Review for 10.1186/s12876-021-01680-1 (2021)

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: 
1 
Date: 
01 Nov 2020
Reviewer's report:
Reviewer comment
Kim et al. have revised the original article in 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". Their revised manuscript answered the
query from reviewer. However, there is a minor suggestion as below.
.
The major comments
2. Bismuth-containing quadruple therapy usually used for the 2nd line therapy
for H. pylori eradication. The idea for changing it to the first line reagent is
novel. However, based on the result of ITT (74.3%) and high adverse (23.1%) of
BQT, it seems to be hard to accept for the first line therapy.
Author Response: The low eradication rate in the ITT analysis was mainly due
to the high rate (15.9%) of participants who declined to participate in the trial or
were lost to follow-up after randomization. Meanwhile, eradication rates of the
10-day BQT were 87.2% in the modified ITT analysis and 92.9% in the per-
protocol analysis, which were acceptable eradication rates.
The participants who treated by the BQT had a higher proportion of those who
discontinued the assigned drugs (23.1%) due to adverse events than those treated
by the STT. However, there is no serious adverse event related to the BQT, and
the eradication rate of the 10-day BQT remained high as much as 83%, even in
participants who consumed only 50%~80% of the study drugs probably due to
adverse event. Therefore, the 10-day BQT could be an alternative empirical first
line therapy in Korea. 
Q1: Because the participants who treated by the BQT had a higher proportion of
those who discontinued the assigned drugs (23.1%) due to adverse events than
those treated by the STT. Although there was no serious adverse event related to
the BQT, these side effects resulted in poor compliance. I strongly suggest
authors need to add a short statement in the "Discussion section" regarding how
to overcome this problem. For example, adding probiotics or modifying drug
composition. Afterward the readers can agree that the 10-day BQT therapy is the
choice for the first-line eradication therapy in Korea.
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