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. 2020 Dec 21:27:44-56.
doi: 10.1016/j.jot.2020.10.010. eCollection 2021 Mar.

Jingshu Keli for treating cervical spondylotic radiculopathy: The first multicenter, randomized, controlled clinical trial

Jianhua Hu  1 , Feng Chen  1 , Guixing Qiu  1 , Tiansheng Sun  2 , Huilin Yang  3 , Huiyong Shen  4 , Peijian Tong  5 , Yimin Chai  6 , Xueli Zhang  7 , Weibin Zhang  8 , Zhidong Yang  9 , Hong Jiang  10 , Yalin Pan  11 , Tianliang Zhu  12 , Chengjian He  13 , Weiping Xiao  14
Affiliations

Jingshu Keli for treating cervical spondylotic radiculopathy: The first multicenter, randomized, controlled clinical trial

Jianhua Hu et al. J Orthop Translat. .

Abstract

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.

Keywords: ALP, alkaline phosphatase; ALT, alanine aminotransferase; ANCOVA, analysis of covariance; AST, aspartate aminotransferase; BUN, blood urea nitrogen; Cervical spondylotic radiculopathy; Cr, creatine; FAS, full analysis set; Herbal medicine; ITT, intention-to-treat; Jingshu keli; LOCF, last observation carried forward; NAG, urine N-acetyl-beta-d-glucosaminidase; PPS, per-protocol set; PT, preferred term; RCT, randomized controlled trial; Randomized controlled trial; SAS, safety analysis set; SNL, spinal nerve ligation; SOC, system organ class; TBIL, total bilirubin; Traditional Chinese medicine; VAS, visual analogue scale; γ-GT, γ-glutamyl transpeptidase.

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Conflict of interest statement

The authors have no conflicts of interest to disclose in relation to this article.

Figures

Figure 1
Figure 1
Distribution diagram of subjects.
Figure 2
Figure 2
Change in pain VAS scores before and after drug administration using the full analysis set (FAS).
Figure 3
Figure 3
Rate of change in pain VAS scores before and after drug administration using the full analysis set (FAS).
Figure 4
Figure 4
Change in pain VAS scores before and after drug administration using the per protocol set (PPS).
Figure 5
Figure 5
Rate of change in pain VAS scores before and after drug administration using the per protocol set (PPS).
Figure 6
Figure 6
Change in pain VAS scores before and after administration using the sensitivity analysis dataset of the full analysis set (FAS).
Figure 7
Figure 7
Rate of change in pain VAS scores before and after drug administration using the sensitivity analysis dataset of the full analysis set (FAS).
Figure 8
Figure 8
Rate of change in neck disability index (NDI) and numbness VAS scores before and after administration.
See this image and copyright information in PMC

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