Background: Cisapride is a propulsive agent, withdrawn from most of the world's health institutes because of its recorded fatalities in addition to serious side effects such as severe arrhythmias. However it is widely available in third world countries and can be easily purchased through the Internet. We did a systematic review to assess its efficacy and safety in relieving constipation.
Objectives: The primary objective is to assess Cisapride's role and safety as a prokinetic drug in the management of constipation and constipation predominant Irritable bowel syndrome (C-IBS).The secondary objective is to assess Cisapride's efficacy in improving symptoms of constipation and IBS.
Search strategy: Cochrane methodology was followed to find available RCTs that assessed the efficacy of cisapride. Electronic databases searched November 2009:Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library 2009 issue 4MEDLINE (from 1966)EMBASE (from 1980)
Selection criteria: All RCTs comparing cisapride to placebo or to active comparators were included. We included patients of all ages who had functional constipation or C-IBS.
Data collection and analysis: Eight RCTs were included, comparing cisapride to a placebo on patients with constipation or C-IBS. The studies were pooled and analysed and a combined effect was calculated using meta-analysis.
Main results: 8 trials included in the review for a total 424 patients who were randomised to Cisapride or placebo, of which 157 were children and 284 were female. Intervention duration was 8 to 12 weeks. Dosage of Cisapride in the adult and children trials were 5mg TDS and 0.2mg/kg/dose TDS respectively.Cisapride showed significant benefit in investigators' assessment of clinical improvement (OR: 0.45, P=0.03), likelihood of passing daily stools (OR: 0.22, P<0.001), passage of normal stools (OR: 0.06, P<0.001) and total gastrointestinal transit time (MD: -19.47, P<0.00001). However Cisapride showed no benefit in global improvement of symptoms (MD: 0.11, P=0.99), abdominal pain (MD: 1.94, P=0.56), stool frequency: weekly (MD: 3.36, P=0.11), visual analogue scale (MD: -0.23, P=0.66), stool consistency (MD: 0.32, P=0.50), bloating (MD: 3.93, P=0.44), persistent bloating(OR: 1.11, P=0.83), 'feeling of incomplete evacuation' (MD: -3.80, P=0.08), straining (MD -0.95, p=0.19).
Authors' conclusions: No clear benefit can be demonstrated with cisapride. We do not feel that cisapride can be justifiably used for chronic constipation or irritable bowel disease given its side effects of arrhythmia and associated 175 recorded deaths.