Jintiange capsule as add-on therapy for lumbar disc herniation: an open-label randomized controlled trial

Lumbar disc herniation (LDH) is a prevalent and costly disorder. Evidence regarding the efficacy and safety of Jintiange (JTG) capsules as add-on therapy for LDH remains limited.

This prospective, single-center, open-label randomized add-on trial compared JTG capsules plus conventional therapy with conventional therapy alone. The Japanese Orthopaedic Association (JOA) score was the sole primary outcome; VAS, SF-12 physical and mental component scores (PCS/MCS), numbness, lumbar muscle elastic modulus, and lumbar range of motion (ROM) were secondary outcomes. All 64 randomized participants were included according to their assigned groups. JOA, VAS, PCS, and MCS were analyzed using baseline-adjusted linear mixed-effects models incorporating all available post-baseline observations. Week 8 objective outcomes were analyzed using baseline-adjusted ANCOVA after multiple imputation. Multiplicity across the specified Week 8 secondary outcomes was controlled using the Holm procedure, and complete-case analyses were performed as sensitivity analyses.

Seven participants discontinued follow-up (2 JTG, 5 control). The adjusted between-group difference in JOA favored the JTG-containing regimen at Week 2 (2.50 points, 95% CI 1.03-3.97; P < 0.001), Week 8 (2.73, 95% CI 1.21-4.26; P < 0.001), and 2-week follow-up (1.79, 95% CI 0.27-3.32; P = 0.021). At Week 8, adjusted differences also favored the JTG-containing regimen for VAS (-0.57, 95% CI -0.89 to -0.25), MCS (10.48, 95% CI 9.58-11.39), PCS (4.02, 95% CI 3.34-4.70), lumbar muscle elastic modulus (left -1.22, 95% CI -2.37 to -0.08; right -1.53, 95% CI -2.19 to -0.86), and ROM measures after multiplicity adjustment. Complete-case analyses showed similar effect directions.

The JTG-containing regimen was associated with greater improvement in JOA and several secondary outcomes than conventional therapy alone. However, the open-label, non-placebo-controlled design, undocumented assessor blinding, differential attrition, multiplicity, small sample size, and single-center setting limit causal attribution and generalizability. Further blinded placebo-controlled multicenter trials are warranted.

https://www.chictr.org.cn/, ChiCTR2300069735.