Liu Qing-Quan, Zhang Jie, Guo Rong-Juan, Xie Ying-Zhen, Fu Qing-Nan, He Tian, Zhu Xue-Qi, Du Jie, Yang Jing, Wang Jia-Lin, Wei Min-Min, Li Qian-Qian, Shi Guang-Xia, Liu Cun-Zhi
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China.
Dongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
BMJ Open. 2016 Feb 2;6(2):e008459. doi: 10.1136/bmjopen-2015-008459.
Insomnia is a highly prevalent, often debilitating and economically burdensome sleep disorder with limited effective therapies. Few data are available to understand which of the therapeutic alternatives is the most effective for patients with insomnia, especially for Traditional Chinese Medicine (TCM). Chinese herbal medicine, as a typical TCM, is one of the most popular complementary and alternative therapies for insomnia. We aim to evaluate the efficacy and safety of the Chaihuguizhiganjiang-suanzaoren granule (CSG), a Chinese herbal medicine treatment, in patients with primary insomnia.
This is a multicentre, placebo-controlled, double-blinded, randomised controlled clinical trial. A total of 258 participants are randomly allocated to two groups: the intervention group or the placebo group. The intervention group receives CSG and the placebo group receives a placebo granule. The patients receive either CSG or placebo two times daily for 8 weeks. The primary outcome is the Pittsburgh sleep quality index (PSQI). Secondary outcomes include the Insomnia Severity Index (ISI), Total Sleep Time (TST) and the Short-Form Health Survey (SF-36). The assessment is performed at baseline (before randomisation), 4, 8 and 12 weeks after randomisation.
The protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (reference: 2014BL-003-01). The trial will be helpful in identifying the efficacy and safety of CSG in patients with primary insomnia.
ISRCTN22001145; Pre-results.
失眠是一种非常普遍、常常使人衰弱且经济负担沉重的睡眠障碍，有效治疗方法有限。对于了解哪种治疗方法对失眠患者最有效，尤其是对传统中医（TCM）而言，可用数据很少。中药作为典型的传统中医，是治疗失眠最受欢迎的补充和替代疗法之一。我们旨在评估一种中药制剂柴胡桂枝干姜 - 酸枣仁颗粒（CSG）治疗原发性失眠患者的疗效和安全性。
这是一项多中心、安慰剂对照、双盲、随机对照临床试验。总共258名参与者被随机分配到两组：干预组或安慰剂组。干预组接受CSG，安慰剂组接受安慰剂颗粒。患者每天服用CSG或安慰剂两次，持续8周。主要结局指标是匹兹堡睡眠质量指数（PSQI）。次要结局指标包括失眠严重程度指数（ISI）、总睡眠时间（TST）和简短健康调查问卷（SF - 36）。在基线（随机分组前）、随机分组后4周、8周和12周进行评估。
该方案已获得首都医科大学附属北京中医医院研究伦理委员会批准（编号：2014BL - 003 - 01）。该试验将有助于确定CSG治疗原发性失眠患者的疗效和安全性。
ISRCTN22001145；预结果。
