Clinical Study On Shugan Granule In Treating Yugan Qi And Qi Stagnation Syndrome (mild To Moderate Depression)

Objective: To observe the clinical efficacy, adverse reactions and safety of the shugan granule in treating mild and moderate-grade depression.Methods: a prospective, randomized, double-blind, double-simulation, positive controlled, parallel group trial was adopted 108 cases were enrolled in this study, and all patients were randomly divided into two groups. Treatment group take orally “Shugan granule” 0.3g tid and one tablet of simulation qd. Control group was given one tablet of Paroxetine Hydrochloride qd and 0.3g simulation granule bid. Both groups were stopped taking all the medicine for for 6w±7days.Before and after treatment, we compared and analyzed HAMD, HAMA, TCM scale scores of two groups, the content of 5-HT, NE, DA, and summarized and observed the security index such as blood RT, ECG, liver and kidney tests.Results:1.TCM scale score comparison: scales scores in the two groups were found significant statistical differences before and after treatment(P<0.01);The results showed that both the two medicines can improve patients’ symptom after treatment, total clinical effective rate in two groups has significant differences(P<0.01). It shows that shugan granule is better than Paroxetine Hydrochloride in improving TCM symptom.2.HAMD scale score comparison: scales scores in the two groups were found significant statistical differences before and after treatment(P<0.01); The results showed that the two medicines can improve patients’ depression; after treatment, total clinical effective rate in the two groups has statistical differences(P<0.05).It shows that shugan granule is better than Paroxetine Hydrochloride in improving depression symptom.3.HAMA scale score comparison: scales scores in the two groups were found significant statistical differences before and after treatment(P<0.01); The results showed that the two medicines can improve patients’ depression; after treatment, total clinical effective rate in the two groups has no significant differences(P>0.05). It shows that shugan granule and Paroxetine Hydrochloride have similar effect in improving anxiety symptom.4.Laboratory analysis: the content of 5-HT,NE were found no statistical differences before and after treatment(P>0.05). The results showed that both the two medicines can not improve the content of 5-HT, NE. The content of DA were found has statistical differences before and after treatment(P<0.05). The results showed that both the two medicines can improve the content of DA. After treatment, the content of DA in the two groups has no significant statisticaldifferences(P>0.05). It shows that shugan granule and paroxetine hydrochloride have similar effect in improving the content of DA.5.Safety judgment: during treatment, all patients in the two groups had not severe adverse reaction, so it is easy to take and be accepted by patients. 4 adverse event were found during treatment, but relieved quickly. ECG, blood routine, liver and kidney function in the two groups were normal during treatment. It shows that both two medicine are safe.Conclusions: Shugan granule for the treatment of mild and moderate-grade depression is effective and safe, and it is worthy of further study.