Abstract

BackgroundChronic intestinal pseudo-obstruction is a disabling condition for which there are no established drug therapies. The condition is caused by a diverse range of intestinal myopathies and neuropathies.AimTo assess the therapeutic efficacy of prucalopride, a selective high-affinity 5-HT4 receptor agonist, we employed a multiple n = 1 study design. Each patient acted as his/her own control, each day counting as one treatment episode, allowing comparison of 168 days on each of active drug and placebo.MethodsDouble-blind, randomised, placebo-controlled, cross-over trial of four 12-week treatment periods, with 2–4 mg prucalopride or placebo daily. In each of the first and second 6 months there was a prucalopride and a placebo treatment. Patients with proven chronic intestinal pseudo-obstruction, including dilated gut, were included. Evaluation was by patient diary and global evaluation.ResultsSeven patients participated (mean 42 years, five female, median symptom duration 11 years). Three discontinued, two due to study length, and one on prucalopride due to unrelated malnutrition and bronchopneumonia. Four patients (three visceral myopathy and one visceral neuropathy) completed the study; prucalopride significantly improved pain in three of four patients, nausea in two, vomiting in one, bloating in four and analgesic intake. Bowel function was not changed substantially.Conclusionsn = 1 studies in rare conditions allow drug efficacy assessment. Prucalopride relieves symptoms in selected patients with chronic pseudo-obstruction.

Highlights

  • The term chronic idiopathic intestinal pseudo-obstruction (CIP) denotes a clinical syndrome of apparent bowel obstruction in the absence of an obstructing lesion

  • The present study aimed to evaluate the efficacy and safety of prucalopride, in a once daily dose of 2–4 mg, in patients with known CIP

  • Trial design We undertook a single-centre, randomised, double-blind, placebo-controlled, cross-over study in subjects with definite, established CIP

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Summary

Introduction

The term chronic idiopathic intestinal pseudo-obstruction (CIP) denotes a clinical syndrome of apparent bowel obstruction in the absence of an obstructing lesion. The term ‘pseudo-obstruction’ was first used to describe a cohort of patients with recurrent vomiting, abdominal pain and distension, who had undergone repeated laparotomy with no obstructive cause demonstrated.[1] The symptoms relate in part to the failure of intestinal propulsion, due to an underlying disorder of enteric nerves or muscle. The condition is rare with a wide spectrum of severity. It is sometimes diagnosed in the setting of abnormal gut motor function and pain without gut morphological change.[5, 6] The diagnosis is definite when the gut is dilated, there is no obstructing lesion, and gut pathology has been established

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