Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No,16 NanXiaoJie, DongZhiMenNei, DongCheng District, Beijing, China.
Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61.
Chinese herbal medicine is one of the most popular Chinese medicine (CM) therapies for primary insomnia. One of the important characteristics of CM is that different Chinese clinicians give different prescriptions even for the same patient. However, there must be some fixed drug patterns in every clinician's prescriptions. This study aims to screen the effective core drug patterns in primary insomnia treatment of three prestigious Chinese clinicians.
METHODS/DESIGN: A triple-blind, randomized, placebo-controlled, parallel-group clinical trial will be performed. Three clinicians will diagnose and treat every eligible patient individually and independently, producing three prescriptions from three clinicians for every patient. Patients will equally be randomized to one of four groups - medical group A, medical group B, medical group C, or placebo group - and observed for efficacy of treatment. The sample will include primary insomnia patients meeting DSM IV-TR criteria, Spiegel scale score >18, and age 18 to 65 years. A sequential design is employed. Interim analysis will be conducted when between 80 and 160 patients complete the study. The interim study could be stopped and treated as final if a statistically significant difference between treatment and placebo groups can be obtained and core effective drug patterns can be determined. Otherwise, the study continues until the maximum sample size reaches 300. Treatment of the CM group is one of three Chinese clinicians' prescriptions, who provide independently prescriptions based on their own CM theory and the patient's disease condition. Assessment will be by sleep diary and Pittsburgh sleep quality index, and CM symptoms and signs will be measured. Primary outcome is total sleep time. Assessment will be carried out at the washout period, weeks 1, 2, 3, and 4 and 4th week after the end of treatment. Effectiveness analysis will be per intent to treat. A multi-dimension association rule and scale-free networks method will be used to explore the effective core drug patterns.
The effective core drug patterns will be found through analyzing several prestigious CM clinicians' treatment information. Screening the effective core drug patterns from prestigious clinicians can accelerate the development of new CM drugs.
NCT01613183.
中草药是治疗原发性失眠的最受欢迎的中医（CM）疗法之一。CM 的一个重要特征是，即使对于同一患者，不同的中医临床医生也会开出不同的处方。然而，每个临床医生的处方中肯定都有一些固定的药物模式。本研究旨在筛选三位知名中医治疗原发性失眠的有效核心药物模式。
方法/设计：将进行一项三盲、随机、安慰剂对照、平行组临床试验。三位临床医生将单独和独立地诊断和治疗每一位符合条件的患者，为每位患者开出三位临床医生的三种处方。患者将被平均随机分为四组之一 - 医疗组 A、医疗组 B、医疗组 C 或安慰剂组 - 并观察治疗效果。样本将包括符合 DSM-IV-TR 标准、Spiegel 量表评分>18 且年龄在 18 至 65 岁之间的原发性失眠患者。采用序贯设计。当 80 至 160 名患者完成研究时，将进行中期分析。如果治疗组与安慰剂组之间存在统计学上的显著差异，并能确定核心有效药物模式，则可以停止中期研究并作为最终研究结果。否则，研究将继续进行，直到达到 300 名最大样本量。CM 组的治疗是三位中医临床医生处方之一，他们根据自己的 CM 理论和患者的病情独立开具处方。评估将通过睡眠日记和匹兹堡睡眠质量指数进行，CM 症状和体征将进行测量。主要结局是总睡眠时间。评估将在洗脱期、第 1、2、3 周和治疗结束后第 4 周以及 4 周后进行。有效性分析将采用意向治疗。多维关联规则和无尺度网络方法将用于探索有效的核心药物模式。
通过分析几位知名 CM 临床医生的治疗信息，将找到有效的核心药物模式。从知名临床医生中筛选有效的核心药物模式可以加速新 CM 药物的开发。
NCT01613183。
