CRD summary

This review, which assessed the effectiveness of prokinetic agents in patients with functional dyspepsia, concluded that prokinetic agents are effective as a short-term treatment. The review appears to have been conducted appropriately, but the reliability and generalisability of the results is potentially hindered by a number of limitations identified with the included studies.

Authors' objectives

To determine the effectiveness of prokinetic agents in patients with functional dyspepsia (FD).

Searching

MEDLINE (1951 to January 2005) and the Cochrane Library (Issue 4, 2004) were searched for publications in English, Chinese, German, Japanese, Portuguese and Spanish; the search terms were reported. In addition, a recursive manual search using references from full papers was undertaken.

Study selection

Assessment of study quality

The validity of the studies was assessed according to the Jadad checklist (scored on a scale of 0 to 4), which included items on randomisation, blinding, and follow-up of all patients. It was a little unclear how the validity assessment was conducted, but it appears to have been undertaken by two reviewers.

Data extraction

Two reviewers independently extracted the data from the included studies, and consensus was reached through discussion. Differences between intervention and placebo group responses were used to calculate summary statistics for treatment effect, along with 95% confidence intervals (CIs).

Methods of synthesis

Results of the review

Twenty RCTs and 7 crossover trials were included in the review (n=1,844 in the intervention group and n=1,591 in the placebo group). Sample sizes ranged from 9 to 414 patients.

The included studies scored between 2 and 4 for the Jadad validity criteria, with 10 studies scoring 4. There was no evidence of publication bias from Begg’s methods or funnel plots.

There was a statistically significant difference in treatment response rates, which favoured the intervention group; the OR was 0.295 (95% CI: 0.208, 0.382, p<0.001), indicating a 30% higher probability of treatment response compared with placebo. Significant statistical heterogeneity was identified for year of publication (p<0.001), treatment duration (p=0.002) and the use of a 5-HT4 agonist (p=0.004). The treatment effect for the 5-HT4 agonist was 23.8%, and duration of treatment showed a negative association (-0.085 for 1-week increases), but recent studies tended to include longer treatment durations.

Authors' conclusions

Prokinetic agents are effective in the short-term treatment of patients with FD.

CRD commentary

The review question was clear and was supported by appropriate inclusion criteria relating to the participants, intervention, outcome and study designs. The literature search was somewhat limited, using only two electronic databases, but a manual search was conducted to identify other potentially relevant papers. Publications were restricted to selected languages and, as there was no apparent search for unpublished material, potentially relevant papers might have been missed. Validity was assessed according to published criteria and attempts were made to minimise error and bias at each stage of the review process. Appropriate methods were used to pool the results and investigate statistical heterogeneity. However, potentially important clinical information on participant characteristics was not reported. Studies had small sample sizes and treatment durations were short, which affects the reliability of the results. The review appears to have been conducted appropriately, but the reliability and generalisability of the results is potentially hindered by some of the limitations highlighted already.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that future studies should include long-term RCTs to investigate the effects of different prokinetic agents in FD subtypes, and the efficacy of prokinetic agents with other treatments such as proton-pump inhibitors.

Funding

Not stated.

Bibliographic details

Hiyama T, Yoshihara M, Matsuo K, Kusunoki H, Kamada T, Ito M, Tanaka S, Nishi N, Chayama K, Haruma K. Meta-analysis of the effects of prokinetic agents in patients with functional dyspepsia. Journal of Gastroenterology and Hepatology 2007; 22(3): 304-310. [PubMed: 17295758]

Indexing Status

Subject indexing assigned by NLM

MeSH

Benzamides /therapeutic use; Benzyl Compounds /therapeutic use; Cisapride /therapeutic use; Domperidone /therapeutic use; Dopamine Antagonists /therapeutic use; Dyspepsia /drug therapy; Gastrointestinal Agents /therapeutic use; Humans; Metoclopramide /therapeutic use; Morpholines /therapeutic use; Trimebutine /therapeutic use

AccessionNumber

12007000618

Database entry date

30/09/2008

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.