Sucralfate in the short-term treatment of duodenal ulcer. A double-blind comparison with cimetidine and placebo.

A phase III randomised, double-blind, placebo controlled study was conducted to compare the efficacy and adverse effects of sucralfate and cimetidine in the short-term management of active duodenal ulcer. Standard therapeutic doses were used. Antacids were permitted on an ad lib basis. Eighty patients with endoscopically proven DU were treated for 4 weeks with sucralfate (SUC) (n = 40), cimetidine (CIM) (n = 20) and placebo (PLA) (n = 20), of whom 60 patients--SUC (32), CIM (14) and PLA (14) completed the trial. Baseline clinical and endoscopic data were comparable amongst the 3 groups. The patients were reexamined clinically at 1, 2 and 4 weeks and endoscopically at 2 and 4 weeks. The data comprising pain and non-pain symptom scores, and ulcer size before and after the trial were analysed using the Mann-Whitney test. There were no significant differences in the rate of ulcer healing between SUC and CIM at 4 weeks. 71.8% of the SUC group had complete healing, as compared with 71.4% in the CIM group and 35% in the PLA group. Both SUC and CIM were superior to PLA. (p less than .05) Non-pain symptom scores at the end of 1 week were significantly lower with CIM (p less than 0.001), but levelled at 4 weeks when compared with SUC. Both SUC and CIM were superior to placebo (p less than .001). Day-time pain relief was significantly better with both SUC and CIM as compared to placebo (p less than 0.1). There was no significant difference in night-pain relief between the 3 groups.(ABSTRACT TRUNCATED AT 250 WORDS)