Effectiveness of OsteoKing in the Treatment of Lumbar Disc Herniation: A Randomized, Double‑Blind, Double‑Dummy, Positive‑Controlled, Multicenter Clinical Trial
Zhuoyun Wu, Shiyu Dong, Hongqing Ma, Yufeng Ma, Kuayue Zhang, Xuehui Wang, Hao Wang, Shuangqing Du, Wenjie Wu, Tao Fan, Jian Wei, Wenge Wang, Yue Han, Chao Ma, Fuhong Cheng, Yuan Pang, Rongxin Sun, Ziqiang Zhu, Linlin Chen, Wei Fang, Xiangrong Liu, Peidong Qing, Baohong Mi, Weiheng ChenABSTRACT
Aim
This study aimed to evaluate the efficacy and safety of OsteoKing compared to a standard active comparator (Yaobitong capsules) for managing lumbar disc herniation (LDH).
Methods
A randomized, double‐blind, double‐dummy, positive‐controlled, multicenter trial was conducted across 17 hospitals in China. A total of 210 eligible patients with LDH were randomized in a 2:1 ratio to receive either OsteoKing ( n = 140) or Yaobitong capsules ( n = 70) for 4 weeks. The primary efficacy endpoint was the change in the Visual Analog Scale (VAS) score from baseline to week 4. Secondary endpoints included the Oswestry Disability Index score, the resolution rate of individual traditional Chinese medicine symptoms, and safety assessments. Missing data and repeated measures were handled using multiple imputation and a mixed‐model for repeated measures.
Results
Baseline characteristics were well‐matched between the two groups. At week 4, both groups experienced substantial improvements in pain and lumbar function. In the full analysis set (FAS), the between‐group least squares mean difference (LSMD) in VAS reduction was −0.37 (95% CI: −0.77 to 0.03; p = 0.074). In the per‐protocol set (PPS) analysis, the OsteoKing group achieved a significantly greater reduction in VAS scores compared to the control group (LSMD: −0.41, 95% CI: −0.82 to −0.01; p = 0.0453). Improvements in ODI scores were comparable between the groups in both the FAS and PPS analyses ( p > 0.05). Additionally, the OsteoKing group demonstrated significantly higher resolution rates for low back pain and fatigue/lassitude at week 4 ( p < 0.05). Both treatments were safe and well‐tolerated, with comparable incidence rates of adverse events (21.43% vs. 24.29%, p = 0.6396).
Conclusions
OsteoKing demonstrated comparable overall efficacy and safety to Yaobitong capsules in improving lumbar function and relieving symptoms in patients with LDH. Furthermore, OsteoKing may offer a modest, short‐term analgesic advantage at the 4‐week mark. OsteoKing represents a safe, effective, and viable conservative therapeutic option for LDH.