Analysis of five hallmark studies from the Netherlands, 2018, Twisk and Corsius

An in-depth analysis of five hallmark studies of
the Dutch Expertise Center for Chronic Fatigue (NKCV) confirms that
cognitive behavorial therapy combined with a graded activity protocol (CBT+)
has no objective positive effect on the (health) status of
patients diganosed with chronic fatigue syndrome (CFS).

The outcomes of the analysis
confirm the image of the controversial PACE-trial:
the (far-reaching) conclusions with regard to the proposed positive effects of CBT+
are by no means substantiated by the data published by the researchers.

A recent study of principal PACE trial investigators confirms
that ‘graded activity’ has a negative effect on a subgroup of CFS patients.

In spite of claims to the contrary
the effect of CBT+ on patients diagnosed with Myalgic Encephalomyelitis (ME),
a neuromuscular disease, has never been analysed.

ARTICLE:

An analysis of Dutch hallmark studies confirms the outcome of the PACE trial:
cognitive behaviour therapy with a graded activity protocol
is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis.
Gen Med Open. 2017. 1(3): 1-12.
doi: 10.15761/GMO.1000117.
Twisk FNM, Corsius LAMM.

Abstract

Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS)
are considered to be enigmatic diseases.

Several studies propose that
the combination of cognitive behaviour therapy with a graded activity protocol (CBT+),
justified by a so-called (bio)psychosocial (explanatory) model,
is an effective treatment option for CFS (ME).


Objective

A critical review of five Dutch hallmark studies
that allegedly support this claim.


Methods

An analysis of the five CBT+ studies with special attention to
the patients studied,
the criteria (subjective and objective measures and cut-off scores)
used to select participants and
to define improvement and recovery,
the consistency of the definitions of caseness
(being diagnosed as a CFS patient at entry)
versus the definitions of improvement and recovery after CBT+, and
the objective effects.


Results

The studies investigated suffer from various methodological flaws.

Apart from these methodological shortcomings,
the claim that CBT+ is an effective treatment option for CFS
is not substantiated by the data reported.

Some studies investigated CFS patients,
other studies investigated CF patients, labelled as CFS patients, or
combinations of CFS and CF patients.

No study investigated the effect of CBT+
in a group of patients meeting the (original) diagnostic criteria for ME.

The effects of CBT+ on subjective measures,
for example fatigue and disability,
if present, are insufficient to achieve normal values.

Impressive recovery and improvement rates
are based on very loose criteria for subjective measures.

Cut-off scores for subjective measures
used to define improvement and recovery in studies
show overlap with cut-off scores for CFS caseness
in one or more of the other studies.

More importantly, looking at the objective measures,
the proof of clinical improvement after CBT+ is lacking.


Conclusion

Solid evidence of effectiveness of CBT+ for CFS, let alone ME,
is lacking in the five hallmark studies.

The lack of objective improvement indicates CBT+ is ineffective.

This conclusion confirms
the outcome of the large-scale PACE-trial in the UK.


Keywords:

Myalgic Encephalomyelitis, chronic fatigue syndrome, cognitive behaviour therapy, graded exercise therapy, measures, effectiveness



http://www.oatext.com/pdf/GMO-1-117.pdf

http://www.hetalternatief.org/Summary NKCV GMO 2018.pdf

 

Indeed.

 

I think @Lou Corsius is the other author? Big thanks to him too.

 

https://twitter.com/user/status/959934462325936130

 

Good to see the Knoop et al., 2007 full recovery paper being criticised.

 

I believe there is a small error here. It should see a score of 60 or more not 61. They are talking about PACE Trial.

 

They are talking about the average scores. Probably some individuals did reach "normal levels", indeed we know some did in Knoop et al, 2007.

 

I don't think this is a strong point with these data. The dropout figures are given in table 1 and similar between the intervention and control groups.

 

I think this is the only outcome measure that could be referred to for this point within these 5 trials:

There could have been individuals who deteriorated in the trials but I don't believe such data was published. There is some evidence from surveys that some people report being made worse by CBT.

 

Some comorbidities like fibromyalgia are not listed. I imagine some of the patients did have such comorbidities in which case the comorbidity rate is higher than 23%.

Also this use dthe CDC criteria so some of the initial sample probably had comorbidities but were excluded from the research study but in clinical practice might still get the diagnosis of CFS.

So I'm not convinced about this point.

 

But the reasons for drop-out in the control and intervention group are most probably different.