Effectiveness and Safety of High-Dose Dual Therapy: Results of the European Registry on the Management of Helicobacterpylori Infection (Hp-EuReg)

Round 1

Reviewer 1 Report

The authors evaluated the effectiveness of High Dose Dual Therapy for the management of H. pylori infection. I agree with the findings and quality of data presented.

The introduction can be presented little better by showing details of studies from Asian countries in the effectiveness of HDDT while no such study done in Europe. This will increase the strength of the paper.

Author Response

We thank the reviewer for the suggestion. We have remarked in the Introduction section that some meta-analyses from Asian countries show a high HDDT efficacy which is equivalent or even superior to other recommended therapies. Also, additional detailed information is shown in the Discussion section.

 

Reviewer 2 Report

In this study, the authors investigated the eradication rate of high-dose dual therapy (HDDT) using European Registry (Hp-EuReg) data. Unlike Asian data, the eradication success rate of HDDT is much lower than expected, and the eradication rate was lower in rescue treatment than first-line treatment. These results may be important to establish treatment strategy for the management of H. pylori infection in European country. However, there are some important considerations.

 

1. The study population included patients receiving HDDT (amoxicillin plus PPI) with or without bismuth. In addition, PPI dosing schedules varied, including standard or low potency of acid suppression. I disagree with the authors that this study was based on data from homogeneously treated patients (Lines 299-333), and it would be beneficial to analyze more homogeneous data that fall within the definition of HDDT, even with a smaller number of patients included.

2. Otherwise, as the authors mentioned in the Discussion section (Lines 237-238, 241-242), comparison of eradication rate according to acid suppression potency or treatment duration would be informative.

3. What kind of tests were used for the confirmation of treatment success (Lines 120-122)? As urea breath test or stool antigen test are recommended after H. pylori eradication, detailed description regarding confirmation of treatment success is necessary.

4. Eradication success rate was analyzed according to three analysis sets: ITT, modified ITT, and PP sets. However, there was only one patients whose compliance was less than 90%, and modified ITT and PP sets are almost same. In addition, this study was based on the retrospective analysis of prospectively collected data. It is recommended to show flow chart of the study instead of using multiple analysis sets.

5. It seems that Table 1 provides little information on the subject of this study.

6. In Table 2, the title of the left column (naïve patients) should be corrected (rescue patients). Also, right column (overall) does not seem necessary because only the denominator is different compared to the left column.

7. In Table 3, data of ITT analysis (HDDT overall) should be corrected (28/60).

Author Response

Please see the attachment

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

The authors addressed responses to the reviewer's comments well, and the manuscript has been improved through revision.

1. Figure 1: It seems that exclusion of patients with compliance <90% should appear at the lower level of the flowchart. For better understanding, it would be also helpful to show each set of analysis set (ITT, mITT, and PP) and its corresponding number of patients step by step.

 

2. Table 1: If it is necessary, data can be shown as supplementary.

Author Response

Please see the attachment

Author Response File: Author Response.docx