301297

THERAPEUTICAL INTERVENTIONS FOR MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME; A REVIEW OF PHASE IV CLINICAL TRIALS

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Last updated: 04 Jan 2025

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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.

DOI

10.21608/bfsa.2023.301297

Keywords

Myalgic encephalomyelitis, Pain, Clinical trials, Chronic Fatigue Syndrome, Therapeutics

Authors

First Name

Nasser

Last Name

Alorfi

MiddleName

M.

Affiliation

Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia

Email

nmorfi@uqu.edu.sa

City

-

Orcid

0000000206367685

Volume

46

Article Issue

1

Related Issue

41495

Issue Date

2023-06-01

Receive Date

2023-03-14

Publish Date

2023-06-01

Page Start

659

Page End

668

Print ISSN

1110-0052

Online ISSN

3009-7703

Link

https://bpsa.journals.ekb.eg/article_301297.html

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https://bpsa.journals.ekb.eg/service?article_code=301297

Order

301,297

Type

Original Article

Type Code

1,096

Publication Type

Journal

Publication Title

Bulletin of Pharmaceutical Sciences Assiut University

Publication Link

https://bpsa.journals.ekb.eg/

MainTitle

THERAPEUTICAL INTERVENTIONS FOR MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME; A REVIEW OF PHASE IV CLINICAL TRIALS

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Article

Created At

25 Dec 2024