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A Placebo-Controlled Trial of Itopride in Functional Dyspepsia

Background. Dyspepsia remains a common and costly problem in primary care and gastroenterology practiceIn most patients who are examined, no structural lesions causing these symptoms are found=FDPharmacologic treatments for patients with functional dyspepsia remain unsatisfactory (H2RA, PPI, HP

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A Placebo-Controlled Trial of Itopride in Functional Dyspepsia

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    1. A Placebo-Controlled Trial of Itopride in Functional Dyspepsia NEJM 02/2005

    2. Background Dyspepsia remains a common and costly problem in primary care and gastroenterology practice In most patients who are examined, no structural lesions causing these symptoms are found=FD Pharmacologic treatments for patients with functional dyspepsia remain unsatisfactory (H2RA, PPI, HP eradication) RCTs and meta-analyses have demonstrated the superiority of cisapride over placebo (SE)

    3. Background In Japan, itopride (50 mg tid), which is a dopamine D2 antagonist with acetylcholinesterase inhibitory actions, is often prescribed for patients with FD This drug has been shown to stimulate gastric motility No controlled trials in patients with FD

    4. Aim Efficacy of itopride in pts with FD: symptom improvement to compare various doses of itopride in terms of efficacy and safety in a white population

    5. Method FD on the basis of the Rome II criteria Persistent or recurrent upper abdominal pain (early satiety, postprandial fullness, bloating, and nausea) Symptoms had to be present for at least 12 weeks within the preceding 12 months, w/o an identifiable structural or biochemical abnormality Patients who had only reflux-related symptoms or who had predominantly reflux-related symptoms were not eligible for participation

    6. Patients were randomly assigned to receive either placebo (three times daily) or one of three doses of itopride (50, 100, or 200 mg three times daily) The study medication was given in a double-blind fashion for eight weeks Symptoms and Global Relief : validated Leeds Dyspepsia Questionnaire (LDQ) 8 symptoms on 0-6 scale (0 = none and 5 very severe); a summary score 0-40             

    7. Primary Outcome Variables: The change in the summary LDQ score relative to baseline after eight weeks of treatment Patients' global assessment of efficacy every two weeks The composite response criterion with respect to the severity of pain in the upper abdomen and the severity of a feeling of excessive fullness

    8. 548 patients

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