However , benefit was limited to antipsychotics and tricyclic antidepressants .
Conclusions Psychotropic drugs may be an effective treatment for FD , but the effect appears to be limited to antipsychotics and tricyclic antidepressants with fewer trials for other agents , meaning that firm conclusions for efficacy can not be made .
Objective Functional dyspepsia ( FD ) is a chronic gastroduodenal disorder .
Individuals with FD demonstrate visceral hypersensitivity , abnormal central pain processing , and low mood , but it is unclear whether psychotropic drugs are an effective treatment for the condition .
Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials
Background : Functional dyspepsia ( FD ) is a common disorder but there is currently little efficacious drug therapy . Itopride , a prokinetic approved in several countries , showed promising efficacy in FD in a phase IIb trial . The aim of this study was to test the efficacy and safety of this drug in FD . Methods : Two similar placebo-controlled clinical trials were conducted ( International and North America ) . Males and females , 18–65 years old , with a diagnosis of FD ( Rome II ) and the absence ( by upper endoscopy ) of any relevant structural disease were recruited . All were negative for Helicobacter pylori and , if present , heartburn could not exceed one episode per week . Following screening , patients were r and omised to itopride 100 mg three times daily or identical placebo . The co- primary end points were : ( 1 ) global patient assessment ( GPA ) of efficacy ; and ( 2 ) Leeds Dyspepsia Question naire ( LDQ ) . Symptoms were evaluated at weeks 2 , 4 and 8 . Secondary measures of efficacy included Nepean Dyspepsia Index ( NDI ) quality of life . Results : The GPA responder rates at week 8 on itopride versus placebo were similar in both trials ( 45.2 % vs 45.6 % and 37.8 vs 35.4 % , respectively ; p = NS ) . A significant benefit of itopride over placebo was observed for the LDQ responders in the International ( 62 % vs 52.7 % , p = 0.04 ) but not the North American trial ( 46.9 % vs 44.8 % ) . The safety and tolerability profile were comparable with placebo , with the exception of prolactin elevations , which occurred more frequently on itopride ( 18/579 ) than placebo ( 1/591 ) . Conclusion : In this population with FD , itopride did not show a difference in symptom response from placebo
However , benefit was limited to antipsychotics and tricyclic antidepressants .
Conclusions Psychotropic drugs may be an effective treatment for FD , but the effect appears to be limited to antipsychotics and tricyclic antidepressants with fewer trials for other agents , meaning that firm conclusions for efficacy can not be made .
Objective Functional dyspepsia ( FD ) is a chronic gastroduodenal disorder .
Individuals with FD demonstrate visceral hypersensitivity , abnormal central pain processing , and low mood , but it is unclear whether psychotropic drugs are an effective treatment for the condition .