Efficacy of Mentha pulegium extract in the treatment of functional dyspepsia: A randomized double-blind placebo-controlled clinical trial

Abstract Ethnopharmacological evidence Mentha pulegium L. leaves are used in the Iranian traditional medicine for the treatment of functional dyspepsia. Aim of study: To study the efficacy and safety of M. pulegium in the treatment of functional dyspepsia patients fulfilling the Rome III criteria. Materials and methods The efficacy and safety of a standardized Mentha pulegium leaf extract (drug extract ratio: 15.9:1, extraction solvent: 70% v/v aqueous ethanol) (330 mg three times daily taken for 2 months) as add-on to one famotidine 40 mg tablet per day in the treatment of 50 functional dyspepsia patients were compared with those of a parallel placebo group (n =50). Results The extract significantly decreased the total dyspepsia score measured by the Hong Kong dyspepsia index compared to the placebo and baseline ( P =0.011 and P P P P =0.003, P P P >0.05). The extract improved the quality of life measured by the SF-36 questionnaire significantly compared to the placebo and baseline ( P =0.003 and P H. pylori infection determined by the urease test significantly compared to the placebo and baseline ( P =0.001 and P P >0.05). The patients did not experience any adverse drug effect. Conclusions M. pulegium extract (genuine drug extract ratio: 19.4:1; extraction solvent: 70% v/v aqueous ethanol) 270 mg three times daily taken for 2 months as adjunct to one famotidine 40 mg tablet per day seems safe, improves dyspeptic symptoms and quality of life and eradicates H. pylori in functional dyspepsia patients.