Reply to the letter to the editor by Ramos-Quiroga et al.

摘要

We have read the letter written by Ramos-Quiroga et al., in which the authors make a methodological critique of our recent paper, based on two issues: the use of all-cause treatment discontinuation as the main outcome of the study, and the measurement of the clinical efficacy of atomoxetine by means of the standardized mean difference (SMD). We aim to address their critiques in the present letter.The authors of the letter argue that all-cause treatment discontinuation, despite being a valid endpoint in the real-world setting, should not be considered a risk: benefit endpoint because it does not represent a primary outcome in randomized placebo controlled clinical trials (RPCCT), is not included in the European Medicines Agency guidelines for the investigation and clinical assessment of the risk:benefit of medicinal products1 and has never been used or accepted by any regulatory agency as a risk: benefit measure. We partially agree with the observations made but not with the conclusion the authors draw from them.