A Double-Blind Comparative Study of the Inhibitory Effect of Intraduodenally Administered Hyoscine-N-Butylbromide on Human Duodenal Motility

Abstract

In a double-blind crossover study hyoscine-N-butylbromide (HBB) was compared with placebo in its inhibitory effect on duodenal motility stimulated by metoclopramide. Measurements were made both by the balloon technique and the open-tipped tube method with pressure transducer. 20 mg or 50 mg HBB or placebo were instilled in random sequence into the intestinal tract of 12 healthy volunteers. The frequency of Type II waves was determined in each experiment after administration of the test substance following prior metoclopramide stimulation. This frequency was used as the inhibitory index for each drug. The test substance was administered 15 minutes before a second stimulation. A four-way analysis of variance (mixed model) was applied to the calculated number of waves per period. Subjects were required to respond equally to stimulation with increased motility on both trial days as evidenced by a minimal difference in the averages following the first stimulation on each trial day and before application of the test substance. The frequency of Type II waves after 20 mg and 50 mg HBB was reduced in a statistically significant manner in each case when compared with placebo. The probabilities of error were p less than 0-05 and p less than 0-025.

Hyoscine butylbromide mode of action on bowel motility: From pharmacology to clinical practice

“…Only two evaluated the effect of oral HBB. [39][40][41][42][43][44] One randomized crossover study has compared the effect of HBB 60 mg, cyclotropium bromide 60 mg and placebo on the gastric emptying and antral motility in response to a semisolid meal as recorded by scintigraphy (N = 24 healthy individuals). 43 Both active medications significantly delayed percentage of gastric emptying but cyclotropium had a greater effect versus HBB.…”

“…Six double‐blind, randomized controlled studies investigated the effect of HBB on gastric and duodenal motility in healthy subjects. Only two evaluated the effect of oral HBB 39‐44 …”

Gastrointestinal Receptors and Drugs in Motility Disorders

“…These drugs are regarded to be efficient and useful in these indications; however, clinical evi dence is rather poor. For instance, for a widely used drug like scopolaminebutylbromide, there are only few controlled clin ical studies which prove efficacy for the in dication of gastrointestinal spasms accord ing to today's standard [20], The same holds true for IBS [21], Ivey reviewed 400 papers on 18 muscarinic antagonists and noted that there was not one single wellcontrolled study [22],…”