Effects Of Qishe Pill,A Compound Taaditional Chinese Herbal Medicine,on Cervical Radicul Opathy:A Double-blind,Randomized Placedo-comtrolled Trial

Objective: To evaluate Qishe pill for patients with cervical radiculopathy symptoms necksafety (adverse events) and efficacy evaluation (visual analogue scale VAS score andcervical spine dysfunction index scale NDI score).To assess the improvement of neck painfor Qishe pills. Qishe Pill was evaluated in improving patients’ physical function (SF-36).Methods:A multi-center,1:1stratified randomized and placebo-controlled clinical trial wasproposed by Longhua Hospital Shanghai University of TCM project， which used3methods.The purpose of the present study is to examine the efficacy and safety of Qishe Pill,and the improvement for patients’ neck pain. The study has two groups, included120casesof the test group and120cases of the placebo group.240patients were assigned for five sitesacross China and diagnosed with cervical radiculopathy. There were48cases for two groupsincluded24cases of the test group,and24cases of the placebo group in Gansu. Time oftherapy is4weeks,follow-up time is the third month and the sixth month. the interventionmethod:the Qishe Pill group and the placebo group. Outcome indicators: NDI score， VASscore， SF-36health survey questionnaire. Safety indicators: the incidence of adverseevents.Results: A total of48cases had shed three cases. Before the treatment, comparing thebasic situation of two groups had no difference in statistics. For NDI score and VAS score, acomparison of the Qishe Pill group and the placebo group had statistical significance. Inaspects of physical function (PF),bodily pain (BP),social function (SF),role emotional(RE) ofSF-36, two groups had statistical significance, and the Qishe pill group was better than theplacebo group. The Qishe Pill group had a statistically significant advantage over the placebogroup after the third month and the sixth month in follow-up in NDI and VAS score. Twopatients were lost to follow-up and no one had an slight adverse drug reaction in the Qishe pillgroup.No patients were lost to follow-up in the placebo group,but three patients come to anslight adverse drug reaction.3cases of adverse reactions in patients were not required to havespecial treatment until the end of this study.Conclusion:The study of the randomized,double-blind,placebo-controlled clinical trials insub centers of Gansu showed:Qishe pill was effective in treatment of nerve root type cervicalspondylosis, The relative efficacy and safety of Qishe pill for neck,shoulder and arm pain could be determined.