Tan Aihua, Wang Miyuan, Liu Jia, Huang Kailin, Dai Disha, Li Lei, Shi Heyuan, Wang Ping
Hubei University of Chinese Medicine, Wuhan, Hubei.
Beijing University of Chinese Medicine, Beijing.
Medicine (Baltimore). 2020 Jul 31;99(31):e21445. doi: 10.1097/MD.0000000000021445.
As a common clinical mental disorder, the prevalence rate of anxiety disorder increased yearly, devastating both physical health and social-economic prospect. The most common treatment relied on the use of western medications which is yet to fulfill ideal performance. While acupuncture is adopted as a treatment for anxiety disorders, the combination treatment of acupuncture and western medicines becomes more acknowledged. Albeit a spike in related literatures, the curative effect and safety of the treatment are still in lack of evidence. Therefore, this systematic review and meta-analysis protocol is planned to evaluate the efficacy and safety of the combination treatment of acupuncture and western medications.
Six English databases (PubMed, Web of science, Medline, EBASE, Springer Cochrane Library and WHO International Clinical Trials Registry Platform) and four Chinese databases (Wan fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database (CNKI) and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to June 1, 2020. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on the Hamilton Anxiety Scale (HANA) and the self-rating anxiety scale (SAS) will be used as the main outcome measure, quality of life scale (SF-36), changes of symptoms in TCM, hormone levels and clinical global impression (CGI) as the secondary outcome. treatment emergent symptom scale (TESS), general physical examination(temperature, pulse, respiration, blood pressure), Routine examination of blood, urine and stool, Electrocardiogram, Liver and kidney function examination as the security indexes. RevMan 5.3.5 will be used for meta-analysis.
This study will provide high-quality evidence to assess the effectiveness and safety of acupuncture combined with western medicine for anxiety.
This systematic review will explore whether acupuncture combined with western medicine is an effective and safe intervention for anxiety.
Ethical approval is not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and will be shared on social media platforms. This review will be disseminated in a peer-reviewed journal or conference presentation.
PROSPERO CRD42020149746.
焦虑症作为一种常见的临床精神障碍，其患病率逐年上升，对身体健康和社会经济前景都造成了严重破坏。最常见的治疗方法依赖于使用西药，但尚未达到理想效果。虽然针灸被用作焦虑症的一种治疗方法，但针灸与西药的联合治疗越来越受到认可。尽管相关文献有所增加，但该治疗方法的疗效和安全性仍缺乏证据。因此，本系统评价和荟萃分析方案旨在评估针灸与西药联合治疗的疗效和安全性。
按照各数据库的检索规则，对六个英文数据库（PubMed、Web of science、Medline、EBASE、Springer Cochrane Library和WHO国际临床试验注册平台）和四个中文数据库（万方数据库、中国科学期刊数据库、中国知网数据库（CNKI）和中国生物医学文献数据库）进行规范检索，检索时间范围为建库至2020年6月1日。两名评价员将独立进行文献筛选、数据收集和偏倚风险评估。如有分歧，将与第三名评价员讨论解决。根据异质性检验结果，采用固定效应模型或随机效应模型进行数据合成。汉密尔顿焦虑量表（HANA）和自评焦虑量表（SAS）得分的变化将作为主要结局指标，生活质量量表（SF-36）、中医症状变化、激素水平和临床总体印象（CGI）作为次要结局指标。治疗中出现的症状量表（TESS）、一般体格检查（体温、脉搏、呼吸、血压）、血、尿及粪便常规检查、心电图、肝肾功能检查作为安全性指标。采用RevMan 5.3.5进行荟萃分析。
本研究将为评估针灸联合西药治疗焦虑症的有效性和安全性提供高质量证据。
本系统评价将探讨针灸联合西药是否是一种有效且安全的焦虑症干预措施。
本研究无需伦理批准。该系统评价将发表在同行评审期刊上，在会议上展示，并将在社交媒体平台上分享。本综述将通过同行评审期刊或会议报告进行传播。
PROSPERO注册号：PROSPERO CRD42020149746。
