Pharmacological interventions for recurrent abdominal pain (RAP) and irritable bowel syndrome (IBS) in childhood: Cochrane systematic review

Abstract

Assessed as up to date: 2006/11/01

Background

Between 4% and 25% of school-age children complain of recurrent abdominal pain (RAP) of sufficient severity to interfere with daily activities. For the majority, no organic cause for their pain can be found on physical examination or investigation and although most children are likely managed by reassurance and simple measures, a large range of interventions have been recommended.

Objectives

To determine the effectiveness of medication for recurrent abdominal pain in school-age children.

Search methods

The Cochrane Library (CENTRAL) 2006 (Issue 4), MEDLINE (1966 to Dec 2006), EMBASE (1980 to Dec 2006), CINAHL (1982 to Dec 2007), ERIC (1966 to Dec 2006), PsycINFO (1872 to Dec 2006), LILACS (1982 to Dec 2006), SIGLE (1980 to March 2005), and JICST (1985 to 06/2000) were searched with appropriate filters

Selection criteria

Studies on school age children with RAP (Apley or the Rome II criteria for gastrointestinal diseases) allocated by random or quasi-random methods to a drug treatment vs. placebo/ no treatment were included.

Data collection and analysis

References identified by the searches were screened against the inclusion criteria by two independent reviewers. Data was extracted and analysed using RevMan 4.2.10.

Main results

Three trials met the inclusion criteria. Symon et al report a cross-over trial comparing pizotifen and placebo in 16 children with "abdominal migraine". Data before cross-over was not available. Results for 14 children showed Mean fewer days in pain of 8.21 (95% CI 2.93, 13.48) while taking the active drug.
Kline et al compared peppermint oil capsules with placebo in a randomised trial in 50 children with RAP and IBS. 42 children completed the study. OR for improvement was 3.33 (95% CI 0.93-12.1)
See et al compared famotidine with placebo in a randomised cross-over trial in 25 children with RAP and dyspepsia. OR for improvement before cross-over was 11 (95%CI 1.6, 75.5).

Authors' conclusions

This review provides weak evidence of benefit on medication in children with RAP. The lack of clear evidence of effectiveness for any of the recommended drugs suggests that there is little reason for their use outside of clinical trials. Clinicians may choose to prescribe drugs in children with severe symptoms that have not responded to simple management. However, if using drugs as a "therapeutic trial", clinicians should be aware that, RAP is a fluctuating condition and any "response" may reflect the natural history of the condition or a placebo effect rather than drug efficacy.

Author(s)

Huertas-Ceballos Angela A, Logan Stuart, Bennett Cathy, Macarthur Colin, Martin Alice E

Summary

Medication for stomach ache with no organic cause in children

Between 4% and 25% of school age children complain of stomach aches / recurrent abdominal pain (RAP) which is severe enough to interfere with their daily activities. For most such children, no organic cause for their pain can be found on physical examination or investigation. Although most children are likely to be managed by reassurance and simple measures, a large range of interventions including medication has been recommended.

Recently it has been suggested that children previously described as having RAP should be classified according to the pattern of symptoms into a series of sub-groups (the Rome II criteria) including irritable bowel syndrome, functional dyspepsia, functional abdominal pain and abdominal migraine. It is not clear whether these categories describe conditions that really differ in either aetiology or responsiveness to treatment but in updating the review we included studies which used these criteria to select participants as well as those using the traditional diagnosis of RAP.

This review attempted to determine the effectiveness of medication. When the original version was published only one paper met the inclusion criteria. In this updated version two more papers were included. All three papers are randomised and two were crossover trials. The interventions assessed (one trial each) were pizotifen, peppermint oil and famotidine.

All three trials were small including 16 (pizotifen), 50 (peppermint oil) and 25 (famotidine) children respectively.

Although the authors of the original trials suggested that pizotifen and famotidine were effective treatments the reviewers conclude that this review provides only weak evidence for the use of drugs in the treatment of RAP and suggest that they should only be used in the context of clinical trials or in children with severe problems refractory to conventional management.

Reviewer's Conclusions

Implications for practice

Overall this review provides only weak evidence for the efficacy of any pharmacological agent in children with recurrent abdominal pain. The lack of clear evidence of effectiveness for any of the recommended drugs suggests that there is little reason for their use outside of clinical trials. Clinicians may choose to prescribe drugs in children in whom symptoms are severe and have not responded to simple management. However, if using drugs as a "therapeutic trial", clinicians need to be aware that, RAP is a fluctuating condition and any "response" may reflect the natural history of the condition or a placebo effect rather than drug efficacy.

Implications for research

The pathogenesis of recurrent abdominal pain in children remains unclear, nor indeed is it clear whether the symptoms reflect one or many different aetiological pathways (Hyams 1998). There is an obvious need for further studies which attempt to elucidate this aetiology. There is also an urgent need for further trials of the many interventions that have been suggested for use in this condition. Such trials are needed not only to guide the management of children with RAP but also to provide information on potential aetiological pathways.

There is a need for large samples of well conducted trials of recommended pharmaceutical interventions in children with RAP. Given the difficulty thus far in providing convincing evidence relating to the aetiology of postulated sub-groups it will be important in future trials of interventions to consider designs which allow examination of differential responsiveness according to the clinical picture.

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