| Objective:Wenshen Juanbi Decoction(decoction for warming kidney and relieving Bi)and modified Wenshen Juanbi Decoction were applied to treat ankylosing spondylitis(AS)patients of kidney deficiency and Du channel cold syndrome.The intention of the study is to systematically evaluate the clinical efficacy and safety of these decoctions by observing the clinical symptoms,TCM syndromes,laboratory indicators,efficacy evaluation standard and functional evaluation indicators of patients before and after the trial.It is planned to provide a basis for optimizing the existing diagnosis and treatment programs and clinical pathways.Methods:1.Patients will be randomly divided into 3 groups,each with 20 cases.Group 1(Wenshen Juanbi Decoction Group),Group 2(Modified Wenshen Juanbi Decoction Group)and Control Group(nonsteroidal anti-inflammatory drug group).The treatment duration is 8 weeks and all the ralated data will be recorded at the time 0w,4w,8w.Patients of Group 1 take the traditional Chinese medicine Wenshen Juanbi Decoction,patients of Group 2 take the Chinese medicine modified Wenshen Juanbi Decoction,and patients of Control Group take Celecoxib,a kind of nonsteroidal anti-inflammatory drug.Celecoxib can be replaced by meloxicam tablet after 4 weeks if its effect is not satisfying.The adverse reactions of patients in all the 3 groups before and after the treatment were observed and recorded.2.All databases of CNKI,VIP,Wanfang Data were searched,and the retrieval date is from the database establishment to October 2019.The experimental groups were treated with chinese medicine under the guidance of Bushen Qiangdu theory(means tonifying the kidney and reinforcing the Du channel),while the control groups were treated with other drugs in all the included randomized controlled trials.Two reviewers extracted data and evaluated the quality of the literature seperately,using Revman 5.3 software for meta analysis.Results:1.Baseline comparisonAs there was no significant difference in age,gender,course of disease,ESR,CRP,BASFI,BASDAI,ASDAS-CRP,TCM syndrome score,blood routine,and liver and kidney function among samples in the three groups at the time of enrollment(P>0.05),the observation indicators are statistically comparable with one another.2.Efficacy comparisonIn terms of the efficacy of TCM syndrome,the total effective rates of Group 1,Group 2 and Control Group were 55.00%,80.00%,and 50.00%,with statistical differences(P<0.05).There were statistical distinctions in the scores of TCM symptoms and signs of the three groups of patients before and after the treatment in terms of low back pain,low back movement limitation,morning stiffness and nocturnal pain(P<0.05).In terms of improving the symptoms of nocturnal pain,soreness and weakness of waist and knees and aversion to cold and desirefor warmth,results of Groups 1 and 2 were better than the Control Group(P<0.05).Group 2 was the best among the three groups in terms of treating low back pain,low back movement limitation,morning stiffness(P<0.05).In terms of BASDAI,ASDAS-CRP,and BASFI,statistical differences exist among the three groups before and after the treatment(P<0.05).Group 2 had a more significant decline in the BASDAI scores compared with the other two groups,and the differences were significant(P<0.05).In terms of BASFI,Group 1 and 2's scores decreased more significantly(P<0.05),while Group 2 and Control Group's scores decreased more significantly in ASDAS-CRP(P<0.05).There were statistical differences in ESR and CRP reduction in the three groups before and after the treatment(P<0.05)The ASAS20 compliance rate of Group 2 was better than the other two groups,and the ASAS40 compliance rate was better than the Control Group,the difference was statistically significant(P<0.05)3.Safety analysis:The 60 patients who were selected as samples show no adverse reactions such as drug allergy and gastrointestinal bleeding,and blood routine and liver and kidney function of patients in all the 3 groups show no obvious abnormality before and after the treatment(P>0.05).4.Meta analysis results:1.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in improving TCM syndrome scores and has a statistical significance[MD=-8.26,95%CI(-14.49,-2.03),P<0.00001];2.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in improving BASDAI scores and has a statistical significance[MD=-2.37,95%CI(-3.26,-1.49),P<0.00001];3.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in improving BASFI scores and has a statistical significance[MD=-0.95,95%CI(-1.46,-0.43),P=0.0003];4.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in improving VAS scores and has a statistical significance[MD=-1.37,95%CI(-1.79,-0.96),P<0.00001];5.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in reducing ESR and has a statistical significance[MD=-4.39,95%CI(-6.44,-2.33),P<0.0001];6.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in reducing CRP and has a statistical significance[MD=-3.43,95%CI(-4.02,-2.85),P<0.00001];7.Treatment of ankylosing spondylitis with kidney deficiency and Du channel cold syndrome,the method of Bushen Qiangdu is superior to the control group in incidence of adverse events and has a statistical significance[RR=0.48,95%CI(0.31,0.73),P=0.0007].Conclusion:1.Wenshen Juanbi Decoction and its modified decoction have significant effects on improving the clinical symptoms and laboratory indicators,reducing the disease activity and improving the functional status.They are verified to be safe.2.From the perspective of evidence-based medicine,it has been proved that the method of Bushen Qiangdu has good efficacy and is safe when treating ankylosing spondylitis due with kidney deficiency and Du channel cold syndrome. |
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