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 the postmenopausal women because of it is non-invasive and has fewer side effects, but the powerful evidence for the clinic is still insufficient. Our study intends to explore the effect of Overall adjustment acupuncture (OA) in the treatment of postmenopausal osteoporosis(PMOP).Methods: 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 three months, the OA group receive real acupuncture treatment and the SA group received placebo acupuncture treatment (non-penetrating,sham skin needle therapy, sham cupping). All patients will receive acupuncture treatment twice per week for three months. The primary outcome is bone mineral density(BMD) and 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, visual 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 treatments(3month).The present protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist.Conclusion: This study will be conducted to compare the efficacy of OA versus SA. This trial will help to evaluate whether OA can effectively prevent and treat postmenopausal osteoporosis by improving the estrogen level of postmenopausal women, the mechanism is to improve the imbalance of osteogenic differentiation and lipogenesis of bone marrow cells under oxidative stress.Trial registration: This trial was registed at Chinese Clinical Trial Registry, registration date: 5 August 2018.URL:http://www.chictr.org.cn,registration number:ChiCTR1800017581.