A Polyherbal Compound for Patients with Non-alcoholic Fatty Liver Disease: A Single Blinded Randomized Clinical Trial

Background and Objective: Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic disorder with a prevalence of ۶-۳۵% worldwide. If NAFLD is not managed at early stages, it progresses to non-alcoholic steatohepatitis, cirrhosis and hepatocellular carcinoma. Up to now, no ideal therapeutic drug has been proven for NAFLD yet. A combination of herbal agents might be more effective when each herb acts through different mechanisms and shows synergistic effect. This study aimed to evaluate the benefits of a polyherbal compound for patients with NAFLD. Materials and Methods: In this double-blind randomized controlled trial, five plants with potent antioxidant, anti-inflammatory, and hypolipidemic effects were choosen. The powders of Anethum graveolens, Citrus bigardia, Cynara scolymus, Portulaca oleracea, and Silybum marianum were mixed together equally and prepared as capsules containing ۴۰۰ mg of the mixture. The participants of study were derived in convenience method from the Internal Medicine Clinic, Imam-Reza Hospital in Mashhad in ۲۰۱۶-۲۰۱۹. Patients were included in the trial if they had grade ≥ ۲ of NAFLD on sonography or had grade ۱ of NAFLD with elevated ALT level (>۴۰U/L). Patients were excluded if they had the following criteria: alcohol intake, cancer, pregnancy, severe infection, renal insufficiency, uncontrolled diabetes, and other forms of liver diseases. Sixty patients with NAFLD were randomly divided two groups (۲:۱ratio): treatment (n=۴۰) and control (n=۲۰). Both groups were advised to take healthy diet and exercise. The treatment group also received the herbal compound for two months (۲capsules, three times daily). Data were analyzed using IBM SPSS statistics ۲۰ software and using paired-sample t-test, independent-sample t-test, and Wilcoxon and Mann-Whitney tests. P-value less than ۰.۰۵ was considered statistically significant. The Ethics Committee of Mashhad University of Medical Sciences approved the study protocol (number: IR.MUMS.fm.REC.۱۳۹۴.۱۱۴).Findings: Of the ۶۰ participants randomized, ۴۶ completed the study (۱۶ control and ۳۰ treatment group). The ratio of female to male was ۳۸/۶۲ in the control group and ۵۰/۵۰ in the treatment group. The mean age of patients was ۴۴±۸ and ۴۹±۱۱ years in the control and treatment groups, respectively. Before starting study, there was no significant difference in the severity of NAFLD between the two group (P=۰.۷۴۰). Treatment with the polyherbal compound significantly improved the grade of fatty liver (P<۰.۰۰۱), but no significant change was found in the control group (P=۰.۳۳۴). Taking polyherbal compound was associated with significant reductions in the ALT, AST and total cholesterol levels (P<۰.۰۵), but no significant changes were found in the control group. In addition, no significant changes were observed in the levels of LDL, HDL and triglyceride in neither of the groups (P<۰.۰۵). Conclusion: The formulated polyherbal compound appears to be effective in improving the biochemical and decreasing the grade of fatty liver in patients with NAFLD.

Keywords:

Anethum graveolens , Citrusbigardia , Cynara scolymus , Portulaca oleracea , Fatty liver