Randomized Sham-Controlled Study of Dual-Modal Intervention with Shiqi Rebi Formula and Governor Vessel Rolling Needle for Lumbar Disc Herniation of Damp-Heat Obstruction Type

Abstract

Objective:

To investigate the clinical efficacy and mechanism of a dual-modal intervention combining Shiqi Rebi Formula with Governor Vessel rolling needle therapy for lumbar disc herniation (LDH) of damp-heat obstruction type. Current Traditional Chinese Medicine (TCM) research on damp-heat obstruction type LDH has primarily focused on single herbal treatments or acupuncture therapies, with existing literature predominantly addressing cold-damp obstruction types. There is limited research on integrated Chinese-Western medical interventions for damp-heat syndrome patterns, particularly a lack of high-quality randomized controlled evidence for dual-modal therapies. This study aims to fill this research gap through a randomized sham-controlled design.

Methods:

A single-center, randomized, double-blind, sham-controlled trial was conducted. One hundred four patients with LDH of damp-heat obstruction type who visited our hospital between January 2023 and December 2023 were randomly assigned to treatment group (n = 54) or control group (n = 50). The treatment group received oral Shiqi Rebi Formula granules combined with Governor Vessel rolling needle therapy; the control group received placebo granules combined with sham acupuncture. Both groups underwent 8-week treatment courses with 6-month follow-up. Evaluation indicators included the following: ① Primary outcomes: Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores; ② Secondary outcomes: serum inflammatory factors [C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6)]; oxidative stress indicators [superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GSH-Px)]; magnetic resonance imaging (MRI) assessment of disc herniation degree and nucleus pulposus signal intensity; and TCM syndrome scores.

Results:

The treatment group showed significantly better improvement in primary outcome measures compared to the control group after 8 weeks of treatment, with VAS scores (3.78 ± 1.25 vs 5.53 ± 1.31), ODI index (42.19 ± 8.87% vs 50.59 ± 9.42%), and JOA scores (18.63 ± 3.21 vs 15.14 ± 2.68) all showing significant improvement (all P < 0.001). The treatment group demonstrated significantly greater reductions in inflammatory factors (CRP: −43.85% ± 12.67%, TNF-α: −36.83% ± 14.72%, IL-6: −37.72% ± 15.34%) and improvements in oxidative stress indicators (SOD: + 31.75% ± 14.68%, MDA: −35.78% ± 13.64%, GSH-Px: +26.21% ± 12.84%) compared to the control group (P < 0.001). MRI assessment showed morphological improvement rate of intervertebral discs in the treatment group (57.41%) was significantly higher than that in the control group (36.00%), with T2 signal intensity ratio increasing by 13.43% ± 5.21% (control group: 4.35% ± 3.18%, P < 0.001). During the 6-month follow-up period, the recurrence rate in the treatment group (14.81%) was significantly lower than that in the control group (32.00%, P = 0.034). Correlation analysis showed that clinical improvement was highly correlated with TNF-α reduction (r = 0.518–0.536) and SOD increase (r = 0.534–0.563) (P < 0.001). There was no significant difference in adverse event rates between the two groups (16.67% vs 14.00%, P = 0.703).

Conclusion:

The combination of Shiqi Rebi Formula and Governor Vessel rolling needle therapy significantly improves clinical symptoms, functional status, and intervertebral disc microenvironment in LDH patients with damp-heat obstruction type. This intervention strategy demonstrates good safety and long-lasting efficacy.