A long-planned study where 100 ME patients will be treated with the alternative method Lightning Process received ethical approval in 2020. Following complaints, the approval was withdrawn in 2021. After a minor adjustment in the study design, the project received new ethical approval. New complaints have now been rejected.

In November 2020, the Regional Committees for Medical and Health Research Ethics, REK Midt, decided to give ethical approval to the study where 100 ME patients will be treated with the alternative method Lightning Process. REK Midt received 8 complaints but did not find grounds to reverse or adjust their decision. It was therefore sent to the National Research Ethics Committees (NEM) for final assessment. NEM accepted the complaint from the Norwegian ME Association and reversed REK Midt’s decision. In the justification it’s stated, among other things, that «NEM believes that the project’s greatest weakness is the research fellow’s active role in all stages of the project, and the conflict of interest that arises because the candidate has strong financial interests in a positive outcome of the project.» The decision from 2021 can be read in full here (Google translated text: Decision-from-NEM-in-the-project-A-3-day-intervention-for-CFS-ME_04.06.2021

Marginal changes

The project has made some minor changes of the study design, e.g. by adding an extra step in the selection of study participants. According to the new application for ethical approval, a «research nurse» will have interviews with and screen study participants in addition to the candidate. REK Midt gave the project new ethical approval in January 2022. This was followed by new complaints but REK Midt upheld their decision.

Appeal

NEM has considered the new complaints over two meetings. Today, NEM states that the complaints are not approved. This means that the Lightning Process study now has ethical approval.

The decision was made by dissent – ie. all the committee members did not agree.

«The majority in NEM believes that the project has a satisfactory methodological approach to a research field characterized by a lack of evidence based knowledge. The project has a satisfactory apparatus for monitoring and preparedness with regard to deterioration among the participants, and the possibility of deterioration is considered not to be unacceptably large in relation to the project’s societal benefit. The majority emphasizes that it is important that participants are thoroughly informed that deterioration cannot be ruled out.

The minority, members Kari Milch Agledahl, Anne Kjersti Befring and Steven Blackman, believe that the change that has been made is not sufficient to make the research ethically sound. The minority believes that the candidate’s strong self-interest and prominent role in the project must be balanced by a solid research method if the results are to have credibility. The primary endpoint of the study is based on a questionnaire with self-evaluation of symptoms and function. This is less suitable as an objective evaluation if there is real doubt about the researchers’ independence, and the validity of the answers also becomes uncertain when a central part of the course consists of learning verbal reformulations of one’s own experiences.

The minority further believes that the potential for physical side effects has not been sufficiently taken into account, as the participants may have unknown underlying diseases. One of the characteristics of CFS / ME, based on the criteria by which the project itself operates, is precisely post exertional malaise, and the risk for vulnerable participants therefore appears to be real. In line with the rest of the committee, the minority also wants increased research on the treatment of CFS / ME. Due to a controversial field, it is important that the research is based on solid methods and that it appears as independent in order to achieve credibility. The combination of self-interest and not very objective outcome measures means that the committee’s minority considers the potential benefit of the research project to be small. Based on an overall assessment, the minority finds that the project is not ethically justifiable to carry out in its current form. «

Read the entire decision here (Google translated text): NEM’s decision 13 July 2022: A 3-day course for chronic fatigue syndrome / Myalgic encephalopathy (CFS / ME) in adults: a randomized, controlled study.

A number of other countries have refrained from recommending therapy as a curative treatment for ME. Brittish health authorities, NICE, warn in particular against offering Lightning Process as treatment for ME, see the guidelines for ME / CFS.

Written by

Nina E. Steinkopf

Formerly HSE- and Quality Director

Now; ME-patient and writer