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

• Published in: Chinese journal of integrative medicine 2022-11, Vol.28 (11), p.963-970
• Main Authors: Zhan, Jia-wen, Li, Kai-ming, Zhu, Li-guo, Wang, Shang-quan, Feng, Min-shan, Wei, Xu, Yu, Jie, Tang, Bin, Yin, Xun-lu, Han, Tao, Zhang, Ping, Li, Ling-hui, Chen, Ming, Shao, Chen-chen
• Format: Article
• Language: English
• Subjects: Medicine; Medicine & Public Health; Original Article
• ISSN: 1672-0415; 1993-0402
• DOI: 10.1007/s11655-022-3505-4

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