Dear Ms Polli,
I am a person who suffers from myalgic encephalomyelitis, and I recently saw the protocol of the
clinical trial on the epigenetics of PEM in ME/CFS. I would like to thank you for your interest into research on ME/CFS; good quality biomedical research is much needed to understand the disease.
I only have one concern about the current protocol. The first inclusion criterion is the following:
diagnosis of ME/CFS established by a MD experienced in the field of internal medicine and ME/CFS - according to the published international criteria developed by the Centre for Disease Control and Prevention (CDC)
However, the CDC-1994 ("Fukuda") criteria for CFS do not require post-exertional malaise as a mandatory symptom. EUROMENE, the European network on ME/CFS, have listed this as an "objection" to using the CDC-1994 criteria [1] and have instead recommended the combined use of the Canadian consensus criteria (CCC) [2] with the CDC-1994 criteria [3]. For example, the CCC have been used successfully for the large phase 3 clinical trial of Rituximab for ME/CFS [4]; they are fit for research purposes.
Worth noting, the international consensus criteria [5] are highly specific for ME as "post-exertional neuro-immune exhaustion", which they define precisely, is the core mandatory symptom.
Since prospective participants will be evaluated by an internist MD experienced in ME/CFS, I am sure that using both CCC and CDC-1994 criteria will not be a practical difficulty. Therefore, I hope the protocol can be updated to require CCC, as a way to 1) make the trial consistent with other good quality studies on ME/CFS, 2) relieve any doubt about the ME/CFS diagnosis of included participants, 3) enable the results of the trial to be used in future research on ME/CFS.
Thank you again for setting up this interesting trial!
Sincerely,
XX
References
[1] Strand EB, Nacul L, Mengshoel AM, Helland IB, Grabowski P, et al. (2019) Myalgic encephalomyelitis/chronic fatigue Syndrome (ME/CFS): Investigating care practices pointed out to disparities in diagnosis and treatment across European Union. PLOS ONE 14(12): e0225995.
https://doi.org/10.1371/journal.pone.0225995
[2] Bruce M. Carruthers, Anil Kumar Jain, Kenny L. De Meirleir, Daniel L. Peterson, Nancy G. Klimas, A. Martin Lerner, Alison C. Bested, Pierre Flor-Henry, Pradip Joshi, A. C. Peter Powles, Jeffrey A. Sherkey & Marjorie I. van de Sande (2003) Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Journal of Chronic Fatigue Syndrome, 11:1, 7-115, DOI:
10.1300/J092v11n01_02
[3] Pheby, D. F. H., Araja, D., Berkis, U., Brenna, E., Cullinan, J., de Korwin, J.-D., … Wang-Steverding, X. (2020). The Development of a Consistent Europe-Wide Approach to Investigating the Economic Impact of Myalgic Encephalomyelitis (ME/CFS): A Report from the European Network on ME/CFS (EUROMENE).
Healthcare,
8(2), 88. doi:
10.3390/healthcare8020088
[4] Fluge Ø, Rekeland IG, Lien K, et al. B-Lymphocyte Depletion in Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2019;170:585–593. [Epub ahead of print 2 April 2019]. doi:
https://doi.org/10.7326/M18-1451
[5] Carruthers, B.M., van de Sande, M.I., De Meirleir, K.L., Klimas, N.G., Broderick, G., Mitchell, T., Staines, D., Powles, A.C.P., Speight, N., Vallings, R., Bateman, L., Baumgarten‐Austrheim, B., Bell, D.S., Carlo‐Stella, N., Chia, J., Darragh, A., Jo, D., Lewis, D., Light, A.R., Marshall‐Gradisbik, S., Mena, I., Mikovits, J.A., Miwa, K., Murovska, M., Pall, M.L. and Stevens, S. (2011), Myalgic encephalomyelitis: International Consensus Criteria. Journal of Internal Medicine, 270: 327-338. doi:
10.1111/j.1365-2796.2011.02428.x
It is good to know that the CCC and IOM criteria will also be applied.
