Trial Report White-matter changes associated with a synergetic treatment for myalgic encephalomyelitis/chronic fatigue syndrome, 2024, Mohamed

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Case Report
White-matter changes associated with a synergetic treatment for myalgic encephalomyelitis/chronic fatigue syndrome
Abdalla Z. Mohamed
Jorge do Campo
Peter Del Fante
Richard Kwiatek
Vince D. Calhoun
&
Zack Y. Shan
Received 24 Jan 2024, Accepted 05 Mar 2024, Published online: 26 Jun 2024

• Cite this article
  
• https://doi.org/10.1080/21641846.2024.236792

ABSTRACT
Objectives
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex and debilitating chronic illness for which there are no well-accepted treatments, aside from some preliminary trials and symptom management strategies, such as low-dose naltrexone and NICE guidelines. A clinician administered a synergistic off-label treatment (SOT) involving spironolactone, colchicine, low-dose naltrexone, and multivitamins to ME/CFS patients, resulting in reported symptom improvement. This study sought to investigate neuroimaging characteristics linked with the treatment.

Methods
A group of treatment-naive patients (N = 8, control) was selected to age – and sex-match eight patients who had received the treatment (SOT). Diffusion-weighted imaging data and clinical measures from the two groups were compared.

Results
Compared to the control group, the SOT group showed reduced depression (Bonferroni corrected P value (PBonf) = .04) and mental deficit symptoms (PBonf = .02). Furthermore, the SOT group at post-treatment showed significantly reduced clinical scores (PBonf < .001) than at the pre-treatment baseline. We also observed higher fractional anisotropy and lower diffusivity measures in various white-matter tracts of the SOT group compared to the control group (Family-wise-error-corrected P value (PFWE) ≤ .05).

Conclusion
These findings provide a first line of evidence for the potential effectiveness of SOT treatment in ME/CFS patients, as indicated by microstructural changes in the brain associated with improved clinical symptoms. Formal randomized controlled trials are required to determine the efficacy of SOT components in treating ME/CFS.