A double-blind randomized, controlled study to investigate the efficacy of cimetidine given in addition to conventional therapy in the prevention of stress ulceration and haemorrhage in patients with acute spinal injury.

The efficacy of cimetidine, 1.2 and 2.4 g/day, compared to placebo treatment given in addition to conventional therapy, which included antacids, in the prevention of gastroduodenal lesions associated with stress in 105 patients with acute spinal injury was investigated. Haematemesis was only observed in 1 placebo-treated patient. Of the 84 patients who completed the 10-day treatment and underwent endoscopy, 12 out of 43 cimetidine-treated patients and 11 out of 41 patients who received placebo were found to have gastroduodenal ulceration and/or erosions. Mean circulating concentrations of gastrin, pancreatic polypeptide and secretin were similar in all groups of patients. Whilst cimetidine has been shown to reduce the incidence of ulceration in patients suffering cranial and thermal injuries, the present study failed to demonstrate a prophylactic effect of cimetidine in the primary prevention of ulcers or erosions in patients with acute spinal injury exceeding that of conventional antacid therapy.

RCT Entities:   Population Interventions Outcomes