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Combination of Yaobitong capsules and lumbar oblique pull manipulation for moderate pain in lumbar disc herniation
Guangqi Lu1, Minghui Zhuang1, Bin Tang1,2
1Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Background:
Lumbar disc herniation with radiculopathy (LDHR) is a leading cause of disability worldwide. For patients with moderate pain, Traditional Chinese Medicine approaches, including Yaobitong (YBT) capsules and lumbar oblique pull manipulation (LOPM), are widely used in clinical practice, often in combination. However, high-quality evidence supporting the superiority of this combination over monotherapy is lacking. This multicenter, randomized, three-arm, parallel-group controlled trial conducted at 13 tertiary hospitals in China aimed to evaluate the efficacy and safety of combining YBT with LOPM in LDHR patients with moderate pain.
Methods:
A total of 426 LDHR patients with moderate pain (Visual Analogue Scale [VAS] score ≥ 4 to < 7) were randomly assigned to receive either YBT alone (n = 146), LOPM alone (n = 137), or a combination of both (n = 143). The primary outcome was change in the Oswestry Disability Index (ODI) from baseline to week 2. Secondary outcomes included leg pain VAS scores, low back pain VAS scores, 12-Item Short Form Health Survey (SF-12), adverse events, and disc resorption rates. Outcome measurements were assessed at baseline, 3 days, 1 week, 2 weeks, 6 weeks, 14 weeks, and 26 weeks.
Results:
At 2 weeks, the mean reduction in ODI was -19.4 (95% CI, -21.4 to -17.5) in the YBT group, -19.4 (95% CI, -21.4 to -17.5) in the LOPM group, and -21.1 (95% CI, -23.0 to -19.1) in the combination group. The adjusted mean difference was 0.5 (95% CI, -2.3 to 4.9; p = 0.99) for YBT versus combination and 1.3 (95% CI, -2.1 to 5.1; p = 0.68) for LOPM versus combination. No statistically significant differences in ODI reduction were detected between groups at any follow-up time point (all p > 0.05). No statistically significant differences in any of the secondary outcomes were detected between groups at any follow-up time point (all p > 0.05). No apparent safety signal was observed in any of the three groups during the short 2-week intervention period.
Conclusion:
The combination therapy with YBT and LOPM was not superior to either monotherapy in improving functional disability, pain, or quality of life among LDHR patients with moderate pain.
Clinical Trial Registration:
https://www.chictr.org.cn, ChiCTR2200066051.
