Authors: Bernhard Sikora , Babak malekian , Agnieszka Magg , Nikon Moghadasian , Mohammed Moghadasian , Oliver Lammel , Afsaneh Gächter , Babak Bahadori ,

Abstract

Background: Hepatic steatosis is the most common chronic liver disease, but pharmacologic options remain limited. Berberine reduces hepatic fat in randomized trials, but has very low oral bioavailability and has been studied almost exclusively as high-dose (1.0–1.5 g/day) capsules.

Case Presentation: We report a single-center, retrospective, uncontrolled before–after case series of 25 adults with ultrasound-defined hepatic steatosis who used a liquid berberine-containing combination preparation during routine care, without a prescribed lifestyle intervention or control group. Twenty patients (16 men; mean age 57 years) had paired UDFF measurements and were included in the complete-case analysis; five lacked follow-up measurements. After a median of 7 weeks, UDFF decreased from 18.2 ± 6.3% to 11.2 ± 4.8% among complete cases (mean change −7.1 percentage points; 95% CI −9.1 to −5.0; p < 0.001). All 20 complete cases had a lower follow-up value, and 12 (60%) had a ≥30% relative reduction. In a conservative sensitivity analysis assigning zero change to the five patients without follow-up, the mean change was −5.6 percentage points and 12 of 25 (48%) met the ≥30% threshold. No adverse events were documented in the available routine-care records.

Conclusion: These uncontrolled observations cannot establish efficacy or identify which component, if any, contributed to the observed change. The findings are susceptible to attrition bias, regression to the mean, unmeasured clinical or lifestyle changes, observation effects, and unblinded measurement. They should be considered hypothesis-generating and require confirmation in an independent randomized controlled trial.

Keywords: Hepatic steatosis, berberine, Berberis, ultrasound-derived fat fraction, case series.