Lee Su Won, Ahn Yong-Jun, Kim Suna, Lee Yeonsun, Cho Hyun-Woo, Hong Yejin, Nam Dongwoo, Park Yeon-Cheol, Kim Eun-Jung, Lee Yoon Jae, Ha In-Hyuk
Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea.
Jaseng Clinical Research Center, Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea.
J Pain Res. 2025 Jul 23;18:3689-3707. doi: 10.2147/JPR.S527880. eCollection 2025.
Cervical disc herniation (CDH) is increasingly prevalent, highlighting the need for more effective treatments. Although pharmacopuncture therapy is one of the most widely used treatment methods for CDH in Korean medicine clinical practice, there are few high-quality studies conducted in Korea. Therefore, we aimed to evaluate the efficacy and safety of pharmacopuncture therapy for CDH through a pragmatic clinical trial that reflects clinical practice while utilizing well-designed study settings of a randomized controlled trial.
This three-armed, pragmatic, pilot, randomized controlled trial included pharmacopuncture (Phm-Acu), acupuncture (Acu), and usual care (UC) groups in a 1:1:1 ratio. Participants were treated twice a week for 6 weeks, with follow-up extending to week 25. The primary outcome was the neck pain Numeric Rating Scale (NRS). The secondary outcomes were arm pain NRS, neck and arm pain Visual Analog Scale, Neck Disability Index (NDI), Northwick Park Questionnaire (NPQ), Patient Global Impression of Change (PGIC), Short Form-12 Health Survey (SF-12), and EuroQol-5-dimension-5-level (EQ-5D-5L).
Eighty participants (Phm-Acu: 29, Acu: 29, and UC: 26) were selected. At week 7, neck pain NRS significantly decreased in the Phm-Acu group than that in the UC (2.73, 95% confidence interval (CI) 1.87-3.59) and Acu groups (1.68, 95% CI 0.84-2.53). Survival analysis revealed that the Phm-Acu group showed the fastest recovery rate. The Phm-Acu group showed significant improvement compared with the Acu and UC groups for all other pain outcomes and PGIC and compared with the UC group for NDI, NPQ, EQ-5D-5L, and SF-12 [physical]. The area under the curve analysis showed that the Phm-Acu group showed significant differences in all outcomes except SF-12 [mental] compared with the UC group. No serious adverse events occurred; four patients experienced mild adverse events.
In CDH, pharmacopuncture was more effective in reducing pain and achieving functional recovery than acupuncture and usual care.
颈椎间盘突出症（CDH）日益普遍，凸显了对更有效治疗方法的需求。尽管药物穴位注射疗法是韩国医学临床实践中治疗CDH最广泛使用的方法之一，但韩国开展的高质量研究较少。因此，我们旨在通过一项务实的临床试验来评估药物穴位注射疗法治疗CDH的疗效和安全性，该试验在反映临床实践的同时采用了设计良好的随机对照试验研究设置。
这项三臂、务实、先导性随机对照试验按1:1:1的比例纳入了药物穴位注射（Phm-Acu）、针灸（Acu）和常规护理（UC）组。参与者每周接受两次治疗，为期6周，随访延长至第25周。主要结局指标是颈部疼痛数字评定量表（NRS）。次要结局指标包括手臂疼痛NRS、颈部和手臂疼痛视觉模拟量表、颈部功能障碍指数（NDI）、诺斯威克公园问卷（NPQ）、患者总体变化印象（PGIC）、简明健康调查12项量表（SF-12）和欧洲五维度健康量表（EQ-5D-5L）。
共纳入80名参与者（药物穴位注射组：29名，针灸组：29名，常规护理组：26名）。在第7周时，药物穴位注射组的颈部疼痛NRS较常规护理组（2.73，95%置信区间（CI）1.87 - 3.59）和针灸组（1.68，95%CI 0.84 - 2.53）显著降低。生存分析显示，药物穴位注射组的恢复速度最快。在所有其他疼痛结局指标和PGIC方面，药物穴位注射组与针灸组和常规护理组相比有显著改善；在NDI、NPQ、EQ-5D-5L和SF-12[身体方面]方面，与常规护理组相比有显著改善。曲线下面积分析显示，与常规护理组相比，药物穴位注射组在除SF-12[心理方面]之外的所有结局指标上均有显著差异。未发生严重不良事件；4名患者经历了轻度不良事件。
在CDH治疗中，药物穴位注射在减轻疼痛和实现功能恢复方面比针灸和常规护理更有效。
