1. In diabetes-free individuals with metabolic dysfunction–associated steatotic liver disease (MASLD) and obesity, berberine is safe, well-tolerated, and associated with a significant reduction in low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (apoB)
Evidence Rating Level: 1 (Excellent)
Berberine, a bioactive alkaloid derived from plants, promotes glucose and fatty acid use, and inhibits de novo lipogenesis, and has been shown to improve insulin sensitivity and suppress hepatic lipid synthesis in patients with MASLD. However, these studies predominantly involved patients with impaired glucose regulation (e.g. diabetes), and it is uncertain if berberine’s effects extend to individuals with normal glucose levels. This double-blinded, randomized clinical trial included 337 diabetes-free patients with MASLD and obesity (mean [SD] age, 41.8 [10.6] years; 34.4% female). 116 patients received berberine hydrochloride 0.5 g twice daily or a matching placebo for 6 months. There was no significant difference in visceral adipose tissue (VAT) area, (mean [SD] change in placebo arm, −2.0% [14.4%]; mean change in berberine arm, −0.6% [16.7%]; placebo-adjusted estimated treatment difference 1.38% [97.5% CI, −2.43% to 5.18%]; P = .42) or liver fat content (mean [SD] change in placebo arm, −1.1% [5.1%]; mean [SD] change in berberine arm, 0.1% [6.2%]; placebo-adjusted estimated treatment difference 0.87% [97.5% CI, −0.39% to 2.13%]; P = .12). Berberine did significantly reduce LDL-C (−7.72 [95% CI, −13.13 to −1.93] mg/dL; P = .008) and apoB (−3.42 [95% CI, −6.33 to −0.51] mg/dL; P = .02). There were no differences between arms in the frequency of adverse events. Berberine is safe and well-tolerated, and significantly reduces LDL-C and apoB but not VAT or liver fat content. These findings suggest berberine may have a role in personalized therapy, but future studies are required to validate these interactions.
Click here to read this study in JAMA Network Open
Image: PD
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