Obj ective:To systematically evaluate the clinical effect and safety of Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,or combined with western medicine in the treatment of primary dysmenorrhea,and to compare its differences with conventional western medicine in the treatment of primary dysmenorrhea,in order to provide more basis and direction for future clinical medication and treatment.Methods:Randomized controlled trials of Shaofu Zhuyu Decoction in the treatment of primary dysmenorrhea were searched in China National Knowledge Infrustructure(CNKI),Wanfang database,VIP database,China Biology Medicine(CBM),PubMed database,Embase database and Cochrane Library.The retrieval time was from the database construction to December 2021.Rev Man 5.3 software was used for meta-analysis of the included literatures.Results:A total of 24 literatures were included in the study,including 2168 patients.The meta-analysis results are as follows:1.Total effective rate:OR=4.26,95%CI[3.10,5.85],Z=8.93,P<0.00001,the difference was statistically significant.Conclusion:Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,or combined with western medicine treatment group can obviously improve the total effective rate,and the effect is better than conventional western medicine control group.2.Dysmenorrhea symptom score:MD=-1.56,95%CI[-2.82,-0.29],Z=2.4 1,P=0.02(<0.05),the difference was statistically significant.Conclusion:Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,or combined with western medicine can significantly reduce the dysmenorrhea symptom score,and the effect is better than the control group of conventional western medicine.The control group was divided into ibuprofen group and indomethacin group according to different intervention measures.(1)Ibuprofen group:MD=-1.63,95%CI[-3.10,0.17],Z=2.19,P=0.03(<0.05),the difference was statistically significant.Conclusion:Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,or combined with western medicine in improving dysmenorrhea symptom score,the effect is better than conventional western medicine ibuprofen treatment.(2)Indomethacin group:MD=-1.1 7,95%CI[-3.0 1,0.66],Z=1.25,P=0.21(>0.05),the difference was not statistically significant.Conclusion:Compared with conventional western medicine indomethacin,Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,has no advantage in improving dysmenorrhea symptom score.3.Pain score:MD=-1.27,95%CI[-1.92,-0.63],Z=3.85,P=0.0001(<0.05),the difference was statistically significant.Conclusion:Shaofu Zhuyu Decoction,or combined withexternal treatment of traditional Chinese medicine,or combined with western medicine treatment group can significantly reduce the pain score,and the effect is better than the conventional western medicine control group.4.Recurrence rate:OR=0.12,95%CI[0.05,0.31],Z=4.49,P<0.00001,the difference was statistically significant.Conclusion:The treatment group of Shaofu Zhuyu Decoction can obviously reduce the recurrence rate,and the effect is better than the control group of conventional western medicine.The control group was divided intoibuprofen group and indomethacin group according to different intervention measures.(1)Ibuprofen group:OR=0.18,95%CI[0.03,1.26],Z=1.72,P=0.08(>0.05),the difference was not statistically significant.Conclusion:Compared with the conventional western medicine ibuprofen,Shaofu Zhuyu Decoction has no advantage in reducing the recurrence rate.(2)Indomethacin group:OR=0.08,9 5%CI[0.04,0.16],Z=7.1 0,P<0.0000 1,the difference was statistically significant.Conclusion:Shaofu Zhuyu Decoction is better than indomethacin in reducing the recurrence rate.5.Incidence of adverse reactions:OR=0.13,95%CI[0.06,0.26],Z=5.80,P<0.00001,the difference was statistically significant.Conclusions:1.Shaofu Zhuyu Decoction,or combined with external treatment of traditional Chinese medicine,or combined with western medicine in the treatment of primary dysmenorrhea have significant effects in improving the total effective rate and pain score,and are significantly better than the control group of conventional western medicine.2.Compared with the conventional western medicine indomethacin control group,Shaofu Zhuyu Decoction or combined external treatment of traditional Chinese medicine in the treatment of primary dysmenorrhea has no advantage in improving dysmenorrhea symptom score;compared with the conventional western medicine ibuprofen control group,Shaofu Zhuyu Decoction has no advantage in reducing the recurrence rate of primary dysmenorrhea.3.Compared with the control group of conventional western medicine,the incidence of adverse reactions in the treatment of primary dysmenorrhea by Shaofu Zhuyu Decoction or combining western medicine is lower and the safety is higher. |