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Eating disorders in transgender youth
The field of transgender health is growing. What began as a lone German physician in 1918 defying the norms of treating gender identity as a disease now has burgeoned into a field that includes 1,079 PubMed articles,two medical guidelines1,2, and a multitude of books. As we learn more about the complexity of gender and gender identity, we also are discovering potential problems that occur when providing care to our transgender patients. One is eating disorders.
A systematic review by Jones et al. showed only a handful of studies on eating disorders in transgender individuals, most of them restricted to case studies.3 In some situations, the issue of gender identity arises during treatment for an eating disorder, as the individual realizes that body dissatisfaction is due to the gender identity instead of a fear of gaining weight. In other cases, a transgender person in the process of transitioning to the affirmed gender develops an eating disorder.
There are two larger quantitative studies on eating disorders among transgender individuals. One study of 289,024 college students reveals that transgender students, compared to cisgender students, are almost five times as likely to report an eating disorder and two times as likely to use unhealthy compensatory methods (e.g., vomiting) for weight control.4 Another study of almost 2,500 teenagers shows that transgender individuals are almost three times as likely to restrict their eating, almost nine times as likely to take diet pills, and seven times as likely to take laxatives.5
The most commonly suggested reason for the possible elevated risk for eating disorders among transgender individuals is that many of them are trying to achieve the unrealistic standards of the ideal masculine or feminine body type. Another explanation is that eating disorders among transgender individuals are maladaptive coping mechanisms to stress from antitrans stigma and discrimination.4 However, these explanations are not mutually exclusive and could simultaneously drive disordered eating among transgender individuals.
To further appreciate the relationship between these two conditions, one must understand their similarities and differences. The Diagnostic Statistical Manual of Mental Disorders V characterizes eating disorders as “a persistent disturbance of eating or eating-related behavior that results in the altered consumption or absorption of food and ... significantly impairs physical health or psychosocial functioning.”6 Anorexia nervosa and bulimia nervosa are driven by fear of gaining weight or by a self-esteem unduly influenced by weight or appearance.6
Gender dysphoria, in comparison, is the distress caused by the incongruence between one’s gender identity and one’s anatomy, along with the desire to have the characteristics of one’s affirmed gender identity. This condition also could severely alter physical and psychosocial functioning,7 partly because of the distress from the incongruence, and partly because of the stress from antitrans stigma and discrimination, as an individual attempts to match the body with the gender identity8 (e.g., wearing clothing to match the gender identity).
The higher risk of developing an eating disorder among transgender individuals makes sense. Dissatisfaction with one’s body characterizes both conditions. The high standards on what is masculine or feminine affects everyone, especially transgender individuals who may feel that they’re “far behind” when they begin to transition to their affirmed gender. In addition, both involve identity. Those who have anorexia nervosa also incorporate this into their own identity.9 This is why treating an eating disorder can be very difficult.
Finally, individuals afflicted by an eating disorder or gender dysphoria engage in certain behaviors to achieve their desired appearance. However, this is where the similarities end. One major distinction between an eating disorder and gender dysphoria is the treatment approach. The goal in treating an eating disorder is to discourage the disordered behavior and encourage healthier eating habits and a more positive body image. Affirming the identity of someone with an eating disorder can be deadly, as it will encourage more disordered eating.10 In contrast, affirming the identity of someone with gender dysphoria through social transition, cross-sex hormones, and/or surgical reassignment is life-saving and therapeutic.11
There is little guidance on how to treat the these disorders simultaneously. What complicates treating both conditions at the same time is that when an eating disorder is accompanied by another mental health disorder (e.g., substance use), one condition over the other is prioritized.12 There is no guidance on whether the eating disorder or gender dysphoria should take priority over the other, or if it is possible to treat both conditions at the same time.
Strandjord et al. suggest a hierarchal approach, in which life-threatening issues (such as suicide or electrolyte disturbances) take priority.13 In addition, if the patient is malnourished, weight restoration should be the initial focus. A patient who is severely malnourished may not have the cognitive capacity nor the physiological ability to manage comorbidities such as anxiety or depression,12 much less have the capacity to process something as complex as gender and gender identity, nor understand the steps necessary for a successful transition to the affirmed gender. However, this does not mean providers should wait to successfully manage an eating disorder before addressing gender dysphoria. Studies have suggested that gender-affirming medical therapies (e.g., cross sex hormones) can be therapeutic for both gender dysphoria and eating disorder symptoms.14 Finally, because of the two ways a transgender patient with an eating disorder can present, I recommend screening for eating disorders in transgender individuals and inquiring about gender identity among those with an eating disorder. Doing so may save a life.
References
1. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.
2. Adv Urol. 2012;2012:581712.
3. Int Rev Psychiatry. 2016;28(1):81-94.
4. J Adolesc Health. 2015 Aug;57(2):144-9.
5. J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.08.027.
6. Feeding and Eating Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
7. Gender Dysphoria. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
8. Psychol Bull. 2003 Sep;129(5):674-97.
9. Int J Law Psychiatry. 2003 Sep-Oct;26(5):533-48.
10. Arch Gen Psychiatry. 2011 Jul;68(7):724-31.
11. Clin Endocrinol (Oxf). 2010 Feb;72(2):214-31.
12. CNS drugs. 2006;20(8):655-63.
13. Int J Eat Disord. 2015 Nov;48(7):942-5.
14. Eat Disord. 2012;20(4):300-11.
The field of transgender health is growing. What began as a lone German physician in 1918 defying the norms of treating gender identity as a disease now has burgeoned into a field that includes 1,079 PubMed articles,two medical guidelines1,2, and a multitude of books. As we learn more about the complexity of gender and gender identity, we also are discovering potential problems that occur when providing care to our transgender patients. One is eating disorders.
A systematic review by Jones et al. showed only a handful of studies on eating disorders in transgender individuals, most of them restricted to case studies.3 In some situations, the issue of gender identity arises during treatment for an eating disorder, as the individual realizes that body dissatisfaction is due to the gender identity instead of a fear of gaining weight. In other cases, a transgender person in the process of transitioning to the affirmed gender develops an eating disorder.
There are two larger quantitative studies on eating disorders among transgender individuals. One study of 289,024 college students reveals that transgender students, compared to cisgender students, are almost five times as likely to report an eating disorder and two times as likely to use unhealthy compensatory methods (e.g., vomiting) for weight control.4 Another study of almost 2,500 teenagers shows that transgender individuals are almost three times as likely to restrict their eating, almost nine times as likely to take diet pills, and seven times as likely to take laxatives.5
The most commonly suggested reason for the possible elevated risk for eating disorders among transgender individuals is that many of them are trying to achieve the unrealistic standards of the ideal masculine or feminine body type. Another explanation is that eating disorders among transgender individuals are maladaptive coping mechanisms to stress from antitrans stigma and discrimination.4 However, these explanations are not mutually exclusive and could simultaneously drive disordered eating among transgender individuals.
To further appreciate the relationship between these two conditions, one must understand their similarities and differences. The Diagnostic Statistical Manual of Mental Disorders V characterizes eating disorders as “a persistent disturbance of eating or eating-related behavior that results in the altered consumption or absorption of food and ... significantly impairs physical health or psychosocial functioning.”6 Anorexia nervosa and bulimia nervosa are driven by fear of gaining weight or by a self-esteem unduly influenced by weight or appearance.6
Gender dysphoria, in comparison, is the distress caused by the incongruence between one’s gender identity and one’s anatomy, along with the desire to have the characteristics of one’s affirmed gender identity. This condition also could severely alter physical and psychosocial functioning,7 partly because of the distress from the incongruence, and partly because of the stress from antitrans stigma and discrimination, as an individual attempts to match the body with the gender identity8 (e.g., wearing clothing to match the gender identity).
The higher risk of developing an eating disorder among transgender individuals makes sense. Dissatisfaction with one’s body characterizes both conditions. The high standards on what is masculine or feminine affects everyone, especially transgender individuals who may feel that they’re “far behind” when they begin to transition to their affirmed gender. In addition, both involve identity. Those who have anorexia nervosa also incorporate this into their own identity.9 This is why treating an eating disorder can be very difficult.
Finally, individuals afflicted by an eating disorder or gender dysphoria engage in certain behaviors to achieve their desired appearance. However, this is where the similarities end. One major distinction between an eating disorder and gender dysphoria is the treatment approach. The goal in treating an eating disorder is to discourage the disordered behavior and encourage healthier eating habits and a more positive body image. Affirming the identity of someone with an eating disorder can be deadly, as it will encourage more disordered eating.10 In contrast, affirming the identity of someone with gender dysphoria through social transition, cross-sex hormones, and/or surgical reassignment is life-saving and therapeutic.11
There is little guidance on how to treat the these disorders simultaneously. What complicates treating both conditions at the same time is that when an eating disorder is accompanied by another mental health disorder (e.g., substance use), one condition over the other is prioritized.12 There is no guidance on whether the eating disorder or gender dysphoria should take priority over the other, or if it is possible to treat both conditions at the same time.
Strandjord et al. suggest a hierarchal approach, in which life-threatening issues (such as suicide or electrolyte disturbances) take priority.13 In addition, if the patient is malnourished, weight restoration should be the initial focus. A patient who is severely malnourished may not have the cognitive capacity nor the physiological ability to manage comorbidities such as anxiety or depression,12 much less have the capacity to process something as complex as gender and gender identity, nor understand the steps necessary for a successful transition to the affirmed gender. However, this does not mean providers should wait to successfully manage an eating disorder before addressing gender dysphoria. Studies have suggested that gender-affirming medical therapies (e.g., cross sex hormones) can be therapeutic for both gender dysphoria and eating disorder symptoms.14 Finally, because of the two ways a transgender patient with an eating disorder can present, I recommend screening for eating disorders in transgender individuals and inquiring about gender identity among those with an eating disorder. Doing so may save a life.
References
1. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.
2. Adv Urol. 2012;2012:581712.
3. Int Rev Psychiatry. 2016;28(1):81-94.
4. J Adolesc Health. 2015 Aug;57(2):144-9.
5. J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.08.027.
6. Feeding and Eating Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
7. Gender Dysphoria. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
8. Psychol Bull. 2003 Sep;129(5):674-97.
9. Int J Law Psychiatry. 2003 Sep-Oct;26(5):533-48.
10. Arch Gen Psychiatry. 2011 Jul;68(7):724-31.
11. Clin Endocrinol (Oxf). 2010 Feb;72(2):214-31.
12. CNS drugs. 2006;20(8):655-63.
13. Int J Eat Disord. 2015 Nov;48(7):942-5.
14. Eat Disord. 2012;20(4):300-11.
The field of transgender health is growing. What began as a lone German physician in 1918 defying the norms of treating gender identity as a disease now has burgeoned into a field that includes 1,079 PubMed articles,two medical guidelines1,2, and a multitude of books. As we learn more about the complexity of gender and gender identity, we also are discovering potential problems that occur when providing care to our transgender patients. One is eating disorders.
A systematic review by Jones et al. showed only a handful of studies on eating disorders in transgender individuals, most of them restricted to case studies.3 In some situations, the issue of gender identity arises during treatment for an eating disorder, as the individual realizes that body dissatisfaction is due to the gender identity instead of a fear of gaining weight. In other cases, a transgender person in the process of transitioning to the affirmed gender develops an eating disorder.
There are two larger quantitative studies on eating disorders among transgender individuals. One study of 289,024 college students reveals that transgender students, compared to cisgender students, are almost five times as likely to report an eating disorder and two times as likely to use unhealthy compensatory methods (e.g., vomiting) for weight control.4 Another study of almost 2,500 teenagers shows that transgender individuals are almost three times as likely to restrict their eating, almost nine times as likely to take diet pills, and seven times as likely to take laxatives.5
The most commonly suggested reason for the possible elevated risk for eating disorders among transgender individuals is that many of them are trying to achieve the unrealistic standards of the ideal masculine or feminine body type. Another explanation is that eating disorders among transgender individuals are maladaptive coping mechanisms to stress from antitrans stigma and discrimination.4 However, these explanations are not mutually exclusive and could simultaneously drive disordered eating among transgender individuals.
To further appreciate the relationship between these two conditions, one must understand their similarities and differences. The Diagnostic Statistical Manual of Mental Disorders V characterizes eating disorders as “a persistent disturbance of eating or eating-related behavior that results in the altered consumption or absorption of food and ... significantly impairs physical health or psychosocial functioning.”6 Anorexia nervosa and bulimia nervosa are driven by fear of gaining weight or by a self-esteem unduly influenced by weight or appearance.6
Gender dysphoria, in comparison, is the distress caused by the incongruence between one’s gender identity and one’s anatomy, along with the desire to have the characteristics of one’s affirmed gender identity. This condition also could severely alter physical and psychosocial functioning,7 partly because of the distress from the incongruence, and partly because of the stress from antitrans stigma and discrimination, as an individual attempts to match the body with the gender identity8 (e.g., wearing clothing to match the gender identity).
The higher risk of developing an eating disorder among transgender individuals makes sense. Dissatisfaction with one’s body characterizes both conditions. The high standards on what is masculine or feminine affects everyone, especially transgender individuals who may feel that they’re “far behind” when they begin to transition to their affirmed gender. In addition, both involve identity. Those who have anorexia nervosa also incorporate this into their own identity.9 This is why treating an eating disorder can be very difficult.
Finally, individuals afflicted by an eating disorder or gender dysphoria engage in certain behaviors to achieve their desired appearance. However, this is where the similarities end. One major distinction between an eating disorder and gender dysphoria is the treatment approach. The goal in treating an eating disorder is to discourage the disordered behavior and encourage healthier eating habits and a more positive body image. Affirming the identity of someone with an eating disorder can be deadly, as it will encourage more disordered eating.10 In contrast, affirming the identity of someone with gender dysphoria through social transition, cross-sex hormones, and/or surgical reassignment is life-saving and therapeutic.11
There is little guidance on how to treat the these disorders simultaneously. What complicates treating both conditions at the same time is that when an eating disorder is accompanied by another mental health disorder (e.g., substance use), one condition over the other is prioritized.12 There is no guidance on whether the eating disorder or gender dysphoria should take priority over the other, or if it is possible to treat both conditions at the same time.
Strandjord et al. suggest a hierarchal approach, in which life-threatening issues (such as suicide or electrolyte disturbances) take priority.13 In addition, if the patient is malnourished, weight restoration should be the initial focus. A patient who is severely malnourished may not have the cognitive capacity nor the physiological ability to manage comorbidities such as anxiety or depression,12 much less have the capacity to process something as complex as gender and gender identity, nor understand the steps necessary for a successful transition to the affirmed gender. However, this does not mean providers should wait to successfully manage an eating disorder before addressing gender dysphoria. Studies have suggested that gender-affirming medical therapies (e.g., cross sex hormones) can be therapeutic for both gender dysphoria and eating disorder symptoms.14 Finally, because of the two ways a transgender patient with an eating disorder can present, I recommend screening for eating disorders in transgender individuals and inquiring about gender identity among those with an eating disorder. Doing so may save a life.
References
1. J Clin Endocrinol Metab. 2009 Sep;94(9):3132-54.
2. Adv Urol. 2012;2012:581712.
3. Int Rev Psychiatry. 2016;28(1):81-94.
4. J Adolesc Health. 2015 Aug;57(2):144-9.
5. J Adolesc Health. 2016. doi: 10.1016/j.jadohealth.2016.08.027.
6. Feeding and Eating Disorders. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
7. Gender Dysphoria. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. (Washington: American Psychiatric Association, 2013).
8. Psychol Bull. 2003 Sep;129(5):674-97.
9. Int J Law Psychiatry. 2003 Sep-Oct;26(5):533-48.
10. Arch Gen Psychiatry. 2011 Jul;68(7):724-31.
11. Clin Endocrinol (Oxf). 2010 Feb;72(2):214-31.
12. CNS drugs. 2006;20(8):655-63.
13. Int J Eat Disord. 2015 Nov;48(7):942-5.
14. Eat Disord. 2012;20(4):300-11.
Novel classification of labial anatomy and evaluation in the treatment of labial agglutination
References
Pardo J, Sola V, Ricci P, Guillof E. Laser labioplasty of labia minora. Int J Gynaecol Obstet. 2006;93(1):38–43.
Chang P, Salisbury MA, Narsete T, Buckspan R, Derrick D, Ersek RA. Vaginal labiaplasty: defense of the simple "clip and snip" and a new classification system. Aesthetic Plast Surg. 2013;37(5): p. 887–891.
Malone DG, Clark TB, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpel tunnel syndrome description of a new technique. J Appl Res. 2010;10(3):116–123.
Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Strategies for prophylactic oophoropexy
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist
References
Pardo J, Sola V, Ricci P, Guillof E. Laser labioplasty of labia minora. Int J Gynaecol Obstet. 2006;93(1):38–43.
Chang P, Salisbury MA, Narsete T, Buckspan R, Derrick D, Ersek RA. Vaginal labiaplasty: defense of the simple "clip and snip" and a new classification system. Aesthetic Plast Surg. 2013;37(5): p. 887–891.
Malone DG, Clark TB, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpel tunnel syndrome description of a new technique. J Appl Res. 2010;10(3):116–123.
Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Strategies for prophylactic oophoropexy
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist
References
Pardo J, Sola V, Ricci P, Guillof E. Laser labioplasty of labia minora. Int J Gynaecol Obstet. 2006;93(1):38–43.
Chang P, Salisbury MA, Narsete T, Buckspan R, Derrick D, Ersek RA. Vaginal labiaplasty: defense of the simple "clip and snip" and a new classification system. Aesthetic Plast Surg. 2013;37(5): p. 887–891.
Malone DG, Clark TB, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpel tunnel syndrome description of a new technique. J Appl Res. 2010;10(3):116–123.
Visit the Society of Gynecologic Surgeons online: sgsonline.org
More videos from SGS:
- Strategies for prophylactic oophoropexy
- Tips and tricks for open laparoscopy
- Complete colpectomy & colpocleisis: Model for simulation
- Natural orifice sacral colpopexy
- Alternative options for visualizing ureteral patency during intraoperative cystoscopy
- Use of suprapubic Carter-Thomason needle to assist in cystoscopic excision of an intravesical foreign object
- Uterine artery ligation: Advanced techniques and considerations for the difficult laparoscopic hysterectomy
- Cervical injection of methylene blue for identification of sentinel lymph nodes in cervical cancer
- Misplaced hysteroscopic sterilization micro-insert in the peritoneal cavity: A corpus alienum
- Laparoscopic cystectomy for large, bilateral ovarian dermoids
- Small bowel surgery for the benign gynecologist
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Not enough time? Time to rethink
Raising children is a lot like drinking out of a fire hose. Feeding, cleaning, dressing, transporting, teaching, entertaining, protecting, comforting, and managing one child is demanding, but is increased exponentially by multiple children, a spouse, and a job.
In our dataset of more than 74,900 parents of 0- to 3-year-olds completing a routine previsit questionnaire about the “best” and “hardest” parts of parenting their child, the most frequent spontaneous comment for the hardest part was “time-life balance.” The goal of asking these questions is to broaden the agenda for the pediatric visit to address stresses that are highly relevant to the child’s life in the family, and their current well-being and future outcome. The hardest part also rather succinctly captures the stress I hear every day from parents coming to me not only for health supervision, but especially for child behavior problems.
Setting limits on work to free up more time is not possible for everyone. Many people are grateful to have a job at all or need multiple jobs to make ends meet. They may not be in a position to negotiate for fewer tasks, hours, or roles. But others more fortunate may have fallen into a habit of taking on extra duties, taking work home, or simply not examining where they might set limits to preserve time for themselves and their family.
Working parents may need to prepare themselves for the onslaught when they get home. If the returning parent retreats into TV, the computer, or the bedroom, it makes the children feel angry and rejected. The parent who has been managing the household for the preceding hour(s) feels resentful, unappreciated, and often exhausted. I sometimes suggest that the returning parent pause 15 minutes to take a walk before picking children up at day care or go to the gym before coming home to be ready to engage, accept, and be present for whatever happens when they open the door.
Eliciting the “hardest part” can insert a pause for some much-needed problem-solving. Pointing out to parents the value to their child of working on their own time-life balance often gives them needed permission to make changes.
Balancing time for some parents may include setting some privacy for “alone time.” Individual desire to be alone varies, but trouble getting it is universal, especially with young children who don’t even respect a closed bathroom door! Given a young child’s need for contact about every 3-5 minutes, parents need to revise their expectations, wait until after bedtime, get some help, learn to do “token” relaxation, or all of these.
Parents often feel guilty for not attending more to their child, but then feel irritable about getting behind on other chores. It can be useful to cite the fact that mothers at home full time typically spend only 20 minutes of exclusive playtime with their child. I regularly prescribe 15 minutes of “special time” daily to break this irritability cycle for both the parent and child. Getting a babysitter does not mean that the parent has to leave the house and the undone laundry. I often suggest to resource-strapped families that they pay an 8-year-old neighbor to play with their kids for an hour several times per week. While not expecting to leave the child alone with such a “sitter,” one could relax in the tub, read a magazine, or make an uninterrupted phone call to a friend with such help.
The same parents feeling the pinch of too little time often are lacking in social support, a major buffer of stress. Sometimes, the solutions overlap. For example, trading play dates with another family by taking all their kids on a regular basis and vice versa requires no money exchange. Several kids playing together are often easier to care for than one’s own with their usual sibling struggles or boredom. And sharing of this kind can build lasting friendships and social support for the adults. Another often forgotten source of adult rest coupled with social support is religious services that offer “Sunday School.” The service has built-in cues to meditation, the kids make new friends protected by accepting teachers, and the social hour builds social support for the parents.
But we can’t really insert more hours in the day, right? Actually, one of the most valuable suggestions may be for parents to keep a diary of their activities for a few days. The average American in 2015 clocked 147 minutes watching TV, 103 minutes in front of a computer, 151 minutes on smart phones, and 43 minutes with a tablet. These time wasters may not only not feel satisfying or even relaxing, but even prompt anxiety or envy, and certainly take away from sleep, exercise, and intimacy. The American Academy of Pediatrics recently provided a Media Calculator and Family Media Plan intended to help families consider these choices for their child’s media life within all the other required activities of a day (including sleep), but adults could benefit from the same approach to making decisions about how they budget their time.
By mapping out actual time spent, parents can then reevaluate and choose differently. A useful question we might ask frazzled parents is “What fills your tank?” to help them come up with a list of activities that (used to be) regenerative to put on the new schedule. Most people blurt out “go on a cruise” (not practical) when “token” activities can suffice and be immediately possible. Coach them to be creative! Instead of a cruise, take a walk around the block; instead of going to a spa, request a back rub at bedtime; instead of a movie, watch a YouTube clip. When allowing oneself to be fully present to such “tokens,” they can have immense value. The practice of mindfulness (for which many training apps are available) can heighten awareness of each moment and expand the sense of time. Meditation and yoga training both are proven to provide benefits for relaxation and well-being that can be fit into anyone’s day.
While this column is intended to help with pediatric practice, I’ll bet you thought I was talking about you! With the pace of current health care practice and emphasis on “productivity,” many pediatricians are struggling with balancing time for themselves and their families as well. All the ideas just discussed also apply to you, but maybe, just maybe, you have the resources to insist on limits on work you haven’t seized. Cherishing the years when you have children in your life is for you, too, not just your patients. Remember, “The days are long, but the years are short.”
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News. Email her at pdnews@frontlinemedcom.com.
Raising children is a lot like drinking out of a fire hose. Feeding, cleaning, dressing, transporting, teaching, entertaining, protecting, comforting, and managing one child is demanding, but is increased exponentially by multiple children, a spouse, and a job.
In our dataset of more than 74,900 parents of 0- to 3-year-olds completing a routine previsit questionnaire about the “best” and “hardest” parts of parenting their child, the most frequent spontaneous comment for the hardest part was “time-life balance.” The goal of asking these questions is to broaden the agenda for the pediatric visit to address stresses that are highly relevant to the child’s life in the family, and their current well-being and future outcome. The hardest part also rather succinctly captures the stress I hear every day from parents coming to me not only for health supervision, but especially for child behavior problems.
Setting limits on work to free up more time is not possible for everyone. Many people are grateful to have a job at all or need multiple jobs to make ends meet. They may not be in a position to negotiate for fewer tasks, hours, or roles. But others more fortunate may have fallen into a habit of taking on extra duties, taking work home, or simply not examining where they might set limits to preserve time for themselves and their family.
Working parents may need to prepare themselves for the onslaught when they get home. If the returning parent retreats into TV, the computer, or the bedroom, it makes the children feel angry and rejected. The parent who has been managing the household for the preceding hour(s) feels resentful, unappreciated, and often exhausted. I sometimes suggest that the returning parent pause 15 minutes to take a walk before picking children up at day care or go to the gym before coming home to be ready to engage, accept, and be present for whatever happens when they open the door.
Eliciting the “hardest part” can insert a pause for some much-needed problem-solving. Pointing out to parents the value to their child of working on their own time-life balance often gives them needed permission to make changes.
Balancing time for some parents may include setting some privacy for “alone time.” Individual desire to be alone varies, but trouble getting it is universal, especially with young children who don’t even respect a closed bathroom door! Given a young child’s need for contact about every 3-5 minutes, parents need to revise their expectations, wait until after bedtime, get some help, learn to do “token” relaxation, or all of these.
Parents often feel guilty for not attending more to their child, but then feel irritable about getting behind on other chores. It can be useful to cite the fact that mothers at home full time typically spend only 20 minutes of exclusive playtime with their child. I regularly prescribe 15 minutes of “special time” daily to break this irritability cycle for both the parent and child. Getting a babysitter does not mean that the parent has to leave the house and the undone laundry. I often suggest to resource-strapped families that they pay an 8-year-old neighbor to play with their kids for an hour several times per week. While not expecting to leave the child alone with such a “sitter,” one could relax in the tub, read a magazine, or make an uninterrupted phone call to a friend with such help.
The same parents feeling the pinch of too little time often are lacking in social support, a major buffer of stress. Sometimes, the solutions overlap. For example, trading play dates with another family by taking all their kids on a regular basis and vice versa requires no money exchange. Several kids playing together are often easier to care for than one’s own with their usual sibling struggles or boredom. And sharing of this kind can build lasting friendships and social support for the adults. Another often forgotten source of adult rest coupled with social support is religious services that offer “Sunday School.” The service has built-in cues to meditation, the kids make new friends protected by accepting teachers, and the social hour builds social support for the parents.
But we can’t really insert more hours in the day, right? Actually, one of the most valuable suggestions may be for parents to keep a diary of their activities for a few days. The average American in 2015 clocked 147 minutes watching TV, 103 minutes in front of a computer, 151 minutes on smart phones, and 43 minutes with a tablet. These time wasters may not only not feel satisfying or even relaxing, but even prompt anxiety or envy, and certainly take away from sleep, exercise, and intimacy. The American Academy of Pediatrics recently provided a Media Calculator and Family Media Plan intended to help families consider these choices for their child’s media life within all the other required activities of a day (including sleep), but adults could benefit from the same approach to making decisions about how they budget their time.
By mapping out actual time spent, parents can then reevaluate and choose differently. A useful question we might ask frazzled parents is “What fills your tank?” to help them come up with a list of activities that (used to be) regenerative to put on the new schedule. Most people blurt out “go on a cruise” (not practical) when “token” activities can suffice and be immediately possible. Coach them to be creative! Instead of a cruise, take a walk around the block; instead of going to a spa, request a back rub at bedtime; instead of a movie, watch a YouTube clip. When allowing oneself to be fully present to such “tokens,” they can have immense value. The practice of mindfulness (for which many training apps are available) can heighten awareness of each moment and expand the sense of time. Meditation and yoga training both are proven to provide benefits for relaxation and well-being that can be fit into anyone’s day.
While this column is intended to help with pediatric practice, I’ll bet you thought I was talking about you! With the pace of current health care practice and emphasis on “productivity,” many pediatricians are struggling with balancing time for themselves and their families as well. All the ideas just discussed also apply to you, but maybe, just maybe, you have the resources to insist on limits on work you haven’t seized. Cherishing the years when you have children in your life is for you, too, not just your patients. Remember, “The days are long, but the years are short.”
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News. Email her at pdnews@frontlinemedcom.com.
Raising children is a lot like drinking out of a fire hose. Feeding, cleaning, dressing, transporting, teaching, entertaining, protecting, comforting, and managing one child is demanding, but is increased exponentially by multiple children, a spouse, and a job.
In our dataset of more than 74,900 parents of 0- to 3-year-olds completing a routine previsit questionnaire about the “best” and “hardest” parts of parenting their child, the most frequent spontaneous comment for the hardest part was “time-life balance.” The goal of asking these questions is to broaden the agenda for the pediatric visit to address stresses that are highly relevant to the child’s life in the family, and their current well-being and future outcome. The hardest part also rather succinctly captures the stress I hear every day from parents coming to me not only for health supervision, but especially for child behavior problems.
Setting limits on work to free up more time is not possible for everyone. Many people are grateful to have a job at all or need multiple jobs to make ends meet. They may not be in a position to negotiate for fewer tasks, hours, or roles. But others more fortunate may have fallen into a habit of taking on extra duties, taking work home, or simply not examining where they might set limits to preserve time for themselves and their family.
Working parents may need to prepare themselves for the onslaught when they get home. If the returning parent retreats into TV, the computer, or the bedroom, it makes the children feel angry and rejected. The parent who has been managing the household for the preceding hour(s) feels resentful, unappreciated, and often exhausted. I sometimes suggest that the returning parent pause 15 minutes to take a walk before picking children up at day care or go to the gym before coming home to be ready to engage, accept, and be present for whatever happens when they open the door.
Eliciting the “hardest part” can insert a pause for some much-needed problem-solving. Pointing out to parents the value to their child of working on their own time-life balance often gives them needed permission to make changes.
Balancing time for some parents may include setting some privacy for “alone time.” Individual desire to be alone varies, but trouble getting it is universal, especially with young children who don’t even respect a closed bathroom door! Given a young child’s need for contact about every 3-5 minutes, parents need to revise their expectations, wait until after bedtime, get some help, learn to do “token” relaxation, or all of these.
Parents often feel guilty for not attending more to their child, but then feel irritable about getting behind on other chores. It can be useful to cite the fact that mothers at home full time typically spend only 20 minutes of exclusive playtime with their child. I regularly prescribe 15 minutes of “special time” daily to break this irritability cycle for both the parent and child. Getting a babysitter does not mean that the parent has to leave the house and the undone laundry. I often suggest to resource-strapped families that they pay an 8-year-old neighbor to play with their kids for an hour several times per week. While not expecting to leave the child alone with such a “sitter,” one could relax in the tub, read a magazine, or make an uninterrupted phone call to a friend with such help.
The same parents feeling the pinch of too little time often are lacking in social support, a major buffer of stress. Sometimes, the solutions overlap. For example, trading play dates with another family by taking all their kids on a regular basis and vice versa requires no money exchange. Several kids playing together are often easier to care for than one’s own with their usual sibling struggles or boredom. And sharing of this kind can build lasting friendships and social support for the adults. Another often forgotten source of adult rest coupled with social support is religious services that offer “Sunday School.” The service has built-in cues to meditation, the kids make new friends protected by accepting teachers, and the social hour builds social support for the parents.
But we can’t really insert more hours in the day, right? Actually, one of the most valuable suggestions may be for parents to keep a diary of their activities for a few days. The average American in 2015 clocked 147 minutes watching TV, 103 minutes in front of a computer, 151 minutes on smart phones, and 43 minutes with a tablet. These time wasters may not only not feel satisfying or even relaxing, but even prompt anxiety or envy, and certainly take away from sleep, exercise, and intimacy. The American Academy of Pediatrics recently provided a Media Calculator and Family Media Plan intended to help families consider these choices for their child’s media life within all the other required activities of a day (including sleep), but adults could benefit from the same approach to making decisions about how they budget their time.
By mapping out actual time spent, parents can then reevaluate and choose differently. A useful question we might ask frazzled parents is “What fills your tank?” to help them come up with a list of activities that (used to be) regenerative to put on the new schedule. Most people blurt out “go on a cruise” (not practical) when “token” activities can suffice and be immediately possible. Coach them to be creative! Instead of a cruise, take a walk around the block; instead of going to a spa, request a back rub at bedtime; instead of a movie, watch a YouTube clip. When allowing oneself to be fully present to such “tokens,” they can have immense value. The practice of mindfulness (for which many training apps are available) can heighten awareness of each moment and expand the sense of time. Meditation and yoga training both are proven to provide benefits for relaxation and well-being that can be fit into anyone’s day.
While this column is intended to help with pediatric practice, I’ll bet you thought I was talking about you! With the pace of current health care practice and emphasis on “productivity,” many pediatricians are struggling with balancing time for themselves and their families as well. All the ideas just discussed also apply to you, but maybe, just maybe, you have the resources to insist on limits on work you haven’t seized. Cherishing the years when you have children in your life is for you, too, not just your patients. Remember, “The days are long, but the years are short.”
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to Frontline Medical News. Email her at pdnews@frontlinemedcom.com.
Brodalumab approved for psoriasis with REMS required
The Food and Drug Administration has approved brodalumab, an interleukin-17 receptor A-antagonist, for treating adults with moderate to severe plaque psoriasis, with a Risk Evaluation and Mitigation Strategy (REMS) that addresses the “observed risk of suicidal ideation and behavior” in clinical trials, the agency announced on Feb. 16.
In the three pivotal phase III studies of 4,373 adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy, 83%-86% of those treated with brodalumab achieved Psoriasis Area and Severity Index (PASI 75) scores at 12 weeks of treatment, compared with 3%-8% of those on placebo. In addition, 37%-44% of those on brodalumab achieved PASI 100 scores, compared with 1% or fewer of those on placebo. In the psoriasis clinical trials, suicidal ideation and behavior, which included four completed suicides, occurred in patients treated with brodalumab, according to the prescribing information
In the statement, the FDA points out that “a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established,” but that “suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq during clinical trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior, compared to users without this history.”
At a meeting in July 2016, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 18-0 in favor of approving brodalumab, with the majority (14) recommending risk management options beyond labeling to address these concerns.
Elements of the REMS include requirements for prescribers, pharmacy certification, and a medication guide for patients with information about the risks of suicidal ideation and behavior. Prescribers are required to counsel patients about this risk, and patients are required to sign a “Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes,” the FDA said. The prescribing information also includes a boxed warning about suicidal ideation and behavior.
The most common adverse events associated with brodalumab, the FDA statement noted, include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, neutropenia, and fungal infections. The recommended dose of brodalumab is 210 mg, administered subcutaneously, at weeks 0, 1, and 2, followed by 210 mg every 2 weeks.
The Food and Drug Administration has approved brodalumab, an interleukin-17 receptor A-antagonist, for treating adults with moderate to severe plaque psoriasis, with a Risk Evaluation and Mitigation Strategy (REMS) that addresses the “observed risk of suicidal ideation and behavior” in clinical trials, the agency announced on Feb. 16.
In the three pivotal phase III studies of 4,373 adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy, 83%-86% of those treated with brodalumab achieved Psoriasis Area and Severity Index (PASI 75) scores at 12 weeks of treatment, compared with 3%-8% of those on placebo. In addition, 37%-44% of those on brodalumab achieved PASI 100 scores, compared with 1% or fewer of those on placebo. In the psoriasis clinical trials, suicidal ideation and behavior, which included four completed suicides, occurred in patients treated with brodalumab, according to the prescribing information
In the statement, the FDA points out that “a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established,” but that “suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq during clinical trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior, compared to users without this history.”
At a meeting in July 2016, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 18-0 in favor of approving brodalumab, with the majority (14) recommending risk management options beyond labeling to address these concerns.
Elements of the REMS include requirements for prescribers, pharmacy certification, and a medication guide for patients with information about the risks of suicidal ideation and behavior. Prescribers are required to counsel patients about this risk, and patients are required to sign a “Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes,” the FDA said. The prescribing information also includes a boxed warning about suicidal ideation and behavior.
The most common adverse events associated with brodalumab, the FDA statement noted, include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, neutropenia, and fungal infections. The recommended dose of brodalumab is 210 mg, administered subcutaneously, at weeks 0, 1, and 2, followed by 210 mg every 2 weeks.
The Food and Drug Administration has approved brodalumab, an interleukin-17 receptor A-antagonist, for treating adults with moderate to severe plaque psoriasis, with a Risk Evaluation and Mitigation Strategy (REMS) that addresses the “observed risk of suicidal ideation and behavior” in clinical trials, the agency announced on Feb. 16.
In the three pivotal phase III studies of 4,373 adults with moderate to severe plaque psoriasis who were candidates for systemic therapy or phototherapy, 83%-86% of those treated with brodalumab achieved Psoriasis Area and Severity Index (PASI 75) scores at 12 weeks of treatment, compared with 3%-8% of those on placebo. In addition, 37%-44% of those on brodalumab achieved PASI 100 scores, compared with 1% or fewer of those on placebo. In the psoriasis clinical trials, suicidal ideation and behavior, which included four completed suicides, occurred in patients treated with brodalumab, according to the prescribing information
In the statement, the FDA points out that “a causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established,” but that “suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq during clinical trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior, compared to users without this history.”
At a meeting in July 2016, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 18-0 in favor of approving brodalumab, with the majority (14) recommending risk management options beyond labeling to address these concerns.
Elements of the REMS include requirements for prescribers, pharmacy certification, and a medication guide for patients with information about the risks of suicidal ideation and behavior. Prescribers are required to counsel patients about this risk, and patients are required to sign a “Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes,” the FDA said. The prescribing information also includes a boxed warning about suicidal ideation and behavior.
The most common adverse events associated with brodalumab, the FDA statement noted, include arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, neutropenia, and fungal infections. The recommended dose of brodalumab is 210 mg, administered subcutaneously, at weeks 0, 1, and 2, followed by 210 mg every 2 weeks.
Vitamin D reduces respiratory infection risk
Administering doses of a vitamin D supplement to patients can significantly mitigate their risk of developing acute respiratory tract infections, according to a recent study published by the BMJ.
“[Existing] epidemiological and in vitro data have prompted numerous randomized controlled trials to determine whether vitamin D supplementation can decrease the risk of acute respiratory tract infection,” wrote the authors of the study, led by Adrian R. Martineau, PhD, of Queen Mary University of London. “A total of five aggregate data meta-analyses incorporating data from up to 15 primary trials have been conducted to date [but] all but one of these aggregate data meta-analyses reported statistically significant heterogeneity of effect between primary trials.”
A total of 532 studies were reviewed by a panel, of which 25 studies were ultimately selected for inclusion in this analysis. The studies included were of varying lengths in terms of trial periods and involved a total of 11,321 subjects ranging from 0 to 95 years of age. Of these, 10,933 (96.6%) subjects experienced at least one acute respiratory tract infection.
No significant benefit was found in subjects who had already experienced an infection, yielding an odds ratio of 0.98 (95% CI, 0.80-1.20; P = .83). Analysis performed to quantify the risk of infection with or without Vitamin D showed that taking Vitamin D supplements significantly decreased infection risk, with an OR of 0.88 (95% CI, 0.81-0.96; P less than .001) after adjusting for age, sex, and the duration of the trial.
Results also demonstrated that bolus doses of Vitamin D did not offer any beneficial value to subjects. Those who received daily or weekly doses without bolus had a better OR, compared with those who did receive at least one bolus dose: 0.81 (95% CI, 0.72-0.91) versus 0.97 (95% CI, 0.86-1.10), respectively (P = .05). Individuals whose baseline 25-hydroxyvitamin D levels were lower than 25 nanomols per liter experienced a greater benefit than those whose levels were above 25: OR = 0.30 (95% CI, 0.17-0.53) and OR = 0.75 (95% CI, 0.60-0.95), respectively (P = .006).
“Our study reports a major new indication for vitamin D supplementation: the prevention of acute respiratory tract infection,” Dr. Martineau and his coauthors concluded, adding that a potential application for these findings would be “the introduction of public health measures such as food fortification to improve vitamin D status, particularly in settings where profound vitamin D deficiency is common.”
The study was funded by a grant from the National Institute of Health Research. Dr. Martineau and his coauthors did not report any relevant financial disclosures.
While the work undertaken by Dr. Martineau et al. is commendable, the results themselves are ultimately underwhelming. The study’s results are too heterogeneous and offer too slight a reduction in overall risk to justify a complete overhaul of clinical procedure and prescribing protocols. These findings should not change clinical practice in any significant way, and there are other groups of individuals, such as those with low serum concentrations of vitamin D, that were omitted from this analysis altogether.
Mark J. Bolland is an associate professor of medicine at the University of Auckland (New Zealand). Alison Avenell is a professor at the University of Aberdeen (Scotland).
While the work undertaken by Dr. Martineau et al. is commendable, the results themselves are ultimately underwhelming. The study’s results are too heterogeneous and offer too slight a reduction in overall risk to justify a complete overhaul of clinical procedure and prescribing protocols. These findings should not change clinical practice in any significant way, and there are other groups of individuals, such as those with low serum concentrations of vitamin D, that were omitted from this analysis altogether.
Mark J. Bolland is an associate professor of medicine at the University of Auckland (New Zealand). Alison Avenell is a professor at the University of Aberdeen (Scotland).
While the work undertaken by Dr. Martineau et al. is commendable, the results themselves are ultimately underwhelming. The study’s results are too heterogeneous and offer too slight a reduction in overall risk to justify a complete overhaul of clinical procedure and prescribing protocols. These findings should not change clinical practice in any significant way, and there are other groups of individuals, such as those with low serum concentrations of vitamin D, that were omitted from this analysis altogether.
Mark J. Bolland is an associate professor of medicine at the University of Auckland (New Zealand). Alison Avenell is a professor at the University of Aberdeen (Scotland).
Administering doses of a vitamin D supplement to patients can significantly mitigate their risk of developing acute respiratory tract infections, according to a recent study published by the BMJ.
“[Existing] epidemiological and in vitro data have prompted numerous randomized controlled trials to determine whether vitamin D supplementation can decrease the risk of acute respiratory tract infection,” wrote the authors of the study, led by Adrian R. Martineau, PhD, of Queen Mary University of London. “A total of five aggregate data meta-analyses incorporating data from up to 15 primary trials have been conducted to date [but] all but one of these aggregate data meta-analyses reported statistically significant heterogeneity of effect between primary trials.”
A total of 532 studies were reviewed by a panel, of which 25 studies were ultimately selected for inclusion in this analysis. The studies included were of varying lengths in terms of trial periods and involved a total of 11,321 subjects ranging from 0 to 95 years of age. Of these, 10,933 (96.6%) subjects experienced at least one acute respiratory tract infection.
No significant benefit was found in subjects who had already experienced an infection, yielding an odds ratio of 0.98 (95% CI, 0.80-1.20; P = .83). Analysis performed to quantify the risk of infection with or without Vitamin D showed that taking Vitamin D supplements significantly decreased infection risk, with an OR of 0.88 (95% CI, 0.81-0.96; P less than .001) after adjusting for age, sex, and the duration of the trial.
Results also demonstrated that bolus doses of Vitamin D did not offer any beneficial value to subjects. Those who received daily or weekly doses without bolus had a better OR, compared with those who did receive at least one bolus dose: 0.81 (95% CI, 0.72-0.91) versus 0.97 (95% CI, 0.86-1.10), respectively (P = .05). Individuals whose baseline 25-hydroxyvitamin D levels were lower than 25 nanomols per liter experienced a greater benefit than those whose levels were above 25: OR = 0.30 (95% CI, 0.17-0.53) and OR = 0.75 (95% CI, 0.60-0.95), respectively (P = .006).
“Our study reports a major new indication for vitamin D supplementation: the prevention of acute respiratory tract infection,” Dr. Martineau and his coauthors concluded, adding that a potential application for these findings would be “the introduction of public health measures such as food fortification to improve vitamin D status, particularly in settings where profound vitamin D deficiency is common.”
The study was funded by a grant from the National Institute of Health Research. Dr. Martineau and his coauthors did not report any relevant financial disclosures.
Administering doses of a vitamin D supplement to patients can significantly mitigate their risk of developing acute respiratory tract infections, according to a recent study published by the BMJ.
“[Existing] epidemiological and in vitro data have prompted numerous randomized controlled trials to determine whether vitamin D supplementation can decrease the risk of acute respiratory tract infection,” wrote the authors of the study, led by Adrian R. Martineau, PhD, of Queen Mary University of London. “A total of five aggregate data meta-analyses incorporating data from up to 15 primary trials have been conducted to date [but] all but one of these aggregate data meta-analyses reported statistically significant heterogeneity of effect between primary trials.”
A total of 532 studies were reviewed by a panel, of which 25 studies were ultimately selected for inclusion in this analysis. The studies included were of varying lengths in terms of trial periods and involved a total of 11,321 subjects ranging from 0 to 95 years of age. Of these, 10,933 (96.6%) subjects experienced at least one acute respiratory tract infection.
No significant benefit was found in subjects who had already experienced an infection, yielding an odds ratio of 0.98 (95% CI, 0.80-1.20; P = .83). Analysis performed to quantify the risk of infection with or without Vitamin D showed that taking Vitamin D supplements significantly decreased infection risk, with an OR of 0.88 (95% CI, 0.81-0.96; P less than .001) after adjusting for age, sex, and the duration of the trial.
Results also demonstrated that bolus doses of Vitamin D did not offer any beneficial value to subjects. Those who received daily or weekly doses without bolus had a better OR, compared with those who did receive at least one bolus dose: 0.81 (95% CI, 0.72-0.91) versus 0.97 (95% CI, 0.86-1.10), respectively (P = .05). Individuals whose baseline 25-hydroxyvitamin D levels were lower than 25 nanomols per liter experienced a greater benefit than those whose levels were above 25: OR = 0.30 (95% CI, 0.17-0.53) and OR = 0.75 (95% CI, 0.60-0.95), respectively (P = .006).
“Our study reports a major new indication for vitamin D supplementation: the prevention of acute respiratory tract infection,” Dr. Martineau and his coauthors concluded, adding that a potential application for these findings would be “the introduction of public health measures such as food fortification to improve vitamin D status, particularly in settings where profound vitamin D deficiency is common.”
The study was funded by a grant from the National Institute of Health Research. Dr. Martineau and his coauthors did not report any relevant financial disclosures.
Key clinical point:
Major finding: For those receiving vitamin D, the odds ratio of reducing respiratory infection risk was 0.88 (P less than .001).
Data source: Systematic review and meta-analysis of data on 11,321 subjects taken from 25 different trials.
Disclosures: Funded by the National Institute for Health Research; authors reported no relevant financial disclosures.
Methotrexate for RA: A 'fascinating drug’
SNOWMASS, COLO. – “When I started working with methotrexate in 1982, I never would have predicted that methotrexate would become the standard of care in treating rheumatoid arthritis. There’s just no way,” Michael E. Weinblatt, MD, recalled at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
“Even now, 35 years later, we continue to learn more about this fascinating drug,” added Dr. Weinblatt, professor of medicine at Harvard Medical School, Boston.
He highlighted recent developments in this ongoing story and presented some tricks of the trade gained in 35 years of up-close experience with the drug.
Enhancing effectiveness of biologics
One of the hottest topics in methotrexate research is the drug’s ability to enhance the effectiveness of many, but not all, biologic agents. All of the anti–tumor necrosis factor (anti-TNF) biologics as well as rituximab (Rituxan) are demonstrably more effective when used in combination with methotrexate. Dr. Weinblatt considers the widespread underutilization of this combination strategy scandalous.
“This is an incredibly important point: All of you use biologics and all of you use methotrexate, but I’ve been depressed by the fact that up to 30%-40% of patients – no matter which data set you look at – are on monotherapy biological therapy,” he said.
He cited data from the ongoing BRASS Registry (Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Registry) to underscore his point that good things happen when biologics and methotrexate are used together. Of 1,395 BRASS Registry participants prospectively followed since 2003, the proportion on biologic therapy has climbed steadily from 41% at the outset to 68% in 2016. Remarkably, 82% of patients on biologic therapy remain on their first biologic agent. Fewer than 4% have switched biologics more than twice. That’s very unlike the experiences reported elsewhere.
“I think one of the reasons we have such positive data is that we have a high percentage of patients staying on their background methotrexate,” said Dr. Weinblatt, codirector of clinical rheumatology and associate director of the Center for Arthritis and Joint Diseases at Brigham and Women’s Hospital, Boston.
He noted that Dutch investigators reported at the 2016 annual meeting of the American College of Rheumatology that among 1,230 consecutive rheumatoid arthritis patients started on etanercept (Enbrel) or adalimumab (Humira), 28% in the etanercept group were on concomitant methotrexate, as were 64% of those who started on adalimumab. The patients spent a median of 1.3-1.6 years and a maximum of 9.2-9.3 years on their biologic agent. Patients on adalimumab monotherapy were 2.61-fold more likely to drop out than were those on dual therapy with methotrexate. Patients on etanercept monotherapy were 1.2-fold more likely to drop out, a difference that didn’t achieve statistical significance.
Although the investigators did not study the mechanism of prolonged on-treatment survival, they speculated that it probably involved methotrexate’s documented ability to prevent formation of anti-adalimumab antibodies. In contrast, patients on etanercept don’t develop blocking antibodies, Dr. Weinblatt observed.
The randomized, double-blind CONCERTO trial conducted in 395 methotrexate- and biologic-naive RA patients demonstrated that methotrexate reduces the immunogenicity of adalimumab in dose-dependent fashion. Participants were randomized to open-label adalimumab at 40 mg every 2 weeks plus weekly double-blind methotrexate at 2.5, 5, 10, or 20 mg. Clinical outcomes at 26 weeks as reflected in 28-joint count disease activity score and the Clinical Disease Activity Index were significantly better in patients on 10 or 20 mg/week of methotrexate than in those on 2.5 or 5 mg/week. Serum adalimumab levels were higher in patients on the two higher doses of methotrexate as well (Ann Rheum Dis. 2015 Jun;74[6]:1037-44).
“It ends up that if you don’t use methotrexate or you use a very low dose you increase the risk of developing antibodies against adalimumab and decrease the efficacy of the drug. So in clinical practice, if you’re going to be working with dose titration of methotrexate and your patient is on adalimumab, there’s a threshold below which you probably shouldn’t go. In this study, doses of 10 mg/week or more induced a greater clinical response,” he said.
With infliximab (Remicade), based upon 20-year-old studies, the threshold is 7.5 mg of methotrexate per week.
“With etanercept, we don’t know what the threshold is. You don’t develop blocking anti-drug antibodies with etanercept, but we do know that methotrexate enhances the efficacy of etanercept, and it doesn’t do it by changing the biologic’s pharmacokinetics and there’s no increase in methotrexate blood levels,” the rheumatologist continued.
Unlike the anti-TNF biologics and rituximab, the efficacy of the Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib is not enhanced when the drugs are used in combination with methotrexate, studies indicate.
The efficacy of certolizumab pegol (Cimzia) wasn’t affected by methotrexate dose category in a prespecified pooled subgroup analysis of the phase III RAPID 1 and RAPID 2 clinical trials. In the 1,273 certolizumab-treated patients, the week-24 treatment response was similar regardless of whether patients were on methotrexate at 10 mg/week or less, 10-15 mg/week, or more than 15 mg/week. The investigators concluded that to minimize treatment-emergent adverse events, physicians can tailor background methotrexate dosing based upon individual patient tolerance without affecting certolizumab’s efficacy (Arthritis Care Res [Hoboken]. 2016 Mar;68[3]:299-307).
An important aspect of this analysis was that among the 325 subjects randomized to placebo rather than certolizumab, the treatment response at week 24 was significantly better in those on more than 15 mg/week of methotrexate than with lower doses of the drug.
“Most patients on methotrexate need more than 15 mg/week. So it astonishes me that such a high percentage of patients enrolled in clinical trials around the world are on, like, 14 mg/week. I mean, most patients need somewhere between 15 and 25 mg/week for a response, although over time you might be able to decrease that dose,” Dr. Weinblatt said.
Side effects of methotrexate
“The biggest issue with methotrexate is the tolerability problem, since serious adverse events are incredibly rare with this molecule,” he said.
Hepatotoxicity is a concern, but Dr. Weinblatt emphasized that elevated liver function tests do not equal cirrhosis.
“Historically, during the first 6 months on methotrexate 20%-25% of patients increase their transaminases in every clinical trial where that’s been looked at. Over time, the liver compensates for the drug. But 5%-6% of patients experience repeated moderate elevations more than 1.5 times the upper limit of normal,” he said.
Key risk factors for methotrexate-related hepatotoxicity were identified in a national observational cohort study of 659 military veterans over age 65 when they started methotrexate for rheumatic diseases. The investigators found a 6% incidence of moderately elevated liver enzymes during a mean follow-up period of 7 months. Obesity was associated with a 1.9-fold increased risk, a serum total cholesterol greater than 240 mg/dL conferred a 5.8-fold elevated risk, and abnormal liver function tests at baseline were associated with a 3.2-fold increased risk (Arthritis Care Res [Hoboken]. 2014 Aug;66[8]:1159-66).
“No surprise: It’s patients who weigh more who are at increased risk for methotrexate-related transaminase increases. I actually think the biggest factor with regard to methotrexate liver disease is the patient’s [body mass index]. Patients in North America aren’t getting any slimmer, so you need to look at this with your patients. If you have a morbidly obese patient on methotrexate whose transaminases suddenly start going up, that’s the patient who’s at greatest risk for methotrexate hepatotoxicity,” he cautioned.
The 3.2-fold increased risk of repeated elevated transaminases associated with abnormal baseline liver function tests in the Veterans Affairs study should be a red flag for rheumatologists.
“I personally think patients shouldn’t start on methotrexate if they have elevated transaminases. They ought to be normal at the start. There are too many other good options now to treat our patients,” Dr. Weinblatt said.
He reported receiving research grants from half a dozen companies and serving as a consultant to more than two dozen.
SNOWMASS, COLO. – “When I started working with methotrexate in 1982, I never would have predicted that methotrexate would become the standard of care in treating rheumatoid arthritis. There’s just no way,” Michael E. Weinblatt, MD, recalled at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
“Even now, 35 years later, we continue to learn more about this fascinating drug,” added Dr. Weinblatt, professor of medicine at Harvard Medical School, Boston.
He highlighted recent developments in this ongoing story and presented some tricks of the trade gained in 35 years of up-close experience with the drug.
Enhancing effectiveness of biologics
One of the hottest topics in methotrexate research is the drug’s ability to enhance the effectiveness of many, but not all, biologic agents. All of the anti–tumor necrosis factor (anti-TNF) biologics as well as rituximab (Rituxan) are demonstrably more effective when used in combination with methotrexate. Dr. Weinblatt considers the widespread underutilization of this combination strategy scandalous.
“This is an incredibly important point: All of you use biologics and all of you use methotrexate, but I’ve been depressed by the fact that up to 30%-40% of patients – no matter which data set you look at – are on monotherapy biological therapy,” he said.
He cited data from the ongoing BRASS Registry (Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Registry) to underscore his point that good things happen when biologics and methotrexate are used together. Of 1,395 BRASS Registry participants prospectively followed since 2003, the proportion on biologic therapy has climbed steadily from 41% at the outset to 68% in 2016. Remarkably, 82% of patients on biologic therapy remain on their first biologic agent. Fewer than 4% have switched biologics more than twice. That’s very unlike the experiences reported elsewhere.
“I think one of the reasons we have such positive data is that we have a high percentage of patients staying on their background methotrexate,” said Dr. Weinblatt, codirector of clinical rheumatology and associate director of the Center for Arthritis and Joint Diseases at Brigham and Women’s Hospital, Boston.
He noted that Dutch investigators reported at the 2016 annual meeting of the American College of Rheumatology that among 1,230 consecutive rheumatoid arthritis patients started on etanercept (Enbrel) or adalimumab (Humira), 28% in the etanercept group were on concomitant methotrexate, as were 64% of those who started on adalimumab. The patients spent a median of 1.3-1.6 years and a maximum of 9.2-9.3 years on their biologic agent. Patients on adalimumab monotherapy were 2.61-fold more likely to drop out than were those on dual therapy with methotrexate. Patients on etanercept monotherapy were 1.2-fold more likely to drop out, a difference that didn’t achieve statistical significance.
Although the investigators did not study the mechanism of prolonged on-treatment survival, they speculated that it probably involved methotrexate’s documented ability to prevent formation of anti-adalimumab antibodies. In contrast, patients on etanercept don’t develop blocking antibodies, Dr. Weinblatt observed.
The randomized, double-blind CONCERTO trial conducted in 395 methotrexate- and biologic-naive RA patients demonstrated that methotrexate reduces the immunogenicity of adalimumab in dose-dependent fashion. Participants were randomized to open-label adalimumab at 40 mg every 2 weeks plus weekly double-blind methotrexate at 2.5, 5, 10, or 20 mg. Clinical outcomes at 26 weeks as reflected in 28-joint count disease activity score and the Clinical Disease Activity Index were significantly better in patients on 10 or 20 mg/week of methotrexate than in those on 2.5 or 5 mg/week. Serum adalimumab levels were higher in patients on the two higher doses of methotrexate as well (Ann Rheum Dis. 2015 Jun;74[6]:1037-44).
“It ends up that if you don’t use methotrexate or you use a very low dose you increase the risk of developing antibodies against adalimumab and decrease the efficacy of the drug. So in clinical practice, if you’re going to be working with dose titration of methotrexate and your patient is on adalimumab, there’s a threshold below which you probably shouldn’t go. In this study, doses of 10 mg/week or more induced a greater clinical response,” he said.
With infliximab (Remicade), based upon 20-year-old studies, the threshold is 7.5 mg of methotrexate per week.
“With etanercept, we don’t know what the threshold is. You don’t develop blocking anti-drug antibodies with etanercept, but we do know that methotrexate enhances the efficacy of etanercept, and it doesn’t do it by changing the biologic’s pharmacokinetics and there’s no increase in methotrexate blood levels,” the rheumatologist continued.
Unlike the anti-TNF biologics and rituximab, the efficacy of the Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib is not enhanced when the drugs are used in combination with methotrexate, studies indicate.
The efficacy of certolizumab pegol (Cimzia) wasn’t affected by methotrexate dose category in a prespecified pooled subgroup analysis of the phase III RAPID 1 and RAPID 2 clinical trials. In the 1,273 certolizumab-treated patients, the week-24 treatment response was similar regardless of whether patients were on methotrexate at 10 mg/week or less, 10-15 mg/week, or more than 15 mg/week. The investigators concluded that to minimize treatment-emergent adverse events, physicians can tailor background methotrexate dosing based upon individual patient tolerance without affecting certolizumab’s efficacy (Arthritis Care Res [Hoboken]. 2016 Mar;68[3]:299-307).
An important aspect of this analysis was that among the 325 subjects randomized to placebo rather than certolizumab, the treatment response at week 24 was significantly better in those on more than 15 mg/week of methotrexate than with lower doses of the drug.
“Most patients on methotrexate need more than 15 mg/week. So it astonishes me that such a high percentage of patients enrolled in clinical trials around the world are on, like, 14 mg/week. I mean, most patients need somewhere between 15 and 25 mg/week for a response, although over time you might be able to decrease that dose,” Dr. Weinblatt said.
Side effects of methotrexate
“The biggest issue with methotrexate is the tolerability problem, since serious adverse events are incredibly rare with this molecule,” he said.
Hepatotoxicity is a concern, but Dr. Weinblatt emphasized that elevated liver function tests do not equal cirrhosis.
“Historically, during the first 6 months on methotrexate 20%-25% of patients increase their transaminases in every clinical trial where that’s been looked at. Over time, the liver compensates for the drug. But 5%-6% of patients experience repeated moderate elevations more than 1.5 times the upper limit of normal,” he said.
Key risk factors for methotrexate-related hepatotoxicity were identified in a national observational cohort study of 659 military veterans over age 65 when they started methotrexate for rheumatic diseases. The investigators found a 6% incidence of moderately elevated liver enzymes during a mean follow-up period of 7 months. Obesity was associated with a 1.9-fold increased risk, a serum total cholesterol greater than 240 mg/dL conferred a 5.8-fold elevated risk, and abnormal liver function tests at baseline were associated with a 3.2-fold increased risk (Arthritis Care Res [Hoboken]. 2014 Aug;66[8]:1159-66).
“No surprise: It’s patients who weigh more who are at increased risk for methotrexate-related transaminase increases. I actually think the biggest factor with regard to methotrexate liver disease is the patient’s [body mass index]. Patients in North America aren’t getting any slimmer, so you need to look at this with your patients. If you have a morbidly obese patient on methotrexate whose transaminases suddenly start going up, that’s the patient who’s at greatest risk for methotrexate hepatotoxicity,” he cautioned.
The 3.2-fold increased risk of repeated elevated transaminases associated with abnormal baseline liver function tests in the Veterans Affairs study should be a red flag for rheumatologists.
“I personally think patients shouldn’t start on methotrexate if they have elevated transaminases. They ought to be normal at the start. There are too many other good options now to treat our patients,” Dr. Weinblatt said.
He reported receiving research grants from half a dozen companies and serving as a consultant to more than two dozen.
SNOWMASS, COLO. – “When I started working with methotrexate in 1982, I never would have predicted that methotrexate would become the standard of care in treating rheumatoid arthritis. There’s just no way,” Michael E. Weinblatt, MD, recalled at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
“Even now, 35 years later, we continue to learn more about this fascinating drug,” added Dr. Weinblatt, professor of medicine at Harvard Medical School, Boston.
He highlighted recent developments in this ongoing story and presented some tricks of the trade gained in 35 years of up-close experience with the drug.
Enhancing effectiveness of biologics
One of the hottest topics in methotrexate research is the drug’s ability to enhance the effectiveness of many, but not all, biologic agents. All of the anti–tumor necrosis factor (anti-TNF) biologics as well as rituximab (Rituxan) are demonstrably more effective when used in combination with methotrexate. Dr. Weinblatt considers the widespread underutilization of this combination strategy scandalous.
“This is an incredibly important point: All of you use biologics and all of you use methotrexate, but I’ve been depressed by the fact that up to 30%-40% of patients – no matter which data set you look at – are on monotherapy biological therapy,” he said.
He cited data from the ongoing BRASS Registry (Brigham and Women’s Hospital Rheumatoid Arthritis Sequential Registry) to underscore his point that good things happen when biologics and methotrexate are used together. Of 1,395 BRASS Registry participants prospectively followed since 2003, the proportion on biologic therapy has climbed steadily from 41% at the outset to 68% in 2016. Remarkably, 82% of patients on biologic therapy remain on their first biologic agent. Fewer than 4% have switched biologics more than twice. That’s very unlike the experiences reported elsewhere.
“I think one of the reasons we have such positive data is that we have a high percentage of patients staying on their background methotrexate,” said Dr. Weinblatt, codirector of clinical rheumatology and associate director of the Center for Arthritis and Joint Diseases at Brigham and Women’s Hospital, Boston.
He noted that Dutch investigators reported at the 2016 annual meeting of the American College of Rheumatology that among 1,230 consecutive rheumatoid arthritis patients started on etanercept (Enbrel) or adalimumab (Humira), 28% in the etanercept group were on concomitant methotrexate, as were 64% of those who started on adalimumab. The patients spent a median of 1.3-1.6 years and a maximum of 9.2-9.3 years on their biologic agent. Patients on adalimumab monotherapy were 2.61-fold more likely to drop out than were those on dual therapy with methotrexate. Patients on etanercept monotherapy were 1.2-fold more likely to drop out, a difference that didn’t achieve statistical significance.
Although the investigators did not study the mechanism of prolonged on-treatment survival, they speculated that it probably involved methotrexate’s documented ability to prevent formation of anti-adalimumab antibodies. In contrast, patients on etanercept don’t develop blocking antibodies, Dr. Weinblatt observed.
The randomized, double-blind CONCERTO trial conducted in 395 methotrexate- and biologic-naive RA patients demonstrated that methotrexate reduces the immunogenicity of adalimumab in dose-dependent fashion. Participants were randomized to open-label adalimumab at 40 mg every 2 weeks plus weekly double-blind methotrexate at 2.5, 5, 10, or 20 mg. Clinical outcomes at 26 weeks as reflected in 28-joint count disease activity score and the Clinical Disease Activity Index were significantly better in patients on 10 or 20 mg/week of methotrexate than in those on 2.5 or 5 mg/week. Serum adalimumab levels were higher in patients on the two higher doses of methotrexate as well (Ann Rheum Dis. 2015 Jun;74[6]:1037-44).
“It ends up that if you don’t use methotrexate or you use a very low dose you increase the risk of developing antibodies against adalimumab and decrease the efficacy of the drug. So in clinical practice, if you’re going to be working with dose titration of methotrexate and your patient is on adalimumab, there’s a threshold below which you probably shouldn’t go. In this study, doses of 10 mg/week or more induced a greater clinical response,” he said.
With infliximab (Remicade), based upon 20-year-old studies, the threshold is 7.5 mg of methotrexate per week.
“With etanercept, we don’t know what the threshold is. You don’t develop blocking anti-drug antibodies with etanercept, but we do know that methotrexate enhances the efficacy of etanercept, and it doesn’t do it by changing the biologic’s pharmacokinetics and there’s no increase in methotrexate blood levels,” the rheumatologist continued.
Unlike the anti-TNF biologics and rituximab, the efficacy of the Janus kinase inhibitors tofacitinib (Xeljanz) and baricitinib is not enhanced when the drugs are used in combination with methotrexate, studies indicate.
The efficacy of certolizumab pegol (Cimzia) wasn’t affected by methotrexate dose category in a prespecified pooled subgroup analysis of the phase III RAPID 1 and RAPID 2 clinical trials. In the 1,273 certolizumab-treated patients, the week-24 treatment response was similar regardless of whether patients were on methotrexate at 10 mg/week or less, 10-15 mg/week, or more than 15 mg/week. The investigators concluded that to minimize treatment-emergent adverse events, physicians can tailor background methotrexate dosing based upon individual patient tolerance without affecting certolizumab’s efficacy (Arthritis Care Res [Hoboken]. 2016 Mar;68[3]:299-307).
An important aspect of this analysis was that among the 325 subjects randomized to placebo rather than certolizumab, the treatment response at week 24 was significantly better in those on more than 15 mg/week of methotrexate than with lower doses of the drug.
“Most patients on methotrexate need more than 15 mg/week. So it astonishes me that such a high percentage of patients enrolled in clinical trials around the world are on, like, 14 mg/week. I mean, most patients need somewhere between 15 and 25 mg/week for a response, although over time you might be able to decrease that dose,” Dr. Weinblatt said.
Side effects of methotrexate
“The biggest issue with methotrexate is the tolerability problem, since serious adverse events are incredibly rare with this molecule,” he said.
Hepatotoxicity is a concern, but Dr. Weinblatt emphasized that elevated liver function tests do not equal cirrhosis.
“Historically, during the first 6 months on methotrexate 20%-25% of patients increase their transaminases in every clinical trial where that’s been looked at. Over time, the liver compensates for the drug. But 5%-6% of patients experience repeated moderate elevations more than 1.5 times the upper limit of normal,” he said.
Key risk factors for methotrexate-related hepatotoxicity were identified in a national observational cohort study of 659 military veterans over age 65 when they started methotrexate for rheumatic diseases. The investigators found a 6% incidence of moderately elevated liver enzymes during a mean follow-up period of 7 months. Obesity was associated with a 1.9-fold increased risk, a serum total cholesterol greater than 240 mg/dL conferred a 5.8-fold elevated risk, and abnormal liver function tests at baseline were associated with a 3.2-fold increased risk (Arthritis Care Res [Hoboken]. 2014 Aug;66[8]:1159-66).
“No surprise: It’s patients who weigh more who are at increased risk for methotrexate-related transaminase increases. I actually think the biggest factor with regard to methotrexate liver disease is the patient’s [body mass index]. Patients in North America aren’t getting any slimmer, so you need to look at this with your patients. If you have a morbidly obese patient on methotrexate whose transaminases suddenly start going up, that’s the patient who’s at greatest risk for methotrexate hepatotoxicity,” he cautioned.
The 3.2-fold increased risk of repeated elevated transaminases associated with abnormal baseline liver function tests in the Veterans Affairs study should be a red flag for rheumatologists.
“I personally think patients shouldn’t start on methotrexate if they have elevated transaminases. They ought to be normal at the start. There are too many other good options now to treat our patients,” Dr. Weinblatt said.
He reported receiving research grants from half a dozen companies and serving as a consultant to more than two dozen.
EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM
March is Colorectal Cancer Awareness Month
Each year, AGA participates in a series of activities in support of Colorectal Cancer Awareness Month – and 2017 is no exception. March provides us with an important platform to help remind patients of the necessity of getting screened. Here are a few easy ways to join us in raising awareness:
- In-person: Take time this month to talk to your patients about their personal history and encourage timely screening. Visit www.gastro.org/CRC for materials you can provide to your patients to help them understand risk factors and screening options.
- On your practice website: When patients visit your website, make sure there is a prominent CRC screening reminder. You can link to AGA’s patient materials or use our awareness videos (also available via the above link) to help spread the word.
- On Facebook: AGA will be running a campaign throughout March to remind patients over 50 to get screened. Make sure to like us (facebook.com/AmerGastroAssn) to see our CRC posts, which you can share with your family and friends. If your practice has a Facebook page, the page can share all of our CRC awareness materials, as well.
- On Twitter: Tweeting is a great way to raise awareness among the public. Follow @AmerGastroAssn (twitter.com/AmerGastroAssn) for information on Twitter chats you can take part in to help raise awareness.
With your support, we can improve the public’s understanding of this deadly cancer and continue to increase screening rates. Stay tuned to AGA eDigest and AGA’s website (gastro.org) for timely CRC Awareness Month updates, and join CRC-related discussions with other AGA members on the AGA Community (community.gastro.org).
Each year, AGA participates in a series of activities in support of Colorectal Cancer Awareness Month – and 2017 is no exception. March provides us with an important platform to help remind patients of the necessity of getting screened. Here are a few easy ways to join us in raising awareness:
- In-person: Take time this month to talk to your patients about their personal history and encourage timely screening. Visit www.gastro.org/CRC for materials you can provide to your patients to help them understand risk factors and screening options.
- On your practice website: When patients visit your website, make sure there is a prominent CRC screening reminder. You can link to AGA’s patient materials or use our awareness videos (also available via the above link) to help spread the word.
- On Facebook: AGA will be running a campaign throughout March to remind patients over 50 to get screened. Make sure to like us (facebook.com/AmerGastroAssn) to see our CRC posts, which you can share with your family and friends. If your practice has a Facebook page, the page can share all of our CRC awareness materials, as well.
- On Twitter: Tweeting is a great way to raise awareness among the public. Follow @AmerGastroAssn (twitter.com/AmerGastroAssn) for information on Twitter chats you can take part in to help raise awareness.
With your support, we can improve the public’s understanding of this deadly cancer and continue to increase screening rates. Stay tuned to AGA eDigest and AGA’s website (gastro.org) for timely CRC Awareness Month updates, and join CRC-related discussions with other AGA members on the AGA Community (community.gastro.org).
Each year, AGA participates in a series of activities in support of Colorectal Cancer Awareness Month – and 2017 is no exception. March provides us with an important platform to help remind patients of the necessity of getting screened. Here are a few easy ways to join us in raising awareness:
- In-person: Take time this month to talk to your patients about their personal history and encourage timely screening. Visit www.gastro.org/CRC for materials you can provide to your patients to help them understand risk factors and screening options.
- On your practice website: When patients visit your website, make sure there is a prominent CRC screening reminder. You can link to AGA’s patient materials or use our awareness videos (also available via the above link) to help spread the word.
- On Facebook: AGA will be running a campaign throughout March to remind patients over 50 to get screened. Make sure to like us (facebook.com/AmerGastroAssn) to see our CRC posts, which you can share with your family and friends. If your practice has a Facebook page, the page can share all of our CRC awareness materials, as well.
- On Twitter: Tweeting is a great way to raise awareness among the public. Follow @AmerGastroAssn (twitter.com/AmerGastroAssn) for information on Twitter chats you can take part in to help raise awareness.
With your support, we can improve the public’s understanding of this deadly cancer and continue to increase screening rates. Stay tuned to AGA eDigest and AGA’s website (gastro.org) for timely CRC Awareness Month updates, and join CRC-related discussions with other AGA members on the AGA Community (community.gastro.org).
CGM safe and effective without additional blood glucose testing
according to the authors of a noninferiority trial published in the April issue of Diabetes Care.
Before December 2016, continuous glucose monitoring (CGM) was approved by the Food and Drug Administration for use only as an adjunct to standard home blood glucose monitoring (BGM), which was required to confirm the continuous glucose monitoring reading before making a decision on insulin dosing.
In this randomized, noninferiority trial, 217 participants with type 1 diabetes who used an insulin pump were randomized either to CGM only (142 individuals) or to CGM with additional BGM before an insulin bolus was administered (75 individuals).
The primary outcome of the 26-week trial was time in the range of 70-180 mg/dL, according to findings from the CGM, and the study found that mean time in this range was the same for the two groups: 65%.
There were no severe hypoglycemic events in the CGM-only group, and only one in the CGM plus BGM group. There were also no significant changes from baseline to 26 weeks in other metrics of glucose control for mean glucose, hyperglycemia, hypoglycemia, and glycemic variability, and no significant differences between the two groups. The results were also similar for subgroups of age, duration of disease, education, use of CGM before study enrollment, baseline hemoglobin A1c, and baseline time in range.
“In addition to randomization and multiple center participation, the strengths of this study include a high degree of participant retention, CGM use, and treatment group adherence,” the authors wrote. “Notably, there was good separation between the treatment groups in the number of BGM tests per day, particularly when recognizing that two of the BGM measurements per day were required for CGM calibration and that, according to the protocol, the calibrations were performed at times such that they would not influence insulin bolusing.”
The authors said the results were likely to be equally applicable to individuals who use multiple daily insulin injections rather than an insulin pump, as the accuracy of the CGM sensor was just as relevant to this group.
They stressed that one major limitation of the trial was that it only included adults with well-controlled type 1 diabetes who were likely to adhere to the study protocol, and it excluded those with less well controlled disease.
Given this, they called for future studies to examine the safety of CGM alone in young people and adults who might be less compliant with their diabetes control, such as those with higher HbA1c levels, who test their blood glucose fewer than four times a day, and who are hypoglycemia-unaware.
“The application of this trial’s results to clinical practice can benefit people with T1D by reducing their burden of multiple daily fingersticks when using CGM and can enhance the cost-effectiveness of CGM therapy by reducing the number of daily BGM test strips,” they wrote. “Furthermore, the demonstration that insulin dosing based on CGM alone is safe has applicability to assessing risk involved with artificial pancreas systems that automate insulin delivery based on CGM sensor glucose measurements.”
The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust, and Dexcom provided the CGM systems used in the trial. Authors declared speakers fees, consultancies, board positions and other funding from a range of pharmaceutical companies, including Dexcom. One author declared stock in Dexcom.
according to the authors of a noninferiority trial published in the April issue of Diabetes Care.
Before December 2016, continuous glucose monitoring (CGM) was approved by the Food and Drug Administration for use only as an adjunct to standard home blood glucose monitoring (BGM), which was required to confirm the continuous glucose monitoring reading before making a decision on insulin dosing.
In this randomized, noninferiority trial, 217 participants with type 1 diabetes who used an insulin pump were randomized either to CGM only (142 individuals) or to CGM with additional BGM before an insulin bolus was administered (75 individuals).
The primary outcome of the 26-week trial was time in the range of 70-180 mg/dL, according to findings from the CGM, and the study found that mean time in this range was the same for the two groups: 65%.
There were no severe hypoglycemic events in the CGM-only group, and only one in the CGM plus BGM group. There were also no significant changes from baseline to 26 weeks in other metrics of glucose control for mean glucose, hyperglycemia, hypoglycemia, and glycemic variability, and no significant differences between the two groups. The results were also similar for subgroups of age, duration of disease, education, use of CGM before study enrollment, baseline hemoglobin A1c, and baseline time in range.
“In addition to randomization and multiple center participation, the strengths of this study include a high degree of participant retention, CGM use, and treatment group adherence,” the authors wrote. “Notably, there was good separation between the treatment groups in the number of BGM tests per day, particularly when recognizing that two of the BGM measurements per day were required for CGM calibration and that, according to the protocol, the calibrations were performed at times such that they would not influence insulin bolusing.”
The authors said the results were likely to be equally applicable to individuals who use multiple daily insulin injections rather than an insulin pump, as the accuracy of the CGM sensor was just as relevant to this group.
They stressed that one major limitation of the trial was that it only included adults with well-controlled type 1 diabetes who were likely to adhere to the study protocol, and it excluded those with less well controlled disease.
Given this, they called for future studies to examine the safety of CGM alone in young people and adults who might be less compliant with their diabetes control, such as those with higher HbA1c levels, who test their blood glucose fewer than four times a day, and who are hypoglycemia-unaware.
“The application of this trial’s results to clinical practice can benefit people with T1D by reducing their burden of multiple daily fingersticks when using CGM and can enhance the cost-effectiveness of CGM therapy by reducing the number of daily BGM test strips,” they wrote. “Furthermore, the demonstration that insulin dosing based on CGM alone is safe has applicability to assessing risk involved with artificial pancreas systems that automate insulin delivery based on CGM sensor glucose measurements.”
The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust, and Dexcom provided the CGM systems used in the trial. Authors declared speakers fees, consultancies, board positions and other funding from a range of pharmaceutical companies, including Dexcom. One author declared stock in Dexcom.
according to the authors of a noninferiority trial published in the April issue of Diabetes Care.
Before December 2016, continuous glucose monitoring (CGM) was approved by the Food and Drug Administration for use only as an adjunct to standard home blood glucose monitoring (BGM), which was required to confirm the continuous glucose monitoring reading before making a decision on insulin dosing.
In this randomized, noninferiority trial, 217 participants with type 1 diabetes who used an insulin pump were randomized either to CGM only (142 individuals) or to CGM with additional BGM before an insulin bolus was administered (75 individuals).
The primary outcome of the 26-week trial was time in the range of 70-180 mg/dL, according to findings from the CGM, and the study found that mean time in this range was the same for the two groups: 65%.
There were no severe hypoglycemic events in the CGM-only group, and only one in the CGM plus BGM group. There were also no significant changes from baseline to 26 weeks in other metrics of glucose control for mean glucose, hyperglycemia, hypoglycemia, and glycemic variability, and no significant differences between the two groups. The results were also similar for subgroups of age, duration of disease, education, use of CGM before study enrollment, baseline hemoglobin A1c, and baseline time in range.
“In addition to randomization and multiple center participation, the strengths of this study include a high degree of participant retention, CGM use, and treatment group adherence,” the authors wrote. “Notably, there was good separation between the treatment groups in the number of BGM tests per day, particularly when recognizing that two of the BGM measurements per day were required for CGM calibration and that, according to the protocol, the calibrations were performed at times such that they would not influence insulin bolusing.”
The authors said the results were likely to be equally applicable to individuals who use multiple daily insulin injections rather than an insulin pump, as the accuracy of the CGM sensor was just as relevant to this group.
They stressed that one major limitation of the trial was that it only included adults with well-controlled type 1 diabetes who were likely to adhere to the study protocol, and it excluded those with less well controlled disease.
Given this, they called for future studies to examine the safety of CGM alone in young people and adults who might be less compliant with their diabetes control, such as those with higher HbA1c levels, who test their blood glucose fewer than four times a day, and who are hypoglycemia-unaware.
“The application of this trial’s results to clinical practice can benefit people with T1D by reducing their burden of multiple daily fingersticks when using CGM and can enhance the cost-effectiveness of CGM therapy by reducing the number of daily BGM test strips,” they wrote. “Furthermore, the demonstration that insulin dosing based on CGM alone is safe has applicability to assessing risk involved with artificial pancreas systems that automate insulin delivery based on CGM sensor glucose measurements.”
The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust, and Dexcom provided the CGM systems used in the trial. Authors declared speakers fees, consultancies, board positions and other funding from a range of pharmaceutical companies, including Dexcom. One author declared stock in Dexcom.
Key clinical point: Continuous glucose monitoring alone is safe and effective without the addition of confirmatory blood glucose monitoring.
Major finding: Mean time spent with blood glucose in the 70-180 mg/dL range was the same for individuals with continuous glucose monitoring and those with additional confirmatory blood glucose testing.
Data source: A randomized noninferiority trial in 217 adults with well-controlled type 1 diabetes.
Disclosures: The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dexcom provided the continuous glucose monitoring systems used in the trial. Authors declared speaking fees, consultancies, board positions and other funding from a range of pharmaceutical companies, including Dexcom. One author declared stock ownership in Dexcom.
Drug produces high response rates in AITL
Photo by Larry Young
SAN FRANCISCO—Treatment with 5-azacitidine (5-AZA) can produce a high response rate in patients with relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL), according to a small study.
The overall response rate (ORR) among AITL patients was 75%, and the complete response (CR) rate was 42%.
However, this study also included patients with other types of peripheral T-cell lymphoma (PTCL), and most of these patients did not respond to 5-AZA.
Richard Delarue, MD, of Necker University Hospital in Paris, France, presented these results at the 9th Annual T-cell Lymphoma Forum.
Results were also presented at the 2016 ASH Annual Meeting (abstract 4164). Dr Delarue reported receiving honoraria from Celgene.
Patients
The study included 19 patients with relapsed/refractory PTCL. Twelve patients had AITL, 3 had adult T-cell leukemia/lymphoma (ATLL), 2 had PTCL not otherwise specified, 1 had enteropathy-associated T-cell lymphoma, and 1 had transformed mycosis fungoides.
At diagnosis, the median age was 71 (range, 39-85) for AITL patients and 59 (range, 32-83) for the other PTCL patients. Seventy-five percent of AITL patients had an IPI score of 3 to 5 and a PIT score of 3 to 4. Eighty-six percent of the other PTCL patients had an IPI score of 3 to 5, and 57% had a PIT score of 3 to 4.
At the time of 5-AZA treatment, all patients had stage III/IV disease. The AITL patients had received a median of 2 (range, 0-6) prior lines of therapy, and the other PTCL patients had received a median of 3 (range, 0-7).
Two patients did not receive chemotherapy before 5-AZA because of the presence of associated chronic myelomonocytic leukemia (CMML) that required treatment first.
Ninety-two percent of AITL patients had TET2 mutations (n=11), 33% had DNMT3A mutations (n=4), and 0% had IDH2 mutations. One of the non-AITL patients had a TET2 mutation.
Treatment
Patients received a subcutaneous injection of 5-AZA at 75 mg/m² for 7 consecutive days every 28 days until progression or unacceptable toxicity. Six patients also received 4 to 8 infusions of rituximab because of EBV-DNA positivity.
The patients received a median of 3 cycles of 5-AZA. At the time of analysis, 4 patients were still receiving therapy.
The median follow-up was 84 days (range, 19 to 1236).
Toxicity
“Hematological toxicity was as expected with 5-azacitidine,” Dr Delarue said.
However, 2 patients had “unusual” adverse reactions. One patient had grade 2 polyneuropathy, which was considered related to a paraneoplastic syndrome.
The other patient had grade 3 diarrhea related to colitis of unknown origin, and this led to treatment interruption.
There were no treatment-related deaths.
Efficacy
Dr Delarue noted that the ORR was significantly higher in AITL patients than in patients with the other PTCL subtypes (P=0.0198).
The ORR was 53% in the entire cohort (10/19), 75% (9/12) among AITL patients, and 14% among patients with other PTCLs (1/7).
“The only patient with a response in the ‘other PTCL’ group was a patient with HTLV1-associated ATLL . . . , but he relapsed a couple of weeks after the second cycle,” Dr Delarue explained.
Among the AITL patients, the CR rate was 42% (5/12), the partial response rate was 33% (4/12), and the rate of stable disease was 25% (3/12).
Six AITL patients eventually progressed—after 2, 2, 3, 4, 4, and 20 cycles of therapy, respectively.
Two AITL patients are off therapy but remain in CR after 9 and 10 months (5 and 6 cycles of treatment), respectively.
The median progression-free survival for AITL patients was 16 months, and the median overall survival was 17 months.
Dr DeLarue noted that 4 of the AITL patients had CMML, 1 had non-CMML myelodysplastic syndrome, 3 had monocytosis without CMML, and 4 had normal monocyte counts.
He also said that, at present, it’s not possible to correlate the results observed in the AITL patients with their mutational status.
However, he and his colleagues are planning a prospective study of 5-AZA in patients with relapsed/refractory AITL and T follicular helper cell PTCL not otherwise specified. 5-AZA will be compared to investigator’s choice in this study.
Dr DeLarue said this trial will provide an opportunity to use the new oral formulation of 5-AZA (CC-486). And he and his colleagues welcome collaborators. 
Photo by Larry Young
SAN FRANCISCO—Treatment with 5-azacitidine (5-AZA) can produce a high response rate in patients with relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL), according to a small study.
The overall response rate (ORR) among AITL patients was 75%, and the complete response (CR) rate was 42%.
However, this study also included patients with other types of peripheral T-cell lymphoma (PTCL), and most of these patients did not respond to 5-AZA.
Richard Delarue, MD, of Necker University Hospital in Paris, France, presented these results at the 9th Annual T-cell Lymphoma Forum.
Results were also presented at the 2016 ASH Annual Meeting (abstract 4164). Dr Delarue reported receiving honoraria from Celgene.
Patients
The study included 19 patients with relapsed/refractory PTCL. Twelve patients had AITL, 3 had adult T-cell leukemia/lymphoma (ATLL), 2 had PTCL not otherwise specified, 1 had enteropathy-associated T-cell lymphoma, and 1 had transformed mycosis fungoides.
At diagnosis, the median age was 71 (range, 39-85) for AITL patients and 59 (range, 32-83) for the other PTCL patients. Seventy-five percent of AITL patients had an IPI score of 3 to 5 and a PIT score of 3 to 4. Eighty-six percent of the other PTCL patients had an IPI score of 3 to 5, and 57% had a PIT score of 3 to 4.
At the time of 5-AZA treatment, all patients had stage III/IV disease. The AITL patients had received a median of 2 (range, 0-6) prior lines of therapy, and the other PTCL patients had received a median of 3 (range, 0-7).
Two patients did not receive chemotherapy before 5-AZA because of the presence of associated chronic myelomonocytic leukemia (CMML) that required treatment first.
Ninety-two percent of AITL patients had TET2 mutations (n=11), 33% had DNMT3A mutations (n=4), and 0% had IDH2 mutations. One of the non-AITL patients had a TET2 mutation.
Treatment
Patients received a subcutaneous injection of 5-AZA at 75 mg/m² for 7 consecutive days every 28 days until progression or unacceptable toxicity. Six patients also received 4 to 8 infusions of rituximab because of EBV-DNA positivity.
The patients received a median of 3 cycles of 5-AZA. At the time of analysis, 4 patients were still receiving therapy.
The median follow-up was 84 days (range, 19 to 1236).
Toxicity
“Hematological toxicity was as expected with 5-azacitidine,” Dr Delarue said.
However, 2 patients had “unusual” adverse reactions. One patient had grade 2 polyneuropathy, which was considered related to a paraneoplastic syndrome.
The other patient had grade 3 diarrhea related to colitis of unknown origin, and this led to treatment interruption.
There were no treatment-related deaths.
Efficacy
Dr Delarue noted that the ORR was significantly higher in AITL patients than in patients with the other PTCL subtypes (P=0.0198).
The ORR was 53% in the entire cohort (10/19), 75% (9/12) among AITL patients, and 14% among patients with other PTCLs (1/7).
“The only patient with a response in the ‘other PTCL’ group was a patient with HTLV1-associated ATLL . . . , but he relapsed a couple of weeks after the second cycle,” Dr Delarue explained.
Among the AITL patients, the CR rate was 42% (5/12), the partial response rate was 33% (4/12), and the rate of stable disease was 25% (3/12).
Six AITL patients eventually progressed—after 2, 2, 3, 4, 4, and 20 cycles of therapy, respectively.
Two AITL patients are off therapy but remain in CR after 9 and 10 months (5 and 6 cycles of treatment), respectively.
The median progression-free survival for AITL patients was 16 months, and the median overall survival was 17 months.
Dr DeLarue noted that 4 of the AITL patients had CMML, 1 had non-CMML myelodysplastic syndrome, 3 had monocytosis without CMML, and 4 had normal monocyte counts.
He also said that, at present, it’s not possible to correlate the results observed in the AITL patients with their mutational status.
However, he and his colleagues are planning a prospective study of 5-AZA in patients with relapsed/refractory AITL and T follicular helper cell PTCL not otherwise specified. 5-AZA will be compared to investigator’s choice in this study.
Dr DeLarue said this trial will provide an opportunity to use the new oral formulation of 5-AZA (CC-486). And he and his colleagues welcome collaborators.
Photo by Larry Young
SAN FRANCISCO—Treatment with 5-azacitidine (5-AZA) can produce a high response rate in patients with relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL), according to a small study.
The overall response rate (ORR) among AITL patients was 75%, and the complete response (CR) rate was 42%.
However, this study also included patients with other types of peripheral T-cell lymphoma (PTCL), and most of these patients did not respond to 5-AZA.
Richard Delarue, MD, of Necker University Hospital in Paris, France, presented these results at the 9th Annual T-cell Lymphoma Forum.
Results were also presented at the 2016 ASH Annual Meeting (abstract 4164). Dr Delarue reported receiving honoraria from Celgene.
Patients
The study included 19 patients with relapsed/refractory PTCL. Twelve patients had AITL, 3 had adult T-cell leukemia/lymphoma (ATLL), 2 had PTCL not otherwise specified, 1 had enteropathy-associated T-cell lymphoma, and 1 had transformed mycosis fungoides.
At diagnosis, the median age was 71 (range, 39-85) for AITL patients and 59 (range, 32-83) for the other PTCL patients. Seventy-five percent of AITL patients had an IPI score of 3 to 5 and a PIT score of 3 to 4. Eighty-six percent of the other PTCL patients had an IPI score of 3 to 5, and 57% had a PIT score of 3 to 4.
At the time of 5-AZA treatment, all patients had stage III/IV disease. The AITL patients had received a median of 2 (range, 0-6) prior lines of therapy, and the other PTCL patients had received a median of 3 (range, 0-7).
Two patients did not receive chemotherapy before 5-AZA because of the presence of associated chronic myelomonocytic leukemia (CMML) that required treatment first.
Ninety-two percent of AITL patients had TET2 mutations (n=11), 33% had DNMT3A mutations (n=4), and 0% had IDH2 mutations. One of the non-AITL patients had a TET2 mutation.
Treatment
Patients received a subcutaneous injection of 5-AZA at 75 mg/m² for 7 consecutive days every 28 days until progression or unacceptable toxicity. Six patients also received 4 to 8 infusions of rituximab because of EBV-DNA positivity.
The patients received a median of 3 cycles of 5-AZA. At the time of analysis, 4 patients were still receiving therapy.
The median follow-up was 84 days (range, 19 to 1236).
Toxicity
“Hematological toxicity was as expected with 5-azacitidine,” Dr Delarue said.
However, 2 patients had “unusual” adverse reactions. One patient had grade 2 polyneuropathy, which was considered related to a paraneoplastic syndrome.
The other patient had grade 3 diarrhea related to colitis of unknown origin, and this led to treatment interruption.
There were no treatment-related deaths.
Efficacy
Dr Delarue noted that the ORR was significantly higher in AITL patients than in patients with the other PTCL subtypes (P=0.0198).
The ORR was 53% in the entire cohort (10/19), 75% (9/12) among AITL patients, and 14% among patients with other PTCLs (1/7).
“The only patient with a response in the ‘other PTCL’ group was a patient with HTLV1-associated ATLL . . . , but he relapsed a couple of weeks after the second cycle,” Dr Delarue explained.
Among the AITL patients, the CR rate was 42% (5/12), the partial response rate was 33% (4/12), and the rate of stable disease was 25% (3/12).
Six AITL patients eventually progressed—after 2, 2, 3, 4, 4, and 20 cycles of therapy, respectively.
Two AITL patients are off therapy but remain in CR after 9 and 10 months (5 and 6 cycles of treatment), respectively.
The median progression-free survival for AITL patients was 16 months, and the median overall survival was 17 months.
Dr DeLarue noted that 4 of the AITL patients had CMML, 1 had non-CMML myelodysplastic syndrome, 3 had monocytosis without CMML, and 4 had normal monocyte counts.
He also said that, at present, it’s not possible to correlate the results observed in the AITL patients with their mutational status.
However, he and his colleagues are planning a prospective study of 5-AZA in patients with relapsed/refractory AITL and T follicular helper cell PTCL not otherwise specified. 5-AZA will be compared to investigator’s choice in this study.
Dr DeLarue said this trial will provide an opportunity to use the new oral formulation of 5-AZA (CC-486). And he and his colleagues welcome collaborators.
Mindfulness in the Workplace
Mindfulness practices, such as meditation, yoga, tai chi, and qigong, are on the rise in the workplace, as more studies show how they can improve health and reduce the costs of stress.
Researchers who analyzed data on 85,004 respondents to the National Health Interview Survey say that their findings are “encouraging”; about 1 in 7 workers report engaging in some form of mindfulness-based activity. From 2002 to 2012, the number of yoga practitioners nearly doubled from 6% to 11%. From 2002 to 2007, the number of people who began meditating increased from 8% to 9.9%.
Related: Mindfulness to Reduce Stress
The rise in activity was seen across different groups of workers. In 2002, 2.2% of farm workers reported engaging in at least 1 of the practices studied, as did 18.2% of white-collar workers in 2007. Mindfulness found a foothold among 9% to 12% of the unemployed as well.
Still the trend is mostly seen among white-collar workers, attributable mainly to differences in household income and education level, the researchers say. After they controlled for those 2 factors, blue-collar workers were still less likely to engage in meditation or yoga, and farm workers were less likely to engage in any of the 4 practices.
Related: Preventing Burnout With Cognitive Empathy
But the lack of engagement among blue-collar and farm workers can’t be explained by sociodemographic factors alone, the researchers say. White-collar workers may have more time, access, and opportunity to practice mindfulness and might have different beliefs about the value of these practices.
Lack of engagement could be ameliorated in part by developing interventions to target those occupational groups, the researchers suggest. They found no studies that focused on blue-collar or farm workers—the low prevalence of mindfulness practices in those groups indicates a “pressing need” for interventions, even though those workplace settings may present “unique implementation challenges.”
Mindfulness practices, such as meditation, yoga, tai chi, and qigong, are on the rise in the workplace, as more studies show how they can improve health and reduce the costs of stress.
Researchers who analyzed data on 85,004 respondents to the National Health Interview Survey say that their findings are “encouraging”; about 1 in 7 workers report engaging in some form of mindfulness-based activity. From 2002 to 2012, the number of yoga practitioners nearly doubled from 6% to 11%. From 2002 to 2007, the number of people who began meditating increased from 8% to 9.9%.
Related: Mindfulness to Reduce Stress
The rise in activity was seen across different groups of workers. In 2002, 2.2% of farm workers reported engaging in at least 1 of the practices studied, as did 18.2% of white-collar workers in 2007. Mindfulness found a foothold among 9% to 12% of the unemployed as well.
Still the trend is mostly seen among white-collar workers, attributable mainly to differences in household income and education level, the researchers say. After they controlled for those 2 factors, blue-collar workers were still less likely to engage in meditation or yoga, and farm workers were less likely to engage in any of the 4 practices.
Related: Preventing Burnout With Cognitive Empathy
But the lack of engagement among blue-collar and farm workers can’t be explained by sociodemographic factors alone, the researchers say. White-collar workers may have more time, access, and opportunity to practice mindfulness and might have different beliefs about the value of these practices.
Lack of engagement could be ameliorated in part by developing interventions to target those occupational groups, the researchers suggest. They found no studies that focused on blue-collar or farm workers—the low prevalence of mindfulness practices in those groups indicates a “pressing need” for interventions, even though those workplace settings may present “unique implementation challenges.”
Mindfulness practices, such as meditation, yoga, tai chi, and qigong, are on the rise in the workplace, as more studies show how they can improve health and reduce the costs of stress.
Researchers who analyzed data on 85,004 respondents to the National Health Interview Survey say that their findings are “encouraging”; about 1 in 7 workers report engaging in some form of mindfulness-based activity. From 2002 to 2012, the number of yoga practitioners nearly doubled from 6% to 11%. From 2002 to 2007, the number of people who began meditating increased from 8% to 9.9%.
Related: Mindfulness to Reduce Stress
The rise in activity was seen across different groups of workers. In 2002, 2.2% of farm workers reported engaging in at least 1 of the practices studied, as did 18.2% of white-collar workers in 2007. Mindfulness found a foothold among 9% to 12% of the unemployed as well.
Still the trend is mostly seen among white-collar workers, attributable mainly to differences in household income and education level, the researchers say. After they controlled for those 2 factors, blue-collar workers were still less likely to engage in meditation or yoga, and farm workers were less likely to engage in any of the 4 practices.
Related: Preventing Burnout With Cognitive Empathy
But the lack of engagement among blue-collar and farm workers can’t be explained by sociodemographic factors alone, the researchers say. White-collar workers may have more time, access, and opportunity to practice mindfulness and might have different beliefs about the value of these practices.
Lack of engagement could be ameliorated in part by developing interventions to target those occupational groups, the researchers suggest. They found no studies that focused on blue-collar or farm workers—the low prevalence of mindfulness practices in those groups indicates a “pressing need” for interventions, even though those workplace settings may present “unique implementation challenges.”