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中药治疗亚健康有效性和安全性的系统评价和 Meta 分析:随机对照试验。

Evaluation on Effectiveness and Safety of Chinese Herbs in Treatment of Sub-health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

China Academy of Chinese Medical Science, Beijing, 100700, China.

Beijing University of Chinese Medicine, Beijing, 100029, China.

出版信息

Chin J Integr Med. 2019 Jun;25(6):471-480. doi: 10.1007/s11655-018-2982-6. Epub 2018 Jun 18.

DOI:10.1007/s11655-018-2982-6
PMID:29915908
Abstract

OBJECTIVE

To evaluate the effectiveness and safety of Chinese herbs in the treatment of sub-health systematically.

METHODS

Nine databases were systematically and extensively searched to collect randomized controlled trials (RCTs) about Chinese herbs in the treatment of sub-health. The outcomes included overall effective rate, main symptoms, quality of life, etc. Literature screening, data extraction and quality assessment were conducted according to Cochrane Handbook 5.1. Meta-analysis was conducted to the included literature with Review Manager Software.

RESULTS

Seventy-two studies involving 9,296 patients with sub-health were included with 4,908 patients in experimental groups and 4,387 patients in control groups. The overall quality of included clinical research was not high. In the aspect of improving overall effective rate, relieving main symptoms, Pittsburgh sleep quality index (PSQI) score, Athens Insomnia Scale (AIS) score, Fatigue Scale-14 (FS-14), Cornell Medical Index (CMI) score and discontinuation rate, the effects of experimental groups were better than that of control groups. According to available research reports, adverse reactions in Chinese herb groups were mainly mild gastrointestinal symptoms, which did not affect the treatment.

CONCLUSION

Chinese herbs have a curative effect in the treatment of sub-health. However, there are no clear criteria for diagnosis and curative effectiveness judgment globally, which would affect the accuracy of curative effect evaluation.

摘要

目的

系统评价中药治疗亚健康的有效性和安全性。

方法

系统全面地检索了 9 个数据库,收集了中药治疗亚健康的随机对照试验(RCT)。结局指标包括总有效率、主要症状、生活质量等。根据 Cochrane 手册 5.1 进行文献筛选、数据提取和质量评估。采用 Review Manager 软件对纳入的文献进行荟萃分析。

结果

共纳入 72 项研究,涉及 9296 例亚健康患者,其中实验组 4908 例,对照组 4387 例。纳入临床研究的整体质量不高。在提高总有效率、缓解主要症状、匹兹堡睡眠质量指数(PSQI)评分、雅典失眠量表(AIS)评分、疲劳量表-14(FS-14)评分、康奈尔医学指数(CMI)评分和停药率方面,实验组的效果优于对照组。根据现有研究报告,中药组的不良反应主要为轻度胃肠道症状,不影响治疗。

结论

中药治疗亚健康有一定疗效。但是,目前全球缺乏明确的诊断和疗效判断标准,这可能会影响疗效评价的准确性。

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