Background: Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, debilitating neuro disorder affecting multiple body systems and roughly 50 million individuals worldwide. It is a complex physiological phenomenon that arises during sustained or repetitive muscular activity, limiting an individual's capacity to perform physical tasks. This debilitating condition is primarily attributed to the inability of muscle fibers to contract effectively. Despite its significant global health impact, our understanding of ME/CFS's causes and pathophysiology is incomplete.
Methods: A search on ClinicalTrials.gov was performed on August 03, 2023, using "chronic fatigue syndrome." Four independent reviewers screened trials matching specified eligibility criteria. Criteria included relevance to CFS, completion status, interventional design, inclusion of older adults, and a defined phase. Key trial data, such as intervention details, therapeutic mechanisms, primary endpoints, participant numbers, study duration, and outcomes, were retrieved for evaluation.
Results: The initial search of the database retrieved 191 clinical trials. Following the screening that excluded incomplete, non-geriatric, and non-interventional studies, 45 trials were shortlisted. Further filtration led to the final selection of 32 clinical trials. Most trials utilized randomized allocation (69.7%) and parallel assignment (69.7%). The most common masking method was open-label (36.4%), and the United States emerged as the leading study host (36.4%). Herbal/Dietary supplements were the most common interventions, accounting for 36.4% of the trials. Prisma flow chart was created to identify the process.
Conclusion: This systematic review aims to provide a comprehensive overview of clinical trials related to the management of ME/CFS in older adults, utilizing data from ClinicalTrials.gov. By systematically reviewing the available evidence, this study contributes to a better understanding of ME/CFS management strategies for older populations, potentially informing clinical practice and future research in this area.
Keywords: Myalgia Encephalomyelitis, chronic fatigue syndrome, movement, neurology, Neurophysiology.