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Date:         Wed, 1 Jul 2009 13:17:22 +0100
Reply-To:     Tom Kindlon <[log in to unmask]>
Sender:       ME/CFS and Fibromyalgia Information Exchange Forum
              <[log in to unmask]>
From:         Tom Kindlon <[log in to unmask]>
Subject:      ACT: (Part 2 of 2) Tom Kindlon's submission on the CDC's draft
              5-year plan for CFS

(Part 2 of 2) (Tom: below the information on surveys is a little bit of extra comment on the CDC's plans, for what it's worth) 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. ================== Survey 7: Koolhaas et al (2008/2009) *Majority of ME/CFS patients negatively affected by Cognitive Behaviour Therapy*** (From: http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0803A&L=CO-CURE&P=R647&I=-3 ) 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. http://home.planet.nl/~koolh222/cgtbijmecvsvanuitperspectiefpatient2008.pdf 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 ISBN: 978-90-812658-1-2 The Netherlands *SUMMARY* *Background *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. *Method *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. *Results *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. *Conclusions *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 patients' associations 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 accompaniment/support 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% 60,9% 5,9% - 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% To summarise the data here for GET/GAT, CBT and Physiotherapy in a way that is easier to read The results for Graded Activity/Exercise Therapy were: 142 respondents Improved: 61 (43.0%) No impact: 34 (23.9%) Disimproved/Made worse: 47 (33.1%) Physiotherapy 203 respondents Improved: 75 (36.9%) No impact: 85 (41.9%) Disimproved/Made worse: 43 (21.2%) Cognitive Behavioural Therapy (CBT) 115 respondents Improved: 35 (30.4%) No impact: 49 (42.6%) Disimproved/Made worse: 31 (27.0%) ~~~~~~~~~~ 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% 60,9% 5,9% - begeleid zoeken naar een balans van activiteiten en rust 44,2% n=172 57,0% 33,7% 9,3% - 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] *Bjørkum T* *Wang CE*, *Waterloo K*. [log in to unmask] Sogndal BUP Postboks 184 6851 Sogndal. http://www.ncbi.nlm.nih.gov/pubmed/19521443 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. 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: 462 respondents 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: Antidepressants 539 respondents 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: Beta-blockers 172 respondents Helped a lot: 33 (19.1%) Helped a little: 39 (22.7%) No effect: 45 (26.2%) Harmful: 55 (32.0%). Colonics 131 respondents 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 currently is not 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. CBT 160 respondents 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 lot) Pacing 601 respondents Helped a lot: 423 (70.4%) Helped a little: 167 (27.8%) No effect: 20 (3.3%) Harmful: 1 (0.2%). As I have pointed out, Peter White has strong views on Graded Exercise Therapy (GET). He has also got strong views against Pacing and at the last moment resigned from the CMO group on CFS/ME (2002) (mentioned above) as it had placed Pacing on the same level as GET and CBT. People involved in the committee were annoyed at this as people had made a lot of concessions to try to get a document people like him would sign. This is relevant when one is talking about an “international consensus on management.” Basically by selecting Peter White for such a committee, it is very likely that the document will recommend GET with few caveats or warnings; alternatively Peter White will resign. His views would not be representative of a lot of the opinions in the UK or internationally, so it would not really be an international consensus if he was on the sole UK representative. As I mentioned before, I believe you need people on any panel who are not in denial about the adverse reactions from GET (like Peter White appears to be). Here are my suggestions again: Charles Shepherd MD [log in to unmask] ; Ellen Goudsmit PhD CPsychol AFBPsS (a Chartered Health Psychologist) [log in to unmask] ; Abhijit Chaudhuri DM MD PhD FACP FRCP (a consultant neurologist) [log in to unmask] ; Neil Abbot MSc PhD (Operations Director, ME Research UK) [log in to unmask] 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). Without individuals who are willing to challenge Peter White on such a panel, I believe one is likely to get a document which hypes the benefits of GET and CBT based on GET and does not give much if any information on potential risks. To me, this would seem like a very irresponsible thing for an agency like the CDC to do. The other point I want to re-iterate is my problems with the way the CDC CFS team have “operationalized” the Fukuda definition with the “empiric definition” (Reeves, 2005). I have previously mentioned virtually all the points I would like to make on the topic as comments on papers that involved the definition. They are appended below in green (as they were included in my last submission). Frustrated with both the lack of feedback and the CDC’s continued use of the definition, I set up a petition on the issue (see Appendix 1). Despite the petition’s text not being very “catchy”, there are 1440 signatures. I am appending the signatures below along with comments they made (more people me they made comments but for some reason some comments never showed up – given these are people signing a petition against the definition, these would not have been positive comments). As I said in my (written) testimony to the May 2009 CFSAC meeting: “If one has a heterogeneous group of patients, it can mean that in intervention trials, if “true” CFS patients only make up a tiny fraction of the cohort, useful interventions could come up as showing no effect (or even being detrimental); alternatively, interventions may come up as being useful for CFS when in fact if one had only looked at those with “true” CFS, the intervention may have made no difference or may even have been detrimental.” Given that the CDC is now moving towards intervention studies, this is a particularly important issue. The CDC’s response to this criticism might be that using subsets can deal with this issue. However the definition has been broadened so much by the empiric definition that it is far from clear that this is enough. The prevalence rates from CDC CFS studies went up from 0.235% to 2.54%. That means that on average, patients satisfying the Fukuda definition as the CDC was previously using it would only make up 9.25% of the patients covered by the “empiric definition”. And of course due to the nature of probabilities, the actual figures could well be lower. And even if 9.25% were inducted into a study, on average in a trial which had at least two “arms”, one of the arms would have a cohort with less than 9.25% of the individuals satisfying the Fukuda definition as the CDC was previously defining it. And of course, even at the earlier stage, it was recognized that even the Fukuda definition captured a heterogeneous population. Of course, this point is true in general with the “empiric” definition – the definition has become so broad that it may now be impossible to find the subsets that make up CFS. One other point: as far as I can see, the only virus group specifically referred to in the CDC’s long 5-year Strategic Plan is HHV6. It would be good if some of the CDC's (not inconsiderable) CFS research budget could be used to investigate enteroviruses in CFS. In 2007 a study involving enteroviruses[4] resulted in much excitement in the media on the subject. It found, in a sample of CFS patients who had gastrointestinal symptoms, that 135/165 (82%) biopsies stained positive for VP1 within parietal cells, whereas 7/34 (20%) of the controls stained positive (p=<0.001). Earlier studies have demonstrated circulating antigen of enterovirus, raised antibody titres and viral RNA in the blood and muscle biopsy specimens of patients with CFS[4-8]. John Chia does recognize that other infections could be playing a part in some CFS cases but enteroviruses are by far the most common infection he is finding in his clinic in California[9]. References [1] Gelman JH, Unger ER, Mawle AC, Nisenbaum R, Reeves WC: Chronic fatigue syndrome is not associated with expression of endogenous retroviral p15E. Molec Diagnosis 2000, 5:155-156. [2] Vernon SD, Shukla S, Reeves WC: Absence of Mycoplasma species DNA in chronic fatigue syndrome. J Med Microbiol 2003, 52:1027-1028. [3] Jones JF, Kulkarni PS, Butera ST, Reeves WC: GB virus-C--a virus without a disease: we cannot give it chronic fatigue syndrome. Jones JF, Kulkarni PS, Butera ST, Reeves WC. BMC Infect Dis 2005, 5:78 [4] Yousef GE, Mann GF, Smith DF, et al: Chronic enterovirus infection in patients with postviral fatigue syndrome. Lancet 1988;1:146-7. [5] Cunningham L, Bowles NE, Lane RJM, et al: Persistence of enteroviral RNA in chronic fatigue syndrome is associated with abnormal production of equal amounts of positive and negative strands of enteroviral RNA. J Gen Virol 1990;71:1399-402. [6] Galbraith DN, Nairn C, Clements GB: Phylogenetic analysis of short enteroviral sequences from patients with chronic fatigue syndrome. J Gen Virol 1995;76:1701-7. [7] Lane RJ, Soteriou BA, Zhang H, et al: Enterovirus related metabolic myopathy: a postviral fatigue syndrome. J Neurol Neurosurg Psychiatry 2003;74:1382-6. [8] Douche-Aourik F, Berlier W, Fe´asson L, et al: Detection of enterovirus to human skeletal muscle from patients with chronic inflammatory muscle disease or fibromyalgia and healthy subjects. J Med Virol 2003;71:540-7. [9] Chia JK, Chia A: Diverse etiologies for the chronic fatigue syndrome. Clin Infect Dis 2003;36:671-2. ---------------------- Other viruses and microbes are also worthy and studies that involve the gut may provide more information than studies that just use blood samples. Thank you for taking the time to read this. Tom Kindlon ==================== Appendix 1: Petition http://www.ipetitions.com/petition/empirical_defn_and_CFS_research/index.htm l CDC CFS research should not involve the empirical definition (2005) The petition We call on the Centers for Disease Control and Prevention (CDC) to stop using the "empirical" definition[1] (also known as the Reeves 2005 definition) to define Chronic Fatigue Syndrome (CFS) patients in CFS research. The CDC claim it is simply a way of operationalizing the Fukuda (1994) definition[2]. However the prevalence rates suggest otherwise: the "empirical" definition gives a prevalence rate of 2.54% of the adult population[3] compared to 0.235% (95% confidence interval, 0.142%-0.327%) and 0.422% (95% confidence interval, 0.29%-0.56%) when the Fukuda definition was used in previous population studies in the US[4,5]. The definition lacks specificity. For example, one research study[6] found that 38% of those with a diagnosis of a Major Depressive Disorder were misclassified as having CFS using the empirical/Reeves definition. References [1] Reeves WC, Wagner D, Nisenbaum R, Jones JF, Gurbaxani B, Solomon L, Papanicolaou DA, Unger ER, Vernon SD, Heim C. Chronic fatigue syndrome--a clinically empirical approach to its definition and study. BMC Med. 2005 Dec 15;3:19. Link: http://www.biomedcentral.com/1... [2] Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome; a comprehensive approach to its definition and study. Ann Int Med 1994, 121:953-959. [3] Reeves WC, Jones JF, Maloney E, Heim C, Hoaglin DC, Boneva RS, Morrissey M, Devlin R. Prevalence of chronic fatigue syndrome in metropolitan, urban, and rural Georgia. Popul Health Metr. 2007 Jun 8;5:5. [4] Reyes M, Nisenbaum R, Hoaglin DC, Unger ER, Emmons C, Randall B, Stewart JA, Abbey S, Jones JF, Gantz N, Minden S, Reeves WC: Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas. Arch Int Med 2003, 163:1530-1536. [5] Jason LA, Richman JA, Rademaker AW, Jordan KM, Plioplys AV, Taylor RR, McCready W, Huang CF, Plioplys S. A community-based study of chronic fatigue syndrome. Arch Intern Med. 1999 Oct 11;159(18):2129-37. [6] Jason, LA, Najar N, Porter N, Reh C. Evaluating the Centers for Disease Control's empirical chronic fatigue syndrome case definition. Journal of Disability Policy Studies 2008, doi:10.1177/1044207308325995. Further reading: Problems with the New CDC CFS Prevalence Estimates Leonard Jason, Ph.D., DePaul University tinyurl.com/2qdgu4 i.e. http://www.iacfsme.org/Issuesw... Brief comment from Tom Kindlon: I have Chronic Fatigue Syndrome (CFS) for over 20 years. I want a lot of research progress in my lifetime and believe the empirical definition (2005) (also known as the Reeves definition (2005)) decreases the chances that this will occur: abnormalities that would show up using a more strictly defined definition won't show up using the empirical/Reeves definition; and abnormalities that might show up in the broad group covered by the empirical/Reeves definition are not necessarily representative of CFS patients. Similarly treatments that might work on a more strictly defined group of patients might not show up using the very broad empirical/Reeves definition and treatments that might appear to work overall on the group defined using the empirical/Reeves definition might not be suitable for people who satisfy a stricter definition. This messes up the CFS literature even further. -- Technical note: I am not sure why some people have grey boxes in the comments section. Some people have told me they have sent comments that never went up. I have not idea why this is happening. Petition sponsor Tom Kindlon, a patient with Chronic Fatigue Syndrome (CFS) for over 20 years. I have done a lot of voluntary work in the area for over a decade. Recently I had two letters on CFS published in medical journals. Links The paper defining the empirical/Reeves definition can be read at: http://www.biomedcentral.com/1741-7015/3/19 Some comments on the paper have been posted at: http://www.biomedcentral.com/1741-7015/3/19/comments An article by Leonard Jason PhD on the issue can be read at: tinyurl.com/2qdgu4 i.e. http://www.iacfsme.org/IssueswithCDCEmpiricalCaseDefinitionandPrev/tabid/105 /Default.aspx http://me-cfs.se/dok/081205-cfs-no-longer-cfs.pdf By Kasper Ezelius M.Sc. This includes some links to other definitions, Kasper's take on the issues and a list of some papers that have involved using the empirical definition (this list is not up-to-date; virtually all the papers from the CDC 2-day Wichita study and also from the Georgia cohort have used the empirical definition to define CFS) http://www.ipetitions.com/petition/empirical_defn_and_CFS_research/signature s-1.html (Included the 1440 signatures and comments) (I also included the text of my previous submission below this in green) --------------------------------------------- Send posts to [log in to unmask] Unsubscribe at http://www.co-cure.org/unsub.htm Select list topic options at http://www.co-cure.org/topics.htm --------------------------------------------- Co-Cure's purpose is to provide information from across the spectrum of opinion concerning medical, research and political aspects of ME/CFS and/or FMS. We take no position on the validity of any specific scientific or political opinion expressed in Co-Cure posts, and we urge readers to research the various opinions available before assuming any one interpretation is definitive. The Co-Cure website <www.co-cure.org> has a link to our complete archive of posts as well as articles of central importance to the issues of our community. ---------------------------------------------


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