Clinical efficacy of a Chinese herbal gel plaster combined with manipulation for lumbar disc herniation: a prospective, randomized, double-blind, placebo-controlled trial.

2026-03-19
Frontiers in pharmacology 17
- Tianhao Wan
- Gezhi Zhang
- Haibao Wen
- Lifeng Zhuang
- Haotian Yang
- Di Xia
- Chao Su
- Jinqiao Zou
- Fajie Li
- Jinyu Gu
- Qing Zhang

PubMed: 41939845
DOI: 10.3389/fphar.2026.1708694

Study Design

Type: Clinical Trial
Population: 100 adults aged 40-60 years with lumbar disc herniation (LDH)
Methods: Randomized, placebo-controlled trial; 2 weeks of Qing dynasty three-movement manipulation plus HTPGP or placebo plaster, with 4 weeks follow-up
Duration: 2 weeks
Funding: Unclear

Background

Haitongpi Formula, derived from the Traditional Chinese Medicine (TCM) classic Yizong Jinjian, has shown efficacy for low back pain, fractures, and osteoarthritis. Haitongpi Formula Gel Paste (HTPGP) is a modern dosage form of this formula, but clinical evidence on its effectiveness and safety remains limited. This study was designed to evaluate the clinical efficacy and safety of HTPGP combined with manipulation in relieving chronic pain caused by lumbar disc herniation (LDH).

Methods

Adults aged 40-60 years with LDH were randomly assigned to receive Qing dynasty three-movement manipulation plus HTPGP or placebo plaster (PLAGP) for 2 weeks, with 4 weeks of follow-up. The primary outcome was pain intensity measured by the visual analog scale (VAS); secondary outcomes included the Oswestry Disability Index (ODI) and surface electromyography (sEMG). Analyses were performed using generalized estimating equations, repeated-measures ANOVA, and Mann-Whitney U tests.

Results

Between October 2024 and June 2025, 100 eligible participants were randomized (HTPGP vs. PLAGP, 1:1). The HTPGP group demonstrated significantly greater VAS improvement from day 7 onwards (Z = 2.644-4.332). ODI scores were consistently lower in the HTPGP group (main effect F = 33.43; time effect F = 227.21; interaction F = 17.19). No significant between-group differences were observed in sEMG outcomes, and no serious adverse events occurred.

Conclusion

In patients with LDH, HTPGP combined with manipulation provided greater pain reduction and better functional improvement than those observed in the placebo group, with a favorable safety profile. Larger randomized trials are required to confirm these findings.

Trial registration

The trial was registered with the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/; No. ITMCTR2024000077).