In CBT/GET research regarding ME/cfs we find a considerable number of studies and outcomes that have been disappeared or reasoned away because they show the opposite of what the researchers want us to believe.
It appears that the academic world has no adequately functioning mechanism for self correction. These articles have been published in scientific journals one would think to be respectable. Despite the severe and well-elaborated criticism these journals have refused to withdraw the publication.
In this short inventarisation some of these researches are presented.
You will find studies or outcomes that have been buried underneath loads of silence or that have been delayed. You will also find studies the researchers bragged about that they were proof their therapy works and in the meantime they chose not to mention the outcomes that prove the opposite. The third kind is mentioning an outcome was opposite to what was expected and then go on polishing that inconvenience away in the discussion and conclusion section. The fourth approach is treating data on and on to obtain a satisfying outcome.
British and Dutch CBT/GET researchers have a longstanding tradition in this kind of scientific juggling.
In November 2017 Frank Twisk and I published an analysis of five Dutch hallmark studies into the efficacy of cognitive behaviour therapy with a graded activity protocol for chronic fatigue syndrome and Myalgic Encephalomyelitis.
These studies show severe shortcomings including inconvenient results that have been hidden.
1. Prins JB, Bleijenberg G, Bazelmans E (2001) Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 357: 841-847. [Crossref]
Apart from the fact that this study incorrectly claimed having selected patients who fulfilled the Fukuda criteria, the objective outcome (actometer) was not published until 9 years later and did not support the efficacy the authors claimed. Prof. dr. James Coyne writes about it on his blog.
2. Bazelmans E, Prins JB, Lulofs R (2005) Cognitive behaviour group therapy for chronic fatigue syndrome: a non-randomised waiting list controlled study. Psychother Psychosom 74: 218-224. [Crossref]
Curiously non-intervention had a positive effect on functional impairment but CBT+ had a small negative effect on the mean SIP 8 score. As the authors phrased it: “For functional impairment, the effect was opposite to what was expected”. The authors polished this incovenient outcome away by stating the therapists (they themselves chose and trained them) were inexperienced. That was the explanation for this effect. The option that their therapy didn’t work in itself and that the underlying hypothesis could have been incorrect, was not considered.
3. Stulemeijer M, de Jong LWAM, Fiselier TJW (2005) Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 330: 14. [Crossref]
The negligible effects of CBT+ on activity levels using an actometer, with great delay published in a secondary outcome study five years later, are at odds with less school absence after CBT+.
4. Knoop H, Bleijenberg G, Gielissen MF (2007) Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome? Psychother Psychosom76: 171-176. [Crossref]
Knoop ‘forgot’ to include the most important treshold in his most comprehensive definition of recovery. So, ‘the most comprehensive definition of recovery’ isn’t based on stringent criteria. Curiously, the SIP 8 score, used as a criterion to select patients (caseness) in this study and other trials, isn’t included in these two definitions of recovery. The study doesn’t report how many CFS patients reached ‘normal levels’ (≤203), but considering the size of the effect of CBT+ on SIP 8 in this study and other trials, few patients, if any, would reach ‘normal levels’. In stead of aknowledging this, they shouted in the press that 70% of the patients did no longer fulfill the criteria for cfs.
5. Nijhof SL, Bleijenberg G, Uiterwaal CS (2012) Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial. Lancet 379: 1412-1418. [Crossref]
In our article we discuss many flaws in this study. Vink, MD and Ghatineh, PhD wrote an extensive article on the serious flaws in this study. In the light of this inventarisation it is important to state that data with regard to objective measures were not reported. The actometer result were not published. They were very important because they can show that the alledgedly positive results were actually based on substitution of activities and not on increasing physical activity in total.
On top of that the follow up study demonstrated that there was no difference between the intervention group and the control group. In all publicity about FITNET this important fact has not been mentioned. In spite of the fact the follow up study proved CBT did not work, the FITNET study has been presented as proof for the efficacy of CBT/GET in the recent Dutch guideline MUS for children (2019). The authors included cfs in this guideline knowingly ignoring the Dutch Health Council advice on ME/CFS (2018). The chair of the guideline committee was prof. dr. Elise van de Putte. She was one of the FITNET authors.
In general these CBT/GET studies are characterised by the fact that the dropout numbers in the intervention group are considerable. Nevertheless the authors claim that the intervention is safe. The argumentation to support this claim is largely insufficient. It is clear that these researchers have the intention to prove their therapy works. Facts that might contradict this proof have been hidden, severely delayed or reasoned away.
The ultimate example of ‘How not to conduct a randomized clinical trial’ is the British Pace-trial published in The Lancet in 2011 and hailed by two Dutch colleagues.
Anything you can think of has been used to hide the fact that the outcome was NILL. A complete special issue of the Journal of Health Psychology was dedicated to this failing study.
Wilshire et al. analysed the study using the original protocol and came to the conclusion that the result was negligible to nill.
Just a couple of these extravagancies:
– Halfway outcome switching with serious impact on the outcomes.
– Changing the inclusion criteria so 13% of participants were sick enough to enter the trial and good enough to be considered recovered at the same time.
– Telling the intervention group (during the intervention) that this was the best therapy and that is was approved by government.
– Refusing to present data for a critical review, claiming that asking for the data was vexatious. (two courts judged they had to present the data)
As the minutes of the steering committee show, the authors were warned during the research period by their Dutch colleagues that the actometer results did not show any improvement. So they deciced to skip this outcome measure.
The negative outcomes of the sister study (FINE) were buried underneath the earlier described loads of silence. As Dr. David Tuller wrote: ‘The FINE results were published in BMJ in April, 2010. Yet when the first PACE results were published in The Lancet the following year, the investigators did not mention the FINE trial in the text. The trial has also been virtually ignored in the subsequent public debate over the results of the PACE trial and the effectiveness, or lack thereof, of the PACE approach.’ See the weblog Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?
In more recent times we have the Dutch Q-fever Qure study and the follow-up study by mainly the same Dutch group of authors, now assisted by new PhD candidates. And again these studies fit in perfectly in the earlier mentioned longstanding tradition. On my weblog I discuss the shortcoming of these two studies.
In this case also, unwelcome (ojective) outcomes such as actometer results were measured but not presented. The (subjective)outcomes that were published, initially seemed to show some improvement, but they were largely insufficient to reach normal values. The follow-up study showed the intervention group did worse than the control group. As in other CBT studies, the dropout rates in the CBT intervention group were considerable compared to the control group.
Despite these facts, CBT for cfs (wich includes activity extending tasks) was added to the guideline for
Q-fever fatigue syndrome. When asked why since there is no proof of efficacy and possible detrimental effects, one of the guideline committee members, a GP, told me it was important he could offer something to his colleagues. That was the important argument. Not the wellbeing of patients.
The research group has performed several statitistic reanalyses of the data to underpin their claim booster sessions would be the answer to the fact that their therapy does not work.
July 5 2020