Evaluation of an integrated multidisciplinary care model for myalgic encephalomyelitis/chronic fatigue syndrome: a prospective, open-label, non-randomized controlled intervention study

BACKGROUND: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disabling condition with limited treatment options and inadequate healthcare structures worldwide. We assessed the effectiveness of an integrated care model specifically adapted for ME/CFS. METHODS: In this prospective, open-label, non-randomized controlled intervention study conducted at Charité Fatigue Center we enrolled patients with ME/CFS between 2022 and 2023. Participants in the intervention group received multidisciplinary specialist assessment, comprehensive clinical management, and tailored inpatient rehabilitation, while the control group received a single outpatient consultation and a medical report for their primary physician. Primary outcome was change in physical functioning, measured using the SF-36 physical functioning subscale, at 12 months. Secondary outcomes included disability, symptom severity, quality of life, handgrip strength, and steps per day. RESULTS: 89 intervention and 93 control participants were included in the per-protocol analysis. At 12 months, no statistically significant difference in SF-36 physical functioning scores was observed between groups. Secondary outcomes also showed no substantial between-group differences. Inpatient rehabilitation was completed by all participants who initiated it. Most participants reported that rehabilitation was helpful for learning disease management strategies, and for coping better with daily life. Post-rehabilitation Bell Disability Scale scores decreased in 42/94 (45%) and increased in only 13/94 (14%) patients. CONCLUSIONS: The integrated multidisciplinary care model was feasible and associated with high retention but did not improve physical functioning or key secondary outcomes at 12 months. Current rehabilitative and management strategies may be insufficient to alter disease trajectory, underscoring the need for more effective, disease-modifying therapeutic interventions.