Estudios clínicos

Muhammed Majeed,1–4 Shaheen Majeed,1–3 Kalyanam Nagabhushanam,2 Sivakumar Arumugam,1 Anurag Pande,2 Mahesh Paschapur,1 and Furqan Ali1 1 Sami Labs Limited, Bangalore, Karnataka, India. 2 Sabinsa Corporation, East Windsor, New Jersey, USA. 3 Sabinsa Corporation, Payson, Utah, USA. 4 ClinWorld Private Limited, Bangalore, Karnataka, India.   ABSTRACT Functional dyspepsia (FD) is a highly prevalent disorder having nonspecific symptoms and varied pathophysiology. Its treatment remains a challenge as therapeutic options are limited, unsatisfactory, and elusive. Thus, safety and efficacy of DigeZyme, a proprietary multienzyme complex (MEC), was evaluated as a dietary supplement in FD patients. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 patients were randomly assigned (1:1 ratio) to receive either MEC (50 mg, TID; n = 20) or placebo (n = 20) for 60 days. Reports of adverse or serious adverse events (AEs), abnormal results of vital signs, abnormal findings during physical examination, and abnormal laboratory investigations were monitored closely. Efficacy measures were change in Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), Nepean Dyspepsia Index-Short Form (NDI-SF), Visual Analog Scale (VAS), Clinical Global Impression Severity Rating Scale (CGI-S), and Glasgow Dyspepsia Severity Score (GDSS) at baseline and follow-up visits on day 15, 30, and 60. Supplementation with MEC was associated with statistically significant differences (P value ranging from .0401 to .0033) in all efficacy parameters compared with placebo. The between-group comparison also revealed that MEC supplement had a significantly greater effect (P < .001) versus placebo. No investigation product-related AEs were reported. There were no clinically significant abnormalities in physical findings and no statistically significant changes in biochemical and hematological parameters, vital signs, body weight, and body mass index observed between the two groups at baseline and follow-up visits. MEC supplementation represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.

INTRODUCTION

Dyspepsia, by definition, is not a single symptom but a constellation of symptoms, such as bloating, early satiety, postprandial fullness, nausea, anorexia and heartburn, regurgitation, and burping.1 Several reports suggest that majority of dyspepsia cases are diagnosed with minor abnormalities of uncertain significance or an entirely normal endoscopy.2 Hence, in the absence of a clinically identifiable...