A randomized placebo controlled trial of ranitidine versus sucralfate in patients with spontaneous intracerebral hemorrhage for prevention of gastric hemorrhage.
OBJECTIVE
Due of paucity of studies on stress ulcer prophylaxis in intracerebral hemorrhage (ICH), we have evaluated the usefulness of ranitidine and sucralfate in preventing gastric hemorrhage (GH) in patients with ICH.


METHODS
In a hospital-based randomized placebo-controlled study, patients with CT-proven ICH within 7 days of ictus were randomized into ranitidine 50 mg i.v. eight hourly, sucralfate 1 g six hourly and placebo groups. Patients were conservatively managed. Primary endpoint was occurrence of GH within 15 days of ictus and secondary endpoint 1-month mortality.


RESULTS
The mean age of the patients was 57.2 (range 25-90) years and 40 were females. There were 45 patients in ranitidine, 49 in sucralfate and 47 in placebo group. Demographic, clinical and radiological features were not significantly different in 3 groups. GH occurred in 11 (23.4%) patients in placebo, 5 (11.1%) in ranitidine and 7 (14.3%) in sucralfate group, which was not significant. Only one female had GH. There were 13 (27.7%) deaths in placebo, 5 (11.1%) in ranitidine and 12 (24.5%) in sucralfate group. Pneumonia occurred in placebo group in 5 (10.6%), ranitidine in 2 (4.4%) and sucralfate in 5 (10.2%) patients, which was not significantly different.


CONCLUSIONS
Ranitidine and sucralfate do not seem to significantly prevent GH or reduce 1-month mortality.
Misra
U K
UK
Department of Neurology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, PGIMS, LKO Raebareily Road, Lucknow 226014, India. ukmisra@sgpgi.ac.in
Kalita
J
J
Pandey
S
S
Mandal
S K
SK
Srivastava
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D001921:Brain / Q000000981:diagnostic imaging / Q000473:pathology; D002543:Cerebral Hemorrhage / Q000150:complications* / Q000000981:diagnostic imaging / Q000473:pathology; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality; D010919:Placebos; D011014:Pneumonia / Q000453:epidemiology; D011859:Radiography; D011899:Ranitidine / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D013312:Stress, Physiological / Q000150:complications* / Q000503:physiopathology; D013392:Sucralfate / Q000627:therapeutic use*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D010919:Placebos; D013392:Sucralfate; D011899:Ranitidine