Background Denosumab is an effective drug for treating postmenopausal osteoporosis (PMO), yet some patients experience inadequate pain relief and suboptimal rates of bone mineral density (BMD) increase. Warm acupuncture, a traditional Chinese therapy, shows potential in alleviating pain and improving bone metabolism. This study aimed to evaluate the efficacy and safety of warm acupuncture combined with denosumab versus denosumab alone for PMO. Methods A prospective, randomized, open-label, controlled design was employed. 120 eligible PMO patients were randomly assigned to the Combination group (n = 60, receiving denosumab + warm acupuncture) or the Control group (n = 60, receiving denosumab only). The treatment period was 6 months. The primary outcome was the percentage change in lumbar spine (L1-L4) BMD. Secondary outcomes included changes in Visual Analogue Scale (VAS) pain score, serum bone turnover markers (β-CTX, PINP), 36-Item Short Form Health Survey (SF-36) scores, and adverse events. Results After treatment, the percentage change in lumbar BMD was significantly greater in the Combination group (+8.32 ± 3.15%) than in the Control group (+5.21 ± 2.78%) (P < 0.001). The Combination group also showed superior improvement in VAS score reduction (−4.45 ± 1.25 vs. −2.88 ± 1.42, P < 0.001), greater decrease in serum β-CTX (−0.40 ± 0.12 ng/mL vs. −0.32 ± 0.11 ng/mL, P < 0.001), and better scores in several SF-36 domains (notably Bodily Pain and Physical Function) (P < 0.05). No serious adverse events occurred in either group. The Combination group reported three cases of mild local burns from moxibustion, and the Control group reported 2 cases of mild flu-like symptoms. Conclusion Warm acupuncture combined with denosumab more effectively increases lumbar spine BMD, alleviates bone pain, further inhibits bone resorption, and improves quality of life in PMO patients, with a favorable safety profile. Warm acupuncture may serve as a beneficial adjunctive therapy to denosumab for PMO.
Zhang et al. (Mon,) studied this question.