Saturday, September 1, 2007

First Five Responses on (UK) NICE Guidelines

The NICE Guidelines for the UK strongly recommended the use of CBT (Cognitive Behavioral Therapy) and GET (Graded Exercise Therapy) for CFS/ME.  These are just the first five responses of why those are inappropriate recommendations.


Diagnosis and management of chronic fatigue syndrome or myalgic
encephalomyelitis (or encephalopathy): summary of NICE guidance
Baker and Shaw (1 September 2007)

Role of Carers/Family in management of CFS 31 August 2007

Gunvant Patel,
St Vincents Hospital, Melbourne, VIC 3065

The Nice guidelines on chronic fatigue syndrome or myalgic
encephalitis produced by Baker and Shaw make no mention of the value
of involving carers and families in the overall management. Perhaps
this is due to lack of 'evidence' from studies and highlights the
limitations of such guidelines for clinicians. Family and couple
therapy as a means of support and for resolving problematic dynamics
would be invaluable in many cases.

Competing interests: None declared


Shirwan A. Mirza, MD, FACP, FACE,
Chairman: Department Of Medicine Clinical Assistant Professor of
Auburn Memorial Hospital, Auburn, NY 13021 USA
Chronic Fatigue Syndrome: NICE and CDC miss the boat

The recent "NICE" guidelines in the UK like their sister guidelines
from the U.S. Center of Disease Control (CDC) on this side of the
Atlantic both miss the boat.

I have seen and analysed hundreds of cases of chronic fatigue over
the past decade without ever having to use the term Chronic Fatigue
Syndrome (CFS). The problem with these guidelines is that they
either omit major causes of fatigue or make flagrant misguided
mistakes such as the following "NICE" statement:

"Vitamin B12 deficiency and folate levels should not be carried out
unless a full blood count and mean cell volume show a macrocytosis".
Vitamin B12 deficiency (or insufficiency) is extremely common even
without macrocytosis. Macrocytosis is a very late sign of this
vitamin deficiency. Furthermore, a concomitant iron deficiency, such
as in celiac disease, would cancel out macrocytosis and the
resultant mean corpuscular volume of the RBC would be normal.

The reference range of vitamin B12, at least in the USA is outdated
and new reference ranges shouldbe implemented (300-1000 pg/ml). It
is very common to miss mild vitamin B12 deficiency without checking
either homocysteine or methylmalonic acid or both. The latter 2
metabolites would be both elevated when serum B12 is insufficient.
Even if B12 level is 300 pg/ml but homocysteine or methylmalonic
acid are elevate, a diagnosis of B12 insufficiency should be made
and the fatigued patient must be treated. Vitamin B12 is a very
common cause of fatigue, malaise, dizziness and vertigo in people
labeled with the diagnosis of CFS.

Vitamin D deficiency is extremely common above the latitude 0f 36 in
the USA. It is even more common in Europe where milk is not widely
fortified with vitamin D. The daily requirement of vitamin D of 400
IU a day is a thing of the past but still promoted as if written in
stone. The recent research-supported daily requirement of vitamin D
is at least 1000-4000 IU a day. 25 Hydroxy vitamin D should be
between 32-100 ng/ml (see a recent NEJM review on vitamin D by
Michael Holick). 25% of the US population have metabolic syndrome.
Many of these have impaired fasting glucose or impaired glucose
tolerance (IGT). These pre- diabetic conditions cause fatigue via
glycosuria. Fasting glucose measurement is not nearly sufficient to
detect early glucose intolerance. A 2-hr glucose tolerance test
(OGTT) is abosoluitely necessary to detect IGT defined as plasma
glucose of > 130 from 30 minute- 120 minute during OGTT.

Many patients with CFS have benign positional vertigo and they don't
know it. They are basically unable to describe their symptoms and
for lack of expression they say they are fatigued. In one such case
the Romberg test was abnormal and symptoms resolved within 7 minutes
of application of the Epley maneuver. I have yet to see a guideline
on CFS that is complete. It is a good point that NICE mentions
ferritin level, although I prefer iron saturation since ferritin is
an acute phase reactant and could be falsely elevated during periods
of acute illnesses due to any cause such as infection. Screening for
celiac disease was also a good addition since this disease is
relatively common in Caucasians (1% of populations with an average
of a decade of late diagnosis due to lack of awareness). Addition of
sleep apnea is also a step in the right direction. I also recommend
addition of free T4to TSH (at least once) so you don't miss central
hypothyroidism. Serum early morning cortisol should be measured in
every patient with CFS. If a male person has sexual dysfunction such
as poor libido and erectile dysfunction, muscle weakness and
infrequent shaving of beard, a free testosterone by dialysis method
plus LH measurement are necessary

In summary, for me a patient with CFS is a patient who has not been
adequately investigated despite adherence to big- name guidelines of
NICE and CDC. A thorough and guided investigation would yield the
diagnosis in almost > 90% of patients.

By adherence to my own time-honoured investigation, I have succeeded
in abolishing chronic fatigue syndrome from my medical vocabulary.

References: Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul

Competing interests: None declared


andrew ashley,
Bath, UK

Dear All and Dear Dr NICE,

It is a shame that the canadian and australian guidelines have been
completely overlooked by NICE as has happened in many other
countries. I must say I do not understand this as the world is so
small now with the internet. The guidelines also show that we as
doctors are not very good at critical reading, if you read a trial
about CBT there are usaully so many essential mistakes and
omissions, for example not clear why of a population of 160 patients
less than half is selected, they ignore people who abandon the CGT
treatment, they have never heard of bedbound CFS/ME patients etc.
And worst of all, they can't diagnose CFS/ME. Most of the time they
treat people with chronic fatigue instead of CFS/ME, and that is the
same as saying I treat patients with Alzheimer's if all they have is

Kind regards,

Andrew Ashley

Competing interests: No competing interests


Belgian Experience of Rehabilitation Clinics for CFS ignored
31 August 2007

Tom Kindlon,
Unavailable for work due to ill-health
Dublin, Rep. of Ireland

When making recommendations on treatments and service provision for
CFS/ME, it is disappointing that the Belgian experience wasn't
looked it. Perhaps it was a language issue as the detailed report on
the rehabilitation clinics that were set up there for people with
CFS (defined by the Fukuda definition [1]) is only available in
French [2] or Dutch [3]. According to the report, over 3000 patients
were referred to the centres, although only a fraction of them went
on to do the rehabilitation programs. The rehab programms were
basically a combination of CBT (Cognitive Behavioural Therapy) and
GET (Graded Exercise Therapy).

A previous review of CFS intervention studies [4] criticised outcome
measures used in many studies in the area, saying that "a more
objective measure of the effect of any intervention would be whether
participants have increased their working hours, returned to work or
school, or increased their physical activities." Work capacity was
assessed in the Belgian clinics: before rehabilitation, the average
amount of paid work was 18.3% (of 38 hours). Immediately after
rehabilitation this was reduced to 14.9% (6% worked more, 10% worked
less), 6 months later it was 16.7%. That is to say, that at the end of the rehabilitation phase and six months later, people were working less than when they started the programme!

[1] Fukuda K, Straus SE, Hickie IB, Sharpe M, Dobbins JG, Komaroff
AL. Chronic fatigue syndrome: a comprehensive approach to its
definition and management. Ann Intern Med 1994; 121: 953-95.

[2] Rapport d'évaluation concernant les centres de référence pour le
syndrome de fatigue chronique (SFC).

[3] Evaluatierapport over de referentiecentra voor het Chronisch
vermoeidheidssyndroom (CVS).

[4] Whiting P, Bagnall A.-M., Sowden AJ, Cornell JE, Mulrow CD,
Ramirez G (2001). Interventions for the Treatment and Management of
Chronic Fatigue Syndrome: A Systematic Review. JAMA 286: 1360-1368

Competing interests: Assistant Chairperson (voluntary position),
Irish ME/CFS Support Group

[TK: If the report was too late for this time, people should insist
it's used next time]


CGT and getting people back at work 1 September 2007

Tessa Vinicius,
Amsterdam, Holland

Really interesting to read the Belgium evaluation. In Holland
something similar has happened but it has been pushed under the
carpet!! Nijmegen claims CGT cures 70% of CFS/ME patients. In 2003 an
evaluation was done by an indepent government institute called TNO,
one of the psychologists from Nijmegen was part of the committee to
help the investigators. Only a very small number of people did get
back to work and if they did it was mainly computer work. So they were
not cured.

You can read this report at:

it is in Dutch and in English!!!

There are some problems with the study but even so (low reponse rates
of 40%), the results are interesting enough to have a look at, for

"In the one year follow-up period, 17% of the population of patients
with ME/CFS who were working, became disabled from work. In the same
time period, 9% of the population that was disabled from work,
returned to their own or another job."

So 9% instead of 70%, and then most of them did not go back to their
own job either. That means even less than 9% was "cured"
unfortunately. So stop wasting time, effort and money in CGT, it will
only help those that have either other problems or a depression
alongside their CFS/ME. Doctor Stein's report, the canadian
psychiatrist, is very clear on that point.
This is also available on
line at:

Competing interests: No competing interests

No comments: