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Research Digest 12/03/21

Welcome to the 65th Emerge Australia Research Digest, where you will find summaries of some of the latest research and information about ME/CFS, with links to the complete articles.

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Homebound versus Bedridden Status among Those with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Authors: Conroy K, Bhatia S, Islam M, Jason L (DePaul University, USA)
Publication: Healthcare
The aim of this study was to examine factors which predict severe ME/CFS (operationally defined as “homebound”) versus non-severe (non-homebound) ME/CFS, and to further differentiate what factors predict bedridden versus non-bedridden status in homebound patients.

The authors examined data from 2138 patients from samples from the US, UK, Norway, Japan, Netherlands and Spain. Data collection varied between samples, including different diagnostic methods and criteria. All participants had completed both the DePaul Symptom Questionnaire (DSQ) and Medical Outcomes Study Short Form 36 (SF-36). Based on their responses to the DSQ, 549 patients (25%) were classified as severe (homebound) and 89 (4%) were classified as very severe (homebound-bedridden).

The authors found that more severe scores on the post-exertional malaise (PEM) domain of the DSQ and lower physical and social functioning scores on the SF-36 were associated with being homebound. Somewhat unexpectedly, people who were homebound-bedridden had lower PEM scores compared with those who were homebound-not bedridden. The authors suggested that this result was likely due to the inability of bedridden patients to engage in activity and trigger PEM.

The authors conclude that clinical management of homebound ME/CFS patients should take into account this heterogeneity between bedridden and not bedridden patients, and should be tailored to the different needs of these two subgroups.

In-Depth Analysis of the Plasma Proteome in ME/CFS Exposes Disrupted Ephrin-Eph and Immune System Signaling

Authors: Germain A, Levine SM, Hanson MR (Cornell University, USA)
Publication: Proteomes

These authors undertook a pilot study examining the proteome of a small group of ME/CFS patients and controls.

The study included 20 females diagnosed with ME/CFS (Fukuda criteria) and 20 age-, gender- and BMI-matched controls. Participants completed the Medical Outcomes Short Form 36 (SF-36) and Bell Disability Scale. Blood samples were taken and aptamer-based proteomic analysis, designed to identify 4790 unique proteins, was undertaken.

The authors found 19 proteins which were significantly different in ME/CFS patients compared with controls. These proteins are involved in the extracellular matrix, immune system and cell-cell communication. Further analysis highlighted disruption to ephrin-Eph signalling, which is involved in cell-cell communication, homeostasis and immune response.

The authors acknowledge that the small sample size is a limitation of their study and recommend that further proteomic analysis be undertaken with larger samples.

Open‐label study with the monoamine stabilizer (‐)‐OSU6162 in myalgic encephalomyelitis/chronic fatigue syndrome

Authors: Haghighi S, Forsmark S, Zachrisson O, Carlsson A, Nilsson MKL, Carlsson ML, Schuit RC, Gottfries CG (University of Gothenburg, Sweden)
Publication: Brain and Behaviour
In preclinical studies (‐)‐OSU6162 has been shown to stabilise brain dopaminergic and serotonergic signalling. Earlier work by this group has already shown that (‐)‐OSU6162 can improve the SF-36 vitality score and depressive symptoms in Huntington’s patients and improve mental fatigue following stroke or traumatic brain injury. This study aimed to determine the safety, tolerability, and therapeutic effects of (‐)‐OSU6162 in ME/CFS patients.
33 ME/CFS patients (meeting both Fukuda and International Consensus Criteria) were recruited to the open-label single-arm study. Only 28 patients completed the full study. Participants were each given an “individualised, flexible, stepwise increasing (‐)‐OSU6162 dosing procedure” for a treatment period of 84 days (12 weeks) where the dose was increased every 28 days. Drug efficacy was assessed using both objective and subjective measures at baseline and at weeks 1, 4, 8 and 12 of treatment. Blood samples and vital signs were taken and physical examinations were performed at days 14 and 84 to evaluate the drug safety. Follow up visits were performed at weeks 16 and 20.
(‐)‐OSU6162 was well tolerated with only one patient experiencing an adverse event. Vital signs and physical examinations showed no abnormal changes and blood analyses showed increased serum prolactin. Therapeutic improvements were seen with all surveys/scales except for the Visual Analog Scale (VAS), which measured pain.

The investigators believe that (‐)‐OSU6162 shows promise as a possible therapeutic intervention to improve fatigue, mood and health related quality of life in ME/CFS patients; however, larger double-blind placebo-controlled studies will need to be performed in the future to confirm their findings.

UK Moves to Revise Guidelines for Treatment of Chronic Fatigue Syndrome

Author: Roush K (American Journal of Nursing, USA)
Publication: American Journal of Nursing
The American Journal of Nursing included an article on the proposed new NICE clinical guidelines for ME/CFS in the news section of its March 2021 issue. The piece notes that the proposed guidelines have been hailed for their “rejection of debunked exercise and cognitive behaviour therapies”. The article also notes that the US Centers for Disease Control and Prevention (CDC) had “eliminated these largely useless and, in some cases, harmful therapies from its recommendations” in 2017, and supported NICE following suit.
Note: The draft NICE guidelines were published in November 2020, and were open for public consultation until late December. The final version of the guidelines are due to be published next month.

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