Randomised trial of medical versus surgical treatment for refractory heartburn

A randomised placebo-controlled study published in the New England Journal of Medicine aimed to compare medical and surgical management of patients with dyspepsia refractory to treatment with proton-pump inhibitors (PPIs).1 Patients presenting with dyspepsia were asked to complete a baseline Gastro-oesophageal Reflux Disease–Health-Related Quality of Life (GERD-HRQL) score and were given a 2-week course of omeprazole 20 mg once daily. Patients with <50% improvement in GERD-HQRL score and with no other identifiable cause of gastro-oesophageal reflux disease (GORD) were deemed to have refractory heartburn and were randomised to further medical or surgical treatment or placebo. Patients were excluded if they had other identifiable causes of heartburn, such as motility disorders, structural abnormalities or other forms of functional heartburn. A total of 366 patients were enrolled in the trial, with 78 patients meeting the inclusion criteria. The authors screened patients for functional disorders by ensuring all trial participants underwent endoscopy and biopsy, oesophageal manometry and oesophageal multichannel intraluminal impedance and pH monitoring.

Patients on medical treatment were given 20 mg of omeprazole with addition of baclofen or placebo. At 3 monthly assessment, desipramine or placebo was added …