The treatment of patients with functional dyspepsia remains unsatisfactory.
Dr Gerald Holtmann and colleagues assessed the efficacy of itopride, a dopamine D2 antagonist with acetylcholinesterase effects.
The investigators randomly assigned 554 patients with functional dyspepsia to receive either itopride at 50, 100, or 200 mg, 3 times daily, or placebo.
After 8 weeks of treatment, 3 primary efficacy endpoints were analyzed.
The first endpoint was the change from baseline in the severity of symptoms of functional dyspepsia, as assessed by the Leeds Dyspepsia Questionnaire.
The second endpoint assessed by the team was the patients' global assessment of efficacy, or the proportion of patients without symptoms or with marked improvement.
|64% receiving itopride 200 mg 3 times daily had no symptoms vs 41% with placebo|
|New England Journal of Medicine|
The final outcome assessed by the investigators was the severity of pain or fullness as rated on a 5-grade scale.
Only 523 patients had outcome data and could be included in the analyses.
After 8 weeks, 41% of the patients receiving placebo were symptom-free or had marked improvement.
The team noted that groups receiving itopride at a dose of 50, 100, or 200 mg, and 3 times daily, had no symptoms or showed improvements in 57%, 59%, and 64%, respectively.
Although the symptom score improved significantly in all 4 groups, an overall analysis revealed that itopride was significantly superior to placebo.
The investigators observed the greatest symptom-score improvement in the 100- and 200-mg groups.
Analysis of the combined end point of pain and fullness showed that itopride yielded a greater rate of response than placebo.
Dr Holtmann's team concluded, “Itopride significantly improves symptoms in patients with functional dyspepsia.”