Double-blind, placebo-controlled endoscopic comparison of the mucosal protective effects of misoprostol versus cimetidine on tolmetin-induced mucosal injury to the stomach and duodenum.
Ninety normal volunteers were entered into a double-blind, placebo-controlled study to compare the efficacy of misoprostol (200 micrograms q.i.d.) vs. cimetidine (300 mg q.i.d.) in protecting the gastric and duodenal mucosa from tolmetin-induced (400 mg q.i.d.) injury. After 6 days of treatment, the degree of mucosal injury between treatments was compared by endoscopy, using a predetermined rating scale of 0 (normal mucosa) to 4+ (greater than 25 hemorrhages or erosions or an invasive ulcer). Utilizing a score of less than or equal to 2+ (2-10 hemorrhages or erosions) as a therapeutic success, the overall success rates were 8/30 (26.7%) for placebo, 19/30 (63.3%) for cimetidine, and 27/29 (93.1%) for misoprostol (p less than 0.001). Pairwise comparisons were also significant: misoprostol vs. placebo (p less than 0.001), misoprostol vs. cimetidine (p = 0.006), and cimetidine vs. placebo (p = 0.004). A separate analysis of the gastric scores alone revealed success rates identical to those in the overall evaluation; however, success rates in the duodenum for both misoprostol (29/29) and cimetidine (29/30) were extremely high and did not differ. It is concluded that misoprostol is highly effective and significantly better than cimetidine in protecting the gastric mucosa from tolmetin-induced injury; however, both agents were highly protective in the duodenum.
D000328:Adult; D000527:Alprostadil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002927:Cimetidine / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000517:prevention & control*; D004384:Duodenoscopy; D005753:Gastric Mucosa / Q000187:drug effects; D005773:Gastroscopy; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects; D008875:Middle Aged; D016595:Misoprostol; D011758:Pyrroles / Q000633:toxicity*; D013276:Stomach Ulcer / Q000517:prevention & control*; D014046:Tolmetin / Q000633:toxicity*
D000897:Anti-Ulcer Agents; D011758:Pyrroles; D016595:Misoprostol; D002927:Cimetidine; D014046:Tolmetin; D000527:Alprostadil