Review Advancing Research and Treatment: An Overview of Clinical Trials in (ME/CFS) and Future Perspective 2024 Seton et al

Full title: Advancing Research and Treatment: An Overview of Clinical Trials in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Future Perspectives

Abstract

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic, debilitating, and multi-faceted illness. Heterogenous onset and clinical presentation with additional comorbidities make it difficult to diagnose, characterize, and successfully treat. Current treatment guidelines focus on symptom management, but with no clear target or causative mechanism, remission rates are low, and fewer than 5% of patients return to their pre-morbid activity levels. Therefore, there is an urgent need to undertake robust clinical trials to identify effective treatments.

This review synthesizes insights from clinical trials exploring pharmacological interventions and dietary supplements targeting immunological, metabolic, gastrointestinal, neurological, and neuroendocrine dysfunction in ME/CFS patients which require further exploration. Additionally, the trialling of alternative interventions in ME/CFS based on reported efficacy in the treatment of illnesses with overlapping symptomology is also discussed.

Finally, we provide important considerations and make recommendations, focusing on outcome measures, to ensure the execution of future high-quality clinical trials to establish clinical efficacy of evidence-based interventions that are needed for adoption in clinical practice.

Open access, https://www.mdpi.com/2077-0383/13/2/325

 

"9. Conclusions

In this review, we have discussed published CTs in ME/CFS that have occurred over the past 33 years targeting immunological, metabolic, GI, neurological, and neuroendocrine disturbances in ME/CFS patients. Rintatolimod [Ampligen] is the standout and the only current example of a successful treatment for ME/CFS. Yet, its status as an experimental drug means it cannot be incorporated into routine treatment. Other interventions including the use of the antivirals VACV, VGVC, and artesunate, metabolic supplements, and probiotics have shown promising results but need to demonstrate clinical efficacy in larger RCTs. Interventions that have proven effective in or are currently being trialled in other chronic diseases with overlapping symptomology to ME/CFS, such as luteolin in long COVID and mast cell stabilisers in neuroinflammatory disease, could be considered for repurposing in ME/CFS. Future CTs in ME/CFS should include suitable objective outcome measures, such as the use of accelerometers to measure physical activity, and rely less on subjective and often patient based questionnaires. Other important considerations in designing CTs in ME/CFS include having appropriately powered studies and numbers of trial participants that are of a uniform clinical subtype that utilize stringent case definitions that include PEM as a core symptom and use evidence-based inclusion criteria."