Category: Treatment

Rituximab impedes natural killer cell function in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis patients: A pilot in vitro investigation

Abstract:

BACKGROUND: A recent in vitro pilot investigation reported Rituximab significantly reduced natural killer (NK) cell cytotoxicity in healthy donors. Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) is a debilitating disorder of unknown etiology. A consistent finding is a significant reduction in NK cell cytotoxicity. Rituximab has been reported having questionable potential therapeutic benefits for the treatment of CFS/ME, however, the potential effects of Rituximab on NK cell cytotoxicity in CFS/ME patients are yet to be determined.

METHODS: A total of eight CFS/ME patients (48.63 ± 15.69 years) and nine non-fatigued controls (NFC) (37.56 ± 11.06 years) were included using the Fukuda case definition. Apoptotic function, lytic proteins and degranulation markers were measured on isolated NK cells using flow cytometry following overnight incubation with Rituximab at 10 μg/ml and 100 μg/ml.

RESULTS: There was a significant reduction in NK cell lysis between CFS/ME patients and NFC following incubation with Rituximab at 100 μg/ml at 12.5:1 and 6.25:1 effecter-target (E:T) ratios (p < 0.05). However, there was no significant difference for NFC following incubation with Rituximab at 10 μg/ml and 100 μg/ml. There was no significant difference between CFS/ME patients and NFC for granzyme A and granzyme B prior to incubation with Rituximab and following overnight incubation with Rituximab at 10 μg/ml. There was a significant decrease in granzyme B in CFS/ME patients compared to NFC with 100 μg/ml of Rituximab prior to K562 cells stimulation (p < 0.05). There was a significant increase in CD107a (p < 0.05) and CD107b expression (p < 0.01) in NFC after stimulation with K562 cells prior to incubation with Rituximab. There was a significant increase in CD107b expression between CFS/ME patients and NFC prior to incubation with Rituximab and without stimulation of K562 cells (p < 0.01). Importantly, there was a significant increase in CD107b following overnight incubation with 100 μg/ml of Rituximab in NFC prior to K562 cells stimulation (p < 0.01).

CONCLUSION: This study reports significant decreases in NK cell lysis and a significant increase in NK cell degranulation following Rituximab incubation in vitro in CFS/ME patients, suggesting Rituximab may be toxic for NK cells. Caution should be observed in clinical trials until further investigations in a safe and controlled in vitro setting are completed.

Source: Eaton N, Cabanas H, Balinas C, Klein A, Staines D, Marshall-Gradisnik S. Rituximab impedes natural killer cell function in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis patients: A pilot in vitro investigation.BMC Pharmacol Toxicol. 2018 Mar 27;19(1):12. doi: 10.1186/s40360-018-0203-8.   https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5870391/ (Full article)

Drug hoped to treat CFS causes impaired immune function, Griffith study says

Reports that a drug used to treat autoimmune diseases and cancer could also treat Chronic Fatigue Syndrome (CFS) have been refuted by a new Griffith University study.

To be published in BMC Pharmacology and Toxicology, the study by Griffith’s National Centre for Neuroimmunology and Emerging Diseases(NCNED) concluded that the use of Rituximab in CFS patients could incur problems with their immune cells and is not beneficial as a potential treatment.

The Natural Killer (NK) cells have vital functions in fighting viruses, bacteria and tumours.

“We found that these functions were significantly impaired when exposed to Rituximab in CFS patients,” says Scientific Co-Director of NCNED, Professor Sonya Marshall-Gradisnik.

CFS – sometimes known as ME (myalgic encephalomyelitis) – is a complex illness characterised by impaired memory and concentration, metabolic, cardiac, gut and immune dysfunction and debilitating muscle pain and fatigue on exertion (also known as neuroimmune exhaustion).

It is estimated that the prevalence rate of CFS/ME worldwide is between 1 and 2 per cent.

Related to the ion channels

The Gold Coast NCNED team has discovered the illness is related to problems in the ion channels that allow calcium into the body’s cells. Calcium is required by almost every cell in the human body and is vital in helping the immune system destroy a virus or infection.

The team has proven that patients with CFS/ME have lower levels of calcium coming into their cells, that their cells store less calcium and that this is the basis of their illness.

Professor Don Staines, Clinical Co-Director of NCNED, says: “These results are important as NK cells are already known to have impaired function in CFS patients, suggesting certain doses of Rituximab may not be beneficial for the treatment of this condition.”

“Undertaking an initial study has enabled us to secure additional research funding from the national competitive grants process from the Mason Foundation where we can now undertake a larger study using this drug in vitro to validate our novel findings,” says Professor Staines.

First author for these world-first scientific findings was PhD student, Ms Natalie Eaton.  She will be presenting the study at an NCNED-sponsored conference later this year.  The focus of the conference will be promoting greater understanding of pathology and pharmacothereapeutics for CFS, through a Research, Innovation, Discovery, Learning and Education (RIDLE) model.

Source: Press Release: Griffith University, March 27, 2018.

An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis

Abstract:

Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) are considered to be enigmatic diseases. Several studies propose that the combination of cognitive behaviour therapy with a graded activity protocol (CBT+), justified by a so-called (bio)psychosocial (explanatory) model, is an effective treatment option for CFS (ME).

Objective :A critical review of five Dutch hallmark studies that allegedly support this claim.

Methods: An analysis of the five CBT+ studies with special attention to the patients studied, the criteria (subjective and objective measures and cut-off scores) used to select participants and to define improvement and recovery, the consistency of the definitions of caseness (being diagnosed as a CFS patient at entry) versus the definitions of improvement and recovery after CBT+, and the objective effects.

Results: The studies investigated suffer from various methodological flaws. Apart from these methodological shortcomings, the claim that CBT+ is an effective treatment option for CFS is not substantiated by the data reported. Some studies investigated CFS patients, other studies investigated CF patients, labelled as CFS patients, or combinations of CFS and CF patients. No study investigated the effect of CBT+ in a group of patients meeting the (original) diagnostic criteria for ME. The effects of CBT+ on subjective measures, for example fatigue and disability, if present, are insufficient to achieve normal values. Impressive recovery and improvement rates are based on very loose criteria for subjective measures. Cut-off scores for subjective measures used to define improvement and recovery in studies show overlap with cut-off scores for CFS caseness in one or more of the other studies. More importantly, looking at the objective measures, the proof of clinical improvement after CBT+ is lacking.

Conclusion: Solid evidence of effectiveness of CBT+ for CFS, let alone ME, is lacking in the five hallmark studies. The lack of objective improvement indicates CBT+ is ineffective. This finding confirms the outcome of the large-scale PACE-trial in the UK.

Source: Twisk FNM (2017) An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis. Gen Med Open, 2017 doi: 10.15761/GMO.1000117 (Full article)

Hemispherx Successfully Completes Commercial Scale Demonstration Batch of Ampligen® at Contract Manufacturer

NEW BRUNSWICK, N.J., Dec. 20, 2017 (GLOBE NEWSWIRE) — Hemispherx Biopharma (NYSE American:HEB) said, its Contract Manufacturing Organization (CMO) for Ampligen® has  completed a commercial scale demonstration/engineering manufacturing run,  along with the re-qualifications of analytical methods that were agreed upon during a previous successful Pre-Approval Inspection (PAI) as necessary prior to the production of commercial lots of Ampligen®.

This accomplishment, in addition to completing all qualification operations to address new equipment and new container closure/vial components, allows the manufacture of current Good Manufacturing Practice (cGMP) clinical product in March 2018 following a scheduled shut down of the CMO for its bi-annual maintenance program.  Completion of the demonstration/engineering manufacturing run provides confidence that the clinical product will meet the stringent quality control release and stability testing prior to release and should be available to patients by the end of the second quarter 2018.  The manufacture of a second clinical lot of Ampligen® is being scheduled to assure maintenance of the clinical supply inventory.

  • Ampligen® has been approved in Argentina for severely debilitated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients. Hemispherx recently reported that discussions are underway with the U.S. FDA on the next steps regarding a New Drug Application (NDA) for Ampligen® in ME/CFS, which afflicts more than one million people in this country, according to the Centers for Disease Control (CDC). Ampligen® is the only drug to have completed a Phase 3 clinical trial in the U.S. in ME/CFS.
  • Earlier this year Hemispherx began supplying Ampligen® for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands.  In addition, work is underway at two leading U.S. cancer centers to define Ampligen®’s potential role in enhancing the effectiveness of PD-1 and PD-L1 checkpoint inhibitors in the fast-growing field of immuno-oncology.

Continue reading “Hemispherx Successfully Completes Commercial Scale Demonstration Batch of Ampligen® at Contract Manufacturer” →

Studies and surveys implicate potential iatrogenic harm of cognitive behavioral therapy and graded exercise therapy for myalgic encephalomyelitis and chronic fatigue syndrome patients

Abstract:

Cognitive behavorial therapy (CBT) and graded exercise therapy (GET) are declared to be effective and safe therapies for Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS). Medical policies in various countries, e.g. the UK and the Netherlands, recommend CBT and GET as evidence-based treatments. But studies and patient surveys in several countries indicate that CBT often has no effect at all and that GET has detrimental effects in a large subgroup of patients.

Editorial

ME is a disease characterized by distinctive muscular symptoms, including muscle weakness and myalgia after minor exertion lasting for days, neurological symptoms implicating cerebral dysfunction, symptoms indicating circulatory impairment and other symptoms [1,2]. CFS is primarily defined by (unexplained) chronic fatigue, which must be accompanied by at least four out of eight ‘additional’’ symptoms [3]. ME and CFS are incorrectly conceived as ‘similar disorders’ [4]. But the case criteria define three patient groups: ME and/or CFS patients [5], labeled as ME/CFS patients within this context.

Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) are declared to be effective [6,7] and safe [7,8] therapies for Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS). Medical policies in various countries, e.g. the UK [9] and the Netherlands [10], recommend CBT and GET as evidence-based treatments.

However various studies implicate that CBT, GET and other behavioral interventions, including graded activity, have negative effects on (subgroups of) ME/CFS patients.

Núñez and co-workers [11] observed that adding CBT and GET to pharmacological treatment had a negative effect on SF-36 physical functioning and pain scores. Jason and others [12,13] found that ‘non-pharmacologic therapies’ had a negative effect on the mean SF- 36 physical functioning score (changes from 5 to -35) of a large subgroup of CFS patients, with lymphocyte subsets data suggesting an elevated humoral immune response (Th2/B Cell). Although ‘Guided graded Exercise Self-help’ (GET) was qualified as “a moderately effective and safe intervention” [14], the investigators acknowledged that a patient subgroup had deteriorated after the GET trial, possibly due to “a worse exacerbation of symptoms in response to GET” [15].

In various surveys [16-18] most ME/CFS patients experienced no improvement after CBT and more than half of the patients reported GET made them worse. A detailed analysis [18] of a large-scale patient survey in the UK [19] shows that, when combinations of therapies are excluded, 73% of the patients they stayed the same after CBT, while 8% of the patients improved and 18% got worse. No less than 74% of the patients reported worsening of their symptoms after GET, 14% of the patients experienced no change and only 12% reported improvement after GET. In a recent patient survey in the Netherlands [20] 11% reported CBT had improved their health situation, 36% experienced no change, and 53% reported CBT had worsened their condition. 63% reported GET had made their symptoms (much) worse and 34% reported no change. Only 3% of the patients experienced improvement after GET. One could argue that patient surveys (through the internet) are potentially prone to many biases, but a study [21] found that ‘’unsolicited’ web-based patient ratings of care correlate well with conventional research findings, i.e. formal measurements.

As affirmed by the medical authorities in the US recently, “ME/CFS is a serious, chronic, complex, multisystem disease” [4] with “strong evidence” indicating that “immunologic and inflammatory pathologic conditions, neurotransmitter signaling disruption, microbiome perturbation, and metabolic or mitochondrial abnormalities are potentially important for the definition and treatment of ME/CFS [22]. Exertion has (prolonged) negative effects in ME/CFS [4]. For that reason studies and surveys indicating potential harm of CBT and GET in large subgroups of ME/CFS patients should be taken seriously. The ‘safety claim’ is at odds with several observations.

References

  1. Dowsett EG, Ramsay AM, McCartney RA, et al. Myalgic Encephalomyelitis – a persistent enteroviral infection? Postgrad. Med. J.66(777), 526-530 (1990).

  2. Ramsay AM, Dowsett EG, Myalgic Encephalomyelitis: Then and now. In Hyde BM, Goldstein J, Levine P, editors. The Clinical and Scientific Basis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Ottawa: The Nightingale Research Foundation pp. 81-84 (1992).

  3. Fukuda K, Straus SE, Hickie I, et al. The chronic fatigue syndrome: a comprehen­sive approach to its definition and study. Ann. Intern. Med. 121(12), 953-959 (1994).

  4. Institute of Medicine. Beyond Myalgic Encephalomyelitis/chronic fatigue syn­drome: redefining an illness. Washington, (2015).

  5. Twisk FNM. Replacing Myalgic Encephalomyelitis and chronic fatigue syndrome with Systemic Exercise Intolerance Disease is not the way forward. Diagnostics (Basel). 6(1), 10 (2016).

  6. Malouff JM, Thorsteinsson EB, Rooke SE, et al. Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: a meta-analysis. Clin. Psychol. Rev. 28(5), 736-745 (2008).

  7. Larun L, Brurberg KG, Odgaard-Jensen J, et al. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 4, CD003200 (2017).

  8. Bleijenberg G, Knoop H. Chronic fatigue syndrome: where to PACE from here? Lancet. 377(9768), 786-788 (2011)

  9. National Institute for Health and Clinical Excellence. Chronic fatigue syndrome/ myalgic encephalomyelitis (or encephalopathy): diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) in adults and children. London (UK), (2007).

  10. CBO. Richtlijn diagnose, behandeling, begeleiding en beoordeling van patiënten met het chronisch vermoeidheidssyndroom (CVS). Utrecht (NL), (2013).

  11. Núñez M, Fernández-Solà J, Nuñez E, et al. 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. Clin. Rheumatol. 30(3), 381-389 (2011).

  12. Jason LA, Torres-Harding S, Friedberg F, et al. Non-pharmacologic interventions for CFS: a randomized trial. J. Clin. Psychol. Med. Settings. 14(4), 275-296 (2007).

  13. Jason LA, Torres-Harding S, Brown M, et al. Predictors of change following participation in non-pharmacologic interventions for CFS. Trop. Med. Health. 36(1), 23-32 (2008).

  14. Clark LV, McCrone P, Ridge D, et al. Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care. J. Psychosom. Res. 5(2), 59-60 (2016).

  15. Cheshire A, Ridge D, Clark L, et al. Why patients with chronic fatigue syndrome/ Myalgic Encephalomyelitis improve or deteriorate with graded exercise therapy. J. Psychosom. Res. 85, 59 (2016).

  16. Kirke KD. PACE investigators’ response is misleading regarding patient survey results. J. Health. Psych. 22(9), 1168-1176 (2017).

  17. Twisk FNM, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients. Neuro. Endocrinol. Lett. 30(3), 284-299 (2009).

  18. Geraghty K, Hann M, Kurtev S. Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys. J. Health. Psychol. (2017).

  19. ME Association. “No decisions about me without me”. ME/CFS illness management survey results, part 1. Gawcott, Bucks (England), (2015).

  20. De Kimpe A, Crijnen B, Kuijper J, et al. Zorg voor ME – Enquête onder ME-patiënten naar hun ervaringen met de zorg in Nederland (2016).

  21. Greaves F, Pape UJ, King D, et al. Associations between Internet-based patient ratings and conventional surveys of patient experience in the English NHS: an observational study. BMJ. Qual. Saf. 21(7), 600-605 (2012).

  22. Green CR, Cowan P, Elk R, et al. National Institutes of Health pathways to prevention workshop: Advancing the research on Myalgic Encephalomyelitis/ chronic fatigue syndrome. Ann. Intern. Med. 162(12), 860-865 (2015).

Source: Frank N.M. Twisk. Studies and surveys implicate potential iatrogenic harm of cognitive behavioral therapy and graded exercise therapy for myalgic encephalomyelitis and chronic fatigue syndrome patients. Research on Chronic Diseases. http://www.openaccessjournals.com/articles/studies-and-surveys-implicate-potential-iatrogenic-harm-of-cognitive-behavioral-therapy-and-graded-exercise-therapy-for-myalgic-en-12190.html

Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys

Abstract:

Cognitive behavioural therapy and graded exercise therapy are promoted as evidence-based treatments for myalgic encephalomyelitis/chronic fatigue syndrome. This article explores patients’ symptom responses following these treatments versus pacing therapy, an approach favoured by many sufferers. We analyse data from a large cross-sectional patient survey ( n = 1428) and compare our findings with those from comparable patient surveys ( n = 16,665), using a mix of descriptive statistics and regression analysis modelling.

Findings from analysis of primary and secondary surveys suggest that cognitive behavioural therapy is of benefit to a small percentage of patients (8%-35%), graded exercise therapy brings about large negative responses in patients (54%-74%), while pacing is the most favoured treatment with the lowest negative response rate and the highest reported benefit (44%-82%).

Source: Geraghty K, Hann M, Kurtev S.Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys. J Health Psychol. 2017 Aug 1:1359105317726152. doi: 10.1177/1359105317726152. [Epub ahead of print] http://journals.sagepub.com/eprint/hWSxVIBTzDtqisvafkhE/full (Full article)

Pharmacological treatment of patients with chronic fatigue syndrome

Abstract:

AIM: To evaluate the efficacy and safety of human placenta extract – laennec infusions in the treatment of patients with confirmed diagnosis of 'Chronic fatigue syndrome' (CFS).

MATERIAL AND METHODS: The study included 38 patients with CFS, randomized into 2 groups: patients of the experimental group (EG, n=24) were treated with 10 intravenous laennec infusions, 4 ml each, 2 times/week, for 5 weeks. The control group (CG) consisted of 14 patients. Treatment efficacy evaluated by the severity of chronic fatigue ('The degree of chronic fatigue' questionnaire), state anxiety, depression and anger (Spilberger test) and quality of life (SF-36v2), exercise tolerance (cardiopulmonary exercise test with gas analysis), blood parameters were assessed before, after, and 5 weeks of follow-up.

RESULTS AND CONCLUSION: The EG patients showed a significant reduction in the index of chronic fatigue, which was accompanied by the significant decrease in state depression, anxiety, improvements in subjective assessment of quality of life, as well as a significant increase in physical performance indices (maximal oxygen consumption, anaerobic threshold, load time to failure, normalization of the lipid 'profile' immediately after course of infusions and in 5 weeks follow-up). No changes in chronic fatigue index and other recorded indicators were identified in CG. Laennec did not cause side effects, was well tolerated by all patients.

Source: Glazachev OS, Dudnik ЕN, Zagaynaya EE. Pharmacological treatment of patients with chronic fatigue syndrome.Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(4):40-44. doi: 10.17116/jnevro20171174140-44. (Article in Russian; Abstract available in Russian from the publisher). https://www.ncbi.nlm.nih.gov/pubmed/2861737

Are Traditional Remedies Useful in Management of Fibromyalgia and Chronic Fatigue Syndrome? A Review Study

Abstract:

Fibromyalgia and chronic fatigue syndrome are disorders that often occur simultaneously and are characterized by widespread pain and persistent fatigue. The patients are associated with disability and impairment social and physical functions. There are many remedies in traditional Persian medicine suggested for management of the disease complaints. The aim of this study was to investigate the clinical presentations and pathophysiology of disorders with the basic and principal textbook of traditional Persian medicine written by Avicenna ( Canon of Medicine).

According to Persian medicine, the term E'aya can be matched by mentioned disorders. Avicenna believed that strenuous activities play an important role in the beginning of some types of fatigue. He classified fatigue into 4 groups, and in each type the clinical symptoms varied. The multifaceted entity of fibromyalgia and chronic fatigue syndrome in Persian medicine and conventional medicine suggests multidisciplinary therapies in management of these disabling disorders.

Source: Mahjoub F, Salari R, Noras MR, Yousefi M.Are Traditional Remedies Useful in Management of Fibromyalgia and Chronic Fatigue Syndrome? A Review Study.J Evid Based Complementary Altern Med. 2017 Jan 1:2156587217712763. doi: 10.1177/2156587217712763. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28597692

Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial

Abstract:

BACKGROUND: A multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking.

AIM: To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective.

METHODS: A multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes.

RESULTS: The data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective.

CONCLUSIONS: The probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective.

TRIAL REGISTRATION: ISRCTN77567702.

Source: Vos-Vromans D, Evers S, Huijnen I, Köke A, Hitters M, Rijnders N, Pont M, Knottnerus A, Smeets R.Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial. PLoS One. 2017 Jun 2;12(6):e0177260. doi: 10.1371/journal.pone.0177260. ECollection 2017. https://www.ncbi.nlm.nih.gov/pubmed/2857498

Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading

Abstract:

There have been a number of studies on Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET) for ME/CFS based on a treatment model where the disease is perpetuated by cognitive processes. Although the studies are flawed and the model lacks scientific support, the treatments are described as evidence based. The studies are non-blinded and rely on subjective outcomes. There are no objective measures of adherence. The diagnostic criteria vary, and the participating patients often have one or several psychiatric diagnoses apart from suffering from chronic fatigue. The underlying model has no theoretical foundation and is at odds with physiological findings. Surveys suggest that the efficacy of CBT is no better than placebo and that GET is harmful. Therefore, cognitive behavioral therapy and graded exercise therapy for ME/CFS are not evidence based.

 

Source: Sten Helmfrid. Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading.

This is a translation of an article published in Socialmedicinsk tidskrift, Stockholm, Sweden, on September 28 th , 2016. http://socialmedicinsktidskrift.se

Academic paper: Studies on Cognitive Behavioral Therapy and Graded Exercise Therapy for ME/CFS are misleading. Available from: https://www.researchgate.net/publication/309351210_Studies_on_Cognitive_Behavioral_Therapy_and_Graded_Exercise_Therapy_for_MECFS_are_misleading [accessed Apr 2, 2017].