OBJECTIVETo evaluate the efficacy and safety of Chaihu Xiaoyao Mixture (CXM) for the treatment of major depressive disorder (MDD).

METHODSOne hundred and ninety patients with MDD were randomly assigned to two groups, the test group and the control group. They were treated by paroxetine combined with CXM or placebo for 8 weeks. The therapeutic efficacy was evaluated at the end of the 2nd, 4th and 8th week by scoring according Hamilton Rating Scale for Depression (HAMD-17) and Clinical Global Impression (CGI) scale, and the adverse reaction was scaled by Treatment Emergent Symptoms Scale (TESS).

RESULTSFollow-up study was completed in 89/92 patients in the test group, and 93/98 patients in the control group, with 3 and 5 cases dropping, respectively. The effective rate in the two groups was 84.8% and 71.4%, and the cure rate was 69.6% and 55.1%, respectively, which were significantly higher in the test group than in the control group (chi2=4.92, P<0.05; chi2=4.22, P<0.05). As compared with the baseline, significant differences in HAMD-17 total score and scores of its various factors as well as the CGI score were shown in both groups after 2, 4 and 8's week treatment (P<0.01). Comparison between groups showed that significant differences presented in HAMD-17 total score and CGI score at the end of the 8th week (P<0.01), while comparison of adverse reactions between groups showed insignificantly statistical difference (P>0.05).

CONCLUSIONCombined treatment of CXM and paroxetine is more effective than that with paroxetine alone in treating MDD, and it could enhance the clinical efficacy with higher safety.