Jiaotai Pills For Insomnia In Pre-clinical And Clinical Studies:A Systematic Review With Network Meta-analysis

Objective: The main objective of this paper was to conduct a systematic review and meta-analysis of Jiaotai pills(both basic and clinical research).In the aspect of animal experiment,we used the network meta-analysis to assess the efficacy of Jiaotai pills for insomia,and to generate a useful ranking of Jiaotai pills with different proportion according to their efficacy.Methods: Literatures about Jiaotai pills for insomia were reviewed from both Chinese database(CNKI,VIP,Wan Fang)and English database(Pub Med,Cochrane Library,OVID,Embase).We conduct the systematic review from the following aspects: data entry,year of publication,disease category,mode of administration,impassioned compatibility and other aspects.In this essay,we also reviewed literatures about the efficacy and safety of Jiao Tai pills in the treatment of insomnia.The Stata12.0 software was used for the network meta data analysis and related chart production.We used the Cochrane bias risk assessment tool to assess the methodological quality of the clinic trials,and used the SYRCLE animal experiment risk assessment tool to evaluate the methodological quality of the animal experiment.Results: According to the study of the Jiaotai pills(basic and clinical research),there were 264 articles,including 164 clinical articles and 100 basic research articles.In the aspect of animal experiment,5 articles were included,which involving 646 animal models.Compared with the Placebo,Jiaotai pills with 7 different proportions(including1:2,1:1,2:1,3:1,4:1,5:1,10:1)were associated with the greater effect on total effective rate(RR=3.66,95%Cl=[2.56,5.23],z=4.41,P<0.0001);Otherwise,Jiaotai pills with 6different proportions(including 1:2,1:1,2:1,3:1,5:1,10:1)also can prolong the sleep time(SMD=1.42,95%Cl=[1.12,1.72],z=9.19,P<0.0001).In the clinical research,19 randomized controlled trials(RCT)were included,which involving 1500 patients reported neither the blinding method,nor the allocation concealment.Either Jiaotai pills or Jiaotai pills plus conventional therapy(Jiaotai pills+)was compared with conventional therapy,such as hypnotic sedative or other traditional proprietary Chinese medicine.Meta-analysis showed that Jiaotai pills+ can significantly improve the clinical efficacy of insomnia(RR=0.88,95%CI=[0.81,0.97],z=2.70,P<0.00001);can improve Pittsburgh Sleep Quality Index(SMD=1.26,95%CI=[0.53,1.99],z=3.36,P=0.001),prolong the sleep time(SMD=0.78,95%CI=[0.32,1.23],z=3.36,P<0.05),improve the sleep efficiency(SMD=0.63,95%CI=[0.36,0.90],z=4.63,P<0.05),improve the sleep disorders(SMD=1.20,95%CI=[0.02,2.39],z=1.99,P<0.05),improve daytime energy(SMD=1.57,95%CI=[0.49,0.65],z=2.84,P<0.05),in addition,the sleep quality(SMD=0.28,95%CI=[-0.07,0.63],z=1.58,P>0.05),sleeping time(SMD=0.20,95%CI=[-0.06,0.46],z=1.48,P>0.05),hypnotic drugs(SMD=1.11,95%CI=[-0.57,2.79],z=1.29,P>0.05)were not statistically significant.Jiaotai pills can also relieve the symptoms of anxiety(SMD=0.48,95%CI=[0.16,0.79],z=2.97,P<0.05)and depression(SMD=0.45,95%CI=[0.14,0.77],z=2.83,P<0.05),reduce the incidence of adverse reactions(SMD=0.45,95%CI=[0.14,0.77],z=2.83,P<0.05).Conclusion: Based on the existing evidence,Jiaotai pills have a relatively accurate treatment for insomnia,moreover,during the different proportion of Huanglian and Rougui,10:1 can get the best results,and compared with the Placebo,Jiaotai pills can reduce the incidence of adverse drug reactions.