THE EXISTENCE OF CLINICALLY RELEVANT RISKS ASSOCIATED WITH THE USE OF SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARMS) IN ADULTS

Introduction: Selective androgen receptor modulators (SARMs) are synthetic compounds that selectively bind to androgen receptors, offering a promising alternative to traditional anabolic steroids for increasing muscle mass and strength. Owing to their potential therapeutic applications, SARMs have gained popularity, particularly among athletes and bodybuilders. However, concerns about their safety, including potential adverse effects on cardiovascular, hepatic, and endocrine functions, remain largely unexplored in the scientific literature. This scoping review aims to map the available evidence regarding the safety profile of SARMs in adults and compare their safety to that of placebo or other anabolic agents across all study designs, as it has been recognized as an emerging public health problem. Objectives: The primary objective of this scoping review is to systematically map and synthesize the available literature on the safety profile of SARMs in adult populations and compare the safety outcomes with those of placebo and other anabolic agents across different study designs. Methods: A scoping review methodology, following the Joanna Briggs Institute (JBI) guidelines and PRISMA-ScR recommendations, will be employed. The search will be conducted across PubMed, Scopus, and Web of Science for studies published between 2010 and 2025. The inclusion criteria will encompass all the study designs, including randomized controlled trials, observational studies, and case reports, resulting in 30 studies included in this review, that assess the safety outcomes of SARMs in adults. Studies that directly compare SARMs to placebo or other anabolic agents should be prioritized. Data on the types of SARMs studied, safety outcomes (e.g., liver function, cardiovascular health, hormonal balance, adverse events), and study methodologies will be extracted. Results: This scoping review mapped the available evidence on the use, safety, and biological effects of selective androgen receptor modulators (SARMs). A total of 1,870 records were identified across three databases, of which 30 studies met the inclusion criteria after duplicate removal and full-text screening. The included studies included clinical trials, observational studies, case reports, pharmacovigilance analyses, and experimental investigations. Evidence has consistently revealed hepatotoxicity, endocrine suppression, and metabolic alterations associated with SARM exposure, particularly in recreational and illicit use contexts. Controlled clinical trials have shown modest anabolic effects with generally mild short-term adverse events. However, real-world use is frequently associated with product adulteration and increased health risks. Overall, the findings highlight substantial safety concerns and important gaps in long-term clinical evidence. Conclusions: This scoping review concludes that although SARMs show anabolic potential in controlled experimental settings, their recreational use is associated with clinically significant risks that challenge their perception as safe alternatives to anabolic steroids. These findings underscore the need for enhanced clinical vigilance, stricter regulatory strategies, and a more active role of healthcare professionals in the identification and prevention of harm related to SARM use. Keywords: Selective androgen receptor modulators (SARMs), safety profile, anabolic agents, adults, adverse effects, comparison, systematic review, clinical outcomes.