摘要
目的采用试验报告统一标准(CONSORT)和针刺临床试验干预措施报告的标准(STRICTA)评价针刺治疗偏头痛随机对照试验(RCT)中英文文献的报告质量。方法计算机检索PubMed、Cochrane Library、中国期刊全文数据库(CNKI)、维普期刊资源整合服务平台(VJIP)数据库,文种限制为中英文,检索时限为2012年1月至2017年4月。由2位评价者根据纳入与排除标准独立进行文献筛选,并采用国际公认的CONSORT声明和STRICTA标准评价报告质量。结果最终纳入18篇文献,根据CONSORT条目,15篇(83.33%)描述各组的基线情况和临床特征;8篇(44.44%)提及产生随机分配序列的方法;10篇(55.56%)描述分配方案隐藏;10篇(55.56%)采用盲法;6篇(33.33%)提及样本含量的计算。根据STRICTA条目,8篇(44.44%)文献提及针刺反应;有11篇(61.11%)提及针刺深度;5篇文献(27.78%)报告治疗师的资历,亦提及医师的临床实践时间。结论研究纳入的针刺治疗偏头痛中英文文献,根据CONSORT声明和STRICTA标准的条目,研究报告质量仍然存在不少问题。今后应提倡采用国际公认的CONSORT声明和STRICTA标准对针刺治疗的RCT进行规范报告。
Objective To evaluate the reporting quality of randomized controlled trials（ RCTs） on acupuncture for migraine.Methods Four databases including PubMed, Cochrane Library,CNKI,VJIP from January 2012 to April 2017 were searched electronically, and only English and Chinese articles were included.Two reviewers independently included the literature according to the inclusion and exclusion criteria.We assessed the quality of these reports according to the Consolidated Standards of Reporting of Trials（ CONSORT） statement and STandards for Reporting Interventions in Controlled Trials of Acupuncture（ STRICTA）.Results Finally 18 RCTs were included.Regarding the CONSORT statement, 15（ 83.33%） RCTs described the baseline demog raphic and clinical characteristics in each group.Only 8（ 44.44%） studies mentioned how the random sequence was generated.10（ 55.56%） RCTs described the concealment in detail.Only 10（ 55.56%） RCTs used blinding.Only 6（ 33.33%） RCTs reported how the sample size was calculated.According to the items in STRICTA, 8（ 44.44%） reported acupuncture response, and 11（ 61.11%）mentioned the depths of insertion.There were only 5 RCTs（ 27.78%） that reported the background of the acupuncture practitioners and the duration of their training.Conclusion The RCTs of acupuncture for migraine meeting the criteria of the CONSORT statement and STRICTA still have room for improvement.Promoting the use of the CONSORT statement and STRICTA would help to improve the reporting quality of acupuncture related research, and hence to elucidate the scientific understanding of acupuncture.
作者
莫文权
裴建
杨晖
Mo Wenquan1,2, Pei Jian1, Yang Hui2(1. Department of Acupuncture, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;2.Department of Acupuncture, Huadong Hospital Fudan University, Shanghai 200040, Chin)
出处
《中华针灸电子杂志》
2018年第1期26-31,共6页
Chinese Journal of Acupuncture and Moxibustion（Electronic Edition）
基金
上海市卫计委中医特色诊疗技术提升项目(ZYJX-2017023)
上海市卫计委海派中医流派“陆氏针灸”传承研究项目(ZY3-CCCX-1-1007)
上海市科委中医引导项目(14401932900)
上海市科委科研重点项目(16401970300)
关键词
偏头痛
针刺
评价研究
随机对照试验
Migraine disorders
Acupuncture
Evaluation studies
Randomized controlled trial
