| ObjectiveUsing the statistical method of evidence-based medicine to systematically review the clinical effect of Tianwangbuxin Dan for the treatment of insomnia.MethodWe searched PubMed,Embase,the Cochrane Library,CBM,CNKI,VIP and Wanfang database from their inceptions to December 2016 for controlled trials of Tianwangbuxin for insomnia.In addition,the included studies and the reference of related reviews were screened to get the literature of potential requirements.Two reviewers screened the citations of the reports,assessed the risk of bias and extracted data independently according to the inclusion and exclusion criteria.RevMan 5.3 software was used to analyze the combined effects of the total clinical effective rate,clinical cure rate,TCM symptom score,PSQI score and the effective rate of sleep quality.However,because of the limited data of adver effect,we just done the descriptive analysis.ResultsTwelve RCTs involving 1,056 insomnia patients were included.There were 555 patients in the Tianwangbuxin Dan group(experimental group),while the rest 501 patients were in the WM group(control group).Comparing to the WM treatment,Tianwangbuxin Dan significantly improved the total response rate(OR=3.35,95%CI[2.28,4.91],P<0.00001)and the clinical cure rate(OR=1.62,95%CI[1.16,2.25],P=0.004).Meta-analysis showed that Tianwangbuxin Dan combined with WM significantly improved the total response rate(OR=5.05,95%CI[1.58,16.12],P=0.006)and the clinical cure rate(OR=2.81,95%CI[1.49,5.28],P=0.001).The results also showed that the Tianwangbuxin Dan can significantly decrease sleep time(WMD=-0.42,95%CI[-0.65,-0.19],P=0.0003),improve the daytime functioning(WMD=-0.50,95%CI[-0.70,-0.31],P < 0.00001),the effective rate of sleep quality(OR=4.31,95%CI[1.97,9.42],P=0.0002)and the TCM symptom score(WMD=-4.24,95%CI[-5.25,-3.22],P < 0.00001).However,the results of total sleep time(WMD=-0.23,95%CI[-0.65,0.19],P=0.28)and sleep quality(WMD=-0.27,95%CI[-0.85,0.31],P=0.36)between the WM group and the Tianwangbuxin Dan group showed no statistically significant.Only 4 included studies reported the untoward effect,and 3 of them reported the symptoms and the number of cases of the untoward effect,from which we inferred that the Tianwangbuxin Dan seems to be safer than the WM.Conclusion1.Compared with the routine Western medicine(WM)treatment for insomnia,Tianwangbuxin Dan appears to be superior to WM for improving the total response rate,the clinical cure rate,daytime functioning and the effective rate of sleep quality,reducing sleep time and the TCM symptom score.Besides,Tianwangbuxin Dan also seems to be safer than the WM.2.It shows no obvious difference between WM and Tianwangbuxin Dan treatment for improving the total sleep time and sleep quality.3.The methodological quality of the included trials was generally substandard,which makes the study results less authority and reliability.It still needs more high-quality RCTs to verify the efficacy and safety of Tianwangbuxin Dan for the treatment of insomnia owing to methodological flaws of previous trials. |
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