Study on the efficacy of flupenthixol melitracen combined with domperidone in the treatment of patients with functional dyspepsia accompanied by anxiety and depression

Abstract

Objective To evaluate the efficacy and adverse effects of flupenthixol meditracen combined with domperidone in the treatment of patients with functional dyspepsia(FD) accompanied by anxiety and depression.Methods The clinical trial was a multi-centre,open,randomized,controlled,prospective study.The patients wiht FD accompanied by anxiety and depression from eight hospitals were divided into control group and experimentd group.The patients of control group were treated with domperidone 10 mg three times per day.On the basis of the treatment of control group,the patients of experimental group were given deanxit one tablet (flupentixol 0.5 mg and melitracen 10 mg) after breakfast and lunch per day.The patients were evaluated by the gastrointestinal symptom rating scale(GSRS),the hospital anxiety and depression scale (HAD),the Hamilton anxiety scale (HAMA) and the Hamilton depression rating scale (HAMD) when enrolled and were followed up at the first,second and fourth week.The adverse effects were recorded.Using rank sum test,chisquare test and t-test to comparison of efficacy between the two groups,respectively.Results A total of 209 patients were enrolled during the trial,including 105 patients in control group and 104 patients in experimental group.Before the treatment,there were no statistical difference between the two groups in gastrointestinal symptoms,the water loading test and the hospital depression scale (all P＞ 0.05).However,the scores of hospitol anxiety scale,HAMA and HAMD in the experimental group were significantly higher than those of control group (t=2.405,3.982,3.374; all P＜0.05).After one week of treatment,the symptoms of both two groups improved.And the longer duration of the treatment,the more obvious of the efficacy.The efficacy of the experimental group was always better than that of the control group.Both of the complete remission rate and significant efficacy rate of the experimental group were higher than those of control group (19.2％,20/104 vs 5.7％,6/105; 37.5％,39/104 vs 11.4％,12/105; Z=4.935,P＜0.01).After four weeks of treatment,the decrease of the scores of HADS,HAMA and HAMD of experimental group was greater than those of control group (HAD:Z=6.779,6.667,HAMA:Z=6.896; HAMD:Z=8.867; all P＜0.01).Besides,51.9 ％ (54/104) patients with FD accompanied by depression became normal,the percentage was higher than that of control group (23.8％,25/105) and the difference was statistically significant (x2 20.460,P＜0.01).During treatment,the common adverse effects were dry mouth and constipation,which were mild and needed no special treatment.Conclusion Flupenthicol melitracen combined with domperidone demonstrateds significant efficacy in the treatment of FD accompanied by anxiety and depression without obvious adverse effects and is worthy of clinical application. Key words: Dyspepsia; Depression; Flupenthixol; Domperidone