GETSET trial

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history

The GETSET trial (short for Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome) was a trial investigating the effectiveness of "guided graded exercise self-help" in patients with CFS/ME. The protocol was published in June 2016.[1] The results were published in June 2017.[2]

Researchers[edit | edit source]

Lead Author Lucy Clark, Peter White, Francesca Pesola, Janice M Thomas, Mario Vergara-Williamson and Michelle Beynon

Funding[edit | edit source]

The trial was funded in full by the National Institute for Health Research's Research for Patient Benefit programme.[3]

Protocol[edit | edit source]

The protocol of the trial was published in JMIR Research Protocols in June 2016.[1]

Publications[edit | edit source]

The results were published on 22 June 2017 in the Lancet: Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial[4]

Commentary was provided by Daniel Clauw in the Lancet: Guided graded exercise self-help as a treatment of fatigue in chronic fatigue syndrome.[5]

The Science Media Centre provided: Expert reaction to study on guided self-help graded exercise therapy as a treatment for chronic fatigue syndrome (CFS).[6]

It was reported in the Telegraph as Exercise can help chronic fatigue syndrome, study shows and other media outlets: Defeating chronic fatigue thanks to guided self-help approach to exercise.[7]

The long term follow-up results were published July 2021 in the Journal of Psychosomatic Research: Guided graded exercise self-help for chronic fatigue syndrome: Long term follow up and cost-effectiveness following the GETSET trial.[8]

Criticism[edit | edit source]

Dr David Tuller criticized the trial in the blog post Trial by Error, Continued: More on Graded Exercise from Peter White and The Lancet. Tuller later also criticized misleading presentation of the long term follow-up results, which presented the results as demonstrating sustained improvement, despite them finding a lack of significant difference between the treated and untreated groups.[9] The paper was subsequently revised in response to this criticism.[10]

Spoonseekerdotcom has criticised the GETSET trial.[11][12][13]

Professor Jonathan Edwards criticised the study for its "incompetent level of science".[14]

The ME Association also criticised the trial in ME Association Review: GETSET fails to demonstrate GET can significantly improve physical function.

Additional criticism has been published by other patients such as Lou Corsius and Cort Johnson.[15][16]

Documents[edit | edit source]

Learn more[edit | edit source]

See also[edit | edit source]

References[edit | edit source]

  1. ↑ 1.0 1.1 Clark, Lucy V.; McCrone, Paul; Ridge, Damien; Cheshire, Anna; Vergara-Williamson, Mario; Pesola, Francesca; White, PeterD. (June 8, 2016), "Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome (GETSET): Protocol for a Randomized Controlled Trial and Interview Study", JMIR research protocols, 5 (2): 70, doi:10.2196/resprot.5395, PMC 4917732, PMID 27278762
  2. ↑ Clark, Lucy V.; Pesola, Francesca; Thomas, Janice; Vergara-Williamson, Mario; Beynon, Michelle; White, PeterD. (June 22, 2017), "Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial", The Lancet, doi:10.1016/S0140-6736(16)32589-2
  3. ↑ "ISRCTN - ISRCTN22975026: Graded Exercise Therapy guided SElf-help Treatment for CFS/ME". isrctn.com. Retrieved January 26, 2020.
  4. ↑ Clark, Lucy V.; Pesola, Francesca; Thomas, Janice M.; Vergara-Williamson, Mario; Beynon, Michelle; White, PeterD. (July 22, 2017). "Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial". The Lancet. 390 (10092): 363–373. doi:10.1016/S0140-6736(16)32589-2. ISSN 0140-6736. PMID 28648402.
  5. ↑ Clauw, Daniel J (July 2017). "Guided graded exercise self-help as a treatment of fatigue in chronic fatigue syndrome". The Lancet. 390 (10092): 335–336. doi:10.1016/S0140-6736(17)30577-9.
  6. ↑ "expert reaction to study on guided self-help graded exercise therapy as a treatment for chronic fatigue syndrome (CFS) | Science Media Centre". Retrieved May 8, 2020.
  7. ↑ "Defeating chronic fatigue thanks to guided self-help approach to exercise". Emergency Live. Retrieved May 8, 2020.
  8. ↑ Clark, Lucy V.; McCrone, Paul; Pesola, Francesca; =Vergara-Williamson, Mario; White, Peter D. (July 1, 2021). "Guided graded exercise self-help for chronic fatigue syndrome: Long term follow up and cost-effectiveness following the GETSET trial". Journal of Psychosomatic Research. 146: 110484. doi:10.1016/j.jpsychores.2021.110484. ISSN 0022-3999.
  9. ↑ "Trial By Error: GETSET Study Reports Null Results for Self-Help Graded Exercise–but Declares Success Anyway". www.virology.ws. Retrieved November 8, 2022.
  10. ↑ Clark, Lucy V.; McCrone, Paul; Pesola, Francesca; =Vergara-Williamson, Mario; White, Peter D. (September 1, 2021). "Corrigendum to "Guided graded exercise self-help for chronic fatigue syndrome: Long term follow up and cost-effectiveness following the GETSET trial" [Journal of Psychosomatic Research 146 (2021) 110484]". Journal of Psychosomatic Research. 148: 110542. doi:10.1016/j.jpsychores.2021.110542. ISSN 0022-3999.
  11. ↑ Spoonseeker, Author (May 23, 2016). "A Few Notes on GETSET". spoonseekerdotcom. Retrieved January 26, 2020.
  12. ↑ Spoonseeker, Author (June 29, 2017). "Do GET Yourself". spoonseekerdotcom. Retrieved January 26, 2020.
  13. ↑ Spoonseeker, Author (July 3, 2017). "Spotlight on GETSET Julie". spoonseekerdotcom. Retrieved January 26, 2020.
  14. ↑ "Trial by Error, Continued: More on Graded Exercise from Peter White and The Lancet". Phoenix Rising ME / CFS Forums. Retrieved January 26, 2020.
  15. ↑ Corsius, Lou (June 23, 2017). "Yet another publication with misleading conclusions from PACE-land". it's about ME (in Nederlands). Retrieved January 26, 2020.
  16. ↑ Johnson, Cort (June 26, 2017). "On Your Marks GETSET: Don't Go - Major Graded Exercise ME/CFS Trial Underwhelms (Again)". Health Rising. Retrieved January 26, 2020.

graded exercise therapy (GET) - A gradual increase in exercise or activity, according to a pre-defined plan. Focuses on overcoming the patient's alleged unhelpful illness beliefs that exertion can exacerbate symptoms, rather than on reversing physical deconditioning. Considered controversial, and possibly harmful, in the treatment or management of ME. One of the treatment arms of the controversial PACE trial.

somatic symptom disorder A psychiatric term to describe an alleged condition whereby a person's thoughts somehow cause physical symptoms. The actual existence of such a condition is highly controversial, due to a lack of scientific evidence. It is related to other psychiatric terms, such as "psychosomatic", "neurasthenia", and "hysteria". Older terms include "somatization", "somatoform disorder", and "conversion disorder". Such terms refer to a scientifically-unsupported theory that claims that a wide range of physical symptoms can be created by the human mind, a theory which has been criticized as "mind over matter" parapsychology, a pseudoscience.

randomized controlled trial (RCT) - A trial in which participants are randomly assigned to two groups, with one group receiving the treatment being studied and a control or comparison group receiving a sham treatment, placebo, or comparison treatment.

randomized controlled trial (RCT) - A trial in which participants are randomly assigned to two groups, with one group receiving the treatment being studied and a control or comparison group receiving a sham treatment, placebo, or comparison treatment.

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