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We thank Dr Graham and Dr Yamaoka for their interest in our recent publication comparing the efficacy of 1 and 2 weeks of triple therapy for the eradication of Helicobacter pylori. They ask about the information given to the patients concerning the dual therapy arm (omeprazole and amoxicillin) with a known low efficacy. As explained in our paper, this arm was included both as a measure of the internal validity of the study and as part of a second long‐term follow‐up study. Each patient was provided, both verbally and via a written information form, with complete details of the treatments, objectives, possible risks and benefits of the study, and informed consent was obtained from all participants. The full versions of the information form and the informed consent form completed by all participants were approved by the ethical committee of each participating centre. The patients with treatment failure received triple therapy at any time during the study if they asked for it, or at the end of the study if they did not wish to be enrolled in the follow‐up study. Those who were enrolled in the second study received triple therapy at the end of follow‐up or if the ulcer recurred. Furthermore, during the trial, we used a dual therapy with amoxicillin and not with clarithromycin so that in the case of treatment failure, clarithromycin‐based triple therapy could be subsequently used without the risk of acquired resistance to clarithromycin and consequent reduced efficacy.1
Dr Graham and Dr Yamaoka also suggest that rather than focusing on the similar efficacy of 1 and 2 weeks of triple therapy, we should have highlighted that the efficacy of this therapy is “unacceptably low”, regardless of its duration. As we discuss in our paper, the eradication rates obtained in our study (1 week of triple therapy intent to treat 79.7%, per protocol 83.6%; 2 weeks of triple therapy intent to treat 81.7%, per protocol 84.9%) add to the body of evidence showing that the efficacy of triple therapy has undoubtedly decreased in recent years. However, these are not substantially below the threshold of 80% defined by the Maastricht III Consensus Report as clinically unacceptable for the treatment of H pylori infection.2 Moreover, triple therapy, referred to by Dr Graham and Dr Yamaoka as a “legacy” treatment, is the treatment recommended by the Maastricht III Consensus Report. Dr Graham is himself one of the authors of this report. We must agree with this recent recommendation, at least until the higher efficacy demonstrated for new treatments3 has been confirmed by other investigators and in large studies in different regions worldwide.
We argue that the importance of our study lies rather in its large sample size and demonstration that extending the duration of triple therapy from 1 to 2 weeks does not significantly increase the rate of H pylori eradication (the difference in eradication rate between 1 and 2 weeks of triple therapy was 2%; 95% CI −4% to 8%). Our trial involved a large number of centres (n=81) in the south, centre and north of Italy, and so patients were recruited from a broad population, providing a good basis for the generalisation of results. Before our study, two meta‐analyses reported that compared with 1 week of treatment, 2 weeks of triple therapy increases the eradication rate by 9–12%.4,5 However, although the results of meta‐analyses are relevant, they cannot substitute for large clinical trials. Indeed, in their meta‐analysis, Calvet et al4 specifically mentioned that their results suggest that larger studies comparing 1 and 2 weeks of therapy are needed. We think that our study has addressed this need.
Competing interests: RMZ has received reimbursement from Janssen‐Cilag and Abbot for attending symposia, and fees for speaking from AstraZeneca, Takeda and Abbott. FB has received fees for speaking from AstraZeneca and Takeda, reimbursement for organising education from Altana and has carried out consultancy work for AstraZeneca.