Traditional Chinese herbal compound as complementary treatment for nonspecific low back pain: A randomized controlled trial.

Background: This prospective randomized controlled trial was designed to evaluate the clinical efficacy and safety of Bu Shen Tong Luo herbal compound as a complementary treatment for nonspecific low back pain (NSLBP).

Methods: A total of 76 patients with NSLBP included from January 2022 to June 2023 according to the criteria were randomly divided into Bushen Tongluo formula (BSTL) group (n = 38) and celecoxib group (n = 38). According to Traditional Chinese Medicine principles, patients of 2 groups were divided into 5 syndrome types. Celecoxib or BSTL herbal compound were used to treat NSLBP of each group for 3 weeks, every week the Visual Analog Scale (VAS), Oswestry Disability Index, and Japanese Orthopaedic Association scores of each patient was record and compared to evaluate the clinical efficacy, and adverse reaction was reported to evaluate the safety of 2 interventions.

Results: A total of 71 patients finished the follow-up, including 36 patients in BSTL group and 35 patients in celecoxib group. The result showed that within 3 weeks, both BSTL and celecoxib interventions were able to treat NSLBP, with improvements in VAS scores and waist function index. However, there were no significant differences in clinical outcomes between these 2 interventions. Then we divided the patients into 5 syndromes on the basis of traditional Chinese medicine principles and observed their clinical outcomes. We found that celecoxib had similar improvements in VAS score and waist function index for each syndrome type and most of the syndromes in the BSTL group, except for the SRBZ syndrome. In the treatment of SRBZ syndrome, BSTL prescription showed no statistically significant clinical improvement. Meanwhile, in the treatment of HSBZ syndrome of NSLBP, BSTL prescription showed better clinical results than celecoxib, although there was no difference in VAS scores between the 2 groups, patients in BSXL group had better waist function than those in celecoxib group.

Conclusion: Both BSTL herbal compound and celecoxib are effective and safe in the clinical treatment of NSLBP, and BSTL herbal compound had unique advantages in the treatment of HSBZ syndrome type of NSLBP especially in waist function improvement.