Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial.
10.1007/s11655-022-3505-4
- Author:
Jia-Wen ZHAN
1
;
Kai-Ming LI
2
;
Li-Guo ZHU
3
;
Shang-Quan WANG
1
;
Min-Shan FENG
4
;
Xu WEI
4
;
Jie YU
5
;
Bin TANG
5
;
Xun-Lu YIN
4
;
Tao HAN
1
;
Ping ZHANG
4
;
Ling-Hui LI
1
;
Ming CHEN
1
;
Chen-Chen SHAO
1
Author Information
1. General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China.
2. Orthopedics Department, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
3. Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. 532414151@qq.com.
4. Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China.
5. The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China.
- Publication Type:Journal Article
- Keywords:
Bushen Huoxue Formula;
discogenic low-back pain;
intervertebral disc degeneration;
randomized controlled trial
- MeSH:
Humans;
Intervertebral Disc Degeneration/therapy*;
Low Back Pain/drug therapy*;
Lumbar Vertebrae;
Pain Measurement;
Treatment Outcome
- From:
Chinese journal of integrative medicine
2022;28(11):963-970
- CountryChina
- Language:English
-
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).
