CalciumNEW2026-08

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

Gao Sha, Zhao Bo — Journal of visualized experiments : JoVE

Summary

This study investigated whether a traditional Chinese herbal medicine called Weishen Decoction could safely and effectively treat osteoporosis in elderly patients. Researchers found that patients taking the herbal remedy experienced improvements in their symptoms and pain, and showed preliminary positive changes in hip bone density, suggesting it could be a safe and beneficial option.

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Key points

A traditional Chinese herbal medicine, Weishen Decoction, was tested for osteoporosis in older adults.
The herbal treatment improved traditional Chinese medicine symptoms and reduced pain.
Preliminary findings suggested a positive effect on hip bone density after 12 weeks.
The Weishen Decoction was found to be safe for use in this elderly population.

What the study looked at

**What question the study asked:** This research aimed to determine if a specific traditional Chinese herbal formula, Weishen Decoction, could safely and effectively treat osteoporosis and related symptoms in older adults who also presented with a traditional Chinese medicine diagnosis of "Kidney-Yang Deficiency." **How it was studied (design/participants):** The study was a randomized, double-blind, placebo-controlled trial, considered a high standard for medical research. Seventy-two elderly patients, aged 60 to 80 years, with osteoporosis were randomly assigned to receive either the Weishen Decoction granules or an inactive placebo for 12 weeks. Importantly, participants did not take any other conventional osteoporosis medications, including calcium or vitamin D supplements, during the study period, allowing researchers to isolate the effects of the herbal treatment. **What it found:** The study found that patients taking Weishen Decoction experienced a greater reduction in their traditional Chinese medicine symptoms and pain compared to those on placebo. While changes in spine bone density were not significant, there was a preliminary suggestion of improved bone density in the hip (femoral neck) in the herbal treatment group. The study also confirmed that the Weishen Decoction was safe, with no serious side effects reported. These findings suggest the herbal formula could be a promising treatment, warranting further long-term investigation.

Dietary takeaway

While this study explored an alternative herbal treatment for osteoporosis, it's crucial to remember that maintaining adequate calcium and vitamin D intake remains a fundamental strategy for bone health. Incorporating calcium-rich foods like dairy products, fortified plant-based milks, leafy green vegetables, and certain fish into your daily diet is a practical way to support strong bones. However, it's important to note that this is just one study on a specific herbal remedy, and its findings do not replace the established importance of calcium and vitamin D in preventing and managing osteoporosis.

Abstract

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.

View on PubMed →DOI: 10.3791/71174