Trithiozine in the treatment of duodenal ulcer a controlled double blind trial of the effect of trithiozine on duodenal ulcer

ABSTRACT

Fifty six patients with endoscopically confirmed duodenal or pyloric ulcers received either trithiozine [26] or placebo [30], for four weeks in a double-blind clinical trial. At four weeks there was complete endoscopic ulcer healing significantly more in patients receiving trithiozine [46.2 per cent] compared with those receiving placebo [20 per cent] [chi[2] = 4.26; p<0.05]. Patients treated by trithiozine consumed significantly less antacids than the placebo treated patients [p<0.01], but there was no difference in the symptomatic assessment of both groups. The trithiozine group had a significant reduction in their basal acid output when measured after two weeks, but when compared to the placebo group, this reduction did not reach significance. Headache, fatigue, dizziness, impotence and proteinuria occurred more in patients taking trithiozine, and myalgias and arthralgias were severe enough to cause three patients taking trithiozine to drop out of the trial. Trithiozine 4 -[3,4,5 trimethoxythiobenzoyl] tetrahydro-1, 4-oxazine1 has been shown to possess some gastric antisecretory properties[2,7]. The site of activity is not known. Studies have suggested that trithiozine heals duodenal ulcer along with symptomatic improvement and without untoward side effect[8,13]. However, we considered the results of studies regarding its antisecretory properties and clinical use as being inconclusive, and so undertook a double-blind controlled trial of trithiozine with the purpose of examining [a] the effect of trithiozine on duodenal ulcer healing, [b] the degree of symptomatic improvement in these patients, [c] the effect on acid output during therapy, and [d] the side effects of the drug