Randomised double‐blind comparison of simethicone with cisapride in functional dyspepsia

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Abstract
Aim: : To compare the efficacy of simethicone with cisapride in patients with functional (non‐ulcer) dyspepsia.Methods: : After standardized diagnostic work‐up and at least 6‐days wash‐out of medication, 177 patients with functional dyspepsia were enrolled; 173 of them (age 19–71 years) were randomized and treated using a double‐dummy technique with simethicone (84 mg t.d.s.) or cisapride (10 mg t.d.s.). At baseline and after 2 and 4 weeks, the intensity of the symptoms was scored from 0 (absent) to 3 (severe) using a standardized symptom questionnaire. Efficacy of the treatment was judged by the patients as ‘very good’, ‘good’, ‘moderate’ or ‘no effect’.Results: : A total of 166 patients completed the trial. After 2 and 4 weeks, 34% and 46% (respectively), of the patients treated with simethicone judged the improvement in symptoms to be excellent compared to 13% and 22% (respectively) of patients treated with cisapride (P < 0.01). After 2 weeks the difference in the improvement in the global symptom score was significantly better (Δ30.7%, P < 0.001) for simethicone than for cisapride, while this difference failed statistical significance after 4 weeks (Δ10.2%, P=0.11).Conclusions: : In patients with functional dyspepsia, simethicone relieves symptoms during the first 2 weeks of treatment significantly better than cisapride.

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