GU Chunhua, REN Junxia, YANG Libo, et al. Multicenter Randomized Double-blind Controlled Trial of Jieyu Chufan Capsule (解郁除烦胶囊) Treating 334 Cases with Depression[J]. Journal of Traditional Chinese Medicine2016, 57(15): 1297-1302.
GU Chunhua, REN Junxia, YANG Libo, et al. Multicenter Randomized Double-blind Controlled Trial of Jieyu Chufan Capsule (解郁除烦胶囊) Treating 334 Cases with Depression[J]. Journal of Traditional Chinese Medicine2016, 57(15): 1297-1302.DOI: 10.13288/j.11-2166/r.2016.15.010.
Multicenter Randomized Double-blind Controlled Trial of Jieyu Chufan Capsule (解郁除烦胶囊) Treating 334 Cases with Depression
Objective To evaluate the clinical effect and safety of Jieyu Chufan Capsule(解郁除烦胶囊) in treating depression. Methods The researchers used randomized double-blind double-dummy multicenter clinical trial design to select 560 subjects randomly into treatment group( 336 cases)
control group( 112 cases) and placebo group(112 cases). The treatment group took Jieyu Chufan Capsules and placebo tablets with fluoxetine hydrochloride. The control group took placebo capsules with Jieyu Chufan Capsules and fluoxetine hydrochloride tablets. The placebo group took placebo capsules with Jieyu Chufan Capsules and placebo tablets with fluoxetine hydrochloride. All courses of treatment were 42 days. Before and after treatment
the researchers gave a mark with Hamilton’s depression scale( HAMD)
Hamilton’ s anxiety scale( HAMA) and Chinese medical syndrome scores. After treatment
the researchers evaluated curative effects of diseases and Chinese medical syndromes
general comment of curative effects about clinical general impression scale( CGI-GI) and safety. Results After treatment
HAMD
HAMA scores and Chinese medical syndrome scores of each group were significantly lower than those before treatment( P < 0. 01). After treatment
HAMD
HAMA scores and Chinese medical syndrome scores of the treatment group and the control group were lower than those of the placebo group( P < 0. 01). And HAMA scores and Chinese medical syndrome scores of the treatment group were lower than those of the control group( P < 0. 01). Total effective rates about curative effects of diseases in the treatment group
the control group and the placebo group respectively were 90. 1%
84. 5% and38. 7%; The total effective rates about curative effects of Chinese medical syndromes were respectively 88. 6%
75. 5% and 34. 2%; The total progress of CGI-GI were respectively 90. 4%
85. 3% and 45. 0%. The therapeutic effect indexes of the treatment group and the control group were better than those of the placebo group( P < 0. 01).Curative effects of Chinese medical syndromes in the treatment group were better than those in the control group( P <0. 01). There was one case with adverse event related to the medicine occurring in the treatment group
showing better clinical safety. Conclusion Jieyu Chufan Capsule has remarkable therpeutic effect and safety in treating depression.