PURPOSE: 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.
PATIENTS AND METHODS: 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).
RESULTS: 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.
CONCLUSION: In CDH, pharmacopuncture was more effective in reducing pain and achieving functional recovery than acupuncture and usual care.
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Physician rater
This is an interesting topic; however, because it is a pilot study, the conclusions cannot and should not be used to inform decisions about treatment effectiveness. The limitations of the study are well described by the authors. Furthermore, the type and quality of pharmacopuncture solutions available also depend on national drug agencies, so the results of this Korean study cannot be generalised.
, McMaster University