白术转腰汤治疗脾肾阳虚、痰瘀互结证退行性腰椎管狭窄症随机双盲对照试验OA北大核心CSTPCD

Objective To observe the efficacy and safety of Baizhu Zhuanyao Decoction(BZZYD)in treating degenerative lumbar spinal stenosis(DLSS)patients with Pi-Shen yang deficiency and inter-coagulation of phlegm and blood stasis syndrome(PSYD-IPBSS).Methods Randomized double-blinded double-simulated parallel controlled trial was adopted.Totally 104 DLSS patients in line with inclusion criteria were selected from 130 patients,and randomly assigned to two groups by 1∶1 ratio,52 patients in the treatment group and 52 patients in the control group.Patients in the treatment group took BZZYD+Mecobalamin Tablet simulant+Celecoxib Capsule simulant.Those in the control group took BZZYD simulant+Mecobalamin Tablet+Celecoxib Capsule.The treatment course of both groups was 3 weeks.Visual Analogue Scale(VAS)score and Oswestry disability index(ODI)score,symptoms score of Chinese medicine and changes of lumbar motion were recorded before treatment,after treatment,and 1 month follow-up after treatment,respectively.Results In the treatment group 7 cases dropped out and 6 in the control group.Totally 91 patients completed the treatment and follow-ups.Among the 45 cases in the treatment group,clinical control were obtained in 3 cases,markedly effective in 5,effective in 30,ineffective in 7,and the total effective rate of was 84.5％(38/45).Among the 46 cases in the control group clinical control were obtained in 2 cases,markedly effective in 2,effective in 33,ineffective in 9,and the total effective rate of was 80.5％(37/46).The total effective rate in the treatment group was higher than that in the control group,but the difference was not statistically significant(x2=0.252,P＞0.05).Compared with before treatment in the same group,VAS and ODI scores significantly decreased after treatment in the two groups(P＜0.05).Scores for primary and secondary Chinese medicine symptoms and syndromes significantly decreased(P＜0.05).After follow-ups VAS and ODI scores increased in the control group(P＜0.05).Scores for primary and secondary Chinese medicine symptoms and syndrome significantly increased as well(P＜0.05).The degrees of intermittent claudication and the numbness score in the lower limbs significantly increased in the treatment group(P＜0.05).After treatment the ranges of motion for lumbar flexion,extension,left lateral bending,right lateral bending,left rotation,and right rotation increased in the two groups(P＜0.05).Compared with the control group at the same period,the ODI score decreased after treatment in the treatment group(P＜0.05).Both VAS and ODI scores decreased after follow-ups(P＜0.05).Scores for primary and secondary Chinese medicine symptoms and syndromes(except lower limbs pain and numbness after treatment/numbness after follow-ups)decreased(P＜0.05).Lumbar extension was more significantly extended(P＜0.05).The incidence of adverse reactions was 4.4％(2/45)in the treatment group and 10.8％(5/46)in the control group,with no statistical difference between the two groups(x2=0.572,P＞0.05).Conclusion BZZYD effectively relieved waist and leg pain and Chinese medicine syndromes and improved the lumbar function in treating DLSS patients with PSYD-IPBSS,with stable and long-lasting effect and good safety.Chinese Clinical Trial Registry(No.ChiCTR2100046515).