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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.

作者信息

Majeed Muhammed, Majeed Shaheen, Nagabhushanam Kalyanam, Arumugam Sivakumar, Pande Anurag, Paschapur Mahesh, Ali Furqan

机构信息

1 Sami Labs Limited , Bangalore, Karnataka, India .

2 Sabinsa Corporation , East Windsor, New Jersey, USA.

出版信息

J Med Food. 2018 Nov;21(11):1120-1128. doi: 10.1089/jmf.2017.4172. Epub 2018 Aug 29.


DOI:10.1089/jmf.2017.4172
PMID:30156436
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6249666/
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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885a/6249666/e0089326a61f/fig-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885a/6249666/42bbe4f4f68d/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885a/6249666/e0089326a61f/fig-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885a/6249666/42bbe4f4f68d/fig-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885a/6249666/e0089326a61f/fig-2.jpg

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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.

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引用本文的文献

[1]
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[2]
The Effects of a Microbial Enzyme Mixture on Macronutrient Hydrolysis in a Static Simulation of Oro-Gastric Digestion That Models Human Digestive Senescence.

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[3]
HP7 Improves Gastric Emptying by Modulating Digestive Factors in a Loperamide-Induced Functional Dyspepsia Mouse Model.

J Microbiol Biotechnol. 2025-3-11

[4]
simulated study of macronutrient digestion in complex food using digestive enzyme supplement.

Heliyon. 2024-4-25

[5]
Exploring Therapeutic Digestive Enzyme Landscape in India: Current Evidence, Profit Motives, Regulations, and Future Perspectives.

Cureus. 2024-1-24

本文引用的文献

[1]
The management of functional dyspepsia in clinical practice: what lessons can be learnt from recent literature?

F1000Res. 2017-9-28

[2]
Helicobacter pylori eradication effect on patients with functional dyspepsia symptoms.

Minerva Gastroenterol Dietol. 2016-6

[3]
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Korean J Intern Med. 2016-5

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Digestive Enzyme Supplementation in Gastrointestinal Diseases.

Curr Drug Metab. 2016

[5]
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N Engl J Med. 2015-11-5

[6]
Is Lipase Supplementation before a High Fat Meal Helpful to Patients with Functional Dyspepsia?

Gut Liver. 2015-7

[7]
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Expert Opin Emerg Drugs. 2015-6

[8]
Lipase Supplementation before a High-Fat Meal Reduces Perceptions of Fullness in Healthy Subjects.

Gut Liver. 2015-7

[9]
A review of drug therapy for functional dyspepsia.

J Dig Dis. 2013-12

[10]
Functional dyspepsia: Glimmers of hope for functional dyspepsia.

Nat Rev Gastroenterol Hepatol. 2013-3

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