中医戒烟随机对照试验的研究特征分析和方法学质量评价

Research Characteristics and Methodological Quality of Randomized Controlled Trials in Traditional Chinese Medicine for Smoking Cessation

目的总结并分析目前国内外发表的中医戒烟随机对照试验的临床研究特征,并通过评价其方法学质量,为未来开展相关临床研究提供参考。方法系统检索中国知网、万方数据知识平台、维普中文期刊服务平台、中国生物医学文献服务系统、PubMed、Cochrane Library收录的以中医为主要干预手段戒烟的随机对照试验,提取纳入文献的基本信息和临床研究特征,使用Cochrane偏倚风险评估工具评价、分析其方法学质量。结果共纳入66项研究,其中53项研究(80.3%)纳入健康成年吸烟者为研究对象,56项研究(84.8%)的干预措施主要为穴位刺激类,28项研究(42.4%)采用了安慰剂对照,选用时点戒断率(24 h至6周)和持续戒断率(14天至5年)作为主要结局指标的研究分别有7项(10.6%)和5项(7.6%),26项研究(39.4%)未对时点戒断率和持续戒断率指标进行区分,仅报告了总体戒断率。纳入研究的方法学质量整体偏低,且均未能充分报告随机序列的生成与分配隐藏、结局评价者盲法、选择性报告结局。28项研究(42.4%)报告使用了盲法,38项研究(57.6%)在受试者和干预提供者盲法方面为高偏倚风险。结论目前中医戒烟随机对照试验对象主要为健康吸烟者,干预措施主要为穴位刺激方法,试验的方法学质量整体偏低,提示需要完整和规范的报告。未来仍需设计良好、偏倚风险低的研究验证中医在戒烟中的有效性和安全性。

Objective To summarize the research characteristics and to evaluate the methodological quality of randomized controlled trials(RCTs)in traditional Chinese medicine(TCM)for smoking cessation,thus providing foundation for further studies.Methods The RCTs using TCM as main intervention for smoking cessation were systematically searched in CNKI,Wanfang,VIP,Sinomed,PubMed and Cochrane Library databases. The basic information and clinical characteristics of the included studies were extracted. The Cochrane Risk of Bias Tool was used for methodological evaluation and analysis.Results Totally,66 studies were included. Fifty-three studies(80. 3%)included healthy adult smokers as research objects,and the intervention was mainly acupoint stimulation(56,84. 8%). Twenty-eight studies(42. 4%)used placebo as the control. Seven studies(10. 6%)used point prevalence abstinence(24 hours to 6 weeks),and five studies(7. 6%)used continuous abstinence rate(14 days to 5 years)as primary outcomes,while 26(39. 4%)studies reported general abstinence rate without distinguishing the point abstinence from continuous abstinence. The overall quality of the included studies was relatively low,failing to report the detailed information in the aspect of random sequence generation,allocation concealment,blinding of outcome assessment,and selective reporting. Twenty-eight studies(42. 4%)reported the use of blinding,while 38 studies(57. 6%)had a high risk of bias in blinding of participants and personnel.Conclusion The RCTs in TCM for smoking cessation mainly recruit the healthy smokers,and the most TCM modality is acupoint stimulation. The quality of the related RCTs is low,indicating that full and standardized reporting is needed. In the future,welldesigned trials with low risk of bias are still needed to verify the effectiveness and safety of TCM for smoking cessation.