Reviewer's report
Title:A prospective, randomized, double-blind, placebo-controlled parallel-group
dual site trial to evaluate the effects of a Bacillus coagulans-based product on
functional intestinal gas symptoms
Version: 3Date:14 August 2009
Reviewer: Carl J Lombard
Reviewer's report:
The description of the experimental design of the study has been improved.
In the abstract the p-value for the GSRS total score is given as p=.055. From the
text and table 2 this should be p=.048.
There is no descriptive information on four of the scores for which an efficacy
analysis was done. SODA: Non-pain symtoms score, satisdaction score, SF
36v2 Physical and Mental components. As a minimum the baseline values in
each arm should be given. Allthough not significant this information will be useful
as planning information for other studies
The recommendation of doing a profile analysis over time (weks 2 and 4 with
week 0 as covariate) still stands. The authors make a comments on the large
within-group variability over time but ignores the potential of doing an analysis
that will offset this. One can still report the efficacy at 4 weeks as required by the
protocl but the standard errors used for this comparison will have the benefit of
the extra information contained in the 2 week measurement. From the details in
the manuscript the 2 week measurements were done in the same way as at 4
weeks and with the same rigor.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Reviewer's report
Title:A prospective, randomized, double-blind, placebo-controlled parallel-group
dual site trial to evaluate the effects of a Bacillus coagulans-based product on
functional intestinal gas symptoms
Version: 3Date:14 August 2009
Reviewer: Carl J Lombard
Reviewer's report:
The description of the experimental design of the study has been improved.
In the abstract the p-value for the GSRS total score is given as p=.055. From the
text and table 2 this should be p=.048.
There is no descriptive information on four of the scores for which an efficacy
analysis was done. SODA: Non-pain symtoms score, satisdaction score, SF
36v2 Physical and Mental components. As a minimum the baseline values in
each arm should be given. Allthough not significant this information will be useful
as planning information for other studies
The recommendation of doing a profile analysis over time (weks 2 and 4 with
week 0 as covariate) still stands. The authors make a comments on the large
within-group variability over time but ignores the potential of doing an analysis
that will offset this. One can still report the efficacy at 4 weeks as required by the
protocl but the standard errors used for this comparison will have the benefit of
the extra information contained in the 2 week measurement. From the details in
the manuscript the 2 week measurements were done in the same way as at 4
weeks and with the same rigor.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:A prospective, randomized, double-blind, placebo-controlled parallel-group
dual site trial to evaluate the effects of a Bacillus coagulans-based product on
functional intestinal gas symptoms
Version: 3Date:14 August 2009
Reviewer: Carl J Lombard
Reviewer's report:
The description of the experimental design of the study has been improved.
In the abstract the p-value for the GSRS total score is given as p=.055. From the
text and table 2 this should be p=.048.
There is no descriptive information on four of the scores for which an efficacy
analysis was done. SODA: Non-pain symtoms score, satisdaction score, SF
36v2 Physical and Mental components. As a minimum the baseline values in
each arm should be given. Allthough not significant this information will be useful
as planning information for other studies
The recommendation of doing a profile analysis over time (weks 2 and 4 with
week 0 as covariate) still stands. The authors make a comments on the large
within-group variability over time but ignores the potential of doing an analysis
that will offset this. One can still report the efficacy at 4 weeks as required by the
protocl but the standard errors used for this comparison will have the benefit of
the extra information contained in the 2 week measurement. From the details in
the manuscript the 2 week measurements were done in the same way as at 4
weeks and with the same rigor.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
assistant