BERBERINE REDUCES ANTIPSYCHOTIC-ASSOCIATED WEIGHT GAIN IN SCHIZOPHRENIA PATIENTS WITH LOW-LEVEL LDL: A POOLED ANALYSIS OF RANDOMIZED CONTROLLED TRIAL

Abstract Background MetS thus has become a major concern in the long-term prescription of antipsychotics, as its prevalence is as high as 33.4% in patients with schizophrenia, and it increases diabetic and cardiovascular morbidity and mortality. Berberine is a naturally occurring alkaloid mainly extracted from the Chinese herbal medicine Coptis chinensis. Although berberine has not been licensed for the treatment of metabolic disorders, in vitro and in vivo experimental evidence confirms that berberine has body weight-lowering effects. Objective To evaluate the efficacy and safety of berberine as an adjuvant in treating antipsychotic- associated weight gain. Method One hundred and thirteen participants with schizophrenia spectrum disorders who had developed metabolic syndrome (MetS) were recruited. They were randomly assigned to berberine (600 mg/day, n=58) or placebo (n=55) groups for 12 weeks. The primary outcome was the change from baseline to week 12 in net weight. Results Compared with the placebo group, the berberine group showed a significantly greater reduction in weight gain at 9 weeks (mean difference [MD]=-0.75, 95% confidence interval [CI]: -1.42 to -0.07, P =0.031, d=0.41) and 12 weeks (MD=-1.08, 95% CI: -1.76 to -0.40, P=0.002, d=0.59) in all patients. In the subgroup patients with low-level LDL at baseline (<2.9 mmol/L), there is a larger effect regarding weight gain at 12 weeks (MD=-2.0, 95%CI: -2.8 to -1.0) compared with high-level LDL (MD=-0.3, 95%CI: -1.3 to 0.7). Berberine was well tolerated without serious adverse events and aggravation of psychotic symptoms compared with placebo. Conclusions Findings suggest that berberine is effective in attenuating antipsychotic-associated weight gain and MetS, especially for patients with low-level LDL.