Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial

Abstract

Background: Osteoporosis is becoming more prevalent in aging societies worldwide, and the economic burden attributable to osteoporotic fractures is substantial. The medications presently available to treat osteoporosis have side effects. Acupuncture is widely used for treating osteoporotic postmenopausal women because it is non-invasive and has fewer side effects, but the powerful clinical evidence for its efficacy remains insufficient. Our study intends to explore the effect of overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis (PMOP). Methods/design: This study is a randomized, sham-controlled, patient-and assessor-blinded trial and aims to evaluate the effect of OA in women with PMOP. We will recruit 104 women aged 45-70 years with a diagnosis of PMOP. Participants will be randomly allocated in a 1:1 ratio to the OA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for 3 months, the OA group receives real acupuncture treatment and the SA group receives placebo acupuncture treatment (non-penetrating, sham skin-needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for 3 months. The primary outcome is bone mineral density (BMD) and the secondary outcomes include estradiol (E2), follicle-stimulating hormone (FSH), bone gla protein (BGP), bone alkaline phosphatase (BALP), total antioxidant capacity (TAC), advanced oxidation protein products (AOPP), PPARγ, β-catenin, FoxO3a levels, visual analog pain scale score (VAS), Traditional Chinese medicine (TCM) syndrome scores and quality of daily life score (QOL). Outcome measures will be collected at baseline, middle of the treatment (1.5 months), the end of treatment (3 months). The present protocol followed the SPIRIT guidelines and fulfills the SPIRIT Checklist. Conclusion: This study will be conducted to compare the efficacy of OA versus SA. This trial should help to evaluate whether OA can effectively prevent and treat PMOP by improving the estrogen levels of postmenopausal women. The mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone-marrow cells under oxidative stress.

Effect of laser acupuncture on pain and density of bone in osteoporotic postmenopausal women: a randomized controlled trial

“…Recently, Shi et al 33 found that catgut embedding at acupoint has a good effect on PMOP by improving BMD and alleviating participants' clinical problems. Overall adjustment acupuncture can improve the level of hormones that play an antideterioration role, correct disturbances of osteogenic and adipogenic activity of bone marrow mesenchymal stem cells, improve mineral density by activating osteoblast synthesis, minimize pain, decline incidence of fractures, and improve the general quality of life of osteoporotic postmenopausal women 34 . Acupuncture can normalize estrogen levels, which enhances calcium deposition and slows the rate of bone degeneration 35 .…”

Overall adjustment acupuncture improves osteoporosis and exerts an endocrine-modulating effect in ovariectomized rats

“…However, these results were obtained from studies on non-human subjects, and evidence in human subjects is lacking. Our ongoing clinical trial was designed to collect data, including estradiol levels, in patients with PMOP upon OA treatment to cover this gap ( 24 ).…”

“…OA has been shown to improve the clinical symptoms and quality of life in patients with osteoporosis ( 23 ). A systematic and comprehensive clinical study is also being conducted by our team to study the efficacy, safety, and mechanism of OA in patients with PMOP to provide more rigorous clinical evidence to promote its application ( 24 ). In the present study, we investigated the anti-osteoporotic effect of OA and explored its mechanism of action through endocrine modulation in a rat model of PMOP induced by bilateral ovariectomy.…”

Discovery of novel serum biomarkers for diagnosing and predicting postmenopausal osteoporosis patients by 4D‐label free protein omics

“…The prevalence of osteoporosis in women in China over 50 years of age is 32.1% and 51.6% in over 60. With the aging of the global population, the global incidence of osteoporosis in postmenopausal women was 50% and the incidence of fracture was 40% in the population of postmenopausal women, 3 severely decreasing the quality of life and increasing the morbidity in old women. Thus, it is important to screen and diagnose PMOP in time to reduce the disease burden.…”