A randomized clinical study on flupentixol and melitracen and mosapride in the treatment of functional dyspepsia

Objective To explore the efficacy and side effects of flupentixol and melitracen (deanxit) and mosapride in the treatment of functional dyspepsia(FD).Methods One hundred and twenty patients with functional gastrointestinal disorder who were diagnosed according to Roma Ⅲ criteria were enrolled in this randomized study and divided into 2 treatment groups.The experimental group (n =60) was given 1 tablet deanxit(containing flupentixol(0.5 mg) and melitracen(10 mg)) twice daily(in the morning and noon) and 5 mg mosapride three times a day (before meals).The control group (n =60) was given 20 mg omeprazole daily (before breakfast) and 5 mg mosapride three times a day(before meals).Effective rates and adverse reactions were compared between the experimental and the control groups after 1 week' s,2 weeks' and 4 weeks' treatment.Scores of FD symptoms(postprandial distress,early satiety,epigastric pain and epigastric burn) were recorded before and after treatment respectively.Results There were 102 patients(52 in the experimental group and 50 in the control group) who completed the 4-week follow-up in this study.Clinical symptoms improved after treatment in both groups,with higher significantly effective rates in the experimental group at 1 week,2 weeks and 4 weeks of treatment than in the control group(1 week:65％ vs.46％,x2 =3.885 ;2 weeks:75％ vs.56％,x2 =4.083 ;4 weeks:88％ vs.64％,x2 =5.976 ; P ＜ 0.05).The scores of FD symptoms after treatment were significantly lower than pre-treatment in both groups (the experimental group:t =35.725,29.116,41.167 and 2.908 respectively,P ＜0.05 ;the control group:t =18.760,16.201,31.497 and 14.940 respectively,P ＜0.05).The experimental group had significantly lower scores of three FD symptoms after treatment than the control group did (postprandial distress:t =33.943 ; early satiety:t =26.672 ; epigastric pain:t =19.035 ; P ＜ 0.05).No significant difference was observed on epigastric burn score between the experimental and the control groups(t =1.872 ;P ＞ 0.05).The rate of somnolence or dizziness was significantly higher in the experimental group who took flupentixol and melitracen than in the control group who took omeprazole(13.3 vs.1.7％,x2 =4.324,P ＜0.05).Conclusion Deanxit and mosapride is more effective than omeprazole and mosapride in treating FD.Flupentixol and melitracen is safe to subjects and its adverse drug reactions are not serious. Key words: Functional dyspepsia; Flupentixol and melitracen; Mosapride