Van Heden S, Chan Y M, Baoubbou Z, Bruyère O, Reginster J-Y, Surquin M, Sanchez-Rodriguez D, Beaudart C
Public Health Aging Research & Epidemiology (PHARE) Group, Research Unit in Clinical Pharmacology and Toxicology (URPC), Department of Biomedical Sciences, Faculty of Medicine, Namur Research Institute for Life Sciences (NARILIS), University of Namur, 5000, Namur, Belgium.
Department of Dietetics, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Malaysia.
Eur Geriatr Med. 2025 Aug 12. doi: 10.1007/s41999-025-01285-x.
This study aimed to identify the most frequently reported outcomes in sarcopenia trials, as a basis for developing a Core Outcome Set (COS).
A systematic review was conducted with a comprehensive search of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from database inception to March 2024 (PRISMA guidelines, PROSPERO: CRD42024525506). Eligible studies were randomized controlled trials (RCTs) on sarcopenia treatment, including patients diagnosed with a consensus definition. All outcomes reported in those studies were extracted and grouped into predefined subcategories.
Among 3985 references, 58 studies (54 unique RCTs) met the inclusion criteria, reporting 214 efficacy and 39 safety outcomes. The most frequently reported outcomes were muscle mass (50 studies, i.e., present in 86.2% of studies), muscle strength (50 studies, 86.2%), physical performance (46 studies, 79.3%), nutrition-related outcomes (29 studies, 50.0%), and fat mass (28 studies, 48.3%). Among the primary outcomes, change in muscle mass was the most commonly reported outcome (23 studies, 39.7%, with appendicular skeletal muscle mass index and fat-free mass as the predominant measures), followed by change in muscle strength (16 studies, 27.6%, mainly assessed by handgrip strength), followed by change in physical performance (13 studies, 22.4%, mainly assessed by gait speed and lower limb physical function). Secondary outcomes included biomarkers, physical status, quality of life, activities of daily living, bone mass, psychological status, cognitive function, and unclassified outcomes.
This review highlights the extensive heterogeneity of reported outcomes in sarcopenia intervention studies and the urgent need for developing a COS.
本研究旨在确定肌肉减少症试验中最常报告的结局，作为制定核心结局集（COS）的基础。
进行了一项系统评价，全面检索了从数据库建立到2024年3月的MEDLINE、Embase和Cochrane对照试验中央注册库（PRISMA指南，PROSPERO：CRD42024525506）。符合条件的研究为关于肌肉减少症治疗的随机对照试验（RCT），包括根据共识定义诊断的患者。提取这些研究中报告的所有结局，并将其分组到预定义的子类别中。
在3985篇参考文献中，58项研究（54项独特的RCT）符合纳入标准，报告了214项疗效结局和39项安全性结局。最常报告的结局是肌肉量（50项研究，即86.2%的研究中出现）、肌肉力量（50项研究，86.2%）、身体功能（46项研究，79.3%）、营养相关结局（29项研究，50.0%）和脂肪量（28项研究，48.3%）。在主要结局中，肌肉量的变化是最常报告的结局（23项研究，39.7%，以四肢骨骼肌量指数和去脂体重为主要测量指标），其次是肌肉力量的变化（16项研究，27.6%，主要通过握力评估），然后是身体功能的变化（13项研究，22.4%，主要通过步速和下肢身体功能评估）。次要结局包括生物标志物、身体状况、生活质量、日常生活活动、骨量、心理状况、认知功能和未分类结局。
本综述强调了肌肉减少症干预研究中报告结局的广泛异质性以及制定COS的迫切需求。
