Efficacy of Trimebutine Maleate in the Treatment of Functional Dyspepsia in Childhood

Peripheral μ-, k- and δ-opioid agonist trimebutine maleate is considered to be an effective therapeutic drug for the treatment of functional gastrointestinal disorders. Ninety-two paediatric outpatients (12- 17 year-old) suffering from functional dyspepsia (epigastric pain and meal-induced dyspeptic symptoms) were enrolled in a prospective openlabel study. For ethical reasons, no placebo group was included. Patients were treated with trimebutine maleate (200 mg three times daily). After a 3-week treatment there was a significant decrease in scores of epigastric pain (p<0.05), postprandial fullness (p<0.05), early satiety (p<0.05), nausea (p<0.05) and belching (p<0.05). The treatment regimen was well tolerated and demonstrated a good compliance. In conclusion, we postulate that trimebutine maleate is an effective medication for relief of main symptoms associated with functional dyspepsia syndrome in childhood. Because of the limited data on therapeutic interventions in functional dyspepsia in childhood and increasing demand for therapies to treat this disorder, further evaluation of the efficacy of trimebutine treatment for children is certain. DOI: http://dx.doi.org/10.3126/jnps.v33i2.7229 J Nepal Paediatr Soc. 2013; 33(2):158-162