Cisapride treatment of constipation–predominant irritable bowel syndrome is not superior to placebo

Abstract

These results indicate that the effect of 15-30 mg cisapride daily on symptoms of constipation-predominant IBS is not significantly superior to placebo. During the 12 week treatment of this trial cisapride proved to be safe and tolerable.

Meta‐analysis: factors affecting placebo response rate in the irritable bowel syndrome

“…The search strategy generated 3383 citations of which 177 appeared to be relevant to the systematic review and were retrieved for further assessment (Figure 1). Of these 177 RCTs, 104 were excluded for various reasons leaving 73 eligible trials, 21–92 containing 8364 individuals with IBS who were randomized to receive placebo. Five of these RCTs were published in abstract form only 73–75, 82, 83 and data from two placebo‐controlled trials of tegaserod in IBS (B307 and B351) were published in a single document on the FDA website 84 .…”

“…There was, however, no significant difference in placebo response rates between these two time periods (Cochran Q = 0.60, P = 0.44) (Table 2). A majority of RCTs were conducted in Europe, 21, 22, 24, 26–31, 34–37, 39–41, 46, 48, 49, 51, 53–56, 58, 61, 81, 85, 87–91 and the pooled placebo response rate was the highest in these trials at 42.7% (Table 2). This rate was significantly higher than that in RCTs conducted in Asia (25.0%, Cochran Q = 8.8, P = 0.003), 23, 25, 50, 67, 70, 80 the Middle‐East (23.0%, Cochran Q = 9.4, P = 0.002), 44, 52, 66, 69 and North America (33.0%, Cochran Q = 7.3, P = 0.007) 38, 42, 45, 47, 59, 60, 62–65, 68, 71, 75, 78, 86, 92 .…”

“…However, the difference between these rates was not statistically significant (Cochran Q = 1.3, P = 0.25 and Cochran Q = 2.15, P = 0.14 respectively). There were few trials that reported the predominant stool pattern reported by the patient, but some trials recruited diarrhoea‐ or constipation‐predominant patients exclusively, 32, 44, 52, 64, 67, 70, 71, 73–78, 80, 82–84, 86–91 allowing us to examine the effect of this patient characteristic on pooled placebo response rates. No statistically significant difference, in terms of pooled placebo response rate, between RCTs recruiting constipation‐predominant or diarrhoea‐predominant IBS patients, was detected (Cochran Q = 0.6, P = 0.45) (Table 2).…”

Serotonin and Its Role in Colonic Function and in Gastrointestinal Disorders

“…Overall, only one of four studies was able to show an improvement in IBS-C patients taking cisapride when compared with placebo. 41,43 Cisapride has been removed from the United States market secondary to the risk of arrhythmias in those with predisposing conditions. 42,75 In light of the welldocumented cardiac risks, cisapride is no longer an alternative for the typical IBS-C patient.…”

Effective Constipation Treatment Changes More Than Bowel Frequency: A Systematic Review and Meta-Analysis

“…Of the articles included in the analysis, 16 focused on chronic constipation, 11,[24][25][26][32][33][34][35][36][37][38][39][40][41][42] 11 enrolled patients with IBS-C, 27,43-51 with one also including patients with mixed bowel patterns. 48 One study did not differentiate IBS-C from constipation.…”