Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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