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

OBJECTIVES: The aim of this study is to investigate the therapeutic property of hydroalcoholic extract of Fenugreek seeds in nonalcoholic fatty liver disease (NAFLD) in adult patients. METHODS: This randomized, placebo-controlled, parallel trial was conducted from November 2014 to June 2017. Patients aged between 18 and 70 years old with confirmed NAFLD were recruited from the Motahhari clinic, affiliated to Shiraz University of Medical Sciences, Iran. Participants either received 1 g hydroalcoholic extract of Fenugreek seeds or placebo daily for 3 months. The primary outcomes were changes in serum alanine transaminase and FibroScan controlled attenuation parameter score. Secondary outcome measures were changes in other laboratory data, liver stiffness measure, liver steatosis percent, and anthropometric variables. Participants were randomly assigned to the groups using blocked randomization method. Participants, investigators, and statistician were blinded to treatments allocation. RESULTS: After screening eighty patients, thirty patients met the inclusion criteria and were divided into two groups (1:1). After 3 months, two and four patients did not complete the trial in Fenugreek and placebo group, respectively. The changes in the anthropometrics, laboratories and FibroScan measurements were not statistically significant between the two groups. CONCLUSION: The evidence to prove the efficacy of the Fenugreek seeds' hydroalcoholic extract in NAFLD was not strong enough; hence, further experiments are still needed to assess the possible efficacy of Fenugreek on the treatment of NAFLD.