Reviewer's report
Title:Efficacy and tolerability of alpha galactosidase in treating gas-related
symptoms in children: a randomized, double-blind, placebo controlled trial.
Version: 4Date:9 May 2013
Reviewer: Bridget Southwell
Reviewer's report:
Major Compulsory Revisions
the authors have responded to most of the questions from the reviewers well,
however I would still like a little more detail added to the manuscript.
The results of the study are very borderline for significance. I think it is worth
publishing but only if the data are clearly shown so that people can decide if they
think it is worth pursuing.
The authors have modified table 1 and included ns for the p value. Please
change this to list each p value.
Please add bloating to table 1 to give a context for table 3.
In the answer to question 3 reviewer 1, you have included a graph. please
suppply a figure legend to make it possible to understand the graph, please
explain the symbols- which is pre and which is post. then it would be useful to
add this to the manuscript.
Please add to the results section of the manuscript- how many patients in each
group improved pain by more than 0.5 units, how many had pain worsen by more
than 0.5 units. Then relate this to the improvement reported by the clinician at
followup.
on page 4 line 21 and 22 - 'The primary endpoint was reduction......Secondary
endpoints were.....'. The endpoint is when will the trial/study be considered to be
finished. I think a reduction in FPS_R at the end of treatment compared to
baseline is the 'primary outcome measure', The reduction in proportion of
patients with relevant symptoms is the 'secondary outcome measure'.
Minor Essential Revisions
page 8 line 7 insert 'of'- ...identify groups 'of' patients who are more likely to
respond.....
page 8 line 8, change 'in which' to 'in whom'.
page 8 line 8, add commas- .....recgonise children in whom, based on the
medical history, food appears......
page 9 line 7 add 's' after 'tend'
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Reviewer's report
Title:Efficacy and tolerability of alpha galactosidase in treating gas-related
symptoms in children: a randomized, double-blind, placebo controlled trial.
Version: 4Date:9 May 2013
Reviewer: Bridget Southwell
Reviewer's report:
Major Compulsory Revisions
the authors have responded to most of the questions from the reviewers well,
however I would still like a little more detail added to the manuscript.
The results of the study are very borderline for significance. I think it is worth
publishing but only if the data are clearly shown so that people can decide if they
think it is worth pursuing.
The authors have modified table 1 and included ns for the p value. Please
change this to list each p value.
Please add bloating to table 1 to give a context for table 3.
In the answer to question 3 reviewer 1, you have included a graph. please
suppply a figure legend to make it possible to understand the graph, please
explain the symbols- which is pre and which is post. then it would be useful to
add this to the manuscript.
Please add to the results section of the manuscript- how many patients in each
group improved pain by more than 0.5 units, how many had pain worsen by more
than 0.5 units. Then relate this to the improvement reported by the clinician at
followup.
on page 4 line 21 and 22 - 'The primary endpoint was reduction......Secondary
endpoints were.....'. The endpoint is when will the trial/study be considered to be
finished. I think a reduction in FPS_R at the end of treatment compared to
baseline is the 'primary outcome measure', The reduction in proportion of
patients with relevant symptoms is the 'secondary outcome measure'.
Minor Essential Revisions
page 8 line 7 insert 'of'- ...identify groups 'of' patients who are more likely to
respond.....
page 8 line 8, change 'in which' to 'in whom'.
page 8 line 8, add commas- .....recgonise children in whom, based on the
medical history, food appears......
page 9 line 7 add 's' after 'tend'
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Please review this paper.
user
Reviewer's report
Title:Efficacy and tolerability of alpha galactosidase in treating gas-related
symptoms in children: a randomized, double-blind, placebo controlled trial.
Version: 4Date:9 May 2013
Reviewer: Bridget Southwell
Reviewer's report:
Major Compulsory Revisions
the authors have responded to most of the questions from the reviewers well,
however I would still like a little more detail added to the manuscript.
The results of the study are very borderline for significance. I think it is worth
publishing but only if the data are clearly shown so that people can decide if they
think it is worth pursuing.
The authors have modified table 1 and included ns for the p value. Please
change this to list each p value.
Please add bloating to table 1 to give a context for table 3.
In the answer to question 3 reviewer 1, you have included a graph. please
suppply a figure legend to make it possible to understand the graph, please
explain the symbols- which is pre and which is post. then it would be useful to
add this to the manuscript.
Please add to the results section of the manuscript- how many patients in each
group improved pain by more than 0.5 units, how many had pain worsen by more
than 0.5 units. Then relate this to the improvement reported by the clinician at
followup.
on page 4 line 21 and 22 - 'The primary endpoint was reduction......Secondary
endpoints were.....'. The endpoint is when will the trial/study be considered to be
finished. I think a reduction in FPS_R at the end of treatment compared to
baseline is the 'primary outcome measure', The reduction in proportion of
patients with relevant symptoms is the 'secondary outcome measure'.
Minor Essential Revisions
page 8 line 7 insert 'of'- ...identify groups 'of' patients who are more likely to
respond.....
page 8 line 8, change 'in which' to 'in whom'.
page 8 line 8, add commas- .....recgonise children in whom, based on the
medical history, food appears......
page 9 line 7 add 's' after 'tend'
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
assistant