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Peer-reviewedCC BY 4.0Frontiers in Pharmacology

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

  • Long Liang1,2
  • Yuxiang Yang1,2
  • Hao Lv1,2
  • Yi Wang1,2
  • Xunlu Yin3
  • Kaiming Li4
  • Xiangwen Gui1,2
  • Yinghao Zhu1
4 affiliations
  1. 1The First Affiliated Hospital of Anhui University of Chinese Medicine
  2. 2Anhui University of Chinese Medicine
  3. 3Wangjing Hospital, China Academy of Chinese Medical Sciences
  4. 4Xiyuan Hospital, China Academy of Chinese Medical Sciences
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Clinical Trial Registration: https://www.chictr.org.cn/ , ChiCTR2300069735.

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Cite

BibTeXRIS
BibTeX
@article{liang2026jintiange,
  title = {{Jintiange capsule as add-on therapy for lumbar disc herniation: an open-label randomized controlled trial}},
  author = {Long Liang and Yuxiang Yang and Hao Lv and Yi Wang and Xunlu Yin and Kaiming Li and Xiangwen Gui and Yinghao Zhu},
  journal = {Frontiers in Pharmacology},
  year = {2026},
  month = oct,
  doi = {10.3389/fphar.2026.1837527},
  url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1837527/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Jintiange capsule as add-on therapy for lumbar disc herniation: an open-label randomized controlled trial
AU  - Long Liang
AU  - Yuxiang Yang
AU  - Hao Lv
AU  - Yi Wang
AU  - Xunlu Yin
AU  - Kaiming Li
AU  - Xiangwen Gui
AU  - Yinghao Zhu
PY  - 2026
DA  - 2026/10/08
JO  - Frontiers in Pharmacology
DO  - 10.3389/fphar.2026.1837527
UR  - https://www.frontiersin.org/articles/10.3389/fphar.2026.1837527/full
AB  - Background: 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.  Methods: 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.  Results: 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.  Conclusion: 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.  Clinical Trial Registration: https://www.chictr.org.cn/ , ChiCTR2300069735.
SN  - 1663-9812
ER  -