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Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

Journal of Medicinal Food 2018년 21권 11호 p.1120 ~ 1128
Majeed Muhammed, Majeed Shaheen, Nagabhushanam Kalyanam, Arumugam Sivakumar, Pande Anurag, Paschapur Mahesh, Ali Furqan,
소속 상세정보
 ( Majeed Muhammed ) - Sami Labs Limited
 ( Majeed Shaheen ) - Sami Labs Limited
 ( Nagabhushanam Kalyanam ) - Sabinsa Corporation
 ( Arumugam Sivakumar ) - Sami Labs Limited
 ( Pande Anurag ) - Sabinsa Corporation
 ( Paschapur Mahesh ) - Sami Labs Limited
 ( Ali Furqan ) - Sami Labs Limited

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?

키워드

digestive enzymes; dyspeptic symptoms; functional dyspepsia; multienzyme complex; nonulcer dyspepsia; safety and efficacy

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