Levosulpiride in functional dyspepsia: a multicentric, double-blind, controlled trial

Abnormalities in gastrointestinal motility have been reported in a substantial proportion of patients with functional dyspepsia, supporting the use of prokinetic drugs for treatment of dyspeptic symptoms. To evaluate efficacy and safety of levosulpiride in short-term treatment, 1298 patients were enrolled in a double-blilnd multicentric study carried out in 45 Italian Gastroenterology Departments. Patients were randomly assigned to either levosulpiride (25 mg tid), domperidone (10 mg tid), metoclopramide (10 mg tid) or placebo 1 tablet tid) for 4 weeks. Patients were selected on the basis of : a) occurrence in the last 4 weeks of at least 5/10 selected symptoms (anorexia, nausea, vomiting, upper abdominal pain, postprandial bloating, abdominal fullness, early satiety, belching, heartburn, regurgitation), severity of which should reach/exceed a total score of 8, as assessed by a specific scale ranging from 0 (absent) to 3 (severe); b) normal resulta of routine biochemical, ultrasound and endoscopic examinations. In addition, each patient subjectively evaluated efficacy fo treatment by a visual analogue scale. Significant improvement was recorded for all symptoms at day 10 and 28 in all groups (p< 0.001), but levosulpiride was significantly (p < 0.01) superior to domperidone, metoclopramide and placebo both in the overall clinical improvement scale as well as in a subgroup of symptoms (postprandial bloating, epigastric pain, heartburn). Active treatments and placebo zere comparable as far as concerns occurrence os side-effects (12-20%) including galactorrhoea, breast tenderness and menstrual changes.