Fan Xu, Su Zhuang, Nie Shichao, Yang Jie, Zhang Xiaoyu, Tan Dongyang, Xie Sihang, Xu Yi, Zhao Yanying, Feng Liu, Gu Mingyi, Sun Xiaomeng
Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning province, China.
Medicine (Baltimore). 2020 Mar;99(11):e19410. doi: 10.1097/MD.0000000000019410.
Insomnia is a global public problem, which has a significant negative impact on both physical and mental health, while increasing the economic burden placed on both sufferers and society. Western medicine has a fast treatment on sleep, but it leads to side effects and strong dependence. Long Dan Xie Gan Tang(LDXGT) is a representative Chinese herbal medicine for the treatment of insomnia especially which has a bad-tempered symptom, and its effectiveness and safety has been validated clinically. However, there is yet to be any evidence-based medicine. Therefore, the effectiveness and safety of LDXGT in the treatment of insomnia are studied and systematically evaluated in this study. It will provide a theoretical support for the treatment of insomnia compared to western medicine.
The study is purposed to evaluate the effectiveness and safety of LDXGT for the treatment of insomnia.
Search was conducted for various databases including Pubmed, Chinese Biomedicine Database(CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. Randomized-controlled trials (RCTs) were identified for insomnia treatment involving LDXGT and LDXGT combined with ordinary Western medicine. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bias. RevMan 5.3 software and STATA 12.0 software were applied to perform the meta-analysis.
Thirteen studies involving 1181 participants were identified in this systematic review. Few studies described the details of random principle. No placebo was involved in treatment. LDXGT was compared with ordinary Western medicine in 11 trials and with LDXGT combined with conventional Western medicine in 2 trials. The results of our meta-analysis showed the relative benefits in effective rates compared with conventional western medicine. (Odds Ratio [OR]= 4.32, I = 0%,95% confidence interval CI [3.05 to 6.13], P < .00001) and recovery rate was (Odds Ratio [OR] = 2.67, I = 0%,95% confidence interval CI [2.04 to 3.48], P < .00001). In two trials, adverse events were reported, but no serious adverse effects were reported.
Our systematic evaluation will provide evidence for the clinical effectiveness and safety of LDXGT in the treatment of insomnia, and the side effects of western medicine are addressed. Further trials are necessary to collect the evidence for the use of LDXGT.
失眠是一个全球性的公共问题，对身心健康均有显著负面影响，同时加重了患者和社会的经济负担。西医治疗失眠起效快，但会导致副作用和较强的依赖性。龙胆泻肝汤是治疗伴有性情急躁症状失眠的代表性中药，其有效性和安全性已得到临床验证。然而，尚无循证医学依据。因此，本研究对龙胆泻肝汤治疗失眠的有效性和安全性进行研究并系统评价，为其在失眠治疗中相较于西医的应用提供理论支持。
本研究旨在评价龙胆泻肝汤治疗失眠的有效性和安全性。
检索多个数据库，包括PubMed、中国生物医学文献数据库（CBM）、中国知网（CNKI）、维普中文科技期刊数据库（VIP）和万方数据库。纳入涉及龙胆泻肝汤及龙胆泻肝汤联合普通西药治疗失眠的随机对照试验（RCT）。采用Cochrane评估工具评估文献质量，以降低偏倚风险。应用RevMan 5.3软件和STATA 12.0软件进行荟萃分析。
本系统评价共纳入13项研究，涉及1181名参与者。很少有研究描述随机原则的细节。治疗中未使用安慰剂。11项试验将龙胆泻肝汤与普通西药进行比较，2项试验将龙胆泻肝汤与传统西药联合应用进行比较。荟萃分析结果显示，与传统西药相比，龙胆泻肝汤在有效率方面具有相对优势（比值比[OR]=4.32，I²=0%，95%置信区间CI[3.05至6.13]，P<0.00001），治愈率方面（比值比[OR]=2.67，I²=0%，95%置信区间CI[2.04至3.48]，P<0.00001）。两项试验报告了不良事件，但未报告严重不良反应。
我们的系统评价将为龙胆泻肝汤治疗失眠的临床有效性和安全性提供证据，并解决了西药的副作用问题。需要进一步试验以收集龙胆泻肝汤应用的证据。
