Reviewer's report
Title:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromeA
randomized group sequential trial
Version: 3Date:22 March 2011
Reviewer: Carl J Lombard
Reviewer's report:
The authors have re-written the manuscript to make it clear that it is the results of
a comparative trial that is being reported. Comparative between two compounds.
Looking at the title of reference 18 made the design clear to me: answering the
question which of the compounds is the best? The word comparative might be
included in the title : a randomized group sequential comparative trial
The description of the stopping boundary and test statistics is fine. Once the
boundary is crossed in the study we can say that the one compund is
significantly better than the other with some p-value. The comments that was not
addressed is the answer to: how much better? The effect size or difference
between the compounds is 22%. You have to provide the estimate and its
appropriate confidence interval since this is the main result of the trial. The
problem you face is the correct calculation of the confidence interval since this is
not a SSD but a sequential design in which you had three looks and then
stopped the study.
You provide the symptom score at baseline were it is good enough for
information purposes but it is not provided for the post randomisation time point.
Your main outcome is based on this and the descriptive statistics of the post
score will be useful for other researchers planning other studies.
P-values should no be reported for baseline comparisons since the difference
observed is known to be due to chance only- the effect you achieved by
randomisation.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
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:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromeA
randomized group sequential trial
Version: 3Date:22 March 2011
Reviewer: Carl J Lombard
Reviewer's report:
The authors have re-written the manuscript to make it clear that it is the results of
a comparative trial that is being reported. Comparative between two compounds.
Looking at the title of reference 18 made the design clear to me: answering the
question which of the compounds is the best? The word comparative might be
included in the title : a randomized group sequential comparative trial
The description of the stopping boundary and test statistics is fine. Once the
boundary is crossed in the study we can say that the one compund is
significantly better than the other with some p-value. The comments that was not
addressed is the answer to: how much better? The effect size or difference
between the compounds is 22%. You have to provide the estimate and its
appropriate confidence interval since this is the main result of the trial. The
problem you face is the correct calculation of the confidence interval since this is
not a SSD but a sequential design in which you had three looks and then
stopped the study.
You provide the symptom score at baseline were it is good enough for
information purposes but it is not provided for the post randomisation time point.
Your main outcome is based on this and the descriptive statistics of the post
score will be useful for other researchers planning other studies.
P-values should no be reported for baseline comparisons since the difference
observed is known to be due to chance only- the effect you achieved by
randomisation.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
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:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromeA
randomized group sequential trial
Version: 3Date:22 March 2011
Reviewer: Carl J Lombard
Reviewer's report:
The authors have re-written the manuscript to make it clear that it is the results of
a comparative trial that is being reported. Comparative between two compounds.
Looking at the title of reference 18 made the design clear to me: answering the
question which of the compounds is the best? The word comparative might be
included in the title : a randomized group sequential comparative trial
The description of the stopping boundary and test statistics is fine. Once the
boundary is crossed in the study we can say that the one compund is
significantly better than the other with some p-value. The comments that was not
addressed is the answer to: how much better? The effect size or difference
between the compounds is 22%. You have to provide the estimate and its
appropriate confidence interval since this is the main result of the trial. The
problem you face is the correct calculation of the confidence interval since this is
not a SSD but a sequential design in which you had three looks and then
stopped the study.
You provide the symptom score at baseline were it is good enough for
information purposes but it is not provided for the post randomisation time point.
Your main outcome is based on this and the descriptive statistics of the post
score will be useful for other researchers planning other studies.
P-values should no be reported for baseline comparisons since the difference
observed is known to be due to chance only- the effect you achieved by
randomisation.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
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