MDedge Psychiatry

Since its introduction in 1950, the combined oral contraceptive pill has been used by countless women as a method for birth control (Liao P. Can Fam Physician. 2012 Dec; 58[12]:e757-e760).

Hormonal contraception (HC) provides women with both contraceptive and noncontraceptive benefits, most notably a method for avoiding unintended pregnancy. In addition to being an effective method of contraception, oral contraceptive pills (OCPs) are well established for treating conditions such as hirsutism, pain symptoms associated with endometriosis and adenomyosis, and pelvic inflammatory disease, among others (Schindler A. Int J Endocrinol Metab. 2013 Winter;11[1]:41-7).

IntimMedicine Specialists

Combined hormonal contraceptives are also first-line treatment for women with menstrual disorders, and in women with polycystic ovary syndrome, can offer an effective long-term method to regulate their menstrual cycle, decrease androgens, clear up oily skin and acne, and reduce facial hair while also providing them with effective contraception (de Melo et al. Open Access J Contracept. 2017;8:13-23).
 

Associations between ‘the pill’ and mood effects remain controversial

More than 100 million women worldwide use hormonal contraceptives today, yet despite this, the data are mixed regarding the prevalence and extent of neuropsychiatric symptoms and mood changes associated with use of “the pill.” Some studies show combined oral contraceptives are associated with a decrease in general well-being, but had no effect on depression, in women compared with placebo (Zethraeus N et al. Fertil Steril. 2017 May;107[5]:1238-45).

However, a large Danish study published in JAMA Psychiatry of more than 1 million women found a significant association between use of hormonal contraception and antidepressant use or first diagnosis of depression, with adolescents having a higher rate of first depression diagnosis and antidepressant use compared with women 20–30 years old (Skovlund C et al. JAMA Psychiatry. 2016 Nov 1;73[11]:1154-62).

Studies have also shown long-term exposure to levonorgestrel is significantly associated with anxiety and sleep problems in women without a history of these issues (Slattery J et al. Drug Saf. 2018 Oct;41[10]:951-8). A recent small nationwide cohort study in France suggests this may also be true of levonorgestrel delivered by intrauterine devices (IUD) and the association may be dose-dependent (Roland N et al. JAMA. 2023;329[3]:257-9).

Of note, a study published in the American Journal of Psychiatry found a nearly twofold risk of suicide attempt and over threefold risk of suicide among women taking hormonal contraception compared with women who had never used hormonal contraceptives (Skovlund et al. Am J Psychiatry. 2017 Nov 17:appiajp201717060616).
 

Knowledge gaps make drawing conclusions difficult

The latest information on use of antidepressant and antianxiety medications in women of reproductive age (18-44 years) is sparse and, in some cases, outdated. According to data from the National Health and Nutrition Examination Survey, 18.6% of adult women 18 years or older reported using antidepressant medications within the last 30 days in 2017-2018, an increase from 13.8% in 2009-2010. Among women aged 15-44 year with private employer–sponsored insurance surveyed during 2008-2013, the results showed 15.4% of women filled a prescription for an antidepressant. We must look back further to find data on antianxiety medication use among women aged 18-44 years where use of antianxiety drugs (anxiolytics, sedatives, and hypnotics) was 4.3% between 2005 and 2008.

A lack of literature in this area is likely due to significant underreporting, and an inability to select patients who are sensitive to or at risk of developing neuropsychiatric symptoms resulting from hormonal contraception use because the true pathophysiology is unknown. Existing studies tend to use varying methods to assess mood changes, and do not usually specify hormonal contraceptive use type in their analyses (Schaffir J et al. Eur J Contracept Reprod Health Care. 2016 Oct;21[5]:347-55).

Studies of this nature also require large sample sizes, but the percentage of women who develop neuropsychiatric symptoms from hormonal contraceptive use has historically been relatively small. In the late 1990s, Rosenberg and colleagues found 46% of 1,657 women discontinued oral contraceptives due to side effects within 6 months of starting a new prescription; of these women, 5% reported mood changes as their reason for discontinuing oral contraceptives (Rosenberg M et al. Am J Obstet Gynecol. 1998 Sep;179[3 Pt 1]:577-82).

One might expect that, as lower dosage combined hormonal contraceptives were developed in the 1980s, that the rate of reporting psychological side effects would continue to decrease as well. Yet greater awareness of the potential for mood changes while on “the pill” as outlined by the lay press and social media may be leading to increased reporting of neuropsychiatric effects in women. In a recent cross-sectional survey of 188 women in New York, 43.6% said they experienced mood changes while on hormonal contraceptives, and 61.2% of women with histories of psychiatric illness reported mood changes they attributed to hormonal contraceptives (Martell S et al. Contracept Reprod Med. 2023;8:9).

Martell and colleagues found 48.3% of women cited side effects as a reason for discontinuing hormonal contraception, and 43 participants mentioned psychological side effects unprompted, including 2 patients with suicidal thoughts. The authors said this suggests “psychological side effects, at least in part, may have impacted” HC users’ decisions to switch from OCPs to an alternative method of contraception.

It is also not clear what risk factors exist for women who develop neuropsychiatric symptoms from hormonal contraceptive use. First, it is important to note that both progestin-only contraceptives and combined hormonal contraceptives are classified by the Centers for Disease Control and Prevention’s US Medical Eligibility Criteria for Contraceptive Use, 2016 as having no restrictions for use, including among patients with depression. While women in a smaller subgroup have significant neuropsychiatric symptoms related to their hormonal contraceptives, the underlying mechanism is unknown, and is thought to be largely related to the progestogen component of combined hormonal contraceptives or progestogen-only contraceptives (Mu E. Aust Prescr. 2022 Jun; 45[3]:75-9). We know that some women are hormone sensitive, while others are less so, and some not at all. Progestogens could affect mood as a direct action of the progestogen, because progestogens can be neurosteroids, or the progestogen effect could be mediated secondarily through a change in that woman’s own production of or bioavailability of androgens or naturally occurring estrogens (Giatti S. J Mol Endocrinol. 2016 Aug;57[2]:R109-26).

Here, we also find that currently available evidence limits our ability to draw firm conclusions. A study by Berry-Bibee and colleagues found a “low concern for clinically significant interactions” between hormonal contraception and psychotropic drugs, but was limited by quality/quantity of evidence (Berry-Bibee E et al. Contraception. 2016 Dec;94[6]:650-67). Interestingly, a study by Robinson and colleagues from the mid-2000s posited based on low evidence that “psychological response to the practice of contraception” was a potential explanation for the side effect profile of hormonal contraception (Robinson S et al. Med Hypotheses. 2004;63[2]:268-73).

Further, it may be that women with premenstrual dysphoric disorder (PMDD) might be selected for oral contraceptives, and they are predisposed to other neuropsychiatric problems. Estimates have placed the prevalence of comorbid psychiatric disorders such as anxiety, major depression, bipolar disorder, and posttraumatic stress disorder as high as 70% for women with PMDD (Sepede G et al. Neuropsychiatr Dis Treat. 2020;16:415-26). This phenomenon is not new, having been characterized in the lay literature nearly 20 years ago, by endocrinologist Geoffrey P. Redmond, MD (Redmond GP. The Hormonally Vulnerable Woman. New York: HarperCollins; 2005).

While the cause is not exactly idiosyncratic, there do appear to be some women who are more sensitive, either mood-related or otherwise, directly or indirectly to their contraceptive progestogens in terms of mood. They tend to have an entire spectrum of responses to the progestogens in combined or progestin-only contraceptives, ranging from just a flattened affect – which could easily be explained by their flattened level of endogenous hormones – to frank depression. Their frank depression, in turn, can be demonstrated to include suicidal ideation and actual suicide.

Compounding this issue is a woman’s perception of her sexuality. Some women with low sexual desire or sexual problems who are younger may have more distress about their problems compared with women of older reproductive age. While the reason for that is not clear, it may be that in the sexual arena, it is more important for some younger women to be a sexual person than in perimenopausal women, or that women who are younger are more likely to be partnered than women of older reproductive age. While the European Society of Sexual Medicine concluded in a 2019 position statement that there is inconclusive evidence whether hormonal contraception may be contributing to changes in sexual desire and sexual dysfunction, it appears that “a minority of women” experience “better or worse sexual functioning” from taking combined oral contraceptives (Both S et al. J Sex Med. 2019 Nov;16[11]:1681-95), suggesting that the majority of women report no significant changes.
 

Practitioners should discuss mood effects during consultation

An ob.gyn., primary care physicians, or others with prescriptive authority (i.e. nurse practitioners and physician assistants) in clinical practice may encounter a patient who seems to have mood side effects owing to progestogen-containing contraceptives that they prescribe. However, many ob.gyns. are likely unaware of the prevalence, or that some of those same patients can have such significant mood effects that they would become or are suicidal.

I believe questioning patients about mood effects during consultation and particularly during follow-up following the initiation of any hormonal contraceptive is worth a passing comment for every patient, which should include mood effects in broader discussion for anyone currently using an antidepressant, patients with a history of antidepressant use, and patients who have considered suicide. As we do with other drugs, these questions can be posed in the form of a questionnaire followed up by the practitioner in counseling.

Practitioners who encounter a patient with mood changes as a result of hormonal contraceptive use can consider changing to a nonhormonal method of birth control, or recommending the patient use a barrier method during sexual activity, as none of these options have neuropsychiatric side effects.

Ultimately, practitioners of all types need to engage in shared decision-making to identify the key benefits and risks of hormonal contraceptive use for each patient, which may involve trial and error to determine the ideal treatment. It is critical that practitioners of all types strike a balance between alleviating patient concerns about potential mood changes, monitoring patients with an appreciable risk of mood changes, and continuing patients on hormonal contraception for whom the benefits outweigh the risks.
 

Dr. Simon is a clinical professor at George Washington University and the medical director and founder of IntimMedicine Specialists in Washington, which provides patient-focused care for women across the reproductive life cycle. He is a past president of the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Dr. Simon has been a consultant to, received grant and research support from, and served on the speakers bureau for various pharmaceutical companies that develop combination hormonal contraceptives. Email Dr. Simon at [email protected].

Since its introduction in 1950, the combined oral contraceptive pill has been used by countless women as a method for birth control (Liao P. Can Fam Physician. 2012 Dec; 58[12]:e757-e760).

Hormonal contraception (HC) provides women with both contraceptive and noncontraceptive benefits, most notably a method for avoiding unintended pregnancy. In addition to being an effective method of contraception, oral contraceptive pills (OCPs) are well established for treating conditions such as hirsutism, pain symptoms associated with endometriosis and adenomyosis, and pelvic inflammatory disease, among others (Schindler A. Int J Endocrinol Metab. 2013 Winter;11[1]:41-7).

IntimMedicine Specialists

Combined hormonal contraceptives are also first-line treatment for women with menstrual disorders, and in women with polycystic ovary syndrome, can offer an effective long-term method to regulate their menstrual cycle, decrease androgens, clear up oily skin and acne, and reduce facial hair while also providing them with effective contraception (de Melo et al. Open Access J Contracept. 2017;8:13-23).
 

Associations between ‘the pill’ and mood effects remain controversial

More than 100 million women worldwide use hormonal contraceptives today, yet despite this, the data are mixed regarding the prevalence and extent of neuropsychiatric symptoms and mood changes associated with use of “the pill.” Some studies show combined oral contraceptives are associated with a decrease in general well-being, but had no effect on depression, in women compared with placebo (Zethraeus N et al. Fertil Steril. 2017 May;107[5]:1238-45).

However, a large Danish study published in JAMA Psychiatry of more than 1 million women found a significant association between use of hormonal contraception and antidepressant use or first diagnosis of depression, with adolescents having a higher rate of first depression diagnosis and antidepressant use compared with women 20–30 years old (Skovlund C et al. JAMA Psychiatry. 2016 Nov 1;73[11]:1154-62).

Studies have also shown long-term exposure to levonorgestrel is significantly associated with anxiety and sleep problems in women without a history of these issues (Slattery J et al. Drug Saf. 2018 Oct;41[10]:951-8). A recent small nationwide cohort study in France suggests this may also be true of levonorgestrel delivered by intrauterine devices (IUD) and the association may be dose-dependent (Roland N et al. JAMA. 2023;329[3]:257-9).

Of note, a study published in the American Journal of Psychiatry found a nearly twofold risk of suicide attempt and over threefold risk of suicide among women taking hormonal contraception compared with women who had never used hormonal contraceptives (Skovlund et al. Am J Psychiatry. 2017 Nov 17:appiajp201717060616).
 

Knowledge gaps make drawing conclusions difficult

The latest information on use of antidepressant and antianxiety medications in women of reproductive age (18-44 years) is sparse and, in some cases, outdated. According to data from the National Health and Nutrition Examination Survey, 18.6% of adult women 18 years or older reported using antidepressant medications within the last 30 days in 2017-2018, an increase from 13.8% in 2009-2010. Among women aged 15-44 year with private employer–sponsored insurance surveyed during 2008-2013, the results showed 15.4% of women filled a prescription for an antidepressant. We must look back further to find data on antianxiety medication use among women aged 18-44 years where use of antianxiety drugs (anxiolytics, sedatives, and hypnotics) was 4.3% between 2005 and 2008.

A lack of literature in this area is likely due to significant underreporting, and an inability to select patients who are sensitive to or at risk of developing neuropsychiatric symptoms resulting from hormonal contraception use because the true pathophysiology is unknown. Existing studies tend to use varying methods to assess mood changes, and do not usually specify hormonal contraceptive use type in their analyses (Schaffir J et al. Eur J Contracept Reprod Health Care. 2016 Oct;21[5]:347-55).

Studies of this nature also require large sample sizes, but the percentage of women who develop neuropsychiatric symptoms from hormonal contraceptive use has historically been relatively small. In the late 1990s, Rosenberg and colleagues found 46% of 1,657 women discontinued oral contraceptives due to side effects within 6 months of starting a new prescription; of these women, 5% reported mood changes as their reason for discontinuing oral contraceptives (Rosenberg M et al. Am J Obstet Gynecol. 1998 Sep;179[3 Pt 1]:577-82).

One might expect that, as lower dosage combined hormonal contraceptives were developed in the 1980s, that the rate of reporting psychological side effects would continue to decrease as well. Yet greater awareness of the potential for mood changes while on “the pill” as outlined by the lay press and social media may be leading to increased reporting of neuropsychiatric effects in women. In a recent cross-sectional survey of 188 women in New York, 43.6% said they experienced mood changes while on hormonal contraceptives, and 61.2% of women with histories of psychiatric illness reported mood changes they attributed to hormonal contraceptives (Martell S et al. Contracept Reprod Med. 2023;8:9).

Martell and colleagues found 48.3% of women cited side effects as a reason for discontinuing hormonal contraception, and 43 participants mentioned psychological side effects unprompted, including 2 patients with suicidal thoughts. The authors said this suggests “psychological side effects, at least in part, may have impacted” HC users’ decisions to switch from OCPs to an alternative method of contraception.

It is also not clear what risk factors exist for women who develop neuropsychiatric symptoms from hormonal contraceptive use. First, it is important to note that both progestin-only contraceptives and combined hormonal contraceptives are classified by the Centers for Disease Control and Prevention’s US Medical Eligibility Criteria for Contraceptive Use, 2016 as having no restrictions for use, including among patients with depression. While women in a smaller subgroup have significant neuropsychiatric symptoms related to their hormonal contraceptives, the underlying mechanism is unknown, and is thought to be largely related to the progestogen component of combined hormonal contraceptives or progestogen-only contraceptives (Mu E. Aust Prescr. 2022 Jun; 45[3]:75-9). We know that some women are hormone sensitive, while others are less so, and some not at all. Progestogens could affect mood as a direct action of the progestogen, because progestogens can be neurosteroids, or the progestogen effect could be mediated secondarily through a change in that woman’s own production of or bioavailability of androgens or naturally occurring estrogens (Giatti S. J Mol Endocrinol. 2016 Aug;57[2]:R109-26).

Here, we also find that currently available evidence limits our ability to draw firm conclusions. A study by Berry-Bibee and colleagues found a “low concern for clinically significant interactions” between hormonal contraception and psychotropic drugs, but was limited by quality/quantity of evidence (Berry-Bibee E et al. Contraception. 2016 Dec;94[6]:650-67). Interestingly, a study by Robinson and colleagues from the mid-2000s posited based on low evidence that “psychological response to the practice of contraception” was a potential explanation for the side effect profile of hormonal contraception (Robinson S et al. Med Hypotheses. 2004;63[2]:268-73).

Further, it may be that women with premenstrual dysphoric disorder (PMDD) might be selected for oral contraceptives, and they are predisposed to other neuropsychiatric problems. Estimates have placed the prevalence of comorbid psychiatric disorders such as anxiety, major depression, bipolar disorder, and posttraumatic stress disorder as high as 70% for women with PMDD (Sepede G et al. Neuropsychiatr Dis Treat. 2020;16:415-26). This phenomenon is not new, having been characterized in the lay literature nearly 20 years ago, by endocrinologist Geoffrey P. Redmond, MD (Redmond GP. The Hormonally Vulnerable Woman. New York: HarperCollins; 2005).

While the cause is not exactly idiosyncratic, there do appear to be some women who are more sensitive, either mood-related or otherwise, directly or indirectly to their contraceptive progestogens in terms of mood. They tend to have an entire spectrum of responses to the progestogens in combined or progestin-only contraceptives, ranging from just a flattened affect – which could easily be explained by their flattened level of endogenous hormones – to frank depression. Their frank depression, in turn, can be demonstrated to include suicidal ideation and actual suicide.

Compounding this issue is a woman’s perception of her sexuality. Some women with low sexual desire or sexual problems who are younger may have more distress about their problems compared with women of older reproductive age. While the reason for that is not clear, it may be that in the sexual arena, it is more important for some younger women to be a sexual person than in perimenopausal women, or that women who are younger are more likely to be partnered than women of older reproductive age. While the European Society of Sexual Medicine concluded in a 2019 position statement that there is inconclusive evidence whether hormonal contraception may be contributing to changes in sexual desire and sexual dysfunction, it appears that “a minority of women” experience “better or worse sexual functioning” from taking combined oral contraceptives (Both S et al. J Sex Med. 2019 Nov;16[11]:1681-95), suggesting that the majority of women report no significant changes.
 

Practitioners should discuss mood effects during consultation

An ob.gyn., primary care physicians, or others with prescriptive authority (i.e. nurse practitioners and physician assistants) in clinical practice may encounter a patient who seems to have mood side effects owing to progestogen-containing contraceptives that they prescribe. However, many ob.gyns. are likely unaware of the prevalence, or that some of those same patients can have such significant mood effects that they would become or are suicidal.

I believe questioning patients about mood effects during consultation and particularly during follow-up following the initiation of any hormonal contraceptive is worth a passing comment for every patient, which should include mood effects in broader discussion for anyone currently using an antidepressant, patients with a history of antidepressant use, and patients who have considered suicide. As we do with other drugs, these questions can be posed in the form of a questionnaire followed up by the practitioner in counseling.

Practitioners who encounter a patient with mood changes as a result of hormonal contraceptive use can consider changing to a nonhormonal method of birth control, or recommending the patient use a barrier method during sexual activity, as none of these options have neuropsychiatric side effects.

Ultimately, practitioners of all types need to engage in shared decision-making to identify the key benefits and risks of hormonal contraceptive use for each patient, which may involve trial and error to determine the ideal treatment. It is critical that practitioners of all types strike a balance between alleviating patient concerns about potential mood changes, monitoring patients with an appreciable risk of mood changes, and continuing patients on hormonal contraception for whom the benefits outweigh the risks.
 

Dr. Simon is a clinical professor at George Washington University and the medical director and founder of IntimMedicine Specialists in Washington, which provides patient-focused care for women across the reproductive life cycle. He is a past president of the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Dr. Simon has been a consultant to, received grant and research support from, and served on the speakers bureau for various pharmaceutical companies that develop combination hormonal contraceptives. Email Dr. Simon at [email protected].

Since its introduction in 1950, the combined oral contraceptive pill has been used by countless women as a method for birth control (Liao P. Can Fam Physician. 2012 Dec; 58[12]:e757-e760).

Hormonal contraception (HC) provides women with both contraceptive and noncontraceptive benefits, most notably a method for avoiding unintended pregnancy. In addition to being an effective method of contraception, oral contraceptive pills (OCPs) are well established for treating conditions such as hirsutism, pain symptoms associated with endometriosis and adenomyosis, and pelvic inflammatory disease, among others (Schindler A. Int J Endocrinol Metab. 2013 Winter;11[1]:41-7).

IntimMedicine Specialists

Combined hormonal contraceptives are also first-line treatment for women with menstrual disorders, and in women with polycystic ovary syndrome, can offer an effective long-term method to regulate their menstrual cycle, decrease androgens, clear up oily skin and acne, and reduce facial hair while also providing them with effective contraception (de Melo et al. Open Access J Contracept. 2017;8:13-23).
 

Associations between ‘the pill’ and mood effects remain controversial

More than 100 million women worldwide use hormonal contraceptives today, yet despite this, the data are mixed regarding the prevalence and extent of neuropsychiatric symptoms and mood changes associated with use of “the pill.” Some studies show combined oral contraceptives are associated with a decrease in general well-being, but had no effect on depression, in women compared with placebo (Zethraeus N et al. Fertil Steril. 2017 May;107[5]:1238-45).

However, a large Danish study published in JAMA Psychiatry of more than 1 million women found a significant association between use of hormonal contraception and antidepressant use or first diagnosis of depression, with adolescents having a higher rate of first depression diagnosis and antidepressant use compared with women 20–30 years old (Skovlund C et al. JAMA Psychiatry. 2016 Nov 1;73[11]:1154-62).

Studies have also shown long-term exposure to levonorgestrel is significantly associated with anxiety and sleep problems in women without a history of these issues (Slattery J et al. Drug Saf. 2018 Oct;41[10]:951-8). A recent small nationwide cohort study in France suggests this may also be true of levonorgestrel delivered by intrauterine devices (IUD) and the association may be dose-dependent (Roland N et al. JAMA. 2023;329[3]:257-9).

Of note, a study published in the American Journal of Psychiatry found a nearly twofold risk of suicide attempt and over threefold risk of suicide among women taking hormonal contraception compared with women who had never used hormonal contraceptives (Skovlund et al. Am J Psychiatry. 2017 Nov 17:appiajp201717060616).
 

Knowledge gaps make drawing conclusions difficult

The latest information on use of antidepressant and antianxiety medications in women of reproductive age (18-44 years) is sparse and, in some cases, outdated. According to data from the National Health and Nutrition Examination Survey, 18.6% of adult women 18 years or older reported using antidepressant medications within the last 30 days in 2017-2018, an increase from 13.8% in 2009-2010. Among women aged 15-44 year with private employer–sponsored insurance surveyed during 2008-2013, the results showed 15.4% of women filled a prescription for an antidepressant. We must look back further to find data on antianxiety medication use among women aged 18-44 years where use of antianxiety drugs (anxiolytics, sedatives, and hypnotics) was 4.3% between 2005 and 2008.

A lack of literature in this area is likely due to significant underreporting, and an inability to select patients who are sensitive to or at risk of developing neuropsychiatric symptoms resulting from hormonal contraception use because the true pathophysiology is unknown. Existing studies tend to use varying methods to assess mood changes, and do not usually specify hormonal contraceptive use type in their analyses (Schaffir J et al. Eur J Contracept Reprod Health Care. 2016 Oct;21[5]:347-55).

Studies of this nature also require large sample sizes, but the percentage of women who develop neuropsychiatric symptoms from hormonal contraceptive use has historically been relatively small. In the late 1990s, Rosenberg and colleagues found 46% of 1,657 women discontinued oral contraceptives due to side effects within 6 months of starting a new prescription; of these women, 5% reported mood changes as their reason for discontinuing oral contraceptives (Rosenberg M et al. Am J Obstet Gynecol. 1998 Sep;179[3 Pt 1]:577-82).

One might expect that, as lower dosage combined hormonal contraceptives were developed in the 1980s, that the rate of reporting psychological side effects would continue to decrease as well. Yet greater awareness of the potential for mood changes while on “the pill” as outlined by the lay press and social media may be leading to increased reporting of neuropsychiatric effects in women. In a recent cross-sectional survey of 188 women in New York, 43.6% said they experienced mood changes while on hormonal contraceptives, and 61.2% of women with histories of psychiatric illness reported mood changes they attributed to hormonal contraceptives (Martell S et al. Contracept Reprod Med. 2023;8:9).

Martell and colleagues found 48.3% of women cited side effects as a reason for discontinuing hormonal contraception, and 43 participants mentioned psychological side effects unprompted, including 2 patients with suicidal thoughts. The authors said this suggests “psychological side effects, at least in part, may have impacted” HC users’ decisions to switch from OCPs to an alternative method of contraception.

It is also not clear what risk factors exist for women who develop neuropsychiatric symptoms from hormonal contraceptive use. First, it is important to note that both progestin-only contraceptives and combined hormonal contraceptives are classified by the Centers for Disease Control and Prevention’s US Medical Eligibility Criteria for Contraceptive Use, 2016 as having no restrictions for use, including among patients with depression. While women in a smaller subgroup have significant neuropsychiatric symptoms related to their hormonal contraceptives, the underlying mechanism is unknown, and is thought to be largely related to the progestogen component of combined hormonal contraceptives or progestogen-only contraceptives (Mu E. Aust Prescr. 2022 Jun; 45[3]:75-9). We know that some women are hormone sensitive, while others are less so, and some not at all. Progestogens could affect mood as a direct action of the progestogen, because progestogens can be neurosteroids, or the progestogen effect could be mediated secondarily through a change in that woman’s own production of or bioavailability of androgens or naturally occurring estrogens (Giatti S. J Mol Endocrinol. 2016 Aug;57[2]:R109-26).

Here, we also find that currently available evidence limits our ability to draw firm conclusions. A study by Berry-Bibee and colleagues found a “low concern for clinically significant interactions” between hormonal contraception and psychotropic drugs, but was limited by quality/quantity of evidence (Berry-Bibee E et al. Contraception. 2016 Dec;94[6]:650-67). Interestingly, a study by Robinson and colleagues from the mid-2000s posited based on low evidence that “psychological response to the practice of contraception” was a potential explanation for the side effect profile of hormonal contraception (Robinson S et al. Med Hypotheses. 2004;63[2]:268-73).

Further, it may be that women with premenstrual dysphoric disorder (PMDD) might be selected for oral contraceptives, and they are predisposed to other neuropsychiatric problems. Estimates have placed the prevalence of comorbid psychiatric disorders such as anxiety, major depression, bipolar disorder, and posttraumatic stress disorder as high as 70% for women with PMDD (Sepede G et al. Neuropsychiatr Dis Treat. 2020;16:415-26). This phenomenon is not new, having been characterized in the lay literature nearly 20 years ago, by endocrinologist Geoffrey P. Redmond, MD (Redmond GP. The Hormonally Vulnerable Woman. New York: HarperCollins; 2005).

While the cause is not exactly idiosyncratic, there do appear to be some women who are more sensitive, either mood-related or otherwise, directly or indirectly to their contraceptive progestogens in terms of mood. They tend to have an entire spectrum of responses to the progestogens in combined or progestin-only contraceptives, ranging from just a flattened affect – which could easily be explained by their flattened level of endogenous hormones – to frank depression. Their frank depression, in turn, can be demonstrated to include suicidal ideation and actual suicide.

Compounding this issue is a woman’s perception of her sexuality. Some women with low sexual desire or sexual problems who are younger may have more distress about their problems compared with women of older reproductive age. While the reason for that is not clear, it may be that in the sexual arena, it is more important for some younger women to be a sexual person than in perimenopausal women, or that women who are younger are more likely to be partnered than women of older reproductive age. While the European Society of Sexual Medicine concluded in a 2019 position statement that there is inconclusive evidence whether hormonal contraception may be contributing to changes in sexual desire and sexual dysfunction, it appears that “a minority of women” experience “better or worse sexual functioning” from taking combined oral contraceptives (Both S et al. J Sex Med. 2019 Nov;16[11]:1681-95), suggesting that the majority of women report no significant changes.
 

Practitioners should discuss mood effects during consultation

An ob.gyn., primary care physicians, or others with prescriptive authority (i.e. nurse practitioners and physician assistants) in clinical practice may encounter a patient who seems to have mood side effects owing to progestogen-containing contraceptives that they prescribe. However, many ob.gyns. are likely unaware of the prevalence, or that some of those same patients can have such significant mood effects that they would become or are suicidal.

I believe questioning patients about mood effects during consultation and particularly during follow-up following the initiation of any hormonal contraceptive is worth a passing comment for every patient, which should include mood effects in broader discussion for anyone currently using an antidepressant, patients with a history of antidepressant use, and patients who have considered suicide. As we do with other drugs, these questions can be posed in the form of a questionnaire followed up by the practitioner in counseling.

Practitioners who encounter a patient with mood changes as a result of hormonal contraceptive use can consider changing to a nonhormonal method of birth control, or recommending the patient use a barrier method during sexual activity, as none of these options have neuropsychiatric side effects.

Ultimately, practitioners of all types need to engage in shared decision-making to identify the key benefits and risks of hormonal contraceptive use for each patient, which may involve trial and error to determine the ideal treatment. It is critical that practitioners of all types strike a balance between alleviating patient concerns about potential mood changes, monitoring patients with an appreciable risk of mood changes, and continuing patients on hormonal contraception for whom the benefits outweigh the risks.
 

Dr. Simon is a clinical professor at George Washington University and the medical director and founder of IntimMedicine Specialists in Washington, which provides patient-focused care for women across the reproductive life cycle. He is a past president of the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Dr. Simon has been a consultant to, received grant and research support from, and served on the speakers bureau for various pharmaceutical companies that develop combination hormonal contraceptives. Email Dr. Simon at [email protected].

Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

Pediatricians increasingly are stepping in to prescribe drugs for anxiety and depression independently, easing the burden on subspecialists amid the child and adolescent mental health crisis, but a review of electronic health records highlights areas for improvement in delivering the care.

The findings were published online in Pediatrics.

The researchers, led by Talia R. Lester, MD, with the division of developmental behavioral pediatrics in the quantitative science unit at Stanford (Calif.) University, identified 1,685 patients aged 6-18 years who had at least one visit with a diagnosis of anxiety and/or depression in a large primary care network in northern California and who were prescribed an SSRI by a network primary care pediatrician (PCP). The team randomly chose 110 patients and reviewed charts from the visit when the SSRI was first prescribed (medication visit); the immediately previous visit; and immediately subsequent visit.
 

Encouraging signs

The chart reviews showed some encouraging signs. For example, when pediatricians prescribe an SSRI, 82% are appropriately documenting rationales for starting the medication at the medication visit. However, they are not monitoring medication side effects systematically, according to the report. Of 69 patients with a visit after the medication visit, fewer than half (48%) had documentation of monitoring for side effects.

Three areas for improvement

The researchers identified three main shortfall areas and suggested improvements.

PCPs often referred patients for unspecified therapy at the medication visit; however, they rarely prescribed evidence-based therapies such as cognitive-behavioral therapy (CBT) (4% of patients). The authors suggested embedding a summary of evidence-based treatment into order sets.

Secondly, PCPs are not often using screening tools. The data show only 26% of patients had a documented depression- or anxiety-specific screening tool result at the medication visit. The authors recommend making the screening tools accessible through the EHR to increase use.

The researchers also found many patients didn’t have a follow-up visit after SSRI medication was prescribed. Even when they did, the range was so wide between the medication visit and the follow-up (7-365 days) that it’s clear pediatricians are taking inconsistent approaches to scheduling follow-up.
 

Half are seeing only their primary care pediatrician

About half of children and adolescents prescribed an SSRI by a pediatrician for mental health reasons were seeing only their primary care pediatrician, the data showed.

Eric M. Butter, PhD, chief of psychology at Nationwide Children’s Hospital and Ohio State University, Columbus, pointed out in an accompanying editorial that some of the news in pediatricians’ expanded role is particularly encouraging.

Pediatricians, he noted, are making medication decisions consistent with decisions a subspecialist would make.

Of cases in which a subspecialist became involved after a pediatrician initiated medication, subspecialists changed the medication for only two patients, which “is encouraging because it validates pediatricians’ decisions,” Dr. Butter said.

It’s important for pediatricians to understand key evidence-based programs that can work in combination with medications to achieve better results, Dr. Butter said. For example, CBT can help with depression “and break the cycle of avoidance that worsens symptoms of anxiety.”

He highlighted Interpersonal Therapy for Adolescents, a 12-session treatment that “can also address depression by improving patients’ personal relationships.”

“No primary care pediatrician will have the training or time to implement the many treatments that are available,” Dr. Butter wrote. “However, pediatricians can work to understand the key features of the evidence-based treatments referenced by Lester et al.”
 

Most concerning statistics

Dr. Butter said the most concerning shortcoming in the pediatricians’ health care delivery was lack of referral for evidence-based psychological treatments and low rates for referral to access supports from schools through programs such as the education 504 plan and Individualized Education Plans.

Dr. Lester’s team found that pediatricians recommended that patients receive support from such programs in only 8% of cases.

“The children’s mental health crisis requires all child-serving health care providers to do more. Improved care for anxiety and depression in pediatric primary care is needed and does not have to be overly burdensome to pediatricians,” Dr. Butter wrote.

The authors and Dr. Butter declared no relevant financial relationships.

Physical exercise is associated with a reduction in suicide attempts, new research suggests.

A meta-analysis of 17 randomized controlled trials (RCTs), which included more than 1,000 participants with mental or physical illnesses, showed there was a significant reduction in suicide attempts in participants randomly assigned to receive exercise interventions, compared with inactive controls. However, there were no differences between the exercise and the control groups in suicidal ideation or mortality.

On the other hand, there was also no significant difference in dropout rates between those randomly assigned to exercise versus inactive controls, suggesting that people with mental or physical impairments are able to adhere to exercise regimens.

“A common misconception is that patients, particularly those suffering from mental of physical illness, are not willing or motivated enough to participate in an exercise [regimen], and this has led to primary care providers underprescribing exercise to those with mental or physical illness,” lead author Nicholas Fabiano, MD, a resident in the department of psychiatry at the University of Ottawa, told this news organization.

As a result of the study findings, “we recommend that providers do not have apprehension about prescribing exercise to patients with physical or mental illness. Exercise may be an effective way to reduce suicidal behaviors” in these patients, he said.

The study was published online  in the Journal of Affective Disorders.
 

Physical, mental health strongly linked

Existing literature has “demonstrated a protective effect of physical activity on suicidal ideation in the general population,” but to date there have been no systematic reviews or meta-analyses investigating its impact on suicide-related outcomes in patients with physical or mental illness, the authors write.

“Those with mental or physical illness are at increased risk of suicide, compared to the general population,” Dr. Fabiano commented.

“We often split up ‘mental health’ and ‘physical health’ in medicine; however, I believe that the two are more on a continuum and a holistic term, such as ‘health,’ should be used instead,” he added.

He noted that mental and physical health are “inexorably intertwined” and those with physical illness are more prone to developing mental illness, whereas those with mental illness are more likely to suffer from a variety of other medical conditions. “Therefore, when treating those with mental illness, it is also imperative that we bolster one’s physical health through easily accessible activities such as exercise,” he said.

The goal of the study was to determine whether individuals with “any mental, physical, clinical, or subclinical condition” might benefit from exercise, particularly in relation to suicide-related outcomes. They searched multiple databases from inception to June 2022 to identify RCTs investigating exercise and suicidal ideation in participants with physical or mental conditions.

Of 673 studies, 17 met the inclusion criteria (total of 1,021 participants). Participants’ mean age was 42.7 years, 82% were female, and 54% were randomly assigned to an exercise intervention.

Most studies (82%) focused on clinical versus subclinical outcomes. Depression was the most commonly included condition (59%). Aerobic exercise (53%) was the most common form of exercise used in the active study groups. This was followed by mind-body exercise and strength training (53%, 17.6%, and 17.6%, respectively). The mean follow-up time was 10 weeks.
 

Reduced impulsivity

The researchers found a difference in post-intervention suicidal ideation when they compared exercise participants to all control and inactive control participants (standardized mean difference, –1.09; 95% confidence interval, –3.08 to 0.90; P = .20, k = 5). However, the difference was not statistically significant.

Similarly, there was no significant difference (P = .60) in suicidal ideation incidence for subgroup analyses that stratified data among participants with depression, sickle cell disease, and suicidality.

All-cause discontinuation also did not significantly differ between participants who were randomly assigned to exercise interventions versus all controls or inactive controls (odds ratio, 0.85; 95% CI, 0.38-1.94; P = .86, k = 12 and OR, 0.81; 95% CI, 0.25-2.68; P = .70). All-cause discontinuation also did not differ between participants randomized to exercise versus active controls (OR, 0.94; 95% CI, 0.38-2.32; P = .79, k = 3).

Likewise, there were nonsignificant differences between participants who underwent aerobic exercise and strength training (P = .20).

However, there were some nonsignificant differences when comparing participants with depression and stress who received the exercise intervention versus controls (P = .46).

There was a significant reduction in suicide attempts in individuals who participated in exercise interventions versus inactive controls (OR, 0.23; 95% CI, 0.09-0.67; P = .04, k = 2). On the other hand, there was no significant difference in mortality (P = .70).

Most of the studies (82%) were “at high risk of bias,” the authors note. In addition, the analysis was limited because the included studies were “few, underpowered, and heterogeneous.”

Dr. Fabiano hypothesized that the lack of effect on suicidal ideation or mortality is “likely due to the limited sample size.” As additional RCTs are conducted, Dr. Fabiano expects to see decreases in both suicidal ideation and suicide attempts.

The findings may “be explained by the ideation-to-action framework, which suggests that the development of suicidal ideation and the progression to suicide attempts are distinct processes with different influential factors,” he said.

Increased levels of exercise have been “shown to reduce emotional impulsivity and, as it has been shown that most suicide attempts are characterized by impulsivity and low lethality, we hypothesize that regular exercise serves as a protective factor against suicide attempts,” he said.
 

Not useful?

Commenting on the study, Fabien Legrand, PhD, a lecturer in clinical psychology, University of Reims Champagne-Ardenne, Reims, France, said that the impact of physical activity is of “particular interest” to him because it is closely linked to his research activity, where he has “been exploring the antidepressant effects of exercise for more than 15 years.”

A small pilot study conducted by Dr. Legrand and colleagues found rigorous physical activity to be helpful in reducing hopelessness in psychiatric patients, compared with controls. “This result is of particular relevance for suicidal patients, since it has long been documented that hopelessness is one of the main triggers of suicide ideation and suicide attempts,” he said.

Initially, Dr. Legrand “warmly welcomed” the current review and meta-analysis on the exercise and suicide. However, he felt that the paper fell short in accomplishing its intended goal. “After a thorough reading of the paper, I don’t think that the information provided can be used in any way,” he stated.

“The paper’s title – ‘Effects of Physical Exercise on Suicidal Ideation and Behavior’ – does not do justice to its content, since 9 of the included 17 RCTs did not measure changes in suicidal ideation and/or suicidal behavior following participation in an exercise program,” noted Dr. Legrand, who was not involved with authorship or the current analysis.

The study was funded by the University of Ottawa department of psychiatry. Dr. Fabiano declares no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Legrand declares no relevant financial relationships.

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

Physical exercise is associated with a reduction in suicide attempts, new research suggests.

A meta-analysis of 17 randomized controlled trials (RCTs), which included more than 1,000 participants with mental or physical illnesses, showed there was a significant reduction in suicide attempts in participants randomly assigned to receive exercise interventions, compared with inactive controls. However, there were no differences between the exercise and the control groups in suicidal ideation or mortality.

On the other hand, there was also no significant difference in dropout rates between those randomly assigned to exercise versus inactive controls, suggesting that people with mental or physical impairments are able to adhere to exercise regimens.

“A common misconception is that patients, particularly those suffering from mental of physical illness, are not willing or motivated enough to participate in an exercise [regimen], and this has led to primary care providers underprescribing exercise to those with mental or physical illness,” lead author Nicholas Fabiano, MD, a resident in the department of psychiatry at the University of Ottawa, told this news organization.

As a result of the study findings, “we recommend that providers do not have apprehension about prescribing exercise to patients with physical or mental illness. Exercise may be an effective way to reduce suicidal behaviors” in these patients, he said.

The study was published online  in the Journal of Affective Disorders.
 

Physical, mental health strongly linked

Existing literature has “demonstrated a protective effect of physical activity on suicidal ideation in the general population,” but to date there have been no systematic reviews or meta-analyses investigating its impact on suicide-related outcomes in patients with physical or mental illness, the authors write.

“Those with mental or physical illness are at increased risk of suicide, compared to the general population,” Dr. Fabiano commented.

“We often split up ‘mental health’ and ‘physical health’ in medicine; however, I believe that the two are more on a continuum and a holistic term, such as ‘health,’ should be used instead,” he added.

He noted that mental and physical health are “inexorably intertwined” and those with physical illness are more prone to developing mental illness, whereas those with mental illness are more likely to suffer from a variety of other medical conditions. “Therefore, when treating those with mental illness, it is also imperative that we bolster one’s physical health through easily accessible activities such as exercise,” he said.

The goal of the study was to determine whether individuals with “any mental, physical, clinical, or subclinical condition” might benefit from exercise, particularly in relation to suicide-related outcomes. They searched multiple databases from inception to June 2022 to identify RCTs investigating exercise and suicidal ideation in participants with physical or mental conditions.

Of 673 studies, 17 met the inclusion criteria (total of 1,021 participants). Participants’ mean age was 42.7 years, 82% were female, and 54% were randomly assigned to an exercise intervention.

Most studies (82%) focused on clinical versus subclinical outcomes. Depression was the most commonly included condition (59%). Aerobic exercise (53%) was the most common form of exercise used in the active study groups. This was followed by mind-body exercise and strength training (53%, 17.6%, and 17.6%, respectively). The mean follow-up time was 10 weeks.
 

Reduced impulsivity

The researchers found a difference in post-intervention suicidal ideation when they compared exercise participants to all control and inactive control participants (standardized mean difference, –1.09; 95% confidence interval, –3.08 to 0.90; P = .20, k = 5). However, the difference was not statistically significant.

Similarly, there was no significant difference (P = .60) in suicidal ideation incidence for subgroup analyses that stratified data among participants with depression, sickle cell disease, and suicidality.

All-cause discontinuation also did not significantly differ between participants who were randomly assigned to exercise interventions versus all controls or inactive controls (odds ratio, 0.85; 95% CI, 0.38-1.94; P = .86, k = 12 and OR, 0.81; 95% CI, 0.25-2.68; P = .70). All-cause discontinuation also did not differ between participants randomized to exercise versus active controls (OR, 0.94; 95% CI, 0.38-2.32; P = .79, k = 3).

Likewise, there were nonsignificant differences between participants who underwent aerobic exercise and strength training (P = .20).

However, there were some nonsignificant differences when comparing participants with depression and stress who received the exercise intervention versus controls (P = .46).

There was a significant reduction in suicide attempts in individuals who participated in exercise interventions versus inactive controls (OR, 0.23; 95% CI, 0.09-0.67; P = .04, k = 2). On the other hand, there was no significant difference in mortality (P = .70).

Most of the studies (82%) were “at high risk of bias,” the authors note. In addition, the analysis was limited because the included studies were “few, underpowered, and heterogeneous.”

Dr. Fabiano hypothesized that the lack of effect on suicidal ideation or mortality is “likely due to the limited sample size.” As additional RCTs are conducted, Dr. Fabiano expects to see decreases in both suicidal ideation and suicide attempts.

The findings may “be explained by the ideation-to-action framework, which suggests that the development of suicidal ideation and the progression to suicide attempts are distinct processes with different influential factors,” he said.

Increased levels of exercise have been “shown to reduce emotional impulsivity and, as it has been shown that most suicide attempts are characterized by impulsivity and low lethality, we hypothesize that regular exercise serves as a protective factor against suicide attempts,” he said.
 

Not useful?

Commenting on the study, Fabien Legrand, PhD, a lecturer in clinical psychology, University of Reims Champagne-Ardenne, Reims, France, said that the impact of physical activity is of “particular interest” to him because it is closely linked to his research activity, where he has “been exploring the antidepressant effects of exercise for more than 15 years.”

A small pilot study conducted by Dr. Legrand and colleagues found rigorous physical activity to be helpful in reducing hopelessness in psychiatric patients, compared with controls. “This result is of particular relevance for suicidal patients, since it has long been documented that hopelessness is one of the main triggers of suicide ideation and suicide attempts,” he said.

Initially, Dr. Legrand “warmly welcomed” the current review and meta-analysis on the exercise and suicide. However, he felt that the paper fell short in accomplishing its intended goal. “After a thorough reading of the paper, I don’t think that the information provided can be used in any way,” he stated.

“The paper’s title – ‘Effects of Physical Exercise on Suicidal Ideation and Behavior’ – does not do justice to its content, since 9 of the included 17 RCTs did not measure changes in suicidal ideation and/or suicidal behavior following participation in an exercise program,” noted Dr. Legrand, who was not involved with authorship or the current analysis.

The study was funded by the University of Ottawa department of psychiatry. Dr. Fabiano declares no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Legrand declares no relevant financial relationships.

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

Physical exercise is associated with a reduction in suicide attempts, new research suggests.

A meta-analysis of 17 randomized controlled trials (RCTs), which included more than 1,000 participants with mental or physical illnesses, showed there was a significant reduction in suicide attempts in participants randomly assigned to receive exercise interventions, compared with inactive controls. However, there were no differences between the exercise and the control groups in suicidal ideation or mortality.

On the other hand, there was also no significant difference in dropout rates between those randomly assigned to exercise versus inactive controls, suggesting that people with mental or physical impairments are able to adhere to exercise regimens.

“A common misconception is that patients, particularly those suffering from mental of physical illness, are not willing or motivated enough to participate in an exercise [regimen], and this has led to primary care providers underprescribing exercise to those with mental or physical illness,” lead author Nicholas Fabiano, MD, a resident in the department of psychiatry at the University of Ottawa, told this news organization.

As a result of the study findings, “we recommend that providers do not have apprehension about prescribing exercise to patients with physical or mental illness. Exercise may be an effective way to reduce suicidal behaviors” in these patients, he said.

The study was published online  in the Journal of Affective Disorders.
 

Physical, mental health strongly linked

Existing literature has “demonstrated a protective effect of physical activity on suicidal ideation in the general population,” but to date there have been no systematic reviews or meta-analyses investigating its impact on suicide-related outcomes in patients with physical or mental illness, the authors write.

“Those with mental or physical illness are at increased risk of suicide, compared to the general population,” Dr. Fabiano commented.

“We often split up ‘mental health’ and ‘physical health’ in medicine; however, I believe that the two are more on a continuum and a holistic term, such as ‘health,’ should be used instead,” he added.

He noted that mental and physical health are “inexorably intertwined” and those with physical illness are more prone to developing mental illness, whereas those with mental illness are more likely to suffer from a variety of other medical conditions. “Therefore, when treating those with mental illness, it is also imperative that we bolster one’s physical health through easily accessible activities such as exercise,” he said.

The goal of the study was to determine whether individuals with “any mental, physical, clinical, or subclinical condition” might benefit from exercise, particularly in relation to suicide-related outcomes. They searched multiple databases from inception to June 2022 to identify RCTs investigating exercise and suicidal ideation in participants with physical or mental conditions.

Of 673 studies, 17 met the inclusion criteria (total of 1,021 participants). Participants’ mean age was 42.7 years, 82% were female, and 54% were randomly assigned to an exercise intervention.

Most studies (82%) focused on clinical versus subclinical outcomes. Depression was the most commonly included condition (59%). Aerobic exercise (53%) was the most common form of exercise used in the active study groups. This was followed by mind-body exercise and strength training (53%, 17.6%, and 17.6%, respectively). The mean follow-up time was 10 weeks.
 

Reduced impulsivity

The researchers found a difference in post-intervention suicidal ideation when they compared exercise participants to all control and inactive control participants (standardized mean difference, –1.09; 95% confidence interval, –3.08 to 0.90; P = .20, k = 5). However, the difference was not statistically significant.

Similarly, there was no significant difference (P = .60) in suicidal ideation incidence for subgroup analyses that stratified data among participants with depression, sickle cell disease, and suicidality.

All-cause discontinuation also did not significantly differ between participants who were randomly assigned to exercise interventions versus all controls or inactive controls (odds ratio, 0.85; 95% CI, 0.38-1.94; P = .86, k = 12 and OR, 0.81; 95% CI, 0.25-2.68; P = .70). All-cause discontinuation also did not differ between participants randomized to exercise versus active controls (OR, 0.94; 95% CI, 0.38-2.32; P = .79, k = 3).

Likewise, there were nonsignificant differences between participants who underwent aerobic exercise and strength training (P = .20).

However, there were some nonsignificant differences when comparing participants with depression and stress who received the exercise intervention versus controls (P = .46).

There was a significant reduction in suicide attempts in individuals who participated in exercise interventions versus inactive controls (OR, 0.23; 95% CI, 0.09-0.67; P = .04, k = 2). On the other hand, there was no significant difference in mortality (P = .70).

Most of the studies (82%) were “at high risk of bias,” the authors note. In addition, the analysis was limited because the included studies were “few, underpowered, and heterogeneous.”

Dr. Fabiano hypothesized that the lack of effect on suicidal ideation or mortality is “likely due to the limited sample size.” As additional RCTs are conducted, Dr. Fabiano expects to see decreases in both suicidal ideation and suicide attempts.

The findings may “be explained by the ideation-to-action framework, which suggests that the development of suicidal ideation and the progression to suicide attempts are distinct processes with different influential factors,” he said.

Increased levels of exercise have been “shown to reduce emotional impulsivity and, as it has been shown that most suicide attempts are characterized by impulsivity and low lethality, we hypothesize that regular exercise serves as a protective factor against suicide attempts,” he said.
 

Not useful?

Commenting on the study, Fabien Legrand, PhD, a lecturer in clinical psychology, University of Reims Champagne-Ardenne, Reims, France, said that the impact of physical activity is of “particular interest” to him because it is closely linked to his research activity, where he has “been exploring the antidepressant effects of exercise for more than 15 years.”

A small pilot study conducted by Dr. Legrand and colleagues found rigorous physical activity to be helpful in reducing hopelessness in psychiatric patients, compared with controls. “This result is of particular relevance for suicidal patients, since it has long been documented that hopelessness is one of the main triggers of suicide ideation and suicide attempts,” he said.

Initially, Dr. Legrand “warmly welcomed” the current review and meta-analysis on the exercise and suicide. However, he felt that the paper fell short in accomplishing its intended goal. “After a thorough reading of the paper, I don’t think that the information provided can be used in any way,” he stated.

“The paper’s title – ‘Effects of Physical Exercise on Suicidal Ideation and Behavior’ – does not do justice to its content, since 9 of the included 17 RCTs did not measure changes in suicidal ideation and/or suicidal behavior following participation in an exercise program,” noted Dr. Legrand, who was not involved with authorship or the current analysis.

The study was funded by the University of Ottawa department of psychiatry. Dr. Fabiano declares no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Legrand declares no relevant financial relationships.

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

Bipolar disorder  is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family. 

In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.  

She discusses two FDA-approved long-acting injectables  for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.  

Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability. 

--

Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio 

Martha Sajatovic, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health 

Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis 

Received royalties from: Springer Press; Johns Hopkins University Press 

Bipolar disorder  is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family. 

In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.  

She discusses two FDA-approved long-acting injectables  for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.  

Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability. 

--

Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio 

Martha Sajatovic, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health 

Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis 

Received royalties from: Springer Press; Johns Hopkins University Press 

Bipolar disorder  is a multifaceted condition associated with an increased risk for hospitalization and suicide as well as high costs to society and family. 

In this ReCAP, Dr Martha Sajatovic, of the University Hospitals of Cleveland, discusses evidence of the short- and long-term consequences of bipolar disorder, including progressive neurologic impact such as changes in brain structure.  

She discusses two FDA-approved long-acting injectables  for bipolar disorder and considerations for their use, including their potential for first-line maintenance treatment and benefits for medication adherence.  

Finally, she considers challenges in the clinical use of the long-acting injectables, including insufficient caregiver involvement and lack of awareness of the drugs' availability. 

--

Martha Sajatovic, MD, Director, Neurological and Behavioral Outcomes Center, University Hospitals of Cleveland, Cleveland, Ohio 

Martha Sajatovic, MD, has disclosed the following relevant financial relationships: 

Received research grant from: Otsuka; International Society for Bipolar Disorders; National Institutes of Health 

Received income in an amount equal to or greater than $250 from: Otsuka; Janssen; Lundbeck; Teva; Neurelis 

Received royalties from: Springer Press; Johns Hopkins University Press 

Time for my periodic reminder about your Occupational Health and Safety Administration (OSHA) obligations. The health care field still has the most work-related illness and injury reports of any industry in the United States, and OSHA standards are in place to minimize potential workplace incidents.

Now might be a good time to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

For starters, do you have an official OSHA poster, enumerating employee rights and explaining how to file complaints? Every office must have one posted in plain sight, and it is the first thing an OSHA inspector will look for. You can download one from OSHA’s website or order one at no charge by calling 800-321-OSHA.

The poster discusses the “general standards” that all workplaces must comply with to avoid work-related illnesses and injuries. The standards most applicable to medical offices are those dealing with personal protective equipment (PPE), bloodborne pathogens, hazard communication, and – increasingly, of late – ionizing radiation.

Physicians have become all too familiar with the PPE standard as a result of the COVID pandemic. Ironically, OSHA considers PPE a less acceptable means of employee protection than the other standards, as safe work practices should always supersede safety equipment. Nevertheless, employers must have a PPE program in place to train employees on what equipment is necessary, and under which conditions.

You also need a written exposure control plan for bloodborne pathogens. It should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, and your implementation of universal precautions – and it is supposed to be updated annually, to reflect changes in technology. You must provide all at-risk employees with hepatitis B vaccine at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

You need not adopt every new safety device as it comes on the market, but you should document which ones you are using – and which you pass up – and why. For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at that decision, and why you feel that your current protocol is as good or better.

The hazard communication (or right-to-know) standard involves compiling a list of hazardous substances, which all employees have a right to know about. Keep in mind that OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are nevertheless classified as “hazardous.” For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

If your office has x-ray equipment, or you are considering one of the new image-guided superficial radiotherapy machines, you must be in compliance with the ionizing radiation standard, which entails shielding, radiation monitors, and clear labeling of equipment.

Other, more general regulations include the physical setup of your office. Everyone must be able to evacuate quickly in case of fire or other emergencies. At a minimum, you (or the owner of the office building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it, and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars. How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you do that? Because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they find.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Time for my periodic reminder about your Occupational Health and Safety Administration (OSHA) obligations. The health care field still has the most work-related illness and injury reports of any industry in the United States, and OSHA standards are in place to minimize potential workplace incidents.

Now might be a good time to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

For starters, do you have an official OSHA poster, enumerating employee rights and explaining how to file complaints? Every office must have one posted in plain sight, and it is the first thing an OSHA inspector will look for. You can download one from OSHA’s website or order one at no charge by calling 800-321-OSHA.

The poster discusses the “general standards” that all workplaces must comply with to avoid work-related illnesses and injuries. The standards most applicable to medical offices are those dealing with personal protective equipment (PPE), bloodborne pathogens, hazard communication, and – increasingly, of late – ionizing radiation.

Physicians have become all too familiar with the PPE standard as a result of the COVID pandemic. Ironically, OSHA considers PPE a less acceptable means of employee protection than the other standards, as safe work practices should always supersede safety equipment. Nevertheless, employers must have a PPE program in place to train employees on what equipment is necessary, and under which conditions.

You also need a written exposure control plan for bloodborne pathogens. It should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, and your implementation of universal precautions – and it is supposed to be updated annually, to reflect changes in technology. You must provide all at-risk employees with hepatitis B vaccine at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

You need not adopt every new safety device as it comes on the market, but you should document which ones you are using – and which you pass up – and why. For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at that decision, and why you feel that your current protocol is as good or better.

The hazard communication (or right-to-know) standard involves compiling a list of hazardous substances, which all employees have a right to know about. Keep in mind that OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are nevertheless classified as “hazardous.” For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

If your office has x-ray equipment, or you are considering one of the new image-guided superficial radiotherapy machines, you must be in compliance with the ionizing radiation standard, which entails shielding, radiation monitors, and clear labeling of equipment.

Other, more general regulations include the physical setup of your office. Everyone must be able to evacuate quickly in case of fire or other emergencies. At a minimum, you (or the owner of the office building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it, and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars. How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you do that? Because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they find.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Time for my periodic reminder about your Occupational Health and Safety Administration (OSHA) obligations. The health care field still has the most work-related illness and injury reports of any industry in the United States, and OSHA standards are in place to minimize potential workplace incidents.

Now might be a good time to get out your OSHA logs, walk through your office, and confirm that you remain in compliance with all the applicable regulations. Even if you hold regular safety meetings (which all too often is not the case), the occasional comprehensive review is always a good idea, and could save you a bundle in fines.

For starters, do you have an official OSHA poster, enumerating employee rights and explaining how to file complaints? Every office must have one posted in plain sight, and it is the first thing an OSHA inspector will look for. You can download one from OSHA’s website or order one at no charge by calling 800-321-OSHA.

The poster discusses the “general standards” that all workplaces must comply with to avoid work-related illnesses and injuries. The standards most applicable to medical offices are those dealing with personal protective equipment (PPE), bloodborne pathogens, hazard communication, and – increasingly, of late – ionizing radiation.

Physicians have become all too familiar with the PPE standard as a result of the COVID pandemic. Ironically, OSHA considers PPE a less acceptable means of employee protection than the other standards, as safe work practices should always supersede safety equipment. Nevertheless, employers must have a PPE program in place to train employees on what equipment is necessary, and under which conditions.

You also need a written exposure control plan for bloodborne pathogens. It should document your use of such protective equipment as gloves, face and eye protection, needle guards, and gowns, and your implementation of universal precautions – and it is supposed to be updated annually, to reflect changes in technology. You must provide all at-risk employees with hepatitis B vaccine at no cost to them. You also must provide and pay for appropriate medical treatment and follow-up after any exposure to a dangerous pathogen.

You need not adopt every new safety device as it comes on the market, but you should document which ones you are using – and which you pass up – and why. For example, you and your employees may decide not to purchase a new safety needle because you don’t think it will improve safety, or that it will be more trouble than it’s worth; but you should document how you arrived at that decision, and why you feel that your current protocol is as good or better.

The hazard communication (or right-to-know) standard involves compiling a list of hazardous substances, which all employees have a right to know about. Keep in mind that OSHA’s list includes alcohol, hydrogen peroxide, acetone, liquid nitrogen, and other substances that you might not consider particularly dangerous, but are nevertheless classified as “hazardous.” For each substance, your employees must have access to the manufacturer-supplied Material Safety Data Sheet, which outlines the proper procedures for working with a specific material, and for handling and containing it in a spill or other emergency.

If your office has x-ray equipment, or you are considering one of the new image-guided superficial radiotherapy machines, you must be in compliance with the ionizing radiation standard, which entails shielding, radiation monitors, and clear labeling of equipment.

Other, more general regulations include the physical setup of your office. Everyone must be able to evacuate quickly in case of fire or other emergencies. At a minimum, you (or the owner of the office building) are expected to establish exit routes to accommodate all employees and to post easily visible evacuation diagrams.

Examine all electrical devices and their power sources. All electrically powered equipment – medical, clerical, or anything else in the office – must operate safely. Pay particular attention to the way wall outlets are set up. Make sure each outlet has sufficient power to run the equipment plugged into it, and that circuit breakers are present and functioning. And beware the common situation of too many gadgets running off a single circuit.

Other components of the rule include proper containment of regulated medical waste, identification of regulated-waste containers, sharps disposal boxes, and periodic employee training regarding all of these things.

Federal OSHA regulations do not require medical and dental offices to keep an injury and illness log, as other businesses must; but your state may have a requirement that supersedes the federal law. Check with your state, or with your local OSHA office, regarding any such requirements.

It is a mistake to take OSHA regulations lightly; failure to comply with them can result in stiff penalties running into many thousands of dollars. How can you be certain you are complying with all the rules? The easiest and cheapest way is to call your local OSHA office and request an inspection. Why would you do that? Because OSHA issues no citations during voluntary inspections as long as you agree to remedy any violations they find.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Memantine, a drug typically used to treat symptoms of Alzheimer’s disease, is linked to a significant reduction in symptoms of trichotillomania and skin-picking disorder, new research shows.

Results from the double-blind, placebo-controlled trial showed that 61% of participants who received memantine were “much or very much improved,” versus 8% in the placebo group.

“Memantine was far more effective than placebo,” lead investigator Jon Grant, MD, MPH, professor of psychiatry and behavioral neuroscience at the University of Chicago, said in an interview. “However, while subjects responded favorably, that didn’t necessarily mean there were no symptoms.”

The study was published online  in the American Journal of Psychiatry.
 

Underrecognized, disabling

The investigators noted that trichotillomania and skin-picking disorder are underrecognized and are often disabling conditions. However, the researchers pointed out that with prevalence rates of 1.7% for trichotillomania and 2.1% for skin-picking disorder, they are not uncommon.

Behavioral therapy that attempts to reverse these habits is considered first-line treatment, but trained therapists are difficult to find. In addition, the investigators wrote that currently, there are no Food and Drug Administration–approved medications for either disorder, and pharmacologic clinical trials are relatively uncommon.

The existing data from double-blind, placebo-controlled studies support the use of the antipsychotic olanzapine, the tricyclic antidepressant clomipramine, and the supplement N-acetyl-L-cysteine (NAC). Dr. Grant also noted that previous drug trials involving patients with trichotillomania have been very short in duration.

Prior research has implicated the glutamate system in repetitive motor habits and the urges that drive them. Memantine, a glutamate receptor antagonist, targets excessive glutamatergic drive. To investigate whether this medication may be beneficial for patients with trichotillomania and skin-picking disorders, the investigators conducted a randomized placebo-controlled trial.

The study included 100 adults (86 women; mean age, 31.4) with trichotillomania, skin-picking disorder, or both; participants received memantine (n = 55) or placebo (n = 45) for 8 weeks; they received memantine 10 mg or placebo for the first 2 weeks, then 20 mg for the next 6 weeks.

The researchers, who were blinded to assignment, assessed participants every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which was modified to include questions for skin-picking disorder.

The team also tracked symptoms and behaviors using additional scales, including the Sheehan Disability Scale and the Clinical Global Impressions severity scale.

At the study’s conclusion, 79 patients remained. Of those, 26 of the 43 participants in the memantine group were “very much” or “much” improved (61%), versus 3 of 36 (8%) in the placebo group. (P < .0001)

Six participants in the memantine group experienced complete remission of symptoms, compared with one in the placebo group. There were no differences between the study groups in terms of adverse events.

Study limitations included the relatively short length of the trial for what should be considered a chronic disease, as well as the inclusion of only mildly to moderately symptomatic participants.

Dr. Grant said that he would like to study how memantine works in combination with behavioral therapy.
 

‘Two great options’

Katharine Phillips, MD, professor of psychiatry at Weill Cornell Medicine, New York, said she has been using memantine for “quite some time” to treat her patients with skin-picking disorder, adding that she uses higher doses of the drug than were tested in the study.

She noted that both NAC and memantine affect glutamate, an amino acid in the brain that is likely involved in repetitive physical or motor habits, such as hair pulling and skin picking.

“The good news is that we have two great options” for the treatment of trichotillomania and skin-picking disorder, said Dr. Phillips, and that both are easy to tolerate.

Future research should focus on longer trials of memantine and at higher doses, as well as other glutamate modulators, she said.

The study was funded by departmental research funds at the University of Chicago. Dr. Grant reported receiving research funding from Biohaven Pharmaceuticals and Janssen, as well as yearly compensation from Springer Publishing for his role as editor-in-chief of the Journal of Gambling Studies. He has also received royalties from American Psychiatric Publishing, McGraw Hill, Oxford University Press, and WW Norton. Dr. Phillips reported receiving royalties from American Psychiatric Publishing and an honorarium from the Merck Manual.

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

Electroconvulsive therapy appears to have a small advantage over ketamine for improving depressive symptoms in adults with a major depressive episode, results of a new review show.

“Although ECT is superior to ketamine for patients with a major depressive episode, our findings suggest that the therapeutic advantage may be smaller than what was demonstrated in prior analyses,” first author Vikas Menon, MD, department of psychiatry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, told this news organization.

“This supports a recommendation for a trial of ketamine before a trial of ECT for patients with MDE, though this recommendation is limited by the small size and number of existing trials,” Dr. Menon said.

The study was published online in JAMA Psychiatry.
 

Questions remain

The meta-analysis included five trials of 278 adults with MDE (141 treated with ketamine and 137 with ECT).

In the main analysis, posttreatment depression ratings showed a trend for lower scores with ECT, compared with ketamine (standardized mean difference, −0.39; 95% confidence interval, −0.81 to 0.02). 

In a sensitivity analysis of the two methodologically stronger trials, ECT was superior to ketamine (pooled SMD, −0.45; 95% CI, −0.75 to −0.14).

ECT was also superior to ketamine in terms of response rates (risk ratio, 1.27; 95% CI, 1.06-1.53) and remission rates (RR, 1.43; 95% CI, 1.12-1.82).

There were no significant between-group differences for number of sessions to response and remission and for cognitive outcomes.

Key limitations of the analysis were the small number of studies with limited sample sizes and a high risk of bias in all trials.

“There is a need for more comparative studies with adequate sample size in non-inferiority designs, examining a wider range of benefits and side effects and followed up for longer durations to answer clinically relevant questions about the nature and durability of observed benefits with ketamine,” said Dr. Menon.

“In patients with MDE for whom the administration of ECT is limited by restricted availability of the treatment, concerns about its cognitive adverse effects, negative patient attitudes, and other issues, clinicians may consider a trial of ketamine,” he added.
 

‘Important research’

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study.

Rupert McShane, MD, psychiatrist at the University of Oxford (England), noted that ECT and ketamine are both “potent” treatments for depression, and this meta-analysis shows that they are, “broadly speaking, equally as good as each other with perhaps a slight advantage for ECT.”

“Whether or not there is a difference depends on exactly how you define it and how you cut the data. Despite the slight advantage for ECT in this analysis, the authors support using ketamine before ECT, especially in patients who are worried about the cognitive risks of ECT. This seems sensible,” Dr. McShane said.

Allan Young, MBChB, clinical psychiatrist at King’s College London, noted that both ketamine and ECT have been shown to help some patients with treatment-resistant depression.

“Clearly the relative benefits of these two treatments need to be understood better, but this review of the existing literature suggests that ECT may benefit some more than ketamine,” said Mr. Young.

“There is evidence that ketamine with ECT may add little extra benefit, but much more work needs to be done to fully understand how these treatments fit best into the treatment pathway for major depressive episodes. However, based on this evidence, ECT clearly still merits a place in the treatment pathway,” Mr. Young added.

George Kirov, PhD, clinical professor, division of psychological medicine and clinical neurosciences, Cardiff University (England), said while the study is conducted well, most of the evidence is coming from one large trial conducted in Sweden.

“The other studies add small numbers of patients and the authors even present a sensitivity analysis after removing studies of poor quality, thus leaving only two studies and exposing even further the dependence of the results on one single study,” Dr. Kirov noted. 

“The small studies should not be blamed for their size, as this is very difficult research to perform. On the other hand, the trends were in the same direction,” he added.

With those caveats in mind, Dr. Kirov said he still thinks this is “important research. It establishes the superiority of ECT against an active comparator (ketamine) which is very popular now and accepted to be quite effective.”

The study had no specific funding. Dr. Menon reports no relevant financial relationships. Dr. McShane is former chair of the ECT and Related Treatments Committee, Royal College of Psychiatrists and runs a ketamine clinic and an ECT service. Mr. Young has received compensation for lectures and advisory boards for AstraZeneca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allergan, Bionomics, Sumitomo Dainippon Pharma, COMPASS, and Sage, and has served as principal investigator on a trial of intranasal esketamine in treatment-resistant depression. Dr. Kirov has no interest to declare other than running the ECT service in Cardiff.

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

Electroconvulsive therapy appears to have a small advantage over ketamine for improving depressive symptoms in adults with a major depressive episode, results of a new review show.

“Although ECT is superior to ketamine for patients with a major depressive episode, our findings suggest that the therapeutic advantage may be smaller than what was demonstrated in prior analyses,” first author Vikas Menon, MD, department of psychiatry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, told this news organization.

“This supports a recommendation for a trial of ketamine before a trial of ECT for patients with MDE, though this recommendation is limited by the small size and number of existing trials,” Dr. Menon said.

The study was published online in JAMA Psychiatry.
 

Questions remain

The meta-analysis included five trials of 278 adults with MDE (141 treated with ketamine and 137 with ECT).

In the main analysis, posttreatment depression ratings showed a trend for lower scores with ECT, compared with ketamine (standardized mean difference, −0.39; 95% confidence interval, −0.81 to 0.02). 

In a sensitivity analysis of the two methodologically stronger trials, ECT was superior to ketamine (pooled SMD, −0.45; 95% CI, −0.75 to −0.14).

ECT was also superior to ketamine in terms of response rates (risk ratio, 1.27; 95% CI, 1.06-1.53) and remission rates (RR, 1.43; 95% CI, 1.12-1.82).

There were no significant between-group differences for number of sessions to response and remission and for cognitive outcomes.

Key limitations of the analysis were the small number of studies with limited sample sizes and a high risk of bias in all trials.

“There is a need for more comparative studies with adequate sample size in non-inferiority designs, examining a wider range of benefits and side effects and followed up for longer durations to answer clinically relevant questions about the nature and durability of observed benefits with ketamine,” said Dr. Menon.

“In patients with MDE for whom the administration of ECT is limited by restricted availability of the treatment, concerns about its cognitive adverse effects, negative patient attitudes, and other issues, clinicians may consider a trial of ketamine,” he added.
 

‘Important research’

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study.

Rupert McShane, MD, psychiatrist at the University of Oxford (England), noted that ECT and ketamine are both “potent” treatments for depression, and this meta-analysis shows that they are, “broadly speaking, equally as good as each other with perhaps a slight advantage for ECT.”

“Whether or not there is a difference depends on exactly how you define it and how you cut the data. Despite the slight advantage for ECT in this analysis, the authors support using ketamine before ECT, especially in patients who are worried about the cognitive risks of ECT. This seems sensible,” Dr. McShane said.

Allan Young, MBChB, clinical psychiatrist at King’s College London, noted that both ketamine and ECT have been shown to help some patients with treatment-resistant depression.

“Clearly the relative benefits of these two treatments need to be understood better, but this review of the existing literature suggests that ECT may benefit some more than ketamine,” said Mr. Young.

“There is evidence that ketamine with ECT may add little extra benefit, but much more work needs to be done to fully understand how these treatments fit best into the treatment pathway for major depressive episodes. However, based on this evidence, ECT clearly still merits a place in the treatment pathway,” Mr. Young added.

George Kirov, PhD, clinical professor, division of psychological medicine and clinical neurosciences, Cardiff University (England), said while the study is conducted well, most of the evidence is coming from one large trial conducted in Sweden.

“The other studies add small numbers of patients and the authors even present a sensitivity analysis after removing studies of poor quality, thus leaving only two studies and exposing even further the dependence of the results on one single study,” Dr. Kirov noted. 

“The small studies should not be blamed for their size, as this is very difficult research to perform. On the other hand, the trends were in the same direction,” he added.

With those caveats in mind, Dr. Kirov said he still thinks this is “important research. It establishes the superiority of ECT against an active comparator (ketamine) which is very popular now and accepted to be quite effective.”

The study had no specific funding. Dr. Menon reports no relevant financial relationships. Dr. McShane is former chair of the ECT and Related Treatments Committee, Royal College of Psychiatrists and runs a ketamine clinic and an ECT service. Mr. Young has received compensation for lectures and advisory boards for AstraZeneca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allergan, Bionomics, Sumitomo Dainippon Pharma, COMPASS, and Sage, and has served as principal investigator on a trial of intranasal esketamine in treatment-resistant depression. Dr. Kirov has no interest to declare other than running the ECT service in Cardiff.

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

Electroconvulsive therapy appears to have a small advantage over ketamine for improving depressive symptoms in adults with a major depressive episode, results of a new review show.

“Although ECT is superior to ketamine for patients with a major depressive episode, our findings suggest that the therapeutic advantage may be smaller than what was demonstrated in prior analyses,” first author Vikas Menon, MD, department of psychiatry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, told this news organization.

“This supports a recommendation for a trial of ketamine before a trial of ECT for patients with MDE, though this recommendation is limited by the small size and number of existing trials,” Dr. Menon said.

The study was published online in JAMA Psychiatry.
 

Questions remain

The meta-analysis included five trials of 278 adults with MDE (141 treated with ketamine and 137 with ECT).

In the main analysis, posttreatment depression ratings showed a trend for lower scores with ECT, compared with ketamine (standardized mean difference, −0.39; 95% confidence interval, −0.81 to 0.02). 

In a sensitivity analysis of the two methodologically stronger trials, ECT was superior to ketamine (pooled SMD, −0.45; 95% CI, −0.75 to −0.14).

ECT was also superior to ketamine in terms of response rates (risk ratio, 1.27; 95% CI, 1.06-1.53) and remission rates (RR, 1.43; 95% CI, 1.12-1.82).

There were no significant between-group differences for number of sessions to response and remission and for cognitive outcomes.

Key limitations of the analysis were the small number of studies with limited sample sizes and a high risk of bias in all trials.

“There is a need for more comparative studies with adequate sample size in non-inferiority designs, examining a wider range of benefits and side effects and followed up for longer durations to answer clinically relevant questions about the nature and durability of observed benefits with ketamine,” said Dr. Menon.

“In patients with MDE for whom the administration of ECT is limited by restricted availability of the treatment, concerns about its cognitive adverse effects, negative patient attitudes, and other issues, clinicians may consider a trial of ketamine,” he added.
 

‘Important research’

Several experts offered perspective on the analysis in a statement from the U.K.-based nonprofit Science Media Centre, which was not involved with the conduct of this study.

Rupert McShane, MD, psychiatrist at the University of Oxford (England), noted that ECT and ketamine are both “potent” treatments for depression, and this meta-analysis shows that they are, “broadly speaking, equally as good as each other with perhaps a slight advantage for ECT.”

“Whether or not there is a difference depends on exactly how you define it and how you cut the data. Despite the slight advantage for ECT in this analysis, the authors support using ketamine before ECT, especially in patients who are worried about the cognitive risks of ECT. This seems sensible,” Dr. McShane said.

Allan Young, MBChB, clinical psychiatrist at King’s College London, noted that both ketamine and ECT have been shown to help some patients with treatment-resistant depression.

“Clearly the relative benefits of these two treatments need to be understood better, but this review of the existing literature suggests that ECT may benefit some more than ketamine,” said Mr. Young.

“There is evidence that ketamine with ECT may add little extra benefit, but much more work needs to be done to fully understand how these treatments fit best into the treatment pathway for major depressive episodes. However, based on this evidence, ECT clearly still merits a place in the treatment pathway,” Mr. Young added.

George Kirov, PhD, clinical professor, division of psychological medicine and clinical neurosciences, Cardiff University (England), said while the study is conducted well, most of the evidence is coming from one large trial conducted in Sweden.

“The other studies add small numbers of patients and the authors even present a sensitivity analysis after removing studies of poor quality, thus leaving only two studies and exposing even further the dependence of the results on one single study,” Dr. Kirov noted. 

“The small studies should not be blamed for their size, as this is very difficult research to perform. On the other hand, the trends were in the same direction,” he added.

With those caveats in mind, Dr. Kirov said he still thinks this is “important research. It establishes the superiority of ECT against an active comparator (ketamine) which is very popular now and accepted to be quite effective.”

The study had no specific funding. Dr. Menon reports no relevant financial relationships. Dr. McShane is former chair of the ECT and Related Treatments Committee, Royal College of Psychiatrists and runs a ketamine clinic and an ECT service. Mr. Young has received compensation for lectures and advisory boards for AstraZeneca, Eli Lilly, Lundbeck, Sunovion, Servier, Livanova, Janssen, Allergan, Bionomics, Sumitomo Dainippon Pharma, COMPASS, and Sage, and has served as principal investigator on a trial of intranasal esketamine in treatment-resistant depression. Dr. Kirov has no interest to declare other than running the ECT service in Cardiff.

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