Safety and Efficacy of Weishen Decoction in Elderly Patients with Osteoporosis and Kidney-Yang Deficiency: A Randomized Trial.

This study described the protocol and evaluated the safety and preliminary efficacy of Weishen Decoction monotherapy. This randomized, double-blind, placebo-controlled trial enrolled 72 eligible patients (aged 60-80 years) who were assigned 1:1 to receive either Weishen Decoction granules or placebo for 12 weeks. No background conventional osteoporosis medications (including calcium or vitamin D) were permitted. The primary outcome was the total effective rate based on the traditional Chinese medicine TCM syndrome score reduction (≥30% reduction using the back pain visual analog scale (VAS), bone mineral density (BMD) at lumbar spine and femoral neck, and serum bone metabolism markers (procollagen type I N‑terminal propeptide (PINP), C‑terminal telopeptide of type I collagen (β-CTX), osteocalcin (OC)). Safety was assessed via laboratory tests and adverse event monitoring. All 72 patients completed the trial. The protocol-defined primary outcome showed a higher total effective rate with Weishen Decoction compared with placebo (66.7% vs. 41.7%; P < 0.05). Exploratory BMD findings suggested a between-group difference in femoral neck BMD change (P < 0.05), whereas lumbar spine BMD changes did not differ significantly. Given the 12‑week treatment duration, these BMD results are preliminary and hypothesis‑generating. No serious adverse events occurred in either group. These trial results demonstrate that a 12‑week course of Weishen Decoction monotherapy is feasible and safe in this population. The observed improvements in TCM symptoms and pain, along with suggestive changes in femoral neck BMD, warrant further long‑term confirmatory trials.