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Open Access Study protocol

Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial

Shiyan Yan1, Runshun Zhang2, Xuezhong Zhou3, Peng Li1, Liyun He1* and Baoyan Liu4*

Author Affiliations

1 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 NanXiaoJie, DongZhiMenNei, DongCheng District, Beijing, China

2 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5 BeiXianGe St., XiCheng District, Beijing, China

3 School of Computer and Information Technology, Beijing Jiaotong University, No.3 ShangYuanCun, Hai Dian District, Beijing, China

4 China Academy of Chinese Medical Sciences, No.16 NanXiaoJie, DongZhiMenNei, DongCheng District, Beijing, China

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Trials 2013, 14:61  doi:10.1186/1745-6215-14-61

Published: 28 February 2013

Abstract

Background

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.

Discussion

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.

Trial registration

NCT01613183

Keywords:
Primary insomnia; Chinese medicine; Randomized controlled trial; Effective core drug pattern