摘要
目的系统评价中药在失眠治疗中的安慰剂效应(Effects Associated With Placebo,EAP)。方法全面检索计算机检索中国生物医学文献数据库(CBM-disc,1978年1月~2015年12月)、中国期刊全文数据库(CNKI,1979年1月~2015年12月)、中文科技期刊全文数据库(VIP,1989年1月~2015年12月)、万方数据库(1978年1月~2015年12月)等。全面收集中药和安慰剂治疗失眠的随机对照实验,同时手工检索及追溯参考文献,由二位研究者根据纳入与排除标准独立筛选文献,提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.3软件进行Meta分析。结果最终纳入18个RCT,共计1913例患者,分别采用有效率和匹兹堡睡眠质量指数(Pittsburgh Sleep quality Index,PSQI)评分进行评价。Meta分析显示:失眠治疗前后有效率:亚组1有效率为60.3%,合并OR值为7.14,95%可信区间CI[4.99,10.21,P<0.00001];亚组2有效率为39.7%,合并OR值为9.64,95%可信区间CI[6.47,14.37,P<0.00001];PSQI评分比较睡眠潜伏期(Sleep Latency,SL)、睡眠总时间(Total Sleep Time,TST)、多导睡眠图(Polysomnographic,PSG)SL安慰剂治疗前后的变化,其差异均有统计学意义。结论未来对于中医药治疗失眠的临床试验中应保留安慰剂治疗,并进一步规范中药安慰剂的制作。
Objective To systematically review the placebo effects on insomnia treated with herbal medicine. Methods The literatures were retrieved from CBM - disc （ January 1978 to December 2015 ） , CNKI （ January 1979 to December 2015 ）, VIP （ January 1989 to December 2015 ） and Wanfang database （ Jan- uary 1978 to December 2015）. The randomized controlled trials（RCTs） were collected on the treatment of insomnia with herbal medicines and placebos. The reference literatures were traced and retrieved manually. According to the inclusive and exclusive criteria, two research staffs were screened the literatures separately. After the data extraction and the evaluation on the methodological quality of the included study, RevMan 5.3 software was used for Meta analysis. Results Finally,18 RCTs were included,with 1913 patients involved. The effective rate and PSQI were used for evaluation. Meta analysis showed：for the effective rate before and after treatment,the effective rate in No. 1 subgroup was 60.3%, OR = 7. 14,95% CI（4.99,10.21 ,P 〈 0. 00001 ） ; the effective rate in No. 2 subgroup was 39.7%, OR = 9.64,95% CI （ 6.47, 14. 37, P 〈 0.00001 ）. In PSQI ,the differences were significant statistically in SL,TST and PSG before and after placebo treatment. Conclusion Placebo treatment with herbal medicine is applicable in future clinical trials on insomnia. The preparation of herbal medicine placebo should be further specified.
出处
《世界中西医结合杂志》
2017年第3期313-317,共5页
World Journal of Integrated Traditional and Western Medicine
基金
第五批全国名老中医药专家学术经验继承工作项目(国家中医药人教教育[2012]40号)
