Background: This study was performed to study the demography, effect of tre
atment with ranitidine and relapse pattern in patients with reflux symptoms
.
Methods: Patients with reflux symptoms were examined by endoscopy and inclu
ded 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 tre
atment. 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 pe
rformed.
Results: Four hundred and twenty-seven patients were randomised. At two wee
ks there was no significant difference between placebo and ranitidine, rega
rding the proportion of patients with complete relief from symptoms or sati
sfied with treatment. Ranitidine was superior to placebo in improving sympt
oms 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.