Meta AnalysisID 5690
草药（百乐眠胶囊）治疗失眠的有效性和安全性：随机对照试验的系统评价和Meta分析
CRD42018114512
To make a systematic review of the clinical effect and safety of traditional Chinese medicine Bailemian capsule in the treatment of insomnia.
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Record Fields
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- Meta Analysis Id
- 5690
- Evidence Id
- 14248
- Core Evidence Id
- 14248
- Source Meta Analysis Id
- 5670
- Herb2 Meta Analysis Id
- HBMA005670
- Crd Id
- CRD42018114512
- Title
- Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: a systematic Review and meta-analysis of randomized controlled trials
- Review Question
- To make a systematic review of the clinical effect and safety of traditional Chinese medicine Bailemian capsule in the treatment of insomnia.
- Study Type Included
- Randomized controlled trials Rejection Indexes 1) non-RCT works of literatures; 2) literature with medicine against the predefined guidelines; 3) literature with inconsistent baseline information of the patient; 4) literature with samples less than 20; 5) literature with incomplete information including case report, overview, and zoopery, without reply from the author; and 6) literature with treatment measurement against the predefined standard.
- Condition Being Studied
- Insomnia refers to lack of normal sleep time due to various reasons. Reports show that in all complaints about sleep, insomnia is the most common one. Currently, the western medicine treats insomnia by drug therapy, including the first generation barbiturates, the second generation benzodiazepines, and the third generation non-benzodiazepines, However, this kind of medicine also comes with disadvantages. It is easy to form drug dependence, discontinuation of recoil, and memory deterioration. From ancient times, traditional Chinese medicine (TCM) has recorded the insomnia as bumei (sleepless in Chinese). Based on the theory of the traditional Chinese medicine, it is caused by many factors, including the enfeeblement of viscera and the imbalance of Yin and Yang, which lead to interference of the mind. Different from the western medicine that treats insomnia from the surface, the TCM focuses on developing the symptoms in general to treat both manifestation and root cause of insomnia. Bailemian capsule (which is made of nacre, lily, gypsum, spina date seed, albizia flower, caulis polygoni multiflori, pilose asiabell root, radix rehmanniae recen, polygala tenuifolia, shizandra berry, rush, manyprickle acanto-panax root, radix ophiopogonis, red sage root, and Indian buead, etc.) has been widely used in China.
- Participant
- The research objects are selected based on the following standards: age, gender, the source of case, primary insomnia or secondary insomnia. The diagnostic standard is according to related diagnostic standards in Governing Principles for Clinical Research of New Traditional Chinese Medicine, DSM-IV US Diagnostic Standard of Mental Diseases and CCMD-3-R Classification and Diagnostic Standard of Mental Disorders.
- Animal
- Human Disease Modelled
- Intervention
- Experimental group: single therapy of the Bailemian capsule or the combination of the Bailemian capsule with western medicine or traditional Chinese medicine (no limitation on the dose, administration frequency, course of the disease, primary insomnia or secondary insomnia, administration interval or course of treatment).
- Comparator Control
- Control group: single therapy of western medicine or traditional Chinese medicine (no limitation on the dose, administration frequency, course of the disease, primary insomnia or secondary insomnia, administration interval or course of treatment).
- Main Outcome
- (1) Total effective rate: it was calculated based on the criteria for the efficacy of insomnia in Guiding Principles for Clinical Research of New Chinese Medicine. Clinical recovery: sleep time returned to normal or increased to more than 6 hours per night, deep sleep, wake up energetic. Markedly effective: sleep time increased by more than 3 hours, and sleep depth increased. Effective: sleep time increased by less than 3 hours, and symptoms relieved. Invalid: no improvement or aggravation of insomnia; TCM syndrome curative effects standard: it is divided into four grades: those whose symptoms disappear after treatment are cured; those whose integral value decreases 2/3 after treatment are effective; those whose integral value decreases 2/3 to 1/3 after treatment are effective; those whose integral value decreases less than 1/3 after treatment are ineffective. (2) PSQI score: It is characterized by the organic combination of the quality and quantity of sleep to assess, indicators include patients' sleep quality, sleep time, sleep time, sleep efficiency, sleep disorders, hypnotics and daytime functions. A total of 4 surveys were conducted for each patient (before treatment, l, 2, 3 weeks after treatment). (3) recurrence rate: (4) adverse reaction ratio. Measures of effect Before and after treatment, the period of treatment is evaluated.
- Outcome Measure
- Additional Outcome
- No serious adverse events occurred in the Bailemian capsule group
- Study Method
- Meta-analysis, Systematic review
- Keyword
- Capsules; Herbal Medicine; Humans; Phytotherapy; Plants, Medicinal; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders
- Contact
- Jingzhi Guan [email protected]
- Organisational Affiliation
- Inner Mobgolia International Mongolian Hospital http://www.gjmyy.cn/
- Funding Source
- Source of support: scientific research project of the Inner Mongolia Autonomous Region health and Family Planning Commission in 2017. (201703042)
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2018-10-23
- Registration Date
- 2018-12-03
- Anticipated Start Date
- 2018-04-05
- Anticipated Completion Date
- 2018-12-05
- Title Cn
- 草药（百乐眠胶囊）治疗失眠的有效性和安全性：随机对照试验的系统评价和Meta分析
- Title En
- Efficacy and safety of herbal medicine (Bailemian capsule) for treating insomnia: a systematic Review and meta-analysis of randomized controlled trials
- Bilingual Status
- complete