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

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 ±â€…5.80 vs 14.23 ±â€…6.33, P < .001; 4w: 10.95 ±â€…4.93 vs 13.54 ±â€…6.35, P < .001; 8w: 10.27 ±â€…5.25 vs 12.84 ±â€…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.

Network Pharmacology with Metabolomics Study to Reveal the Mechanisms of Bushen Huoxue Formula in Intervertebral Disc Degeneration Treatment.

Background: Intervertebral disc degeneration (IVDD) is a pathophysiological process that leads to severe back pain or neurological deficits. The Bushen Huoxue Formula (BSHXF) is a traditional herbal remedy widely used to treat diseases related to IVDD. However, its pharmacological mechanism needs further exploration. Objective: This study aimed to elucidate the mechanisms through which BSHXF treats IVDD-related diseases by integrating metabolomics with network pharmacology. Methods: Network pharmacology was utilized to identify potential targets of BSHXF against IVDD. Additionally, an animal model of needle puncture-induced disc degeneration was established to assess the effect of BSHXF. Mice were randomly assigned to the sham group, model group, and BSHXF group. Various techniques, including PCR, CCK-8 assay, MRI, histological examinations, and immunohistochemical analyses, were employed to evaluate degenerative and oxidative stress conditions in mouse disc tissue and cultured nucleus pulposus (NP) cells. UHPLC-HRMS/MS was used to differential distinct metabolites in the disc tissue from different groups, and MetaboAnalyst 5.0 was employed to enrich the metabolic pathways. Results: Through network pharmacology, 15 core proteins were identified through protein-protein interaction (PPI) network construction. Functional enrichment analysis highlighted the critical role of BSHXF in addressing IVDD by influencing the response to oxidative stress. Furthermore, experimental evidence demonstrated that BSHXF significantly improved the pathological progression of IVDD and increased oxidative stress markers SOD-1 and GPX1, both in the disc degeneration model and cultured NP cells. Metabolomics identified differential metabolites among the three groups, revealing 15 metabolic pathways between the sham and model groups, and 13 metabolic pathways enriched between the model and BSHXF groups. Conclusion: This study, integrating network pharmacology and metabolomics, suggests that BSHXF can alleviate IVDD progression by modulating oxidative stress. Key metabolic pathways associated with BSHXF-mediated reduction of oxidative stress include the citrate cycle, cysteine and methionine metabolism, alanine, aspartate and glutamate metabolism, glycine, serine and threonine metabolism, D-glutamine and D-glutamate metabolism, glutathione metabolism, and tryptophan metabolism. While this research demonstrates the therapeutic potential of BSHXF in reducing oxidative stress levels in IVDD, further research is needed to thoroughly understand its underlying mechanisms.

[Efficacy analysis of intermediate screws technique plus injectable calcium sulfate for thoracolumbar fracture in postmenopausal patients].

OBJECTIVE: To explore the clinical efficacies of intermediate screws plus injectable calcium sulfate MIIGX3 for thoracolumbar fracture in postmenopausal patients. METHODS: A total of 21 postmenopausal patients with vertebral compression fractures reconstructed with posterior internal fixation of intermediate screws technique and anterior vertebral augmentation of MIIGX3 technique in three dimension were retrospectively analyzed. The changes of fracture vertebral height and Cobb's angle were compared.Visual analogue scale (VAS) was performed to evaluate their symptoms. All patients were followed up. RESULTS: Intermediate screws surgical technique plus MIIGX3 was successfully performed. The average injection dose was 4.6 ml.Leakage occurred intraoperatively in two cases. The average follow-up period was 15 (6-36) months. The VAS system demonstrated that pain decreased significantly (preoperative:7.8, postoperative:2.2). The height and Cobb's angle of fractured vertebra improved greatly. The preoperative values were 45.0 ± 6.4% and 19.4 ± 4.5° and postoperative ones 15.4 ± 3.9% and 8.64 ± 3.18° respectively. There was no occurrence of severe complications related with treatment.Except for 2 patients with a loss of 15% of vertebral height, the average heights of fractured vertebra in other 19 patients recovered to 85% of normal ones. CONCLUSION: Thoracolumbar fracture in postmenopausal patients may be managed satisfactorily by intermediate screws and injectable calcium sulfate technique.Such a technique is both safe and effective. And its stable and durable reduction offers significant improvement.