The Effectiveness of a Poly-herbal Formulation from Traditional Persian Medicine (TPM) in Gastroesophageal Reflux Disease (GERD), a Double-Blinded Randomized Clinical Trial

Abstract

Introduction:: Gastroesophageal reflux disease (GERD) leads to increased contact of the acidic refluxate with the esophageal mucosa. Nearly 10- 20 % of the world's population is affected by GERD. Due to the complications associated with GERD, as well as complications of long-term treatment with current medications, and global demand toward Complementary and Alternative Medicine (CAM), this study evaluated the efficacy of a poly-herbal formulation known as Mastic pill (Habb-e-Mastaki) from traditional Persian medicine (TPM), previously reformulated and standardized, in a double-blinded randomized clinical trial. Method:: 34 patients in the drug group received 4 capsules of Mastic pill plus Omeprazole capsule 20 mg daily. 34 patients in the placebo group received the same dosing of Omeprazole and placebo. The medication was given to patients for a total duration of 4 weeks. All patients were requested to fill out the modified GERD-HRQL questionnaire at the beginning and every two weeks for a total duration of six weeks. Result:: Reflux, and heartburn severity score as well as disruption of personal life score significantly reduced in both groups, but it was more remarkable in the drug group (P-value = 0.0001). Dysphagia, early satiation, and nausea significantly reduced in the drug group while the placebo group showed no improvement. Our results suggest that constipation, bloating, belching, and odynophagia did not significantly improve in none of the groups. Conclusion:: This study showed that Habb-e-Mastaki is effective against GERD. Further detailed in vitro and in vivo studies aimed at discovering the mechanism of action of this formulation and clinical studies involving a larger population will be necessary to explain and confirm the results obtained in the present study.