Sucralfate and cimetidine as single agents and in combination for treatment of active duodenal ulcers: A double-blind, placebo-controlled trial

• Published in: The American journal of medicine Vol. 79; no. 2; pp. 39 - 44
• Main Authors: Van Deventer, Gary M., Schneidman, Daria, Walsh, John H.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 30.08.1985
• Subjects: Aluminum - administration & dosage; Aluminum - therapeutic use; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - therapeutic use; Cimetidine - administration & dosage; Cimetidine - therapeutic use; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer - drug therapy; Duodenal Ulcer - pathology; Duodenoscopy; Female; Humans; Male; Middle Aged; Placebos; Random Allocation; Sucralfate
• ISSN: 0002-9343; 1555-7162
• DOI: 10.1016/0002-9343(85)90571-6

A randomized, double-blind, double-placebo study was conducted to compare the rates and predictors of healing in patients with endoscopically proved duodenal ulcers during treatment with sucralfate, cimetidine, or a combination of the two drugs. Standard therapeutic dosage regimens were used in each group. No antacids were allowed. Endoscopy was repeated at two weeks and, if needed, at four and eight weeks. Healing was defined as complete re-epithelialization of all ulcers. Cases in which there was a worsening of the ulcer or of symptoms were considered unhealed. Eight patients were dropped for protocol violations or unrelated medical Illnesses; data from 61 patients were suitable for analysis. The healing rates achieved with sucralfate and cimetidine did not differ significantly at any time. However, the healing rate at two weeks for combination therapy (33 percent) was higher than for either sucralfate alone (15 percent) or cimetidine alone (10 percent). Cigarette smoking, a prior history of ulcer disease, and a low pepsinogen I to pepsinogen II ratio were significant predictors of delayed healing.