Tom Kindlon · @TomKindlon
4th Jul 2014 from TwitLonger
The meme that people with ME/CFS can be returned to full health with GET/GAT
My unpublished e-letter in reply the BMJ #CFS-can-be-seen-as-a-meme e-letter. #MECFS #NeuroME #CFIDS #CFSME
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I submitted this in reply to the Collings & Newton BMJ e-letter http://www.bmj.com/node/759165 which said "CFS, then, might be usefully viewed as a meme, a dysfunctional culturally-transmitted idea-infection."
Normally the BMJ publish nearly all of my e-letters but didn't on this occasion for some reason. I've heard from two other people whose e-letters also weren't posted.
This isn't my tightest letter - I just wrote it quickly but ended up taking some time so thought I'd share it.
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The meme that people with ME/CFS can be returned to full health with graded activity/exercise programmes
Collings & Newton argue that myalgic encephalomyelitis (ME) or chronic fatigue syndrome (CFS) might be considered a meme(1). However, they offer no compelling evidence to support their theory, and have ignored the hundreds of papers that been published that found an assortment of physical abnormalities in ME/CFS. Possibly some of the most convincing studies are those which found that a stereotypical collection of symptoms is found in a percentage of patients after an infection; in this regard, the BMJ published an important study, funded by the US Centers for Disease Control and Prevention (CDC), back in 2006(2).
A more interesting meme to discuss is the idea that ME/CFS is primarily maintained by maladaptive beliefs and behaviours, and that patients can be rehabilitated back to full functioning and health with rehabilitation methods such as graded exercise therapy (GET) and a form of cognitive behavioural therapy (CBT) based on graded activity/exercise. There are now dozens of studies that have found exercise abnormalities that can’t be explained by the GET and CBT models of the illness which are based on symptoms being due to deconditioning(3-6). Despite a lack of evidence, this meme has spread quickly. Humans (including doctors) seem to have difficulty accepting conditions which are not fully medically explained and in such scenarios can often see the victims as responsible for their own condition. The CBT and GET models for the illness do this: the impairment and disabling symptoms are claimed to be reversible with the therapies(3,4).
This meme is attractive to insurance companies who can use it to deny disability payments and pensions to patients who are unable to work.
The meme can be attractive to health bodies who are wondering what services to provide for such patients but who want to minimise spending on testing and drug therapies.
The meme seems to be difficult to dislodge as audits of ME/CFS services, that have provided such therapies, have reported poor results(7-10) particularly on objective measures, but the enthusiasm for such therapies does not seem to abate.
Collings and Newton mention such therapies in their Rapid Response(1) and a representative from their service previously claimed(11): “These guidelines recommend rehabilitation therapies to help patients recover their health, along with specialist medical care. We are pleased to say we can help the majority of patients whom we see, using an integrated, holistic approach provided by a team of therapists and a consultant physician working closely together. Some patients make a complete recovery, which is better news for patients than just symptom relief, as outlined by Dr Greensmith in the Gazette.”
Recovery is the key measure by which the GET/CBT model or meme should be tested. The model suggests there is no ceiling of activity, in contrast to other models such as those for pacing, so patients using CBT & GET should be able to work their way to full functioning.
The PACE Trial was supposed to be the “definitive” trial to assess such issues(12). It was a very expensive trial costing £5 million of UK taxpayers' money. What it found was though patients self-reported some improvements on subjective outcomes such as the SF-36 physical functioning (SF-36 PF) subscale and the Chalder fatigue questionnaire (CFQ), there were generally no differences on more objective measures such as for employment, disability payments, total service use and the 6-minute walking test(13-14) (this echoed what was found previously in the Belgian rehabilitation clinics and a mediation analysis of three Dutch CBT studies(7-9,15)). There were slight improvements for the GET group (but not the CBT group) on the 6-minute walking test in the PACE Trial, to an average of 379 metres, or 35 metres more than the (no therapy) specialist medical care-only group; however this is well-short of the 644 or so metres predicted by population norms(6). Such slight improvement could be predicted by the ceiling of activity model (cf. CBT and GET model), where certain patients may be below their ceiling of activity before treatment and so could do a little more (without being able to get back to full functioning as predicted by the CBT and GET model).
Unfortunately, the data for the recovery criteria promised in the PACE Trial’s published protocol have never been published(16). Such data would give a good idea for what percentage of patients the CBT/GET model holds. I estimate that the percentages who would have been counted as recovered following CBT and GET would be in single figures in the PACE Trial (based on mean and standard deviation data that has been published). Such low figures suggest that that CBT and GET model is not a good general model for ME/CFS. The post hoc recovery criteria that have been published for the PACE Trial are so broad that they do not give us proper data on whether recovery has occurred(17-33). To give an idea of how absurd the post hoc recovery criteria are as recovery criteria, patients can score worse on either the SF-36 PF or CFQ than baseline (when they were required to have disabling fatigue) and still be counted as recovered.
An appeal has recently been lodged to try to get the data on the protocol defined recovery criteria from the PACE Trial under the Freedom of Information Act(34). I hope Peter White and Queen Mary, University of London will have a change of heart and release the important data (that was promised in the published protocol) now that we have seen the preposterous speculations clinicians with authority over patients are led to when they are provided with such exaggerated claims for the biopsychosocial interventions they provide. I believe the sobering results would once and for all help kill off the inaccurate meme which so distorts the way that ME/CFS patients are viewed and treated. The field could then move forward with theories that are more plausible and evidence-based given our knowledge of the biology of the condition.
References:
1. Collings AD, Newton D. Re: What causes chronic fatigue syndrome? BMJ 2014 (18 June).
2. Hickie I, Davenport T, Wakefield D, Vollmer-Conna U, Cameron B, Vernon SD, Reeves WC, Lloyd A; Dubbo Infection Outcomes Study Group. Post-infective and chronic fatigue syndromes precipitated by viral and non-viral pathogens: prospective cohort study. BMJ. 2006 Sep 16;333(7568):575.
3. Bavinton J, Darbishire L, White PD -on behalf of the PACE trial management group. Graded Exercise Therapy for CFS/ME (Therapist manual): http://www.pacetrial.org/docs/get-therapist-manual.pdf (Accessed: June 25, 2014)
4. Burgess M, Chalder T. PACE manual for therapists. Cognitive behaviour therapy for CFS/ME.http://www.pacetrial.org/docs/cbt-therapist-manual.pdf (Accessed: June 25, 2014)
5. Twisk FNM, Maes M. A review on Cognitive Behavorial Therapy (CBT) and Graded Exercise Therapy (GET) in Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30:284-299.
6. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx
7. Rapport d’évaluation (2002-2004) portant sur l’exécution des conventions de rééducation entre le Comité de l’assurance soins de santé (INAMI) et les Centres de référence pour le Syndrome de fatigue chronique (SFC). 2006. <http://www.inami.fgov.be/care/fr/re...mation/studies/study-sfc-cvs/pdf/rapport.pdf> . (French language edition) (Accessed: June 25, 2014)
8. Evaluatierapport (2002-2004) met betrekking tot de uitvoering van de revalidatieovereenkomsten tussen het Comité van de verzekering voor geneeskundige verzorging (ingesteld bij het Rijksinstituut voor Ziekte- en invaliditeitsverzekering) en de Referentiecentra voor het Chronisch vermoeidheidssyndroom (CVS). 2006. Available online: <http://www.inami.fgov.be/care/nl/re...mation/studies/study-sfc-cvs/pdf/rapport.pdf> Accessed September 16, 2011 (Dutch language version) (Accessed: June 25, 2014)
9. Stordeur S, Thiry N, Eyssen M. Chronisch Vermoeidheidssyndroom: diagnose, behandeling en zorgorganisatie. Health Services Research (HSR). Brussel: Federaal Kenniscentrum voor de Gezondheidszorg (KCE); 2008. KCE reports 88A (D/2008/10.273/58)https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf (Accessed: June 25, 2014)
10. Crawley E, Collin SM, White PD, Rimes K, Sterne JA, May MT; CFS/ME National Outcomes Database. Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database. QJM. 2013 Jun;106(6):555-65
11. "How we can help ME sufferers in north Essex" http://www.gazette-news.co.uk/search/4453571.How_we_can_help_ME_sufferers_in_north_Essex/
12. Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials. 2013 Nov 13;14:386.
13. White PD, Goldsmith KA, Johnson AL, et al; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36.
14. McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One. 2012;7(8):e40808.
15. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7.
16. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007 Mar 8;7:6.
17. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Oct;43(10):2227-35.
18. Adamowicz JL, Caikauskaite I, Friedberg F. Defining recovery in chronic fatigue syndrome: a critical review. Qual Life Res. 2014 May 3.
19. Shepherd C. Letter to the editor: comments on 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial'. Psychol Med. 2013 Aug;43(8):1790-1.
20. Maryhew C. Letter to the editor: comments on 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial'. Psychol Med. 2013 Aug;43(8):1789-90.
21. Cox D. Letter to the editor: 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial': data on the recovery groups as a whole would be useful. Psychol Med. 2013 Aug;43(8):1789.
22. Courtney R. Letter to the editor: 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial': an appropriate threshold for a recovery? Psychol Med. 2013 Aug;43(8):1788-9.
23. Carter S. Letter to the editor: 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial': recovery or remission? Psychol Med. 2013 Aug;43(8):1787-8.
24. Agardy S. Letter to the editor: comments on 'Recovery from chronic fatigue syndrome after treatments given in the PACE trial'. Psychol Med. 2013 Aug;43(8):1787.
25. Kindlon T. Author's response: Criticisms of the PACE Trial were justified. BMJ. October 16, 2013http://www.bmj.com/content/347/bmj.f5963/rr/667107
26. Kindlon T. PACE trial: Simply giving a reason why an outcome measure was changed is not necessarily sufficient. BMJ November 2013 http://www.bmj.com/content/347/bmj.f5963/rr/670755.
27. Clarke D. It is wrong to prevent patients from making informed decisions about their medical care. BMJ November 26, 2013. http://www.bmj.com/content/347/bmj.f5963/rr/674255
28. McPhee G. A fundamental misuse of statistics. BMJ November 21, 2013http://www.bmj.com/content/347/bmj.f5963/rr/673572
29. Baldwin A. PACE trial steering group fail to spot error in reasons for protocol changes. BMJ November 21, 2013 http://www.bmj.com/content/347/bmj.f5963/rr/673502
30. Matthees A. Did PACE make major unapproved protocol changes after seeing outcomes data? BMJ November 29, 2013 http://www.bmj.com/content/347/bmj.f5963/rr/674770
31. Carter S. Published protocols exist to protect patients. BMJ December 2, 2013http://www.bmj.com/content/347/bmj.f5963/rr/675525
32. Clifford Couch I. SF-36 Scale for Normal Physical Function, Age Matters. BMJ December 2, 2013http://www.bmj.com/content/347/bmj.f5963/rr/675527
33. Kirby SBM. Re: PACE trial authors’ reply to letter by Kindlon. BMJ February 1, 2014http://www.bmj.com/content/347/bmj.f5963/rr/684828
34. "Selected data on PACE Trial participants" request:https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part