Study Supports Use Of 2 Controversial Treatments For Chronic Fatigue
Inviato 20 febbraio 2011 - 17:09:22
(CNN) -- British researchers reported Friday that two controversial treatments for chronic fatigue syndrome appear to be more effective than a third, more commonly accepted treatment, and none of them appears to be linked to major safety problems.
In the clinical trial, whose results were published in the British journal The Lancet, 640 patients with CFS were randomized to one of four treatment groups. For 52 weeks, all of them got specialist medical care.
A quarter of them got nothing more than that; a quarter also got cognitive behavior therapy; another quarter also got graded exercise therapy; and the final quarter also got adaptive pacing therapy.
The study was carried out because previous trials supporting cognitive behavior therapy and graded exercise therapy were small and controversial: Two British patients' organizations had surveyed their members and concluded the interventions were not only ineffective, but were harmful, said Dr. Michael Sharpe, professor of psychological medicine at the University of Edinburgh and one of the study's authors.
As an alternative, he told reporters in a news conference posted on the internet, the patient groups were expressing a preference for CFS patients to see specialists and undergo another intervention, called adaptive pacing therapy.
The non-rehabilitative pacing treatment helps patients live within the limits imposed by the illness rather than attempting to break through those limits.
It considers CFS to be an organic disease process that cannot be reversed by changing behavior and that leaves patients with a finite amount of energy. Advocates of the treatment urge patients to pace themselves to avoid fatigue. A therapist advises patients on how to prioritize what they do, but urges them not to try to over do it.
The other two therapies push patients to try to overcome the limits of the illness: cognitive behavior therapy considers CFS to be reversible and recommends changes in behavior and cognition to gradually increase physical and mental activity. Advocates of graded exercise therapy seek to help patients gradually increase their energy level by challenging themselves to boost their exercise and other activity.
But the patient groups' anecdotal conclusions that cognitive behavior therapy and graded exercise therapy were detrimental did not hold up when subjected to the scrutiny of the rigorously designed study, which was carried out at six centers.
Over the course of a year, 59% of the cognitive behavior therapy group and 61% of the graded exercise therapy group improved a given amount for fatigue and physical function versus 42% of the adaptive pacing therapy group and 45% of the group that got only specialist medical care.
There was no statistical difference among the groups in serious adverse reactions, which ranged from 1% to 2%.
"We suggest that these findings show that either CBT(cognitive behavior therapy) or GET (graded exercise therapy), when added to SMC (specialist medical care), is an effective treatment for chronic fatigue syndrome, and the size of this effect is moderate," the authors wrote.
"This is something which has a useful effect for a substantial proportion of the people, but it's clearly not the final solution to the illness," Sharpe said.
The need for reliable treatment data is undisputed. In Britain, CFS is estimated to affect about 250,000 people. Symptoms typically include severe fatigue so disabling that it prevents patients from leading normal lives. It is commonly also associated with difficulties in concentration and memory as well as other symptoms, such as disturbed sleep and widespread pain.
"If people are left untreated, the prognosis is very poor," said Professor Trudie Chalder, professor of cognitive behavioral therapy at Kings College London and another author of the study.
Fewer than 10% of patients recover without treatment, said Sharpe.
The British government was the primary funder of the study, which had limitations, since it excluded patients who were too sick to get to the hospital, the authors acknowledged. In addition, they noted, measurement of outcomes was subjective.
Though the trial shows that recovery from CFS is possible, "there is clearly room for improvement with both interventions," wrote researchers Sijs Bleijenberg and Hans Knoop of the Expert Centre for Chronic Fatigue at Radbourd University Nijmegen Medical Center in the Netherlands.
In an accompanying commentary, they called for more work to come up with better interventions.
The president and CEO of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, Kim McCleary, said the study focused on treatments that many in the United States have no access to.
"I think it would be challenging, at least in the U.S. system, to purchase the services that they've tested in this trial," she said in a telephone interview.
The alphabet soup of acronyms that represent the interventions used in Britain is "just not something that our health care service offers, is reimbursable, or is really available here," McCleary said.
The report comes as researchers have been making progress on the possible role of viruses in causing the disease, she noted. "It's kind of a shame that we're still limited to talking about approaches to coping mechanisms as the only therapy that's available," she said.
A 2007 study by the Centers for Disease Control estimated that approximately 2.5% of the adult population of Georgia suffers from CFS.
McCleary said national estimates put the number of Americans with CFS at 1 million to 4 million.
"In medicina tutto quello che è sconosciuto è malattia mentale" (...)
"Una delle malattie più diffuse è la diagnosi." (Karl Kraus)
Le foto di Zac qui: PhotoZac
Inviato 20 febbraio 2011 - 17:17:20
"Off the PACE" provides analysis of the study and controversial conclusions.
Falling Off the PACE
The CFIDS Association of America op zaterdag 19 februari 2011 om 17:26.
Falling Off the PACE
Analysis of the Lancet study
A paper published Feb. 18, 2011 in the Lancet, “Comparison of adaptive pacing therapy, cognitive behavior therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial” compares four treatment approaches in a population of 641 patients in the United Kingdom (U.K.). The study reported that patients who received a six-month course of cognitive behavioral therapy (CBT) or graded exercise therapy (GET) had improvement in self-reported symptom scores at higher rates than those who were provided specialized medical care alone (SMC) or adaptive pacing therapy (APT). In the Discussion section of the paper, the authors led by Peter D. White acknowledge, “Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed. The effectiveness of behavioural treatments does not imply that the condition is psychological in nature.”
The study has received a great deal of media attention following a press conference held on Feb. 17, 2011. White et al, begin the paper by drawing attention to the controversy the application of these therapies in CFS has generated over the years, “Trial findings show CBT and GET can be effective treatments for CFS, but patients’ organisations have reported that these treatments can be harmful and favour pacing and specialist health care.” This opening statement set up the rather adversarial nature of the study itself and its conclusions, and it flavored much of the news coverage. As we have seen with other recent studies, statements made in the press release and press conference get more attention than somewhat more tempered statements or details of the paper itself. Headlines have touted more conclusive results than the data support.
The study and services, called the PACE Trial, were designed by a large steering committee and the service providers were specially trained to deliver the highly structured programs for the benefit of the National Health Service. It was funded by the U.K. Medical Research Council, the U.K. Department of Health and the U.K. Department for Work and Pensions. The patient population was selected using the Oxford criteria for CFS. 3,148 patients diagnosed with CFS recruited from six CFS specialty clinics were screened to identify 641 subjects who met study criteria. The Oxford criteria are broader than either the 1994 international research case definition or the 2003 Canadian criteria for ME/CFS, suggesting that the term CFS is used by physicians in the U.K. to identify a broad spectrum of medically unexplained illness. There are no data in the paper indicating how many subjects might have been excluded on the basis of neurologic or cardiovascular signs or symptoms. (The National Health Service guidelines for CFS state that the presence of these symptoms warrants further investigation and consideration of alternate diagnoses.)
Table 1 describes study participantsIn the data analysis, patients were also stratified according to the international CFS criteria and the London criteria for myalgic encephalomyelitis (M.E.). Two-thirds of the subjects met the international CFS criteria and about half met the M.E. criteria, which require the presence of post-exertional relapse and exclude individuals with depressive or anxiety disorders. One-third had depression and almost half had a history of some depressive disorder. The authors state, “Our findings were much the same for participants meeting the different diagnostic criteria for CFS and for M.E., for those with depressive disorder, and after allowing for clustering effects.”
It is important to note that study participants had to be able to attend sessions at a hospital or clinic, and therefore more severely ill or homebound patients were not included. The study recruited patients age 18 and older. The average duration of illness was about three years and no subject had been ill longer than six years. The average age was 38; 77 percent of the subjects were women and 93 percent were Caucasian.
Table 4 reports safety outcomes for each groupAssessments using self-report measures were taken at baseline, 12 weeks into therapy, at 24 weeks (post-therapy) and at 52 weeks for follow-up. Improvement and adverse events were also assessed using several self-report measures. Subjects were also asked to rate how successful they thought the treatment would be before sessions began and how satisfied they were at the end of therapy. There were no biological measures reported. Studies of CBT in other conditions including HIV/AIDS and cardiovascular disease, routinely collect data on immune markers or other biological measures in attempt to understand how and why CBT works in the context of the condition studied.
The services delivered in this study were highly structured and are described in the study and in a manual posted to http://www.pacetrial...trialinfo.html. At least three sessions of medical care were provided to all 641 participants over the six-month study period, and additional sessions were available as needed. These sessions included basic pharmacologic support, especially for sleep, pain and mood. For all groups the medical services were delivered by specialists with experience treating CFS. The pacing group received its services from occupational therapists, using a modified “energy envelope” approach that encouraged patients to “plan and pace activity to reduce or avoid fatigue, achieve prioritized activities and provide the best conditions for natural recovery.” CBT services were delivered by clinical psychologists and nurse therapists. They guided patients to establish a baseline of activity and rest and a regular sleep pattern, and then make collaboratively planned gradual increases in both physical and mental activity. Participants were helped to address social and emotional obstacles to improvement through problem-solving. GET services were provided by physiotherapists and one exercise physiologist. Therapeutic strategies in the GET group consisted of establishing a baseline of achievable exercise or physical activity, followed by a negotiated, incremental increase in the duration of time spent physically active. Target heart rate ranges were set when necessary to avoid overexertion, which eventually aimed at 30 minutes of light exercise five times a week. The subjects receiving only specialized medical care were seen 5-6 times during the study, while the subjects in the other three programs were seen a total of 16-17 times during the study.
Table 5 provides data about participants' impressions of their therapyThe PACE Trial reported a moderate beneficial effect of CBT and GET compared to adaptive pacing therapy and specialized medical care alone. Participants’ global impressions of the therapy report positive change by 41 percent of those receiving CBT or GET at the one year mark; 31 percent of the pacing group had positive change and 25 percent of the specialized medical care (alone) group had positive change. Negative change was reported by six percent of the CBT group, seven percent of the GET and pacing groups, and nine percent of the group receiving specialized medical care alone. Serious adverse events were lowest in the CBT and medical care alone group with four percent; highest was the pacing group with nine percent. Rates of serious adverse reactions and serious deterioration did not differ between treatment groups.
The characteristic feature of CFS is post-exertional relapse and provoking the relapse of all symptoms after even modest physical or mental activity is of great concern to patients who experience it. Eighty-four percent of the subjects reported this symptom at baseline and the distribution of subjects into the four groups resulted in fairly even distribution of this symptom across the four treatment groups. The greatest improvement in this symptom was seen in the GET group, where participants were advised to gradually return to appropriate physical activities and reverse deconditioning. At the one-year mark the report of post-exertional relapse in this group had dropped from 82 percent to 44 percent of participants. In the CBT group where participants were encouraged to do more than they thought they could, post-exertional relapse was reported by 49 percent of the participants at follow-up. In the pacing group, participants were advised not to undertake activities that demanded more than 70 percent of participants’ perceived energy envelopes. Increased activities were encouraged, if the participant felt able, and as long as they did not exacerbate symptoms. At the end of the study, 63 percent of the pacing participants reported post-exertional malaise. In the group that received specialized medical care only, participants were simply counseled to avoid the extremes of rest and activity; 63 percent of them reported post-exertional malaise at follow-up.
Given the size of this study and its potential implications for health policy in the U.K. and other countries, it is deeply disappointing that there was no attempt to include measures that might provide a biologic explanation for the outcomes reported. In fact, the word biology is not mentioned once in this paper. The lack of biological explanation for observed improvements reinforces the perception that CFS is mind over matter, even while the paper says it should not. While most people recognize that CBT and GET can be effective in many chronically ill populations as an adjunct to medical care, the news coverage of studies like this one often fails to underscore this point. In several studies of CBT and infection, CBT is shown to work by helping decrease chronic inflammation and tempering the number and activity of harmful immune cell activity. Again, no such correlations were attempted in the PACE trial. Further, it is unclear whether the moderate benefits achieved from such an intensive course of CBT and GET are sustained. The authors indicate that long-term follow-up will be reported in other papers, along with a cost-effectiveness assessment.
The takeaway message from this study is that the current standard medical care available to people with CFS (by any definition) remains very limited and is relatively ineffective on its own. Structured programs that seek to expand function and reduce symptoms may provide modest benefits when added to standard medical care, but they do not offer complete resolution of symptoms or cure, and the benefits are equivalent to those seen in other studies of chronic illness. Younger, less severely ill and more recently ill individuals may benefit more, according to the effects seen in this select study population. It is worth noting that the specialized medical care provided to all subjects in this study – at least three sessions over a six-month period – represents more access to medical care delivered by professionals educated about CFS than most CFS patients in the United States (and other countries) can obtain, regardless of their financial resources. Without that important adjunct, it is unknown how successful these behavioral treatment modalities would be, especially if delivered outside this type of structured program by lesser trained professionals who lack basic information about the rather specific and unique challenges posed by CFS.
The CFIDS Association of America is committed to advancing research that leads to the early detection, objective diagnosis and effective treatment of CFS. The scientific and medical communities are obligated to understand the biological roots of CFS so that targeted and effective treatments can be made available to the millions of people around the world who suffer from CFS.
February 19, 2011
"In medicina tutto quello che è sconosciuto è malattia mentale" (...)
"Una delle malattie più diffuse è la diagnosi." (Karl Kraus)
Le foto di Zac qui: PhotoZac
Inviato 01 marzo 2011 - 03:08:08
Give a look at this spanish study, dated January 2011:
Clin Rheumatol. 2011 Jan 15. [Epub ahead of print]
Health-related quality of life in patients with chronic fatigue syndrome: group cognitive behavioural therapy and graded exercise versus usual treatment. A randomised controlled trial with 1 year of follow-up.
Núñez M, Fernández-Solà J, Nuñez E, Fernández-Huerta JM, Godás-Sieso T, Gomez-Gil E.
Rheumatology Service, Functional Readaptation Unit, Hospital Clinic, Barcelona, Spain, email@example.com.
Chronic fatigue syndrome (CFS) produces physical and neurocognitive disability that significantly affects health-related quality of life (HRQL). Multidisciplinary treatment combining graded exercise therapy (GET) cognitive behavioural therapy (CBT) and pharmacological treatment has shown only short-term improvements. To compare the effects on HRQL of (1) multidisciplinary treatment combining CBT, GET, and pharmacological treatment, and (2) usual treatment (exercise counselling and pharmacological treatment) at 12 months of follow-up. Prospective, randomized controlled trial with a follow-up of 12 months after the end of treatment. Patients consecutively diagnosed with CFS (Fukuda criteria) were randomly assigned to intervention (n = 60) or usual treatment (n = 60) groups. HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form questionnaire (SF-36). Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Questionnaire (HAQ) and comorbidities. At baseline, the two groups were similar, except for lower SF-36 emotional role scores in the intervention group. At 12 months, the intervention did not improve HRQL scores, with worse SF-36 physical function and bodily pain scores in the intervention group. Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL. The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis.
PMID: 21234629 [PubMed - as supplied by publisher]
Here you can find a petition on-line calling for the resignation of all Action For ME trustees who supported the funding of the PACE trial: http://www.thepetiti...e-resignations/
The 3 principal investigators it refers to as promoters of the psychosocial model are: Peter White, Trudie Chalder, and Michael Sharpe; two of them are autors of this recent paper:
JRSM Short Rep. 2010 Sep 6;1(4):28.
Psychiatric misdiagnoses in patients with chronic fatigue syndrome.
Lawn T, Kumar P, Knight B, Sharpe M, White PD.
East London Foundation Trust , St Bartholomew's Hospital , London EC1A 7BE , UK.
OBJECTIVES: The aim of this study was to examine the accuracy of doctors at diagnosing co-morbid psychiatric disorders in patients with chronic fatigue syndrome (CFS).
DESIGN: Case series comparing clinical diagnoses with a standardized structured psychiatric interview.
SETTING: Secondary care specialist chronic fatigue syndrome clinic.
PARTICIPANTS: One hundred and thirty-five participants of a randomized controlled trial of non-pharmacological treatments at one centre in the PACE trial.
MAIN OUTCOME MEASURES: Current psychiatric diagnoses made by CFS specialist doctors, compared with current psychiatric diagnoses made independently using a structured psychiatric interview.
RESULTS: Clinicians identified 59 (44%, 95% CI 39-56%) of patients as suffering from a co-morbid psychiatric disorder compared to 76 (56%, CI 53-69%) by structured interview. Depressive and anxiety disorders were most common. Clinicians were twice as likely to miss diagnoses (30 patients, 22%) than misdiagnose them (13, 10%). Psychiatrists were less likely to miss diagnoses than other clinicians, but were as likely to misdiagnose them.
CONCLUSIONS: Doctors assessing patients in a chronic fatigue syndrome clinic miss psychiatric diagnoses more often than misdiagnosing them. Missed diagnoses are common. CFS clinic doctors should be trained to diagnose psychiatric disorders.
In Italian language the petition sounds like this:
Petizione sponsorizzata da : Louise Ellis, paziente con ME
Noi sottoscritti, chiediamo le dimissioni di tutti i membri del consiglio di amministrazione della AfME, Action for ME, che ha supportato il finanziamento dello studio PACE.
Senza il sostegno della AfME lo studio non avrebbe potuto essere finanziato.
Mentre la AfME esprimeva il proprio fermo sostegno per il finanziamento dello studio PACE, le altre principali associazioni per la ME richiedevano l'abbandono dei finanziamenti per lo studio, e molte altre mettevano in guardia per le possibili conseguenze disastrose.
Il principali criteri diagnostici usati per lo studio PACE sono gli Oxford Criteria, che individuano soggetti con fatica, invece che i malati di ME. I tre principali ricercatori coinvolti nello studio sono dei noti promotori del modello psicosociale della CFS.
Lo studio PACE ha portato ad una propaganda di massa che promuove il mito secondo cui la ME è una malattia psicosociale/mentale. Le conclusioni dello studio contraddicono radicalmente i risultati di vaste indagini sulla CBT e sulla GET.
Lo studio PACE è probabile che abbia effetti devastanti sui trattamenti a disposizione, sul finanziamento della ricerca, e sui sussidi per le persone con ME.
La petizione verrà spedita alla presidenza amministrativa della AfME.
I 3 ricercatori cui la petizione fa riferimento sono: Peter White, Trudie Chalder, and Michael Sharpe;
due di questi hanno recentemente pubblicato lo studio che ho riportato sopra dove si conclude che le diagnosi di disturbo psichiatrico in presenza di CFS è spesso mancata durante la visita specialistica, mentre viene evidenziata dai test, perciò i medici CFS devono esser meglio istruiti ad evidenziare i disturbi psichiatrici nei pazienti CFS.
Ecco cosa pensano questi ricercatori dello studio PACE!
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