针刺治疗原发性高血压RCT报告质量的研究

Study on the Report Quality of Randomized Controlled Trials of Acupuncture in the Treatment of Essential Hypertension

目的评价针刺治疗原发性高血压的临床随机对照试验(RCT)报告质量。方法计算机检索Web of Science、PubMed、Embase、Cochrane Library、中国知网、万方、维普七大数据库建库以来至2019年12月关于针刺治疗原发性高血压的RCT报告,由2名研究者按照纳排标准筛选出符合的文献,并采用Cochrane风险偏倚评估工具、CONSORT声明以及STRICTA标准评估报告质量。结果最终纳入87篇RCT报告。Cochrane偏倚风险评估工具统计结果表明,大多数文献各类偏倚风险较高或不清楚。CONSORT声明及STRICTA标准条目统计结果表明,纳入文献中仅部分条目的完整报告率较高,受试者合格标准、资料收集的场所和地点、干预措施、结局指标的统计学方法分析、针刺治疗的类型、针刺刺激方式、留针时间、治疗单元数、治疗单元的频数和持续时间的完整报告率分别为63.2%、59.8%、50.5%、88.5%、100%、92%、81.6%、86.2%及75.9%,其余条目完整报告率均偏低甚至无报告。结论纳入的针刺治疗原发性高血压RCT报告质量不佳,未来的研究中需注重研究设计、严格实施过程、规范试验报告,与国际前沿接轨,以利于针刺疗法的发展和传播。

Objective To evaluate the quality of clinical randomized controlled trials(RCT)of acupuncture in the treatment of essential hypertension.Methods We searched the RCT reports about acupuncture treatment of essential hypertension in seven databases from the database establishment to December 2019,including Web of Science,PubMed,EMBASE,Cochrane Library,CNKI,Wanfang Date,and VIP.Two researchers screened out the eligible literatures according to the inclusion and exclusion criteria,and adopted Cochrane risk bias assessment tool and consort Statement and stricta standard to assess the quality of these reports.Results 87 RCT reports were included.The statistical results of Cochrane bias risk assessment tools show that the risk of bias in most literatures is high or unclear.According to the evaluation results of CONSORT statement and STRICTA standard items,only a few items have a high rate of complete report including the eligibility criteria of subjects,the place of data collection,intervention measures,statistical method analysis of outcome indicators,types of acupuncture treatment,acupuncture stimulation methods,needle retention time,number of treatment units,frequency and duration of treatment units,and the complete report rates of those items were 63.2%,59.8%,50.5%,88.5%,100%,92%,81.6%,86.2%and 75.9%.The complete report rate of other items is low or even not reported.Conclusion The quality of RCT reports of acupuncture treatment is not good.In the future research,we should pay attention to the research design,strict implementation process,standardized test report,and connect with the international front,so as to facilitate the development and spread of acupuncture treatment.