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

Abstract

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.