Gastro-oesophageal reflux symptoms -: Clinical findings and effect of ranitidine treatment

Background: This study was performed to study the demography, effect of treatment with ranitidine and relapse pattern in patients with reflux symptoms. Methods: Patients with reflux symptoms were examined by endoscopy and included in a double-blind, comparative trial of placebo and ranitidine 150 mg b.i.d. for two weeks. At two weeks satisfied patients continued the same treatment. Non-satisfied patients were randomised to ranitidine 150 mg b.i.d. or q.i.d for another two weeks. After four weeks medication was stopped and satisfied patients were followed for 24 weeks. No further endoscopy was performed. Results: Four hundred and twenty-seven patients were randomised. At two weeks there was no significant difference between placebo and ranitidine, regarding the proportion of patients with complete relief from symptoms or satisfied with treatment. Ranitidine was superior to placebo in improving symptoms at two weeks. Ranitidine, 150 mg q.i.d. offered no additional advantage in weeks three to four over prolonging treatment with 150 mg b.i.d. after the first two weeks. Patients with oesophagitis at inclusion relapsed more than those with symptoms only, 67% compared with 52%, (p = 0.013). Conclusions: The effect of ranitidine was marginal compared to placebo. The relapse rate was high after treatment stopped.