舒肝解郁胶囊治疗轻中度抑郁症的随机双盲安慰剂对照研究

Randomized,double blind,placebo-controlled trial of Shuganjieyu capsule in the treatment of mild or moderate depression

目的:评价舒肝解郁胶囊治疗轻中度抑郁症的疗效及安全性。方法:采用随机双盲多中心安慰剂平行对照的研究方法。共入组患者120例,舒肝解郁胶囊组80例,安慰剂组40例,疗程6周。以汉密尔顿抑郁量表、中医证候量化评分作为疗效评价指标。结果:基于汉密尔顿抑郁量表评估,舒肝解郁胶囊组总有效率68.0%,安慰剂组29.0%(组间比较P<0.01);基于中医证候评估,舒肝解郁胶囊组有效率为59.0%,安慰剂胶囊组有效率为23.7%(组间比较P<0.01);总的不良事件及不良反应发生率两组比较均无统计学意义。结论:舒肝解郁胶囊治疗轻中度抑郁症安全有效。

Objective： To evaluate the efficacy and safety of Shuganjieyu capsule in the treatment of mild and moderate depression.Methods： A randomized,double-blind,placebo controlled,and multi-center trail recruited 120 patients with mild and moderate depression.They received Shuganjieyu capsule（n=80） or placebo capsule（n=40） for 6 weeks.The efficacy was evaluated by Hamilton Depression Scale（HAMD）,and Symptom of Traditional Chinese Medicine（STCM）.Results： The responded rates of Shuganjieyu and placebo were 68.0% and 29.0% based on HAMD（P〈0.01）,and 59.0% and 23.7% based on STCM（P〈0.01）,respectively.The total adverse events and the incidence rates of adverse effects were not significantly different between Shuganjieyu and placebo.Conclusion： Shuganjieyu capsule is an effective and safe antidepressant.