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Time to take the fear out of the hormone therapy conversation
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
koakes@frontlinemedcom.com
On Twitter @karioakes
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
koakes@frontlinemedcom.com
On Twitter @karioakes
PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.
“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.
Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.
An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.
Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.
The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.
Cardiovascular risks
Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.
“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”
“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”
Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.
Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.
Breast cancer
“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.
Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.
Bioidentical HT
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.
The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.
Symptom relief
For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.
“Hormone therapy is the most effective treatment for hot flashes,” said Dr. Pinkerton, and using HT improves sleep quality and duration in women with bothersome nighttime hot flashes.
Fracture prevention
Data from the Women’s Health Initiative showed a highly significant 33% reduction in hip fractures for women using both estrogen alone and estrogen with progestogen. “That seems to get forgotten,” Dr. Pinkerton said. Though HT’s osteoporosis and fracture prevention effects stop when HT is discontinued, there’s no evidence of elevated fracture risk above baseline in women who have used HT and then stopped.
“Younger women may need higher doses to protect bone, but make sure you get adequate endometrial protection if you do that,” said Dr. Pinkerton, professor of obstetrics and gynecology at the University of Virginia.
Unapproved uses
“Hormone therapy is not recommended at any age to prevent or treat cognition or dementia,” said Dr. Pinkerton, citing a lack of data to support its use for these reasons. Observational data may show some reduction in risk of Alzheimer’s disease in women who use HT at younger ages or soon after menopause, she said.
Though HT users have a reduced risk of developing type 2 diabetes, diabetes prevention is not a Food and Drug Administration–approved indication for HT. Abdominal fat accumulation and weight gain may be reduced by HT as well, Dr. Pinkerton said.
Similarly, there are no data to support the use of HT for the treatment of clinical depression. Perimenopausal – but not postmenopausal – women may see some benefit from estrogen therapy; progestins may actually contribute to mood disturbance, she said.
Special populations
“Systemic hormone therapy is not recommended for survivors of breast cancer,” Dr. Pinkerton said. Any consideration for systemic HT in this population should include the oncologist, and only be entertained after other nonhormonal options have been tried, she said.
Women with a family history of breast or ovarian cancer, or with the BRCA mutation, do not appear to have their risk increased by the use of HT, though the ovarian cancer data are limited and observational, Dr. Pinkerton said.
The NAMS position statement also addresses the use of HT in other special populations, including survivors of other cancers and women who have primary ovarian insufficiency or early menopause, BRCA-positive women who have undergone oophorectomy, and those over age 65 years.
“The recommendation to routinely discontinue systemic hormone therapy after age 65 is not supported by data,” Dr. Pinkerton said. “I would tell you that there’s a lack of good data about prolonged duration. What I tell patients is, we really are in another data-free zone.” She recommends an individualized approach that balances benefits and risks and includes ongoing surveillance.
New message
“So what do I want us to do? I want us to change the message,” she said. Rather than advocating for HT to be used in “the lowest dose, for the shortest period of time,” she said the new message should be for women to use “appropriate hormone therapy to meet their treatment goals.”
The bottom line? After accounting for women who should avoid HT for specific contraindications, “benefits are likely to outweigh risks for symptomatic women who initiate hormone therapy when aged younger than 60 years and within 10 years of menopause,” Dr. Pinkerton said.
Dr. Pinkerton reported that she has received grant or research support from TherapeuticsMD.
koakes@frontlinemedcom.com
On Twitter @karioakes
AT NAMS 2017
Biologic approved for moderate to severe psoriasis in adolescents
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
The Food and Drug Administration approval of ustekinumab has been expanded to include adolescents aged 12 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, based on the results of a phase 3 study.
The manufacturer, Janssen Biotech, announced the expanded indication in a press release on Oct. 13.
Ustekinumab, an interleukin-12 and -23 antagonist administered subcutaneously, was first approved by the FDA in 2009 for the same indication in adults; it is also approved for adults with active psoriatic arthritis, and for adults with moderately to severely active Crohn’s disease.
Ustekinumab is marketed as Stelara.
Cryotherapy can reduce signs of CIPN
A new study suggests cryotherapy can reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Researchers found that having chemotherapy patients wear frozen gloves and socks for 90-minute periods significantly reduced the incidence of CIPN symptoms.
Hiroshi Ishiguro, MD, PhD, of International University of Health and Welfare Hospital in Tochigi, Japan, and colleagues reported these findings in the Journal of the National Cancer Institute.
The researchers prospectively evaluated the efficacy of cryotherapy for preventing CIPN. Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for 1 hour) wore frozen gloves and socks on one side of their bodies for 90 minutes, including the entire duration of drug infusion.
The researchers then compared symptoms on the treated sides with those on the untreated sides.
The primary endpoint was CIPN incidence assessed by changes in tactile sensitivity from a pretreatment baseline. The researchers also assessed subjective symptoms, as reported in the Patient Neuropathy Questionnaire, and patients' manual dexterity.
Among the 40 patients studied, 4 did not reach the cumulative dose due to the occurrence of pneumonia, severe fatigue, liver dysfunction, and macular edema. Of the 36 remaining patients, none dropped out due to cold intolerance.
The incidence of objective and subjective signs of CIPN was clinically and statistically significantly lower on the intervention side than on the control side for most measurements, which includes (among other measures):
- Hand tactile sensitivity—27.8% and 80.6%, respectively (odds ratio[OR]= 20.00, P<0.001)
- Foot tactile sensitivity—25.0% and 63.9%, respectively (OR=infinite, P<0.001)
- Hand warm sense—8.8% and 32.4%, respectively (OR=9.00, P=0.02)
- Foot warm sense—33.4% and 57.6%, respectively (OR=5.00, P=0.04)
- Hand cold sense—2.8% and 13.9%, respectively (OR=infinite, P=0.13)
- Foot cold sense—12.6% and 18.8%, respectively (OR=2.00, P=0.69)
- Severe CIPN in the hand according to the Patient Neuropathy Questionnaire—2.8% and 41.7%, respectively (OR=infinite, P<0.001)
- Severe CIPN in the foot according to the Patient Neuropathy Questionnaire—2.8% and 36.1%, respectively (OR=infinite, P<0.001).
A new study suggests cryotherapy can reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Researchers found that having chemotherapy patients wear frozen gloves and socks for 90-minute periods significantly reduced the incidence of CIPN symptoms.
Hiroshi Ishiguro, MD, PhD, of International University of Health and Welfare Hospital in Tochigi, Japan, and colleagues reported these findings in the Journal of the National Cancer Institute.
The researchers prospectively evaluated the efficacy of cryotherapy for preventing CIPN. Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for 1 hour) wore frozen gloves and socks on one side of their bodies for 90 minutes, including the entire duration of drug infusion.
The researchers then compared symptoms on the treated sides with those on the untreated sides.
The primary endpoint was CIPN incidence assessed by changes in tactile sensitivity from a pretreatment baseline. The researchers also assessed subjective symptoms, as reported in the Patient Neuropathy Questionnaire, and patients' manual dexterity.
Among the 40 patients studied, 4 did not reach the cumulative dose due to the occurrence of pneumonia, severe fatigue, liver dysfunction, and macular edema. Of the 36 remaining patients, none dropped out due to cold intolerance.
The incidence of objective and subjective signs of CIPN was clinically and statistically significantly lower on the intervention side than on the control side for most measurements, which includes (among other measures):
- Hand tactile sensitivity—27.8% and 80.6%, respectively (odds ratio[OR]= 20.00, P<0.001)
- Foot tactile sensitivity—25.0% and 63.9%, respectively (OR=infinite, P<0.001)
- Hand warm sense—8.8% and 32.4%, respectively (OR=9.00, P=0.02)
- Foot warm sense—33.4% and 57.6%, respectively (OR=5.00, P=0.04)
- Hand cold sense—2.8% and 13.9%, respectively (OR=infinite, P=0.13)
- Foot cold sense—12.6% and 18.8%, respectively (OR=2.00, P=0.69)
- Severe CIPN in the hand according to the Patient Neuropathy Questionnaire—2.8% and 41.7%, respectively (OR=infinite, P<0.001)
- Severe CIPN in the foot according to the Patient Neuropathy Questionnaire—2.8% and 36.1%, respectively (OR=infinite, P<0.001).
A new study suggests cryotherapy can reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN).
Researchers found that having chemotherapy patients wear frozen gloves and socks for 90-minute periods significantly reduced the incidence of CIPN symptoms.
Hiroshi Ishiguro, MD, PhD, of International University of Health and Welfare Hospital in Tochigi, Japan, and colleagues reported these findings in the Journal of the National Cancer Institute.
The researchers prospectively evaluated the efficacy of cryotherapy for preventing CIPN. Breast cancer patients treated weekly with paclitaxel (80 mg/m2 for 1 hour) wore frozen gloves and socks on one side of their bodies for 90 minutes, including the entire duration of drug infusion.
The researchers then compared symptoms on the treated sides with those on the untreated sides.
The primary endpoint was CIPN incidence assessed by changes in tactile sensitivity from a pretreatment baseline. The researchers also assessed subjective symptoms, as reported in the Patient Neuropathy Questionnaire, and patients' manual dexterity.
Among the 40 patients studied, 4 did not reach the cumulative dose due to the occurrence of pneumonia, severe fatigue, liver dysfunction, and macular edema. Of the 36 remaining patients, none dropped out due to cold intolerance.
The incidence of objective and subjective signs of CIPN was clinically and statistically significantly lower on the intervention side than on the control side for most measurements, which includes (among other measures):
- Hand tactile sensitivity—27.8% and 80.6%, respectively (odds ratio[OR]= 20.00, P<0.001)
- Foot tactile sensitivity—25.0% and 63.9%, respectively (OR=infinite, P<0.001)
- Hand warm sense—8.8% and 32.4%, respectively (OR=9.00, P=0.02)
- Foot warm sense—33.4% and 57.6%, respectively (OR=5.00, P=0.04)
- Hand cold sense—2.8% and 13.9%, respectively (OR=infinite, P=0.13)
- Foot cold sense—12.6% and 18.8%, respectively (OR=2.00, P=0.69)
- Severe CIPN in the hand according to the Patient Neuropathy Questionnaire—2.8% and 41.7%, respectively (OR=infinite, P<0.001)
- Severe CIPN in the foot according to the Patient Neuropathy Questionnaire—2.8% and 36.1%, respectively (OR=infinite, P<0.001).
VIDEO: AF ablation boosts survival in heart failure patients
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
The results of several studies have shown that patients with both atrial fibrillation and heart failure have about a 40% increased mortality, compared with heart failure patients without atrial fibrillation.
Five prior randomized controlled trials assessed the impact of AF ablation, compared with rate or rhythm control, in heart failure patients. But unlike CASTLE AF, all the prior studies used freedom from AF as the primary endpoint.
Enrolled patients were symptomatic from AF. Would asymptomatic patients get the same benefits? All enrolled patients had failed prior antiarrhythmic treatment or were intolerant or unwilling to take it. Does this mean the trial enrolled patients who generally were unresponsive to antiarrhythmic drugs, thereby skewing the results toward worse outcomes in control patients? Also, the 5-week run-in period used before randomization may have shifted enrollment toward patients well suited to ablation. The enrolled patients were also relatively young (averaging 64 years of age), and about 60% were New York Heart Association functional class II. A minority had longstanding AF. Were these younger and healthier patients better able to tolerate ablation? And can centers with less experience performing ablations have similar results?
The CASTLE AF results suggest that the time has come to offer AF ablation to patients with heart failure with reduced ejection fraction and AF, but we must be careful to select patients who are similar to the ones enrolled in this trial.
Carina Blomström-Lundqvist, MD, an electrophysiologist at Uppsala (Sweden) University Hospital, made these comments as designated discussant for the report. She has received research funding from Medtronic and Cardiome, and she has received honoraria from Biotronik, Bayer, Bristol-Myers Squibb, Medtronic, Merck, Pfizer, and Sanofi.
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
BARCELONA – In patients with heart failure with reduced ejection fraction who also have atrial fibrillation, catheter ablation of the arrhythmia produced significantly improved long-term survival and a significant reduction in heart failure hospitalizations, in results from a multicenter randomized trial with more than 350 patients.
During 5-year follow-up, heart failure patients who underwent an ablative procedure for their atrial fibrillation (AF) had a statistically significant 37% lower rate of the combined primary endpoint of all-cause death or hospitalization for worsening heart failure, compared with control patients managed by standard medical therapy, Nassir F. Marrouche, MD, said at the annual congress of the European Society of Cardiology. The results also showed significant reductions from ablation, compared with controls, for the individual secondary endpoints of all-cause mortality, heart failure hospitalizations, cardiovascular mortality, and cardiovascular hospitalizations, said Dr. Marrouche, a professor of medicine and electrophysiologist at the University of Utah in Salt Lake City.
“Catheter ablation of atrial fibrillation is already done in heart failure patients, but now we have added information that this treatment may not just improve AF symptoms but also lead to a significant improvement in prognosis,” said Johannes Brachmann, MD, a coinvestigator on the study and professor and chief of cardiology at Coburg (Germany) Hospital.
The CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial was investigator initiated and run at 31 centers in nine countries. The study randomized patients with paroxysmal or persistent AF and heart failure with a left ventricular ejection fraction of 35% or less. All patients also had to have failed treatment with, been intolerant of, or refused treatment with at least one antiarrhythmic drug, and they had to have been implanted with either an implantable cardioverter defibrillator or a cardiac resynchronization therapy and defibrillation device. The researchers randomized 179 patients to catheter ablation by pulmonary vein isolation, and 184 patients to either a standard rate or rhythm-control regimen plus anticoagulation to prevent ischemic stroke.
The ablation procedure also cut the average AF burden by more than half, compared with medical therapy throughout the 5-year follow-up, Dr. Marrouche reported.
The results “support the need to monitor patients with heart failure for atrial fibrillation,” Dr. Brachmann said in a video interview. This means broader use of monitoring technologies to diagnose AF in heart failure patients, such as implanted loop recorders or implanted rhythm devices.
The prevalence of atrial fibrillation in patients with heart failure with reduced ejection fraction can run 30% or higher. In patients with NYHA class IV heart failure, the AF prevalence is about 50%, Dr. Brachmann said.
CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: AF ablation was linked to a 37% 5-year reduction in mortality and heart failure hospitalization, compared with standard treatment.
Data source: CASTLE AF, a multicenter randomized trial with 363 patients.
Disclosures: CASTLE AF was funded by Biotronik. Dr. Marrouche has been a consultant to and received research funding from Biotronik and from several other companies. Dr. Brachmann has been a speaker for and has received research funding from Biotronik and from Abbott and Medtronic.
Counsel fair-skinned patients on cancer prevention, says task force
The U.S. Preventive Services Task Force has recommended that clinicians counsel fair-skinned young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet radiation to reduce their risk of skin cancer, in a draft recommendation statement that is available online.
The grade B recommendation applies to asymptomatic individuals who have fair skin, are aged 6 months to 24 years, and have no history of skin cancer; the recommendation is being issued because members of this population are at increased risk and are the subject of most of the existing research on skin cancer counseling, according to the USPSTF. The task force found a moderate net benefit when clinicians in a primary care setting offered behavioral counseling on skin cancer prevention to members of this population.
The draft recommendation is open for public comment until 8:00 p.m. Eastern Standard Time on Nov. 6, 2017.
The draft recommendation can be viewed and comments can be submitted online at the USPSTF site.
The U.S. Preventive Services Task Force has recommended that clinicians counsel fair-skinned young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet radiation to reduce their risk of skin cancer, in a draft recommendation statement that is available online.
The grade B recommendation applies to asymptomatic individuals who have fair skin, are aged 6 months to 24 years, and have no history of skin cancer; the recommendation is being issued because members of this population are at increased risk and are the subject of most of the existing research on skin cancer counseling, according to the USPSTF. The task force found a moderate net benefit when clinicians in a primary care setting offered behavioral counseling on skin cancer prevention to members of this population.
The draft recommendation is open for public comment until 8:00 p.m. Eastern Standard Time on Nov. 6, 2017.
The draft recommendation can be viewed and comments can be submitted online at the USPSTF site.
The U.S. Preventive Services Task Force has recommended that clinicians counsel fair-skinned young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet radiation to reduce their risk of skin cancer, in a draft recommendation statement that is available online.
The grade B recommendation applies to asymptomatic individuals who have fair skin, are aged 6 months to 24 years, and have no history of skin cancer; the recommendation is being issued because members of this population are at increased risk and are the subject of most of the existing research on skin cancer counseling, according to the USPSTF. The task force found a moderate net benefit when clinicians in a primary care setting offered behavioral counseling on skin cancer prevention to members of this population.
The draft recommendation is open for public comment until 8:00 p.m. Eastern Standard Time on Nov. 6, 2017.
The draft recommendation can be viewed and comments can be submitted online at the USPSTF site.
FROM USPSTF
FISH and PCR aid in diagnosis of human intestinal spirochetosis
Fluorescence in situ hybridization (FISH) combined with 16S rRNA gene amplification and sequencing allowed researchers to make a definitive diagnosis of human intestinal spirochetosis (HIS) and further identify the causative pathogens.
Pablo Rojas, PhD, of Charité Universitätsmedizin Berlin, and his colleagues evaluated 149 paraffin-embedded or native intestinal biopsies from 91 consecutive patients with histologically diagnosed HIS. The reasons for endoscopy and histological investigation included chronic diarrhea, cancer/adenoma screening, inflammatory bowel disease, and endoscopic detection of polyps or colitis. In all, 12 patients were HIV-positive.
The researchers used a FISH probe to confirm Brachyspira spp. HIS for 77 of the 91 patients. A polymerase chain reaction (PCR) analysis of part of the bacterial 16S rRNA gene confirmed the presence of Brachyspira spp. in 75 patients. The sequencing allowed the researchers to drill down on the pathogen, identifying both the B. aalborgi and B. pilosicoli species lineage among the samples.
There were 14 cases in which researchers could not confirm the diagnosis of HIS with either FISH or RNA sequencing, but they noted that these cases were likely misdiagnosed by histopathology.
“FISH at the interface of histopathology and molecular biology is a valuable diagnostic tool for the diagnosis of HIS. The bright FISH signal in most cases already allowed rapid localization of Brachyspira spp. at 400 magnification. All samples that could be tested via PCR were consistent with the FISH results, whereas 14 cases were diagnosed false positive by histopathology,” the researchers wrote. “On these grounds, we propose to include FISH for the diagnosis and follow-up observation of HIS in routine practice.”
Find the full study in Anaerobe (2017 Oct. doi: 10.1016/j.anaerobe.2017.03.012).
Fluorescence in situ hybridization (FISH) combined with 16S rRNA gene amplification and sequencing allowed researchers to make a definitive diagnosis of human intestinal spirochetosis (HIS) and further identify the causative pathogens.
Pablo Rojas, PhD, of Charité Universitätsmedizin Berlin, and his colleagues evaluated 149 paraffin-embedded or native intestinal biopsies from 91 consecutive patients with histologically diagnosed HIS. The reasons for endoscopy and histological investigation included chronic diarrhea, cancer/adenoma screening, inflammatory bowel disease, and endoscopic detection of polyps or colitis. In all, 12 patients were HIV-positive.
The researchers used a FISH probe to confirm Brachyspira spp. HIS for 77 of the 91 patients. A polymerase chain reaction (PCR) analysis of part of the bacterial 16S rRNA gene confirmed the presence of Brachyspira spp. in 75 patients. The sequencing allowed the researchers to drill down on the pathogen, identifying both the B. aalborgi and B. pilosicoli species lineage among the samples.
There were 14 cases in which researchers could not confirm the diagnosis of HIS with either FISH or RNA sequencing, but they noted that these cases were likely misdiagnosed by histopathology.
“FISH at the interface of histopathology and molecular biology is a valuable diagnostic tool for the diagnosis of HIS. The bright FISH signal in most cases already allowed rapid localization of Brachyspira spp. at 400 magnification. All samples that could be tested via PCR were consistent with the FISH results, whereas 14 cases were diagnosed false positive by histopathology,” the researchers wrote. “On these grounds, we propose to include FISH for the diagnosis and follow-up observation of HIS in routine practice.”
Find the full study in Anaerobe (2017 Oct. doi: 10.1016/j.anaerobe.2017.03.012).
Fluorescence in situ hybridization (FISH) combined with 16S rRNA gene amplification and sequencing allowed researchers to make a definitive diagnosis of human intestinal spirochetosis (HIS) and further identify the causative pathogens.
Pablo Rojas, PhD, of Charité Universitätsmedizin Berlin, and his colleagues evaluated 149 paraffin-embedded or native intestinal biopsies from 91 consecutive patients with histologically diagnosed HIS. The reasons for endoscopy and histological investigation included chronic diarrhea, cancer/adenoma screening, inflammatory bowel disease, and endoscopic detection of polyps or colitis. In all, 12 patients were HIV-positive.
The researchers used a FISH probe to confirm Brachyspira spp. HIS for 77 of the 91 patients. A polymerase chain reaction (PCR) analysis of part of the bacterial 16S rRNA gene confirmed the presence of Brachyspira spp. in 75 patients. The sequencing allowed the researchers to drill down on the pathogen, identifying both the B. aalborgi and B. pilosicoli species lineage among the samples.
There were 14 cases in which researchers could not confirm the diagnosis of HIS with either FISH or RNA sequencing, but they noted that these cases were likely misdiagnosed by histopathology.
“FISH at the interface of histopathology and molecular biology is a valuable diagnostic tool for the diagnosis of HIS. The bright FISH signal in most cases already allowed rapid localization of Brachyspira spp. at 400 magnification. All samples that could be tested via PCR were consistent with the FISH results, whereas 14 cases were diagnosed false positive by histopathology,” the researchers wrote. “On these grounds, we propose to include FISH for the diagnosis and follow-up observation of HIS in routine practice.”
Find the full study in Anaerobe (2017 Oct. doi: 10.1016/j.anaerobe.2017.03.012).
FROM ANAEROBE
Thoracic syndesmophytes common in ankylosing spondylitis
Thoracic syndesmophytes are common in ankylosing spondylitis, even in the absence of lumbar syndesmophytes, according to a study published in the Journal of Rheumatology.
Sovira Tan, PhD, and his colleagues from the National Institute of Arthritis and Musculoskeletal and Skin Diseases wrote that the current standard for radiographic assessment of ankylosing spondylitis scores only the cervical and lumbar spine because of difficulties visualizing the thoracic spine.
“Consequently, the involvement of the thoracic spine with syndesmophytes has not been widely studied,” they wrote. “If syndesmophytes differentially develop in the thoracic spine, exclusion of this large region may affect the validity of spinal fusion biomarker studies.”
In this study, 18 patients with ankylosing spondylitis who did not show complete lumbar fusion on radiographs underwent thoracolumbar CT and lumbar radiography (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.170340). The patients had ankylosing spondylitis for a mean duration of about 19 years, and 11 were treated with tumor necrosis factor inhibitors.
Researchers found syndesmophytes were common overall in intervertebral disc spaces, ranging from 56% to 89%. The rate of syndesmophytes peaked around the thoracolumbar junction, and bridging was both more evident and more extensive in the superior thoracic levels, compared with the lumbar levels.
In all the patients, thoracic syndesmophytes on the CT scan were at least as common as lumbar, and patients with extensive syndesmophytes at multiple lumbar locations typically also had the same in the thoracic region.
However, there were also patients with no, or very few, lumbar syndesmophytes on CT who still had thoracic syndesmophytes, some of which were extensive.
“Importantly, if syndesmophytes were observed on a lumbar radiograph, one could expect there to be syndesmophytes in the thoracic spine, but not the converse,” the authors wrote. “Several patients with normal lumbar radiographs had substantial thoracic syndesmophytes.”
The authors commented that because of its two-dimensional character, radiography has a relatively low sensitivity for detecting syndesmophytes, compared with CT. This could explain why patients with any syndesmophytes in the lumbar region on radiography also had them in the thoracic CT scans.
“By the time syndesmophytes are detectable on lumbar radiographs, structural damage may already have occurred in large portions of the thoracolumbar spine.”
They acknowledged that their method was a research tool and not intended for clinical practice, but also pointed out that CT technology had improved to allow more extensive spine coverage, at an equal effective dose, without compromising scan quality.
The study was supported by the National Institutes of Health. No conflicts of interest disclosures were available.
Thoracic syndesmophytes are common in ankylosing spondylitis, even in the absence of lumbar syndesmophytes, according to a study published in the Journal of Rheumatology.
Sovira Tan, PhD, and his colleagues from the National Institute of Arthritis and Musculoskeletal and Skin Diseases wrote that the current standard for radiographic assessment of ankylosing spondylitis scores only the cervical and lumbar spine because of difficulties visualizing the thoracic spine.
“Consequently, the involvement of the thoracic spine with syndesmophytes has not been widely studied,” they wrote. “If syndesmophytes differentially develop in the thoracic spine, exclusion of this large region may affect the validity of spinal fusion biomarker studies.”
In this study, 18 patients with ankylosing spondylitis who did not show complete lumbar fusion on radiographs underwent thoracolumbar CT and lumbar radiography (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.170340). The patients had ankylosing spondylitis for a mean duration of about 19 years, and 11 were treated with tumor necrosis factor inhibitors.
Researchers found syndesmophytes were common overall in intervertebral disc spaces, ranging from 56% to 89%. The rate of syndesmophytes peaked around the thoracolumbar junction, and bridging was both more evident and more extensive in the superior thoracic levels, compared with the lumbar levels.
In all the patients, thoracic syndesmophytes on the CT scan were at least as common as lumbar, and patients with extensive syndesmophytes at multiple lumbar locations typically also had the same in the thoracic region.
However, there were also patients with no, or very few, lumbar syndesmophytes on CT who still had thoracic syndesmophytes, some of which were extensive.
“Importantly, if syndesmophytes were observed on a lumbar radiograph, one could expect there to be syndesmophytes in the thoracic spine, but not the converse,” the authors wrote. “Several patients with normal lumbar radiographs had substantial thoracic syndesmophytes.”
The authors commented that because of its two-dimensional character, radiography has a relatively low sensitivity for detecting syndesmophytes, compared with CT. This could explain why patients with any syndesmophytes in the lumbar region on radiography also had them in the thoracic CT scans.
“By the time syndesmophytes are detectable on lumbar radiographs, structural damage may already have occurred in large portions of the thoracolumbar spine.”
They acknowledged that their method was a research tool and not intended for clinical practice, but also pointed out that CT technology had improved to allow more extensive spine coverage, at an equal effective dose, without compromising scan quality.
The study was supported by the National Institutes of Health. No conflicts of interest disclosures were available.
Thoracic syndesmophytes are common in ankylosing spondylitis, even in the absence of lumbar syndesmophytes, according to a study published in the Journal of Rheumatology.
Sovira Tan, PhD, and his colleagues from the National Institute of Arthritis and Musculoskeletal and Skin Diseases wrote that the current standard for radiographic assessment of ankylosing spondylitis scores only the cervical and lumbar spine because of difficulties visualizing the thoracic spine.
“Consequently, the involvement of the thoracic spine with syndesmophytes has not been widely studied,” they wrote. “If syndesmophytes differentially develop in the thoracic spine, exclusion of this large region may affect the validity of spinal fusion biomarker studies.”
In this study, 18 patients with ankylosing spondylitis who did not show complete lumbar fusion on radiographs underwent thoracolumbar CT and lumbar radiography (J Rheumatol. 2017 Oct 1. doi: 10.3899/jrheum.170340). The patients had ankylosing spondylitis for a mean duration of about 19 years, and 11 were treated with tumor necrosis factor inhibitors.
Researchers found syndesmophytes were common overall in intervertebral disc spaces, ranging from 56% to 89%. The rate of syndesmophytes peaked around the thoracolumbar junction, and bridging was both more evident and more extensive in the superior thoracic levels, compared with the lumbar levels.
In all the patients, thoracic syndesmophytes on the CT scan were at least as common as lumbar, and patients with extensive syndesmophytes at multiple lumbar locations typically also had the same in the thoracic region.
However, there were also patients with no, or very few, lumbar syndesmophytes on CT who still had thoracic syndesmophytes, some of which were extensive.
“Importantly, if syndesmophytes were observed on a lumbar radiograph, one could expect there to be syndesmophytes in the thoracic spine, but not the converse,” the authors wrote. “Several patients with normal lumbar radiographs had substantial thoracic syndesmophytes.”
The authors commented that because of its two-dimensional character, radiography has a relatively low sensitivity for detecting syndesmophytes, compared with CT. This could explain why patients with any syndesmophytes in the lumbar region on radiography also had them in the thoracic CT scans.
“By the time syndesmophytes are detectable on lumbar radiographs, structural damage may already have occurred in large portions of the thoracolumbar spine.”
They acknowledged that their method was a research tool and not intended for clinical practice, but also pointed out that CT technology had improved to allow more extensive spine coverage, at an equal effective dose, without compromising scan quality.
The study was supported by the National Institutes of Health. No conflicts of interest disclosures were available.
FROM JOURNAL OF RHEUMATOLOGY
Key clinical point:
Major finding: Within individual patients, CT-detected syndesmophytes were either more common in or equally present in thoracic intervertebral disc spaces, compared with lumbar.
Data source: CT and radiography study of 18 patients with ankylosing spondylitis.
Disclosures: The study was supported by the National Institutes of Health. No conflicts of interest disclosures were available.
Trump halts ACA cost-sharing reduction subsidy payments
“The Democrats ObamaCare [sic] is imploding. Massive subsidy payments to their pet insurance companies has stopped. Dems should call me to fix!” President Trump tweeted Oct. 13.
The action prompted criticism from medical organizations and health insurers alike.
In a statement, American Medical Association President David Barbe said he was “deeply discouraged” by the cuts. “This most recent action by the administration creates still more uncertainty in the ACA marketplace just as the abbreviated open enrollment period is about to begin, further undermining the law and threatening access to meaningful health insurance coverage for millions of Americans,” Dr. Barbe said.
“We need constructive solutions that increase consumer choice, lower consumer costs, and stabilize local markets,” America’s Health Insurance Plans and the Blue Cross Blue Shield Association said in a joint statement. “Terminating this critical program will do just the opposite. This action will make it harder for patients to access the care they need. Costs will go up and choice will be restricted.”
The U.S. Senate Committee on Health, Education, Labor & Pensions was working on a bipartisan, narrowly focused bill that would have, among other things, codified cost-sharing reduction payments in legislation for at least a year, after witnesses from across the political spectrum testified during four hearings that maintenance of the payments would bring stability to the individual market. That effort was derailed when Senate Majority Leader Mitch McConnell (R-Ky.) instead pushed a broad repeal-and-replace effort, which never reached the Senate floor for consideration when it was clear the action did not have enough votes to pass.
The president’s move follows an executive order that could further destabilize the individual market through broader use of association health plans and an expansion of short-term health insurance plans, neither of which would have to meet the coverage and benefits requirements of the Affordable Care Act.
“The Democrats ObamaCare [sic] is imploding. Massive subsidy payments to their pet insurance companies has stopped. Dems should call me to fix!” President Trump tweeted Oct. 13.
The action prompted criticism from medical organizations and health insurers alike.
In a statement, American Medical Association President David Barbe said he was “deeply discouraged” by the cuts. “This most recent action by the administration creates still more uncertainty in the ACA marketplace just as the abbreviated open enrollment period is about to begin, further undermining the law and threatening access to meaningful health insurance coverage for millions of Americans,” Dr. Barbe said.
“We need constructive solutions that increase consumer choice, lower consumer costs, and stabilize local markets,” America’s Health Insurance Plans and the Blue Cross Blue Shield Association said in a joint statement. “Terminating this critical program will do just the opposite. This action will make it harder for patients to access the care they need. Costs will go up and choice will be restricted.”
The U.S. Senate Committee on Health, Education, Labor & Pensions was working on a bipartisan, narrowly focused bill that would have, among other things, codified cost-sharing reduction payments in legislation for at least a year, after witnesses from across the political spectrum testified during four hearings that maintenance of the payments would bring stability to the individual market. That effort was derailed when Senate Majority Leader Mitch McConnell (R-Ky.) instead pushed a broad repeal-and-replace effort, which never reached the Senate floor for consideration when it was clear the action did not have enough votes to pass.
The president’s move follows an executive order that could further destabilize the individual market through broader use of association health plans and an expansion of short-term health insurance plans, neither of which would have to meet the coverage and benefits requirements of the Affordable Care Act.
“The Democrats ObamaCare [sic] is imploding. Massive subsidy payments to their pet insurance companies has stopped. Dems should call me to fix!” President Trump tweeted Oct. 13.
The action prompted criticism from medical organizations and health insurers alike.
In a statement, American Medical Association President David Barbe said he was “deeply discouraged” by the cuts. “This most recent action by the administration creates still more uncertainty in the ACA marketplace just as the abbreviated open enrollment period is about to begin, further undermining the law and threatening access to meaningful health insurance coverage for millions of Americans,” Dr. Barbe said.
“We need constructive solutions that increase consumer choice, lower consumer costs, and stabilize local markets,” America’s Health Insurance Plans and the Blue Cross Blue Shield Association said in a joint statement. “Terminating this critical program will do just the opposite. This action will make it harder for patients to access the care they need. Costs will go up and choice will be restricted.”
The U.S. Senate Committee on Health, Education, Labor & Pensions was working on a bipartisan, narrowly focused bill that would have, among other things, codified cost-sharing reduction payments in legislation for at least a year, after witnesses from across the political spectrum testified during four hearings that maintenance of the payments would bring stability to the individual market. That effort was derailed when Senate Majority Leader Mitch McConnell (R-Ky.) instead pushed a broad repeal-and-replace effort, which never reached the Senate floor for consideration when it was clear the action did not have enough votes to pass.
The president’s move follows an executive order that could further destabilize the individual market through broader use of association health plans and an expansion of short-term health insurance plans, neither of which would have to meet the coverage and benefits requirements of the Affordable Care Act.
Are those hemorrhoids? Get to know the anorectal imitators
ESTES PARK, COLO. – As a colorectal surgeon, Michelle Cowan, MD, sees a steady parade of primary care referrals for surgical evaluation of hemorrhoids.
The thing is, most of the time, the referred patients don’t have hemorrhoids. They have one of the other common anorectal disorders, including anal fissure, anoperineal abscess, fistula-in-ano, or an anorectal sexually transmitted infection, according to Dr. Cowan.
The diagnostic challenge stems from the fact that most common anorectal diseases – whether benign or malignant – present with the same constellation of symptoms: pain, bleeding, itching or burning, swelling, and leakage.
The quality and intensity of the pain “down under” provides a useful clue in differentiating the disorders.
“Hemorrhoids rarely cause legit pain,” said Dr. Cowan, who practices at the University of Colorado at Denver, Aurora. “Excruciating pain, where the patient will only sit on one side, that’s typically an abscess, a fissure, or an STI.”
The exceptions in the hemorrhoid realm are external thrombosed hemorrhoids, which are exceedingly painful but also readily identifiable, and incarcerated hemorrhoids, which are quite rare.
The pain associated with an anal fissure is distinct from that of an abscess or thrombosed hemorrhoid – it’s a throbbing pain lasting minutes to hours per episode.
“These are the people who won’t sit down in your office,” Dr. Cowan said.
Anal fissure is a common condition in young and middle-aged adults, and especially in peripartum women. The pathophysiology involves microtrauma, typically either because of passing rock-hard stools, diarrhea, or the rigors of childbirth, any of which can cause a break in the anal mucosa. That break causes the internal sphincter muscle to go into spasm, temporarily choking off the blood supply to the area of the fissure. Those wounds won’t heal on their own. Close to 90% of the fissures are located in the posterior midline; if the fissure is ectopic, it’s time to consider Crohn’s disease, HIV infection, tuberculosis, cancer, and other possibilities.
The patient with an anoperineal abscess presents with extreme pain, a sensation of fullness in the anus and rectum, erythema, fullness of the perineum, drainage, and sometimes fever.
“This is legit pain, like with a fissure or thrombosed hemorrhoids,” she explained. “Patients with any of these conditions can tell you exactly when they went from feeling normal to when the pain started.”
The abscess is caused by an infected anal gland. The location is most commonly perianal or ischioanal. If that’s not the suppuration site, the abscess is intersphincteric or supralevator, in which case a confirmatory CT scan is called for before proceeding with treatment.
Regardless of the suspected cause of a patient’s anorectal symptoms, any GI bleeding needs to be taken seriously. Young adults are the only segment of the population in whom the incidence of colorectal cancer is going up. In response, the American Society for Gastrointestinal Endoscopy and other groups now recommend colonoscopy for all patients older than age 40 years with GI bleeding, even if their family histories for colorectal cancer are negative and they lack other high-risk factors. For those younger than age 40 years, flexible sigmoidoscopy is recommended, even if it’s obvious that the patient has external thrombosed hemorrhoids that are bleeding.
“I tell people that I will not do hemorrhoid surgery until they have the scope,” Dr. Cowan said.
Office-based treatment of common anorectal disorders
Nonoperative treatment of anal fissures and internal hemorrhoids is all about encouraging patient adherence.
“Patient expectations are often overlooked,” according to the surgeon. “It’s rare that these patients actually need to go to surgery, but they oftentimes don’t do what we tell them to do, which is why they end up in my office.”
With anal fissure, the goal is to relax the spastic sphincter muscle, allowing the fissure to heal. That can be accomplished medically or surgically.
Medically, treatment consists of increased water intake, incorporation of more fiber in the diet, undertaking warm sitz baths a couple times a day, and application of a pea-sized amount of topical 2% diltiazem three times daily on the outside of the anus for 6-8 weeks.
“Compliance is huge. This whole thing is about consistency. Oftentimes, the reason treatment fails is people can’t do this. They feel good after about a week, so they stop before the fissure is completely healed,” she said.
The topical diltiazem must be prepared at a compounding pharmacy. It’s usually covered by insurance. Even if it’s not, an 8-week prescription costs only about $25. The drug is effective in up to 95% of patients who follow the instructions.
Topical 0.2% nitroglycerin, an alternative treatment, is less attractive because 30% of patients experience often-disabling headaches as a side effect. Topical diltiazem has a much better side effect profile, Dr. Cowan noted. If a patient shows a partial response to 6-8 weeks of topical diltiazem, it’s worth prescribing a second round. If the fissure still hasn’t healed after that, it’s time for referral to a surgeon. The options are onabotulinumtoxinA (Botox) and lateral internal sphincterotomy.
Botox is effective in 60%-80% of patients, she explained, providing temporary benefit lasting up to 3 months with a much lower risk of incontinence than with lateral internal sphincterotomy. Open and closed sphincterotomy techniques yield a similar success rate, with healing in 93% of cases.
For internal hemorrhoids, stool softeners, 25-30 g of fiber supplements per day, warm sitz baths, avoiding straining during defecation, and not loitering on the toilet are key elements in achieving symptomatic control nonoperatively.
Patients who don’t have a bathtub in which to take sitz baths can accomplish the same thing using an easily removable, commercially available device that fits over a toilet bowl.
Disposable baby wipes for adults have become the No. 1 cause of anal itching and are to be shunned by patients with internal hemorrhoids or other anorectal disorders.
“Patients often engage in excessive wiping because of the poor consistency of their bowel movements,” Dr. Cowan explained. “If they’re pasty and not coming out in one fell swoop, it leads to residue that patients appropriately feel they need to wipe multiple times to keep clean. The majority of these dipe wipes for adults are alcohol based, and even though on your exam you may see nothing, the dipe wipes cause microexcoriations of the skin. The patient itches and doesn’t know why.”
Primary care physicians can readily learn to do mucosal banding for grade II and III prolapsing hemorrhoids in the office, she noted. However, banding should never be attempted on external thrombosed hemorrhoids, though.
Surgical excisional hemorrhoidectomy is a lasting solution for such hemorrhoids, but patients need to understand that even though it’s only a 10- to 15-minute procedure performed in an outpatient setting, it’s excruciatingly painful for a week – and that’s not the end of the story.
“I tell patients to take a week off work,” the surgeon said. “And don’t sit on a donut; it pulls on the suture line. Pillows are okay. But it takes 6-8 weeks to heal, so even though they’re only in excruciating pain for about a week, they have to poop past the suture line, so they’ve got to avoid rock-hard stools.”
With an anoperineal abscess, first-line treatment is incision of the abscess as close as possible to the anus, followed by placement of a drain to be left in place for 7-10 days. Prophylactic antibiotics are reserved for immunosuppressed patients.
Patients need to understand up front that, 30%-50% of the time, a fistula can develop after drainage of an abscess. Indeed, abscessed anoperineal fistula is one of the most common conditions Dr. Cowan sees in the emergency department and clinic. The telltale symptoms are recurrent abscess and/or persistent drainage. Those patients need referral to a colorectal surgeon.
“Fistula-in-ano is a frustrating disease for the patient and the surgeon. As surgeons, we like to fix – and there’s really no good option,” according to Dr. Cowan.
Among the surgical treatment options are debridement followed by fibrin glue injection, an anal fistula plug, an endorectal flap closure, and ligation of the intersphincteric fistula tract, or LIFT, procedure.
Dr. Cowan reported serving as a consultant to Applied Medical.
ESTES PARK, COLO. – As a colorectal surgeon, Michelle Cowan, MD, sees a steady parade of primary care referrals for surgical evaluation of hemorrhoids.
The thing is, most of the time, the referred patients don’t have hemorrhoids. They have one of the other common anorectal disorders, including anal fissure, anoperineal abscess, fistula-in-ano, or an anorectal sexually transmitted infection, according to Dr. Cowan.
The diagnostic challenge stems from the fact that most common anorectal diseases – whether benign or malignant – present with the same constellation of symptoms: pain, bleeding, itching or burning, swelling, and leakage.
The quality and intensity of the pain “down under” provides a useful clue in differentiating the disorders.
“Hemorrhoids rarely cause legit pain,” said Dr. Cowan, who practices at the University of Colorado at Denver, Aurora. “Excruciating pain, where the patient will only sit on one side, that’s typically an abscess, a fissure, or an STI.”
The exceptions in the hemorrhoid realm are external thrombosed hemorrhoids, which are exceedingly painful but also readily identifiable, and incarcerated hemorrhoids, which are quite rare.
The pain associated with an anal fissure is distinct from that of an abscess or thrombosed hemorrhoid – it’s a throbbing pain lasting minutes to hours per episode.
“These are the people who won’t sit down in your office,” Dr. Cowan said.
Anal fissure is a common condition in young and middle-aged adults, and especially in peripartum women. The pathophysiology involves microtrauma, typically either because of passing rock-hard stools, diarrhea, or the rigors of childbirth, any of which can cause a break in the anal mucosa. That break causes the internal sphincter muscle to go into spasm, temporarily choking off the blood supply to the area of the fissure. Those wounds won’t heal on their own. Close to 90% of the fissures are located in the posterior midline; if the fissure is ectopic, it’s time to consider Crohn’s disease, HIV infection, tuberculosis, cancer, and other possibilities.
The patient with an anoperineal abscess presents with extreme pain, a sensation of fullness in the anus and rectum, erythema, fullness of the perineum, drainage, and sometimes fever.
“This is legit pain, like with a fissure or thrombosed hemorrhoids,” she explained. “Patients with any of these conditions can tell you exactly when they went from feeling normal to when the pain started.”
The abscess is caused by an infected anal gland. The location is most commonly perianal or ischioanal. If that’s not the suppuration site, the abscess is intersphincteric or supralevator, in which case a confirmatory CT scan is called for before proceeding with treatment.
Regardless of the suspected cause of a patient’s anorectal symptoms, any GI bleeding needs to be taken seriously. Young adults are the only segment of the population in whom the incidence of colorectal cancer is going up. In response, the American Society for Gastrointestinal Endoscopy and other groups now recommend colonoscopy for all patients older than age 40 years with GI bleeding, even if their family histories for colorectal cancer are negative and they lack other high-risk factors. For those younger than age 40 years, flexible sigmoidoscopy is recommended, even if it’s obvious that the patient has external thrombosed hemorrhoids that are bleeding.
“I tell people that I will not do hemorrhoid surgery until they have the scope,” Dr. Cowan said.
Office-based treatment of common anorectal disorders
Nonoperative treatment of anal fissures and internal hemorrhoids is all about encouraging patient adherence.
“Patient expectations are often overlooked,” according to the surgeon. “It’s rare that these patients actually need to go to surgery, but they oftentimes don’t do what we tell them to do, which is why they end up in my office.”
With anal fissure, the goal is to relax the spastic sphincter muscle, allowing the fissure to heal. That can be accomplished medically or surgically.
Medically, treatment consists of increased water intake, incorporation of more fiber in the diet, undertaking warm sitz baths a couple times a day, and application of a pea-sized amount of topical 2% diltiazem three times daily on the outside of the anus for 6-8 weeks.
“Compliance is huge. This whole thing is about consistency. Oftentimes, the reason treatment fails is people can’t do this. They feel good after about a week, so they stop before the fissure is completely healed,” she said.
The topical diltiazem must be prepared at a compounding pharmacy. It’s usually covered by insurance. Even if it’s not, an 8-week prescription costs only about $25. The drug is effective in up to 95% of patients who follow the instructions.
Topical 0.2% nitroglycerin, an alternative treatment, is less attractive because 30% of patients experience often-disabling headaches as a side effect. Topical diltiazem has a much better side effect profile, Dr. Cowan noted. If a patient shows a partial response to 6-8 weeks of topical diltiazem, it’s worth prescribing a second round. If the fissure still hasn’t healed after that, it’s time for referral to a surgeon. The options are onabotulinumtoxinA (Botox) and lateral internal sphincterotomy.
Botox is effective in 60%-80% of patients, she explained, providing temporary benefit lasting up to 3 months with a much lower risk of incontinence than with lateral internal sphincterotomy. Open and closed sphincterotomy techniques yield a similar success rate, with healing in 93% of cases.
For internal hemorrhoids, stool softeners, 25-30 g of fiber supplements per day, warm sitz baths, avoiding straining during defecation, and not loitering on the toilet are key elements in achieving symptomatic control nonoperatively.
Patients who don’t have a bathtub in which to take sitz baths can accomplish the same thing using an easily removable, commercially available device that fits over a toilet bowl.
Disposable baby wipes for adults have become the No. 1 cause of anal itching and are to be shunned by patients with internal hemorrhoids or other anorectal disorders.
“Patients often engage in excessive wiping because of the poor consistency of their bowel movements,” Dr. Cowan explained. “If they’re pasty and not coming out in one fell swoop, it leads to residue that patients appropriately feel they need to wipe multiple times to keep clean. The majority of these dipe wipes for adults are alcohol based, and even though on your exam you may see nothing, the dipe wipes cause microexcoriations of the skin. The patient itches and doesn’t know why.”
Primary care physicians can readily learn to do mucosal banding for grade II and III prolapsing hemorrhoids in the office, she noted. However, banding should never be attempted on external thrombosed hemorrhoids, though.
Surgical excisional hemorrhoidectomy is a lasting solution for such hemorrhoids, but patients need to understand that even though it’s only a 10- to 15-minute procedure performed in an outpatient setting, it’s excruciatingly painful for a week – and that’s not the end of the story.
“I tell patients to take a week off work,” the surgeon said. “And don’t sit on a donut; it pulls on the suture line. Pillows are okay. But it takes 6-8 weeks to heal, so even though they’re only in excruciating pain for about a week, they have to poop past the suture line, so they’ve got to avoid rock-hard stools.”
With an anoperineal abscess, first-line treatment is incision of the abscess as close as possible to the anus, followed by placement of a drain to be left in place for 7-10 days. Prophylactic antibiotics are reserved for immunosuppressed patients.
Patients need to understand up front that, 30%-50% of the time, a fistula can develop after drainage of an abscess. Indeed, abscessed anoperineal fistula is one of the most common conditions Dr. Cowan sees in the emergency department and clinic. The telltale symptoms are recurrent abscess and/or persistent drainage. Those patients need referral to a colorectal surgeon.
“Fistula-in-ano is a frustrating disease for the patient and the surgeon. As surgeons, we like to fix – and there’s really no good option,” according to Dr. Cowan.
Among the surgical treatment options are debridement followed by fibrin glue injection, an anal fistula plug, an endorectal flap closure, and ligation of the intersphincteric fistula tract, or LIFT, procedure.
Dr. Cowan reported serving as a consultant to Applied Medical.
ESTES PARK, COLO. – As a colorectal surgeon, Michelle Cowan, MD, sees a steady parade of primary care referrals for surgical evaluation of hemorrhoids.
The thing is, most of the time, the referred patients don’t have hemorrhoids. They have one of the other common anorectal disorders, including anal fissure, anoperineal abscess, fistula-in-ano, or an anorectal sexually transmitted infection, according to Dr. Cowan.
The diagnostic challenge stems from the fact that most common anorectal diseases – whether benign or malignant – present with the same constellation of symptoms: pain, bleeding, itching or burning, swelling, and leakage.
The quality and intensity of the pain “down under” provides a useful clue in differentiating the disorders.
“Hemorrhoids rarely cause legit pain,” said Dr. Cowan, who practices at the University of Colorado at Denver, Aurora. “Excruciating pain, where the patient will only sit on one side, that’s typically an abscess, a fissure, or an STI.”
The exceptions in the hemorrhoid realm are external thrombosed hemorrhoids, which are exceedingly painful but also readily identifiable, and incarcerated hemorrhoids, which are quite rare.
The pain associated with an anal fissure is distinct from that of an abscess or thrombosed hemorrhoid – it’s a throbbing pain lasting minutes to hours per episode.
“These are the people who won’t sit down in your office,” Dr. Cowan said.
Anal fissure is a common condition in young and middle-aged adults, and especially in peripartum women. The pathophysiology involves microtrauma, typically either because of passing rock-hard stools, diarrhea, or the rigors of childbirth, any of which can cause a break in the anal mucosa. That break causes the internal sphincter muscle to go into spasm, temporarily choking off the blood supply to the area of the fissure. Those wounds won’t heal on their own. Close to 90% of the fissures are located in the posterior midline; if the fissure is ectopic, it’s time to consider Crohn’s disease, HIV infection, tuberculosis, cancer, and other possibilities.
The patient with an anoperineal abscess presents with extreme pain, a sensation of fullness in the anus and rectum, erythema, fullness of the perineum, drainage, and sometimes fever.
“This is legit pain, like with a fissure or thrombosed hemorrhoids,” she explained. “Patients with any of these conditions can tell you exactly when they went from feeling normal to when the pain started.”
The abscess is caused by an infected anal gland. The location is most commonly perianal or ischioanal. If that’s not the suppuration site, the abscess is intersphincteric or supralevator, in which case a confirmatory CT scan is called for before proceeding with treatment.
Regardless of the suspected cause of a patient’s anorectal symptoms, any GI bleeding needs to be taken seriously. Young adults are the only segment of the population in whom the incidence of colorectal cancer is going up. In response, the American Society for Gastrointestinal Endoscopy and other groups now recommend colonoscopy for all patients older than age 40 years with GI bleeding, even if their family histories for colorectal cancer are negative and they lack other high-risk factors. For those younger than age 40 years, flexible sigmoidoscopy is recommended, even if it’s obvious that the patient has external thrombosed hemorrhoids that are bleeding.
“I tell people that I will not do hemorrhoid surgery until they have the scope,” Dr. Cowan said.
Office-based treatment of common anorectal disorders
Nonoperative treatment of anal fissures and internal hemorrhoids is all about encouraging patient adherence.
“Patient expectations are often overlooked,” according to the surgeon. “It’s rare that these patients actually need to go to surgery, but they oftentimes don’t do what we tell them to do, which is why they end up in my office.”
With anal fissure, the goal is to relax the spastic sphincter muscle, allowing the fissure to heal. That can be accomplished medically or surgically.
Medically, treatment consists of increased water intake, incorporation of more fiber in the diet, undertaking warm sitz baths a couple times a day, and application of a pea-sized amount of topical 2% diltiazem three times daily on the outside of the anus for 6-8 weeks.
“Compliance is huge. This whole thing is about consistency. Oftentimes, the reason treatment fails is people can’t do this. They feel good after about a week, so they stop before the fissure is completely healed,” she said.
The topical diltiazem must be prepared at a compounding pharmacy. It’s usually covered by insurance. Even if it’s not, an 8-week prescription costs only about $25. The drug is effective in up to 95% of patients who follow the instructions.
Topical 0.2% nitroglycerin, an alternative treatment, is less attractive because 30% of patients experience often-disabling headaches as a side effect. Topical diltiazem has a much better side effect profile, Dr. Cowan noted. If a patient shows a partial response to 6-8 weeks of topical diltiazem, it’s worth prescribing a second round. If the fissure still hasn’t healed after that, it’s time for referral to a surgeon. The options are onabotulinumtoxinA (Botox) and lateral internal sphincterotomy.
Botox is effective in 60%-80% of patients, she explained, providing temporary benefit lasting up to 3 months with a much lower risk of incontinence than with lateral internal sphincterotomy. Open and closed sphincterotomy techniques yield a similar success rate, with healing in 93% of cases.
For internal hemorrhoids, stool softeners, 25-30 g of fiber supplements per day, warm sitz baths, avoiding straining during defecation, and not loitering on the toilet are key elements in achieving symptomatic control nonoperatively.
Patients who don’t have a bathtub in which to take sitz baths can accomplish the same thing using an easily removable, commercially available device that fits over a toilet bowl.
Disposable baby wipes for adults have become the No. 1 cause of anal itching and are to be shunned by patients with internal hemorrhoids or other anorectal disorders.
“Patients often engage in excessive wiping because of the poor consistency of their bowel movements,” Dr. Cowan explained. “If they’re pasty and not coming out in one fell swoop, it leads to residue that patients appropriately feel they need to wipe multiple times to keep clean. The majority of these dipe wipes for adults are alcohol based, and even though on your exam you may see nothing, the dipe wipes cause microexcoriations of the skin. The patient itches and doesn’t know why.”
Primary care physicians can readily learn to do mucosal banding for grade II and III prolapsing hemorrhoids in the office, she noted. However, banding should never be attempted on external thrombosed hemorrhoids, though.
Surgical excisional hemorrhoidectomy is a lasting solution for such hemorrhoids, but patients need to understand that even though it’s only a 10- to 15-minute procedure performed in an outpatient setting, it’s excruciatingly painful for a week – and that’s not the end of the story.
“I tell patients to take a week off work,” the surgeon said. “And don’t sit on a donut; it pulls on the suture line. Pillows are okay. But it takes 6-8 weeks to heal, so even though they’re only in excruciating pain for about a week, they have to poop past the suture line, so they’ve got to avoid rock-hard stools.”
With an anoperineal abscess, first-line treatment is incision of the abscess as close as possible to the anus, followed by placement of a drain to be left in place for 7-10 days. Prophylactic antibiotics are reserved for immunosuppressed patients.
Patients need to understand up front that, 30%-50% of the time, a fistula can develop after drainage of an abscess. Indeed, abscessed anoperineal fistula is one of the most common conditions Dr. Cowan sees in the emergency department and clinic. The telltale symptoms are recurrent abscess and/or persistent drainage. Those patients need referral to a colorectal surgeon.
“Fistula-in-ano is a frustrating disease for the patient and the surgeon. As surgeons, we like to fix – and there’s really no good option,” according to Dr. Cowan.
Among the surgical treatment options are debridement followed by fibrin glue injection, an anal fistula plug, an endorectal flap closure, and ligation of the intersphincteric fistula tract, or LIFT, procedure.
Dr. Cowan reported serving as a consultant to Applied Medical.
EXPERT ANALYSIS FROM THE ANNUAL INTERNAL MEDICINE PROGRAM
Negative nasal swabs reliably predicted no MRSA infection
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
SAN DIEGO – , said Darunee Chotiprasitsakul, MD, of Johns Hopkins Medicine in Baltimore.
But physicians often prescribed vancomycin anyway, accumulating nearly 7,400 potentially avoidable treatment days over a 19-month period, she said during an oral presentation at an annual meeting on infectious diseases.
Current guidelines recommend empiric vancomycin to cover MRSA infection when ill patients have a history of MRSA colonization or recent hospitalization or exposure to antibiotics. Patients whose nasal screening swabs are negative for MRSA have been shown to be at low risk of subsequent infection, but guidelines don’t address how to use swab results to guide decisions about empiric vancomycin, Dr. Chotiprasitsakul said.
Therefore, she and her associates studied 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance in adult ICUs at Johns Hopkins. A total of 441 patients (4%) had positive swabs, while 96% tested negative.
Among patients with negative swabs, only 25 (0.22%) developed MRSA infection requiring treatment. Thus, the negative predictive value of a nasal swab for MRSA was 99%, making the probability of infection despite a negative swab “exceedingly low,” Dr. Chotiprasitsakul said.
But clinicians seemed not to use negative swab results to curtail vancomycin therapy, she found. Rates of empiric vancomycin use were 36% among patients with positive swabs and 39% among those with negative swabs. Over 19 months, ICU patients received 7,371 avoidable days of vancomycin, a median of 3 days per patient.
Matching patients by ICU and days at risk identified no significant predictors of MRSA infection, Dr. Chotiprasitsakul said. Johns Hopkins Medicine has robust infection control practices, high compliance with hand hygiene and contact precautions, and low rates of nosocomial MRSA transmission, she noted. The predictive value of a negative MRSA nasal swab could be lower at institutions where that isn’t the case, she said.
Johns Hopkins is working to curtail unnecessary use of vancomycin, said senior author Sara Cosgrove, MD, professor of medicine in infectious diseases and director of the department of antimicrobial stewardship. The team has added the findings to its guidelines for antibiotic use, which are available in an app for Johns Hopkins providers, she said in an interview.
The stewardship also highlights the data when discussing starting and stopping vancomycin in patients at very low risk for MRSA infections, she said. “In general, providers have responded favorably to acting upon this new information,” Dr. Cosgrove noted.
Johns Hopkins continues to track median days of vancomycin use per patient and per 1,000 days in its units. “[We] will assess if there is an impact on vancomycin use over the coming year,” said Dr. Cosgrove.
The investigators had no conflicts of interest. The event marked the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
AT IDWEEK 2017
Key clinical point: Only 0.2% of ICU patients with negative surveillance nasal swabs developed MRSA infections during the same hospitalization.
Major finding: The predictive value of a negative swab was 99%.
Data source: A study of 11,882 adults without historical MRSA infection or colonization who received nasal swabs for routine surveillance.
Disclosures: The investigators had no conflicts of interest.