A controlled trial of glycopyrronium and l-hyoscyamine in the long-term treatment of duodenal ulcer

Abstract

SUMMARY A controlled single-blind trial has been carried out to determine the value of long-term anticholinergic therapy in duodenal ulcer. Of 106 male patients with symptomatic and radiologically proven duodenal ulcer admitted to the trial, 91 completed the study. Patients were divided randomly into three groups. They received either glycopyrronium, or 1-hyoscyamine in a sustained-release form, or inert tablets for one year.Progress was judged on the basis of frequency and severity of symptoms, monthly assessments by patients, antacid consumption, and radiology. By all criteria, glycopyrronium and 1-hyoscyamine were not significantly superior to placebo. Symptomatic improvement, both subjective and objective, occurred in approximately 80% of all patients during the year of observation; there was no significant difference between the groups.Because anticholinergic agents reduce gastric motility and acid secretion, they have been used extensively in the treatment of peptic ulcer. In Britain the annual expenditure on such drugs is about two million pounds. Their value, however, in clinical practice is disputed and conclusions from clinical trials, many of which were uncontrolled, are conflicting.We have attempted in this study to assess the value of two anticholinergic drugs-one a natural alkaloid, the other a synthetic compound-in the long-term treatment of patients with duodenal ulceration.Method PATIENTS One hundred and six male patients (aged between 20 and 65) were admitted to the trial. They had had symptoms of peptic ulcer during the previous six months, and had had an ulcerated and/or deformed,duodenal cap demonstrated by radiology.At the first interview, the nature and purpose of the trial were explained, and a standard ques-

Modern Drug Treatment for Peptic Ulcer

“…Synthetic anticholinergic drugs have been claimed to produce better symptomatic responses than atropine or placebo tablets (Ruffin & Cayer 1962), and tricyclamol and glycopyrronium have been claimed to reduce the chances of ulcer relapse and complications respectively (Sun 1962(Sun , 1964). By contrast a marginally better initial symptomatic response obtained with methantheline compared with a placebo was not maintained later (Friedlander 1954) and further trials conducted with glycopyrronium, and glycopyrronium or hyoscyamine in maximal doses, respectively showed no difference in the incidence of relapse, or the rate of symptomatic improvement when compared with the responses to dummy tablets (Trevino et al 1967, Kaye et al 1970); results which are in accord with others obtained using synthetic anticholinergic com-pounds (Melrose & Pinkerton 1961, Lennard Jones 1961.…”

Dark Classics in Chemical Neuroscience: An Evidence-Based Systematic Review of Belladonna

“…The anticholinergics have historically used for the management for ulcer and gastric acid secretion related diseases due to their potential to inhibit gastrointestinal secretions. In 1968–1970, Kaye et al conducted two randomized trials to evaluate the antiulcer properties of l -hyoscyamine and short- and long-acting preparations of l -hyoscyamine compared with glycopyrronium and placebo in duodenal ulcer and gastric acid secretions. , One of these was a controlled single-blind trial to investigate the efficacy of two anticholinergics, l -hyoscyamine and glycopyrronium, in patients with duodenal ulcer . The study comprised 91 patients with ages of 20 to 65, who were divided into three groups: l -hyoscyamine (31), glycopyrronium (28), and placebo (32).…”

“…We collected the following information from each selected study: (1) disease condition; (2) type of study (randomized clinical trial, cohort study, or case-control study); (3) author’s name and year of publication; (4) age of the patients; (5) number of patients in the study; (6) number of patients taking belladonna or its alkaloids; (7) number of patients in the placebo group; and (8) outcome of the study (Table ). − …”

Carbenoxolone sodium capsules in the treatment of duodenal ulcer. An endoscopic controlled trial.

“…Attempts have been made in the past to demonstrate that a variety of treatments will accelerate ulcer healing at the remission of symptoms, but no convincing evidence has yet been advanced to support the use of any other agent. Thus, anticholinergic agents have been thought by some to induce remission of ulcer symptoms or to prevent relapse (Sun, 1964;Sun and Ryan, 1970;Walan, 1970), but others have failed to show that such treatment is of any value (Trevino et al, 1967;Kaye et al, 1970;Cocking, 1972). Poor results have in the past also been reported with the use of carbenoxolone sodium capsules, but these may be attributed in part to reliance on radiological change as a measure of healing-although radiological and endoscopic findings often correlate poorly, in part to the reporting of results obtained in small groups of patients, and in part to the inevitable random scatter which will occur when multiple independent examinations of treatment value are made (Colin Jones et al, 1968;Cliff and Milton Thompson, 1970).…”