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      Efficacy and safety of traditional Chinese medicine yangxin anshen therapy for insomnia : A protocol of systematic review and meta-analysis

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          Abstract

          Background:

          Traditional Chinese medicine (TCM) has gradually drawn the attention of clinicians as an alternative choice for insomniacs and TCM yangxin anshen therapy (TYAT), as a crucial therapy of treating insomniacs, is based on the theory of syndrome differentiation. However, owing to the lack of evidence-based medical evidence, the authors intend to carry out this study to evaluate TYAT's effectiveness and safety.

          Methods:

          Seven electronic databases will be searched from inception to July 2019. Two authors will independently identify randomized controlled trials, fetch data and assess the risk of bias with tools provided by Cochrane. A comprehensive meta-analysis will be conducted with the Cochrane Collaboration software (Review Manager 5.3) for eligible and appropriate studies. Further, the evidence will be assessed with the grading of recommendations assessment, development, and evaluation approach.

          Results:

          This article will be dedicated to assessing TYAT's efficacy and safety for insomniacs.

          Conclusion:

          This systematic review and meta-analysis may provide persuasive evidence for the clinical application of TYAT in treating insomnia.

          Trial registration number:

          PROSPERO CRD 42019135115.

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          Most cited references16

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          The prevalence of insomnia in the general population in China: A meta-analysis

          This is the first meta-analysis of the pooled prevalence of insomnia in the general population of China. A systematic literature search was conducted via the following databases: PubMed, PsycINFO, EMBASE and Chinese databases (China National Knowledge Interne (CNKI), WanFang Data and SinoMed). Statistical analyses were performed using the Comprehensive Meta-Analysis program. A total of 17 studies with 115,988 participants met the inclusion criteria for the analysis. The pooled prevalence of insomnia in China was 15.0% (95% Confidence interval [CI]: 12.1%-18.5%). No significant difference was found in the prevalence between genders or across time period. The pooled prevalence of insomnia in population with a mean age of 43.7 years and older (11.6%; 95% CI: 7.5%-17.6%) was significantly lower than in those with a mean age younger than 43.7 years (20.4%; 95% CI: 14.2%-28.2%). The prevalence of insomnia was significantly affected by the type of assessment tools (Q = 14.1, P = 0.001). The general population prevalence of insomnia in China is lower than those reported in Western countries but similar to those in Asian countries. Younger Chinese adults appear to suffer from more insomnia than older adults. Trial Registration: CRD 42016043620
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            Syndrome differentiation in modern research of traditional Chinese medicine.

            Syndrome differentiation (Bian Zheng) in traditional Chinese medicine (TCM) is the comprehensive analysis of clinical information gained by the four main diagnostic TCM procedures: observation, listening, questioning, and pulse analysis, and it is used to guide the choice of treatment either by acupuncture and/or TCM herbal formulae, that is, Fufang. TCM syndrome differentiation can be used for further stratification of the patients' conditions with certain disease, identified by orthodox medical diagnosis, which could help the improvement of efficacy of the selected intervention. In modern TCM research it is possible to integrate syndrome differentiation with orthodox medical diagnosis leading to new scientific findings in overall medical diagnosis and treatment. In this review, the focus is to screen published evidence on the role of syndrome differentiation in modern TCM research with particular emphasis on basic and clinical research as well as, pharmacological evaluation of TCM herbal formulary for drug discovery. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
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              The direct and indirect costs of untreated insomnia in adults in the United States.

              To estimate the direct and indirect cost burden of untreated insomnia among younger adults (age 18-64), and to estimate the direct costs of untreated insomnia for elderly patients (age 65 and over). A retrospective, observational study comparing insomnia patients to matched samples without insomnia. Self-insured, employer sponsored health insurance plans in the U.S. 138,820 younger adults and 75,558 elderly patients with insomnia, plus equal-sized, matched comparison groups. NA. Direct costs included inpatient, outpatient, pharmacy, and emergency room costs for all diseases, for six months before an index date. The index date for insomnia patients was the date of diagnosis with or the onset of prescription treatment for insomnia, some-time during July 1, 1999-June 30, 2003. Non-insomnia patients were assigned the same index dates as the insomnia patients to whom they were matched. Indirect costs included costs related to absenteeism from work and the use of short-term disability programs. Propensity score matching was used to find insomnia and non-insomnia patients who had similar demographics, location, health plan type, comorbidities, and drug use patterns. Regression analyses controlled for factors that were different even after matching was completed. We found that average direct and indirect costs for younger adults with insomnia were about $1,253 greater than for patients without insomnia. Among the elderly, direct costs were about $1,143 greater for insomnia patients. Insomnia is associated with a significant economic burden for younger and older patients.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                September 2019
                13 September 2019
                : 98
                : 37
                : e16945
                Affiliations
                [a ]Clinical College of Traditional Chinese Medicine
                [b ]Institute of Gerontology, Hubei University of Chinese Medicine
                [c ]Hubei Cancer Hospital
                [d ]The First Clinical College, Hubei University of Chinese Medicine
                [e ]Encephalopathy Department, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan City, Hubei Province, China.
                Author notes
                []Correspondence: Ping Wang, Institute of Gerontology, Hubei University of Chinese Medicine, Wuhan City, Hubei Province, China (e-mail: pwang54@ 123456aliyun.com ).
                Article
                MD-D-19-05929 16945
                10.1097/MD.0000000000016945
                6750329
                31517815
                89a3a335-eadb-41cf-a8ce-b86ac5b4ffc4
                Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 28 July 2019
                : 31 July 2019
                Categories
                3800
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                insomnia,meta-analysis,protocol,systematic review,traditional chinese medicine,yangxin anshen therapy

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