Homeopathic medicines for non-alcoholic fatty liver disease: A randomized trial
Description
Non-alcoholic fatty liver disease (NAFLD) is a common chronic liver disorder for which effective and acceptable treatments remain needed. Evidence regarding the efficacy and safety of individualized homeopathic medicines (IHMs) in NAFLD is limited. A randomized, double-blind, placebo-controlled trial was conducted in adults with NAFLD. Participants were allocated 2:1 to IHMs or placebo, alongside supportive care comprising lifestyle, dietary, sleep, and physical-activity advice. The prespecified primary efficacy estimand was the baseline-adjusted, multiplicity-corrected between-group difference in serum alanine aminotransferase (ALT) after 3 months. Secondary outcomes included aspartate aminotransferase, total, direct, and indirect bilirubin, total protein, albumin, globulin, alkaline phosphatase, total cholesterol, triglycerides, high- and low-density lipoprotein cholesterol, and very-low-density lipoprotein cholesterol, measured after 3 months; the Chronic Liver Disease Questionnaire (CLDQ) and Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP2), measured monthly, until 3 months. Safety was measured throughout. Of 105 assessed individuals, 72 were randomized: IHMs 48, placebo 24. At month 3, the baseline-adjusted mean difference in ALT was −1.562 IU/L (95% CI −4.873 to 7.998; multiplicity-adjusted p = 0.769). No statistically significant between-group differences were identified for the other liver profile, lipid profile, CLDQ, or MYMOP2 after multiplicity correction. Blinding appeared adequate. Six mild adverse events occurred, three in each group; all resolved without sequelae. In adults with NAFLD, although safe, IHMs did not demonstrate a statistically significant or clinically meaningful benefit over placebo for the prespecified ALT or the measured secondary biochemical, quality-of-life, and symptom outcomes after 3 months.
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Institutions
- West Bengal University of Health SciencesWest Bengal, Kolkata