Comparison of the efficacy of oral fenugreek seeds hydroalcoholic extract vs placebo in the treatment of non-alcoholic fatty liver disease; a randomized, triple-blind controlled pilot clinical trial

Background and Objective: Non-alcoholic fatty liver disease (NAFLD) is a common metabolic disease in the world with the prevalence of 25.24%. The anti-hyperglycemic and insulin-sensitizing effect of fenugreek along with its antioxidant, anti-inflammatory and hepatoprotective properties suggest that fenugreek can be used to treat NAFLD. The aim of this randomized, placebo-controlled, clinical trial was to investigate the therapeutic effect of hydroalcoholic extract of fenugreek seeds on the treatment of NAFLD in human. Materials and Methods: This randomized, placebo-controlled, triple-blind, parallel trial was conducted from November 2014 to June 2017. Patients aged between 18-70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran. Increased serum levels of alanine transaminase (ALT) between 1.5 to 10 times greater than upper normal values and confirmation of fatty liver disease by ultrasonography were used as inclusion criteria. Presence of any other liver or metabolic disease were considered as excluding criteria. Participants either received 1 gram hydroalcoholic extract of fenugreek seeds or placebo daily for 3 months. The primary outcomes were changes in ALT and FibroScan controlled attenuation parameter (CAP) score. Secondary outcome measures were changes in other laboratory data, liver stiffness measure (LSM), liver steatosis percent and anthropometric variables. Participants were randomly assigned to the groups using blocked randomization method. Participants, investigators, and statistician were blinded to the identity and allocation of the treatments. Changes in anthropometric variables and laboratory data over the course of the study were analyzed by using two-way (drug * time) repeated measures ANOVA. The analysis was conducted using SPSS 23 software (SPSS Inc., Chicago, IL, USA). P values less than 0.05 were considered to be statistically significant. Findings: After screening 80 patients, 30 patients met the inclusion criteria and were divided into two groups (1:1). After three months, two and four patients did not complete the trial in fenugreek and placebo group l, respectively. The mean (SD) age of group A was 39.08 (11.00), while the mean age of group B was 39.55 (8.70) (p-value=0.910). Baseline characteristics and paraclinical data of patients are shown in table 1. While CAP score and steatosis percentage of fenugreek group reduced more than placebo group, this was not statistically significant. The changes in BMI, weight, waist to hip ratio, ALT, aspartate aminotransferase, alkaline phosphatase, albumin, fasting blood sugar, and LSM were not statistically significant between the two groups. Table 2 summarizes the trend of anthropometric, laboratory and fibroscan data of patients in the study. Conclusion: The evidence to prove the efficacy of the hydroalcoholic extract of fenugreek seeds in NAFLD was not strong enough; hence, further experiments are still needed to assess the possible efficacy of fenugreek on the treatment of NAFLD.

کلیدواژه ها:

Liver diseases ، Trigonella ، Placebos ، Glucose ، Iran