摘要：Background Jingshu Keli (or Jingshu granules), a traditional Chinese medicine, are widely used for treating cervical spondylotic radiculopathy in China; however, no randomized, double-blind, controlled study has verified their effectiveness. Purpose To evaluate the efficacy and safety of Jingshu Keli for the treatment of cervical spondylotic radiculopathy in a randomized controlled trial. Design From August 2015 to July 2017, a multicenter, randomized, double-blind, placebo-controlled trial was conducted at 13 large- and medium-sized hospitals in China. Patient sample A total of 360 and 120 patients were initially enrolled in the Jingshu and control groups, respectively; 386 patients completed the study, with 299 in the Jingshu group and 87 in the control group. Outcome measures The main index for evaluating the curative effect was the pain score on a visual analogue scale (VAS; 0–100 points). Methods All patients were administered a bag of Jingshu Keli or placebo 3 times a day for 4 weeks, and were interviewed at the second and fourth weeks. The decrease in pain scores and rate of change in pain scores after treatment were calculated, related laboratory indices were reviewed, and adverse reactions were recorded. Results In the Per Protocol Set (PPS) analysis, the baseline pain VAS scores in the control and Jingshu groups were 49.31 ± 6.97 and 50.06 ± 7.33, respectively, with no significant difference between the groups (P > 0.05). While there were no differences at 2 weeks between groups, at four weeks the pain VAS scores in the control and Jingshu groups decreased by 12.86 ± 13.45 and 22.72 ± 15.08, respectively relative to the values at baseline, with significant group differences (P < 0.0001). While there were similar significant differences between the groups (P < 0.0001) in the Full Analysis Set (FAS) analyses neither group achieved the minimal clinically important difference at any time point. Conclusions Jingshu Keli are effective for the treatment of cervical spondylotic radiculopathy. Translational potential statement This is the first prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial that confirmed the clinical efficacy and safety of Jingshu Keli for treating cervical spondylotic radiculopathy, which can provide evidence for clinical treatment.
关键词：Cervical spondylotic radiculopathy ; Herbal medicine ; Jingshu keli ; Randomized controlled trial ; Traditional Chinese medicine ; RCT randomized controlled trial ; VAS visual analogue scale ; AST aspartate aminotransferase ; ALT alanine aminotransferase ; ALP alkaline phosphatase ; TBIL total bilirubin ; γ-GT γ-glutamyl transpeptidase ; Cr creatine ; BUN blood urea nitrogen ; NAG urine N-acetyl-beta- d -glucosaminidase ; FAS full analysis set ; ITT intention-to-treat ; LOCF last observation carried forward ; PPS per-protocol set ; SAS safety analysis set ; SNL spinal nerve ligation ; PT preferred term ; SOC system organ class ; ANCOVA analysis of covariance
