Search

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.

The effects of a new carbenoxolone analogue (BX24), zinc sulphate, and vitamin A on the healing of gastric ulcer have been assessed in a multifactorial clinical trial conducted in out-patients treated for four weeks.Forty-eight patients completed the trial. Three groups of eight patients were given respectively 300, 600, and 1 200 mg of BX24 daily and were compared with 24 patients who were given 300 mg of carbenoxolone sodium daily. The size of the ulcer niche was reduced on average by 14.6% in the eight patients given BX24 300 mg daily, by 47.6% in the patients given 600 mg daily, and by 51.0% in the patients given 1 200 mg daily. In the patients given carbenoxolone the size of the niche was reduced by 68.9%. These results were compared with those obtained previously with carbenoxolone and inert tablets and it was concluded that BX24 is without clinically useful effect in the doses used. Eleven of the 24 patients (46%) treated with carbenoxolone sodium developed side effects due to fluid retention and electrolyte disturbances. None of the patients given BX24 experienced such effects. In addition to carbenoxolone or BX24, 24 patients were given zinc sulphate, 660 mg daily, and in 24 patients these tablets were withheld. Among the patients given carbenoxolone the reduction in the size of the niche was much the same irrespective of whether or not the patients received zinc sulphate. Among the 12 patients given BX24 with zinc sulphate the ulcer healed completely in four and, on average, the size of the niche was reduced by 53.5%, compared with 21.9% in the 12 patients given BX24 alone. This difference is not statistically significant but the possibility of a beneficial effect from zinc is not excluded. No side effects attributable to zinc were observed.Twenty-four patients were also given vitamin A, 50 000 units daily, and in 24 patients the vitamin was withheld. No evidence was obtained to suggest that vitamin A had any beneficial effect on the healing of gastric ulcer.

A high-dose double-blind trial of carbenoxolone sodium capsules (Duogastrone) in the treatment of duodenal ulceration was combined with endoscopic diagnosis and follow-up. Thirty-one ambulant patients with an endoscopically visible duodenal ulcer were allocated at random to a 12-week course of treatment with either carbenoxolone sodium 300 mg daily or a placebo. Symptomatic and endoscopic follow-up was performed at 2-4 weeks, 6-8 weeks, and 12-16 weeks. Carbenoxolone was shown to increase the rate of healing of duodenal ulcers in the early stages of treatment, but by 12 weeks there was no difference between the two groups. There was no significant difference in symptomatic improvement between the two groups at any stage of treatment. Side effects, especially hypokalaemia, were prominent in the patients treated with carbenoxolone. There was a poor relation between endoscopic and symptomatic improvement in patients on either form of treatment.

In 68 patients with chronic gastric ulcer treated in an outpatient clinical trial with either carbenoxolone or gefarnate ulcer healing was consistently greater during carbenoxolone treatment, even though the dose of gefarnate was ultimately increased to four times that recommended. One-third of the patients receiving carbenoxolone gained weight rapidly and unexpectedly, and were given diuretic treatment, compared with two of the 35 patients receiving gefarnate, neither of whom developed clinical oedema.