国内针灸治疗焦虑障碍临床实验的GRADE证据评价

GRADE Evaluation on Clinical Data from Acupuncture Treatment of Anxiety Disorders in China

目的:GRADE系统评价单纯针灸治疗焦虑障碍临床实验的证据等级。方法:收集针灸治焦虑障碍临床研究随机对照文献,计算机检索万方数字化期刊群(1998—),CBM(1979—)、CNKI(1979—)和VIP(1989—),所有检索时间截至2016年2月15日,并手工检索广州中医药大学图书馆过刊资料库,统计学分析采用Rev Man5.2软件,证据质量评估采用GRADE profiler3.6软件。结果:本研究纳入14个随机对照试,结局指标为治疗3周的HAMA有效率、8周的HAMA评分、1个月及2个月后随访的HAMA评分、60 d的SAS有效率,证据质量均为非常低。其中治疗60 d的SAS有效率比较,差别有统计学意义,其余均无统计学意义。结局指标为治疗4、6周的HAMA有效率,4、5、6周的HAMA评分,4周的SAS评分,证据质量均为低级。其中治疗4、6周的HAMA评分比较,差别有统计学意义,其余均无统计学意义。结局指标为治疗后3、6个月后随访的HAMA评分,证据质量为中级,差别无统计学意义。结论:针灸治疗焦虑障碍的随机对照的证据质量总体偏低,需完善随机对照实验的设计及报告,以为临床及指南制定提供高级别的针灸治疗证据。

Objective：To evaluate the evidence from clinical trials of acupuncture treatment in anxiety disorders by GRADE（The Grading of Recommendations Assessment,Development and Evaluation）.Methods：Randomized controlled clinical literature about acupuncture treatment in anxiety disorders were collected through computer retrieval in Wan Fang Digital Periodicals（1998—）,CBM（1979—）,CNKI（1979—） and VIP（1989—） and we also hand searched relevant journals in Guangzhou University of Chinese Medicine library until February 15 in 2014.We applied Rev Man 5.2software for statistical analysis,and GRADE profiler 3.6 software for quality of evidence evaluation.Results：A total of 14 randomized controlled trials were included,several outcome measures,for example HAMA efficient of 3 weeks treatment,HAMA score of 8 weeks treatment,HAMA score of 1 and 2 months follow-up,SAS efficiency of 60 days treatment,such the quality of evidence above were very low.However,only the difference about SAS efficiency of 60 days treatment was statistically significant and the difference of the rest outcome measures was not statistically significant.Outcome measures about HAMA efficient of 4 and 6 weeks treatment;HAMA score of 4,5 and 6 weeks treatment;SAS scores of 4weeks treatment,such quality of the evidence above were low.According to HAMA score of 4 weeks,6 weeks treatment,the difference of those two outcome measures were statistically significant,but the rest were not.The quality of evidence about HAMA score of 3 and 6 months follow-up were moderate and the difference of those two outcome measures were not statistically significant.Conclusion：The overall evidence quality of acupuncture and moxibustion treatment for anxiety disorders were low,which indicated that we need to improve the design and reports of randomized controlled trials in order to provide high level evidence of acupuncture treatment to clinical research and guideline drawing up.