Evaluation of therapeutic effects of flupentixol and melitracen combined with Saccharomyces boulardii on patients with diarrhea-predominant irritable bowel syndrome accompanied with anxiety and depression / 中华消化杂志

ABSTRACT

Objective To assess the therapeutic effects of flupentixol and melitracen tablets combined with Saccharomyces boulardii on patients with diarrhea-predominant irritable bowel syndrome (IBS) accompanied with anxiety and depression.Methods This multi-center,randomized,prospective study enrolled 84 patients with diarrhea-predominant IBS who were divided into combined treatment group (42 patients) and control group (42 patients).Saccharomyces boulardii was administrated in both of the groups,and flupentixol and melitracen was added in combined treatment group.The treatment course was four weeks.The gastrointestinal symptoms and mood disorders were evaluated before treatment,one week and four weeks after treatment.Adverse reactions were also observed.Chi-square test was performed for statistical analysis.Results At the end of one week after treatment,the efficacy rates of gastrointestinal symptoms improvement of combined treatment group and control group were 31.0％ (13/42) and 23.8％ (10/42),and there was no statistically significant difference (P＞0.05).At the end of four weeks after treatment,the efficacy rate of gastrointestinal symptoms improvement of combined treatment group was 92.5％ (37/40),which was higher than that of control group (73.2％,30/41),and the difference was statistically significant (x2 =5.291,P =0.037).At the end of one week after treatment,the efficacy rates of Hamilton Depression Scale score improvement of combined treatment group and control group were 31.6％ (12/38) and 12.1％ (4/33),and there was no statistically significant difference (P＞0.05).At the end of four weeks after treatment,the efficacy rates of Hamilton Depression Scale score improvement of combined treatment group was 63.9％ (23/36),which was higher than that of control group (34.4％,11/42),and the difference was statistically significant (x2 =6.433,P=0.043).At the end of one week and four weeks after treatment,the efficacy rates of Hamilton Depression Scale score improvement of combined treatment group were 35.7％ (15/42) and 80.0％ (32/40),which were higher than those of control group (15.4％,6/39 and 34.2％,13/38),and the differences were statistically significant (x2 =9.759,P=0.007; x2 =17.105,P＜0.01).One week after treatment,the adverse events rates of combined treatment group and control group were 4.8％ (2/42) and 4.8％ (2/42) ; four weeks after treatment,the adverse events rates of combined treatment group and control group were 2.5％ (1/40) and 2.4％ (1/41).There was no statistically significant difference in adverse events rates between two groups (both P＞0.05).Conclusions Flupentixol and melitracen combined with Saccharomyces boulardii treatment could not only improve the anxiety and depression symptoms of patients with diarrhea-predominant IBS,but also effectively improve gastrointestinal symptoms.The efficacy of combined treatment is better than monotherapy Saccharomyces boulardii alone treatment.