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.

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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].

Do graded activity therapies cause harm in chronic fatigue syndrome?

Abstract:

Reporting of harms was much better in the PACE (Pacing, graded Activity, and Cognitive behavioural therapy: a randomised Evaluation) trial than earlier chronic fatigue syndrome trials of graded exercise therapy and cognitive behavioural therapy. However, some issues remain. The trial’s poor results on objective measures of fitness suggest a lack of adherence to the activity component of these therapies. Therefore, the safety findings may not apply in other clinical contexts. Outside of clinical trials, many patients report deterioration with cognitive behavioural therapy and particularly graded exercise therapy. Also, exercise physiology studies reveal abnormalities in chronic fatigue syndrome patients’ responses to exertion. Given these considerations, one cannot conclude that these interventions are safe and risk-free.

 

Source: Tom Kindlon. Do graded activity therapies cause harm in chronic fatigue syndrome? Journal of Health Psychology. March 20, 2017. http://journals.sagepub.com/doi/full/10.1177/1359105317697323 (Full article)

 

Chronic fatigue syndrome patients need an effective therapeutic, leading expert argues

Ampligen, the first drug ever seeking approval to treat chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently hit another roadblock with the U.S. Food and Drug Administration (FDA). In its long quest to treat 1 million Americans suffering from this debilitating illness, the FDA advisory panel did not recommend the drug to be sold on the market, largely because CFS/ME doesn’t have clear biomarkers such as blood tests to define patients who most likely to respond to the drug. Data from clinical trials of Ampligen has not convinced the FDA so far.

Nancy Klimas, M.D., one of the world’s leading researchers and clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis (CFS/ME), is the director the NSU Institute for Neuro Immune Medicine. “The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated,” she says. “CFS/ME feels like you’ve been run over by a truck — pain, inflammation, utter exhaustion and trouble concentrating.”

Klimas has been caring for patients with CFS/ME for 26 years now. “It’s heartbreaking seeing them struggle and suffer from this serious illness that has been trivialized by science and society. One of the early controversies quickly disproven suggested that CFS/ME is a form of depression. This led to enduring public policies that allowed insurance companies to limit coverage to CFS/ME to either mental health or exercise therapy, neither get to the root cause of CFS/ME,” she explains.

“CFS/ME researchers, including myself, have seen major advances in our understanding of the biology of CFS/ME. It seems to resemble an illness we know how to treat like multiple sclerosis (MS), chronic viral diseases and autoimmune diseases.”

Around since the late 1980s, this drug is not new to science and medicine. Two phase 3 clinical studies have been completed. The data shows that a subgroup of CFS/ME patients showed marked improvement, even recovery on the drug.

“Yet, that’s not enough evidence for the FDA advisory committee to approve because they would like to see a conclusive biomarker,” notes Klimas. “As a physician, I could live with this decision if I had other effective therapies to treat my CFS/ME patients. But I do not. Moreover, it defies common logic in used in drug approval for other complex immune mediated diseases.”

Take for example, MS: Its earliest approved treatments had opposite immune effects. One interferon increased immune activity and a second interferon quieted immune activity. In the studies that led to approval, MS drugs, like Ampligen, had about a 40 percent success rate.

Clinical research for these early MS drugs produced no biomarkers other than a patient’s successful response to therapy, such as the case of Ampligen. The biomarker the FDA relied on for approval of MS — seeing if the lesions in a patient’s brain decreased — had no correlation to the patient’s improvement.

Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple, Klimas says. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

“With or without a biomarker, the FDA should recognize the seriousness of CFS/ME and approve Ampligen, and open the door for other targeted therapies now,” she says.

 

Source: Nova Southeastern University. “Chronic fatigue syndrome patients need an effective therapeutic, leading expert argues.” ScienceDaily. ScienceDaily, 24 January 2013. https://www.sciencedaily.com/releases/2013/01/130124183448.htm

 

Chronic Fatigue Patients Show Lower Response To Placebos

Contrary to conventional wisdom, patients with chronic fatigue syndrome respond to placebos at a lower rate than people with many other illnesses, according to the first systematic review of the topic.

According to the new analysis by Dr. Hyong Jin Cho of King’s College London and colleagues, 19.6 percent of patients with chronic fatigue syndrome improved after receiving inactive treatments, compared with a widely accepted figure of about 30 percent for other conditions.

Because the placebo effect seems to be strongest in diseases with highly subjective symptoms, some medical professionals believed it could be as high as 50 percent among CFS patients.

The review, reported in the current issue of Psychosomatic Medicine, pooled data from 29 studies in which 1,016 people with CFS received various placebos.

CFS is a complex illness that has no known cause or cure. Myriad symptoms include severe malaise, muscle and joint pain, sleep and mood disturbances and headache. The symptoms continue for at least six months and cannot be explained by any other medical conditions. The Centers for Disease Control and Prevention estimate that as many as 500,000 Americans may have CFS or related conditions.

With so many mysteries surrounding CFS, a great deal of controversy exists among both doctors and patients as to whether its origins are primarily psychological or physiological. Current evidence suggests that emotional or social stresses such as bereavement or problems at work, combined with other triggers such as common viral infections, contribute to the disorder. Additional factors, such as avoidance of physical activity, may cause the symptoms to become chronic, says Cho.

The authors propose several possible explanations for the surprisingly low placebo response revealed in the analysis. Perhaps patients have low expectations due to the reality that CFS is very difficult to treat and often persists for many years. Alternatively, disconnects between how patients and doctors view the illness “may impede development of a collaborative therapeutic relationship,” reviewers suggest.

The study also showed that the placebo response is 24 percent for medical interventions but only 14 percent for psychiatric/psychological treatments. The authors say the reason may be that many CFS sufferers seen in specialist settings or self-help groups “have a firm conviction that their illness is of physical origin” and thus would have little faith in psychiatric/psychological treatments. This finding supports the idea that the placebo response is greatly influenced by patients’ expectations of improvement.

According to the review, behavioral therapy and graded exercise therapy have benefits, and if patients were more aware of them, says Cho, they might be “more open, more optimistic, and more collaborative with the professionals, and the overall outcome of the treatments could be enhanced.”

Dr. Lucinda Bateman, an internist who specializes in CFS and fibromyalgia and serves on the board of the American Association for Chronic Fatigue Syndrome, has worked with about 500 CFS patients over the past 15 years.

“In my clinical experience, I have found that CFS is among the most difficult conditions to improve at all, with either physical or psychological interventions.” This is true in part, she says, because there is a great deal of variation among patients diagnosed with CFS, and Bateman believes that ultimately CFS may be found to involve more than one disease.

In the absence of a cure, Bateman has found that the most effective treatment for CFS combines improving symptoms with medication, helping patients retain physical conditioning when possible and using psychological and psychiatric interventions to help patients adapt to living with chronic illness.

She doesn’t discount the placebo effect, however. “When you say to people, ‘I believe you, I will help you manage your symptoms, I will advocate for you,’ that hope and feeling of control over their disease could be considered placebo effect, but it’s an important part of delivering medical care.”‘

 

Source: Center For The Advancement Of Health. “Chronic Fatigue Patients Show Lower Response To Placebos.” ScienceDaily. ScienceDaily, 22 March 2005. https://www.sciencedaily.com/releases/2005/03/050322120639.htm