Efficacy of a new nutraceutical formulation (CHETOGERD®) in patients with nonerosive reflux disease (NERD): a prospective observational study.

Abstract

Nonerosive reflux disease (NERD) is a gastrointestinal disorder that leads to symptoms such as heartburn and regurgitation without visible esophageal mucosal injury, and it is treated with proton-pump inhibitors (PPIs). CHETOGERD® gel or orosoluble (oro) formulations-an association of natural active ingredient: hyaluronic acid, altea, malva, apple active TM, Aloe vera, L-triptophan, calcium gluconate, sodium bicarbonate, Musa paradisiaca)-may be an alternative or a coadjutant treatment in patients with NERD. The aim of the study was to evaluate, prospectively, the efficacy of CHETOGERD® gel and oro in inducing symptom's reduction or remission, in consecutive patients with NERD. Patients were divided in two groups and treated with CHETOGERD® gel or CHETOGERD® oro, 3 sachets/day for 3months, decreased to 1 sachet/day for other 3months. Symptoms were evaluated at baseline, 3 and 6months using the reflux disease questionnaire (RDQ). Symptoms' remission was defined as reduction of retrosternal pain or burning, epigastric pain or burning, regurgitation and acid sensation in mouth. Frequency, distribution analyses and non-parametric tests were used for the statistical analysis. Results were considered statistically significant for p values < 0.05. Four hundred and twenty-three patients (M/F 240/183; mean age 50years) were diagnosed with NERD and were consecutively enrolled. 146 patients underwent therapy with CHETOGERD® gel, while 277 were treated with CHETOGERD® oro. 108 patients from the first group and 172 patients from the second group completed follow up at 3months, while 100 patients from each group completed follow-up at 6months. Both formulations were able to significantly reduce the frequency and intensity of symptoms analysed with RDQ. No adverse events were reported. CHETOGERD® gel and oro are two valid alternatives to control symptoms in patients with nonerosive reflux disease.