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

Zhan, Jia-Wen; Li, Kaiming; Zhu, Liguo; Wang, Shang-Quan; Feng, Minshan; Wei, Xu; Yu, Jie; Tang, Bin; Yin, Xunlu; Han, Tao; Zhang, Ping; Li, Ling-Hui; Chen, Ming; Shao, Chen-Chen

doi:10.1007/s11655-022-3505-4

Cited by 7 publications

(5 citation statements)

References 28 publications

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“…Some previous study has shown amelioration of clinical symptoms by BSHXF in patients suffered from LBP. [27,28] In the present study, the results confirmed that BSHXF could significantly relieve the symptom of LBP and restore the lumbar function. Patients in the BSHXF group obtained significantly lower ODI, VAS, and RMDQ scores no matter compared to the pre-management period or the control group at 2-week, 4-week, and 8-week after the treatment.…”

Section: Discussionsupporting

confidence: 80%

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A randomized controlled trial: The efficacy and safety of Bushen Huoxue formula in the management of lower back pain from lumbar disc herniation

Yang,

Jia,

Zhang

et al. 2024

Medicine

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Background: Lower back pain (LBP) arising from lumbar disc herniation (LDH) poses a challenging health issue, often necessitating therapeutic interventions. Bushen Huoxue formula (BSHXF) has proved as a potential treatment option with great clinical effect. However, comprehensive investigations into its efficacy and safety in conjunction with celecoxib for managing LBP from LDH are lacking. The objective of this article is to investigate the efficacy and safety of BSHXF in the management of patients with LBP from LDH. Methods: This single center, randomized clinical trial was conducted from March 2023 to September 2023 and all patients suffered from LBP of LDH. Participants were randomly assigned to the BSHXF group (celecoxib and BSHXF) or the control group (celecoxib and placebo). The patients received treatment for 2 weeks. Assessment was conducted before treatment, the last day of the treatment, 4 weeks and 8 weeks after the treatment. Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), Timed up and go test (TUGT), trunk range of movement (Trunk ROM), Hospital Anxiety and Depression Scale (HADS) were used for the evaluation. Results: A total of 206 subjects completed treatment, among whom 104 participants were randomized to the BSHXF group and 102 participants were randomized to the control group. There were no significant differences between groups in terms of the observed indicators (P > .05). After treatment, patients in BSHXF group obtained significant lower scores at 2-week, 4-week, 8-week of VAS, ODI, RMDQ, TUGT, Trunk ROM and HADS than the baseline data (P < .05). The ODI score was significantly lower than the control group at 2-week, 4-week, 8-week (2w: 11.30 ± 5.80 vs 14.23 ± 6.33, P < .001; 4w: 10.95 ± 4.93 vs 13.54 ± 6.35, P < .001; 8w: 10.27 ± 5.25 vs 12.84 ± 6.57, P = .002). Similarly, the scores of VAS, RMDQ, TUGT, Trunk ROM scores of the BSHXF group markedly decreased at 2, 4, and 8-week when compared to their control group (P < .05). Furthermore, no significant difference showed up in the score of HADS between the between the BSHXF and the control group after treatment (P > .05). Conclusion: This randomized clinical trial found that BSXHF can help significantly improve the clinical outcomes of celecoxib including pain intensity reduction and lumbar function improvement in LBP patients.

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Section: Discussionsupporting

confidence: 80%

“…Some previous study has shown amelioration of clinical symptoms by BSHXF in patients suffered from LBP. [ 27 , 28 ]…”

Section: Discussionmentioning

confidence: 99%

A randomized controlled trial: The efficacy and safety of Bushen Huoxue formula in the management of lower back pain from lumbar disc herniation

Yang,

Jia,

Zhang

et al. 2024

Medicine

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“…It has been suggested that IDD shows similarity changing in cartilage with articular cartilage degeneration 20 . As the same time, it has been found that SSTZF can also have a good treatment for IDD 22 . But the exact mechanism has not been clari ed, which limits the further development and application of SSTZF.…”

Section: Introductionmentioning

confidence: 82%

Protective effects of Shensuitongzhi formula on intervertebral disc degeneration via downregulation NF-κB signaling pathway and inflammatory response

Ge,

Wang,

Zeng

et al. 2023

Preprint

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Low back pain (LBP) is a common orthopedic disease over the world. Lumbar intervertebral disc degeneration (IDD) is been regarded as an important cause of LBP. Shensuitongzhi formula (SSTZF) is a drug used in clinical treatment for orthopedic diseases. It has been found that SSTZF can have a good treatment for IDD. But the exact mechanism has not been clarified. The results showed that SSTZF protects against LSI-induced degeneration of cartilage endplates and intervertebral discs. Meanwhile, SSTZF treatment dramatically reduce the expression of inflammatory factor as well as the expression of catabolism protein and upregulate the expression of anabolism protein in LSI-induced mice. In addition, SSTZF delayed the progression of LSI-induced IDD via downregulation the level of NF-κB signaling key gene RELA and phosphorylation of key protein P65 in endplate chondrocytes. Our study has illustrated the treatment as well as the latent mechanism of SSTZF in IDD.

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“…Several studies have demonstrated the favorable efficacy of BSHXF in reducing symptoms and improving function in patients with IDD [ 20 ]. Furthermore, laboratory investigations have revealed that BSHXF-containing serum effectively attenuate the loss of proteoglycan and type II collagen in degenerating discs, reduces endplate calcification and delays the progression of IDD [ 21 , 22 ].…”

Section: Discussionmentioning

confidence: 99%

Role of Bushen Huoxue Formula and transplanted endothelial progenitor cells play in promoting endplate microcirculation and attenuating intervertebral disc degeneration

Xie,

Zhang,

Yang

et al. 2024

Heliyon

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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

Cited by 7 publications

References 28 publications

A randomized controlled trial: The efficacy and safety of Bushen Huoxue formula in the management of lower back pain from lumbar disc herniation

A randomized controlled trial: The efficacy and safety of Bushen Huoxue formula in the management of lower back pain from lumbar disc herniation

Protective effects of Shensuitongzhi formula on intervertebral disc degeneration via downregulation NF-κB signaling pathway and inflammatory response

Role of Bushen Huoxue Formula and transplanted endothelial progenitor cells play in promoting endplate microcirculation and attenuating intervertebral disc degeneration

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