Student Research Committee, Zahedan University of Medical Sciences, Zahedan, Iran.
Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
PLoS One. 2024 Feb 13;19(2):e0297235. doi: 10.1371/journal.pone.0297235. eCollection 2024.
Caffeine's potential benefits on multiple sclerosis (MS), as well as on the ambulatory performance of non-MS populations, prompted us to evaluate its potential effects on balance, mobility, and health-related quality of life (HR-QoL) of persons with MS (PwMS).
This single-arm pilot clinical trial consisted of a 2-week placebo run-in and a 12-week caffeine treatment (200 mg/day) stage. The changes in outcome measures during the study period (weeks 0, 2, 4, 8, and 12) were evaluated using the Generalized Estimation Equation (GEE). The outcome measures were the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for self-reported ambulatory disability, Berg Balance Scale (BBS) for static and dynamic balance, Timed Up and Go (TUG) for dynamic balance and functional mobility, Multiple Sclerosis Impact Scale (MSIS-29) for patient's perspective on MS-related QoL (MS-QoL), and Patients' Global Impression of Change (PGIC) for subjective assessment of treatment efficacy. GEE was also used to evaluate age and sex effect on the outcome measures over time. (Iranian Registry of Clinical Trials, IRCT2017012332142N1).
Thirty PwMS were included (age: 38.89 ± 9.85, female: 76.7%). Daily caffeine consumption significantly improved the objective measures of balance and functional mobility (BBS; P-value<0.001, and TUG; P-value = 0.002) at each study time point, and the subjective measure of MS-related QoL (MSIS-29; P-value = 0.005) two weeks after the intervention. Subjective measures of ambulatory disability (MSWS-12) and treatment efficacy (PGIC) did not significantly change. The effect of age and sex on the outcome measures were also assessed; significant sex-time interaction effects were found for MSWS-12 (P-value = 0.001) and PGIC (P-value<0.001). The impact of age on BBS scores increased as time progressed (P-value = 0.006).
Caffeine may enhance balance, functional mobility, and QoL in PwMS. Being male was associated with a sharper increase in self-reported ambulatory disability over time. The effects of aging on balance get more pronounced over time.
This study was registered with the Iranian Registry of Clinical Trials (Registration number: IRCT2017012332142N1), a Primary Registry in the WHO Registry Network.
咖啡因对多发性硬化症（MS）的潜在益处，以及对非 MS 人群的活动能力的影响，促使我们评估其对 MS 患者（PwMS）的平衡、移动能力和与健康相关的生活质量（HR-QoL）的潜在影响。
这项单臂试验性临床试验包括为期 2 周的安慰剂导入期和为期 12 周的咖啡因治疗（每天 200 毫克）阶段。使用广义估计方程（GEE）评估研究期间（第 0、2、4、8 和 12 周）的结局测量变化。结局测量包括用于自我报告的活动能力障碍的 12 项多发性硬化症行走量表（MSWS-12）、用于静态和动态平衡的伯格平衡量表（BBS）、用于动态平衡和功能性移动性的计时起立和行走测试（TUG）、用于患者对 MS 相关 QoL（MS-QoL）的观点的多发性硬化症影响量表（MSIS-29），以及用于治疗效果主观评估的患者整体印象变化量表（PGIC）。GEE 还用于评估年龄和性别对随时间变化的结局测量的影响。（伊朗临床试验注册中心，IRCT2017012332142N1）。
共纳入 30 名 PwMS（年龄：38.89±9.85，女性：76.7%）。每日咖啡因摄入显著改善了平衡和功能性移动性的客观测量（BBS；P 值<0.001，和 TUG；P 值=0.002），并在干预后两周改善了与 MS 相关的 QoL 的主观测量（MSIS-29；P 值=0.005）。活动能力障碍的主观测量（MSWS-12）和治疗效果（PGIC）没有显著变化。还评估了年龄和性别对结局测量的影响；在 MSWS-12（P 值=0.001）和 PGIC（P 值<0.001）中发现了显著的性别时间交互作用效应。BBS 评分随时间的推移，年龄对其的影响逐渐增大（P 值=0.006）。
咖啡因可能会增强 PwMS 的平衡、功能性移动性和 QoL。男性随时间推移，自我报告的活动能力障碍的增加更为明显。年龄对平衡的影响随时间的推移而变得更加明显。
这项研究在伊朗临床试验注册中心（注册号：IRCT2017012332142N1）注册，该中心是世界卫生组织注册网络中的一个主要注册机构。
