Study with alternative treatment for fatigue after cancer treatment – without ethical approval

In a study at the Norwegian «Comprehensive Cancer Center», Radiumhospitalet, 13 adolescent cancer survivors received alternative treatment for fatigue. (1) The participants were fully or partially on sick leave and their physical and psychosocial function was severely impaired. The method which was tested, Lightning Process (LP), is according to founder Phil Parker a mix of hypnotherapy, neurolinguistic programming and coaching. (2) The Norwegian Directorate of Health regards LP instructors as alternative practitioners according to the Act relating to the alternative treatment of disease. (3) The method consists of i.a. saying «Stop!» to symptoms and to tell yourself and others that you have recovered. The participants were evaluated and selected by the LP instructor and only the most motivated were allowed to participate. The instructor, leader of the Norwegian Association for Lightning Process Instructors Kristin Blaker, is not a medical professional. The method has according to the Directorate of Health clear health-related intentions in relation to treatment of disease.

The Norwegian Regional Ethics Committees for Health Research, REK, state on their website that «All medical and health research projects need prior ethical approval from REK.» (4)

On January 23rd 2019, REK South-East received a request to assess whether the project was required to be submitted for approval. In REK’s response the following day, January 24th 2019, REK considers that the project is not required to apply for ethical approval.  According to REK’s assessment, the project fell outside the scope of the Health Research Act and could be carried out without the approval from REK.

The assessment is justified as such: «The purpose is decisive, not whether the research is carried out by health personnel or on patients / vulnerable groups or uses health information.». The justification refers to section 2 of the Health Research Act, and the scope of the Act: «The Act applies to medical and health research on humans, human biological material or health information.» Surprisingly, the second sentence of the statutory section: «Such research also includes pilot studies and experimental treatment.» is omitted from the grounds. (5)

In the request to assess it is not informed that the method is alternative treatment but LP is described as a “cognitive training method”. There is also no information about negative effects of LP, cf. The National Research Center in Complementary and Alternative Medicine (NAFKAM)’s report from 2015 which shows that 39% had a negative effect. (6)

REK South-East did not wish to answer my questions about this but emphasizes in an email on August 25th 2021 that the chairman of the committee (at that time) Knut Engedal considered the purpose as outside of the scope of the Health Research Act, and that the project as such has not been assessed by REK. REK has pointed out that the assessment and conclusion is to be regarded as indicative, cf. the Public Administration Act § 11 and that «If you [the project] still wish to apply for ethical approval from REK, the application will be considered in a committee meeting, and an individual decision will be made under the Public Administration Act».

Engedal was also the leader of the monitoring group of a LP study on patients with Myalgic Encephalomyelitis (ME) which has been planned since 2018. REK Midt decided to give this project ethical approval in 2020, but the decision was later revoked by the National Research Ethics Committees NEM. (7)

When I asked NEM if they are of the same opinion as REK South-East’s assessment of this LP study on cancer survivors, NEM answers in an email on August 25th  2021 that they do not wish to go into an assessment of REK’s decision in a case they have not had on their own table. Furthermore, NEM will probably not look any further into the matter unless a complaint is filed.

The study

The effect of LP is similar to what occurs in relation to placebo and nocebo effects. LP participants are told that in order for the method to work, they must tell themselves and others that they are recovered. This could affect the responses from the study participants for reasons other than real improvement, as NEM also pointed out in the decision regarding the LP study on ME patients. (7)

The paper claims that LP has a positive effect on ME. There is, however, no scientific basis for such a claim. The SMILE study which the article refers to, where 100 adolescents were treated with LP, has a 3,000-word correction due to major methodological weaknesses. (8) ME also differs from unexplained chronic fatigue by the cardinal symptom post-exertional malaise (PEM). A recent Dutch study shows that exercise had a different effect on patients with ME than on other patients with fatigue. (9)

The intention of  the study was to explore whether LP could significantly increase a.o. workplace attendance. The results show that by 6 months follow-up 3 of 13 participants had a score lower than 10 on «The Work and Social Adjustment Scale» which is in the area «Low impairment». 1 (one) of these reported actual increased work attendance from 30% to 100%. The participants received 5 booster sessions with the LP-instructor before the 6 months follow-up. The results of the first follow-up – at week one, are not included in the article. The study had a very short follow-up time and no objective outco me measures and thus has a very limited scientific value.

The study’s conclusion is – not surprisingly – positive. Despite modest results which are overemphasised, the researchers believe that they “should be of interest to the general oncological community.”.

It seems like REK is inconsistent in its assessments of studies on the method when a study on cancer survivors does not need ethical approval, while a similar study on ME patients needs it.

Written by

Nina E. Steinkopf

Former HSEQ chief executive – now; ME-patient and writer



References

  1. Fauske L, Bruland ØS, Dahl AA, Myklebostad A, Reme SE. 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
  2. Phil Parker, The Lightning Process – A new me, https://lightningprocess.com/the-lightning-process-a-new-me/
  3. Directorate of Health, letter to NAFKAM, April 13th 2018
  4. REK, About applying REK, https://rekportalen.no/#hjem/s%C3%B8ke_REK
  5. REK south east, Asssessment, evaluation, January 24th 2019
  6. NAFKAM: Både pluss og minus ved Lightning Process, 2015. https://uit.no/om/enhet/aktuelt/nyhet?p_document_id=438334&p_dimension_id=88112
  7. NEM 2020/177, REK Midt 101699 | [Complaint], «En tre-dagers intervensjon for CFS/ME», 4. juni 2021 https://www.forskningsetikk.no/om-oss/komiteer-og-utvalg/nem/sok-i-nems-vedtak/en-3-dagers-intervensjon-for-cfsme/
  8. Crawley EM, Gaunt DM, Garfield K, 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. https://adc.bmj.com/content/103/2/155
  9. C. (Linda) M. C. van Campen & F. C. Visser, Comparing Idiopathic Chronic Fatigue and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in Males: Response to Two-Day Cardiopulmonary Exercise Testing Protocol, Healthcare, juni 2021.

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