title: A double-blind comparative study of cimetidine and placebo in adult Nigerian duodenal ulcer patients with special reference to gastroduodenal mucosal morphology and intestinal bacterial activity.
abstract: Twenty-seven adult Nigerian patients with endoscopically proven active duodenal ulcers have received in a double-blind trial either the histamine H2 - receptor antagonist cimetidine 1g daily or placebo tablets of identical appearance for 4 weeks. Fifty-six per cent of the cimetidine patients and 18% of those receiving placebo had endoscopically completely healed ulcers and total pain relief at the completion of trial. This response amounted to clinical cure. An additional 19% of patients in the cimetidine group experienced clinical improvement either in endoscopic or symptomatic reassessment but not in both, thus leading to a disparity between clinical cure rate (56%), healing rate (69%), and pain relief (64%). Though therefore significantly better than placebo, this less favourable response to cimetidine in this study may be due to the short trial period, the disparity between healing and pain relief rates or to co-existing and persistent antroduodenitis in ulcer patients as shown on gastroduodenal mucosal biopsies taken at the time of the clinical investigation. There were no untoward clinical laboratory side effects with the exception of the one cimetidine patient who experienced diarrhoea and a small number who showed slight, asymptomatic rise in plasma creatinine level. Of particular interest to the reported occurrence of diarrhoea with cimetidine therapy is the finding in the bacteriological studies of intestinal aspirates and biochemistry estimations for indicanuria in the consenting patients which showed that orally administered cimetidine 1g daily for 4 weeks neither produced demonstratable alterations in the bacterial content of the small bowel not pathological indicanuria, thereby excluding bacterial overgrowth syndrome as a therapeutic hazard in the clinical application of cimetidine.
mesh_terms: D000328:Adult; D002927:Cimetidine / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000473:pathology; D006146:Guanidines / Q000627:therapeutic use*; D006801:Humans; D007200:Indican / Q000652:urine; D007413:Intestinal Mucosa / Q000187:drug effects / Q000382:microbiology / Q000473:pathology; D010919:Placebos
chemical_list: D006146:Guanidines; D010919:Placebos; D002927:Cimetidine; D007200:Indican