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Sufficient control of heartburn in endoscopy‐negative gastro‐oesophageal reflux disease trials

More than half the number of patients who report troublesome heartburn symptoms suggestive of gastro-oesophageal reflux disease (GORD) to their doctor present with no obvious oesophageal lesions at endoscopy (1–3). They do require medical therapy, however, and the objective of treatment in this endoscopy-negative group is symptom improvement and relief to a level where the symptoms are perceived as being under control. In clinical trials, the therapeutic response to treatment is usually assessed by asking patients to define the frequency and severity of their heartburn symptoms. While this may give reasonably accurate information about a very subjective outcome measure, it fails to address the question as to whether the patients perceive that they experienced sufficient heartburn control from their therapy, which is the aim of treatment in clinical practice. This analysis of data from a clinical trial relates preand post-treatment heartburn assessments to a standardized question to the patient: ‘Does the study medication give sufficient control of your heartburn?’ This relationship may guide the choice of a clinically relevant efficacy measure based on heartburn severity and frequency.