Quality of life in acute and maintenance treatment of non‐erosive and mild erosive gastro‐oesophageal reflux disease

Summary Background: Quality of life has been assessed in a large, multicentre randomized, open label study. Aim: To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro‐oesophageal reflux disease patients at 451 gastroenterological centres in Italy. Methods: Adult gastro‐oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II–IV oesophagitis according to Savary–Miller's classification. Burden of gastro‐oesophageal reflux disease was measured at baseline by the generic questionnaire Short‐Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7‐point scale. Results: A comparison between Short‐Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro‐oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4‐week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P