A cost-utility analysis of pharmacopuncture versus physiotherapy for chronic low back pain: A multicenter, pragmatic randomized controlled trial

Chronic low back pain (CLBP) represents one of the greatest global health challenges, affecting more than half a billion people and imposing substantial economic impact through work impairment and high medical expenditures. This multicenter randomized controlled trial, conducted at four Korean traditional medicine hospitals, evaluated for the first time the cost-effectiveness of pharmacopuncture compared with conventional physical therapy for CLBP.

Pharmacopuncture is a specialized technique that combines acupuncture point stimulation with the injection of herbal extracts or medicinal substances, enhancing therapeutic effects through both mechanical and biochemical mechanisms. While previous studies demonstrated its clinical efficacy and safety, its economic analysis remained unexplored.

The study included 100 patients with CLBP for at least 6 months and pain intensity ≥5 on the numeric rating scale. They were randomized into two groups of 50 participants each: pharmacopuncture or physical therapy, both receiving 10 sessions over 5 weeks. The protocol was pragmatic, allowing physicians to apply treatments according to clinical judgment based on patients' symptoms and radiologic findings.

Health-related quality of life was measured using the EQ-5D-5L to calculate quality-adjusted life years (QALYs). Costs were assessed from both healthcare system and societal perspectives, including direct medical costs, transportation costs, time lost for treatment, and loss of work productivity assessed by the WPAI questionnaire.

The results demonstrated clear superiority of pharmacopuncture. From the healthcare system perspective, although the initial treatment cost was higher (a $238 USD difference), pharmacopuncture generated QALY gains of 0.014, resulting in an incremental cost-effectiveness ratio (ICER) of $16,575 USD per QALY. This value is well below the willingness-to-pay threshold of $26,647 USD, indicating cost-effectiveness with a 64% probability.

More impressive was the societal perspective analysis, where pharmacopuncture proved to be dominant, providing better outcomes at lower costs. Total savings were $2,781 USD per patient, primarily due to a significant reduction in productivity loss ($2,984 USD less than physical therapy). Patients treated with pharmacopuncture reported less absenteeism and presenteeism, returning to work more effectively.

Clinical benefits supported the economic findings. The pharmacopuncture group showed a 0.043-point improvement in EQ-5D-5L quality of life at week 6, exceeding the minimum clinically important difference of 0.03. These improvements were maintained through week 25, suggesting durable benefits.

Sensitivity analyses confirmed the robustness of the results. Complete-case analysis, considering only employed workers for productivity costs, and assessment of productivity loss in the last month all maintained pharmacopuncture as dominant.

This study offers pioneering evidence on the economic feasibility of pharmacopuncture for CLBP, especially relevant given the growing interest in non-pharmacologic strategies that avoid opioids. The reduction in productivity loss represents a particularly important finding, demonstrating that effective treatments for chronic pain can have economic impacts that extend well beyond direct healthcare costs.

Limitations include the relatively short follow-up period of 25 weeks and conduct only in Korea, where traditional medicine is well established. Future studies with larger samples, longer follow-up, and conducted in different healthcare systems are needed to confirm the generalizability of these promising findings.