Maintenance therapy with cisapride after healing of erosive oesophagitis: a double‐blind placebo‐controlled trial

Abstract

The relapsing nature of re¯ux oesophagitis has been well documented in a number of short-term follow-up studies 1±3 and it is known that re¯ux symptoms persist in the majority of oesophagitis patients at least 10 years after diagnosis. 4 To date the best results for maintenance therapy after healing of oesophagitis have been achieved with proton pump inhibitors, which have been reported to reduce relapse rates at 1 year to 10± 30%. 3,5,6 However, although proton pump inhibitors are now accepted as the most effective healing therapy for oesophagitis, concerns remain regarding their safety for long-term maintenance therapy. 7±9It has been reported that the lower oesophageal sphincter pressure in oesophagitis patients who relapse is lower than in non-relapsers.10 Cisapride would seem to be an obvious choice for maintenance therapy given that it can improve lower oesophageal sphincter pressure.11 A few studies have shown that cisapride SUMMARYBackground: There are few data on the role of prokinetic agents as maintenance therapy in moderately severe re¯ux oesophagitis despite the high relapse rate of this condition after healing. Aims: To determine whether cisapride is more effective than placebo as maintenance therapy after healing of moderate erosive oesophagitis in two respects: ®rst, in preventing symptomatic relapse and preserving quality of life; and, second, in improving oesophageal motor function. Patients: Forty-two patients whose grade II±III oesophagitis had been healed with omeprazole were randomized to receive either cisapride 20 mg nocte or placebo for 6 months. Oesophageal pH monitoring and manometry were performed before starting maintenance therapy and after 4 weeks, and symptomatic status and quality of life were assessed at weeks 0, 4, 13 and 26.

The effect of motilin agonist ABT‐229 on gastro‐oesophageal reflux, oesophageal motility and lower oesophageal sphincter characteristics in GERD patients

“…Two studies found that cisapride caused a reduction in oesophageal acid exposure 31 , . 32 In contrast, three other studies, in which a larger number of GERD patients were investigated, showed that cisapride had no effect on acid reflux 33 –35 …”

“…However, this effect was not significant in the supine and in the total 24 h periods, and cisapride did not affect the mean time of exposure of the oesophagus to acid reflux. Previous studies on the effects of an oral dose of cisapride on oesophageal pH in adult GERD patients have yielded conflicting results 31 –35 . Two studies found that cisapride caused a reduction in oesophageal acid exposure 31 , .…”

Cisapride: What can we learn from the rise and fall of a prokinetic?

“…The fact that the latter was more reproducible in the pivotal US studies led to the rather unusual and restrictive labeling for nocturnal heartburn. Furthermore, other studies examining both the induction of remission 78 and prevention of relapse [79][80][81] showed unimpressive benefits for cisapride as a monotherapy, especially when compared to omeprazole. 81 In children, in contrast to, and despite its advocacy in this patient group, 16 there was no evidence of benefit when all studies were critically evaluated.…”

Gastric emptying and adynamic ileus

“…It would appear that cisapride has little effect on gut function in normality, but only enhances gastric motor function when a pathological motor dysfunction is present (Brummer et al 1997). For example, in the lower oesophageal sphincter (LOS), cisapride has a normalising action when the sphincter pressure is low (McDougall et al 1997), but has little effect on the LOS when pressures are within the normal range.…”