Clinical study of Duogastrone in the treatment of duodenal ulcers

Abstract

SUMMARY This study confirms the preliminary reports that Duogastrone effectively controls the symptoms of duodenal ulceration and appears to hasten healing. In a double-blind trial, 14 patients with active duodenal ulcers were treated with Duogastrone capsules, one four times daily, half-an-hour before meals, while a comparable control group of 14 patients was treated similarly with a placebo containing magnesium trisilicate. Treatment continued for 12 weeks with clinical assessments fortnightly and a radiological assessment at the start and at the end of treatment.Only one of the 14 patients receiving Duogastrone did not respond. The remaining 13 showed marked clinical improvement with complete relief of pain and ceased to require supplementary antacids. Radiological evidence of healing or marked improvement was seen in eight of the 14 patients.None of the patients in the control group showed any marked improvement either of pain or tenderness and no changes were detectable by radiology. Patients in this group showed no reduction in their demand for supplementary antacids to relieve symptoms. No significant side effects were encountered.It is concluded that Duogastrone accelerates the healing of duodenal ulcer in ambulant patients and affords a much greater and more rapid relief of symptoms than does magnesium trisilicate.Many investigations have confirmed the value of carbenoxolone sodium tablets (Biogastrone) in the treatment of gastric ulcer in ambulant patients. The rate of healing in these trials has been comparable with bed rest in hospital. The tablets, however, have not been shown to have a therapeutic effect in duodenal ulceration. probably because carbenoxolone is rapidly absorbed from the stomach. The precise mode of action of the drug is not known but there is evidence that its effect is topical rather than systemic.A special positioned-release capsule (Duogastrone) has been designed which releases 50 mg carbenoxolone sodium directly into the duodenum in a concentrated form and preliminary studies

Carbenoxolone in the Treatment of Duodenal Ulcer

“…In four double‐blind studies carbenoxolone, one cap sule 4 times daily, was compared with placebo capsules, the length of treatment being for 4 to 12 weeks. Two of these trials (Craig et al , 1967; Amure, 1970) gave statistically highly significant results in favour of carbenoxolone. In one trial (Colin‐Jones et al , 1967), of 39 patients entering the trial only 11 had symptoms at the commencement and although no radiological improvement was demonstrated there was some difference in favour of carbenoxolone symptomatically.…”

Duogastrone-induced hypokalaemic nephropathy and myopathy with myoglobinuria

“…Clinical trials have given conflicting results. Some double-blind trials have shown a significant advantage in the Duogastrone-treated group (Craig et al, 1968;Hunt, 1968;Amure, 1970), while others have shown no advantage in the test group (Colin-Jones et al, 1968;Cliff & Milton-Thompson, 1970).…”

The Medical Treatment of Duodenal Ulceration ?

“…Of four early trials reported of the use of carbenoxolone in duodenal ulceration, three (Hunt, 1968; Lawrence et al , 1968; Cliff, 1968) were favourable and a more recent study has also been encouraging (Amure, 1970). Although the drug certainly seems to be helpful in achieving symptomatic relief and aiding ulcer healing, the longterm effects and the ability of the drug to prevent relapse or the complications of ulcer disease remain uncertain.…”