Controlled trial of Duogastrone in duodenal ulcer.

A double-blind placebo-controlled trial of carbenoxolone, as 50 mg Duogastrone capsules, and in a dose of 200 mg daily for 12 weeks, was carried out in 40 ambulant subjects with endoscopically diganosed duodenal ulceration, of whom 34 were available for final analysis. Each patient was seen every two weeks and endoscoped at four, eight and 12 weeks. Serum carbenoxolone was measured at each visit. Complete ulcer healing occurred in a significantly greater number of patients receiving Duogastrone than placebo, the significance being greater after four and eight weeks treatment (P less than 0-01) than at 12 weeks (P less than 0-02). While significant symptomatic improvement also was achieved (P less than 0-05), but only after 12 weeks on Duogastrone, there was much closer correlation between ulcer healing and symptom relief, 69% on Duogastrone returning to normal, compared with 22% of controls (P less than 0-02). Rise of systolic blood pressure and reduction in serum potassium levels, especially during the last four treatment weeks, were the most common effects noted in patients taking Duogastrone, and five patients required thiazide diuretics and potassium supplements. Higher serum carbenoxolone levels were found in patients with healed ulcers as well as in those with more marked side-effects.

RCT Entities:   Population Interventions Outcomes