Efficacy of Mentha pulegium extract in the treatment of functional dyspepsia: A randomized double-blind placebo-controlled clinical trial. (12th July 2017)

• Record Type: Journal Article
• Authors: Khonche, Ahmad; Fallah Huseini, Hasan; abdi, Hamed; Mohtashami, Reza; Nabati, Farzaneh; Kianbakht, Saeed
• Is Part Of: Journal of ethnopharmacology. Volume 206(2017)
• Page Start: 267
• Page End: 273
• Publication Date: 2017-07-12
• Subjects: Mentha pulegium -- Labiatae -- Functional dyspepsia -- Trial; Ethnopharmacology -- Periodicals; Pharmacognosy -- Periodicals; Herbs -- Periodicals; Herbs -- Periodicals; Pharmacognosy -- Periodicals; Pharmacognosie -- Périodiques; Herbes -- Périodiques; 615.1
• DOI: 10.1016/j.jep.2017.05.026
• Languages: English
• ISSNs: 0378-8741

Abstract

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 <0.001 respectively). The stomach pain, upper abdominal bloating, upper abdominal dull ache, belching and total dyspepsia scores were decreased from baseline in the extract group significantly compared to the placebo ( P <0.001, P <0.001, P =0.003, P <0.001 and P <0.001 respectively). However, the decreases of other dyspepsia symptoms scores from baseline in the extract group were not significant compared to the placebo ( 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 <0.001 respectively). Moreover, the extract lowered the rate of H. pylori infection determined by the urease test significantly compared to the placebo and baseline ( P =0.001 and P <0.001 respectively). The extract did not significantly affect the complete blood count and liver and kidney function tests ( 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. Graphical abstract: