The PACE Trial Results

7/30/2019 The PACE Trial Results

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The PACE Trial Results - opinion

The PACE Trial results (White et al. 2011) for improved show that Graded ExerciseTherapy (GET) had an effect for 16% and Cognitive Behaviour Therapy (CBT) for14% over and above the control group. The results for normal ranges show that

GET had an effect for 13% and CBT for 15%. The results produce a number neededto treat figure of 7 (Sharpe. 2011). When 7 patients are treated, one will improvedue to treatment.

The PACE Trial Protocol (White et al 2007) states:"GET will be based on the illness model of deconditioning and exercise intolerance"."CBT will be based on the illness model of fear avoidance".

For 2 different theories and treatments to result in such similar outcomes ispotentially problematic. Clinical Trials are designed to avoid such coincidences.

However, this might not be a coincidence because the theories and therapies havesome important similarities: Both theories believe that there is no pathophysiology (excepting deconditioning) Both believe that the patient is only using a small amount of their potential foractivity Both rationalize symptoms and Both are based on a graded exposure to activity (White et al. 2011)Therefore the 2 theories and therapies are fundamentally the same which couldexplain their similar results.

The CBT arm was based on fear avoidance. Fear avoidance refers to anxiety aboutactivities that the patient believes will be painful or cause them harm. This istheorised to be an obstacle to rehabilitation. Addressing fear avoidance isstraightforward and similar to treating phobia with desensitization. Systematicdisconfirmation (Asmundson et al 2004) or graded exposure (George and Zeppieri2009) are established approaches. There is even evidence that including fearavoidant participants in research could give better results for a therapy becausethese patients record greater improvements (George and Stryker. 2011).

Patients with Severe M.E. were excluded from the PACE Trial. Therefore the testingwas largely carried out on those representing the 75% of patients that do not havethe severe form of the illnesses. Those who are still working or studying could beincluded. Participants who are parents may still be looking after children and manywill be maintaining family/social relations, managing personal and household careand other activities. Evidence from patients shows that many strive to maintain asmuch of a normal a life as they possibly can. This does not sound like significant fearavoidance. The fact that the 640 participants willingly joined and remainedthroughout the PACE Trial, shows that fear avoidance does not affect to them to avery significant degree. If it did, they would have stayed at home. Thereforeparticipants fear avoidance should be moderate and treatable.

Deconditioning should also be straightforward to treat. Anyone that does more thanthey did on the previous day will, within a week or a month be well on their way to


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full fitness. With no physical illness or injury to prevent this (according to the theory),people with M.E. and CFS should soon be fully recovered from deconditioning.

The PACE Trial represented the culmination of many years of theorising and researchefforts by the investigators to prove their theories about M.E. and CFS. It took 9

years and cost the taxpayer 5 million. The researchers produced specializedtreatment manuals for therapists and patients. Therapy was closely supervised andparticipants were followed-up for a year. Participant retention, adherence andsatisfaction were very high. This was an all-out effort for the researchers to provetheir theories. Yet the results prove their theories are wrong.

85% of participants did not improve or reach normal ranges due to GET or CBT.This shows that the theories on which the treatments were based are wrong. If theresearchers theories were correct, it would be reasonable to expect the recovery ofthe majority as a result of GET or CBT. It seems probable that if 85% of participants

had improved due to GET or CBT the researchers would claim that thisunequivocally proved their theories. The opposite should also be true. 85% failureunequivocally disproves their theories.

The PACE Trial has shown emphatically that GET and CBT do not treat M.E. and CFS.Therefore it is reasonable to speculate that the 15% that responded to thesetreatments were misdiagnosed. Those participants may have had illnesses thatincluded deconditioning and fear-avoidance ameliorable with the therapies.

People with M.E. and CFS should not be expected to make-do with treatments that

have been shown to be ineffective for their illnesses. GET and CBT should not berecommended to patients with these illnesses. They are a waste of time and money.

These are important findings of the PACE Trial, yet this information has not beenpublicized; it has been ignored in favour of information that appears to serve thepurposes of the researchers. The evidence of the PACE Trial strongly supports theopinions of those who believe that there is underlying pathophysiology in M.E. andCFS. This opinion rationally explains the failure of GET and CBT to treat M.E. andCFS.

Peter KempAugust 2012

REFERENCESAsmundson, Gordon J.G., Vlaeyen, Johan W.S., Crombez, Geert editors. 2004.Understanding and Treating Fear of Pain. Oxford University Press. New York.

George, S. Z, Zeppieri G. 2009. Physical therapy utilization of graded exposure forpatients with low back pain. Journal of Orthopaedic Sports Physiotherapy. Jul;39(7).

George, Steven Z., Stryker, Sandra E. 2011. Fear-Avoidance Beliefs and ClinicalOutcomes for Patients Seeking Outpatient Physical Therapy for Musculoskeletal Pain


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Conditions. Journal of Orthopaedic Sports and Physical Therapy. 2011;41(4).

Sharpe, Professor M. 2011. COMPARISON OF TREATMENTS FOR CHRONIC FATIGUESYNDROME. Health Report. [Online transcript]. Availableat: http://www.abc.net.au/rad.... Accessed July 24th 2012.

White, Professor P. D., et al. 2007. Protocol for the PACE Trial. BMC Neurology.[Online]. Available at: http://www.biomedcentral....Accessed Aug 1st 2012.

White, Professor P. D., et al. 2011. Comparison of adaptive pacing therapy, cognitivebehaviour therapy, graded exercise therapy, and specialist medical care for chronicfatigue syndrome (PACE): a randomised trial. The Lancet. 2011; 377: 82336.Competing interests declared: M.E. patient and advocate
http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296http://www.biomedcentral.com/1471-2377/7/6/http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296http://www.biomedcentral.com/1471-2377/7/6/

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The PACE Trial Results