The Efficacy of The Herbal Formula of Bunium Persicum and Coriandrum Sativum on Clinical Symptoms of Patients with Functional Dyspepsia: A Double-Blind Randomized Controlled Trial

Abstract

Background:Functional dyspepsia (FD) is one of the most prevalent chronic disorders affecting up to 30% of the world population with considerable impairment of quality of life. This study evaluated the efficacy of the herbal formula of Bunium persicum (Boiss.) B.Fedtsch. and Coriandrum Sativum L. on symptom severity, symptom frequency, and quality of life of patients with FD. Methods:This double-blind randomized controlled clinical trial, with parallel groups allocation ratio of 1:1, was conducted in a referral clinic of Afzalipour Hospital affiliated with Kerman University of Medical Sciences in Kerman, southeastern Iran. A total of 90 patients with FD (diagnosed based on the Rome IV criteria) were included in this study. The patients with complications during the intervention, pregnancy or lactation, a history of allergy to herbal drugs, and severe organic or psychiatric disorders were excluded.The participants received one capsule containing 500 mg of herbal formula or placebo twice a day for 4 weeks and were subsequently followed up for 4 more weeks.Clinical outcomes were assessed via the Dyspepsia Severity Questionnaire, the Rome IV Diagnostic Questionnaire, and Nepean Dyspepsia Index Questionnaire. Results:A total 40 participants in each group completed the follow-up period, and their data were analyzed statistically. All clinical outcomes showed significant improvements in herbal formula compared to the placebo without serious side effects (P <0.05). Conclusions:Although this herbal formula can alleviate both epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS), PDS seems to be improved higher than EPS. Trial registration:This trial was registered in the Iranian Registry of Clinical Trials (IRCT) under Reg. No. IRCT20190304042911N1 on 03/11/2019.