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Objective To investigate the curative effect of Zhizhukuanzhong capsule combined with Deanxit in the treatment of functional dyspepsia ( FD) of spleen -deficiency and qi -stagnation.Methods Seventy -six patients with FD were randomly divided into three groups .A group (24 cases)_was given Zhizhukuanzhong combined with Deanxit,B group (26 cases) was given Zhizhukuanzhong ,C group (26 cases) received trimebutine dispersible tablets treatment.After treatment for 8 weeks,the symptoms of indigestion,depressive state and therapeutic effect were observed.Results Before treatment,there were no statistically significant differences in the symptoms of dyspepsia (all P>0.05).After treatment,the symptoms of dyspepsia were improved in different degree ,the effective rates of A, B,C three groups were 91.6%,65.4% and 42.3%,respectively,there was no statistically significant difference between A group and B group(χ2 =1.579,P=0.209);there was statistically significant difference between A group and C group(χ2 =13.549,P=0.000);there was no statistically significant difference between B group and C group (χ2 =2.786,P=0.09).The FD patients complicated with varying degrees of anxiety and depression ,there was no statistically significant difference among the three groups before treatment (P>0.05).After treatment,comparison of HAMA and HAMD scores among the three groups:there were statistically significant differences between A group and B group (tHAMA =6.839,tHAMD =4.607,all P<0.05),A group and C group (tHAMA =20.069,tHAMD =15.342,all P<0.01),B group and C group (tHAMA =11.951,tHAMD =12.071,all P<0.01).After treatment,the HAMA,HAMD scores of A group and B group were significantly decreased compared with before treatment ( A group tHAMA =52.758,tHAMD=49.970,B group tHAMA =30.230,tHAMD =17.151,all P<0.01).Those in C group had no statistically significant decline compared with before treatment (tHAMA =7.845,tHAMD =3.530,all P>0.05).The adverse reactions of A group were mainly weakness ,dizziness,drowsiness,which were alleviated within 2 weeks.The adverse reactions of B group were slight stomach disease and stool frequency increased ,which not affected the treatment.The adverse reactions of C group were digestive tract symptoms ,which lasted for more than 2 weeks.Conclusion Zhizhukuanzhong capsule combined with Deanxit in the treatment of FD of spleen -deficiency and qi -stagnation can obtain good curative effect,it is safe,convenient,and with minor side effects,good compliance.
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Objective To investigate clinical effects of Deanxit in non-erosive gastroesophageal re-flux disease ( NERD) with anxiety and depression.Methods A total of 76 patients diagnosed NERD with anxiety and depression by endoscopy and hospital anxiety and depression scale ( HAD) were randomly divid-ed into regular treatment group and Deanxit treatment group.Clinical efficacy, symptom score, and anxiety and depression score were observed after one week, four weeks, and eight weeks.Results Deanxit signifi-cantly increased the clinical efficacy after one week ( P <0.01) and remission rate after one week ( P <0.05), four and eight weeks ( P <0.01).It improved symptoms, depression, and anxiety, which showed significant differences ( P <0.01) compared to control group after one week, four and eight weeks adminis-tration.Conclusions Deanxit can be applied in NERD with anxiety and depression treatment, which has quick effect and high remission rate, and improve patient's reflux symptoms and anxiety depression.
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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.
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Objective To investigate the efficacy of proton pump inhibitors (PPI) combined with flupethixol melitracen in the treatment of non-erosive gastroesophageal reflux disease (NERD) with anxiety and depression.Methods Fifty six NERD patients with anxiety and depression were evenly divided into the positive treatment group and positive control group.Thirty NERD patients without anxiety and depression were set as negative control group.Both flupethixol melitracen (20 mg per day after breakfast) and PPI esomeprazole magnesium (20 mg per day,20 minutes before breakfast) were administrated in positive treatment group.Only esomeprazole magnesium was given in positive control group and negative control group and the dosage was same as that of positive treatment group.The treatment course of three groups was eight weeks.Before and after the treatment,the symptoms of patients were scored according to gastroesophageal reflux disease questionnaire (GERDQ),Hamilton anxiety scale (HAMA),Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI).Adverse effects were also observed.Variance analysis was performed for the comparison among three groups.Variance analysis or Post-hoc analysis were used for comparison between two groups.Results The differences of different score value before and after treatment of three groups were statistically significant in total score of GERD Q,score of type A,score of type C,score of HAMA,score of HAMD and PSQI (F=6.32,3.93,5.63,49.61,78.69 and 7.07,all P＜ 0.05).The differences of the score value before and after treatment of positive treatment group in total score of GERD Q,score of type A,score of type C,score of HAMA,score of HAMD and PSQI (4.24±2.05,3.16±1.46,1(0,3),9.32±3.21 and 8.88±2.92) were all higher than those of positive control group (2.38±2.22,1.68±1.33,0(0,2),3.72±2.95 and 3.84±1.97) and negative control group (2.32±2.18,2.48±1.34,0(0,1),2.36±1.25 and 2.36±0.79).And the differences were statistically significant (positive treatment group vs positive control group:Post-hoc analysis,P=0.002,0.022,0.003,0.002 and 0.002; positive treatment group vs negative control group:Post-hoc analysis,P=0.001,0.021,0.004,0.001 and 0.001).The difference of the score value before and after treatment of positive treatment group in PSQI (4 (2,6)) was higher than that of negative control group (2 (1,3),Post-hoc analysis,P=0.001).Two cases of positive treatment group had mild dizziness and the symptom relieved after three to four days.Conclusions For NERD patients with anxiety and depression,anti-depression drug flupenthixol melitracen can be used and the effect is superior to using PPI alone.
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Objective To evaluate the efficacy difference between flupentixol and melitracen combined with conventional medicine and conventional drug alone in the treatment of irritable bowel syndrome (IBS).Methods Studies on flupentixol and melitracen combined with conventional medicine (pinaverium bromide and trimebutine maleate) and conventional medicine alone in the treatment of IBS were collected and reviewed through searching the Chinese Academic Journals Full-text Database,Chinese VIP Full-text Database and PubMed database.After that,the test for homogeneity and the combined effect test were estimated. Results A total of 12 clinical studies on flupentixol and melitracen combined with conventional medicine for four to twelve weeks in the treatment of IBS were collected six studies indicated the homogeneity test of flupentixol and melitracen combined with pinaverium bromide (x2 =1.90,df=5,P=0.86,I2 =0).For the fixed-effect model,the odds ratio was 7.92 and 95％ CI was between 4.85 and 12.95,which suggested the combined therapy was better.The other six studies indicated the homogeneity test of flupentixol and melitracen combined with trimebutine maleate (x2 =5.60,df=5,P =0.35,I2 =10.6 ％).For the fixed-effect model,the odds ratio was 5.91 and 95％ CI was between 4.06 and 8.61,which suggested the combined therapy was better.After merging the 12 studies it indicated the homogeneity test of flupentixol and melitracen combined with conventional medicine (x2 =8.40,df =11,P =0.68,I2 =0).For the fixed effect model,the odds ratio was 6.63 and 95％ CI was between 4.92 and 8.93.Conclusion The efficacy of flupentixol and melitracen combined with conventional medicine in the treatment of IBS was better than that of conventional medicine alone,however,still more high quality trials are needed for further confirmation.
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Objective To evaluate the efficacy and safety of wuling capsule compared with deanxit in treatment of patients with depression or anxiety status. Methods A total of 139 patients with depression or anxiety status were enrolled in a multi-center double blind clinical trial. All patients were randomized into two groups, 67 patients in wuling capsule group and 73 patients in deanxit group. Efficacy and adverse effects were evaluated with Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD),Pittsburgh Sleep Quality Index (PSQI) and Treatment Emergent Symptoms Scale (TESS) before treatment and 1, 2, 4, 6 weeks after treatment to verify the noninferiority of wuling capsule. Results There was no significant difference in score decline of HAMA and HAMD between the two groups (HAMA: wuling vs deanxit group: 9.0 ± 5.4 vs 10.3 ± 5.4, F = 2.11, P =0.148 ; HAMD: wuling vs deanxit: 9.1±5.6 vs 10.5±5.7, F = 1.61, P=0.207). There was no significant difference in response rate and remission rate between the two groups. No significant difference was found in score decline of PSQI between the two groups (wuling vs deanxit group: 4.1±4.5 vs 5.0 ± 4.2, F = 0.72, P=0.192). The incidence of adverse events was 41% in the wuling group and 55% in the deanxit group respectively. The main adverse effects were symptoms of gastrointestinal and neurology system. Conclusion Safe and well tolerated, wuling capsule improves the anxiety, depression and insomnia symptoms of patients with depression or anxiety status.