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恩可散治疗普通感冒:一项遵循PRISMA标准的随机对照试验系统评价

Eunkyosan for the common cold: A PRISMA-compliment systematic review of randomised, controlled trials.

作者信息

Lee Hesol, Kang Bohyung, Hong Minna, Lee Hye-Lim, Choi Jun-Yong, Lee Ju Ah

机构信息

Department of Internal Medicine, College of Oriental Medicine, Gachon University.

Department of Internal Medicine, Korean Medicine Hospital of Pusan National University.

出版信息

Medicine (Baltimore). 2020 Jul 31;99(31):e21415. doi: 10.1097/MD.0000000000021415.

Abstract

BACKGROUND

Eunkyosan (EKS), also known as the Yinqiaosan formula, is widely applied for the common cold in East Asia. Many clinical trials have reported the efficacy and safety of the EKS formula for the treatment of the common cold.

OBJECTIVES

This study aimed to assess the clinical evidence for and against the use of EKS formula as a treatment for the common cold.

DATA SOURCES

The following databases were searched from inception to the present: MEDINLE, EMBASE, CENTRAL, AMED CINAHL for English articles; OASIS, the Korean Traditional Knowledge Portal, the Korean Studies Information Service System, KoreaMed, the Korean Medical Database and DBPIA); and 3 Chinese databases, including CNKI (i.e., the China Academic Journal, the China Doctoral Dissertations and Master's Theses Full-text Database, the China Proceedings of Conference Full-Text Database and the Century Journal Project), Wanfang and VIP. In addition, we searched a Japanese database and conduct non-electronic searches of conference proceedings.

STUDY ELIGIBILITY CRITERIA

Prospective randomised controlled trials (RCTs) evaluating the effectiveness of EKS for the common cold were included in this review.

PARTICIPANTS

All types of common colds were eligible for inclusion. Participants who had both the common cold and other conditions were excluded. There were no restrictions based on other factors, such as age, sex, or symptom severity.

INTERVENTIONS

Studies that evaluated any type of formulation (ie, decoction, tablet, pill, powder) of EKS were eligible for inclusion.

STUDY APPRAISAL AND SYNTHESIS METHODS

Differences between intervention and control groups were assessed. Mean differences with 95% confidence intervals (CIs) were used to measure the effects of treatment for continuous data.

METHODS AND ANALYSIS

Fourteen databases were searched in March 2018. We included RCTs examining EKS decoctions for any type of common cold. All RCTs of decoctions or modified decoctions were included. The methodological qualities of the RCTs were assessed using the Cochrane Collaboration tool for assessing risk of bias; confidence in the cumulative evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument.

RESULTS

A total of 315 potentially relevant studies were identified, and 4 RCTs met our inclusion criteria. Four RCTs tested the effects of EKS on the common cold, and all RCTs showed that EKS was superior regarding the treatment effect.

LIMITATIONS

All RCTs were conducted in China, and the generalisation of these results to other countries might be limited. Most trials did not use internationally recognised reliability and validity outcome measurements. Moreover, the result of the response rate can be distorted by the practitioner. Future trials in compliance with international standards in the evaluation of treatment effects may resolve this issue.

CONCLUSION

Our systemic review and meta-analysis provides suggestive evidence of the superiority of EKS over other therapies for treating the common cold. The level of evidence is low because of the high risk of bias.

IMPLICATIONS OF KEY FINDINGS

The results of this systematic review and meta-analysis provide suggestive evidence of the superiority of EKS alone or combined with conventional drugs.

REGISTRATION NUMBER

CRD42018087694.

摘要

背景

银翘散在东亚地区广泛用于治疗普通感冒。许多临床试验报告了银翘散治疗普通感冒的有效性和安全性。

目的

本研究旨在评估支持和反对使用银翘散治疗普通感冒的临床证据。

数据来源

检索了以下数据库自建库至目前的文献:MEDINLE、EMBASE、CENTRAL、AMED CINAHL(用于检索英文文章);OASIS、韩国传统知识门户、韩国研究信息服务系统、KoreaMed、韩国医学数据库和DBPIA;以及3个中文数据库,包括中国知网(即《中国学术期刊》《中国博士学位论文全文数据库》《中国优秀硕士学位论文全文数据库》《中国重要会议论文全文数据库》和《世纪期刊》项目)、万方和维普。此外,检索了一个日本数据库,并对会议论文进行了非电子检索。

研究纳入标准

本综述纳入评估银翘散治疗普通感冒有效性的前瞻性随机对照试验(RCT)。

参与者

所有类型的普通感冒均符合纳入标准。同时患有普通感冒和其他疾病的参与者被排除。在年龄、性别或症状严重程度等其他因素方面没有限制。

干预措施

评估银翘散任何剂型(即汤剂、片剂、丸剂、散剂)的研究均符合纳入标准。

研究评价与综合方法

评估干预组与对照组之间的差异。采用95%置信区间(CI)的均值差异来衡量连续数据的治疗效果。

方法与分析

2018年3月检索了14个数据库。我们纳入了研究银翘散汤剂治疗任何类型普通感冒的RCT。纳入了所有汤剂或改良汤剂的RCT。使用Cochrane协作网评估偏倚风险的工具评估RCT的方法学质量;使用推荐分级的评估、制定与评价(GRADE)工具评估对累积证据的信心。

结果

共识别出315项可能相关的研究,4项RCT符合我们的纳入标准。4项RCT测试了银翘散对普通感冒的疗效,所有RCT均表明银翘散在治疗效果方面更优。

局限性

所有RCT均在中国进行,这些结果推广到其他国家可能会受到限制。大多数试验未使用国际认可的可靠性和有效性结局测量方法。此外,应答率结果可能会受到从业者的影响而失真。未来符合国际标准的治疗效果评估试验可能会解决这个问题。

结论

我们的系统评价和荟萃分析提供了银翘散在治疗普通感冒方面优于其他疗法的提示性证据。由于偏倚风险高,证据水平较低。

主要发现的意义

该系统评价和荟萃分析的结果提供了银翘散单独使用或与传统药物联合使用更优的提示性证据。

注册号

CRD42018087694。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5152/7402720/c3411b3b3e88/medi-99-e21415-g001.jpg

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