No clear evidence that Cisapride relieves symptoms related to constipation or irritable bowel disease.

Aboumarzouk OM, Agarwal T, Antakia R, Shariff U, Nelson RL

Published Online:

January 19, 2011

Cisapride has been used as a prokinetic to treat constipation, but was found to have some serious side effects and was directly associated with fatalities from those side effects. Though it has been removed from the market and has not been used in most of the world's health institutes, it can still be prescribed in certain situations and is easily purchased through dealers on the Internet. We conducted a systematic review to assess whether or not cisapride actually relieves constipation and controls the symptoms of irritable bowel disease, in addition to looking at whether or not these effects are worth its use compared to the risk of cisapride's dangerous side effects. Through a detailed look at the literature, we found no clear evidence to suggest that cisapride has a role in controlling symptoms related to constipation or IBS and believe its not worth the risk of its possibly fatal arrhythmia side effects.

Abstract (click to read)

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Cisapride is a propulsive agent, withdrawn from most of the world's health institutes because of its recorded fatalities in addition to serious side effects such as severe arrhythmias.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 4

MEDLINE (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.

This record should be cited as:

Aboumarzouk OM, Agarwal T, Antakia R, Shariff U, Nelson RL. Cisapride for Intestinal Constipation. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD007780. DOI: 10.1002/14651858.CD007780.pub2

Assessed as up to date:

September 5, 2010

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Primary Review Group:

Colorectal Cancer Group

Health topics:

Gastroenterology > Functional bowel disorders > Childhood constipation and soiling

Gastroenterology > Functional bowel disorders > Chronic constipation

Gastroenterology > Functional bowel disorders > Irritable bowel syndrome

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

No clear evidence that Cisapride relieves symptoms related to constipation or irritable bowel disease.

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