Berberine did not reduce visceral adipose tissue or liver fat content in patients with obesity and metabolic dysfunction–associated steatotic liver disease who did not have diabetes, according to a randomized clinical trial.

Researchers enrolled 337 patients at 11 hospitals in China and randomly assigned them to receive oral berberine 1 g daily (n = 169) or placebo (n = 168) for 6 months. All patients also received lifestyle interventions. The mean age was 42 years, and 221 patients were male.

The primary outcomes were changes in visceral adipose tissue (VAT) area and liver fat content assessed by computed tomography. After 6 months, there were no statistically significant differences between groups in either measure. Findings were consistent across subgroups defined by age, sex, lipid levels, prediabetes status, and liver function.

Berberine was associated with greater reductions in low-density lipoprotein cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein (hs-CRP) compared with placebo. It did not significantly affect glycated hemoglobin, glucose levels, insulin resistance measures, triglycerides, blood pressure, body weight, or liver fibrosis markers.

Post hoc analyses suggested that reductions in lipid levels and hs-CRP were more pronounced among patients with higher baseline hs-CRP levels. The researchers described these findings as exploratory.

The incidence of serious and nonserious adverse events was similar between groups. The investigators reported that berberine had an excellent safety profile.

“In this randomized clinical trial of diabetes-free patients with obesity and metabolic dysfunction–associated steatotic liver disease (MASLD), a 6-month berberine treatment at a daily dose of 1 g had an excellent safety profile but did not reduce VAT area or liver fat content,” the researchers concluded.

The researchers reported no conflicts of interest.

Source: JAMA Network Open