EFFECTS OF CISAPRIDE ON CONSTIPATION IN PARAPLEGIC PATIENTS - A PLACEBO-CONTROLLED RANDOMIZED DOUBLE-BLIND CROSS-OVER STUDY

Objective: To evaluate the effects of cisapride on constipation in paraplegics. Design: Prospective placebo-controlled double-blind cross-over study. Patients acted as their own controls. The study consisted of two drug phases lasting 8 weeks each. They were separated by a 3-week wash-out period. The first drug phase was preceded by a 3-week run-in phase. Setting: Rehabilitation centre and gastroenterology department. Patients: Ten patients suffering from constipation due to complete supraconal spinal cord lesion. Ultimately seven patients completed the study protocol. Methods: During the entire study period clinical parameters concerning defecation were recorded on a diary card by each patient. These parameters included defecation frequency, ease of evacuation, consistency of stools, percentage of defecations preceded by digital reflex stimulation or suppository and time between suppository and successive defecation. We measured oro-caecal and oro-anal transit time in all four phases. Results: Both cisapride and placebo made defecation significantly easier. Improvement of stool consistency was restricted to the cisapride phase. There was a remarkable but not a significant reduction of the use of digital reflex stimulation and suppositories due to cisapride. Also the time between suppository and successive defecation showed an improving tendency. Conclusions: The outcome of this study does not support the optimistic view expressed in previous case reports. Because some tendencies are promising, we advise that a more extensive study be performed in order to establish the precise role of cisapride in the treatment of constipation in paraplegics.