Review for 10.1186/s12876-020-01410-z (2020)

Reviewer’ s report
Title: Efficacy of a High-Dose Proton Pump Inhibitor in Patients with Gastroesophageal Reflux
Disease: A Single Center, Randomized, Open-Label Trial
Version: 0Date: 16 May 2020
Reviewer's report:
In this manuscript the authors address a common problem of extra-GI manifestations of GERD,
which have been addressed even earlier by several groups. Therefore, any new study to impact thepractice patterns will have to be done in a very stringent manner keeping in the view the highestquality standards. Unfortunately, in my view, the current study does not fulfil these criteria.Following are my major concerns.1. The primary outcome measure was evaluated in a subjective manner, which can result in bias inthe final results.2. How was the sample size determined? Authors have not mentioned any sample size calculationrationale and process in the manuscript.3. It would have been more meaningful had the authors conducted this a double blinded study.4. Authors have conducted a per protocol analyses. However, due to a high number of consentwithdrawal and drop outs, per protocol analyses is bound to give falsely higher proportion ofimprovement. Therefore it was mandatory to conduct a intention to treat analyses.
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
No
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the authors.
YesAre the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
NoAre you able to assess any statistics in the manuscript or would you recommend an
additional statistical review?If an additional statistical review is recommended, please specify what aspects require furtherassessment in your comments to the editors.
I am able to assess the statistics
Quality of written English
Please indicate the quality of language in the manuscript:
Needs some language corrections before being publishedDeclaration of competing interests
Please complete a declaration of competing interests, considering the following questions:
1. Have you in the past five years received reimbursements, fees, funding, or salary from an
organisation that may in any way gain or lose financially from the publication of this
manuscript, either now or in the future?
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose
financially from the publication of this manuscript, either now or in the future?
3. Do you hold or are you currently applying for any patents relating to the content of the
manuscript?
4. Have you received reimbursements, fees, funding, or salary from an organization that holds
or has applied for patents relating to the content of the manuscript?
5. Do you have any other financial competing interests?6. Do you have any non-financial competing interests in relation to this paper?
If you can answer no to all of the above, write 'I declare that I have no competing interests' below.
If your reply is yes to any, please give details below.
None
Reviewer Publication Consent. I agree for my report to be made available under an Open Access
Creative Commons CC-BY License (http://creativecommons.org/licenses/by/4.0) if this manu-script is accepted for publication. Any comments that I do not wish to be included in the publishedreport have been included as confidential comments to the editor, which will not be published.Ifyou are not happy for us to publish this report, please contact the editorial office before completingthe review.If you wish, you can include your name in your published report. Please note you mustdecide whether to include your name at the start of the process and confirm this decision wheneverprompted. If you change your decision later, we will not be able to publish your name.
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