Evaluation of Duogastrome (carbenoxolone sodium) for the treatment of duodenal ulcer: a multicentre study.

A double-blind study was carried out in 152 Canadian patients, 76 given Duogastrone (carbenoxolone sodium) capsules, 50 mg qid, and 76 given placebo capsules qid for 6 weeks. All patients had a duodenal ulcer diagnosed by roentgenography or endoscopy, or both. Evaluation of the efficacy of Duogastrone therapy was based on data from the 119 patients (59 treated with Duogastrone and 60 with placebo) who met all the strict requirements of the protocol. The ulcers healed completely in 75% (44/59) of the patients treated with Duogastrone and in 48% (29/60) of those treated with placebo; this difference is significant (P less than 0.01). The proportions were similar in the patients assessed only endoscopically: 76% (32/42) and 55% (26/47), respectively. In the group treated with Duogastrone the following side effects were noted: weight gain, edema, mild hypokalemia, increase in blood pressure and slight increases in serum concentrations of lactic dehydrogenase and alkaline phosphatase. None was serious. However, close clinical monitoring by weekly visits to their physician is recommended for every patient undergoing Duogastrone therapy, at least during the 1st month.