Analysis on the outcomes in randomized controlled trials of perimenopausal syndrome treated with acupuncture and moxibustion

针灸治疗围绝经期随机对照试验的结局指标分析

Chao CHEN(陈超)^a, Yan-ke AI (艾艳珂)^b,*,  Bao-yan LIU (刘保延)^c, Li-yun HE (何丽云)^b 

^a Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China (中国中医科学院中医基础理论研究所, 北京100700, 中国)

^b Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China (中国中医科学院中医临床基础医学研究所, 北京100700, 中国)

^c China Academy of Chinese Medical Sciences, Beijing 100700, China (中国中医科学院, 北京100700, 中国)

ABSTRACT

Objective: To search systematically the application situation of the outcomes in the randomized controlled trials (RCTs) of perimenopausal syndrome treated with acupuncture and moxibustion so as to provide the foundation for the core outcome set in treatment of periomenopausal syndrome with acupuncture and moxibustion.

Methods: The articles of RTCs on perimenopausal syndrome treated with acupuncture and moxibustion were searched by computer in China National knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), VIP Chinese Journal Service Platform (VIP), Pubmed, Excerpt medica database (Embase) and Cochrane central register of controlled trials (CENTRAL) databases from January 1, 2010 to December 31, 2020. Two reviewers screened the articles, extracted data and analyzed the application of outcomes in the eligible trials independently.

Results: A total of 9391 articles were retrieved initially and 79 articles of them were eligible, including 43 articles in English and 36 articles in Chinese. 115 outcomes were involved totally and collected according to 7 outcome domains, of which, the effective rate was the outcome with the highest use frequency. 35 articles reported adverse events and 17 articles reported the effect in followup.

Conclusion: At present, the outcomes of RCTs on perimenopausal syndrome in treatment with acupuncture and moxibustion are big in divergence, absent in normalization and lack of indicators for long-term prognosis and in economics, as well as have the issues on the incomplete reports on the differentiation between the primary and the secondary outcomes, safety indicators and followup outcomes. It needs to construct the core outcome sets in line with the characteristics of acupuncture-moxibustion discipline so as to improve the quality of clinical trials of acupuncture and moxibustion.

Keywords

Acupuncture-moxibustion

Perimenopausal period

Randomized controlled trial

Outcome

【摘要】

目的：系统研究针灸治疗围绝经期综合征随机对照试验（RCTs）结果的应用情况，为针灸治疗围绝经期综合征的核心结果集提供依据。

方法：在中国国家知识基础设施（CNKI）、万方数据知识服务平台（Wanfang）、VIP中文期刊服务平台（VIP）、Pubmed、摘录医学数据库（Embase）和Cochrane对照试验中心注册数据库（central）的计算机上检索关于针灸治疗围绝经期综合征的随机对照试验文章，时间范围为2010年1月1日至2020年12月31日。两位评审员对文章进行筛选，提取数据，并独立分析合格试验结果的应用。

结果：初步检索到9391篇文章，其中79篇合格，其中英文43篇，中文36篇。共涉及115个结果，按7个结果领域收集，其中有效率为使用频率最高的结果。35篇报道了不良事件，17篇报道了随访中的影响。

结论：目前针灸治疗围绝经期综合征的随机对照试验结果分歧较大，缺乏规范化，缺乏长期预后指标和经济学指标，存在主次疗效、安全性指标和随访结果差异报道不全的问题。构建符合针灸学科特点的核心结果集，提高针灸临床试验的质量。

【关键词】针灸、围绝经期、随机对照试验、结果