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Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial

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Abstract

Objective

To assess the efficacy and safety of Bushen Huoxue Formula (BSHXF) for the treatment of discogenic low-back pain (DLBP).

Methods

This was a parallel, double-blind, randomized, clinical trial performed between May 2019 and June 2020. Seventy patients were assigned by computerized random number table to the treatment group (lumbar traction and BSHXF, 35 cases) or the control group (lumbar traction and placebo, 35 cases). The patients received intervention for 3 weeks. Assessment was conducted before treatment and at week 1, 2, 3 during treatment. Primary outcome was the self-reported score of Oswestry Disability Index (ODI). Secondary outcomes included Visual Analog Scale (VAS), clinical efficacy rate by minimal clinically important difference (MCID) as well as lumbar tenderness, muscle tone and lumbar spine mobility. Adverse reactions were recorded. Follow-up was performed at 1 and 3 months after the end of treatment.

Results

In the treatment group, ODI score was significantly decreased compared with baseline (P<0.05) and the control group at 2- and 3- week treatment. Similarly, VAS score decreased compared with the baseline (P<0.05) and was lower than that in the control group at 2- and 3- week treatment (P<0.05). The clinical efficacy rate of the treatment group was higher than that of the control group after treatment [32.35% (11/34) vs. 3.13% (1/32), P<0.05). Moreover, the tenderness, and muscle tone, as well as the back extension and left flexion in lumbar spine mobility in the treatment group at 3-week treatment were significantly improved compared with the control group (P<0.05). Follow-up showed that at 1-month after treatment, the treatment group had better outcomes than the control group with regard to a total score of ODI and VAS scores, as well as clinical efficacy rate (all P<0.05). Moreover, VAS score was still significantly lower than the control group at 3-month follow-up (P<0.05). No adverse reactions were reported during the study.

Conclusion

BSXHF combined with lumbar traction can significantly improve the clinical symptoms including pain intensity, functionality, muscle tone, and lumbar spine mobility in DLBP patients. (Registration No. ChiCTR1900027777).

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Data Availability

All data analyzed during this study are included in the manuscript. The raw data used and analyzed during the study are available from the corresponding author upon reasonable request.

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Author information

Authors and Affiliations

  1. General Orthopedics Department, Wang**g Hospital, China Academy of Chinese Medical Sciences, Bei**g, 100102, China

    Jia-wen Zhan, Shang-quan Wang, Tao Han, Ling-hui Li, Ming Chen & Chen-chen Shao

  2. Key Laboratory of Bei**g of Traditional Chinese Medicine Bone Setting, Bei**g, 100102, China

    Jia-wen Zhan, Li-guo Zhu, Min-shan Feng, Xu Wei, Xun-lu Yin, Tao Han & ** Zhang

  3. Orthopedics Department, **yuan Hospital, China Academy of Chinese Medical Sciences, Bei**g, 100091, China

    Kai-ming Li

  4. The Second Department of Spine, Wang**g Hospital, China Academy of Chinese Medical Sciences, Bei**g, 100102, China

    Li-guo Zhu, Min-shan Feng, Jie Yu, Bin Tang & Xun-lu Yin

Authors
  1. Jia-wen Zhan
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  2. Kai-ming Li
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  3. Li-guo Zhu
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  5. Min-shan Feng
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  10. Tao Han
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  12. Ling-hui Li
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Contributions

Zhan JW and Li KM contributed equally to this work. Zhu LG designed the study. Li KM, Yin XL, Han T, Zhang P, Tang B, Li LH, Chen M, and Shao CC conducted the experiments. Li KM and Wang SQ composed the manuscript. Feng MS and Wei X plotted the manuscript. Zhan JW, Zhu LG, and Yu J revised the manuscript. All authors approved the final version of the manuscript.

Corresponding author

Correspondence to Li-guo Zhu.

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Conflict of Interest

The authors declare that they have no conflicts of interest regarding the publication of this paper.

Supported by National Natural Science Foundation of China (No. 81930118), Central Public Welfare Research Institutes (No. ZZ13-YQ-038), Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (No. ZYYCXTD-C-202003), and National Key R & D Program of China (No. 2021YFC1712800)

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Zhan, Jw., Li, Km., Zhu, Lg. et al. Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial. Chin. J. Integr. Med. 28, 963–970 (2022). https://doi.org/10.1007/s11655-022-3505-4

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