PMID- 35840851 OWN - NLM STAT- MEDLINE DCOM- 20221026 LR - 20221026 IS - 1993-0402 (Electronic) IS - 1672-0415 (Linking) VI - 28 IP - 11 DP - 2022 Nov TI - Efficacy and Safety of Bushen Huoxue Formula in Patients with Discogenic Low-Back Pain: A Double-Blind, Randomized, Placebo-Controlled Trial. PG - 963-970 LID - 10.1007/s11655-022-3505-4 [doi] AB - 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). CI - (c) 2022. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature. FAU - Zhan, Jia-Wen AU - Zhan JW AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. FAU - Li, Kai-Ming AU - Li KM AD - Orthopedics Department, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. FAU - Zhu, Li-Guo AU - Zhu LG AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. 532414151@qq.com. AD - The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. 532414151@qq.com. FAU - Wang, Shang-Quan AU - Wang SQ AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Feng, Min-Shan AU - Feng MS AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. AD - The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Wei, Xu AU - Wei X AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. FAU - Yu, Jie AU - Yu J AD - The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Tang, Bin AU - Tang B AD - The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Yin, Xun-Lu AU - Yin XL AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. AD - The Second Department of Spine, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Han, Tao AU - Han T AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. FAU - Zhang, Ping AU - Zhang P AD - Key Laboratory of Beijing of Traditional Chinese Medicine Bone Setting, Beijing, 100102, China. FAU - Li, Ling-Hui AU - Li LH AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Chen, Ming AU - Chen M AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. FAU - Shao, Chen-Chen AU - Shao CC AD - General Orthopedics Department, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, 100102, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220715 PL - China TA - Chin J Integr Med JT - Chinese journal of integrative medicine JID - 101181180 RN - 0 (bushen huoxue) SB - IM MH - Humans MH - *Intervertebral Disc Degeneration/therapy MH - *Low Back Pain/drug therapy MH - Lumbar Vertebrae MH - Pain Measurement MH - Treatment Outcome OTO - NOTNLM OT - Bushen Huoxue Formula OT - discogenic low-back pain OT - intervertebral disc degeneration OT - randomized controlled trial EDAT- 2022/07/16 06:00 MHDA- 2022/10/27 06:00 CRDT- 2022/07/15 23:35 PHST- 2021/07/11 00:00 [accepted] PHST- 2022/07/16 06:00 [pubmed] PHST- 2022/10/27 06:00 [medline] PHST- 2022/07/15 23:35 [entrez] AID - 10.1007/s11655-022-3505-4 [pii] AID - 10.1007/s11655-022-3505-4 [doi] PST - ppublish SO - Chin J Integr Med. 2022 Nov;28(11):963-970. doi: 10.1007/s11655-022-3505-4. Epub 2022 Jul 15.