Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double-Blinded Randomized-Controlled Study.

Carmen Mannucci,Santi Inferrera,Luisa Rizza,Andrea Bonina,Gioacchino Calapai,Umberto Alecci,Francesco Bonina

doi:10.1155/2016/2581461

Abstract

Gastroesophageal reflux (GER) is a common, chronic, relapsing symptom. Often people self-diagnose and self-treat it even though health-related quality of life is significantly impaired. In the lack of a valid alternative approach, current treatments focus on suppression of gastric acid secretion by the use of proton pump inhibitors (PPIs), but people with GER have a significantly lower response rate to therapy. We designed a randomized double-blinded controlled clinical study to evaluate the efficacy and the safety of a formulation based on sodium alginate/bicarbonate in combination with extracts obtained from Opuntia ficus-indica and Olea europaea associated with polyphenols (Mucosave®; verum), on GER-related symptoms. Male/female 118 (intention to treat) subjects with moderate GER and having at least 2 to 6 days of GER episodes/week were treated with verum (6 g/day) or placebo for two months. The questionnaires Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQoL) and Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) were self-administered by participants before the treatment and at the end of the treatment. Verum produced statistically significant reduction of GERD-HRQoL and GSAS scores, −56.5% and −59.1%, respectively, in comparison to placebo. Heartburn and acid regurgitation episodes for week were significantly reduced by verum (p < 0.01). Results indicate that Mucosave formulation provides an effective and well-tolerated treatment for reducing the frequency and intensity of symptoms associated with gastroesophageal reflux.

Highlights

Gastroesophageal reflux (GER) is a chronic, relapsing symptom that carries a risk of significant morbidity from resultant complications
After two months’ treatment Group 1 and Group 2 subjects answered the GERDHRQoL questionnaire producing the score of 5.76 ± 1.3 (p < 0.01) and 18.15 ± 2.9 (p < 0.05), respectively (Figure 2), showing that treatment with verum significantly produced in Group 1 reduction of symptoms associated with GER in the percentage of 74.3%
With analysis of data collected with Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) questionnaire, a scale GSAS is sensitive to changes in severity of GER symptoms, showing similar results

Summary

Introduction

Gastroesophageal reflux (GER) is a chronic, relapsing symptom that carries a risk of significant morbidity from resultant complications. GER is due to the passage of gastric content into the esophagus [1]. It is a common condition and its prevalence in the general population has been evaluated to be about 5% in Asian countries and from 10 to 20% in Western countries [2]. Most of people with GER fall into 1 of 2 categories: those with nonerosive reflux or those with erosive esophagitis [3]. Nonerosive reflux has been commonly defined as the presence of classic gastroesophageal reflux in the absence of esophageal mucosal injury [4]

Methods

Results

Conclusion