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Levosulpiride in functional dyspepsia: a multicentric, double-blind, controlled trial
G R Corazza1, F Biagi, O Albano
1Cattedra di Fisiopatologia Medica, Università de L'Aquila, Italy.
The Italian Journal of Gastroenterology
|July 1, 1996
Summary
Levosulpiride effectively treated functional dyspepsia symptoms, outperforming domperidone and metoclopramide. This prokinetic drug offers a safe and beneficial short-term treatment option for dyspeptic patients.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Medicine
Background:
- Functional dyspepsia (FD) is frequently associated with gastrointestinal motility disorders.
- Prokinetic drugs are often used to manage FD symptoms.
Purpose of the Study:
- To evaluate the efficacy and safety of levosulpiride compared to domperidone, metoclopramide, and placebo in short-term FD treatment.
Main Methods:
- A double-blind, multicentric study involved 1298 FD patients across 45 Italian centers.
- Patients received levosulpiride (25 mg tid), domperidone (10 mg tid), metoclopramide (10 mg tid), or placebo for 4 weeks.
- Efficacy was assessed using a clinical improvement scale and visual analogue scale for symptom severity.
Main Results:
- All treatments showed significant symptom improvement (p < 0.001) at 10 and 28 days.
- Levosulpiride demonstrated superiority over domperidone, metoclopramide, and placebo (p < 0.01) in overall improvement and specific symptoms (bloating, epigastric pain, heartburn).
- Side-effect incidence (12-20%) was comparable across all groups, including placebo.
Conclusions:
- Levosulpiride is an effective and safe option for short-term management of functional dyspepsia.
- The drug shows superior efficacy compared to other prokinetic agents and placebo for key dyspeptic symptoms.