[Comparison of a new medical device with domperidone in functional dyspepsia: a randomized, cross-over, controlled study].

Abstract

AIM:

Management of functional dyspepsia is still controversial. Different controlled trials reported a superiority of prokinetics, H2-receptor antagonists and proton-pump inhibitors over placebo; nevertheless, symptomatic improvement after therapy is often incomplete and some of these drugs possess serious side effects. The aim of the study was to evaluate the efficacy of a new medical device in respect to domperidone in patients with functional dyspepsia.

METHODS:

In a cross-over, randomized trial, 36 patients with functional dyspepsia ingested two daily doses of a medical device (Digerfast) or domperidone (Peridon) for 21 days. Clinical evaluation was performed at baseline (T0) and after 21 days (T1) for each treatment. A Visual Analogue Scale (VAS) and the generic scale 36-item Short Form (SF-36) were used to assess symptom intensity and changes in health-related quality of life, respectively.

RESULTS:

At T0 no statistical difference was found for each symptom between medical device and domperidone. At T1 both treatments significantly improved in respect to baseline values all the evaluated gastrointestinal symptoms (P<0.5 for all comparisons) except for vomiting. No difference in gastrointestinal symptoms between the two treatments was found at T1. Regarding SF-36 evaluation, at T0 no statistical differences were found for each SF-36 parameter between the two regimens. At T1 both treatments significantly improved most of the evaluated SF-36 parameters in respect to baseline values. No difference in SF-36 parameters between the two treatments was found at T1.

CONCLUSION:

Both the medical device and domperidone significantly improved gastrointestinal symptoms and quality of life in subjects with functional dyspepsia, not showing significant difference in efficacy.

• Authors: A Gallo, M Giovinale, C Fonnesu, M Covino, M Montalto, G Gasbarrini
• Journal: Minerva medica (Minerva Med) Vol. 102 Issue 2 Pg. 133-9 (Apr 2011) ISSN: 0026-4806 [Print] Italy
• Vernacular Title: Confronto tra un nuovo dispositivo medico e domperidone in pazienti con dispepsia funzionale: studio randomizzato, cross-over, controllato.
• PMID: 21483400 (Publication Type: Comparative Study, English Abstract, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Drug Carriers
• Drug Combinations
• Gastrointestinal Agents
• Sorbitol
• Domperidone
• Simethicone
• Potassium Citrate

Topics

• Adult
• Cross-Over Studies
• Domperidone (therapeutic use)
• Drug Carriers (administration & dosage, chemistry)
• Drug Combinations
• Dyspepsia (drug therapy)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Male
• Pain Measurement
• Potassium Citrate (therapeutic use)
• Quality of Life
• Simethicone (therapeutic use)
• Sorbitol (therapeutic use)
• Statistics, Nonparametric
• Treatment Outcome