Reply to the letter by Dr Graham concerning ethical and interpretation issues with vonoprazan-containing H. pylori eradication therapy

We thank Dr Graham for his interest in our article.1 2 In Japan, 7 days administration of PPI+amoxicillin+clarithromycin is standard treatment for Helicobacter pylori eradication3 and is the only approved treatment as first-line therapy in Japan. Therefore, there is no ethical issue in increasing sample size to match the current eradication rate. In a blinded interim analysis, the overall eradication rate was 81.6%, which was a lower rate than 90% that we used in the initial sample size estimation. However, at the time, it was difficult to determine whether this was due to a difference between a high eradication rate of vonoprazan-based triple therapy and a low eradication rate of lansoprazole-based triple therapy or due to the eradication rates for both treatment regimens being identical. Once again, given that we used the approved first-line treatment for H. pylori eradication in Japan as our comparator...
Source: Gut - Category: Gastroenterology Authors: Tags: PostScript Source Type: research