A RANDOMIZED CONTROLLED TRIAL OF BERBERINE EFFICACY ON METABOLIC SYNDROME PLUS HIV

Background: Antiretroviral therapy has increased the life expectancy of people living with HIV (PLWH). Nevertheless, this increase is not free of comorbidities, and metabolic syndrome is among the most prevalent1. Berberine is an alkaloid that has been shown to ameliorate metabolic syndrome components like glucose tolerance and insulin resistance, but it had not been tested in PLWH2,3. Our aims were to evaluate the efficacy of berberine for improving clinical features, insulin resistance, metabolic profile, and inflammatory markers. Methods: A randomized, double‐blind, placebo‐controlled trial was performed in adults living with HIV under virological suppression and with metabolic syndrome diagnosis who were assigned to receive either berberine 500 mg TID or placebo for 20 weeks. The primary outcomes were a composite of weight reduction, insulin resistance decrease, and lipid profile improvement. Results: Forty‐three participants were randomized (22 in the berberine group (BBR) and 21 in the placebo group (CTR)); at the end, 19 in the BBR and 17 in the CTR group completed the intervention period and were analyzed. At 20 weeks, the BBR group showed the following improvements: reduction in weight and body mass index (2.8 kg, p=0.001; 0.99, p=0.003, respectively), lower insulin resistance revealed by a TyG∗BMI decrease of 8 points (p=0.01); additionally, a reduction in TNF‐alpha of 1 pg/mL was found (p=0.023), and a tendency toward benefit was shown in HOMA‐IR and HOMA‐%beta (decrease 0.59, p=0.085; increase 3.5%, p=0.065, respectively). Conversely, the CTR group had higher total cholesterol and c‐LDL (increase 22 mg/dL, p=0.005; increase 20 mg/dL, p=0.024, respectively), and worse IL‐6 concentration (increase 0.69 pg/ mL, p=0.018). Furthermore, an increase in HOMA‐IR (increase 0.23, p=0.041) was concurrent with a decrease in beta‐cell function (HOMA‐%beta decreased 1%, p=0.041) and higher C‐peptide levels (increase 174 pg/mL, p=0.039). See table 1. There were no serious adverse effects in both group. Conclusion: In PLWH under virological suppression, berberine improves metabolic syndrome by reducing weight and body mass index, insulin resistance, and proinflammatory profile, among a tendency to increase betacell function, while the control group showed worsening in total cholesterol, c‐LDL, IL‐6 levels, insulin resistance, and beta‐cell function, at the end of the follow‐up. Further studies with more people and longer intervention periods need to be explored (Table Presented).