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Description: Osteoporosis is a chronic bone lytic disease attributed to imbalance between bone ossification and bone resorption characterized by decreased bone mass, altered bone micro-architecture and increased bone fragility. It is related to high fracture risk, with an accident of osteoporotic fracture every 3 seconds. With a prevalence of 200 - 300 million patients worldwide, osteoporosis has become a major public health concern. However, its treatment remains a challenge around the world. Given the complications and side effects of currently available treatments,5 developing new therapeutic approaches for the prevention and interventions of osteoporosis with phytomedicine may be promising. Phytotherapy including herbs has been safely used for thousands of years, attracting great attention worldwide. Epimedium (Epimedium), also known as Yinyanghuo or Xianlingpi in Chinese, is derived from the dried leaf of the Epimedii Folium brevicornu Maxim, which has been widely used in treating bone diseases in traditional Chinese medicine. Studies have reported pharmacological activity of Epimedium extracts like icariin, flavonoids, lignins, daidzein, genistein, and many other compounds. Efficacy of Epimedium-containing herbal formula for osteoporosis has been suggested by several reviews. However, the effect of Epimedium alone or combined with conventional pharmaceutical treatment on osteoporosis remains poorly understood clinically and has not been evaluated systematically, which limits clinical application and overall recognition of Epimedium treatment. To identify the effect of Epimedium alone or combined with conventional pharmaceutical treatment with current evidence of clinical studies, and to update and improve the previous reviews, we conducted this systematic review and meta-analysis. We designed this study following Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA). The search strategy aimed to identify randomized controlled trials (RCTs) comparing Epimedium alone or combined with conventional pharmaceutical treatment on osteoporosis. Systematic literature searches in Web of Science, WorldCat, Cochrane Library, EMBASE, Science Direct, Google Scholar, PubMed, SinoMed, Chongqing VIP Chinese Science and Technology Periodical Database, China National Knowledge Infrastructure (CNKI), and Wanfang Data were conducted. All the electronic databases were searched from the earliest available date to 30 March 2021 (updated September 21, 2021). In order to collect a more comprehensive data, a combination of the following English terms was used in the database searches: (“Epimedium” or “Epimediums” or “Epimedium sagittatum” or “Epimedium sagittatums” or “sagittatum, Epimedium” or “sagittatums, Epimedium” or “Epimedium grandiflorum” or “Epimedium grandiflorums” or “grandiflorum, Epimedium” or “grandiflorums, Epimedium” or “Epimedii Folium”) and (“Osteoporosis” or “Osteoporosis, Senile” or “Osteoporoses, Senile” or “Senile Osteoporoses” or “Senile Osteoporosis” or “Osteoporosis, Age Related” or “Bone Loss, Age-Related” or “Age-Related Bone Loss” or “Age-Related Bone Losses” or “Bone Loss, Age Related” or “Bone Losses, Age-Related” or “Age-Related Osteoporosis” or “Age Related Osteoporosis” or “Age-Related Osteoporoses” or “Osteoporoses, Age-Related”) and “randomized controlled trial”. No limits or restrictions were used. For the Chinese databases, the following keywords were used in combine: (“Yinyanghuo” or “Xianlingpi”) and “Osteoporosis” and “randomized controlled trial”. Furthermore, reviews and the reference lists of all the related articles were screened to check for potential eligible RCTs. Search strategies for all databases could be found in the supplementary material. Primary outcomes included BMD which was measured by dual-energy X-ray bone density analyzer before and after the treatment, clinical efficacy (effective: the clinical symptoms such as pain and fatigue were relieved, BMD increased than that before treatment, and functional activities significantly improved), and pain intensity using a VAS. Secondary outcomes included pain relief time, adverse events, plasma or serum concentrations of bone metabolic markers like alkaline phosphatase (ALP), blood phosphorus (P), blood calcium ion (Ca2+), Estradiol (E2) as well as interleukin 6 (IL-6) in osteoporosis patients. When available data in the articles were insufficient, researchers attempted to contact the corresponding authors by e-mail. No trials were excluded due to their publication status or language, thus reducing the risk of publication bias.