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Adverse reactions to Graded Exercise Therapy
Sunday 20 September 2009
Tom Kindlon has collated research results that show Graded Exercise Therapy produces a high rate of adverse reactions in ME/CFS.
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 reactions.
I'm saying that in this situation, surveys of patients' experiences are
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 the 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.
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.
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.
*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 317):
[Aside: there are three changes by 1% (in italics) 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%).
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
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):
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)
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 Exercise Therapy.
The treatment with the highest percentage of people saying it helped was pacing of activities:
Pacing also had one of the lowest rates of people saying they were made worse by the treatment.
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 replies.
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 treatment.”
With Section 16b Funding through The Scottish Government, Action for ME produced a report: "Scotland M.E./CFS Scoping Exercise Report" (October 2007)
"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)
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)
Numbers Tried: 172
Helpful: 11.63% (=5/43) (20)
Numbers Tried: 224
Helpful: 32.14% (=18/56) (72)
Numbers Tried: 298
Helpful: 86.52% (=77/89) (258)
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.
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:
Under an Ot:
Under a Doctor:
Under a Behavioural Therapist:
If one combines
So those who did GET under a professional had much higher rates of adverse reactions.
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 no difference.
[Added September 2009: Using either a Chi-squared test or a Fisher exact test, there was no difference between the rate of adverse reactions in the group who did GET under an NHS specialist compared to the rest of the people who did GET]
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; Ellen Goudsmit PhD CPsychol AFBPsS (a Chartered Health Psychologist); Abhijit Chaudhuri DM MD PhD FACP FRCP (a consultant neurologist) 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 published.
*Majority of ME/CFS patients negatively affected by Cognitive Behaviour Therapy***
To the best of my 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
*In recent years, Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis (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 treatment of ME/CFS. The different treatments can be subdivided into two groups, the pharmacological and the psychosocial therapies. Most of the scientific articles on treatment emphasize the psychosocial approach.
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 the employment rates, and could possibly increase the number of patients receiving educational training, engaged in sports, maintaining social contacts and doing household tasks.
*By means of a questionnaire posted at various newsgroups on the internet, the reported subjective experiences of 100 respondents who underwent this therapy were collected. 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
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 patients' associations
Number sent: 740
Total number of responses: 449
Treatment or accompaniment/support/management
Column 1: % that has had (the) treatment
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
[Patients' experience with treatment of chronic fatigue syndrome.]
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 this context.
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 condition.
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.
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:
Numerically this was the highest rate of adverse reactions. Numerically the second highest rate of adverse reactions was reported for antidepressants:
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:
CBT had a lower rate of adverse reactions compared to the rates seen in other surveys. This may be because CBT in the US 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.
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 lot)
The full results are available as a PDF file:
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