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Studie PACE trials

(CGT/GET):

hoe leidt je met pr

de media en politici

af van de feiten?

 

 

 

 


 

De door de Engelse overheid gefinancierde PACE trial is een doorslaand succes,

althans volgens de Engelse vermoeidheidsdeskundigen Sharpe en White in de media.

 

Hoe anders liggen de feiten zoals die vastgelegd zijn in het studierapport (zie onder).

Maar net als in ons land wordt in de media een ander verhaal verkocht (klik hier, hier en hier).

 

Terwijl AfME op basis van voorlopige bevindingen meldt dat 62% van de patiŽnten achteruit (zie onder) gaat door GET (hetgeen kwa ordegrootte overeenkomt met andere onderzoeken),

melden de "vermoeidheidsdeskundigen" dat CGT/GET in 60% van de gevallen succes heeft.

 

In de Lancet zijn ze een stuk genuanceerder: slechts 30% "herstelt" m.b.v. CGT/GET.

 

Uiteraard is CGT/GET niet potentieel schadelijk, door ons beweerd en door Nunez bevestigd.

 

 

Voor een uitgebreidere analyse van deze conclusie, klik op onderstaande afbeelding:

 

 

 

 


 

The PACE Trial Study in a Nutshell

 

Summary

 

76.4% / 70.9% / 41%,

79.9% / 70.1% / 41%,

64,7% / 49.0% / 31%, resp.

63.6% / 57.1% / 25% of

people with "disabling chronic fatigue"

(of which 47% suffered from psychiatric disorder and

Ī35% used antidepressants during treatment)

improved by CBT, GET, APT resp. SMC

based upon the subjective measures of

"fatigue", "physical functioning" and "general health".

 

The placebo effect for psychological interventions on ME/CFS is 14% [4].

 

Only 30% "recovered" from "CFS"

(based upon cut-off scores for "fatigue" and "physical functioning",

largely insufficient for a CFS diagnosis according to the Fukuda criteria [5]).

 

The participants were also "atypical patients" when looking at their attitude:

71% of the participants considered CBT to be a logical therapy for "CFS" and

57% was confident about CBT treatment and

84% considered GET to be a logical treatment and

70% was confident about GET therapy.

 

 


 

 

Psychotherapy Eases Chronic Fatigue Syndrome, Study Finds

 

By DAVID TULLER

Published: February 17, 2011

 

 

A new study suggests that psychotherapy and a gradual increase in exercise can significantly benefit patients with chronic fatigue syndrome.

 

While this may sound like good news, the findings - published Thursday in The Lancet - are certain to displease many patients and to intensify a fierce, long-running debate about what causes the illness and how to treat it.

 

...

 

 

http://www.nytimes.com/2011/02/18/health/research/18fatigue.html

 

 


 

Chronic fatigue syndrome: where to PACE from here?

The Lancet, Early Online Publication, 18 February 2011.

doi:10.1016/S0140-6736(11)60172-4.

Gijs Bleijenberg, Hans Knoop.

 

 

...

 

This finding is important and should be communicated to patients to dispel unnecessary concerns about the possible detrimental effects of cognitive behaviour therapy and graded exercise therapy, which will hopefully be a useful reminder of the potential positive effects of both interventions.

 

...

 

Graded exercise therapy and cognitive behaviour therapy might assume that recovery from chronic fatigue syndrome is possible, but The answer depends on oneís definition of recovery. PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy personís score. In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30% - although not very high, the rate is significantly higher than that with both other interventions.

 

...

 

 


 

 

 

Physical rehab survey: initial results

 

...

 

Our 2010 survey has found that 60.2% of those people with M.E. who responded, citing GET [graded exercise therapy] as their most recent form of physical therapy, reported that it had made their condition worse. Of these, 44.1% said it had made them much worse or very much worse, compared with only 22.2% who reported any degree of improvement.

 

For exercise on prescription [EP], the results were similar: 52.2% reported that the therapy had made them worse, and only 26.1% reported an improvement.

 

Only GAT [graded activity therapy] emerged as doing more good than harm, with 26.3% reporting that they were worse following therapy, while 39.4% reported an improvement.

 

Action for M.E.s CEO, Sir Peter Spencer, says:

 

Although the results cannot be interpreted as representing all people with M.E., because the 273 participants were self-selected, our findings are disturbing.

 

...

 

 

 

 

Effect of therapy

GET

GAT

EP

OTHER

Total

No.

No.

No.

No.

No.

 

Better

26

22,0%

15

39,5%

6

26,1%

6

23,1%

53

 

25,9%

No change

21

17,8%

12

31,6%

5

21,7%

4

15,4%

42

 

20,5%

Worse

71

60,2%

10

26,3%

12

52,2%

12

46,2%

105

 

51,2%

Too early to tell

0

0,0%

1

2,6%

0

0,0%

4

15,4%

5

 

2,4%

Total

118

 

38

 

23

 

26

 

205

 

 

 

 

bron:

InterAction 75 Spring 2011

http://www.afme.org.uk/res/img/resources/InterAction%2075%20v5%2011-13.pdf

 

 

 


 

 

 

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.

The Lancet, Early Online Publication, 18 February 2011.

doi:10.1016/S0140-6736(11)60096-2..

White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M, on behalf of the PACE trial management group.

 

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2

 

 

Summary

 

Background

 

Trial findings show

cognitive behaviour therapy (CBT) and graded exercise therapy (GET)

can be effective treatments for chronic fatigue syndrome,

but patients' organisations

have reported that these treatments can be harmful and

favour pacing and specialist health care.

 

We aimed to assess effectiveness and safety of all four treatments.

 

 

Methods

 

In our parallel-group randomised trial,

patients meeting Oxford criteria for chronic fatigue syndrome

were recruited from six secondary-care clinics in the UK and

randomly allocated by computer-generated sequence

to receive

specialist medical care (SMC) alone

or with adaptive pacing therapy (APT), CBT, or GET.

 

Primary outcomes

were

fatigue (measured by Chalder fatigue questionnaire score) and

physical function (measured by short form-36 subscale score)

up to 52 weeks after randomisation, and

safety was assessed primarily by recording all serious adverse events,

including serious adverse reactions to trial treatments.

 

Primary outcomes were rated by participants,

who were necessarily unmasked to treatment assignment;

the statistician was masked to treatment assignment

for the analysis of primary outcomes.

 

We used longitudinal regression models

to compare SMC alone

with other treatments,

APT with CBT, and

APT with GET.

 

The final analysis included

all participants for whom we had data for primary outcomes.

 

This trial is registered at http://isrctn.org, number ISRCTN54285094.

 

 

Findings

 

We recruited 641 eligible patients, of whom

160 were assigned to the APT group,

161 to the CBT group,

160 to the GET group, and

160 to the SMC-alone group.

 

Compared with SMC alone,

mean fatigue scores at 52 weeks were

3,4 (95% CI 1,8 to 5,0) points lower for CBT (p=0,0001) and

3,2 (1,7 to 4,8) points lower for GET (p=0,0003),

but did not differ for APT (0,7 [−0,9 to 2,3] points lower; p=0,38).

 

Compared with SMC alone,

mean physical function scores were

7,1 (2,0 to 12,1) points higher for CBT (p=0,0068) and

9,4 (4,4 to 14,4) points higher for GET (p=0,0005),

but did not differ for APT (3,4 [−1,6 to 8,4] points lower; p=0,18).

 

Compared with APT,

CBT and GET

were associated with

less fatigue (CBT p=0,0027; GET p=0,0059) and

better physical function (CBT p=0,0002; GET p<0,0001).

 

Subgroup analysis of

427 participants meeting international criteria for chronic fatigue syndrome and

329 participants meeting London criteria for myalgic encephalomyelitis

yielded equivalent results.

 

Serious adverse reactions were recorded in

two (1%) of 159 participants in the APT group,

three (2%) of 161 in the CBT group,

two (1%) of 160 in the GET group, and

two (1%) of 160 in the SMC-alone group.

 

 

Interpretation

 

CBT and GET can safely be added to SMC

to moderately improve outcomes for chronic fatigue syndrome,

but APT is not an effective addition.