Wing-Fai Yeung, PhD, from the Hong Kong Polytechnic University, and colleagues evaluated the effectiveness of SAA taught via a short training course on reducing knee OA pain in middle-aged and older adults (aged 50 years and older). The analysis included 314 participants randomly assigned to acupressure twice daily for 12 weeks or a control education session on knee health.

The researchers found that at week 12, the intervention group had a significantly greater reduction in a numerical rating scale pain score (mean difference, −0.54 points) and higher enhancement in the Short Form 6 Dimensions utility score (mean difference, 0.03 points) versus the control group. However, there were no significant differences in the Western Ontario and McMaster University Osteoarthritis Index, Timed Up and Go, or Fast Gait Speed tests. There was greater than 90% probability that the intervention is cost-effective at a willingness-to-pay threshold of 1 GDP per capita.

“It was noteworthy that participants showed high acceptability and compliance with the SAA training program,” the authors write. “Our cost-effectiveness analysis indicated that the SAA was a cost-effective intervention.”

One author disclosed ties to AstraZeneca and Boehringer Ingelheim.

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Companies have 18 to 24 months to voluntarily add child-deterrent packaging and improve warning language on the labels of over-the-counter melatonin products, the Council for Responsible Nutrition (CRN) said Monday in a news release announcing the more stringent guidelines.

The new guidelines also stress the need for manufacturers to adopt child-safe bottles for gummies and chewable tablets.

“With the growing popularity of gummy dietary supplements among consumers of all ages, CRN’s new guidelines for [melatonin] gummy supplements specifically address the unique aspects of these products,” the council said in its statement. “The new recommendations focus on labeling clarity, reducing unsupervised access by children, addressing potential choking hazards for small children and ensuring products are used as intended.”

Experts welcomed the move.

“What’s significant here is that the industry recognizes that melatonin supplements do pose serious risks, particularly to children, and that the industry needs to do a much better job at ensuring the products are safe and well-manufactured,” Dr Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Massachusetts who authored a 2023 study on the dangers of melatonin gummies, told CNN.

“Whether this voluntary recommendation will be followed is another matter entirely, and we’ll need to see,” Cohen added.

Cohen’s study found that 25 products labeled as melatonin gummies contained dangerous levels of the hormone. One over-the-counter product contained up to 347% more melatonin than listed on the label, while another contained no melatonin at all because it was entirely composed of cannabidiol (CBD).

Meanwhile, a March 2024 report from the US Centers for Disease Control and Prevention discovered that some 11,000 children had been seen in emergency rooms between 2019 and 2022 after ingesting melatonin while unsupervised. Melatonin gummies were involved in nearly 5000 of these cases.

More than half of the accidental ingestions involved children between the ages of 3 and 5, the agency added. About three-quarters of the cases involved bottles that young children were able to open or bottles that weren’t closed properly.

Melatonin use can be especially dangerous in children and should only be used after consulting a pediatrician, experts say.

Melatonin is a hormone produced by the brain in response to darkness. It regulates the body’s natural sleep-wake cycle. As a dietary supplement, melatonin is not regulated by the U.S. Food and Drug Administration, even though the demand for melatonin among both adults and children has skyrocketed over the last decade, experts noted.

The new council guidelines call for labels that warn consumers about the danger of drowsiness after taking a melatonin supplement and state they should not be taken with alcohol. In addition, the labels should tell purchasers that melatonin is intended for intermittent or occasional use only.

More information

The National Institutes of Health has more on melatonin supplements.

SOURCE: Council for Responsible Nutrition, news release, April 15, 2024; CNN

Aida Mohammadi, from University of Social Welfare and Rehabilitation Sciences in Iran, and colleagues evaluated the effects of probiotic/vitamin D (400 IU) supplementation on cognitive function and disease severity in 69 patients (aged 18 to 65 years) with schizophrenia.

The researchers found that the Montreal Cognitive Assessment (MoCA) score increased by 1.96 units in the probiotic-containing supplement group vs the group receiving placebo. Further, the percentage of individuals with a MoCA score 26 or more rose significantly in the intervention group. There were significant decreases in total cholesterol, fasting blood sugar, and C-reactive protein in the supplement group versus placebo group. There was a trend toward reduction in Positive and Negative Syndrome Scale scores with the probiotic supplement, but the difference between the study groups was not statistically significant.

“Targeting the microbiota-gut-brain axis with co-administration of probiotics and vitamin D might provide a novel approach to promote mental health,” the authors write.

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Shebani Sethi, MD, from Stanford Medicine in California, and colleagues investigated the effects of a four-month ketogenic diet on individuals with schizophrenia or bipolar disorder with existing metabolic abnormalities. The analysis included 23 participants in a single arm.

The researchers found improvements in metabolic health, with no participants meeting metabolic syndrome criteria by study conclusion. There were significant reductions in weight (12%), body mass index (12%), waist circumference (13%), and visceral adipose tissue (36%) among adherent individuals. There were also improvements in biomarkers, including a 27% decrease in homeostatic model assessment for insulin resistance and a 25% drop in triglyceride levels. Participants with schizophrenia showed a 32% reduction in Brief Psychiatric Rating Scale scores. Additionally, overall Clinical Global Impression (CGI) severity improved by an average of 31% and the proportion of participants who started with elevated symptomatology improved at least 1 point on the CGI (79%). Participants reported increased life satisfaction (17%) and enhanced sleep quality (19%).

“The ketogenic diet has been proven to be effective for treatment-resistant epileptic seizures by reducing the excitability of neurons in the brain,” Sethi said in a statement. “We thought it would be worth exploring this treatment in psychiatric conditions.”

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Rony Abou-Khalil, PhD, from the Holy Spirit University of Kaslik in Jounieh, Lebanon, and colleagues examined the effects of ACV consumption on weight and blood glucose, triglyceride, and cholesterol levels in 120 individuals of the Lebanese population with overweight and obesity. Participants were randomly assigned to an intervention group receiving 5, 10, or 15mL of ACV or a control group receiving a placebo during a 12-week period. At weeks 0, 4, 8, and 12, measurements of anthropometric parameters, fasting blood glucose, and triglyceride and cholesterol levels were taken.

The researchers observed associations for daily consumption of the three doses of ACV for four to 12 weeks with significant reductions in anthropometric variables (weight, body mass index, waist/hip circumferences, and body fat ratio), blood glucose, and triglyceride and cholesterol levels. During the 12 weeks of ACV intake, there were no significant risk factors observed.

“These results suggest that ACV might have potential benefits in improving metabolic parameters related to obesity and metabolic disorders in obese individuals,” the authors write. “The results may contribute to evidence-based recommendations for the use of ACV as a dietary intervention in the management of obesity.”

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Cynthia A. Thomson, PhD, RD, from the Mel and Enid Zuckerman College of Public Health at the University of Arizona in Tucson, and colleagues examined long-term health outcomes among postmenopausal women in the Women’s Health Initiative CaD trial involving 36,282 women with no history of breast or colorectal cancer. Participants were randomly assigned to receive 1000mg calcium carbonate with 400 IU vitamin D₃ daily or placebo.

The researchers found that after a median cumulative follow-up of 22.3 years, women randomly assigned to CaD vs placebo had a reduction in cancer mortality (hazard ratio, 0.93), and an increase in CVD mortality (hazard ratio, 1.06). No overall effect was seen on other measures, including all-cause mortality. There was considerable variation observed in estimates of cancer incidence when stratified by whether participants reported supplement use before randomization, while no variation was seen for estimates in mortality, except for CVD mortality.

“Effects of vitamin D supplementation for cancer prevention may depend on achieving serum vitamin D concentrations above 50nmol/L,” the authors write. “Given the study design, we could not disentangle the added benefit or harms of supplementation with CaD in combination vs vitamin D alone, a topic worthy of future study.”

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Devin I. Freeman, from the Oak Ridge Institute for Science and Education in Tennessee, and colleagues used data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project to identify cases of emergency department visits for unsupervised melatonin ingestion by infants and children aged 5 years and younger during 2019 to 2022.

The researchers found that during 2019 to 2022, there were an estimated 10,930 emergency department visits for unsupervised melatonin ingestion by infants and children aged 5 years and younger in the US, accounting for 7.1% of all emergency department visits for unsupervised medication exposures in this age group. Children aged 3 to 5 years accounted for about half (52.4%) of all estimated emergency department visits for melatonin ingestion by infants and children aged 5 years or younger; 93.5% did not result in hospitalization. In 90.2% of emergency department visits for melatonin ingestion, melatonin was the only medication involved. In 95.7% of emergency department visits for melatonin ingestions, a solid dosage form product was accessed, with gummy formulations the most commonly documented dosage form (47.3%).

“The occurrence of approximately 11,000 emergency department visits for unsupervised melatonin ingestions by infants and young children during 2019 to 2022 highlights the continued need to educate parents and other caregivers about the importance of keeping all medications and supplements (including gummies) out of children’s reach and sight,” the authors write.

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Michael Hollifield, MD, from the Tibor Rubin VA Medical Center in Long Beach, California, and colleagues randomly assigned 93 veterans seeking treatment for PTSD to verum or sham acupuncture (24 one-hour sessions, twice weekly).

The researchers found a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean Δ, 7.1; t₉₀ = 2.87; d, 0.63) in the intention-to-treat analysis. In the treatment-completed analysis, the effect pattern was similar (verum d, 1.53; sham d, 0.86; between-group mean Δ, 7.4; t₆₉ = 2.64; d, 0.63). For fear-potentiated startle during extinction (i.e., better fear extinction), there was a significant symptom reduction from pretreatment to posttreatment in the verum but not the sham group and a significant correlation (r = 0.31). Rates of withdrawal were low.

“These data call for more research about relative effectiveness and synergy of acupuncture to current best practices, mechanisms of action, the durability of treatment in broader populations, and perhaps most importantly early predictors of treatment response to enhance efficiency of treatment choice,” the authors write.

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Nicola Marotta, MD, from the University of Catanzaro “Magna Graecia” in Italy, and colleagues evaluated the impact of yoga asana on the flexion-relaxation phenomenon in women with nonspecific LBP. The analysis included 11 healthy women and 10 women with chronic nonspecific LBP who underwent an 8-session yoga asana program, with the first session conducted in clinic and the rest delivered with a tele-approach.

The researchers found that the repeated-measures test in the chronic nonspecific LBP group showed a significant decrease in pain intensity after the 4-week follow-up (visual analog scale: 6.80 vs 3.30) and an improvement in the flexion-relaxation ratio after the intervention (5.12 vs 9.49), with effect sizes of 0.77 and 0.47, respectively.

“Our findings demonstrated the feasibility and safety of a tele-delivered yoga intervention that could be integrated in a rehabilitation plan for patients with nonspecific LBP,” the authors write. “Further research is warranted to confirm the long-term effects of yoga for managing LBP.”

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Juliane Hannemann, PhD, from the University Medical Center Hamburg-Eppendorf in Germany, and colleagues conducted a randomized prospective study to examine the effects of 2mg of sustained-release melatonin vs placebo in 24 rotating NS workers during 12 weeks of treatment, followed by a 12-week washout. The timing of melatonin administration (night or morning) depended on the shift schedule. Baseline profiles were compared for NS workers and 12 healthy non-night shift (NNS) working controls.

The researchers found that in NS vs NNS workers, indices of insulin resistance were significantly impaired at baseline, but there were no differences seen in oral glucose tolerance tests nor in the diurnal profiles of melatonin, cortisol, or blood pressure. There was no significant improvement observed in insulin resistance with 12 weeks of melatonin treatment, nor was there a significant impact on diurnal blood pressure or melatonin and cortisol profiles. Sleep quality was significantly impaired in NS vs NNS workers at baseline and was significantly improved with melatonin administration.

“Melatonin’s effects at the dosing scheme applied here were not sufficient to cause clinically relevant changes in diurnal blood pressure profiles, glucose tolerance, or insulin resistance indices,” the authors write.

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Michael Noetel, PhD, from the University of Queensland in St. Lucia, Australia, and colleagues conducted a systematic review and network meta-analysis to identify the optimal dose and modality of exercise for treating major depressive disorder. A total of 218 unique studies with 495 arms and 14,170 participants were included.

The researchers found moderate reductions in depression for walking or jogging, yoga, strength training, mixed aerobic exercises, and tai chi or qigong compared with active controls (e.g., usual care, placebo tablet; (Hedges’ g, −0.62, −0.55, −0.49, −0.43, and −0.42, respectively). The impact of exercise was proportional to the intensity. The most acceptable modalities seemed to be strength training and yoga. The results were robust to publication bias; only one study met the Cochrane criteria for a low risk for bias. Confidence in the network meta-analysis was considered low for walking and jogging and very low for other modalities.

“Our findings support the inclusion of exercise as part of clinical practice guidelines for depression, particularly vigorous intensity exercise,” the authors write. “Doing so may help bridge the gap in treatment coverage by increasing the range of first-line options for patients and health systems.”

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Editorial

Chia-Yu Huang, from Taichung Tzu Chi Hospital in Taiwan, and colleagues conducted a propensity score-matched cohort study involving 23,226 patients with newly diagnosed RA between January 1, 1997, and December 31, 2010. The acupuncture cohort included patients who were administered acupuncture therapy from the initial date of RA diagnosis to December 31, 2010; the no-acupuncture cohort included patients who did not receive acupuncture during the same time interval.

The researchers found that the cumulative incidence of ischemic stroke was lower in the acupuncture cohort. At the end of the study, 341 and 605 patients in the acupuncture and no-acupuncture groups, respectively, experienced ischemic stroke (5.95 and 12.4 per 1,000 person-years, respectively; adjusted subhazard ratio, 0.57). The reduction in incidence of ischemic stroke was independent of sex, age, types of drugs used, and comorbidities.

“Our study demonstrates that the ischemic stroke risk could be reduced by acupuncture treatment in patients with RA in Taiwan,” the authors write. “The possible mechanism may involve reducing proinflammatory cytokines through acupuncture therapy, thereby attenuating cardiovascular disease, including ischemic stroke.”

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Richard L. Nahin, PhD, from the National Institutes of Health in Bethesda, Maryland, and colleagues used data from the 2002, 2012, and 2022 National Health Interview Survey to examine trends in CHA use (including acupuncture, chiropractic care, guided imagery and/or progressive muscle relaxation, massage, naturopathy, and yoga) among US adults.

The researchers found that adults reporting use of any of the seven approaches increased significantly from 19.2 percent in 2002 to 36.7% in 2022. For each individual modality, trends were significant. The largest increase in use was seen for yoga (5.0% in 2002 to 15.8% in 2022). Meditation had the highest prevalence used by 17.3% of individuals in 2022. Acupuncture was increasingly covered by insurance, and use increased from 1.0% in 2002 to 2.2% in 2022. Among participants reporting use of any CHA, the percentage reporting use for pain management increased significantly for each modality and overall, from 42.3% in 2002 to 49.2% in 2022. Among modalities used for pain management, yoga showed the largest increase in use for pain management, while chiropractic care had the highest use.

“This shift in utilization coincides with increased pain prevalence nationally and may be attributable to several factors, including randomized clinical trials suggesting that some CHAs provide low to moderate levels of pain management, incorporation of CHAs into best practice pain management guidelines, and the need to mitigate unnecessary use of potentially harmful opioids through use of nonopioid interventions,” the authors write.

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Asli Korkmaz, from Dokuz Eylul University in Izmir, Turkey, and colleagues examined whether SKY can reduce psychological distress and improve wellness in physicians. Analysis included participants randomly assigned to SKY (66 individuals) vs a stress management education control (63 individuals).

The researchers found that compared with the stress management education control group, participants in the SKY group had significantly decreased stress on the 42-item Depression, Anxiety, and Stress Scale at posttraining (difference, −6.8 points) and at 8 weeks postintervention (difference, −6.0 points). SKY was also associated with significantly decreased depression at posttraining (difference, −5.7 points) and postintervention (difference, −5.4 points) and significantly decreased anxiety at postintervention. Lastly, in the SKY group, there was a significant decrease in insomnia from baseline to postintervention (difference, −0.3 points). While the intervention had no effect on self-reported medical errors, the SKY group showed significantly increased professional fulfillment as well as significant decreases in work exhaustion, interpersonal disengagement, and burnout.

“These findings suggest that SKY represents a practical and efficient approach for improving physician well-being,” the authors write.

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Hyein Jung, from Chung Ang University in Anseong, South Korea, and colleagues assessed the association between kimchi consumption and obesity using data from 115,726 participants (aged 40 to 69 years) enrolled in the Health Examinees study in Korea.

The researchers found that in men, total kimchi consumption of one to three servings per day was related to a lower prevalence of obesity (odds ratios, 0.875 and 0.893 for 1 to 2 servings per day and for 2 to 3 servings per day, respectively) compared with less than 1 serving per day. Men with the highest consumption of cabbage kimchi had 10% lower odds of obesity and abdominal obesity. When compared with no consumption, median consumption or higher of radish kimchi was inversely associated with lower odds of abdominal obesity (8% for men and 11% for women).

“Since all results showed a ‘J-shaped’ association, it is recommended to limit excessive kimchi intake,” the authors write.

Two authors disclosed being members of the staff at the World Institute of Kimchi.

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Hongjiang Wu, from The Chinese University of Hong Kong, and colleagues examined the association of weight change at one year after diabetes diagnosis with long-term incidence and sustainability of type 2 diabetes remission in a population-based observational study involving 37,326 people with newly diagnosed type 2 diabetes.

The researchers found that 6.1% of people achieved diabetes remission during a median follow-up of 7.9 years, with an incidence rate of 7.8 per 1000 person-years. The hazard ratios for diabetes remission were 3.28, 2.29, and 1.34, respectively, for people with 10 or greater, 5 to 9.9, and 0 to 4.9% weight loss within one year of diagnosis compared with those with weight gain, after adjustment for confounding variables. Overall, 67.2% of people who had achieved diabetes remission returned to hyperglycemia during a median follow-up of 3.1 years, with an incidence rate of 184.8 per 1000 person-years. Compared with those with weight gain, those with 10 or greater, 5 to 9.9, and 0 to 4.9% weight loss had adjusted hazard ratios for returning to hyperglycemia of 0.52, 0.78, and 0.90, respectively. The risk for all-cause mortality was reduced in association with diabetes remission (hazard ratio, 0.69).

“Our study provides evidence for policymakers to design and implement early weight management interventions and diabetes remission initiative,” the authors write.

Several authors disclosed ties to the biopharmaceutical and nutrition industries.

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M. Diana van Die, PhD, from Western Sydney University in Penrith, Australia, and colleagues reviewed prospective and retrospective observational studies examining the impact of soybean, lignans, cruciferous vegetables, green tea, or their phytonutrients on breast cancer survival outcomes. Data were included from 32 studies.

The researchers found that the risk for recurrence was reduced in association with soy isoflavones (hazard ratio, 0.74), especially among postmenopausal and estrogen receptor-positive survivors (hazard ratios, 0.72 and 0.82, respectively), with the greatest reduction in risk seen at 60mg/day. The reduction was mainly at 20 to 40mg/day for mortality outcomes. An inverse association was seen for soy protein and soy products with cancer-specific mortality for estrogen receptor-positive disease (hazard ratio, 0.75). Serum or plasma enterolactone, measured prediagnosis and early postdiagnosis, was inversely associated with cancer-specific mortality and all-cause mortality (hazard ratios, 0.72 and 0.69, respectively). There were no effects observed for cruciferous vegetables. Prediagnostic green tea intake was associated with a reduced risk for recurrence for stage I and II breast cancer (hazard ratio, 0.56).

“To further inform clinical practice, evidence is required on the impact of dietary and supplemental intakes of phytonutrients introduced or substantially increased following diagnosis and treatment,” the authors write.

Several authors disclosed ties to industry.

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Alysha S. Thompson, from Queen’s University Belfast in Northern Ireland, and colleagues examined associations between healthful and unhealthful plant-based diet indices (hPDI and uPDI) and T2DM using prospective data from the UK Biobank involving participants aged 40 to 69 years at baseline.

During 12 years of follow-up, 2628 of the 113,097 study participants developed T2DM. The researchers found that compared with participants with the lowest hPDI scores (quartile 1), those with the highest scores (quartile 4) had a lower risk for T2DM (hazard ratio, 0.76). The association was mediated by lower body mass index (BMI) and lower waist circumference (proportion mediated, 28% for both), as well as lower concentrations of hemoglobin A1c, triglycerides, alanine aminotransferase, gamma glutamyl transferase, C-reactive protein, insulin-like growth factor 1, cystatin C, and urate (11, 9, 5, 4, 4, 4, 4, and 4%, respectively). There was an association seen between higher uPDI scores and higher T2DM risk (hazard ratio, 1.37), which was potentially mediated by higher waist circumference, BMI, and higher concentrations of triglycerides (17, 7, and 13%, respectively).

“Our findings suggest that high-quality plant-based diets, characterized by high consumption of fruits, vegetables, nuts, legumes, whole grains, tea and coffee, are beneficial for T2DM prevention, in line with existing dietary recommendations to increase plant food consumption to reduce T2DM risk,” the authors write.

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Chirag M. Vyas, MBBS, MPH, from Massachusetts General Hospital in Boston, and colleagues examined the effects of MVM supplementation on cognitive change using in-person, detailed neuropsychological assessments and conducted a meta-analysis to assess the MVM effects on cognition within the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) substudies. A total of 573 participants were included in the clinic subcohort of COSMOS (COSMOS-Clinic) who completed all cognitive tests administered at baseline. Nonoverlapping participants across 3 COSMOS substudies were included in the meta-analysis (COSMOS-Clinic [573 participants], COSMOS-Mind [2158 participants], and COSMOS-Web [2472 participants]).

The researchers found that over 2 years, there was a modest benefit for MVM vs placebo on global cognition in COSMOS-Clinic, with a significantly more favorable change in episodic memory but not in executive function/attention. Clear evidence of the benefits of MVM on global cognition and episodic memory were seen in the meta-analysis of COSMOS substudies. The magnitude of the effect on global cognition was equivalent to a two-year reduction in cognitive aging.

“These findings will garner attention among many older adults who are, understandably, very interested in ways to preserve brain health, as they provide evidence for the role of a daily multivitamin in supporting better cognitive aging,” senior author Olivia Okereke, M.D., also from Massachusetts General Hospital, said in a statement.

The study was partially funded by Mars Edge, Contract Pharmacal Corp., and Pfizer Consumer Healthcare.

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The hallucinogenic drug psilocybin, when used in combination with psychotherapy sessions, may reduce or eliminate depression in patients with cancer, new research suggests.^1,2

Prior research showed that depression reduces quality of life and increases the risk of death in patients with cancer, and common treatments for depression have generally produced poor results in cancer patients.¹

However, psilocybin and psychotherapy sessions provided a sustained improvement in depressive symptoms in a small trial of cancer patients with moderate to severe depression.^1,2

Though more research is needed, these findings “could have implications for helping millions of patients with cancer who are also struggling with the severe psychological impact of the disease,” study author Manish Agrawal MD, of Sunstone Therapies in Rockville, Maryland, said in a statement.³

Psilocybin had previously demonstrated benefits in patients with life-threatening illnesses and psychologic distress.¹ Psilocybin is a serotonergic agonist, found in many species of mushrooms, that interacts with 5-HT_2A receptors in the brain, resulting in altered perception, cognition, affect, and ego function. ^1,4

Because of a high potential for psilocybin misuse and production of an altered mental state, studies of psilocybin are typically designed with a 2:1 therapist‐to‐patient ratio.¹ To maximize safety for both patients and staff, most studies have been performed in psychiatric hospitals or academic centers.

For their phase 2 study (ClinicalTrials.gov Identifier: NCT04593563), Dr Agrawal and colleagues tested psilocybin in combination with psychotherapy in the outpatient setting and with a 1:1 therapist‐to‐patient ratio.¹

Study Details and Design

The study included 30 adult cancer patients who had moderate to severe depression and no psychotic features. The patients were referred by psychiatric and oncology services. They were required to be off antidepressant drugs, antipsychotic agents, and medical cannabis when screened for the study. 

About half of the patients (46.7%) had curable cancers. The most common cancers were breast cancer (33.3%) and leukemia/lymphoma (26.7%). Most patients (70%) had received at least 1 prior line of cancer therapy, and 50% had previously received antidepressants. The mean age of the patients was 56 years, 70% were women, and 80% were White.

After screening, each patient first met with their therapist alone for a preparatory session. In this session, patients received information about psilocybin treatment, had their medical history taken, and underwent some testing (physical exam, echocardiogram, etc.).

Patients had a second visit 1 day before receiving psilocybin treatment. In this visit, patients had group therapy for 75 minutes and individual therapy for 45 minutes. Patients received additional education during this visit, and any concerns they had were addressed.

At visit 3, patients received psilocybin at 25mg (five 5mg capsules). They were required to remain in the treatment facility for 8 hours after treatment. They were treated in groups of 3 or 4 people, but they were situated in adjacent rooms that were separated by sliding doors and open to a common area. Each patient was observed by their therapist, and 2 lead clinicians monitored the sessions via live video.

Visits 4 and 5 included both group and individual therapy sessions, exploring the significance, meaning, and impact of the experience. The researchers also assessed the safety and efficacy of treatment during visits 4 to 7.

Results: “Robust” and Sustained Benefit

The researchers measured changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS), which consists of 10 items, scored from 0 (normal) to 6 (severe).

Patients experienced rapid and “robust” reductions in MADRS scores from baseline, according to the researchers. The mean difference from baseline to week 8 was -19.1 points (P <.001). There was a mean difference of -17.8 points from baseline to week 1 and -19.2 points from baseline to week 3.

Overall, 80% of patients had a sustained response to psilocybin. Half of patients had a full remission of depressive symptoms (defined as a MADRS score below 10) at week 1, which persisted for at least 8 weeks.

Most patients had clinically meaningful reductions in their depressive symptoms from baseline to week 8, whether they had curable cancers (79.6%) or noncurable cancers (61.9%).

The researchers noted that there were no serious adverse events (AEs) related to psilocybin and no reports of suicidality. AEs were generally mild. The most common AEs of any severity were headache (80%), nausea (40%), crying (26.7%), and mood alteration (26.7%).

Patient Perceptions and Implications

In a companion study to the phase 2 trial, researchers evaluated patients’ reactions to the group therapy sessions.²

The researchers conducted interviews with 28 of the patients after the final psychotherapy session. Interviews were conducted an average of 2.9 months later, and the average duration of the interviews was 90 minutes.

Patients said the group therapy approach made them feel safe and prepared for psilocybin treatment and fostered feelings of connection, belonging, self-transcendence, and compassion.

“Many described an ongoing transformative impact on their lives and well-being more than 2 months after having received psilocybin, feeling better equipped to cope with cancer and, for some, end of life,” study author Yvan Beaussant MD, of the Dana-Farber Cancer Institute in Boston, said in a statement.³

The authors acknowledged that additional research is needed but concluded that these findings suggest psilocybin-assisted psychotherapy could potentially be integrated into cancer care.

“It’s really, really new, and there are a lot of kinks to work out, but it looks very, very promising from a research perspective and from what I see clinically,” said Larry Shapiro, PhD, of Quantum Behavioral LLC, in St Louis, Missouri, who was not involved in this research.

Disclosures: Dr Shapiro disclosed a relationship with Compass Pathways PLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original references for those disclosures.

Alice Newman-Sanders, from the University of Birmingham and Birmingham Women’s and Children’s NHS Foundation Trust in the United Kingdom, and colleagues assessed young adults’ awareness of the potential impacts of gym lifestyle factors and supplementation on male infertility. The analysis included 153 survey responses from gym enthusiasts.

The researchers observed a statistically significant difference between male and female awareness of the potential impacts of some forms of high-intensity exercise and protein supplementation on male reproductive health. Only 14% of male participants considered how gym routines or supplement use might impact fertility.

Overall, fewer men had thought about their fertility vs those who were curious about their fertility and those who believed their personal fertility is important to them. If a behavior were to have a long-term vs short-term effect on their fertility, then more men were likely to make a change in their behavior.

“Men have a potentially alarming lack of concern over their own fertility and how factors such as gym supplements can have negative long-term impacts,” the authors write.

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Ali M. Alasmari, from the National Heart and Lung Institute at Imperial College London, and colleagues conducted a randomized trial involving stable COPD patients with home SBP measurement 130 mmHg or greater. Participants were randomly assigned to 70mL of nitrate-rich beetroot juice (400mg NO₃) or an identical nitrate-depleted placebo juice once daily for 12 weeks (40 and 41 patients, respectively).

The researchers found that active treatment lowered SBP (Hodges-Lemman treatment effect mean difference, −4.5 mm Hg), improved 6-minute walk distance (+30.0 m), and improved measures of endothelial function (reactive hyperemia index [+0.34] and augmentation index [−7.61%]) compared with placebo.

“There is some evidence that beetroot juice as a source of nitrate supplementation could be used by athletes to improve their performance, as well as a few short-term studies looking at blood pressure. Higher levels of nitrate in the blood can increase the availability of nitric oxide, a chemical that helps blood vessels relax. It also increases the efficiency of muscles,” lead author Nicholas Hopkinson, PhD, also of Imperial College London, said in a statement. “This is one of the longest-duration studies in this area so far. The results are very promising, but will need to be confirmed in larger, longer-term studies.”

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Chirag M. Vyas, MBBS, from Massachusetts General Hospital in Boston, and colleagues compared whether daily supplementation with cocoa extract produces better cognitive change over two years than placebo. Analysis included 492 adults (≥60 years).

The researchers found that daily cocoa extract supplementation had no significant effect on 2-year change in global cognition. Additionally, compared to placebo, cocoa extract had no significant effects on change in episodic memory or executive function/attention over time. However, cocoa extract may have cognitive benefits for participants with poorer baseline diet quality.

“Additional research on the role of cocoa extract supplementation in more diverse populations and among those with lower diet quality is warranted,” the authors write.

Several authors disclosed ties to Mars Edge, which helped fund the study.

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Hana Kahleova, MD, PhD, from the Physicians Committee for Responsible Medicine in Washington, DC, and colleagues randomly assigned 84 postmenopausal women to an intervention of a low-fat, vegan diet and cooked soybeans (½ cup [86g] daily) or their usual diet for 12 weeks. Microbiome analysis was conducted in a subset of 11 women.

The researchers found that in the subset of women who underwent microbiome testing, total hot flashes decreased by 95% during the dietary intervention, with severe hot flashes disappearing (from 0.6 to 0.0/day; moderate-to-severe hot flashes decreased by 96%). There were no significant differences observed in the intervention group for alpha and beta diversity between baseline and 12 weeks. Changes in the relative abundance of Porphyromonas and Prevotella corporis were associated with a decline in severe day hot flashes, even after adjusting for changes in body mass index. There was an association seen between changes in relative abundance of Clostridium asparagiforme and reduction in total severe hot flashes and severe night hot flashes.

“Women who want to fight hot flashes should feed the bacteria in their gut a vegan diet rich in fruits, vegetables, grains, and beans, which also leads to weight loss and protects against heart disease and type 2 diabetes,” Kahleova said in a statement.

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Kim L. Feingold, PhD, from Northwestern University Feinberg School of Medicine in Chicago, and colleagues randomly assigned (1:1) patients undergoing primary valve surgery via sternotomy to acupuncture (51 individuals) or standard care (49 individuals). Daily inpatient acupuncture sessions started on postoperative day 1.

The researchers found that an average of 3.8 acupuncture sessions were delivered per patient during a mean hospital stay of 4.6 days. Acupuncture was associated with lower pain, nausea, stress, and anxiety after each session and across admission vs standard care. Additionally, acupuncture was associated with a lower incidence of postoperative atrial fibrillation (acupuncture, 13.7%; standard care, 32.7%), fewer discharges on amiodarone (acupuncture, 9.8%; standard care, 26.5%), and fewer hours in the intensive care unit (acupuncture, 30.3; standard care, 37.0).

“We learned that acupuncture after open heart surgery is feasible in this fast-paced environment, even in the intensive care unit the day after surgery, and was well tolerated by patients with no adverse effects,” Feingold said in a statement. “The majority of patients had no prior history with acupuncture, demonstrating their openness to receive integrative therapies after surgery. Overall, patients reported that it was a pleasant and positive aspect of their cardiovascular surgery recovery.”

Several authors disclosed ties to the medical technology industry.

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