Pilot study on the efficacy and safety of berberine in people with metabolic syndrome and human immunodeficiency virus infection, database BBR vs CTR

A pilot randomized, double-blind, placebo-controlled clinical trial was designed with two groups, each one with 20 patients: group A) Berberine 500 mg per capsule three times daily for 20 weeks, and group B) Placebo (calcinate magnesia) 400 mg per capsule three times daily for 20 weeks.Participants were randomly assigned using an Excel program to receive berberine or a placebo, one capsule after each meal for 20 weeks. All participants received medical and nutritional guidance; we emphasized consumption of fiber according to weight, and avoidance of saturated and trans fats; also, we recommended maintaining the same physical activity that was part of their daily routine to avoid interfering with the final outcomes.Basal and final measurements of hematology, glucose, creatinine, urea, total cholesterol, LDL-c, HDL-c, VLDL-c, triglycerides, high sensitivity C-reactive protein (hs-CRP), total bilirubin, total proteins, albumin, AST, ALT, GGT, alkaline phosphatase, HBsAg, anti-HCV antibodies, insulin, C-peptide, glucagon and glycated hemoglobin (HbA1c) were obtained, with at least 8 h of fasting.Cardiovascular risk was estimated.We calculated: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), the HOMA-%β, and the HOMA-%S.Serum levels of proinflammatory cytokines: IL-1β, TNF-a, and IL-6, insulin, glucagon, and C-peptide were quantified.