Systematic Review of Safety of Selective Androgen Receptor Modulators in Healthy Adults: Implications for Recreational Users

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Abstract

Selective Androgen Receptor Modulators (SARMs) are not FDA approved, and obtaining SARMs for personal use is illegal. Nevertheless, SARM use is increasingly popular amongst recreational athletes. Recent case reports of drug-induced liver injury (DILI) and tendon rupture raise serious concerns for the safety of recreational SARM users. On 10 November 2022 PubMed, Scopus, Web of Science, and ClinicalTrials.gov were searched for studies that reported safety data of SARMs. A multi-tiered screening approach was utilized, and any study or case report of generally healthy individuals exposed to any SARM was included. Thirty-three studies were included in the review with 15 case reports or case series and 18 clinical trials (total patients N = 2136 patients, exposed to SARM N = 1447). There were case reports of drug-induced liver injury (DILI) (N = 15), Achilles tendon rupture (N = 1), rhabdomyolysis (N = 1), and mild reversible liver enzyme elevation (N = 1). Elevated alanine aminotransferase (ALT) was commonly reported in clinical trials in patients exposed to SARM (mean 7.1% across trials). Two individuals exposed to GSK2881078 in a clinical trial were reported to have rhabdomyolysis. Recreational SARM use should be strongly discouraged, and the risks of DILI, rhabdomyolysis, and tendon rupture should be emphasized. However, despite warnings, if a patient refuses to discontinue SARM use, ALT monitoring or dose reduction may improve early detection and prevention of DILI.

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The PRISMA 2020 statement: An updated guideline for reporting systematic reviews

Matthew J L Page, Joanne E. Mckenzie, Patrick Bossuyt … (2021)

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

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Sarcopenia in older adults.

Jeremy Walston (2012)

Sarcopenia, or the decline of skeletal muscle tissue with age, is one of the most important causes of functional decline and loss of independence in older adults. The purpose of this article is to review the current definitions of sarcopenia, its potential causes and clinical consequences, and the potential for intervention. Although no consensus diagnosis has been reached, sarcopenia is increasingly defined by both loss of muscle mass and loss of muscle function or strength. Its cause is widely regarded as multifactorial, with neurological decline, hormonal changes, inflammatory pathway activation, declines in activity, chronic illness, fatty infiltration, and poor nutrition, all shown to be contributing factors. Recent molecular findings related to apoptosis, mitochondrial decline, and the angiotensin system in skeletal muscle have highlighted biological mechanisms that may be contributory. Interventions in general continue to target nutrition and exercise. Efforts to develop a consensus definition are ongoing and will greatly facilitate the development and testing of novel interventions for sarcopenia. Although pharmaceutical agents targeting multiple biological pathways are being developed, adequate nutrition and targeted exercise remain the gold standard for therapy.

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The global epidemiology of anabolic-androgenic steroid use: a meta-analysis and meta-regression analysis.

Dominic Sagoe, Helge Molde, Cecilie Andreassen … (2014)

To estimate the global lifetime prevalence rate of anabolic-androgenic steroid (AAS) use and investigate moderators of the prevalence rate. A meta-analysis and meta-regression analysis was performed using studies gathered from searches in PsycINFO, PubMed, ISI Web of Science, and Google Scholar among others. Included were 187 studies that provided original data on 271 lifetime prevalence rates. Studies were coded for publication year, region, sample type, age range, sample size, assessment method, and sampling method. Heterogeneity was assessed by the I(2) index and the Q-statistic. Random effect-size modeling was used. Subgroup comparisons were conducted using Bonferroni correction. The global lifetime prevalence rate obtained was 3.3% (95% confidence interval [CI], 2.8-3.8; I(2) = 99.7, P < .001). The prevalence rate for males, 6.4% (95% CI, 5.3-7.7, I(2) = 99.2, P < .001), was significantly higher (Qbet = 100.1, P < .001) than the rate for females, 1.6% (95% CI, 1.3-1.9, I(2) = 96.8, P < .001). Sample type (athletes), assessment method (interviews only and interviews and questionnaires), sampling method, and male sample percentage were significant predictors of AAS use prevalence. There was no indication of publication bias. Nonmedical AAS use is a serious widespread public health problem. Copyright © 2014 Elsevier Inc. All rights reserved.