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 patiënten 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
±35% 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 one’s 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 person’s 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.
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