Efficacy and safety of double doses of SHUGANJIEYU capsules in treating moderate depressive disor-der:a multicenter, random, double-blind, and parallel-controlled trial
10.3969/j.issn.1002-0152.2016.10.002
- VernacularTitle:舒肝解郁胶囊剂量加倍治疗中度抑郁症的随机、双盲、平行对照、多中心临床研究
- Author:
Qingwei LI
;
Jun YAO
;
Wenyuan WU
;
Xueqin YU
;
Wei WANG
;
Yiwen HU
;
Lijun YANG
;
Mei LI
;
Xiumei LI
- Keywords:
SHUGANJIEYU capsule;
Depressive disorder;
Randomized controlled trial
- From:
Chinese Journal of Nervous and Mental Diseases
2016;42(10):580-585
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the efficacy and safety of double dosage of SHUGANJIEYU capsule on mod?erate depression. Methods The study was conducted by a multicenter, random, double-blind and parallel-controlled trial. Trial group received SHUGANJIEYU capsules 4# twice a day. Control group got two SHUGANJIEYU capsules and two simulated ones twice a day. The study lasted 56 days (8 weeks) for both groups. Primary efficacies were evalu? ated by the total score and score changed rate of Hamilton depression scale-17 (HAMD-17)and Hamilton anxiety scale (HAMA) as well safety by reported adverse events and laboratory tests for patients. Results One hundred twenty patients were recruited in trial group and 120 patients in control group. After a 8-week treatment, the remission ratio was 84.2% and 63.3% for the trial group and the control group, respectively according to the HAMD-17. The differ?ence in the remission ratio was significant (P<0.05). Furthermore, the reduction rate of the total scores of HAMD-17 was 35.4% and 27.1% for the trial group and the control group at the 14th day of treatment, respectively, whereas 79.0%and 65.9%for the trial group and the control group at the 56th day. The reduction ratio was significantly higher in trial group than control group (P<0.01). The median time to response was 14 days in both groups. Based on the HA?MA, the remission ratio was 93.3%and 77.5%for the trial group and the control group respectively after 8 weeks and the difference in the remission ratio was significant between the two groups (P<0.05). Incidences of adverse effect were not significantly different between the two groups (17.5%vs. 11.7%, P>0.05). Conclusion SHUGANJIEYU capsule ex?hibits a good therapeutic effect on the depressive symptoms and anxiety symptoms in patients with moderate depres?sion. Double doses of SHUGANJIEYU capsule can increase the effect of SHUGANJIEYU and accelerates SHUGAN?JIEYU-induced improvement of depression symptoms with an acceptable safety.
