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[The efficacy of a combination herbal medicine in the treatment of functional dyspepsia. Meta-analysis of randomized double-blind studies on the basis of a valid gastrointestinal symptom profile].

BACKGROUND AND AIM
Functional dyspepsia is a heterogeneous clinical entity of incompletely known etiology. Overall, four randomized double-blind studies from the nineteen-nineties investigating acute treatment of this condition with the combination herbal medicine Iberogast, are available. A meta-analysis of the studieswas carried out to evaluate the overall therapeutic effect.


PATIENTS AND METHODS
In all four, triple-arm, controlled multicentre studies, the efficacy of 4 weeks of treatment with 3 x 20 drops daily, applied after a washout phase, was investigated, the primary efficacy parameter being a specific gastrointestinal symptom score. Of the 592 participants in the studies, 196 were treated with Iberogast, 131 with placebo, and 61 with cisapride as positive control. The remaining 204 patients, who were treated with an experimental herbal preparation of similar composition, were not admitted to the final analysis.


RESULTS
While overall appreciable improvement of the clinically relevant symptoms of moderate severity was seen under treatment with the combination herbal preparation, the individual studies differed in terms of the statistical significance of the results obtained. The meta-analysis of studies revealed a clear therapeutic effect for the herbal medicine (p < 0.0001).


CONCLUSION
The clinical experience with the combination preparation for the treatment of functional dyspepsia was confirmed by the meta-analysis of the modern double-blind studies.