I'm just doing a relatively quick submission to the CDC on their 5-research
plan which involves an estimated budget of US$20m over that period. Bill
Reeves seems to have been taken
in the proponents of the therapies, Graded Exercise Therapy (GET) and CBT
based on GET. I am thus concentrating largely on this issue so they will
have been warned if they then promote dangerous treatments especially if
they do it without warnings.
I'm pointing out that with pharamaceutical drugs reports of adverse reaction
are taken seriously and that warnings are given out about these adverse
reactions (or in some cases drugs are taken off the market if the
risk/benefit ratio is unsatisfactory). However, with
non-pharmaceutical interventions (particularly for CFS) information is
rarely if ever formally
collated and also generally it is less easy for patients to report adverse
I'm saying that in this situation, surveys of patients' experiences are
I'm including details from 10 from the following countries: UK (6), the
Netherlands (2), Norway (1), USA (1).
I'm appending what I've written on the surveys below. If anyone has
information on other surveys, feel free to send them on. I will probably
send out my completed submission so people will then see a fuller list of
surveys if I have missed some.
Even if people don't get to write to me in the next 24 hours, I will still
be interested in other data.
I'm also pointing out that the CFS experts the CDC are using from the UK and
Netherlands may not be telling them about the reports of adverse reactions
in their countries.
(By the way, I am also highlighting the petition on the CDC's empirical
definition http://CFSdefinitionpetition.notlong.com i.e.
http://www.ipetitions.com/petition/empirical_defn_and_CFS_research/ . It's
at 1433 signatures now - it'd be "nice" to have over 1500
when I send it in in 24 hours but that may not happen).
If time allows, I may also do a very quick submission to the UK's APPG
Review pointing out the need for a system where ME/CFS patients can report
adverse reactions to treatments - if I do this, I'll include the data from
surveys to show the need for such a system.
Don't support the Reeves/empirical definition/criteria for CFS?
Sign the petition at: http://CFSdefinitionpetition.notlong.com
Extract from my draft submission on CDC's Draft 5-year Strategic Plan
Anyway, to move to some numerical data, here are the results of some
numerical data from surveys of patients.
Survey 1: (UK) Action for ME (2001)
In the UK, the Chief Medical Officer (CMO) (i.e. a government job somewhat
similar to the position of Surgeon General in the US) set up in 1999 a
working group to report on the area of "CFS/ME".
Amongst other things, when they reported in 2002, the report included the
following data from a survey.
Therapy* Respondents Helpful No change Made worse
Drug medication for pain 1394 61% 28% 11%
Drug medication for sleep 1300 67% 17% 16%
Pacing your activities 2180 89% 9% 1%
Graded exercise 1214 34% 15% 50%
Diet changes 1864 65% 32% 3%
Nutritional supplements 1953 61% 36% 3%
Rest, including bed rest 2162 91% 8% 1%
Cognitive Behavioural Therapy 285 7% 67% 26%
Other 878 76% 11% 14%
*Not all the respondents experienced each treatment approach
(Action for ME Membership Survey, 2001. 2338 respondents in total)
This data was then included in the Full NICE Guidance on CFS/ME (Page 95 of
Helpful No change Made worse
Drug medication for pain 61% 28% 11%
Drug medication for sleep 67% 17% 16%
Pacing your activities 89% 9% 2%
Graded exercise 34% 16% 50%
Diet changes 65% 32% 3%
Nutritional supplements 62% 36% 3%
Rest, including bed-rest 91% 8% 1%
Cognitive behavioural therapy 7% 67% 26%
Other 75% 11% 14%
[Aside: there are three changes by 1% from the figures given in the CMO
Report - these are on "occasions" when the first numbers did not add to 100%
but with the changes, the numbers all added to 100%. Somebody presumably
thought they need to be changed. Due to rounding, the numbers do not need to
add to 100% to be accurate, so I believe the first set of figures should be
considered the most accurate data]
As one can see, Graded Exercise Therapy had a terrible safety profile in this data – 50% of 1214 people reported being made worse – that's the equivalent of 607 reports of adverse reactions! CBT had the second worst
safety profile with 26% reporting being made worse by it. But this was for
a smaller number of patients (285) than GET, so is equivalent to 74 reports
of adverse reactions.
Pacing and rest (including bed rest) had both the highest rates of people reporting they were helpful (89% and 91%) and also the lowest rates of
adverse reactions – just 1% for each (note: as I say, the first set of data
appears to be the most accurate one with the second data having being
adjusted to add to 100%).
Survey 2: (UK) ME Association (2009)
The UK's ME Association recently organised possibly the largest ever survey
of people with ME/CFS. In its Spring 2009 magazine, it included data on 25
therapies. Yet again, Graded Exercise Therapy (GET) had the highest rates of adverse reactions with a whopping 56.5% of people reporting being made worse by the intervention:
Graded Exercise Therapy
Made much worse: 33.1%
Slightly worse: 23.4%
No change: 21.4%
Greatly improved: 3.4%
The related treatment modality of physiotherapy (i.e. therapy provided by a physical therapist) also had a high rate of adverse reactions (32.8% in total):
Made much worse: 15.7%
Slightly worse: 17.1%
No change: 36.7%
Greatly improved: 3.5%
Cognitive Behaviour Therapy (CBT) had a lower but still significant rate of adverse reactions 19.5% or 194 out of 997 cases:
Cognitive Behaviour Therapy (CBT)
Made much worse: 7.9%
Slightly worse: 11.6%
No change: 54.6%
Greatly improved: 3.4%
CBT also came very low (21st of 25) on the table of treatments based on the
percentage of people helped by them. The only treatments below them were
Imunovir (which had only being tried by 62 patients, the lowest number of
the 25 treatments) (25.8% reporting it helped them), NADH and Graded
The treatment with the highest percentage of people saying it helped was
pacing of activities:
Made much worse: 1.2%
Slightly worse: 3.5%
No change: 24.1%
Greatly improved: 11.6%
Pacing also had one of the lowest rates of people saying they were made
worse by the treatment.
Survey 3: (UK) 25% ME Group (2004)
In the UK, there is an ME charity specifically for severely affected
patients with ME, called the 25% ME Group.
It conducted a survey of its members which got a response rate of 66% or 437
This is a direct quote from their report where they quote the statistics
i.e. out of 170 patients who had tried Graded Exercise Therapy (GET), 139
had been made worse by it!
"By far the most unhelpful form of treatment was considered to be Graded
Exercise Therapy (GET). This is a finding that may surprise some readers,
given the current medical popularity of this approach. However, these
patients' perceptions are supported by data from previous experience: of
the 39% of our members who had actually used Graded Exercise Therapy, a
shocking 82% reported that their condition was made worse by this treatment. On the basis of our members' experiences we question whether GET is an
appropriate approach for patients with ME. It is worth noting that some
patients were not severely affected before trying GET. Thus, it is not only
people with severe ME who may be adversely affected by this form of
Survey 4: "Scotland M.E./CFS Scoping Exercise Report" (October 2007)
With Section 16b Funding through The Scottish Government, Action for ME
produced a report: "Scotland M.E./CFS Scoping Exercise Report" (October
"In total 564 people with M.E. were sent a questionnaire (510 sent hard
copies, 54 electronic versions). 399 completed questionnaires were received
which represents a 71% return." (Page 8)
Table (Page 9)
Helpful no effect made me worse didn't try
CBT 15.5% 17.5% 7% 60%
GET 5% 6% 32% 57%
Graded Activity 18% 8% 30% 44%
Pacing 77% 8.5% 3.5% 11%
Translating these percentages into percentages solely based on people who
had actually tried a treatment (more interesting figures, I think most
people would agree), would give the following figures (the actual figures
may have been a tiny bit different because of rounding):
Numbers Tried: 160
Helpful: 38.75% (=15.5/40) (62)
No effect: 43.75% (=17.5/40) (70)
Made me worse: 17.5% (=7/40) (28)
GET (i.e. Graded Exercise Therapy)
Numbers Tried: 172
Helpful: 11.63% (=5/43) (20)
No effect: 13.95% (=6/43) (24)
Made me worse: 74.42% (=32/43) (128)
Numbers Tried: 224
Helpful: 32.14% (=18/56) (72)
No effect: 14.29% (=8/56) (32)
Made me worse: 53.57% (=30/56) (120)
Numbers Tried: 298
Helpful: 86.52% (=77/89) (258)
No effect: 9.55% (=8.5/89) (28)
Made me worse: 3.93% (=3.5/89) (12)
The odd proponent of GET has tried to say that figures from surveys are
somehow not significant because we don't know whether the people did Graded
Exercise Therapy under a professional or not. Firstly surveys 5 and 6
(below) show that the evidence isn't there to show that doing these
treatments under a specialist is safer. Also the fact remains that GET is
like an "over-the-counter" drug. People will try it if information is put
out that it is an effective treatment either under a professional or by
themselves. Which means promoting it as a treatment for ME/CFS risks
damaging people's health.
Survey 5: (UK) Action for ME (2003)
Action for ME in 2003 wanted to follow up on its previous survey to see
whether changes were occurring with regards to members' experiences of
treatments. It restricted responses to treatments received over the
previous three years so that the results would not overlap with a previous
survey. 550 patients were sent a questionnaire, "your experiences", with
354 people responding (a response rate of 64%).
List of results for people who did GET broken down by the practitioner:
Under a physio:
Negative 12 (67%) Neutral 0 (0%) Positive 6 (33%)
Under an Ot:
Negative 6 (100%) Neutral 0 (0%) Positive 0 (0%)
Under a Doctor:
Negative 3 (27%) Neutral 1 (9%) Positive 7 (64%)
Under a Behavioural Therapist:
Negative 1 (25%) Neutral 1 (25%) Positive 2 (50%)
Negative 3 (100%) Neutral 0 (0%) Positive 0 (0%)
Negative 1 (8.33%) Neutral 4 (33%) Positive 7 (58%)
With regard to this group the authors of the report say:
"Had NO professional input (had they therefore paced themselves ?) -
mostly with positive outcomes"
If one combines
Under a physio + Under an OT + Under a doctor + Under a behavioural
therapist, to get a figure for under a professional:
Negative 22 (56.41%) Neutral 2 (5.13%) Positive 15 (38.46%)
So those who did GET under a professional had much higher rates of adverse
Survey 6: (UK) Action for ME/Association for Youth with ME (2008):
This is another large survey, with 2763 patients with ME or CFS in the UK
responding to a questionnaire which asked about people's experiences of
treatments over the last three years (to avoid overlap with other surveys
Action for ME had undertaken).
It found that of 699 who said they'd tried Graded Exercise Therapy, 34% said
they'd been made worse by it compared to 45% who said they'd been helped and
21% who said it made no difference.
The contention that people would not have being made worse by a treatment if
they had done the treatment under specialist supervision, is not backed up
by the data from this study. Patients were asked who provided the GET
treatment. Of the 567 who answered this question, 181 (31.92%) said it had
made them worse compared to 276 (48.68%) who said it helped and 110 (19.40%)
who said it made no difference; these are very similar percentages to the
subgroup of 335 patients who had done the management strategy under an "NHS
specialist": 111 (31.27%) of this group said they'd been made worse compared
to 162 (45.63%) who said they'd been helped and 82 (23.10%) who said it made
So a large proportion of patients in the UK have experienced adverse
reactions for trying Cognitive Behaviour Therapy (CBT) and in particularly
Graded Exercise Therapy (GET). However it is my experience from reading
Peter White's writings and hearing him talk that he does not inform people
of this information.
Given the seriousness of the issue, I feel it would irresponsible if the CDC
allows Peter White to be the only representative from the UK.
Suggestions for others on the ground who are not in denial of the issue of
adverse reactions from GET (like Peter White appears to be) include: Charles
Shepherd MD email@example.com ; Ellen Goudsmit PhD
CPsychol AFBPsS (a Chartered Health Psychologist) ellengoudsmit@HOTMAIL.COM
; Abhijit Chaudhuri DM MD PhD FACP FRCP (a consultant neurologist)
firstname.lastname@example.org and William Weir MD (an infectious disease consultant
who ran an NHS clinic for ME for a number of years – I don't have an E-mail
address at the time of writing but he can be contacted through his practice
at: +44-207-467-8478 (i.e. from the US: 00-44-207-467-8478). All of these
four professionals have published in the area and been in the area for over
10 years – I think Dr William Weir is in the area for approximately 20 years
and Drs Shepherd and Goudsmit for over 20 years. Drs Chaudhuri and Goudsmit
did their PhDs in the area.
Surveys from other countries:
The 6 above surveys are from the UK. I have information on some surveys
undertaken by local groups in the UK which would also report high rates of
adverse reactions both from CBT and especially GET.
However reports of adverse reactions are not restricted to the UK.
Gijs Bleijenberg PhD is a Dutch psychologist which the CDC has worked with.
I fear he will not have shared with the CDC or others results of surveys of
patients which show a somewhat different picture to the studies he has
Koolhaas et al (2008/2009)
*Majority of ME/CFS patients negatively affected by Cognitive Behaviour
To the best knowledge, this was presented at the 2009 IACFS/ME conference by
Dr Van Hoof.
The following summary is from page 4 of the Dutch-language study.
Cognitieve gedragstherapie bij het chronische vermoeidheidssyndroom (ME/CVS)
vanuit het perspectief van de patiënt
Drs. M.P. Koolhaas, H. de Boorder, prof. dr. E. van Hoof
Date: February 2008
*In recent years, Chronic Fatigue Syndrome, also known as Myalgic
(ME/CFS), has been getting a lot of attention in scientific literature.
However its aetiology
remains unclear and it has yet to be clarified why some people are more
prone to this
condition than others. Furthermore, there is as yet no consensus about the
ME/CFS. The different treatments can be subdivided into two groups, the
and the psychosocial therapies. Most of the scientific articles on treatment
The most intensively studied psychological therapeutic intervention for
ME/CFS is cognitive
behaviour therapy (CBT). In recent years several publications on this
subject have been
published. These studies report that this intervention can lead to
significant improvements in
30% to 70% of patients, though rarely include details of adverse effects.
This pilot study was
undertaken to find out whether patients' experiences with this therapy
confirm the stated
percentages. Furthermore, we examined whether this therapy does influence
employment rates, and could possibly increase the number of patients
training, engaged in sports, maintaining social contacts and doing household
*By means of a questionnaire posted at various newsgroups on the internet,
subjective experiences of 100 respondents who underwent this therapy were
These experiences were subsequently analysed.
*Only 2% of respondents reported that they considered themselves to be
completely cured upon finishing the therapy. Thirty per cent reported 'an
improvement' as a result of the therapy and the same percentage reported no
change. Thirty-eight percent said the therapy had affected them adversely, the majority of them even reporting substantial deterioration. Participating in CBT proved to have little impact on the number of hours people were capable of maintaining social contacts or doing household tasks. A striking outcome is that the number of those respondents who were in paid employment or who were studying while taking part in CBT was adversely affected. The negative outcome in paid employment was statistically significant. CBT did, however, lead to an
increase in the number of patients taking up sports.
A subgroup analysis showed that those patients who were involved in legal
proceedings in order to obtain disability benefit while participating in CBT
did not score worse than those who were not. Cases where a stated objective
of the therapy was a complete cure, did not have a better outcome. Moreover,
the length of the therapy did not affect the results.
*This pilot study, based on subjective experiences of ME/CFS sufferers, does
not confirm the high success rates regularly claimed by research into the
effectiveness of CBT for ME/CFS. Over all, CBT for ME/CFS does not improve
patients' well-being: more patients report deterioration of their condition
rather than improvement. Our conclusion is that the claims in scientific
publications about the effectiveness of this therapy based on trials in
strictly controlled settings within universities, has been overstated and
are therefore misleading. The findings of a subgroup analysis also
contradict reported findings from research in strictly regulated settings.
Survey 8: Survey of 3 Dutch ME/CFS patient organizations (December 2008):
3 Dutch ME/CFS patient organisations published in December 2008 at:
http://www.nivel.nl/pdf/Rapport-draagvlakmeting-CVS-ME-2008.pdf the results
of a large survey they undertook. Following the link, one can see the
questionnaire that was used.
Table 2.1 numbers of sent questionnaires and responses returned to the
Number sent: 740
Total number of responses: 449
% response rate (gross): 60.7%
Number of filled in questionnaires: 412
% Net response rate: 55.7%
(Rough) Translation into English of the results tables from a large survey
of the membership of three Dutch ME/CFS patient organisations (part 2 of 2)
Table 4.10 Treatment or accompaniment/support/management concerning the
diagnosis ME/CFS and the impact experienced of that treatment or
Treatment or accompaniment/support/management
Column 1: % that has had (the) treatment
Column 2: Number of those that have answered
Column 3: Impact: After (i.e. because of) the treatment, improved
Column 4: No impact
Column 5: Impact: After (i.e. because of) the treatment, disimproved
- Diet 65,2% n=251 50,2% 43,8% 6,0%
- Homoeopathy 64,6% n=247 30,8% 62,8% 6,5%
- Physiotherapy 52,4% n=203 36,9% 41,9% 21,2%
- Vitamin B12 48,2% n=184 32,1% 63,0% 4,9%
- Psychotherapy (not CBT), Psychological support 46,1% n=169 33,1%
- Management based on trying to have a balance of rest and activity 44,2%
n=172 57,0% 33,7% 9,3%
- Antidepressants 43,0% n=165 32,7% 36,4% 30,9%
- Carnitine 40,9% n=156 37,2% 53,8% 9,0%
- Melatonin 38,0% n=146 32,9% 50,7% 16,4%
- Graded Activity/Exercise Therapy 37,3% n=142 43,0% 23,9% 33,1%
- Painkillers 37,0% n=138 47,1% 47,8% 5,1%
- Cognitive Behavioural Therapy (CBT) 29,9% n=115 30,4% 42,6% 27,0%
- oefentherapie (I think this is a cross between physiotherapy and the
Alexander Technique) 27,0% n=102 20,6% 42,2% 37,3%
- Herbal Medicine 26,7% n=97 28,9% 61,9% 9,3%
- Bed-rest 11,7% n=45 48,9% 44,4% 6,7%
- Participation at a rehabilitation centre 10,2% n=40 45,0% 35,0% 20,0%
- Immunological therapy 7,7% n=25 44,0% 40,0% 16,0%
- Neurofeedback 3,8% n=14 35,7% 57,1% 7,1%
Tabel 4.10 Behandeling of begeleiding in verband met de diagnose ME/CVS en
het ervaren effect van die behandeling of begeleiding
Behandeling of begeleiding % dat
Column 1: % dat behandeling heeft gehad
Column 2: aantal dat vraag naar effect heeft beantwoord
Column 3: Effect: Het ging daarna beter
Column 4: Geen effect
Column 5: Effect: Het ging daarna slechter
- dieet 65,2% n=251 50,2% 43,8% 6,0%
- homeopathie 64,6% n=247 30,8% 62,8% 6,5%
- fysiotherapie 52,4% n=203 36,9% 41,9% 21,2%
- vitamine B12 48,2% n=184 32,1% 63,0% 4,9%
- psychotherapie (niet CGT), psychologische begeleiding 46,1% n=169 33,1%
- begeleid zoeken naar een balans van activiteiten en rust 44,2% n=172 57,0%
- antidepressiva 43,0% n=165 32,7% 36,4% 30,9%
- carnitine 40,9% n=156 37,2% 53,8% 9,0%
- melatonine 38,0% n=146 32,9% 50,7% 16,4%
- begeleide opbouw van activiteiten 37,3% n=142 43,0% 23,9% 33,1%
- pijnstillers 37,0% n=138 47,1% 47,8% 5,1%
- cognitieve gedragstherapie (CGT) 29,9% n=115 30,4% 42,6% 27,0%
- oefentherapie 27,0% n=102 20,6% 42,2% 37,3%
- kruidentherapie 26,7% n=97 28,9% 61,9% 9,3%
- bedrust met begeleiding 11,7% n=45 48,9% 44,4% 6,7%
- opname in revalidatiecentrum 10,2% n=40 45,0% 35,0% 20,0%
- immunologische therapie 7,7% n=25 44,0% 40,0% 16,0%
- neurofeedback 3,8% n=14 35,7% 57,1% 7,1%
Survey 9: Norway (2009)
[Patients' experience with treatment of chronic fatigue syndrome.]
Tidsskr Nor Laegeforen. 2009 Jun 11;129(12):1214-6
[Article in Norwegian]
email@example.com Sogndal BUP Postboks 184 6851 Sogndal.
BACKGROUND: Chronic fatigue syndrome is a highly debated condition. Little
is known about causes and treatment. Patients" experience is important in
MATERIAL AND METHODS: 828 persons with chronic fatigue syndrome
(ICD-10 code: G93.3) were included in the study. They were recruited through
two Norwegian patient organizations (ME-association and MENiN). The
participants filled in a questionnaire on their experience with various
approaches to alleviate their condition.
RESULTS: Pacing was evaluated as useful by 96% of the participants, rest by 97%, and 96% of the participants considered complete shielding and quietness to be useful. 57% of the participants who had received help to identify and
challenge negative thought patterns regarded this useful. 79% of the participants with experience from graded training regarded this to worsen their health status.
Overall, the results were similar, irrelevant of the severity of the
INTERPRETATION:Most participants in this study evaluated pacing, rest and
complete shielding and quietness to be useful. The experience of the
participants indicate that cognitive behaviour therapy can be useful for
some patients, but that graded training may cause deterioration of the
condition in many patients. The results must, however, be interpreted with
care, as the participants are not a representative sample, and we do not
know the specific content of the approaches.
Survey 10: (US) The CFIDS Association of America 1999 Reader Survey:
The largest survey of ME/CFS patients that I am aware of in the US was
published by the the CFIDS Association of America in 1999 (questionnaires
were also distributed that year).
I can send a copy of the page of results of 28 therapies on request.
Unfortunately, I do not have time to type in all the results at present.
820 readers filled in the questionnaire.
The results for Graded Exercise Therapy were:
Helped a lot: 111 (24.0%)
Helped a little: 170 (36.8%)
No effect: 51 (11.0%)
Harmful: 130 (28.1%).
Numerically this was the highest rate of adverse reactions. Numerically the
second highest rate of adverse reactions was reported for antidepressants:
Helped a lot: 163 (30.2%)
Helped a little: 154 (28.6%)
No effect: 104 (19.3%)
Harmful: 118 (21.9%).
In terms of percentages, Graded Exercise Therapy had the third highest rate
of adverse reactions. Two treatments, Beta-blockers and colonics, which I
think the CDC is unlikely to recommend, were marginally higher:
Helped a lot: 33 (19.1%)
Helped a little: 39 (22.7%)
No effect: 45 (26.2%)
Harmful: 55 (32.0%).
Helped a lot: 14 (10.7%)
Helped a little: 38 (29.0%)
No effect: 42 (32.1%)
Harmful: 37 (28.2%).
CBT had a lower rate of adverse reactions compared to the rates seen in
other surveys. This may be because CBT in the US is not currently simply based on
GET – there are different forms offered some which might encourage the
pacing of activities. However this might change if information from the
form of CBT that tends to be used in the UK and the Netherlands is
highlighted by the CDC.
Helped a lot: 48 (30.0%)
Helped a little: 60 (37.5%)
No effect: 38 (23.8%)
Harmful: 16 (10.0%).
The treatment with the best results was Pacing of activities. It had the
lowest rate of adverse reactions (1/601 or 0.2%) and the highest helpful
percentage (i.e. the sum of the percentages for helped a little and helped a
Helped a lot: 423 (70.4%)
Helped a little: 167 (27.8%)
No effect: 20 (3.3%)
Harmful: 1 (0.2%).