A randomized, controlled, multi-centre clinical study on the efficacy of flupenthixol melitracen in the treatment of patients with functional dyspepsia accompanied by depression / 中华消化杂志

ABSTRACT

Objective To explore the efficacy of flupenthixol melitracen in the treatment of functional dyspepsia (FD) and its effects on receptivity expansion and visceral sensitivity.Methods A randomized,controlled,multi-centre study was carried out.The FD patients with depression were divided into anti-depression group and control group.The patients of both groups received omeprazole and mosapride treatment for eight weeks.The patients of anti-depression group added flupenthixol melitracen and psychotherapy.Before the treatment,by the end of the second,fourth,sixth and eighth week of the treatment,the scores of upper gastrointestinal symptoms and adverse effects of the patients of the two groups were recorded,the psychological status was evaluated by Hamilton depression scale and the gastric receptivity expansion and visceral sensitivity were assessed by water loading test (WLT).The data were analyzed by t test and chi-square test.Results Among two hundred and fifty enrolled FD patients with depression,245 patients (129 in anti-depression group,116 in control group) were enrolled in intention-to treat analysis.Before the treatment and by the end of the eighth week of the treatment,the scores of upper gastrointestinal symptoms of anti depression group were 12.23±4.45 and 2.31±2.13 (t=22.837,P=0.008),the control group were 12.29± 4.62 and 8.58±3.76 (t=6.708,P=0.184).By the end of the eighth week of treatment,the difference between the two groups was statistically significant (t =16.261,P＜0.05).By the end of the fourth and eighth week of treatment,the total effective rates of the improvement of upper gastrointestinal symptoms of anti-depression group were 76.0％ (98/129) and 83.7％ (108/129),control group were 14.7 ％ (17/116) and 25.9 ％ (30/116),the differences between the two groups were statistically significant (x2 =92.191 and 83.117,both P＜0.05).By the end of the eighth week of treatment,the total effective rate of the improvement of depression of anti depression group was 71.3％ (92/129),which was higher than that of control group (23.3％,27/116),the difference between two groups was statistically significant (x2 54.434,P＜0.01).Before the treatment,the maximum WLT volume of anti depression group was (850±130) mL,by the end of the eighth week of treatment was (1400±210) mL (t=25.292,P＜0.01).Before the treatment and by the end of the eighth week of treatment,the maximum WLT volumes of control group were (800± 120) mL and (960±140) mL (t=9.345,P＜0.01).All the adverse effects of anti depression therapy were mild.Conclusion The treatment of flupenthixol melitracen can improve the efficacy in patients with FD,relieve the depression status,improve gastric receptivity expansion and visceral sensitivity with a good safety and tolerability.