OBJECTIVE: Effective antisecretory drugs are available to treat GERD, and result in dramatic improvement of pyrosis over placebo. Assessing a similar improvement of HRQL would appear of value. METHOD: A critical appraisal of published controlled trials was performed using a checklist. RESULTS: Although trials comparing proton pump inhibitors (PPI) to placebo or to H2-blockers or cisapride showed a clinically significant difference in the rate of complete relief of pyrosis, none was able to show a clear and unbiased HRQL improvement. For each trial, several or all of the following issues that may help to have confidence in the results are not presented or are missing: justification of the choice of questionnaires; hypotheses of changes in HRQL scores and power estimation (even if HRQL assessment is a secondary endpoint); justification of the use of several questionnaires (are they covering different concepts?); statistical analysis plan; description and imputation of missing data, and intent to treat analysis (e.g. 408 patients among 599 randomized in a trial are analyzed for HRQL with no explanation about missing data); adjustment for multiple statistical comparisons; presentation of all the scores. Generic questionnaire (Psychological General Well Being is the most frequently used) results in non significant difference or without clinical significance (effect size <0.30). This raises the uncertainty of its responsiveness, knowing that the pyrosis is largely improved and that the sample size of trials is ranging from 300 to 800. Specific questionnaire, i.e. Gastrointestinal Symptom Rating Scale, leads to significant results, but it may be argued whether this questionnaire is not simply a symptom scale, as only 2 items of the questionnaire concern bother about pyrosis and regurgitation. CONCLUSION: There is concern to conclude that despite a large improvement of pyrosis, especially with PPI, there is no definite demonstration that HRQL is improved in GERD.