and other drug-resistant gram-negative bacteria. Cases of CA-CRE were compared with HCA-CRE, with 1499 cases in 1,194 case-patients being analyzed. Though Klebsiella pneumoniae was the most common isolate, there were some differences between metropolitan areas.

The incidence of CRE cases per 100,000 population was 2.96 (95% confidence interval, 2.81-3.11) overall and 0.29 (95% CI, 0.25-0.25) for CA-CRE. Most CA-CRE cases were in White persons (73%) and women (84%). Urine cultures were the source of 98% of all CA-CRE cases, compared with 86% of HCA-CRE cases (P < .001). Though small numbers, the numbers of patients with CA-CRE without apparent underlying medical condition (n = 51; 37%) was greater when compared with patients with HCA-CRE (n = 36; 3%; P < .001).

Asked for independent comment, Lance Price, PhD, of George Washington University and the founding director of GW’s Antibiotic Resistance Action Center, Washington, said, “what’s striking about these data is that: ‘Who is the front line, at least in the United States for CRE?’ It’s women, older women. ... At some point, we have to frame drug resistance as a women’s health issue.”

Dr. Price noted that the 10% of patients with CA-CRE acquired it in the community. “I would argue that probably none of them had any idea, because there’s this silent community epidemic,” he said. “It’s asymptomatic carriage and transmission in the community. Somebody can be this walking reservoir of these really dangerous bacteria and have no idea.”

This is an increasingly serious problem for women, Dr. Price said, because, “with a community-acquired bladder infection, you’re going to call your doctor or go to an urgent care, and they’re not going to test you. They’re going to guess what you have, and they’re going to prescribe an antibiotic, and that antibiotic is going to fail. So then your bladder infection continues, and then you wait a few more days, and you start to get flank pain and kidney infection. ... If you start getting a fever, they might admit you. They are going to start treating you immediately, and they might miss it because you’ve got this organism that’s resistant to all the best antibiotics. ... The gateway to the blood is the UTI.”

Because of such empiric treatment and increasing resistance, the risk for treatment failure is quite high, especially for older women. Ms. Bulens, however, said that, “[although] 10% of CRE were in persons without health care risk factors, the proportion of all UTIs in this population that are CRE is going to be very, very small.”

This study involved cultures from 2012 to 2015. Before the pandemic, from 2012 to 2017, U.S. deaths from antibiotic resistance fell by 18% overall and by 30% in hospitals.

But in the first year of the COVID-19 pandemic, there was a 15% increase in infections and deaths from antibiotic-resistant (AMR), hospital-acquired bacteria. In 2020, 29,400 patients died from AMR infections. There was a 78% increase in carbapenem-resistant Acinetobacter baumannii health care–associated infections, a 35% increase in carbapenem-resistant Enterobacterales, and 32% increases in both multidrug-resistant Pseudomonas aeruginosa and extended-spectrum beta-lactamase–producing Enterobacterales. Aside from gram-negative bacteria, methicillin-resistant Staphylococcus aureus rose 13%, and Candida auris rose 60%. But owing to limited surveillance, recent sound figures are lacking.

Ms. Bulens and Dr. Price reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Human papillomavirus (HPV) vaccine given around the time women have surgery for precancerous cervical lesions might lead to a reduction in the risk of lesions returning, as well as other HPV-related diseases, but the effects of this remain unclear.

The authors of the new study, published in The BMJ, explained that women who have been treated for high-grade cervical intra-epithelial neoplasia (CIN) have a “lifelong residual high risk of cervical cancer and other malignancies related to HPV infection,” and some research suggests that giving a preventive HPV vaccine alongside treatment for CIN might help to “reduce the risk in these women.”

HPV vaccination is highly effective at preventing the development of precancerous cervical lesions, CIN, and in the U.K., HPV vaccination is offered to girls and boys around the age of 12 or 13.

Eluned Hughes, head of information and engagement at Jo’s Cervical Cancer Trust, said: “Recent evidence has found that cases of cervical cancer have fallen 87% since the introduction of the HPV vaccine program in U.K. schools in 2008.”

“However, women over the age of 27, for whom the vaccine was not available, remain at increased risk of cervical cancer,” she highlighted.
 

Significant risk of bias and scarcity of data

In the study, researchers set out to explore the efficacy of HPV vaccination on the risk of HPV infection and recurrent diseases related to HPV infection in individuals undergoing local surgical treatment of preinvasive genital disease.

The systematic review and meta-analysis, led by researchers at Imperial College London, screened data from PubMed (Medline), Scopus, Cochrane, Web of Science, and ClinicalTrials.gov from inception to March 31, 2021.

The researchers analyzed the results of 18 studies – two randomized controlled trials (RCTs), 12 observational studies, and four post-hoc analyses of RCTs.

The authors said that the two RCTs were classified as low risk of bias, while in the observational studies and post-hoc analyses, risk of bias was moderate for seven, serious for seven, and critical for two. Average length of follow-up was 36 months.

There was a reduction of 57% in the risk of recurrence of high-grade pre-invasive disease (CIN2+) in individuals who were vaccinated, compared with those who were not vaccinated. “The effect estimate was “even more pronounced” – a relative 74% reduction – when the risk of recurrence of CIN2+ was assessed for disease related to the two high-risk HPV types – HPV16 and HPV18,” explained the authors.

However, the researchers noted that these effects are unclear because of the “scarcity of data” and the “moderate to high overall risk of bias” of the available studies.
 

Quality of evidence inconclusive – more trials needed

With regards to CIN3, the risk of recurrence of was also reduced in patients who were vaccinated, but there was a high level of uncertainty about the quality of this evidence, cautioned the authors.

Evidence was also lacking on the benefit of HPV vaccination for recurrence of vulvar, vaginal, and anal lesions, as well as genital warts.

Analysis of the post-hoc studies from randomized controlled trial data with historic vaccination at randomization before the development of the disease reported inconsistent results, the authors said.

Several study limitations were acknowledged by the authors, including that most of the studies were observational, of low to moderate quality, and with relatively short follow-up times, which they pointed out prevented assessment of long-term effects. In addition, the average age of participants was not provided in most studies, and factors such as smoking – associated with a higher risk of recurrence – were not controlled for in many studies.

“HPV vaccination might reduce the risk of recurrence of CIN, in particular when related to HPV16 or HPV18, in women treated with local excision,” they concluded. However, they cautioned that “quality of evidence indicated that the data were inconclusive.”

“Large, appropriately powered, randomized controlled trials are required to establish the effectiveness of adjuvant HPV vaccination at the time of local surgical treatment of CIN,” they recommended.

“Given that the incidence of recurrence of high-grade disease is low in quality assured national screening programs, such as in the United Kingdom, absolute risks and a cost effectiveness analysis would be important in determining the implementation strategy of HPV vaccination after treatment,” the authors said.

Ms. Hughes said that the charity was pleased to see emerging research into the value of using the HPV vaccine to prevent the recurrence of cervical cell changes. She said that the charity looks forward to seeing “further large-scale studies into the effectiveness of this method.”

In the meantime, the charity encourages all women and other people with a cervix to attend their cervical screening and for young people to have the HPV vaccination when invited, as “these are the best tools we currently have to prevent cervical cancer,” she said.

A version of this article first appeared on Medscape UK.

Human papillomavirus (HPV) vaccine given around the time women have surgery for precancerous cervical lesions might lead to a reduction in the risk of lesions returning, as well as other HPV-related diseases, but the effects of this remain unclear.

The authors of the new study, published in The BMJ, explained that women who have been treated for high-grade cervical intra-epithelial neoplasia (CIN) have a “lifelong residual high risk of cervical cancer and other malignancies related to HPV infection,” and some research suggests that giving a preventive HPV vaccine alongside treatment for CIN might help to “reduce the risk in these women.”

HPV vaccination is highly effective at preventing the development of precancerous cervical lesions, CIN, and in the U.K., HPV vaccination is offered to girls and boys around the age of 12 or 13.

Eluned Hughes, head of information and engagement at Jo’s Cervical Cancer Trust, said: “Recent evidence has found that cases of cervical cancer have fallen 87% since the introduction of the HPV vaccine program in U.K. schools in 2008.”

“However, women over the age of 27, for whom the vaccine was not available, remain at increased risk of cervical cancer,” she highlighted.
 

Significant risk of bias and scarcity of data

In the study, researchers set out to explore the efficacy of HPV vaccination on the risk of HPV infection and recurrent diseases related to HPV infection in individuals undergoing local surgical treatment of preinvasive genital disease.

The systematic review and meta-analysis, led by researchers at Imperial College London, screened data from PubMed (Medline), Scopus, Cochrane, Web of Science, and ClinicalTrials.gov from inception to March 31, 2021.

The researchers analyzed the results of 18 studies – two randomized controlled trials (RCTs), 12 observational studies, and four post-hoc analyses of RCTs.

The authors said that the two RCTs were classified as low risk of bias, while in the observational studies and post-hoc analyses, risk of bias was moderate for seven, serious for seven, and critical for two. Average length of follow-up was 36 months.

There was a reduction of 57% in the risk of recurrence of high-grade pre-invasive disease (CIN2+) in individuals who were vaccinated, compared with those who were not vaccinated. “The effect estimate was “even more pronounced” – a relative 74% reduction – when the risk of recurrence of CIN2+ was assessed for disease related to the two high-risk HPV types – HPV16 and HPV18,” explained the authors.

However, the researchers noted that these effects are unclear because of the “scarcity of data” and the “moderate to high overall risk of bias” of the available studies.
 

Quality of evidence inconclusive – more trials needed

With regards to CIN3, the risk of recurrence of was also reduced in patients who were vaccinated, but there was a high level of uncertainty about the quality of this evidence, cautioned the authors.

Evidence was also lacking on the benefit of HPV vaccination for recurrence of vulvar, vaginal, and anal lesions, as well as genital warts.

Analysis of the post-hoc studies from randomized controlled trial data with historic vaccination at randomization before the development of the disease reported inconsistent results, the authors said.

Several study limitations were acknowledged by the authors, including that most of the studies were observational, of low to moderate quality, and with relatively short follow-up times, which they pointed out prevented assessment of long-term effects. In addition, the average age of participants was not provided in most studies, and factors such as smoking – associated with a higher risk of recurrence – were not controlled for in many studies.

“HPV vaccination might reduce the risk of recurrence of CIN, in particular when related to HPV16 or HPV18, in women treated with local excision,” they concluded. However, they cautioned that “quality of evidence indicated that the data were inconclusive.”

“Large, appropriately powered, randomized controlled trials are required to establish the effectiveness of adjuvant HPV vaccination at the time of local surgical treatment of CIN,” they recommended.

“Given that the incidence of recurrence of high-grade disease is low in quality assured national screening programs, such as in the United Kingdom, absolute risks and a cost effectiveness analysis would be important in determining the implementation strategy of HPV vaccination after treatment,” the authors said.

Ms. Hughes said that the charity was pleased to see emerging research into the value of using the HPV vaccine to prevent the recurrence of cervical cell changes. She said that the charity looks forward to seeing “further large-scale studies into the effectiveness of this method.”

In the meantime, the charity encourages all women and other people with a cervix to attend their cervical screening and for young people to have the HPV vaccination when invited, as “these are the best tools we currently have to prevent cervical cancer,” she said.

A version of this article first appeared on Medscape UK.

Human papillomavirus (HPV) vaccine given around the time women have surgery for precancerous cervical lesions might lead to a reduction in the risk of lesions returning, as well as other HPV-related diseases, but the effects of this remain unclear.

The authors of the new study, published in The BMJ, explained that women who have been treated for high-grade cervical intra-epithelial neoplasia (CIN) have a “lifelong residual high risk of cervical cancer and other malignancies related to HPV infection,” and some research suggests that giving a preventive HPV vaccine alongside treatment for CIN might help to “reduce the risk in these women.”

HPV vaccination is highly effective at preventing the development of precancerous cervical lesions, CIN, and in the U.K., HPV vaccination is offered to girls and boys around the age of 12 or 13.

Eluned Hughes, head of information and engagement at Jo’s Cervical Cancer Trust, said: “Recent evidence has found that cases of cervical cancer have fallen 87% since the introduction of the HPV vaccine program in U.K. schools in 2008.”

“However, women over the age of 27, for whom the vaccine was not available, remain at increased risk of cervical cancer,” she highlighted.
 

Significant risk of bias and scarcity of data

In the study, researchers set out to explore the efficacy of HPV vaccination on the risk of HPV infection and recurrent diseases related to HPV infection in individuals undergoing local surgical treatment of preinvasive genital disease.

The systematic review and meta-analysis, led by researchers at Imperial College London, screened data from PubMed (Medline), Scopus, Cochrane, Web of Science, and ClinicalTrials.gov from inception to March 31, 2021.

The researchers analyzed the results of 18 studies – two randomized controlled trials (RCTs), 12 observational studies, and four post-hoc analyses of RCTs.

The authors said that the two RCTs were classified as low risk of bias, while in the observational studies and post-hoc analyses, risk of bias was moderate for seven, serious for seven, and critical for two. Average length of follow-up was 36 months.

There was a reduction of 57% in the risk of recurrence of high-grade pre-invasive disease (CIN2+) in individuals who were vaccinated, compared with those who were not vaccinated. “The effect estimate was “even more pronounced” – a relative 74% reduction – when the risk of recurrence of CIN2+ was assessed for disease related to the two high-risk HPV types – HPV16 and HPV18,” explained the authors.

However, the researchers noted that these effects are unclear because of the “scarcity of data” and the “moderate to high overall risk of bias” of the available studies.
 

Quality of evidence inconclusive – more trials needed

With regards to CIN3, the risk of recurrence of was also reduced in patients who were vaccinated, but there was a high level of uncertainty about the quality of this evidence, cautioned the authors.

Evidence was also lacking on the benefit of HPV vaccination for recurrence of vulvar, vaginal, and anal lesions, as well as genital warts.

Analysis of the post-hoc studies from randomized controlled trial data with historic vaccination at randomization before the development of the disease reported inconsistent results, the authors said.

Several study limitations were acknowledged by the authors, including that most of the studies were observational, of low to moderate quality, and with relatively short follow-up times, which they pointed out prevented assessment of long-term effects. In addition, the average age of participants was not provided in most studies, and factors such as smoking – associated with a higher risk of recurrence – were not controlled for in many studies.

“HPV vaccination might reduce the risk of recurrence of CIN, in particular when related to HPV16 or HPV18, in women treated with local excision,” they concluded. However, they cautioned that “quality of evidence indicated that the data were inconclusive.”

“Large, appropriately powered, randomized controlled trials are required to establish the effectiveness of adjuvant HPV vaccination at the time of local surgical treatment of CIN,” they recommended.

“Given that the incidence of recurrence of high-grade disease is low in quality assured national screening programs, such as in the United Kingdom, absolute risks and a cost effectiveness analysis would be important in determining the implementation strategy of HPV vaccination after treatment,” the authors said.

Ms. Hughes said that the charity was pleased to see emerging research into the value of using the HPV vaccine to prevent the recurrence of cervical cell changes. She said that the charity looks forward to seeing “further large-scale studies into the effectiveness of this method.”

In the meantime, the charity encourages all women and other people with a cervix to attend their cervical screening and for young people to have the HPV vaccination when invited, as “these are the best tools we currently have to prevent cervical cancer,” she said.

A version of this article first appeared on Medscape UK.

In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.

Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.

That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .

Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.

Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.

“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.

But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.

To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.

Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
 

Outliers

So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.

According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.

In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.

At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.  

“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.

While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
 

A preferred vaccine and antiviral in pregnancy

One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.

Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.

Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.

ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.

The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
 

Current outbreak ‘very different,’ but lessons apply

In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.

“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.

But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.

“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.

In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
 

Addition to the differential diagnosis

A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.

“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.

Jamieson echoed the call for increased vigilance.

“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”

Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.

A version of this article first appeared on Medscape.com.

In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.

Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.

That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .

Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.

Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.

“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.

But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.

To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.

Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
 

Outliers

So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.

According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.

In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.

At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.  

“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.

While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
 

A preferred vaccine and antiviral in pregnancy

One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.

Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.

Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.

ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.

The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
 

Current outbreak ‘very different,’ but lessons apply

In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.

“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.

But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.

“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.

In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
 

Addition to the differential diagnosis

A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.

“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.

Jamieson echoed the call for increased vigilance.

“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”

Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.

A version of this article first appeared on Medscape.com.

In creating a guide about monkeypox for ob.gyns., Denise J. Jamieson, MD, MPH, turned to research she relied on during another outbreak of the disease nearly 20 years ago.

Dr. Jamieson, the James Robert McCord Professor and chair of the department of gynecology and obstetrics at Emory Healthcare, Atlanta, had been working for the Centers for Disease Control and Prevention in 2003 when doctors diagnosed monkeypox in several states.

That year, the virus was mainly transmitted by contact with pet prairie dogs, including in childcare and school settings. Of the approximately 70 suspected and confirmed cases, 55% occurred in female patients, according to one study .

Dr. Jamieson, an obstetrician with a focus on emerging infectious diseases, and colleagues at the agency published a commentary in Obstetrics & Gynecology highlighting the need for physicians to stay up to date with relevant information about the virus.

Fast forward to 2022: Dr. Jamieson – again with coauthors from the CDC – is delivering a similar message in the same journal about the need for clinicians to be prepared for this virus.

“Most ob.gyns. have never seen a case of monkeypox virus infection and may not be aware of testing, treatment, or pre-exposure or postexposure vaccine options,” she and her coauthors wrote in a primer published online.

But if a woman were to contract the virus, her ob.gyn. might well be the first clinician she called. “We are often the first people, the first physicians to see and evaluate women with various symptoms,” Dr. Jamieson said.

To promptly diagnose, treat, and prevent further spread of monkeypox, ob.gyns. need up-to-date information, Dr. Jamieson and colleagues said.

Based on data from related viruses like smallpox, monkeypox may be more severe in pregnant women and entail risk for adverse pregnancy outcomes, Dr. Jamieson said.
 

Outliers

So far this year, monkeypox has predominantly spread among men who have sex with men. Cases have occurred in women, however, some of whom have required hospitalization.

According to the CDC, as of July 25, 1,373 cases of monkeypox in the United States were in men and 13 in women. The total confirmed case count exceeded 5,800 as of Aug. 1. The agency recently announced that it planned to make the disease a reportable condition.

In the United Kingdom, which has been hit hard by the outbreak, researchers are keeping a close eye on the number of cases in women to assess how the disease is spreading.

At least one case of monkeypox in the United States has occurred in a pregnant woman who delivered. The mother and baby, who received immune globulin as a preventive measure, are doing well, according to health officials.  

“We know that infection can occur through placental transfer. In the case that we are aware of presently, it does not appear that the virus was transmitted,” said John T. Brooks, MD, the CDC’s chief medical officer in the division of HIV prevention, on a July 23 call with clinicians.

While monkeypox can be transmitted in utero and during sexual activity, it also can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC.
 

A preferred vaccine and antiviral in pregnancy

One monkeypox vaccine, Jynneos, is preferred for use during pregnancy, while another, ACAM2000, is contraindicated, the CDC advises.

Jynneos can be offered to people who are pregnant or breastfeeding who are eligible for vaccination based on confirmed or likely contact with cases, ideally within 4 days of exposure. People at high risk for exposure, such as laboratory workers, may receive the vaccine in advance.

Developmental toxicity studies in animals showed no evidence of harm with the Jynneos vaccine, Dr. Jamieson said.

ACAM2000, however, can cause fetal vaccinia and should not be used in people who are pregnant or breastfeeding, according to the CDC.

The Society for Maternal-Fetal Medicine notes that, if treatment for monkeypox is warranted, tecovirimat should be considered the first-line antiviral for pregnant, recently pregnant, and breastfeeding people, in line with CDC guidance.
 

Current outbreak ‘very different,’ but lessons apply

In 2003, some women exposed to monkeypox through contact with infected prairie dogs were pregnant – which is how Dr. Jamieson came to be involved in responding to the outbreak and studying the effects of the virus in pregnancy.

“When this resurfaced this year, of course it caught my attention,” Dr. Jamieson said. The extensive person-to-person transmission and far greater number of cases today make the current outbreak “very different” from the prior one, she said.

But key principles in managing the disease and understanding its potential risks in pregnancy – despite relatively limited information – remain the same.

“Whenever you are looking at an infectious disease, you want to think about, are pregnant persons more susceptible or more likely to have severe disease,” Dr. Jamieson said. Smallpox, a similar orthopoxvirus, “is more severe during pregnancy with a higher case fatality rate,” which is one reason for concern with monkeypox in this population.

In terms of pregnancy outcomes, researchers have data from only a handful of confirmed cases of monkeypox, which makes it difficult to draw conclusions, Dr. Jamieson said. A review of five cases from outside the United States in prior years found that three resulted in loss of the pregnancy. One resulted in preterm delivery of an infant who subsequently died. One child was apparently healthy and born at term.
 

Addition to the differential diagnosis

A separate team of researchers has proposed a clinical management algorithm for pregnant women with suspected exposure to monkeypox.

“Clinicians must maintain a high index of suspicion for monkeypox virus in any pregnant woman presenting with lymphadenopathy and vesiculopustular rash – including rash localized to the genital or perianal region – even if there are no apparent epidemiological links,” Pradip Dashraath, MBBS, National University Hospital, Singapore, and coauthors wrote in The Lancet.

Jamieson echoed the call for increased vigilance.

“As ob.gyns., people may present to us with genital lesions concerning for sexually transmitted infection. And it is important to include monkeypox in our differential,” Dr. Jamieson said. “We are trying to get the word out that it needs to be part of what you think about when you see a patient with genital ulcers.”

Health care professionals have acquired monkeypox through contact with patients or fomites, so clinicians should be sure to use appropriate precautions when evaluating patients who might have monkeypox, Dr. Jamieson added. Appropriate protective measures include wearing a gown, gloves, eye protection, and an N95.

A version of this article first appeared on Medscape.com.

A new study sheds light on some of the risk factors for the development of psychosis, including the potentially causative role of sexual assault.

Investigators conducted an exposome-wide association analysis on more than 155,000 individuals. Of more than 140 correlates of psychotic experiences that they identified, they narrowed it down to 36 variables, which they further explored using Mendelian randomization analysis.

The analysis found that having been the victim of a sexual assault might be a potential causal risk factor for psychotic experiences. On the other hand, having experienced a physical violent crime, cannabis use, and prolonged worry after embarrassment showed a pleiotropic association and appeared to be an aftereffect of psychotic experience.

“From a public health perspective, we need more investment in comprehensive strategies to prevent traumatic experiences at the population level to decrease the burden of psychosis,” senior author Sinan Gülöksüz, MD, PhD, associate professor in the department of psychiatry and neuropsychiatry, Maastricht University Medical Center, the Netherlands, said in an interview.

“From a clinical perspective, clinicians should be aware of the harmful influence of traumatic experiences on mental health and address this through interventions such as trauma-informed care,” he said.

The study was published online in JAMA Psychiatry.

‘Disentangling’ cause and effect

“Previous research has shown associations between psychosis and a few environmental factors, such as substance use, urbanicity, pregnancy complications, and traumatic experiences, but research has so far investigated only a few specific environmental factors by singling them out in individual studies,” Dr. Gülöksüz said.

“Yet, environment is a much more complex and interactive network that includes many factors shaping our health – where we live, what we eat, our lifestyle preferences and habits such as exercise and smoking, and our social surrounding,” he continued. “Rarely has it been possible to understand whether these environmental factors have causal roles in developing psychosis.”

To investigate the question, the researchers turned to the UK Biobank, one of the largest population-based datasets in the world. The current study focused on individuals with completed data on mental questionnaires that assessed psychotic experiences (n = 155,247; mean [SD] age, 55.94 [7.74] years; 57% female).

They began by conducting an exposome-wide association study, using logistic regression analyses with psychotic experiences as the outcome and adjusting all analyses for age and sex.

“Initially, we identified many associations between environmental factors and psychotic experiences in this large cohort,” Dr. Gülöksüz reported.

In the final multivariable model, variables associated with psychotic experiences were further analyzed using “genetically informed approaches to probe potential associations.”

The researchers utilized Mendelian randomization (MR) methodology “to disentangle cause and effect in this observational study,” Dr. Gülöksüz said. “This method reduces confounding and reverse causation in observational studies by using genetic variants that have been passed on from generation to generation randomly as instruments.”

MR analysis “has allowed us to assess whether these associations reflect potentially causal influences of environmental factors on psychotic experiences,” he added.
 

Well-studied and unexplored risk factors

The researchers identified 162 variables associated with psychotic experiences in the discovery dataset and were able to replicate 148. When these 148 variables were subjected to multivariable analyses, 36 were found to be statistically significantly associated with psychotic experiences. Of these variables, 28 had “significant genetic overlap” with psychotic experiences.

When the researchers conducted one-sample MR analyses, they found forward associations with three variables and reverse associations with three variables.

Forward associations were found with ever having experienced sexual assault (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.14-1.52; P = 2.67), and forward associations (with pleiotropy) were found with ever having experienced a physically violent crime and risk-taking behavior (OR, 1.25, 95% CI, 1.11-1.41; P = 3.28 and OR, 1.21, 95% CI, 1.08-1.35; P = 1.34, respectively).

“The allele scores for these 3 variables explained 0.03% to 0.23% variance of the corresponding variable” and the F statistics “ranged from 21.53 to 181.84, indicating that the results did not suffer from a weak-instrument bias,” the authors reported.

The researchers calculated an instrument based on increasing psychotic experiences risk allele scores and found that these scores explained 0.14% variance of psychotic experiences (F statistic, 19.26).

Using that calculation, they found a reverse association with having experienced a physically violent crime (OR, 1.08; 95% CI, 1.04-1.13; P = 3.92 × 10-4), cannabis use (OR, 1.11; 95% CI, 1.06-1.15; P = 2.64 × 10-6), and worrying too long after embarrassment (OR, 1.06; 95% CI, 1.03-1.10; P = 3.96 × 10-4). They then validated these associations.

The presence of all five correlates was associated with tenfold increased odds of psychotic experiences (OR, 10.63; 95% CI, 8.27-13.65, P = 1.2 × 10-114).

“Associations with psychotic experiences were found with both well-studied and unexplored multiple correlated variables,” the authors stated.
 

Era of ‘big data’

In a comment, Chirag Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, who was not involved with the study, said he thought the study was “a nice example of a data-driven and comprehensive study of the environment coupled with attempts to triangulate evidence from genetics, made possible by biobank data.

“To guide public health policies and implementation of prevention strategies for psychosis, we need more systematic analyses and triangulate evidence with genetically informed methods to identify potentially modifiable risk factors in the era of ‘big data,’ ” he said.

“For instance, traumatic experiences contribute to poor mental and physical health, including psychosis,” Dr. Gülöksüz added.

The Kootstra Talent Fellowship, the Ophelia Research Project, and the Vidi Award from the Netherlands Scientific Organization provided funding to individual investigators. Dr. Gülöksüz and coauthors declared no relevant financial conflicts. Dr. Patel served as a reviewer on the study.

A version of this article first appeared on Medscape.com.

A new study sheds light on some of the risk factors for the development of psychosis, including the potentially causative role of sexual assault.

Investigators conducted an exposome-wide association analysis on more than 155,000 individuals. Of more than 140 correlates of psychotic experiences that they identified, they narrowed it down to 36 variables, which they further explored using Mendelian randomization analysis.

The analysis found that having been the victim of a sexual assault might be a potential causal risk factor for psychotic experiences. On the other hand, having experienced a physical violent crime, cannabis use, and prolonged worry after embarrassment showed a pleiotropic association and appeared to be an aftereffect of psychotic experience.

“From a public health perspective, we need more investment in comprehensive strategies to prevent traumatic experiences at the population level to decrease the burden of psychosis,” senior author Sinan Gülöksüz, MD, PhD, associate professor in the department of psychiatry and neuropsychiatry, Maastricht University Medical Center, the Netherlands, said in an interview.

“From a clinical perspective, clinicians should be aware of the harmful influence of traumatic experiences on mental health and address this through interventions such as trauma-informed care,” he said.

The study was published online in JAMA Psychiatry.

‘Disentangling’ cause and effect

“Previous research has shown associations between psychosis and a few environmental factors, such as substance use, urbanicity, pregnancy complications, and traumatic experiences, but research has so far investigated only a few specific environmental factors by singling them out in individual studies,” Dr. Gülöksüz said.

“Yet, environment is a much more complex and interactive network that includes many factors shaping our health – where we live, what we eat, our lifestyle preferences and habits such as exercise and smoking, and our social surrounding,” he continued. “Rarely has it been possible to understand whether these environmental factors have causal roles in developing psychosis.”

To investigate the question, the researchers turned to the UK Biobank, one of the largest population-based datasets in the world. The current study focused on individuals with completed data on mental questionnaires that assessed psychotic experiences (n = 155,247; mean [SD] age, 55.94 [7.74] years; 57% female).

They began by conducting an exposome-wide association study, using logistic regression analyses with psychotic experiences as the outcome and adjusting all analyses for age and sex.

“Initially, we identified many associations between environmental factors and psychotic experiences in this large cohort,” Dr. Gülöksüz reported.

In the final multivariable model, variables associated with psychotic experiences were further analyzed using “genetically informed approaches to probe potential associations.”

The researchers utilized Mendelian randomization (MR) methodology “to disentangle cause and effect in this observational study,” Dr. Gülöksüz said. “This method reduces confounding and reverse causation in observational studies by using genetic variants that have been passed on from generation to generation randomly as instruments.”

MR analysis “has allowed us to assess whether these associations reflect potentially causal influences of environmental factors on psychotic experiences,” he added.
 

Well-studied and unexplored risk factors

The researchers identified 162 variables associated with psychotic experiences in the discovery dataset and were able to replicate 148. When these 148 variables were subjected to multivariable analyses, 36 were found to be statistically significantly associated with psychotic experiences. Of these variables, 28 had “significant genetic overlap” with psychotic experiences.

When the researchers conducted one-sample MR analyses, they found forward associations with three variables and reverse associations with three variables.

Forward associations were found with ever having experienced sexual assault (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.14-1.52; P = 2.67), and forward associations (with pleiotropy) were found with ever having experienced a physically violent crime and risk-taking behavior (OR, 1.25, 95% CI, 1.11-1.41; P = 3.28 and OR, 1.21, 95% CI, 1.08-1.35; P = 1.34, respectively).

“The allele scores for these 3 variables explained 0.03% to 0.23% variance of the corresponding variable” and the F statistics “ranged from 21.53 to 181.84, indicating that the results did not suffer from a weak-instrument bias,” the authors reported.

The researchers calculated an instrument based on increasing psychotic experiences risk allele scores and found that these scores explained 0.14% variance of psychotic experiences (F statistic, 19.26).

Using that calculation, they found a reverse association with having experienced a physically violent crime (OR, 1.08; 95% CI, 1.04-1.13; P = 3.92 × 10-4), cannabis use (OR, 1.11; 95% CI, 1.06-1.15; P = 2.64 × 10-6), and worrying too long after embarrassment (OR, 1.06; 95% CI, 1.03-1.10; P = 3.96 × 10-4). They then validated these associations.

The presence of all five correlates was associated with tenfold increased odds of psychotic experiences (OR, 10.63; 95% CI, 8.27-13.65, P = 1.2 × 10-114).

“Associations with psychotic experiences were found with both well-studied and unexplored multiple correlated variables,” the authors stated.
 

Era of ‘big data’

In a comment, Chirag Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, who was not involved with the study, said he thought the study was “a nice example of a data-driven and comprehensive study of the environment coupled with attempts to triangulate evidence from genetics, made possible by biobank data.

“To guide public health policies and implementation of prevention strategies for psychosis, we need more systematic analyses and triangulate evidence with genetically informed methods to identify potentially modifiable risk factors in the era of ‘big data,’ ” he said.

“For instance, traumatic experiences contribute to poor mental and physical health, including psychosis,” Dr. Gülöksüz added.

The Kootstra Talent Fellowship, the Ophelia Research Project, and the Vidi Award from the Netherlands Scientific Organization provided funding to individual investigators. Dr. Gülöksüz and coauthors declared no relevant financial conflicts. Dr. Patel served as a reviewer on the study.

A version of this article first appeared on Medscape.com.

A new study sheds light on some of the risk factors for the development of psychosis, including the potentially causative role of sexual assault.

Investigators conducted an exposome-wide association analysis on more than 155,000 individuals. Of more than 140 correlates of psychotic experiences that they identified, they narrowed it down to 36 variables, which they further explored using Mendelian randomization analysis.

The analysis found that having been the victim of a sexual assault might be a potential causal risk factor for psychotic experiences. On the other hand, having experienced a physical violent crime, cannabis use, and prolonged worry after embarrassment showed a pleiotropic association and appeared to be an aftereffect of psychotic experience.

“From a public health perspective, we need more investment in comprehensive strategies to prevent traumatic experiences at the population level to decrease the burden of psychosis,” senior author Sinan Gülöksüz, MD, PhD, associate professor in the department of psychiatry and neuropsychiatry, Maastricht University Medical Center, the Netherlands, said in an interview.

“From a clinical perspective, clinicians should be aware of the harmful influence of traumatic experiences on mental health and address this through interventions such as trauma-informed care,” he said.

The study was published online in JAMA Psychiatry.

‘Disentangling’ cause and effect

“Previous research has shown associations between psychosis and a few environmental factors, such as substance use, urbanicity, pregnancy complications, and traumatic experiences, but research has so far investigated only a few specific environmental factors by singling them out in individual studies,” Dr. Gülöksüz said.

“Yet, environment is a much more complex and interactive network that includes many factors shaping our health – where we live, what we eat, our lifestyle preferences and habits such as exercise and smoking, and our social surrounding,” he continued. “Rarely has it been possible to understand whether these environmental factors have causal roles in developing psychosis.”

To investigate the question, the researchers turned to the UK Biobank, one of the largest population-based datasets in the world. The current study focused on individuals with completed data on mental questionnaires that assessed psychotic experiences (n = 155,247; mean [SD] age, 55.94 [7.74] years; 57% female).

They began by conducting an exposome-wide association study, using logistic regression analyses with psychotic experiences as the outcome and adjusting all analyses for age and sex.

“Initially, we identified many associations between environmental factors and psychotic experiences in this large cohort,” Dr. Gülöksüz reported.

In the final multivariable model, variables associated with psychotic experiences were further analyzed using “genetically informed approaches to probe potential associations.”

The researchers utilized Mendelian randomization (MR) methodology “to disentangle cause and effect in this observational study,” Dr. Gülöksüz said. “This method reduces confounding and reverse causation in observational studies by using genetic variants that have been passed on from generation to generation randomly as instruments.”

MR analysis “has allowed us to assess whether these associations reflect potentially causal influences of environmental factors on psychotic experiences,” he added.
 

Well-studied and unexplored risk factors

The researchers identified 162 variables associated with psychotic experiences in the discovery dataset and were able to replicate 148. When these 148 variables were subjected to multivariable analyses, 36 were found to be statistically significantly associated with psychotic experiences. Of these variables, 28 had “significant genetic overlap” with psychotic experiences.

When the researchers conducted one-sample MR analyses, they found forward associations with three variables and reverse associations with three variables.

Forward associations were found with ever having experienced sexual assault (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.14-1.52; P = 2.67), and forward associations (with pleiotropy) were found with ever having experienced a physically violent crime and risk-taking behavior (OR, 1.25, 95% CI, 1.11-1.41; P = 3.28 and OR, 1.21, 95% CI, 1.08-1.35; P = 1.34, respectively).

“The allele scores for these 3 variables explained 0.03% to 0.23% variance of the corresponding variable” and the F statistics “ranged from 21.53 to 181.84, indicating that the results did not suffer from a weak-instrument bias,” the authors reported.

The researchers calculated an instrument based on increasing psychotic experiences risk allele scores and found that these scores explained 0.14% variance of psychotic experiences (F statistic, 19.26).

Using that calculation, they found a reverse association with having experienced a physically violent crime (OR, 1.08; 95% CI, 1.04-1.13; P = 3.92 × 10-4), cannabis use (OR, 1.11; 95% CI, 1.06-1.15; P = 2.64 × 10-6), and worrying too long after embarrassment (OR, 1.06; 95% CI, 1.03-1.10; P = 3.96 × 10-4). They then validated these associations.

The presence of all five correlates was associated with tenfold increased odds of psychotic experiences (OR, 10.63; 95% CI, 8.27-13.65, P = 1.2 × 10-114).

“Associations with psychotic experiences were found with both well-studied and unexplored multiple correlated variables,” the authors stated.
 

Era of ‘big data’

In a comment, Chirag Patel, PhD, associate professor of biomedical informatics at Harvard Medical School, Boston, who was not involved with the study, said he thought the study was “a nice example of a data-driven and comprehensive study of the environment coupled with attempts to triangulate evidence from genetics, made possible by biobank data.

“To guide public health policies and implementation of prevention strategies for psychosis, we need more systematic analyses and triangulate evidence with genetically informed methods to identify potentially modifiable risk factors in the era of ‘big data,’ ” he said.

“For instance, traumatic experiences contribute to poor mental and physical health, including psychosis,” Dr. Gülöksüz added.

The Kootstra Talent Fellowship, the Ophelia Research Project, and the Vidi Award from the Netherlands Scientific Organization provided funding to individual investigators. Dr. Gülöksüz and coauthors declared no relevant financial conflicts. Dr. Patel served as a reviewer on the study.

A version of this article first appeared on Medscape.com.

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”

After the US Supreme Court overturned Roe v Wade in June, Gilbert R. Cisneros Jr., Under Secretary of Defense for Personnel and Readiness, released a memo on “Ensuring Access to Essential Women’s Health Care Services for Service Members, Dependents, Beneficiaries, and Department of Defense Civilian Employees.” In the memo, Cisneros clarified the US Department of Defense (DoD) policies and emphasized, “There will be no interruption to this care.”

Covered abortions—instances where the life of the mother would be endangered if the fetus were carried to term, or when the pregnancy is the result of rape or incest—are still covered. Health care professionals will continue to follow this policy and military medical facilities leadership will implement measures to ensure continued access to care.

The implications of the Supreme Court decision are complicated, Cisneros said. “It is the Department of Justice’s longstanding position that States generally may not impose criminal or civil liability on federal employees who perform their duties in a manner authorized by federal law,” the memo continues. “We will work with the Department of Justice to ensure access to counsel for such civilian employees and Service members if needed and as appropriate.”

The decision also does not affect the DoD’s existing leave policies, which authorize active-duty service members to travel as necessary to receive abortion care. The travel may be government-funded official travel for a covered abortion, or for all other cases, may be undertaken as regular leave at the service member’s expense. DoD civilian employees may continue to use sick leave or other forms of leave to care for themselves or their family members. Sick leave may be used to cover travel to obtain any type of medical treatment.

The Court’s decision “will have significant implications,” Cisneros wrote, adding, “As Secretary Austin has made clear, nothing is more important than the health and well-being of our Service members, the civilian workforce, and DoD families, and we are committed to taking care of all our people and ensuring that the entire Force remains ready and resilient.”