Therapeutical interventions for myalgic encephalomyelitis/chronic fatigue syndrome; A review of phase IV Clinical trials

Abstract

Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling and complex illness with multifactorial etiology. Current clinical trials were examined to understand the characteristics of ME/CFS as well as possible therapeutical interventions. Aim: To identify features of clinical trials related to ME/CFS registered at ClinicalTrials.gov, specifically, the therapeutical interventions used to manage the syndrome in phase IV. Method: Analysis of all clinical trials registered at ClinicalTrials.gov for ME/CFS. Those clinical trials that employed a targeted therapy were included. The analysis identified a selection of clinical trials examining a targeted therapy for ME/CFS, providing a platform for further exploration of potential treatments. Results: By November 19th, 2022, 151 clinical trials related to ME/CFS had been found. Interventional studies were the most prevalent type. However, the trials were restricted to specific continents and were not extensively conducted in pediatric patients. Micronutrients were the most commonly used intervention. Phase IV studies had fewer clinical trials with limited interventional measures. Only three out of nine studies completed pharmacological interventional studies, and of these, sodium oxybate was being used most frequently. Conclusion: Among the clinical trials identified through this paper, there were few related to ME/CFS treatment. The interventions in the completed phase IV studies involved drugs that mainly interacted with the CNS, and more rarely that had an effect on blood vessels and blood perfusion. The limited number of phase IV clinical trials meant that the results were inconclusive.