Reviewer’s report
Title: 
Ten-day bismuth-containing quadruple therapy versus 7-day proton pump
inhibitor-clarithromycin containing triple therapy as first-line empirical therapy
for the Helicobacter pylori infection in Korea: A randomized open-label trial
Version: 
0 
Date: 
30 Jun 2020
Reviewer's report:
Comments to the Author:
In this randomized controlled trial, the authors evaluated 10-day bismuth
quadruple therapy (BQT) as compared with 7-day standard triple therapy (STT)
in the first-line Helicobacter pylori eradication. They found that 10-day BQT had
higher eradication rates than 7-day STT. This study is well design, well
conducted, and consequently, of scientific validity. The findings of this trial also
have clinical importance in the context of clinical practice in Korea. I have a
couple of minor comments.
1. Discussion, page 13, lines 18 - 21. 
"Because chronic gastritis is not an indication for H. pylori eradication in Korea
[5], the participants with chronic gastritis might not want to receive a study
therapy because of the concern of adverse events or changed their mind and
refused to continue participating in the clinical trial."
Please present whether the proportion of participants who withdrew or were lost
to follow-up after randomization differed according to indications for H. pylori
treatment.
2. Discussion, page 16, lines 15 - 16.
"Thus, we also performed the modified intention-to-treat analysis after excluding
those participants."
This sentence is somewhat confusing. It seems that modified intention-to-treat
(mITT) analysis was conducted 'because there were larger than expected number
of follow-up loss or withdrawal'. Please make clear whether mITT analysis was
planned in advance or conducted as ad hoc. If it was pre-planned, this sentence
should be revised because the authors expected 7% of loss and the actual number
was higher than this value. If it was conducted ad hoc, please state clearly that
mITT was an ad hoc analysis in the methods. 
Publons Reviewer Recognition
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review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
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for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the
authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Yes
Are 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 further assessment 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:
Acceptable
Declaration 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.
The first and corresponding authors are coauthors of my recent study.
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 manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the editorial
office before completing the review.
If you wish, you can include your name in your published report. Please note
you must decide whether to include your name at the start of the process and
confirm this decision whenever prompted. If you change your decision later, we
will not be able to publish your name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Reviewer’s report
Title: 
Ten-day bismuth-containing quadruple therapy versus 7-day proton pump
inhibitor-clarithromycin containing triple therapy as first-line empirical therapy
for the Helicobacter pylori infection in Korea: A randomized open-label trial
Version: 
0 
Date: 
30 Jun 2020
Reviewer's report:
Comments to the Author:
In this randomized controlled trial, the authors evaluated 10-day bismuth
quadruple therapy (BQT) as compared with 7-day standard triple therapy (STT)
in the first-line Helicobacter pylori eradication. They found that 10-day BQT had
higher eradication rates than 7-day STT. This study is well design, well
conducted, and consequently, of scientific validity. The findings of this trial also
have clinical importance in the context of clinical practice in Korea. I have a
couple of minor comments.
1. Discussion, page 13, lines 18 - 21. 
"Because chronic gastritis is not an indication for H. pylori eradication in Korea
[5], the participants with chronic gastritis might not want to receive a study
therapy because of the concern of adverse events or changed their mind and
refused to continue participating in the clinical trial."
Please present whether the proportion of participants who withdrew or were lost
to follow-up after randomization differed according to indications for H. pylori
treatment.
2. Discussion, page 16, lines 15 - 16.
"Thus, we also performed the modified intention-to-treat analysis after excluding
those participants."
This sentence is somewhat confusing. It seems that modified intention-to-treat
(mITT) analysis was conducted 'because there were larger than expected number
of follow-up loss or withdrawal'. Please make clear whether mITT analysis was
planned in advance or conducted as ad hoc. If it was pre-planned, this sentence
should be revised because the authors expected 7% of loss and the actual number
was higher than this value. If it was conducted ad hoc, please state clearly that
mITT was an ad hoc analysis in the methods. 
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the
authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Yes
Are 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 further assessment 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:
Acceptable
Declaration 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.
The first and corresponding authors are coauthors of my recent study.
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 manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the editorial
office before completing the review.
If you wish, you can include your name in your published report. Please note
you must decide whether to include your name at the start of the process and
confirm this decision whenever prompted. If you change your decision later, we
will not be able to publish your name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
Please review this paper.
user
Reviewer’s report
Title: 
Ten-day bismuth-containing quadruple therapy versus 7-day proton pump
inhibitor-clarithromycin containing triple therapy as first-line empirical therapy
for the Helicobacter pylori infection in Korea: A randomized open-label trial
Version: 
0 
Date: 
30 Jun 2020
Reviewer's report:
Comments to the Author:
In this randomized controlled trial, the authors evaluated 10-day bismuth
quadruple therapy (BQT) as compared with 7-day standard triple therapy (STT)
in the first-line Helicobacter pylori eradication. They found that 10-day BQT had
higher eradication rates than 7-day STT. This study is well design, well
conducted, and consequently, of scientific validity. The findings of this trial also
have clinical importance in the context of clinical practice in Korea. I have a
couple of minor comments.
1. Discussion, page 13, lines 18 - 21. 
"Because chronic gastritis is not an indication for H. pylori eradication in Korea
[5], the participants with chronic gastritis might not want to receive a study
therapy because of the concern of adverse events or changed their mind and
refused to continue participating in the clinical trial."
Please present whether the proportion of participants who withdrew or were lost
to follow-up after randomization differed according to indications for H. pylori
treatment.
2. Discussion, page 16, lines 15 - 16.
"Thus, we also performed the modified intention-to-treat analysis after excluding
those participants."
This sentence is somewhat confusing. It seems that modified intention-to-treat
(mITT) analysis was conducted 'because there were larger than expected number
of follow-up loss or withdrawal'. Please make clear whether mITT analysis was
planned in advance or conducted as ad hoc. If it was pre-planned, this sentence
should be revised because the authors expected 7% of loss and the actual number
was higher than this value. If it was conducted ad hoc, please state clearly that
mITT was an ad hoc analysis in the methods. 
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
No
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the
authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
Yes
Are 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 further assessment 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:
Acceptable
Declaration 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.
The first and corresponding authors are coauthors of my recent study.
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 manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the editorial
office before completing the review.
If you wish, you can include your name in your published report. Please note
you must decide whether to include your name at the start of the process and
confirm this decision whenever prompted. If you change your decision later, we
will not be able to publish your name.
I agree to the terms of the CC-BY 4.0 license; please 
do not
 publish my name
with my report. (default)
assistant