Hydroxocobalamin, thiamine, and pyridoxine as an adjunct to standard treatment in chronic low back pain: a randomized clinical trial.

BACKGROUND AND

OBJECTIVE

Chronic low back pain is one of the leading causes of disability. Current therapies offer limited efficacy and carry potential adverse risks. Vitamins B1, B6, and B12 have shown promise in the amelioration of musculoskeletal pain. The aim of this study was to evaluate the efficacy and safety of a combined injectable formulation of hydroxocobalamin (B12), thiamine hydrochloride (B1), and pyridoxine hydrochloride (B6) (TPH) as an adjunct treatment for chronic low back pain.

METHODS

a randomized, double-blind, phase 3 clinical trial was conducted across six centers in Peru. A total of 163 patients with chronic mechanical lower back pain were included and assigned to receive TPH plus NSAIDs (n=81) or placebo plus NSAIDs (n=82). The primary outcome was the proportion of patients achieving ≥30% reduction in the NRS-11 score by day 28. Analyses were performed using an intention-to-treat approach and models adjusted for covariates.

RESULTS

In the treatment group, 84% of participants achieved ≥30% reduction in the NRS-11 score compared to 64% in the control group (RR=1,31; 95% CI: 1,08-1,59; p=0,007). This effect remained significant after adjusting for BMI and albumin. Improvements were also observed in the Patient Global Assessment (PGA) and a favorable trend in the Oswestry Disability Index. The incidence of adverse events was higher in the treatment group, but no significant differences in serious events were found.

CONCLUSION

TPH as an adjunct to standard treatment was effective in reducing chronic low back pain and demonstrated an acceptable safety profile.