Title: Comparison of vonoprazan dual therapy, quadruple therapy and standard quadruple
therapy for Helicobacter pylori infection in Hainan: A single- center, open-label, non-inferiority,
randomized controlled trial
Version: 1 Date: 09 Feb 2024
Reviewer's report:
This study investigated H. pylori eradication outcomes with vonoprazan-based dual and
quadruple therapies compared to conventional PPI quadruple therapy. The concept is interesting,
but there are some concerns. Please refer to the following comments.
1. This study seems to compare three treatment groups with a chi-square test. I do not think
that this result supports the conclusion that “VPZ dual therapy or quadruple therapy was found
to be equally effective and safer and less costly than standard quadruple therapy”. The “not
significant difference between the 3 groups” does not mean equal treatment efficacy. To indicate
the outcome, an appropriate non-inferiority test (with multiple testing corrections) between V1
vs V2 and V2 vs V3 is needed.
2. The one-side alpha level of 0.1 is generally insufficient. This level means that the outcomes
are evaluated at 80% CI. So, it has a higher Type I error.
3. This study compares three treatment groups. Multiple testing corrections (e.g., Bonferroni or
Benjamini-Hochberg) are needed to indicate appropriate outcomes.
4. Which methods were used for confirming H. pylori infection at the study registration (i.g.
rapid urease test, culture, antibody test, stool antigen, or others)? As the diagnostic accuracy
differs a little bit between the methods, it potentially affects the treatment outcomes in each
group. Used methods in each group should be shown.
5. There are some representative articles worldwide related to this topic (Gut.
2020;69(6):1019-1026. Gastroenterology. 2022;163(3):608-619.), but why did the authors refer
to only studies from China? Scientific articles in English have been published worldwide. So,
the authors should mention and discuss with international studies.
Title: Comparison of vonoprazan dual therapy, quadruple therapy and standard quadruple
therapy for Helicobacter pylori infection in Hainan: A single- center, open-label, non-inferiority,
randomized controlled trial
Version: 1 Date: 09 Feb 2024
Reviewer's report:
This study investigated H. pylori eradication outcomes with vonoprazan-based dual and
quadruple therapies compared to conventional PPI quadruple therapy. The concept is interesting,
but there are some concerns. Please refer to the following comments.
1. This study seems to compare three treatment groups with a chi-square test. I do not think
that this result supports the conclusion that “VPZ dual therapy or quadruple therapy was found
to be equally effective and safer and less costly than standard quadruple therapy”. The “not
significant difference between the 3 groups” does not mean equal treatment efficacy. To indicate
the outcome, an appropriate non-inferiority test (with multiple testing corrections) between V1
vs V2 and V2 vs V3 is needed.
2. The one-side alpha level of 0.1 is generally insufficient. This level means that the outcomes
are evaluated at 80% CI. So, it has a higher Type I error.
3. This study compares three treatment groups. Multiple testing corrections (e.g., Bonferroni or
Benjamini-Hochberg) are needed to indicate appropriate outcomes.
4. Which methods were used for confirming H. pylori infection at the study registration (i.g.
rapid urease test, culture, antibody test, stool antigen, or others)? As the diagnostic accuracy
differs a little bit between the methods, it potentially affects the treatment outcomes in each
group. Used methods in each group should be shown.
5. There are some representative articles worldwide related to this topic (Gut.
2020;69(6):1019-1026. Gastroenterology. 2022;163(3):608-619.), but why did the authors refer
to only studies from China? Scientific articles in English have been published worldwide. So,
the authors should mention and discuss with international studies.
Please review this paper.
user
Title: Comparison of vonoprazan dual therapy, quadruple therapy and standard quadruple
therapy for Helicobacter pylori infection in Hainan: A single- center, open-label, non-inferiority,
randomized controlled trial
Version: 1 Date: 09 Feb 2024
Reviewer's report:
This study investigated H. pylori eradication outcomes with vonoprazan-based dual and
quadruple therapies compared to conventional PPI quadruple therapy. The concept is interesting,
but there are some concerns. Please refer to the following comments.
1. This study seems to compare three treatment groups with a chi-square test. I do not think
that this result supports the conclusion that “VPZ dual therapy or quadruple therapy was found
to be equally effective and safer and less costly than standard quadruple therapy”. The “not
significant difference between the 3 groups” does not mean equal treatment efficacy. To indicate
the outcome, an appropriate non-inferiority test (with multiple testing corrections) between V1
vs V2 and V2 vs V3 is needed.
2. The one-side alpha level of 0.1 is generally insufficient. This level means that the outcomes
are evaluated at 80% CI. So, it has a higher Type I error.
3. This study compares three treatment groups. Multiple testing corrections (e.g., Bonferroni or
Benjamini-Hochberg) are needed to indicate appropriate outcomes.
4. Which methods were used for confirming H. pylori infection at the study registration (i.g.
rapid urease test, culture, antibody test, stool antigen, or others)? As the diagnostic accuracy
differs a little bit between the methods, it potentially affects the treatment outcomes in each
group. Used methods in each group should be shown.
5. There are some representative articles worldwide related to this topic (Gut.
2020;69(6):1019-1026. Gastroenterology. 2022;163(3):608-619.), but why did the authors refer
to only studies from China? Scientific articles in English have been published worldwide. So,
the authors should mention and discuss with international studies.
assistant