PMID- 30156436
OWN - NLM
STAT- MEDLINE
DCOM- 20190122
LR  - 20190122
IS  - 1557-7600 (Electronic)
IS  - 1096-620X (Print)
IS  - 1096-620X (Linking)
VI  - 21
IP  - 11
DP  - 2018 Nov
TI  - Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with 
      Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study.
PG  - 1120-1128
LID - 10.1089/jmf.2017.4172 [doi]
AB  - 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((R)), 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.
FAU - Majeed, Muhammed
AU  - Majeed M
AD  - 1 Sami Labs Limited , Bangalore, Karnataka, India .
AD  - 2 Sabinsa Corporation , East Windsor, New Jersey, USA.
AD  - 3 Sabinsa Corporation , Payson, Utah, USA.
AD  - 4 ClinWorld Private Limited , Bangalore, Karnataka, India .
FAU - Majeed, Shaheen
AU  - Majeed S
AD  - 1 Sami Labs Limited , Bangalore, Karnataka, India .
AD  - 2 Sabinsa Corporation , East Windsor, New Jersey, USA.
AD  - 3 Sabinsa Corporation , Payson, Utah, USA.
FAU - Nagabhushanam, Kalyanam
AU  - Nagabhushanam K
AD  - 2 Sabinsa Corporation , East Windsor, New Jersey, USA.
FAU - Arumugam, Sivakumar
AU  - Arumugam S
AD  - 1 Sami Labs Limited , Bangalore, Karnataka, India .
FAU - Pande, Anurag
AU  - Pande A
AD  - 2 Sabinsa Corporation , East Windsor, New Jersey, USA.
FAU - Paschapur, Mahesh
AU  - Paschapur M
AD  - 1 Sami Labs Limited , Bangalore, Karnataka, India .
FAU - Ali, Furqan
AU  - Ali F
AD  - 1 Sami Labs Limited , Bangalore, Karnataka, India .
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20180829
PL  - United States
TA  - J Med Food
JT  - Journal of medicinal food
JID - 9812512
RN  - 0 (Enzymes)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Double-Blind Method
MH  - Dyspepsia/metabolism/*therapy
MH  - *Enzyme Therapy
MH  - Enzymes/*administration & dosage/adverse effects/chemistry
MH  - Female
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - Surveys and Questionnaires
MH  - Young Adult
PMC - PMC6249666
OTO - NOTNLM
OT  - digestive enzymes
OT  - dyspeptic symptoms
OT  - functional dyspepsia
OT  - multienzyme complex
OT  - nonulcer dyspepsia
OT  - safety and efficacy
COIS- The authors are founder/employees of Sami/Sabinsa that manufacture and market 
      DigeZyme((R)).
EDAT- 2018/08/30 06:00
MHDA- 2019/01/23 06:00
PMCR- 2018/11/15
CRDT- 2018/08/30 06:00
PHST- 2018/08/30 06:00 [pubmed]
PHST- 2019/01/23 06:00 [medline]
PHST- 2018/08/30 06:00 [entrez]
PHST- 2018/11/15 00:00 [pmc-release]
AID - 10.1089/jmf.2017.4172 [pii]
AID - 10.1089/jmf.2017.4172 [doi]
PST - ppublish
SO  - J Med Food. 2018 Nov;21(11):1120-1128. doi: 10.1089/jmf.2017.4172. Epub 2018 Aug 
      29.