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

ABSTRACT: 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.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.

SUBMITTER: Yan S

PROVIDER: S-EPMC3599277 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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

Yan Shiyan S Zhang Runshun R Zhou Xuezhong X Li Peng P He Liyun L Liu Baoyan B

Trials 20130228

<h4>Background</h4>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.<h4>Methods/design</h4>A tr ...[more]

PMID: 23448313

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Project description:BackgroundDyslipidemia is commonly characterized by the abnormal quantity and quality of lipids in plasma, which is strongly associated with an increased risk of cardiovascular disease and also a major cause of morbidity and even leads to mortality. In China and East Asia, Chinese herbal medicine has been widely used to treat diverse diseases for thousands of years. As an important means of traditional Chinese medicine treatment, Chinese herbal medicine plays a more important role in the treatment of dyslipidemia. The aim of this study is to assess the efficacy and safety of Chinese herbal medicine for dyslipidemia.MethodsSeven electronic databases (included The Cochrane Library, MEDLINE, Embase, CNKI, VIP, CBM, and WANGFANG) will be searched regardless of publication date or language. Randomized controlled trials will be included if they recruited participants with dyslipidemia for assessing the effect of Chinese herbal medicine vs control (placebo, no treatment, and other therapeutic agents). Primary outcomes will include serum lipid and advent events. Two authors will independently scan the articles searched, extract the data from articles included, and assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by discussion among authors. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. Dichotomous variables will be reported as risk ratio or odds ratio with 95% confidence intervals (CIs) and continuous variables will be summarized as mean difference or standard mean difference with 95% CIs.ResultsThis review will be to assess the efficacy and safety of Chinese herbal medicine for dyslipidemia.ConclusionsOur findings will assist clinicians and health professionals make clinical decisions regarding dyslipidemia prevention, and promising way for prevention and treatment of patients with dyslipidemia.Ethics and disseminationThis study is a protocol for systematic review of Chinese herbal medicine as a treatment of dyslipidemia. This review will be published in a journal and disseminated in print by peer-review.Systematic review registrationPROSPERO (CRD42018085556).

Project description:BackgroundMultiple primary outcomes are commonly used in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM). Analysis and interpretation of the results of CHM RCTs with many outcomes are not clear. No previous studies have systematically assessed the use of multiple primary outcomes in this area. This study aimed to assess the reporting of multiple primary outcomes and the statistical methods used to adjust multiplicity in RCTs of CHM.MethodsSearch for RCTs of CHM published in English between January 2010 and December 2019 in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was undertaken. We randomly selected 20% of the included RCTs as the analyzing sample of this study. The number of multiple primary outcomes, the methods used to adjust the multiplicity in statistical analysis and sample size estimate, and the trial information were collected. For RCTs that adopted multiple primary outcomes without the multiplicity adjustment, we used Bonferroni correction to adjust.Results227 CHM RCTs were included in our study. 92 (40.5%) failed to report what their primary outcome was. Of 135 (59.5%) RCTs that reported primary outcome, 93 (68.9%) reported one and 42 (31.1%) reported more than one primary outcome (range 2-5). Of 42 RCTs that reported multiple primary outcomes, only 5 adjusted for multiple outcomes. If multiplicity had been accounted for using Bonferroni correction, 10 (37.0%) RCTs that reported a significant result had demonstrated a nonsignificant result, giving the adjusted P value. Only one of the 42 RCTs calculated sample size based on multiple primary outcomes. Adopting multiple primary outcomes showed a slow growth trend with the publication year. The proportion of primary outcome reported explicitly in RCTs was different in terms of the nationality of the first author (P=0.004), in which mainland China has the lowest proportion (55.8%). The highest percentage of the studies with primary outcome reporting explicitation was mental and behavioural disorders (83.3%), and the most frequently adopting multiple primary outcomes were studies on the disease of the nervous system (66.7%). The percentage of reporting primary outcome explicitly was associated with sample size (P < 0.001); for the percentage of RCTs adopting multiple primary outcomes, there was no statistically significant difference (P=0.739).ConclusionsMultiple primary outcomes are prevalent in CHM RCTs. However, appropriate methods are not usually taken in most of the analyses to safeguard the inferences against multiplicity. Sample size estimation based on multiple primary outcomes is still lacking. These issues complicate the interpretability of trial results and can lead to spurious conclusions. Guidelines to improve analyzing and reporting for multiple primary outcomes in CHM RCTs are warranted.

Dataset Information

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

Publications

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

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