Double blind cross-over placebo controlled study of omeprazole in the treatment of patients with reflux symptoms and physiological levels of acid reflux - The 'sensitive oesophagus'

Abstract

Background - At least 10-15% of patients with reflux symptoms have a normal endoscopy and physiological levels of acid reflux on pH monitoring. Such patients with 50% or more of symptoms associated with acid reflux episodes have 'a positive symptom index' (SI), and it has been proposed that this defines the 'sensitive oesophagus'. Aim - To test the response to omeprazole 20 mg twice daily for four weeks of patients with normal levels of acid reflux using a randomised, placebo controlled, double blind, cross-over design. Patients - Eighteen patients with normal levels of reflux, 12 of whom had a positive SI. Methods - Response was measured by symptomatic assessment and the SF-36 quality of life (QOL) questionnaire. Results - Patients with a positive SI showed the following improvements on omeprazole compared with placebo: decrease in symptom frequency (p<0.01), severity (p<0.01) and consumption of antacids (p<0.01). In the group with a negative SI only one patient clearly improved. The QOL parameters for bodily pain (65.6 v 53.4, p=0.03) and vitality (60.6 v 48.8, p=0.049) were significantly better on omeprazole than placebo for the group overall. Conclusion - Omeprazole improves symptoms in 11 of 18 patients with normal endoscopy and pH monitoring, particularly those with a positive SI. This supports the theory that such patients have an oesophagus which is 'sensitive' to acid reflux and are part of the GORD spectrum.