Objective:The effectiveness and safety of Tianma Gouteng Granules(天麻钩藤颗粒)in the treatment of dizziness were systematically evaluated.Methods:A randomized controlled trial of Tianma Gouteng Granules for dizziness...Objective:The effectiveness and safety of Tianma Gouteng Granules(天麻钩藤颗粒)in the treatment of dizziness were systematically evaluated.Methods:A randomized controlled trial of Tianma Gouteng Granules for dizziness was screened out by searching CNKI,Wanfang Data,VIP,SinoMed,Cochrane Library,PubMed,Embase,Web of Science in a systematic way and was based on Handbook 5.1 evaluation criteria and tools and RevMan 5.3 software for meta-analysis of the final inclusion of the study.Results:A total of 7 studies were included,6 studies were included in meta-anlysis and 1 other study,with a total sample size of 568 cases,including 328 cases in the experiential group and 240 cases in the control group.The systolic pressure of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness is better than conventional treatment alone(MD=-3.38,95%CI[-4.90,-1.86],P<0.00001).The diastolic pressure of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness had no difference compared with conventional treatment alone(MD=-1.35,95%CI[-2.36,-0.34],P=0.72).The TCM syndromes score of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness was better than conventional treatment(MD=-5.18,95%CI[-6.89,-5.47],P<0.00001).The marked effective rate of Tianma Gouteng Granules combined with conventional treatment in the treatment of dizziness was better than conventional treatment(RR=2.09,95%CI[1.35,3.24],P=0.001).The marked effective rate of Tianma Gouteng Granules in the treatment of dizziness was better than conventional treatment(RR=1.85,95%CI[1.34,2.54],P=0.0002).Adverse actions included stomach discomfort,dry mouth,headache,dizziness,nausea,insomnia,rash,etc.The number of reported cases in both groups was small.Conclusion:The treatment of systolic pressure,TCM syndrome score and marked effective rate of Tianma Gouteng Granules alone or combined with conventional treatment for dizziness was better than conventional treatment.There was no difference between Tianma Gouteng Granules alone or combined with conventional treatment on diastolic pressure.No serial reverse actions were reported,and all reverse actions were reported after drug withdrawal or dose reduction,and the sample size was small,requiring large samples for further verification.However,the quality of the study is not high,and it is necessary to improve the level of evidence quality by using clinical trial schemes with large samples,rational design and compliance with international standards.展开更多
基金2018 National Key R&D Program of the Ministry of Science and Technology"Research on modernization of traditional Chinese medicine"project"Demonstration study on evidence-based evaluation and effect mechanism of the treatment of major diseases after the marketing of ten large varieties of proprietary Chinese medicines and classic formulas"(2018YFC1707400)。
文摘Objective:The effectiveness and safety of Tianma Gouteng Granules(天麻钩藤颗粒)in the treatment of dizziness were systematically evaluated.Methods:A randomized controlled trial of Tianma Gouteng Granules for dizziness was screened out by searching CNKI,Wanfang Data,VIP,SinoMed,Cochrane Library,PubMed,Embase,Web of Science in a systematic way and was based on Handbook 5.1 evaluation criteria and tools and RevMan 5.3 software for meta-analysis of the final inclusion of the study.Results:A total of 7 studies were included,6 studies were included in meta-anlysis and 1 other study,with a total sample size of 568 cases,including 328 cases in the experiential group and 240 cases in the control group.The systolic pressure of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness is better than conventional treatment alone(MD=-3.38,95%CI[-4.90,-1.86],P<0.00001).The diastolic pressure of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness had no difference compared with conventional treatment alone(MD=-1.35,95%CI[-2.36,-0.34],P=0.72).The TCM syndromes score of Tianma Gouteng Granules alone or combined with conventional treatment in the treatment of dizziness was better than conventional treatment(MD=-5.18,95%CI[-6.89,-5.47],P<0.00001).The marked effective rate of Tianma Gouteng Granules combined with conventional treatment in the treatment of dizziness was better than conventional treatment(RR=2.09,95%CI[1.35,3.24],P=0.001).The marked effective rate of Tianma Gouteng Granules in the treatment of dizziness was better than conventional treatment(RR=1.85,95%CI[1.34,2.54],P=0.0002).Adverse actions included stomach discomfort,dry mouth,headache,dizziness,nausea,insomnia,rash,etc.The number of reported cases in both groups was small.Conclusion:The treatment of systolic pressure,TCM syndrome score and marked effective rate of Tianma Gouteng Granules alone or combined with conventional treatment for dizziness was better than conventional treatment.There was no difference between Tianma Gouteng Granules alone or combined with conventional treatment on diastolic pressure.No serial reverse actions were reported,and all reverse actions were reported after drug withdrawal or dose reduction,and the sample size was small,requiring large samples for further verification.However,the quality of the study is not high,and it is necessary to improve the level of evidence quality by using clinical trial schemes with large samples,rational design and compliance with international standards.
