Medical Bulletin 10/June/2025

Participants were asked if they followed any specific diet to lose weight or for health reasons. The diets were categorized into four groups: calorie-restrictive, nutrient-restrictive (such as low-fat or low-carb diets), established dietary patterns (like diabetes-specific diets), and no diet. Most respondents (87%) reported not following any particular diet, while 8% were on a calorie-restricted diet.

The results showed that PHQ-9 scores were 0.29 points higher in those following calorie-restrictive diets compared to those not on any specific diet. The association was even stronger in overweight individuals. Calorie-restrictive diets were also linked to higher cognitive-affective symptom scores, which measure the relationship between thoughts and feelings. Nutrient-restrictive diets, meanwhile, were associated with increased somatic symptom scores, such as anxiety and physical distress.

Gender differences were also observed. Men on nutrient-restrictive diets had higher cognitive-affective symptom scores than women not on a diet, and all diet types were associated with increased somatic symptoms in men.

The researchers caution that this is an observational study and cannot prove causation. Misclassification of diets by participants and other confounding factors may also have influenced the findings. However, they suggest that real-life calorie-restricted diets may lack essential nutrients and induce physiological stress, potentially worsening mental health.

The study concludes that while low-calorie diets are often promoted for physical health, their impact on mental health, especially in specific groups, deserves closer scrutiny.

Reference: Gabriella Menniti, Shakila Meshkat, Qiaowei Lin, Wendy Lou, Amy Reichelt, Venkat Bhat. Mental health consequences of dietary restriction: increased depressive symptoms in biological men and populations with elevated BMI. BMJ Nutrition, Prevention & Health, 2025; bmjnph-2025-001167 DOI: 10.1136/bmjnph-2025-001167

Clinical Trial Shows Diabetes Drug May Help Treat Liver Inflammation

A new study found that dapagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, improved key liver conditions associated with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis according to a new clinical trial published in The BMJ.

MASH is a form of non-alcoholic fatty liver disease (NAFLD) characterized by the accumulation of fat in the liver, leading to inflammation and, in many cases, scarring or fibrosis. It is considered a major global health concern, with few effective pharmacological treatments currently available.

To evaluate the impact of dapagliflozin on MASH, researchers enrolled 154 adults across six medical centers in China between November 2018 and March 2023. Participants had all been diagnosed with MASH following a liver biopsy. Nearly half had type 2 diabetes, and almost all had evidence of liver fibrosis.

Patients were randomly assigned to receive either 10 mg of dapagliflozin or a placebo once daily for 48 weeks. They also attended biannual health education sessions and underwent regular assessments of liver enzymes, blood glucose, insulin, lipid profiles, and other metabolic markers.

At the end of the trial, a second liver biopsy showed that 53% of those receiving dapagliflozin experienced improvement in MASH without worsening of fibrosis, compared with 30% in the placebo group. Additionally, resolution of MASH without fibrosis worsening was observed in 23% of the dapagliflozin group, versus 8% in the placebo group. Improvement in fibrosis without worsening MASH was reported in 45% of the dapagliflozin group, compared to 20% of those given the placebo.

The researchers noted the trial’s limitations, including its focus on a predominantly male, Chinese population, and the need for broader and longer-term studies. Still, they concluded: “Our findings indicate that dapagliflozin may affect key aspects of MASH by improving both steatohepatitis and fibrosis.”

An accompanying editorial highlights the growing momentum in developing pharmacological treatments for MASH, emphasizing the future importance of individualized treatment strategies that also address cardiovascular health and safety.

Reference: Lin J, Huang Y, Xu B, Gu X, Huang J, Sun J et al. Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial BMJ 2025; 389 :e083735 doi:10.1136/bmj-2024-083735

Diabetes and Weight-Loss Drug Semaglutide Linked to Rare Eye Condition: European Medical Agency

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of semaglutide-containing medicines, confirming a potential link between the drug and a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION). The findings, published by the EMA, indicate that NAION should now be listed as a “very rare” side effect in the product information for semaglutide-based treatments such as Ozempic, Rybelsus, and Wegovy.

Semaglutide is a GLP-1 receptor agonist widely prescribed for type 2 diabetes and obesity. It mimics the action of a natural hormone to stimulate insulin production, regulate blood sugar, and reduce appetite. However, concerns about vision loss led the EMA to investigate the drug’s safety profile more closely.

The PRAC conducted a thorough evaluation of all available data, including non-clinical studies, clinical trials, post-marketing surveillance, and findings from published medical literature. According to the committee, “NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).”

Epidemiological studies showed that adults with type 2 diabetes treated with semaglutide had about a two-fold increased risk of developing NAION compared to those not on the drug. Clinical trials also reported a slightly elevated risk in patients taking semaglutide versus placebo.

The EMA now advises that patients using semaglutide who experience sudden vision loss or rapidly declining eyesight should contact a healthcare provider immediately. “If NAION is confirmed, treatment with semaglutide should be stopped,” the PRAC stated.

The PRAC’s recommendations will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), followed by a final legally binding decision from the European Commission, applicable across all EU member states.

While semaglutide remains an effective treatment for diabetes and obesity, these new findings highlight the importance of ongoing pharmacovigilance to safeguard patient health.

Reference: https://www.ema.europa.eu/en/news/prac-concludes-eye-condition-naion-very-rare-side-effect-semaglutide-medicines-ozempic-rybelsus-wegovy