A prospective randomised controlled study of the use of ranitidine in patients with gastric cancer

J N Primrose,^a G V Miller,^a S R Preston,^a J Gokhale,^a N S Ambrose,^a U M Ward,^a J G Mills,^b R S B Ehsanullah,^b B Darekar,^b and the Yorkshire GI Tumour Group

^a St James's University Hospital, Leeds, UK, ^b GlaxoWellcome Research and Development, Greenford, Middlesex, UK

Correspondence to: Professor J N Primrose, University Surgical Unit, F level, Centre Block, Southampton General Hospital, Tremona Rd, Southampton, UK.

Accepted for publication 2 May 1997

BackgroundDoes the use of the histamine H₂ receptor antagonist ranitidine improve the outcome of patients with gastric cancer?
PatientsA total of 222 patients with gastric cancer who had received radical or palliative resection or who were deemed inoperable at presentation.
SettingHospitals within Yorkshire, the participating clinicians being members of the Yorkshire GI Tumour Group.
MethodsA multicentre prospective randomised double blind trial comparing ranitidine 150 mg twice daily with placebo twice daily was undertaken. The principal outcome measures were survival and survival excluding those who died within 30 days of operation.
ResultsThe median survival (95% confidence intervals) was 331 (232 to 393) days for patients in the ranitidine group compared with 187 (143 to 269) for those in the placebo group. The difference in survival was not statistically significant (p = 0.225). When patients who died within 30 days of operation were excluded (21 in the placebo group, 15 in the ranitidine group), the difference in survival remained not significant (p = 0.358). No subgroup could be identified who significantly benefited from treatment, but for patients with stage VIa cancer the median survival was 134 days with placebo compared with 313 days with ranitidine (p = 0.073).
ConclusionThis study does not show significant benefit from the use of ranitidine for gastric cancer but further larger studies may be indicated.
(GUT 1998;42:17-19)

Keywords: rantitidine;  cimetidine;  H₂ histamine receptor antagonist;  gastric cancer