On the 22 August 2007 The National
Institute of Health and Clinical Excellence (NICE)
published guidelines for doctors, titled: Chronic
Fatigue Syndrome / myalgic encephalomyelitis (or
encephalopathy) - Diagnosis and management for CFS/ME in
adults and children.
Eight of the biggest ME
organisations and more in the UK are strongly critical
of the NICE guidelines and have declared them ’unfit for
purpose’. They demand a considerable
rewrite of the guidelines. We think, as they do, that
the NICE guidelines will make the situation even worse
for ME patients than it is at present.
Some of the critical points
include:
Cognitive behavioural therapy (CBT)
and graded/graduated exercise therapy (GET) are
recommended as first line treatments for mild or
moderate CFS/ME, and ‘Activity Management strategy’,
which has elements of CBT and GET, for the most severely
ill. These therapies have shown to have little effect
(CBT) or are potentially harmful (GET). Large scale
patient surveys in the UK show opposite results to the
NICE guidelines. Apart from the outlined concerns, the
key psychiatrists themselves, who actively promote these
approaches say that CBT and GET cannot be described as
‘curative’ and/or have only a short term effect. (
Michael Sharp, AACFS, (now IACFS/ME) ) International CFS
Conference, Cambridge, Mass., 10.-11.
oktober 1998. S. Wessely, Editorial, JAMA
19.9.2001:286:11), Marcus JH Huibers + S. Wessely,
Psychological Medicine, 2006:36(7):895-900).
CBT and GET are not specific
methods for ME/CFS because the cause is unknown. Many
have been made worse by these therapies.
(Devanur & Kerr 2006):
http://www.cfids-cab.org/rc/Devanur.pdf
The NICE Guidelines did not want to
include or concentrate on research which actually
documents the claims of the users.
Results of cognitive behavioural
therapy and graded excercise therapy from large scale
patient surveys
* 3074 patients
(Jones, 2003)
-
CBT made no difference 55 %
-
CBT made worse 22 %
-
GET made no difference 16 %
-
GET made worse 48 %
-
Pacing activity with rest
was the most helpful 90 %
-
Bed rest the most helpful 89
%
* 2338 patients (Action for M.E.,
2001)
-
CBT helpful 7 %
-
CBT not helpful 67 %
-
CBT made worse 50 %
-
Activity managment most
favourable 89 %
-
Rest most favourable 91 %
* 437 patients
(25 % M.E. Group, 2004)
-
CBT helpful 7 %
-
CBT not helpful 93 %
-
GET helpful 5 %
-
GET not helpful 95 %
-
Psychotherapy helpful 10 %
-
Psychotherapy not helpful 90
%
-
The most helpful was
activity managment and symptom control respct. 70 % -
75 %
At a conference in Fort Lauderdale,
January 2007, Professor Fred Friedberg talked about a
two year study in which patients used an actigraph (
pedometer) to register their activity level.
The patients reported subjectively
increased activity levels, but at the same time the
actigraph showed that the number of steps taken sank
drastically. The results showed that graded excercise
therapy did not lead to improvement in relation to
increased total activity level (Friedberg 2002).
Physical activity exceeding
”limit/ceiling effect” leads to increased symptoms and
deterioration of the condition (Black & McCully 2005):
http://www.dynamic-med.com/content/pdf/1476-5918-4-10.pdf
Patients can develop training
intolerance, and this is shown by reduced activity level
after 4-10 days. The inability to maintain an activity
level, caused by worsening of symptoms, suggests that
patients have reached an activity threshold. See also a
more recent study by Yoshiuchi et. al
(2007) which documents increased symptoms following
graded excercise
http://www.cfids-cab.org/rc/Yoshiuchi.pdf
It has been shown that patients
with ME have increased oxidative stress during excercise,
and this increase continues even after the the
excercise has been stopped(Kennedy et
al. 2005):
http://www.cfids-cab.org/rc/Kennedy.pdf
It is important to note that
patients do not protest about treatments which make them
better, but they do protest against treatments which
either do not work or make them worse.
Action for M.E. M.E. in the UK.
Severely neglected. Membership survey, 2001.
http://www.afme.org.uk/res/img/resources/Severely%20Neglected.pdf
Jones DM.
Some facts and figures on CBT, GET and other
approaches, 2003.
http://www.meactionuk.org.uk/SOME_FACTS_AND_FIGURES_ON_CBT.htm
25 % M.E. Group. Severely Affected
ME (Myalgic Encephalomyelitis) Report on Questionnaire,
Issued January 2004.
http://www.25megroup.org/Group%20Leaflets/Group%20reports/March%202004%20Severe%20ME%20Analysis%20Report.doc
VanNess JM,
Snell CR. Stevens SR, Bateman L, Keller BA. FACSM.
Using Serial Cardiopulmonary Exercise Tests to Support a
Diagnosis of Chronic Fatigue Syndrome. Medicine &
Science in Sports & Exercise: Volume 38(5) Supplement
May 2006 p S85
http://www.acsm-msse.org/pt/re/msse/fulltext.00005768-200605001-01259.htm;jsessionid=HV9HJwhtvwtNlGyB7vvTzBpDQt0xbKl87pnqpqrSnCTT9QlWCNXx!65375592!181195628!8091!-1?nav=search&fullimage=true
VanNess and his coworkers (2006)
have written the following:
“Reduced functional capacity
and post-exertional malaise following physical
activity are hallmark symptoms of Chronic Fatigue
Syndrome (CFS). That these symptoms are often
delayed may explain the equivocal results for
clinical cardiopulmonary exercise testing (GXT) with
CFS patients. The reproducibility of VO max in
healthy subjects is well documented. This may not be
the case with CFS due to delayed recovery symptoms.
Conclusion: In the absence of a second exercise
test, the lack of any significant differences for
the first test would appear to suggest no functional
impairment in CFS patients. However, the results
from the second test indicate the presence of a CFS
related post-exertional malaise. It might be
concluded then that a single exercise test is
insufficient to demonstrate functional impairment in
CFS patients. A second test may be necessary to
document the atypical recovery response and
protracted malaise unique to CFS.”
Both the Association of British
Neurologists and The British Psychological Society have
criticised the NICE guidelines.
Much of the
research referred to, has been done on patients with
fatigue, but who do not have ME.
The project has not been a
cooperation where professionals and carers have taken
part as it is described in the NICE guidelines.
It is written that there was
cooperation but the ones who have been involved as user
representatives feel it was not real cooperation, but a
form of masquerade. Considerable and documented
contributions from users and experts who support the
physical/organic cause of the illness have been ignored
in a great degree. This and lack of real user
contribution has also been confirmed in personal
communication between organisations and Norway’s ME
Association. The documents have been delivered to
Competence Network co/Cecilie Daae.
The NICE guideline’s definition of
the illness is so wide that it includes almost everyone
with unexplained fatigue, and not ME, diagnostic code
G93.3. There is a clear need to
subgroup patients who fall under the umbrella term CF (fatique
syndromes). The use of overview articles as research
methods, have clear weaknesses when studies of
heterogeneous populations are included - the
methodology critique doesn’t focus on the fact that the
evidence base is very weak and the dropout analysis
cannot find out who, and why, the dropout rate in a few
studies is very high. See also the critique the
Association has produced in relation to the Knowledge
centre’s report.
A lot of information on the
physiological abnormalities was presented, but NICE has
ignored this for the benefit of the ”biopsychosocial
model” of the illness. This is a
clear action which favours political strategies instead
of medical and scientific evidence. The urgent need for
biomedical research to uncover the underlying cause(s)
have not been taken onboard. NICE has failed on
several “Key Items” (Key Items 3, 5, 8, 10 and
20) in the use of AGREE INSTRUMENT
(Appraisal of Guidelines Research and Evaluation, the
AGREE Collaboration, Sept. 2001).
Costing
report
The cost of
these treatment strategies is based on assumptions,
which the costing report says in the introduction. In
addition the report comments on excisting uncertainties
in the diagnosis and treatment of patients with CFS/ME.
The high costs are expected to become even higher than
estimated. The British organisations are questioning
these costs for interventions which don’t have
documented effect, and which the ptients themselves
don’t want, at the same time when official bodies don’t
prioritise biomedical research.
Legal
evaluation
The critique of
the NICE guidelines for ME/CFS was taken to High Court
in the Royal Courts of Justice on June 17 2008. Two
named persons act as litigants. The judge concluded that
there are grounds for a full hearing. It is estimated
that the hearing will take at least two days. The date
has not determined, but expected soon. (Editor: the date
is set for 11 and 12 February 2009)
There is diminishing trust in NICE
within the British population because its decisions are
constantly criticised and challenged. One questions its
evaluation process and whether some distinct groups are
disadvantaged by the process. There is a separate report
where a wide range of patient organisations, among
others cancer and multiple sclerosis organisations,
Alzheimer’s Society and many other organisations for
neurological and autoimmune conditions, have come
forward with searing critique of NICE’s conduct and
evaluations process. (House of Commons Health Committee:
National Institute for Health and Clinical Excellence
(NICE). Written evidence. HC 503-II. 17. May 2007).
