User login
Metformin linked to reduced osteoarthritis risk
Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.
“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.
The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.
In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.
The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.
Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.
The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).
“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.
This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.
”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.
Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.
Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.
Nonsignificant lower risk for posttraumatic knee osteoarthritis
Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.
Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.
Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.
Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).
In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.
“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.
The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.
Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.
“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.
The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.
In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.
The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.
Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.
The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).
“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.
This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.
”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.
Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.
Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.
Nonsignificant lower risk for posttraumatic knee osteoarthritis
Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.
Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.
Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.
Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).
In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.
“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.
The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.
Patients taking metformin for type 2 diabetes had a lower risk of developing osteoarthritis than did patients taking a sulfonylurea, according to a cohort study published in JAMA Network Open. The findings jibe with those seen in a 2022 systematic review of preclinical and observational human studies finding potentially protective effects of metformin on osteoarthritis.
“Our study provides further, robust epidemiological evidence that metformin may be associated with protection in the development and progression of osteoarthritis in individuals with type 2 diabetes,” wrote Matthew C. Baker, MD, MS, an assistant professor of medicine in immunology and rheumatology at Stanford (Calif.) University, and his colleagues.
The findings also fit with the results of a poster presented at the Osteoarthritis Research Society International 2023 World Congress, although that abstract’s findings did not reach statistical significance.
In the published study, the researchers analyzed deidentified claims data from Optum’s Clinformatics Data Mart Database between December 2003 and December 2019. The database includes more than 15 million people with private insurance or Medicare Advantage Part D but does not include people with Medicaid, thereby excluding people from lower socioeconomic groups.
The researchers included all patients who were at least 40 years old, had type 2 diabetes, were taking metformin, and had been enrolled in the database for at least 1 uninterrupted year. They excluded anyone with type 1 diabetes or a prior diagnosis of osteoarthritis, inflammatory arthritis, or joint replacement. The authors then compared the incidence of osteoarthritis and joint replacement in these 20,937 participants to 20,937 control participants who were taking a sulfonylurea, matched to those taking metformin on the basis of age, sex, race, a comorbidity score, and duration of treatment. More than half the overall population (58%) was male with an average age of 62.
Patients needed to be on either drug for at least 3 months, but those who were initially treated with metformin before later taking a sulfonylurea could also be included and contribute to both groups. Those who first took a sulfonylurea and later switched to metformin were included only for the sulfonylurea group and censored after their switch to ensure the sulfonylurea group had enough participants. The comparison was further adjusted for age, sex, race, ethnicity, geographic region, education, comorbidities, and outpatient visit frequency.
The results revealed that those who were taking metformin were 24% less likely to develop osteoarthritis at least 3 months after starting the medication than were those taking a sulfonylurea (P < .001). The rate of joint replacements was not significantly different between those taking metformin and those taking a sulfonylurea. These two results did not change in a sensitivity analysis that compared patients who only ever took metformin or a sulfonylurea (as opposed to those who took one drug before switching to the other).
“When stratified by prior exposure to metformin within the sulfonylurea group, the observed benefit associated with metformin ... was attenuated in the people treated with a sulfonylurea with prior exposure to metformin, compared with those treated with a sulfonylurea with no prior exposure to metformin,” the authors further reported. A possible reason for this finding is that those taking a sulfonylurea after having previously taken metformin gained some protection from the earlier metformin exposure, the authors hypothesized.
This observational study could not show a causative effect from the metformin, but the researchers speculated on potential mechanisms if a causative effect were present, based on past research.
”Several preclinical studies have suggested a protective association of metformin in osteoarthritis through activating AMP-activated protein kinase signaling, decreasing the level of matrix metalloproteinase, increasing autophagy and reducing chondrocyte apoptosis, and augmenting chondroprotective and anti-inflammatory properties of mesenchymal stem cells,” the authors wrote.
Among this study’s limitations, however, was the lack of data on body mass index, which is associated with osteoarthritis in the literature and may differ between patients taking metformin versus a sulfonylurea. The researchers also did not have data on physical activity or a history of trauma to the joints, though there’s no reason to think these rates might differ between those taking one or the other medication.
Another substantial limitation is that all patients had type 2 diabetes, making it impossible to determine whether a similar protective effect from metformin might exist in people without diabetes.
Nonsignificant lower risk for posttraumatic knee osteoarthritis
Similar to the published study, the OARSI poster compared 5-year odds of incident osteoarthritis or total knee replacement surgery between patients taking metformin and those taking sulfonylureas, but it focused on younger patients, aged 18-40 years, who underwent anterior cruciate ligament or meniscus surgery.
Using data from MarketScan commercial insurance claims databases between 2006 and 2020, the authors identified 2,376 participants who were taking metformin or a sulfonylurea when they underwent their surgery or began taking it in the 6 months after their surgery. More than half the participants were female (57%) with an average age of 35.
Within 5 years, 10.8% of those taking metformin developed osteoarthritis, compared with 17.9% of those taking a sulfonylurea. In addition, 3% of those taking metformin underwent a total knee replacement, compared with 5.3% of those taking a sulfonylurea. After adjustment for age, sex, obesity, and a history of chronic kidney disease, liver disease, and depression, however, both risk difference and odds ratios were not statistically significant.
Risk of osteoarthritis was 17% lower in patients taking metformin (95% confidence interval, –0.18 to 0.09), whose odds of osteoarthritis were approximately half the odds of those taking a sulfonylurea (OR, 0.5; 95% CI, 0.21-1.67). Risk of a total knee replacement was 10% lower in metformin users (95% CI, –0.28 to 0.08) with a similar reduction in odds, compared with those taking a sulfonylurea (OR, 0.53; 95% CI, 0.2-1.44).
In this study, the researchers did not specifically determine whether the participants were diagnosed with diabetes, but they assumed all, or at least most, were, according to S. Reza Jafarzadeh, PhD, DVM, an assistant professor of medicine at Boston University.
“The goal was not to only focus on the diabetes population, but on people who received that exposure [of metformin or sulfonylureas],” Dr. Jafarzadeh said in an interview. Dr. Jafarzadeh noted that a larger randomized controlled trial is underway to look at whether metformin reduces the risk of osteoarthritis independent of whether a patient has diabetes.
The published study was funded by grants from the National Institutes of Health, the Department of Veterans Affairs, and Stanford University, and the authors reported no disclosures. The poster at OARSI was funded by NIH and the Arthritis Foundation, and the authors reported no disclosures.
FROM JAMA NETWORK OPEN AND OARSI 2023
Neuropsychiatric side effects of hormonal contraceptives: More common than you think!
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).
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, 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).
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, 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).
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, 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].
ChatGPT as a tool in the ob.gyn. office
Artificial intelligence (AI) has recently gained significant public attention, primarily driven by the launch of a noteworthy program by OpenAI called Chat Generative Pre-trained Transformer (ChatGPT). This large language model is an AI system that enables users to interact with it using plain language. In just the first 2 months since its release, over 100 million subscribers have registered to use ChatGPT.
AI is now deeply integrated into our daily lives, pervading a wide array of smart devices such as phones, tablets, and numerous other gadgets that we rely on every day. These sophisticated technologies operate seamlessly in the background, often without us being consciously aware of their presence. Nevertheless, we greatly appreciate the way they enhance our lives by simplifying tasks and streamlining our routines.
A key factor contributing to ChatGPT’s popularity is its ability to accept input in the form of prompts in plain English. Our team published a comprehensive journal article showcasing examples of how this technology can be utilized by general ob.gyn. practitioners. ChatGPT has the potential to streamline work flow, generate letters to insurance companies, draft clinical plans, and assist with various other routine tasks in any ob.gyn. practice environment.
As with any new technology, it is essential for users to familiarize themselves with its capabilities and understand its limitations. A critical aspect to consider with the current version of ChatGPT is that it was developed using information primarily sourced from the Internet up until September 2021. This limitation is especially significant in the field of medicine, where practitioners consistently seek the most up-to-date and current information to inform their decisions.
However, it is expected that, in the near future, these programs will gain access to real-time information from a diverse range of sources, including but not limited to the Internet. This development will enhance the program’s utility and relevance in medical contexts.
Another limitation of ChatGPT is its propensity to “hallucinate.” Large language models are trained to respond to the best of their abilities, occasionally attempting to fill knowledge gaps with fabricated information. Being aware of these limitations enables users to recognize the program’s potential while also understanding the need for careful monitoring.
Our expertise and clinical knowledge are crucial in guiding and refining this technology, ensuring that it serves as a valuable tool in the ever-evolving landscape of medicine.
Another crucial factor to consider is that users must adhere to all guidelines and policies established within their work environment. This entails complying with HIPAA regulations and ensuring that any information generated by these programs is thoroughly examined before being integrated into practice work flows. As an increasing number of organizations develop specific guidelines for such technologies, the aim is to safeguard patients, users, and the organization itself. The individuals utilizing these technologies must exercise utmost caution and refrain from storing or sharing any sensitive or proprietary information.
The aim of this article is not to provide an exhaustive overview, but rather to offer a selection of examples and inspire readers to consider adopting these programs. By doing so, we hope to facilitate the exploration of innovative approaches that can improve the practice of ob.gyn.
The first example illustrates a common scenario that we frequently encounter – the situation in which an insurance company denies coverage for specific care or treatment for a patient. In fact, this was one of the first examples that was demonstrated by others on social media as a possible benefit for this technology. It effectively demonstrated the ability to save time and surmount the challenges of writer’s block that we occasionally encounter.
Prompt input:
“Write a letter to the insurance company who is denying cervical length surveillance for a patient with a short cervix and add references.”
ChatGPT response:
[Your Name]
[Your Address]
[City, State, Zip Code]
[Date]
[Insurance Company Name]
[Claims Department]
[Insurance Company Address]
[City, State, Zip Code]
Re: Request for Reconsideration – Cervical Length Surveillance
Policy Number: [Policy Number]
Insured: [Patient’s Name]
Date of Birth: [Patient’s Date of Birth]
Claim Number: [Claim Number]
Date of Service: [Date of Service]
Dear Claims Reviewer,
I am writing to request a reconsideration of the denial for cervical length surveillance for my patient, [Patient’s Name], who has been diagnosed with a short cervix. As a healthcare provider, I strongly believe that this is a medically necessary service for the patient in order to prevent preterm birth and its associated complications.
A short cervix is a well-established risk factor for preterm birth, and numerous studies have shown the efficacy of cervical length surveillance in the prevention and management of preterm birth. I kindly request that you reconsider the coverage for this essential service and refer to the following authoritative sources:
Berghella, V., & Saccone, G. (2019). Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database of Systematic Reviews, 2019(7). doi:10.1002/14651858.CD004843.pub3
American College of Obstetricians and Gynecologists (2016). Practice Bulletin No. 171: Management of Preterm Labor. Obstetrics & Gynecology, 128(4), e155-e164. doi:10.1097/AOG.0000000000001711
Society for Maternal-Fetal Medicine (SMFM), McIntosh, J., Feltovich, H., Berghella, V., & Manuck, T. (2016). The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. American Journal of Obstetrics & Gynecology, 215(3), B2-B7. doi:10.1016/j.ajog.2016.03.015
By denying coverage for cervical length surveillance, the insurance company is putting [Patient’s Name] at an increased risk for preterm birth and the numerous health complications that can accompany it, both for the mother and the infant. It is crucial to provide this service in order to improve health outcomes and reduce the risk of costly neonatal intensive care unit (NICU) admissions and long-term medical issues.
I kindly request that you review this case with the provided references and reconsider the coverage for cervical length surveillance for [Patient’s Name]. Thank you for your attention to this matter. Please feel free to contact me if you require any further information or clarification.
Sincerely,
[Your Name]
[Your Title]
[Your Phone Number]
[Your Email Address]
The document took less than 15 seconds to generate, it is well written and concise, and can also be utilized as a template for future use. But as mentioned above, it is important to confirm all the information within the document. For example, references 1 and 3 in the ChatGPT-generated letter above include document objective identifiers that do not correctly correspond to the reference.
Other uses that the reader might consider: patient education, helping to answer a patient question utilizing appropriate grade-level language, dietary plans for a patient - the potential list is endless. Another key aspect of utilizing these types of programs is understanding how to effectively ask a question. This involves providing ample detail about the inquiry you wish to have answered by the program. With some practice and review of guidance on how to do this from the Internet, one can become highly proficient at crafting questions and generating relevant responses. But as mentioned above, it is important to keep in mind that all information generated by this program needs to be vetted prior to utilization.
This groundbreaking technology is not only here to stay but will continue to become increasingly pervasive. It is already being integrated into conventional search engines such as Google and Bing. Microsoft has ambitious plans to incorporate this innovation into its entire suite of Office products. Just imagine working on a document and seeking assistance for editing or rephrasing, effortlessly searching your inbox for all emails containing a specific phrase or topic, or even crafting a PowerPoint presentation for a lecture while receiving help with both content and formatting. These scenarios offer just a glimpse of how AI programs can significantly assist and enhance our workflow.
I also anticipate that our patients will increasingly adopt this type of technology to generate customized lists of questions tailored to their specific medical conditions, which they can then ask their health care providers. Often, our patients express uncertainty about the appropriate questions to ask during a particular visit. Now envision a scenario in which they can effortlessly obtain a comprehensive list of relevant questions, specifically designed for their office consultation. This would empower them to engage more actively in their health care and enhance communication with their clinical team.
I highly recommend that readers explore and experiment with these programs. By doing so, we can provide valuable assistance and guidance not only within our specific medical specialties but also for our patients. In this way, we can effectively harness the power of technology to improve patient care and optimize our office work flow, ultimately benefiting both our patients and our practices.
Dr. Chavez is professor, department of obstetrics and gynecology, at NYU Long Island School of Medicine and director of maternal and fetal medicine at NYU Langone Hospital–Long Island, both in Mineola, N.Y. He has no disclosures.
Artificial intelligence (AI) has recently gained significant public attention, primarily driven by the launch of a noteworthy program by OpenAI called Chat Generative Pre-trained Transformer (ChatGPT). This large language model is an AI system that enables users to interact with it using plain language. In just the first 2 months since its release, over 100 million subscribers have registered to use ChatGPT.
AI is now deeply integrated into our daily lives, pervading a wide array of smart devices such as phones, tablets, and numerous other gadgets that we rely on every day. These sophisticated technologies operate seamlessly in the background, often without us being consciously aware of their presence. Nevertheless, we greatly appreciate the way they enhance our lives by simplifying tasks and streamlining our routines.
A key factor contributing to ChatGPT’s popularity is its ability to accept input in the form of prompts in plain English. Our team published a comprehensive journal article showcasing examples of how this technology can be utilized by general ob.gyn. practitioners. ChatGPT has the potential to streamline work flow, generate letters to insurance companies, draft clinical plans, and assist with various other routine tasks in any ob.gyn. practice environment.
As with any new technology, it is essential for users to familiarize themselves with its capabilities and understand its limitations. A critical aspect to consider with the current version of ChatGPT is that it was developed using information primarily sourced from the Internet up until September 2021. This limitation is especially significant in the field of medicine, where practitioners consistently seek the most up-to-date and current information to inform their decisions.
However, it is expected that, in the near future, these programs will gain access to real-time information from a diverse range of sources, including but not limited to the Internet. This development will enhance the program’s utility and relevance in medical contexts.
Another limitation of ChatGPT is its propensity to “hallucinate.” Large language models are trained to respond to the best of their abilities, occasionally attempting to fill knowledge gaps with fabricated information. Being aware of these limitations enables users to recognize the program’s potential while also understanding the need for careful monitoring.
Our expertise and clinical knowledge are crucial in guiding and refining this technology, ensuring that it serves as a valuable tool in the ever-evolving landscape of medicine.
Another crucial factor to consider is that users must adhere to all guidelines and policies established within their work environment. This entails complying with HIPAA regulations and ensuring that any information generated by these programs is thoroughly examined before being integrated into practice work flows. As an increasing number of organizations develop specific guidelines for such technologies, the aim is to safeguard patients, users, and the organization itself. The individuals utilizing these technologies must exercise utmost caution and refrain from storing or sharing any sensitive or proprietary information.
The aim of this article is not to provide an exhaustive overview, but rather to offer a selection of examples and inspire readers to consider adopting these programs. By doing so, we hope to facilitate the exploration of innovative approaches that can improve the practice of ob.gyn.
The first example illustrates a common scenario that we frequently encounter – the situation in which an insurance company denies coverage for specific care or treatment for a patient. In fact, this was one of the first examples that was demonstrated by others on social media as a possible benefit for this technology. It effectively demonstrated the ability to save time and surmount the challenges of writer’s block that we occasionally encounter.
Prompt input:
“Write a letter to the insurance company who is denying cervical length surveillance for a patient with a short cervix and add references.”
ChatGPT response:
[Your Name]
[Your Address]
[City, State, Zip Code]
[Date]
[Insurance Company Name]
[Claims Department]
[Insurance Company Address]
[City, State, Zip Code]
Re: Request for Reconsideration – Cervical Length Surveillance
Policy Number: [Policy Number]
Insured: [Patient’s Name]
Date of Birth: [Patient’s Date of Birth]
Claim Number: [Claim Number]
Date of Service: [Date of Service]
Dear Claims Reviewer,
I am writing to request a reconsideration of the denial for cervical length surveillance for my patient, [Patient’s Name], who has been diagnosed with a short cervix. As a healthcare provider, I strongly believe that this is a medically necessary service for the patient in order to prevent preterm birth and its associated complications.
A short cervix is a well-established risk factor for preterm birth, and numerous studies have shown the efficacy of cervical length surveillance in the prevention and management of preterm birth. I kindly request that you reconsider the coverage for this essential service and refer to the following authoritative sources:
Berghella, V., & Saccone, G. (2019). Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database of Systematic Reviews, 2019(7). doi:10.1002/14651858.CD004843.pub3
American College of Obstetricians and Gynecologists (2016). Practice Bulletin No. 171: Management of Preterm Labor. Obstetrics & Gynecology, 128(4), e155-e164. doi:10.1097/AOG.0000000000001711
Society for Maternal-Fetal Medicine (SMFM), McIntosh, J., Feltovich, H., Berghella, V., & Manuck, T. (2016). The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. American Journal of Obstetrics & Gynecology, 215(3), B2-B7. doi:10.1016/j.ajog.2016.03.015
By denying coverage for cervical length surveillance, the insurance company is putting [Patient’s Name] at an increased risk for preterm birth and the numerous health complications that can accompany it, both for the mother and the infant. It is crucial to provide this service in order to improve health outcomes and reduce the risk of costly neonatal intensive care unit (NICU) admissions and long-term medical issues.
I kindly request that you review this case with the provided references and reconsider the coverage for cervical length surveillance for [Patient’s Name]. Thank you for your attention to this matter. Please feel free to contact me if you require any further information or clarification.
Sincerely,
[Your Name]
[Your Title]
[Your Phone Number]
[Your Email Address]
The document took less than 15 seconds to generate, it is well written and concise, and can also be utilized as a template for future use. But as mentioned above, it is important to confirm all the information within the document. For example, references 1 and 3 in the ChatGPT-generated letter above include document objective identifiers that do not correctly correspond to the reference.
Other uses that the reader might consider: patient education, helping to answer a patient question utilizing appropriate grade-level language, dietary plans for a patient - the potential list is endless. Another key aspect of utilizing these types of programs is understanding how to effectively ask a question. This involves providing ample detail about the inquiry you wish to have answered by the program. With some practice and review of guidance on how to do this from the Internet, one can become highly proficient at crafting questions and generating relevant responses. But as mentioned above, it is important to keep in mind that all information generated by this program needs to be vetted prior to utilization.
This groundbreaking technology is not only here to stay but will continue to become increasingly pervasive. It is already being integrated into conventional search engines such as Google and Bing. Microsoft has ambitious plans to incorporate this innovation into its entire suite of Office products. Just imagine working on a document and seeking assistance for editing or rephrasing, effortlessly searching your inbox for all emails containing a specific phrase or topic, or even crafting a PowerPoint presentation for a lecture while receiving help with both content and formatting. These scenarios offer just a glimpse of how AI programs can significantly assist and enhance our workflow.
I also anticipate that our patients will increasingly adopt this type of technology to generate customized lists of questions tailored to their specific medical conditions, which they can then ask their health care providers. Often, our patients express uncertainty about the appropriate questions to ask during a particular visit. Now envision a scenario in which they can effortlessly obtain a comprehensive list of relevant questions, specifically designed for their office consultation. This would empower them to engage more actively in their health care and enhance communication with their clinical team.
I highly recommend that readers explore and experiment with these programs. By doing so, we can provide valuable assistance and guidance not only within our specific medical specialties but also for our patients. In this way, we can effectively harness the power of technology to improve patient care and optimize our office work flow, ultimately benefiting both our patients and our practices.
Dr. Chavez is professor, department of obstetrics and gynecology, at NYU Long Island School of Medicine and director of maternal and fetal medicine at NYU Langone Hospital–Long Island, both in Mineola, N.Y. He has no disclosures.
Artificial intelligence (AI) has recently gained significant public attention, primarily driven by the launch of a noteworthy program by OpenAI called Chat Generative Pre-trained Transformer (ChatGPT). This large language model is an AI system that enables users to interact with it using plain language. In just the first 2 months since its release, over 100 million subscribers have registered to use ChatGPT.
AI is now deeply integrated into our daily lives, pervading a wide array of smart devices such as phones, tablets, and numerous other gadgets that we rely on every day. These sophisticated technologies operate seamlessly in the background, often without us being consciously aware of their presence. Nevertheless, we greatly appreciate the way they enhance our lives by simplifying tasks and streamlining our routines.
A key factor contributing to ChatGPT’s popularity is its ability to accept input in the form of prompts in plain English. Our team published a comprehensive journal article showcasing examples of how this technology can be utilized by general ob.gyn. practitioners. ChatGPT has the potential to streamline work flow, generate letters to insurance companies, draft clinical plans, and assist with various other routine tasks in any ob.gyn. practice environment.
As with any new technology, it is essential for users to familiarize themselves with its capabilities and understand its limitations. A critical aspect to consider with the current version of ChatGPT is that it was developed using information primarily sourced from the Internet up until September 2021. This limitation is especially significant in the field of medicine, where practitioners consistently seek the most up-to-date and current information to inform their decisions.
However, it is expected that, in the near future, these programs will gain access to real-time information from a diverse range of sources, including but not limited to the Internet. This development will enhance the program’s utility and relevance in medical contexts.
Another limitation of ChatGPT is its propensity to “hallucinate.” Large language models are trained to respond to the best of their abilities, occasionally attempting to fill knowledge gaps with fabricated information. Being aware of these limitations enables users to recognize the program’s potential while also understanding the need for careful monitoring.
Our expertise and clinical knowledge are crucial in guiding and refining this technology, ensuring that it serves as a valuable tool in the ever-evolving landscape of medicine.
Another crucial factor to consider is that users must adhere to all guidelines and policies established within their work environment. This entails complying with HIPAA regulations and ensuring that any information generated by these programs is thoroughly examined before being integrated into practice work flows. As an increasing number of organizations develop specific guidelines for such technologies, the aim is to safeguard patients, users, and the organization itself. The individuals utilizing these technologies must exercise utmost caution and refrain from storing or sharing any sensitive or proprietary information.
The aim of this article is not to provide an exhaustive overview, but rather to offer a selection of examples and inspire readers to consider adopting these programs. By doing so, we hope to facilitate the exploration of innovative approaches that can improve the practice of ob.gyn.
The first example illustrates a common scenario that we frequently encounter – the situation in which an insurance company denies coverage for specific care or treatment for a patient. In fact, this was one of the first examples that was demonstrated by others on social media as a possible benefit for this technology. It effectively demonstrated the ability to save time and surmount the challenges of writer’s block that we occasionally encounter.
Prompt input:
“Write a letter to the insurance company who is denying cervical length surveillance for a patient with a short cervix and add references.”
ChatGPT response:
[Your Name]
[Your Address]
[City, State, Zip Code]
[Date]
[Insurance Company Name]
[Claims Department]
[Insurance Company Address]
[City, State, Zip Code]
Re: Request for Reconsideration – Cervical Length Surveillance
Policy Number: [Policy Number]
Insured: [Patient’s Name]
Date of Birth: [Patient’s Date of Birth]
Claim Number: [Claim Number]
Date of Service: [Date of Service]
Dear Claims Reviewer,
I am writing to request a reconsideration of the denial for cervical length surveillance for my patient, [Patient’s Name], who has been diagnosed with a short cervix. As a healthcare provider, I strongly believe that this is a medically necessary service for the patient in order to prevent preterm birth and its associated complications.
A short cervix is a well-established risk factor for preterm birth, and numerous studies have shown the efficacy of cervical length surveillance in the prevention and management of preterm birth. I kindly request that you reconsider the coverage for this essential service and refer to the following authoritative sources:
Berghella, V., & Saccone, G. (2019). Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database of Systematic Reviews, 2019(7). doi:10.1002/14651858.CD004843.pub3
American College of Obstetricians and Gynecologists (2016). Practice Bulletin No. 171: Management of Preterm Labor. Obstetrics & Gynecology, 128(4), e155-e164. doi:10.1097/AOG.0000000000001711
Society for Maternal-Fetal Medicine (SMFM), McIntosh, J., Feltovich, H., Berghella, V., & Manuck, T. (2016). The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. American Journal of Obstetrics & Gynecology, 215(3), B2-B7. doi:10.1016/j.ajog.2016.03.015
By denying coverage for cervical length surveillance, the insurance company is putting [Patient’s Name] at an increased risk for preterm birth and the numerous health complications that can accompany it, both for the mother and the infant. It is crucial to provide this service in order to improve health outcomes and reduce the risk of costly neonatal intensive care unit (NICU) admissions and long-term medical issues.
I kindly request that you review this case with the provided references and reconsider the coverage for cervical length surveillance for [Patient’s Name]. Thank you for your attention to this matter. Please feel free to contact me if you require any further information or clarification.
Sincerely,
[Your Name]
[Your Title]
[Your Phone Number]
[Your Email Address]
The document took less than 15 seconds to generate, it is well written and concise, and can also be utilized as a template for future use. But as mentioned above, it is important to confirm all the information within the document. For example, references 1 and 3 in the ChatGPT-generated letter above include document objective identifiers that do not correctly correspond to the reference.
Other uses that the reader might consider: patient education, helping to answer a patient question utilizing appropriate grade-level language, dietary plans for a patient - the potential list is endless. Another key aspect of utilizing these types of programs is understanding how to effectively ask a question. This involves providing ample detail about the inquiry you wish to have answered by the program. With some practice and review of guidance on how to do this from the Internet, one can become highly proficient at crafting questions and generating relevant responses. But as mentioned above, it is important to keep in mind that all information generated by this program needs to be vetted prior to utilization.
This groundbreaking technology is not only here to stay but will continue to become increasingly pervasive. It is already being integrated into conventional search engines such as Google and Bing. Microsoft has ambitious plans to incorporate this innovation into its entire suite of Office products. Just imagine working on a document and seeking assistance for editing or rephrasing, effortlessly searching your inbox for all emails containing a specific phrase or topic, or even crafting a PowerPoint presentation for a lecture while receiving help with both content and formatting. These scenarios offer just a glimpse of how AI programs can significantly assist and enhance our workflow.
I also anticipate that our patients will increasingly adopt this type of technology to generate customized lists of questions tailored to their specific medical conditions, which they can then ask their health care providers. Often, our patients express uncertainty about the appropriate questions to ask during a particular visit. Now envision a scenario in which they can effortlessly obtain a comprehensive list of relevant questions, specifically designed for their office consultation. This would empower them to engage more actively in their health care and enhance communication with their clinical team.
I highly recommend that readers explore and experiment with these programs. By doing so, we can provide valuable assistance and guidance not only within our specific medical specialties but also for our patients. In this way, we can effectively harness the power of technology to improve patient care and optimize our office work flow, ultimately benefiting both our patients and our practices.
Dr. Chavez is professor, department of obstetrics and gynecology, at NYU Long Island School of Medicine and director of maternal and fetal medicine at NYU Langone Hospital–Long Island, both in Mineola, N.Y. He has no disclosures.
USPSTF releases updated recommendations on skin cancer screening
.
This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.
“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”
Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”
The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.
Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.
There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.
In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.
Thus, differences in anatomical distribution of skin cancers in in the various subpopulations needs to be considered when performing skin screening, they write. “Furthermore, while skin cancer risk is lower among people with darker skin pigmentation, survival is often worse for cancers like melanoma, highlighting the potential need for screening.”
“More data are needed, particularly regarding genetic and environmental risk factors for skin cancer in people with darker pigmentation, to help inform guidelines that can be broadly applied to the U.S. population,” add Dr. Asgari and Dr. Crane. “The diversity of the U.S. population extends also to geography, culture, and socioeconomic status, all of which affect skin cancer risk.”
Review of evidence
The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.
Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.
The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.
Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
Research is needed
In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.
The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”
Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”
Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.
“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”
The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.
None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.
A version of this article originally appeared on Medscape.com.
.
This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.
“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”
Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”
The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.
Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.
There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.
In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.
Thus, differences in anatomical distribution of skin cancers in in the various subpopulations needs to be considered when performing skin screening, they write. “Furthermore, while skin cancer risk is lower among people with darker skin pigmentation, survival is often worse for cancers like melanoma, highlighting the potential need for screening.”
“More data are needed, particularly regarding genetic and environmental risk factors for skin cancer in people with darker pigmentation, to help inform guidelines that can be broadly applied to the U.S. population,” add Dr. Asgari and Dr. Crane. “The diversity of the U.S. population extends also to geography, culture, and socioeconomic status, all of which affect skin cancer risk.”
Review of evidence
The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.
Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.
The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.
Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
Research is needed
In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.
The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”
Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”
Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.
“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”
The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.
None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.
A version of this article originally appeared on Medscape.com.
.
This final recommendation applies to the general public and is not meant for those at higher risk, such as people with a family history of skin cancer or who have any signs or symptoms, such as irregular moles.
“The new recommendations are consistent with those from 2016, and we are unable to balance benefits and harms,” said Task Force member Katrina Donahue, MD, MPH, professor and vice chair of research in the department of family medicine at the University of North Carolina, Chapel Hill. “Unfortunately, there is not enough evidence to recommend for or against screening, and health care professionals should use their judgment when deciding whether or not to screen.”
Dr. Donahue told this news organization that this is a call for more research: “Our recommendations are for patients who present to primary care without symptoms, and after a careful assessment of benefit and harms, we didn’t have evidence to push us towards screening as a benefit. We did look at data from two large screening programs, but they were from Europe and not representative of the U.S. population. They also did not show a benefit for reducing melanoma-related mortality.”
The USPSTF final recommendation statement and corresponding evidence summary have been published online in JAMA, as well as on the USPSTF website.
Skin cancer is the most commonly diagnosed cancer in the United States, but there are different types that vary in their incidence and severity. Basal and squamous cell carcinomas are the most common types of skin cancer, but they infrequently lead to death or substantial morbidity, notes the USPTSF. Melanomas represent about 1% of skin cancer and cause the most skin cancer deaths. An estimated 8,000 individuals in the United States will die of melanoma in 2023.
There are racial differences in melanoma incidence; it is about 30 times more common in White versus Black persons, but disease in persons with darker skin color tends to be diagnosed at a later stage. These disparities may be due to differences in risk factors, access to care, and clinical presentation.
In an accompanying editorial, Maryam M. Asgari, MD, MPH, of the department of dermatology, Massachusetts General Hospital, Boston, and Lori A. Crane, PhD, MPH, of the Colorado School of Public Health, University of Colorado, Aurora, point out that people with darker skin phenotypes also tend to be affected by skin cancers that are not associated with UV radiation, such as acral melanoma, which arises on the palms and soles, and skin cancers that arise in areas of chronic inflammation, such as wounds.
Thus, differences in anatomical distribution of skin cancers in in the various subpopulations needs to be considered when performing skin screening, they write. “Furthermore, while skin cancer risk is lower among people with darker skin pigmentation, survival is often worse for cancers like melanoma, highlighting the potential need for screening.”
“More data are needed, particularly regarding genetic and environmental risk factors for skin cancer in people with darker pigmentation, to help inform guidelines that can be broadly applied to the U.S. population,” add Dr. Asgari and Dr. Crane. “The diversity of the U.S. population extends also to geography, culture, and socioeconomic status, all of which affect skin cancer risk.”
Review of evidence
The USPSTF commissioned a systematic review to evaluate the benefits and harms of screening for skin cancer in asymptomatic adolescents and adults, including evidence for both keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma) and cutaneous melanoma.
Foundational evidence showed that the sensitivity of visual skin examination by a clinician to detect melanoma ranged from 40% to 70% and specificity ranged from 86% to 98%. Evidence that evaluated the diagnostic accuracy of visual skin examination to detect keratinocyte carcinoma was limited and inconsistent. There were no new studies reporting on diagnostic accuracy for an asymptomatic screening population.
The USPSTF also reviewed 20 studies in 29 articles (n = 6,053,411). This included three nonrandomized studies evaluating two skin cancer screening programs in Germany, but results were inconsistent. In addition, the ecological and nonrandomized design of the studies limited the conclusions that could be drawn and the applicability to a U.S. population was difficult to assess because of differences in population diversity and health care delivery in the United States.
Other nonrandomized studies that looked at various outcomes, such as harms and stage at diagnosis and melanoma or all-cause mortality, also did not provide sufficient evidence to support screening.
Research is needed
In a second accompanying editorial published in JAMA Dermatology, Adewole S. Adamson, MD, MPP, of the division of dermatology and dermatologic surgery at the University of Texas, Austin, pointed out that unlike other cancer screening programs, such as those for breast, colon, and prostate cancer, skin cancer screening programs are somewhat less organized.
The other programs focus on defined groups of the population, generally with easily identifiable characteristics such as age, sex, and family history, and importantly, there are always defined ages for initiation and halting of screening and intervals for screening frequency. None of these basic screening parameters have been widely adopted among dermatologists in the United States, he wrote. “One important reason why skin cancer screening has remained inconsistent is that it is not covered by Medicare or by many commercial insurance companies,” Dr. Adamson told this news organization. “The test, in this case the skin exam, is often performed as part of a routine dermatology visit.”
Dermatologists should take the lead on this, he said. “Dermatologists should push for a high quality prospective clinical trial of skin cancer screening, preferably in a high-risk population.”
Dr. Donahue agrees that research is needed, as noted in the recommendation. For example, studies are needed demonstrating consistent data of the effects of screening on morbidity and mortality or early detection of skin cancer, and clearer descriptions of skin color and inclusion of a full spectrum of skin colors in study participants. Clinical research is also needed on outcomes in participants that reflect the diversity of the U.S. population.
“I hope funding agencies will be interested in this area of study,” she said. “We put out the whole systematic review and point out the gaps. We need consistent evidence in detecting cancer early and reducing complications from skin cancer.”
The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.
None of the USPSTF authors report any disclosures. Dr. Asgari reported receiving royalties from UpToDate. Dr. Crane did not make any disclosures. Dr. Adamson reported serving as an expert reviewer for the U.S. Preventive Services Task Force skin cancer screening report, as well as support from the Robert Wood Johnson Foundation, the Dermatology Foundation Public Health Career Development Award, the National Institutes of Health, the American Cancer Society, and Meredith’s Mission for Melanoma.
A version of this article originally appeared on Medscape.com.
Perinatal HIV nearly eradicated in U.S.
, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.
The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.
Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.
Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.
“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.
The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.
“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said.
Disparities persist
But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”
Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.
Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.
Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.
They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.
“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
Progress in ‘danger’
Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.
Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.
“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.
In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.
“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”
A version of this article first appeared on Medscape.com.
, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.
The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.
Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.
Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.
“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.
The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.
“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said.
Disparities persist
But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”
Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.
Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.
Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.
They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.
“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
Progress in ‘danger’
Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.
Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.
“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.
In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.
“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”
A version of this article first appeared on Medscape.com.
, with less than 1 baby for every 100,000 live births having the virus, a new study released by researchers at the Centers for Disease Control and Prevention finds.
The report marks significant progress on the U.S. government’s goal to eradicate perinatal HIV, an immune-weakening and potentially deadly virus that is passed from mother to baby during pregnancy. Just 32 children in the country were diagnosed in 2019, compared with twice as many in 2010, according to the CDC.
Mothers who are HIV positive can prevent transmission of the infection by receiving antiretroviral therapy, according to Monica Gandhi, MD, MPH, a professor of medicine at University of California, San Francisco’s division of HIV, infectious disease and global medicine.
Dr. Gandhi said she could recall only one case of perinatal HIV in the San Francisco area over the last decade.
“This country has been really aggressive about counseling women who are pregnant and getting mothers in care,” Dr. Gandhi said.
The treatment method was discovered more than 30 years ago. Prior to the therapy and ensuing awareness campaigns to prevent transmission, mothers with HIV would typically pass the virus to their child in utero, during delivery, or while breastfeeding.
“There should be zero children born with HIV, given that we’ve had these drugs for so long,” Dr. Ghandi said.
Disparities persist
But challenges remain in some communities, where babies born to Black mothers are disproportionately affected by the disease, the new study found. “Racial and ethnic differences in perinatal HIV diagnoses persisted through the 10-year period,” the report’s authors concluded. “The highest rates of perinatal HIV diagnoses were seen among infants born to Black women.”
Although rates of perinatal HIV declined for babies born to Black mothers over the decade-long study, the diagnosis rate was above the goal of elimination at 3.1 for every 100,000 live births, according to the data.
Meanwhile, transmission rates hovered around 1%-2% for Latinx and Hispanic women and mothers who identified as “other races,” including Native American.
Despite the availability of medication, expectant mothers may face several hurdles to getting the daily treatment they need to prevent transmission to their fetus, according to Jennifer Jao, MD, MPH, a physician of infectious diseases at Lurie Children’s Hospital of Chicago.
They might have trouble securing health insurance or finding transportation to doctor’s appointments, or face other problems like lacking secure housing or food – all factors that prevent them from prioritizing the care.
“All of those things play into the mix,” Dr. Jao said. “We see over and over again that closing the gap means you’ve got to reach the women who are pregnant and who don’t have resources.”
Progress in ‘danger’
Experts said they’re not sure what the impact of the COVID-19 pandemic, accompanied by a recent uptick in sexually transmitted diseases, will be on rates of perinatal HIV. Some women were unable to access prenatal health care during the pandemic because they couldn’t access public transportation or childcare, the U.S. Government Accountability Office said in 2022.
Globally, a decline in rates of HIV and AIDS rates has slowed, prompting the World Health Organization to warn last year that progress on the disease is in danger. Researchers only included HIV rates in the United States through 2019, so the data are outdated, Dr. Gandhi noted.
“All of this put together means we don’t know where we are with perinatal transmission over the last 3 years,” she said.
In an accompanying editorial, coauthors Nahida Chakhtoura, MD, MsGH, and Bill Kapogiannis, MD, both with the National Institutes of Health, urge health care professionals to take an active role in eliminating these racial and ethnic disparities in an effort to – as the title of their editorial proclaims – achieve a “road to zero perinatal HIV transmission” in the United States.
“The more proactive we are in identifying and promptly addressing systematic deficiencies that exacerbate health inequities in cutting-edge research innovations and optimal clinical service provision,” they write, “the less reactive we will need to be when new transmissible infections appear at our doorstep.”
A version of this article first appeared on Medscape.com.
FDA OKs stem cell therapy for blood cancer patients to reduce infection risks
Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B3, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.
The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.
The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.
The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.
The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.
Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”
The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).
Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.
Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.
A version of this article originally appeared on Medscape.com.
Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B3, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.
The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.
The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.
The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.
The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.
Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”
The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).
Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.
Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.
A version of this article originally appeared on Medscape.com.
Omidubicel is made from umbilical cord donor stem cells that are processed with nicotinamide, a form of vitamin B3, to enhance and expand the number of progenitor cells, the product’s maker, Jerusalem-based Gamida Cell, explained in a press announcement.
The FDA approval was based on phase 3 testing that pitted the use of omidubicel in 62 patients against standard unmanipulated cord blood transplants in 63 patients following myeloablative conditioning.
The median time to neutrophil recovery was 12 days in the omidubicel group, compared with 22 days with standard care. Overall, 87% of patients who received omidubicel achieved neutrophil recovery versus 83% of patients with standard transplants.
The incidence of grade 2/3 bacterial or grade 3 fungal infections 100 days following transplant was 39% with omidubicel versus 60% with standard transplants.
The FDA’s “approval is an important advance in cell therapy treatment in patients with blood cancers. Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency press release.
Abbey Jenkins, president and CEO of Gamida, called the approval “a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”
The most common grade 3–5 adverse reactions in the approval study were pain (33%), mucosal inflammation (31%), hypertension (25%), and gastrointestinal toxicity (19%).
Adverse events are consistent with allogeneic hematopoietic stem cell transplantation. Among 117 patients who received omidubicel for any indication, infusion reactions occurred in 47% of patients, acute graft-versus-host disease occurred in 58%, chronic GVHD occurred in 35%, and graft failure occurred in 3%. Labeling includes a boxed warning of the possibilities. There is also a small risk of infections and malignancies from donor blood.
Omidubicel is manufactured in Gamida’s facility in Kiryat Gat, Israel. It is available for order now and is expected to be delivered to transplant centers within 30 days after the start of manufacturing, the company said.
A version of this article originally appeared on Medscape.com.
Intermittent fasting plus early eating may prevent type 2 diabetes
, indicate the results of a randomized controlled trial.
The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.
The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.
However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.
“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.
This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.
“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
Adherence difficult to IF plus early time-restricted eating
Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.
“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”
Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.
She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago. “These regimens make social eating very difficult, which results in high attrition.
“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.
Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”
“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
A novel way to cut calories?
The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.
Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.
To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.
The participants were randomized to one of three groups:
- IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
- Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
- Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.
There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.
A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m2.
In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.
The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).
“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.
IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.
Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).
Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.
IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
Calorie restriction easier to stick to, less likely to cause fatigue
When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.
In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.
At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.
Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.
The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.
No relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
, indicate the results of a randomized controlled trial.
The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.
The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.
However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.
“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.
This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.
“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
Adherence difficult to IF plus early time-restricted eating
Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.
“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”
Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.
She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago. “These regimens make social eating very difficult, which results in high attrition.
“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.
Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”
“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
A novel way to cut calories?
The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.
Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.
To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.
The participants were randomized to one of three groups:
- IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
- Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
- Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.
There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.
A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m2.
In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.
The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).
“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.
IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.
Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).
Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.
IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
Calorie restriction easier to stick to, less likely to cause fatigue
When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.
In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.
At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.
Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.
The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.
No relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
, indicate the results of a randomized controlled trial.
The study involved more than 200 individuals randomized to one of three groups: eat only in the morning (from 8:00 a.m. to noon) followed by 20 hours of fasting 3 days per week and eat as desired on the other days; daily calorie restriction to 70% of requirements; or standard weight loss advice.
The IF plus early time-restricted eating intervention was associated with a significant improvement in a key measure of glucose control versus calorie restriction at 6 months, while both interventions were linked to benefits in terms of cardiovascular risk markers and body composition, compared with the standard weight loss advice.
However, the research, published in Nature Medicine, showed that the additional benefit of IF plus early time-restricted eating did not persist, and less than half of participants were still following the plan at 18 months, compared with almost 80% of those in the calorie-restriction group.
“Following a time-restricted, IF diet could help lower the chances of developing type 2 diabetes,” senior author Leonie K. Heilbronn, PhD, University of Adelaide, South Australia, said in a press release.
This is “the largest study in the world to date, and the first powered to assess how the body processes and uses glucose after eating a meal,” with the latter being a better indicator of diabetes risk than a fasting glucose test, added first author Xiao Tong Teong, a PhD student, also at the University of Adelaide.
“The results of this study add to the growing body of evidence to indicate that meal timing and fasting advice extends the health benefits of a restricted-calorie diet, independently from weight loss, and this may be influential in clinical practice,” Ms. Teong added.
Adherence difficult to IF plus early time-restricted eating
Asked to comment, Krista Varady, PhD, said that the study design “would have been stronger if the time-restricted eating and IF interventions were separated” and compared.
“Time-restricted eating has been shown to naturally reduce calorie intake by 300-500 kcal/day,” she said in an interview, “so I’m not sure why the investigators chose to combine [it] with IF. It ... defeats the point of time-restricted eating.”
Dr. Varady, who recently coauthored a review of the clinical application of IF for weight loss, also doubted whether individuals would adhere to combined early time-restricted eating and IF. “In all honesty, I don’t think anyone would follow this diet for very long,” she said.
She added that the feasibility of this particular approach is “very questionable. In general, people don’t like diets that require them to skip dinner with family/friends on multiple days of the week,” explained Dr. Varady, professor of nutrition at the University of Illinois, Chicago. “These regimens make social eating very difficult, which results in high attrition.
“Indeed, evidence from a recent large-scale observational study of nearly 800,000 adults shows that Americans who engage in time-restricted eating placed their eating window in the afternoon or evening,” she noted.
Dr. Varady therefore suggested that future trials should test “more feasible time-restricted eating approaches,” such as those with later eating windows and without “vigilant calorie monitoring.”
“These types of diets are much easier to follow and are more likely to produce lasting weight and glycemic control in people with obesity and prediabetes,” she observed.
A novel way to cut calories?
The Australian authors say there is growing interest in extending the established health benefits of calorie restriction through new approaches such as timing of meals and prolonged fasting, with IF – defined as fasting interspersed with days of ad libitum eating – gaining in popularity as an alternative to simple calorie restriction.
Time-restricted eating, which emphasizes shorter daily eating windows in alignment with circadian rhythms, has also become popular in recent years, although the authors acknowledge that current evidence suggests any benefits over calorie restriction alone in terms of body composition, blood lipids, or glucose parameters are small.
To examine the combination of IF plus early time-restricted eating, in the DIRECT trial, the team recruited individuals aged 35-75 years who had a score of at least 12 on the Australian Type 2 Diabetes Risk Assessment Tool but did not have a diagnosis of diabetes and had stable weight for more than 6 months prior to study entry.
The participants were randomized to one of three groups:
- IF plus early time-restricted eating, which allowed consumption of 30% of calculated baseline energy requirements between 8:00 a.m. and midday, followed by a 20-hour fast from midday on 3 nonconsecutive days per week. They consumed their regular diet on nonfasting days.
- Calorie restriction, where they consumed 70% of daily calculated baseline energy requirements each day and were given rotating menu plans, but no specific mealtimes.
- Standard care, where they were given a booklet on current guidelines, with no counseling or meal replacement.
There were clinic visits every 2 weeks for the first 6 months of follow-up, and then monthly visits for 12 months. The two intervention groups had one-on-one diet counseling for the first 6 months. All groups were instructed to maintain their usual physical activity levels.
A total of 209 individuals were enrolled between Sept. 26, 2018, and May 4, 2020. Their mean age was 58 years, and 57% were women. Mean body mass index was 34.8 kg/m2.
In all, 40.7% of participants were allocated to IF plus early time-restricted eating, 39.7% to calorie restriction, and the remaining 19.6% to standard care.
The results showed that IF plus early time-restricted eating was associated with a significantly greater improvement in the primary outcome of postprandial glucose area under the curve (AUC) at month 6 compared with calorie restriction, at –10.1 mg/dL/min versus –3.6 mg/dL/min (P = .03).
“To our knowledge, no [prior] studies have been powered for postprandial assessments of glycemia, which are better indicators of diabetes risk than fasting assessment,” the authors underlined.
IF plus early time-restricted eating was also associated with greater reductions in postprandial insulin AUC versus calorie restriction at 6 months (P = .04). However, the differences between the IF plus early time-restricted eating and calorie restriction groups for postmeal insulin did not remain significant at 18 months of follow-up.
Both IF plus early time-restricted eating and calorie restriction were associated with greater reductions in A1c levels at 6 months versus standard care, but there was no significant difference between the two active interventions (P = .46).
Both interventions were also associated with improvements in markers of cardiovascular risk versus standard care, such as systolic blood pressure at 2 months, diastolic blood pressure at 6 months, and fasting triglycerides at both time points, with no significant differences between the two intervention groups.
IF plus early time-restricted eating and calorie restriction were also both associated with greater reductions in BMI and fat mass in the first 6 months, as well as in waist circumference.
Calorie restriction easier to stick to, less likely to cause fatigue
When offered the chance to modify their diet plan at 6 months, 46% of participants in the IF plus early time-restricted eating group said they would maintain 3 days of restrictions per week, while 51% chose to reduce the restrictions to 2 days per week.
In contrast, 97% of those who completed the calorie-restriction plan indicated they would continue with their current diet plan.
At 18 months, 42% of participants in the IF plus early time-restricted eating group said they still undertook 2-3 days of restrictions per week, while 78% of those assigned to calorie restriction reported that they followed a calorie-restricted diet.
Fatigue was more common with IF plus early time-restricted eating, reported by 56% of participants versus 37% of those following calorie restriction, and 35% of those in the standard care group at 6 months. Headaches and constipation were more common in the intervention groups than with standard care.
The study was supported by a National Health and Medical Research Council Project Grant, an Australian Government Research Training Program Scholarship from the University of Adelaide, and a Diabetes Australia Research Program Grant.
No relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
FROM NATURE MEDICINE
High prevalence of migraine among women with endometriosis
Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.
Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P = .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.
Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.
Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.
Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020
Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.
Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P = .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.
Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.
Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.
Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020
Key clinical point: Women with endometriosis seemed prone to migraine, with menstrual-related migraine being the most common type and dysmenorrhea and dysuria being more frequent when endometriosis and migraine coexisted.
Major finding: Overall, 53.4% of women had migraine, of which 64.3% had migraine related to menstruation and 35.7% had non-menstrual migraine. Typical endometriosis-related pain symptoms such as dysmenorrhea (94.3% vs 82.0%; P = .03) and dysuria (27.1% vs 9.8%; P < .01) occurred significantly more frequently in patients with vs without migraine.
Study details: This was a prospective, nested case-control study including 131 women with endometriosis with or without migraine.
Disclosures: This study was supported by a grant from Ministero della Salute, Italy. The authors declared no conflicts of interest.
Source: Pasquini B, Seravalli V, et al. Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhea. Reprod Biomed Online. 2023 (Apr 6). Doi: 10.1016/j.rbmo.2023.03.020
Study identifies risk factors associated with PsA occurrence in patients with psoriasis
Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.
Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P = .015), genital psoriasis (P = .027), nail psoriasis (P = .038), classic chronic-plaque psoriasis (P = .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P = .003), and use of conventional nonbiologic agents (P = .014) were significantly associated with PsA occurrence.
Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.
Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.
Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059
Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.
Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P = .015), genital psoriasis (P = .027), nail psoriasis (P = .038), classic chronic-plaque psoriasis (P = .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P = .003), and use of conventional nonbiologic agents (P = .014) were significantly associated with PsA occurrence.
Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.
Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.
Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059
Key clinical point: Age, body mass index (BMI), chronic-plaque psoriasis, hospitalization for psoriasis, use of systemic therapy, and genital and nail involvement in psoriasis were the risk factors for psoriatic arthritis (PsA) occurrence in patients with psoriasis.
Major finding: Overall, 226 patients were diagnosed with PsA, with an incidence of 1.9 cases per 100 patient-years. Age between 40-59 years (P < .001), BMI ≥25 (P = .015), genital psoriasis (P = .027), nail psoriasis (P = .038), classic chronic-plaque psoriasis (P = .014), previous hospitalization for psoriasis (P < .001), previous use of systemic therapy for psoriasis (P = .003), and use of conventional nonbiologic agents (P = .014) were significantly associated with PsA occurrence.
Study details: This cohort study included 8895 patients with a confirmed diagnosis of psoriasis from the PsoReal registry.
Disclosures: This study was sponsored by Bristol Myers Squibb. K Heidemeyer and L Naldi declared receiving honoraria from various sources, including AbbVie, Almirall, or Bristol Myers Squibb.
Source: Heidemeyer K et al. Variables associated with joint involvement and development of a prediction rule for arthritis in psoriasis patients. An analysis of the Italian PsoReal database. J Am Acad Dermatol. 2023 (Mar 23). Doi: 10.1016/j.jaad.2023.02.059
Patients with PsA have lower vitamin D levels than general population, says meta-analysis
Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D3) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs psoriasis.
Major finding: The serum 25(OH)D3 levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs control individuals (MD −0.08).
Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).
Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.
Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200
Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D3) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs psoriasis.
Major finding: The serum 25(OH)D3 levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs control individuals (MD −0.08).
Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).
Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.
Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200
Key clinical point: Patients with psoriatic arthritis (PsA) had lower serum vitamin D (25(OH)D3) levels and bone mineral density (BMD) compared with the general population; however, serum vitamin D levels were higher in patients with PsA vs psoriasis.
Major finding: The serum 25(OH)D3 levels in patients with PsA were lower than those in control individuals (mean difference [MD] −6.42; P < .01) but higher than those in patients with psoriasis (MD 2.37; P < .01). Lumbar spine BMD was significantly lower in patients with PsA vs control individuals (MD −0.08).
Study details: This was a meta-analysis of nine studies, of which four studies included patients with PsA (n = 264) and control individuals from the general population (n = 287) and five studies included patients with PsA (n = 225) and psoriasis (n = 391).
Disclosures: This study was supported by the project “Digitalization and improvement of nutritional care for patients with chronic diseases” cofinanced by the European Regional Development Fund. The authors declared no conflicts of interest.
Source: Radić M et al. Vitamin D in psoriatic arthritis – A systematic review and meta-analysis. Semin Arthritis Rheum. 2023;60:152200 (Apr 1). Doi: 10.1016/j.semarthrit.2023.152200