Reviewer's report
Title:Efficacy of omeprazole, famotidine, mosapride and teprenone in patients
with upper gastrointestinal symptoms: an omeprazole-controlled randomized
study (J-FOCUS)
Version: 3Date:28 October 2011
Reviewer: Grigorios Leontiadis
Reviewer's report:
The authors have adequately responded to the points, with the exception of
points #5, 6 and 8. Please see my comments below:
Point # 5. (Urine antibody testing is not a valid method to test for H. pylori
infection. Were all patients tested for H. pylori or only a proportion of them?)
Response to authors’ response: Urine antibody testing is FDA approved, but if
the authors cannot identify national or international guidelines that recommend
this test as a diagnostic test in clinical practice, they should add the choice of test
in the list of study limitations.
Point #6. (One of the exclusion criteria was when a patient was “judged to be
ineligible for study entry by the investigator”. This is vague and subjective and
does not allow comparison of the results of the current study with previous or
future studies. It also undermines the generaliseablity of the results in clinical
practice. How can the clinicians be sure that their patients are similar to the study
population if one exclusion criterion is not defined?)
Response to authors’ response: I do not agree that this is a common criterion in
clinical trials, at least not in high quality trials. The purpose of having pre-defined
and well-defined inclusion criteria is to minimize subjectivity during eligibility
assessment; this purpose is defeated when an additional exclusion criterion
named “judged to be ineligible for study entry by the investigator” is used. The
authors should elaborate on this in the discussion of study limitations.
Point # 8. (What measures were taken to maintain concealment of allocation
prior to study entry?)
Response to authors’ response: The authors’ response is not relevant to the
question. The authors are advised to read the article: Schulz, K.F., Grimes, D.A.
(2002). Allocation concealment in randomised trials: Defending against
deciphering. The Lancet, 359(9306), 614-618. This explains what allocation
concealment is and what is meant by measures taken to maintain it. The revised
response to point #8 should be included in the article.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I have acted as a consultant for AstraZeneca and Axcan Pharma and have
received speaking honoraria from AstraZeneca, Sanofi-Aventis, Janssen-Cilag,
and GlaxoSmithKline
Reviewer's report
Title:Efficacy of omeprazole, famotidine, mosapride and teprenone in patients
with upper gastrointestinal symptoms: an omeprazole-controlled randomized
study (J-FOCUS)
Version: 3Date:28 October 2011
Reviewer: Grigorios Leontiadis
Reviewer's report:
The authors have adequately responded to the points, with the exception of
points #5, 6 and 8. Please see my comments below:
Point # 5. (Urine antibody testing is not a valid method to test for H. pylori
infection. Were all patients tested for H. pylori or only a proportion of them?)
Response to authors’ response: Urine antibody testing is FDA approved, but if
the authors cannot identify national or international guidelines that recommend
this test as a diagnostic test in clinical practice, they should add the choice of test
in the list of study limitations.
Point #6. (One of the exclusion criteria was when a patient was “judged to be
ineligible for study entry by the investigator”. This is vague and subjective and
does not allow comparison of the results of the current study with previous or
future studies. It also undermines the generaliseablity of the results in clinical
practice. How can the clinicians be sure that their patients are similar to the study
population if one exclusion criterion is not defined?)
Response to authors’ response: I do not agree that this is a common criterion in
clinical trials, at least not in high quality trials. The purpose of having pre-defined
and well-defined inclusion criteria is to minimize subjectivity during eligibility
assessment; this purpose is defeated when an additional exclusion criterion
named “judged to be ineligible for study entry by the investigator” is used. The
authors should elaborate on this in the discussion of study limitations.
Point # 8. (What measures were taken to maintain concealment of allocation
prior to study entry?)
Response to authors’ response: The authors’ response is not relevant to the
question. The authors are advised to read the article: Schulz, K.F., Grimes, D.A.
(2002). Allocation concealment in randomised trials: Defending against
deciphering. The Lancet, 359(9306), 614-618. This explains what allocation
concealment is and what is meant by measures taken to maintain it. The revised
response to point #8 should be included in the article.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I have acted as a consultant for AstraZeneca and Axcan Pharma and have
received speaking honoraria from AstraZeneca, Sanofi-Aventis, Janssen-Cilag,
and GlaxoSmithKline
Please review this paper.
user
Reviewer's report
Title:Efficacy of omeprazole, famotidine, mosapride and teprenone in patients
with upper gastrointestinal symptoms: an omeprazole-controlled randomized
study (J-FOCUS)
Version: 3Date:28 October 2011
Reviewer: Grigorios Leontiadis
Reviewer's report:
The authors have adequately responded to the points, with the exception of
points #5, 6 and 8. Please see my comments below:
Point # 5. (Urine antibody testing is not a valid method to test for H. pylori
infection. Were all patients tested for H. pylori or only a proportion of them?)
Response to authors’ response: Urine antibody testing is FDA approved, but if
the authors cannot identify national or international guidelines that recommend
this test as a diagnostic test in clinical practice, they should add the choice of test
in the list of study limitations.
Point #6. (One of the exclusion criteria was when a patient was “judged to be
ineligible for study entry by the investigator”. This is vague and subjective and
does not allow comparison of the results of the current study with previous or
future studies. It also undermines the generaliseablity of the results in clinical
practice. How can the clinicians be sure that their patients are similar to the study
population if one exclusion criterion is not defined?)
Response to authors’ response: I do not agree that this is a common criterion in
clinical trials, at least not in high quality trials. The purpose of having pre-defined
and well-defined inclusion criteria is to minimize subjectivity during eligibility
assessment; this purpose is defeated when an additional exclusion criterion
named “judged to be ineligible for study entry by the investigator” is used. The
authors should elaborate on this in the discussion of study limitations.
Point # 8. (What measures were taken to maintain concealment of allocation
prior to study entry?)
Response to authors’ response: The authors’ response is not relevant to the
question. The authors are advised to read the article: Schulz, K.F., Grimes, D.A.
(2002). Allocation concealment in randomised trials: Defending against
deciphering. The Lancet, 359(9306), 614-618. This explains what allocation
concealment is and what is meant by measures taken to maintain it. The revised
response to point #8 should be included in the article.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I have acted as a consultant for AstraZeneca and Axcan Pharma and have
received speaking honoraria from AstraZeneca, Sanofi-Aventis, Janssen-Cilag,
and GlaxoSmithKline
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