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

Gastroenterology. 1988 Aug;95(2):289-94. doi: 10.1016/0016-5085(88)90482-9.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Alprostadil / analogs & derivatives*
  • Alprostadil / therapeutic use
  • Anti-Ulcer Agents / therapeutic use*
  • Cimetidine / therapeutic use*
  • Clinical Trials as Topic
  • Double-Blind Method
  • Duodenal Ulcer / prevention & control*
  • Duodenoscopy
  • Gastric Mucosa / drug effects
  • Gastroscopy
  • Humans
  • Intestinal Mucosa / drug effects
  • Middle Aged
  • Misoprostol
  • Pyrroles / toxicity*
  • Stomach Ulcer / prevention & control*
  • Tolmetin / toxicity*


  • Anti-Ulcer Agents
  • Pyrroles
  • Misoprostol
  • Cimetidine
  • Tolmetin
  • Alprostadil