Review for 10.1186/1471-230X-9-85 (2009)

Reviewer's report
Title:A prospective, randomized, double-blind, placebo-controlled parallel-group
dual site trial to evaluate the effects of Gas Defense on intestinal gas symptoms
in otherwise healthy adults
Version: 2Date:30 June 2009
Reviewer: Sutep Gonlachanvit
Reviewer's report:
Comments to the authors
The authors study the effects of Bacillus coagulans plus an enzyme blend of
cellulases on postprandial intestinal gas symptoms. This study is of interested
since few research studies are available regarding the effects of Bacillus
coagulans on gastrointestinal symptoms.
Below are my major and minor comments to the authors for improving the
manuscript.
Major comments
Title:
1. The title “A prospective, randomized, double-blind, placebo-controlled parallel
group dual site trial to evaluate the effects of Gas Defense on intestinal gas
symptoms in otherwise healthy adults” is confusing.
The term “otherwise healthy adults”. What does it mean? If the authors try to
imply that this group of patients had no organic conditions the term “functional
intestinal gas symptoms” may be more appropriated.
2. In the title, the generic term eg. probiotic or Bacillus coagulans plus an enzyme
blend of cellulases should be used in stead of “Gas Defense”.
Background:
1. Should focus on the rational of Bacillus coagulans on the treatment of
intestinal gas symptoms.
Methods:
1. Patient population:
- The condition “self-reported post-meal intestinal gas-related symptoms in
otherwise healthy adults” was poorly defined. Was it functional dyspepsia
(post-prandial distress syndrome subgroup?) or an organic condition? The
authors should provide more information regarding inclusion criteria eg. severity
and duration of the symptoms and how organic and other specific functional
gastrointestinal conditions eg. biliary tract diseases, small bowel bacterial over
growth, functional dyspepsia, and ect. were excluded.
- Whether all patients underwent endoscopy, ultrasonography, or lactose
hydrogen breath test should be mentioned.
- Whether small bowel bacterial overgrowth patients were excluded and how
lactose intolerant patients were excluded eg. by using a symptom questionnaire
or a breath test should be clarified.
Statistical methods:
I’m not a statistician. This should be reviewed by an expert statistician.
Results and discussion:
1. The authors should provide baseline symptom profiles and scores of targeted
symptoms including abdominal pain, distention, bloating, flatus, and gas for
placebo and treatment group.
2. Why the blood pressure and heart rate results were important should be
discussed. If it is not important or not relevant to the treatment it should be
omitted or shortened.
Conclusions:
1. Should be shortened.
2. Should focus on the main finding and clinical relevance of the findings.
Writing:
The writing is difficult to understand with a lot of complex sentences.
Minor comments
1. Several parts in conclusions eg. para 1 and 2 should be moved to discussion.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Not suitable for publication unless extensively edited
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests