What treatments are being tested? Ongoing, registered or planned clinical trials for ME/CFS

What treatments are being tested? Ongoing, registered or planned clinical trials for ME/CFS

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I am delighted to have a guest blog from the talented blogger and advocate Michiel Tack and the remarkable advocate Evelien Van Den Brink (who famously lobbied the European Parliament). They investigated what studies of new treatments were underway or had been funded and present the results here. There’s not as much in the pipeline as ME/CFS needs, which reflects the lack of fundamental research. However, COVID-19 and Long Covid have the potential to rapidly improve the situation.

Evelien and I were interested in what clinical trials are currently planned or ongoing for ME/CFS. It can take many years to conduct a clinical trial and report the results, so we wanted to know what we can expect to come out in the next years.

Method: a search of databases that register clinical trials

We did a quick search of the main databases where researchers are supposed to register their clinical trials. We were mainly interested in randomized controlled trials that have the intention to test the efficacy of a treatment and less interested in phase I studies (that focus on safety testing) or open-label studies (that have no control group).

Unfortunately, the WHO International Clinical Trials Registry Platform (ITCRP) website was not functioning, due to heavy traffic generated by the COVID-19 outbreak. We did manage to search the other main databases that are the main data suppliers for the WHO, namely: Clinicaltrials.gov, ISRCTN, ANZCTR, DRKS, EudraCT, and NTR. We also had a look at the main charities that fund ME/CFS research to see if they had plans for clinical trials. The results of our search are summarized in this Google document (which should be open for all to see and comment on). If you know of any (randomized controlled) trials for ME/CFS that aren’t listed in this document, feel free to make a comment or let me know through social media.

Few drug trials, several on fecal microbiota transplantation

We found approximately 30 trials, which can be grouped into different categories. First off are drug trials, but unfortunately, there are very few of these.

There’s one by Jarred Younger on Low Dose Naltrexone (LDN), but it’s temporarily suspended so he can focus on other projects.

At Brigham & Women’s Hospital, Dr. David Systrom will trial the drug Mestinon, in association with Open Medicine Foundation’s Harvard ME/CFS collaboration. Systrom hopes that this will treat the preload failure (where the heart doesn’t fill with blood properly during exertion) that some ME/CFS patients demonstrate during invasive cardiopulmonary exercise testing.

That’s about it. The Open Medicine Foundation recently announced a study in Sweden that will test Kynurenine, a treatment based on the metabolic trap hypothesis], but this trial hasn’t been registered yet.

Other preliminary reports such as the ones on CT38,the drug developed by the small biopharmaceutical company Cortene, and cyclophosphamide,which was trialed by the Norwegian research team of Mella and Fluge, have raised hope that larger trials will follow. But thus far we couldn’t find plans, protocols, or registration of further studies to test the efficacy of these treatments.

A whole lot of shit

Secondly, there are a couple of trials into fecal microbiota transplantation (FMT) where doctors take fecal matter of a healthy donor and insert it into an ME/CFS patient, hoping that it will restore the gut microbiome and help alleviate symptoms. Both Dr Ian Lipkin’s and Dr Derya Unutmaz’s collaboratives are researching the impact of the gut microbiome in ME/CFS. The comeback study in Norway will test this procedure in 80 patients, but there is also a registered Finnish study and one supported by Invest in ME at the Quadram Institute that hope to test FMT in ME/CFS.

Supplements, Chinese remedies, and behavioral interventions

There are more trials in the third category, namely those that will test supplements. The most prominent one is the one by Dikoma Shungu on N-acetylcysteine, which among other things can affect neurotransmitters and act as an antioxidant]. Others plan to test a mixture of supplements that have names such as RiaGev™, ReConnect®, Gutmagnific, or ImmunoVit. In our view, many of these trials are not so much a sign of hope but an indication that the ME/CFS research community hasn’t reached the level of professionalism that patients deserve.

The same can be said about the handful of studies that will test ancient Chinese remedies, such as acupuncture, tao yin exercises, moxibustion, and Sijunzi decoction. It is doubtful that the investigators of these trials really know what ME/CFS entails. One trial description, for example, starts with the error: “Chronic fatigue syndrome (CFS), also known as idiopathic chronic fatigue (ICF)…” To be upfront, we have the impression that quite a few of these researchers mistake ME/CFS for unexplained tiredness of a less severe nature.

“many of these trials are not so much a sign of hope but an indication that the ME/CFS research community hasn’t reached the level of professionalism that patients deserve”

Lastly, there are trials on behavioral interventions such as the MAGENTA and FITNET-NHS studies led by Esther Crawley in the UK. Apparently, there are still a few researchers who hold high hopes of changing patients’ thoughts and behavior as a treatment for ME/CFS, despite the failures of the past. There are registered ME/CFS trials on self-paced exercise, video gaming, computerized cognitive training, relaxation methods, biofeedback therapy, and so on.

COVID-19 to the rescue

We can’t avoid the conclusion that the results of our search were rather bleak. The hope for change lies, not in clinical trials but in fundamental research into the underlying pathology of ME/CFS. A breakthrough in this area would enable more targeted attempts at finding a treatment for ME/CFS.

The You + ME registry, the Genome-wide association study, and the new ME/CFS Center at Harvard-affiliated hospitals are positive signs that the research field is getting more professional. In addition to that, the coronacrisis has provided an exceptional opportunity for new and talented researchers to enter the field of postviral syndromes. This might provide a fresh perspective at a medical conundrum where progress has been long overdue.

My recent blog on the potential of long covid to help understand ME/CFS.

Follow-up blog from Michiel and Evelien: A disease funding comparison: is ME/CFS getting too little?

Michiel Tack and Evelien Van Den Brink

This blog first appeared on ME/CFS skeptic on 18 September 2020.

Evelien Van Den Brink has been ill with ME/CFS for 22 years. She initiated a successful European petition and delivered a speech in the European parliament about the need for more biomedical research on ME/CFS. This resulted in the first resolution on ME/CFS adopted by the European parliament. She is co-founder of the European ME Coalition (EMEC).

Michiel Tack has been ill with ME/CFS for 12 years. He follows ME/CFS research closely and occasionally writes blogs or letters to the editor to point out flaws in studies. He is involved in several ME/CFS advocacy projects.

Image credits: Photo by Karolina Grabowska from Pexels

12 thoughts on “What treatments are being tested? Ongoing, registered or planned clinical trials for ME/CFS

  1. Great article, thank you. There is also the Suramin trial of Dr. Naviaux, that was about to start, but is delayed because of Covid-19. The trial is FDA approved and would run for 3 years.

    1. Thanks for pointing out the Suramin trial of Dr. Naviaux Sylvia Iversen!

      I see it mentioned on the website of Naviaux lab (with UCSD code IRB#170199) but I can’t find other sources about the trial.

      Do you happen to know more about the trial or have a link to a registration/protocol/description etc?

      Many thanks in advance

      1. Rachel Riggs (who is a pwME on Facebook) is connected with Dr. Naviaux and may be able to answer questions – or find answers to questions – about the Suramin trial.

      2. Details about the Suramin trial of Dr. Naviaux can be seen at 32:46 in this video: https://www.youtube.com/watch?v=OcrxK-PAe_I
        Just like you, Michiel Tack, I searched for the study some time ago and I could not find it either. So maybe it would be good to ask Dr. Naviaux about this.
        Lots of luck and thank you for your great work!

  2. A depressingly short list. I saw a video where jarred younger said he had been testing several compounds including curcumin from turmeric for anti neuro inflammatory effects, had seen some were effective but didn’t at that point know which ones as trial was double blind.

  3. Please can someone tell ME/CFS researchers that they could consider New Zealand as a safe country for patient research because New Zealand is Covid Free in the entire country (apart from people who arrive and are in managed isolation quarantine)

    New Zealand has top quality Universities and they could be used right now to keep progress going. Otago University has Professor Warren Tait and Massy University has Dr Lynette Hodges. There’s other high quality research centres and universities too.

  4. great job. There is also the http://www.gutmagnific.com trial in Sweden with Dr. Per Julin at Stora Sköndal ME clinic in Stockholm. And there will be another treatment trial in Sweden towards the end of next year which will be game changer for ME patients! More to come. There needs to be some measurement clinical trials first which are now being written up for Swedish ethics board before trials can begin in completely new areas of research.

  5. Thanks for that
    Thomas Borody Australian scientist and Doctor.
    Developed a triple therapy with
    Invermactin, that seemed to be having remarkable results
    It can be used as a preventive measure and also be used to treat
    And alleviate the symptoms of any one infected
    Seems strange that it’s not being followed up
    As the drugs are already widely used,
    And proven safe, With minimum side effects
    You start to wonder if they’re really interested in finding something that would help in the fight against covid19

  6. Thank you for compiling this list. It is encouraging as it is disappointing but we must have hope in these trials. No mention of the very exciting and near breakthrough that Ron Davis is doing . He is working on a biomarker for M.E and his work is near breakthrough for a nano needle to detect M.E in the blood. Follow his work on the Open Medicine Foundation FB page

  7. Were there any trials specifically for EBV and EBV in MECFS patients. This should be scientifically focused since interest lies in PV Postviral effects on VI patients.
    There are many new studies on EBV as a major risk for Covid-19. I have been a EBV VI MECFS patient for 19 years.

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