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

Jianhua Hu; Feng Chen; Guixing Qiu; Tiansheng Sun; Huilin Yang; Huiyong Shen; Peijian Tong; Yimin Chai; Xueli Zhang; Weibin Zhang; Zhidong Yang; Hong Jiang; Yalin Pan; Tianliang Zhu; Chengjian He; Weiping Xiao

doi:10.1016/j.jot.2020.10.010

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

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

Authors

Jianhua Hu¹, Feng Chen¹, Guixing Qiu¹, Tiansheng Sun², Huilin Yang³, Huiyong Shen⁴, Peijian Tong⁵, Yimin Chai⁶, Xueli Zhang⁷, Weibin Zhang⁸, Zhidong Yang⁹, Hong Jiang¹⁰, Yalin Pan¹¹, Tianliang Zhu¹², Chengjian He¹³, Weiping Xiao¹⁴

Affiliations

¹ Department of Orthopedics, Peking Union Medical College Hospital (PUMCH), Peking, China.
² Department of Orthopedics, People's Liberation Army General Hospital, Peking, China.
³ Department of Orthopedics, The First Affiliated Hospital of Soochow University, Soochow, Jiangsu, China.
⁴ Department of Orthopedics, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
⁵ Department of Orthopedics, Zhejiang Provincial Hospital of TCM, Hangzhou, Zhejiang, China.
⁶ Department of Orthopedics, Shanghai Sixth People's Hospital, Shanghai, China.
⁷ Department of Spine Surgery, Tianjin People's Hospital, Tianjin, China.
⁸ Department of Orthopedics, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China.
⁹ Department of Orthopedics, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
¹⁰ Department of Orthopedics, Suzhou Hospital of Traditional Chinese Medicine, Soochow, Jiangsu, China.
¹¹ Department of Orthopedics, People's Hospital of Anyang City, Anyang, Henan, China.
¹² Department of Orthopedics, Chongqing General Hospital, Chongqing, China.
¹³ Department of Orthopedics, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China.
¹⁴ Department of Orthopedics, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi China.

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.