Prostaglandins in the treatment of reflux oesophagitis: double-blind placebo controlled clinical trial.

The efficacy of the prostaglandin analogue, rioprostil, in the treatment of reflux oesophagitis has been assessed in a double-blind, randomized, placebo-controlled trial of 25 patients with endoscopic and histological evidence of reflux oesophagitis. At the beginning and end of the study, endoscopic appearances were graded 0-4 (0 = no oesophagitis, 4 = severe oesophagitis) and the symptoms of heartburn, regurgitation, pain and dysphagia were each graded 0-3 (0 = none, 3 = severe). Fourteen patients received rioprostil, 300 micrograms twice daily, and 11 patients received identically marked placebo for a period of 12 weeks. At the end of the study there were no significant differences between the groups in mean (s.d.) endoscopic grading (rioprostil 2.4 (1.3); placebo 1.9 (0.9)) and mean (s.d.) cumulative symptom score (rioprostil 2.5 (3.1); placebo 2.6 (1.5)). Five patients in the rioprostil group reported diarrhoea. Rioprostil had no significant benefit over placebo in the treatment of reflux oesophagitis.

RCT Entities:   Population Interventions Outcomes