| OBJECTIVE: To observe the clinical efficacy and safety of Shuganjieyu capsule on the treatment of functional dyspepsia(FD) with mild to moderate depression symptom.METHODS: Two hundread and forty-five cases of FD with mild to moderate depression were randomly assigned into the experimental group(n=135)and the control group(n=110), both groups receiveing rabeprazole and domperidone.The patients of the experimental group were extra given Shuganjieyu capsule,and the patients of the control group were given placebo.The course of treatment was for 4 weeks.The clinical efficacy, the total score of the Gastrointestinal Symptom Rating Scale(GSRS),the depression score of the Hospital Anxiety Depression Scale(HADS) and the adverse reactions before and after treatment were compared between the two groups.RESULTS: After 4 weeks of treatment,24 cases(17.8%) in the experimental group were markedly effective,81 cases(60.0%)were effective and 30 cases(22.2%)were ineffective,with the effective rate of 77.8%.In the control group,4 case(3.6%)was markedly effective,35 cases(31.8%)were effective and 71 cases(64.5%)were ineffective,with the effective rate 35.5%.Compared with the control group, the effective rate in the experimental group was significantly higher(P<0.05).The total score of GSRS and the depression score of HADS in the experimental group were significantly lower than those in the control group(P<0.05).There were no severe adverse effects in both groups.CONCLUSION: Shuganjieyu capsule combined with proton pump inhibitors and gastrokinetic agents shows obvious short term effects on treating FD with mild to moderate depression symptom and has no severe adverse reactions,which is safe and reliable. |