Science on ME is misused. Research affects how ME patients are treated. Poor quality research leads to stigma and harmful treatment. It is time politicians and health authorities make demands for solid research methods, ethical approval and information about financial conflicts of interest.

I have taken a closer look at the quality of some studies that are often referred to when it comes to ME, and what the publications are used for.

1. Cochrane: Systematic review from 2001. The study is used as evidence that exercise therapy has a positive effect in ME, even if it doesn’t show that. The article has been revised several times and has been under a new revision since 2019. Read more at Forskning.no from 2018: “Wish to retract ME research after criticism” (Norwegian text). The article has received harsh criticism because of subjective endpoints, because it is uncertain whether only ME patients were included in the study and because data on the harmful effects of the intervention is not included: Kindlon (2015), Courtney (2016) and Vink (2018).

2. A Customer satisfaction survey carried out by the Norwegian company Aktiv Prosess in 2008. The survey is used as documentation that the alternative method Lightning Process (LP) has a positive effect on ME. LP instructor Live Landmark, who started the company, refers to the survey as «hypothesis-generating» in the Journal of the Norwegian Medical Association. The survey, which was carried out by the LP instructors themselves, says nothing about the participants’ diagnoses. Therefore, it is unknown whether anyone of those who took part in the survey actually had ME. During the course the participants learn that in order for the method to work they have to tell themselves and others that they are recovered. In the survey they were asked whether they were recovered. The probability is high that they said they where satisfied with the course when the course instructor called and asked. The survey was used as evidence for positive effect on ME in an application for ethical consent of an LP study in 2022.

3. Hypothesis from 2009: Prof. Vegard B. B. Wyller is the person in Norway who has been allocated most of the research funds granted in the field since 2005. His hypothesis, that ME is a sustained arousal, has still not been confirmed. Wyller is referred to as an ME expert even though he doesn’t study ME: ME expert is not researching ME.

4. PACE, British scandal study from 2011 which cost 5 million British pounds. The study is used as evidence that graded exercise therapy can have a positive effect on ME. The criteria used to select study participants makes it impossible to know whether they had ME or whether they had primarily psychological disorders. Thus, it is also impossible to distinguish which had a positive or negative effect of the treatment. A new review of the data shows that the treatment had no effect and that the study’s endpoints were changed along the way. The study is also used as a textbook example of shoddy research and is, according to Professor Emeritus of Biostatistics Bruce Levin at Columbia University, is «the pinnacle of amateurism in clinical studies.» 100 renowned scientists from around the world demand that the journal who published the article, The Lancet, undertake an independent reanalysis of the study. Researchers and patients from all over the world are also demanding that the follow-up study be withdrawn.

5. Study from 2012 showing that ME patients spend more time on the internet than other patient groups. The article is used to denigrate the patient group: «Internet forum activity may also be reinforced by the creation of in-group identity and pre-morbid personality traits.». The researchers do not take into account that the nature of the disease can make ME sufferers very isolated and use the internet to make contact with others. Psychiatrist Gunvor Launes refers to this article when she claims ME patients are not fatigued. See video of the interview with psychologist Sondre Liverød in 2018; Liverød: – But they are so fatigued. Launes: – No, but they are not! (Norwegian speech)

Correction 23^rd January 2024: The regional ethics committee, REK stated in June 2023 that they had searched their archives, but found no information about this study. This is wrong. REK has now found both the research protocol and REK’s evaluation. It is, as stated in the article, without objections.

6. In 2012, psychologist Silje E. Reme interviewed nine young people with self-reported chronic fatigue who had taken courses in the Lightning Process (LP). Reme assessed that the participants satisfied the Oxford criteria for chronic fatigue. The study is used as documentation of the positive effect of LP against ME even if the participants did not have ME according to The Canada criteria and although according to Reme itself it is not an effect study.

7. “United We Stand” by Olaug Lian, 2014. Lian studied ME patients on social media in 2013 without their knowledge and without their consent to participate. The study is used to tarnish and undermine the patient group: «The norm in the online community is strong in relation to what is allowed to be said and what is not allowed to be said, and there is no room for dissenting voices.». The study received strong criticism from the Norwegian National Committee for Research Ethics in the Social Sciences and the Humanities.

8. In the Norwegian Directorate of Health’s guideline for CFS/ME from 2014, 100 out of 103 articles that the guideline refers to are studies that have been carried out without claims for the presence of the cardinal symptom of ME Post Exertional Malaise (PEM), and without psychological disorders having been ruled out as a cause of the symptoms. In other words, it is not possible to know if the research the guideline is based on has actually been done on ME sufferers. Half of the articles were from psychological journals, and three quarters were at the time more than ten years old. After the guideline was published in 2014, three thousand research reports and 7 international knowledge summaries on ME have been published.

9. A systematic literature search on «Cause and treatment effect of chronic fatigue syndrome» was carried out by the Norwegian Institute of Public Health in 2016. The report was part of the knowledge base for the call for research funds for CFS/ME. The researchers did not read the articles in full text and did not assess the methodological quality of the overviews or obtain results from the overviews. They may thus have included titles that would have turned out not to be relevant and may also have missed potentially relevant overviews.

10. Article on investigation of suspected CFS/ME from 2016 is used to claim that psychological disorders are largely misdiagnosed as ME. It doesn’t show that. The study shows that doctors who refer patients to the specialist health service have too little knowledge about ME and that many with ME symptoms don’t meet the criteria for an ME diagnosis. Read more in Dagens Medisin: Just under two out of ten investigated for ME had ME. (Norwegian text)

11. The SMILE trial from 2017 is used as evidence that LP can cure ME. The researchers don’t state that the method, which was developed by a “medical clairvoyant”, involves telling yourself and others that you are recovered. The article has a 3,000-word correction, i.a. because the researchers changed the endpoints along the way and included participants who had been recruited before the study was registered.

12. In a master’s thesis from 2017, it is claimed that the reason ME patients don’t score high on interpersonal problems in research is that the patients underreport. They don’t want to realize or admit their problems. Furthermore, it is claimed that this is the reason why therapy has a poor effect. It is recommended that information be obtained about the patients’ interpersonal problems via their significant other and that the patient’s surroundings are also treated. Read more here: Economic interests, stereotypes and conflicts in ME research. (Norwegian text)

13. Psychiatrist Bjarte Stubhaug published a study in 2018 in which it is claimed that cognitive behavioral therapy has a curative effect in ME. In the application for ethical approval, it is stated that the research was to be conducted on a «general psychiatric patient population». The subject in the article, on the other hand, is CFS/ME. According to Stubhaug, this is still not a treatment program for ME in particular. The study had no control group and no objective measures of improvement in the patients. In addition, the study participants are not representative. Therefore, the results can’t be transferred to patients with the cardinal symptom PEM. The article doesn’t disclose Stubhaug’s financial conflict of interest: that the research took place at his private clinic, or the agreement with the public health service Helse Vest for the supply of rehabilitation services for the same patient group.

14. In a study published in 2020, ME patients were treated with music therapy. Most ME patients are sound-sensitive and music will then be contraindicated. The researchers claim the results were positive. They weren’t. During the programme, the focus and therapy was aimed at the children’s personalities, the parents and the family dynamics. Both the participants and the parents were thus implicitly made co-responsible for the «situation» and for the outcome of the therapy. The article was retracted after criticism, then amended and re-published under a new DOI. Read more here: Curing ME with music? and here: The music therapy study has been retracted, amended and republished; the results are worse than first reported.

15. Norwegian study from 2020 by Lillebeth Larun, Signe Flottorp et. al. on: Potential causal factors of CFS/ME: a concise and systematic scoping review of factors researched. Method: The researchers have read the abstracts of 1161 studies. Only 217 of these abstracts report which diagnostic criteria were used.

16. Study in which patients with chronic fatigue after cancer treatment were treated with Lightning Process, 2021. The researchers claim the results were positive even though they are not. For some reason, the project was assessed as not subject to application for ethical approval and thus does not have ethical approval: Study with alternative treatment for fatigue after cancer treatment without ethical approval.

17. A study from 2021 in which 236 ME patients were treated with cognitive behavioral therapy is referred to in the media as «- Important findings». An analysis shows that the results are presented in misleading graphs. The study had no real control group. The results of the only objective endpoint VO2max has not been published but is «kept for later articles». Read more here: Comments to Frontiers. The article now has a correction because one of the researchers in the project, Tore C. Stiles, failed to disclose his financial conflict of interest. The study took place at Stiles’ private company Coperio Rehab Center, which have invoiced the public health service Helse-Midt for NOK 131.5 million for rehabilitation services from 2010 – 2022. Stiles’ conflict of interest is not disclosed in 78 other studies he has contributed to.

18. Doctoral dissertation from 2022 which casts doubt on ME and undermines recognized diagnostic criteria. Common to the diagnostic criteria CCC and SEID, which the dissertation discuss, is the absolute requirement that PEM must be present before the diagnosis of ME can be set. The thesis claims that PEM is a subjective symptom. It is not true. An overview of 42 studies shows that PEM is measured objectively by using a two-day CPET (Cardiopulmonary Exercise Test). Read more here: Doctoral dissertation casts doubt on ME.

19. The Norwegian Women’s Public Health Association’s study on young women recovering from severe ME/CFS from 2023 received 1st prize for this year’s original article at the Faculty of Health Sciences at OsloMet University. 13 young women who have recovered or improved from ME were interviewed. It is uncertain whether these are among the 5% who spontaneously recover. The researchers believe the study is an important contribution to understanding how demanding it is to recover from ME and attribute the recovery process to «the individual’s ability«. The tens of thousands who are still ill or who got worse after trying the same methods are not mentioned. Nor that their effort and ability to keep hope is just as heroic as of those who have recovered. As the researchers themselves write, there is no cure for ME. Nevertheless, they conclude that new routines for sleep, rest and meals appear to be the very essence of the recovery process in ME/CFS. There is no support in clinical research for such a claim.

Unacceptable quality

Research on cognitive behavioral therapy and graded exercise therapy as a treatment for ME is generally of very low quality. In preparing new guidelines for ME/CFS, the British health authorities have assessed the quality of 236 studies using these methods and found that the quality is low for 19% and 11% and very low for respectively 81% and 89% of the studies. None were of acceptable quality. Read prof. Brian Hughes: No more Mr. NICE guy.

Many of these studies are part of the knowledge base for treatment recommendations, political decisions and the allocation of research funds. The studies are also used as a professional basis for the rehabilitation of ME patients; measures the Labour and Welfare Administration requires as a condition for financial assistance.

The science the Norwegian Institute of Public Health FHI relates to is outdated and of an unacceptably low quality. Read more here: The Norwegian Institute of Public Health’s controversial ME science.

The Norwegian National Competence Unit for CFS/ME has a so-called «biopsychosocial» approach to ME. The Competence Unit recommends exercise as treatment and believes ME patients should be treated with the Lightning Process. The Unit’s task has been to increase knowledge about ME for ten years. For just as long, they have misinformed the services and therefore carry a large part of the responsibility for the desperate situation the patient group is in.

In 2007, The Social- and Health Directorate’s report concluded that there was a lack of knowledge about ME. The same was reported by Sintef in in 2011 and in the Norwegian ME association’s surveys from 2012, 2014, 2016, 2018 and 2019. ME patients deteriorate in contact with the services and are largely left to fend for themselves. Many people don’t dare to make contact in fear of being reported to child protection services when their ME-sick child deteriorates from the treatment they receive.

As early as 2008, researchers concluded that “… reports about patronizing attitudes and ignorance among doctors call for development of evidence based strategies and empowerment of patients, acknowledging the patients’ understanding of symptoms and the complex nature of the disease.” (20)

The Fafo study from 2023 shows that ME patients still deteriorate in contact with the services. The researchers have found that the patients are broken down by the system and what in sociology can hardly be described as anything other than abuse. (21)

ME is a serious, chronic, complex, and multisystem disease. An overview of 15 studies shows that cognitive behavioral therapy is ineffective and that exercise therapy can be harmful in ME. The knowledge summaries of other countries’ health authorities show the same: USA (2014), USA (2015), USA (2016), Netherlands (2018), Belgium (2020), Great Britain (2021), USA (2023) og Germany (2023).

In Norway, on the other hand, we have a guideline for CFS/ME that was already out of date when it was published in 2014.

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A study is now underway, supported by the health authorities, in which 100 ME patients will be treated with quackery: the Lightning Process. The ph.d.-candidate will screen, approve and treat the study participants herself. The Labour and Welfare Administration is recruiting participants from among its users – patients who are dependent on them. The study is financed via the scheme Public ph.d. despite the fact that the candidate is a private business owner and earns tens of millions giving courses and lectures on the method. She has received good help from her large network, including Norway’s Prime Minister Jonas Gahr Støre, who wrote the foreword in her book. The aim of the study, which is rigged for a positive result, is to get the method approved as treatment in the public health sector. British health authorities, on the other hand, specifically warn against offering the method to ME patients. The reason is the risk of side effects. Read more here: Study on ME sufferers; Cynical, unethical and indefensible.  

ME patients deserve better than this.

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Written by

Nina E. Steinkopf

Former HSEQ Chief Executive

Now: ME patient and writer

References

1. Larun L, et al. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD003200. doi: 10.1002/14651858.CD003200.pub8.
2. Landmark, L et al. Kronisk utmattelsessyndrom og erfaring med Lightning Process, Tidsskr Nor Legeforen 2016, 136:396, doi: 10.4045/tidsskr.15.1214
3. Wyller, V.B. et.al. Can sustained arousal explain the Chronic Fatigue Syndrome?. Behav Brain Funct 5, 10 (2009). https://doi.org/10.1186/1744-9081-5-10
4. White, P.D et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, 2011 https://doi.org/10.1016/S0140-6736(11)60096-2
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6. Reme SE, et al. Experiences of young people who have undergone the Lightning Process to treat chronic fatigue syndrome/myalgic encephalomyelitis–a qualitative study. Br J Health Psychol. 2013 Sep;18(3):508-25. doi: 10.1111/j.2044-8287.2012.02093.x.
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8. Helsedirektoratet, Nasjonal veileder Pasienter med CFS/ME: Utredning, diagnostikk, behandling, rehabilitering, pleie og omsorg, 2014 IS- 1944 ISBN-nr. 978-82-8081-239-1
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10. Furlund Owe J, et.al, Investigation of suspected chronic fatigue syndrome/myalgic encephalopathy, https://pubmed.ncbi.nlm.nih.gov/26860382/  
11. Crawley EM, et al., Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial, Archives of Disease in Childhood 2018;103:155-164. http://dx.doi.org/10.1136/archdischild-2017-313375 https://adc.bmj.com/content/103/2/155
12. Klarström, A «Interpersonlige problemer ved Kronisk utmattelsessyndrom (CFS/ME)» Institutt for psykologi, NTNU, 2017
13. B. Stubhaug, B et al. A 4-Day Mindfulness-Based Cognitive Behavioral Intervention Program for CFS/ME. An Open Study, With 1-Year Follow-Up, Front. Psychiatry, 2018 https://doi.org/10.3389/fpsyt.2018.00720
14. Malik S, et al. Retracted: Cognitive–behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study, BMJ Paediatrics Open 2020;4:e000620. doi: 10.1136/bmjpo-2019-000620
15. Muller, A.E., Tveito, K., Bakken, I.J. et al. Potential causal factors of CFS/ME: a concise and systematic scoping review of factors researched. J Transl Med 18, 484 (2020). https://doi.org/10.1186/s12967-020-02665-6
16. Reme SE, et al. Does the Lightning Process Training Programme Reduce Chronic Fatigue in Adolescent and Young Adult Cancer Survivors? A Mixed-Methods Pilot Study. Cancers. 2021; 13(16):4076. https://doi.org/10.3390/cancers13164076
17. Gotaas ME, et al. Cognitive Behavioral Therapy Improves Physical Function and Fatigue in Mild and Moderate Chronic Fatigue Syndrome: A Consecutive Randomized Controlled Trial of Standard and Short Interventions. Front Psychiatry. 2021 doi: 10.3389/fpsyt.2021.580924  Erratum in: Front Psychiatry. 2023 Mar 13;13:1122220.
18. Asprusten TT, «Diagnosis of Chronic Fatigue Syndrome in Adolescents” Dissertation for the Degree of PhD 2022, Institute of Clinical Medicine, Faculty of Medicine University of Oslo, ISBN 978-82-8377-988-2
19. Krabbe, SH., Groven, KS., Schrøder Bjorbækmo, W., Sveen, U. & Mengshoel, AM. (2023) The fragile process of Homecoming – Young women in recovery from severe ME/CFS, International Journal of Qualitative Studies on Health and Well-being, 18:1, DOI: 10.1080/17482631.2022.2146244
20. Malterud, K, et al. Obstructions for quality care experienced by patients with chronic fatigue syndrome (CFS)—A case study, Patient Education and Counseling, Volume 73, Issue 1, 2008, Pages 36-41, ISSN 0738-3991, https://doi.org/10.1016/j.pec.2008.04.001
21. Kielland A, Liu J, Jason LA. Do diagnostic criteria for ME matter to patient experience with services and interventions? Key results from an online RDS survey targeting fatigue patients in Norway. Journal of Health Psychology. 2023;0(0). doi:10.1177/13591053231169191