Category: Treatment

Treatment of 741 Italian patients with chronic fatigue syndrome

Abstract:

BACKGROUND: Chronic Fatigue Syndrome (CFS) is a distinctive syndrome characterized by specific symptoms cluster. CFS mostly affects women and often results in severe functional limitation. Its prevalence varies from 0.4 to 2.5% in the general population. In our prior studies on the clinical features of 205 CFS patients we founded immunological and brain abnormalities. In this paper we illustrate our caseload on CFS treatment.

PATIENTS AND METHODS: From January 2000 to December 2005, we evaluated all the patients admitted at the CFS Unit of the Aviano National Cancer Institute, for staging procedures and treatments. Patients not meeting the Fukuda diagnostic criteria were excluded.

RESULTS: 250 male and 491 female (median age 35.5 and 39.3 years, respectively) were enrolled and treated for CFS. As expected, CFS resulted from previous infectious disease in all patients. Female patients showed to be more affected by symptoms than male patients. The treatment schedules followed by the patients included nutritional supplements alone, corticosteroids, antidepressant/sedative drugs, and antiviral/immunoglobulin drugs. Antiviral/ immunoglobulin drugs achieved the best response (15.3% positive responses vs. 8.3% negative responses; OR 0.44, CI 0.26-0.74, p = 0.002). The carrying out of 4 or more treatments showed a protective effect (OR 0.46, CI 0.28-0.77, p = 0.003). This finding was confirmed in the multivariate analysis, adjusted by type of drugs (OR 0.49, CI 0.28-0.84, p = 0.009) and number of treatments carried out (OR 0.51, CI 0.30-0.86, p = 0.01); these two variables were independent.

CONCLUSIONS: These findings show that the antiviral/immunoglobulin approach has a longer positive disease free survival in comparison with other approaches. However, CFS still remains a difficult disease to be effectively treated.

 

Source: Tirelli U, Lleshi A, Berretta M, Spina M, Talamini R, Giacalone A. Treatment of 741 Italian patients with chronic fatigue syndrome. Eur Rev Med Pharmacol Sci. 2013 Nov;17(21):2847-52. http://www.europeanreview.org/article/5782 (Full article available as PDF)

 

Randomized clinical trial to evaluate the efficacy and safety of valganciclovir in a subset of patients with chronic fatigue syndrome

Abstract:

There is no known treatment for chronic fatigue syndrome (CFS). Little is known about its pathogenesis. Human herpesvirus 6 (HHV-6) and Epstein-Barr virus (EBV) have been proposed as infectious triggers.

Thirty CFS patients with elevated IgG antibody titers against HHV-6 and EBV were randomized 2:1 to receive valganciclovir (VGCV) or placebo for 6 months in a double-blind, placebo-controlled trial. Clinical endpoints aimed at measuring physical and mental fatigue included the Multidimensional Fatigue Inventory (MFI-20) and Fatigue Severity Scale (FSS) scores, self-reported cognitive function, and physician-determined responder status. Biological endpoints included monocyte and neutrophil counts and cytokine levels.

VGCV patients experienced a greater improvement by MFI-20 at 9 months from baseline compared to placebo patients but this difference was not statistically significant. However, statistically significant differences in trajectories between groups were observed in MFI-20 mental fatigue subscore (P = 0.039), FSS score (P = 0.006), and cognitive function (P = 0.025). VGCV patients experienced these improvements within the first 3 months and maintained that benefit over the remaining 9 months. Patients in the VGCV arm were 7.4 times more likely to be classified as responders (P = 0.029). In the VGCV arm, monocyte counts decreased (P < 0.001), neutrophil counts increased (P = 0.037) and cytokines were more likely to evolve towards a Th1-profile (P < 0.001). Viral IgG antibody titers did not differ between arms.

VGCV may have clinical benefit in a subset of CFS patients independent of placebo effect, possibly mediated by immunomodulation and/or antiviral effect. Further investigation with longer treatment duration and a larger sample size is warranted.

TRIAL REGISTRATION: ClinicalTrials.gov NCT00478465.

© 2013 Wiley Periodicals, Inc.

 

Source: Montoya JG, Kogelnik AM, Bhangoo M, Lunn MR, Flamand L, Merrihew LE, Watt T, Kubo JT, Paik J, Desai M. Randomized clinical trial to evaluate the efficacy and safety of valganciclovir in a subset of patients with chronic fatigue syndrome. J Med Virol. 2013 Dec;85(12):2101-9. doi: 10.1002/jmv.23713. Epub 2013 Aug 19. https://www.ncbi.nlm.nih.gov/pubmed/23959519

 

Article on CFS does not reflect current best treatment practices

TO THE EDITOR: We feel that the overview of the diagnosis and treatment of chronic fatigue syndrome (CFS) was incomplete and did not reflect current best treatment practices. The discussion of current CFS research omitted key studies, such as evidence from prospective cohort studies indicating that up to 10 percent of patients with postinfectious syndromes develop CFS, regardless of the type of infectious agent.1 Biomarker research has shown distinct patterns of gene expression correlating with cytokine, adrenergic, and sensory receptor changes after modest exercise in patients with CFS compared with healthy sedentary patients.2 Indeed, many peer-reviewed publications support a physiologic etiology of CFS.

You can read the rest of this comment here: http://www.aafp.org/afp/2013/0401/ol1.html

Comment on: Chronic fatigue syndrome: diagnosis and treatment. [Am Fam Physician. 2012]

 

Source: Bateman L, Spotila J. Article on CFS does not reflect current best treatment practices. Am Fam Physician. 2013 Apr 1;87(7):Online. http://www.aafp.org/afp/2013/0401/ol1.html (Full article)

 

Treating chronic fatigue syndrome – a study into the scientific evidence for pharmacological treatments

Abstract:

BACKGROUND: Chronic fatigue syndrome, or myalgic encephalomyelitis (CFS), is a severe disabling condition. Patients with CFS usually trial many different medicines, both conventional and complementary. An overview of the pharmacological treatments used by CFS patients and the available evidence underpinning the use of these treatments would be of great value to both patients and their healthcare providers.

METHODS: Ninety-four CFS patients recruited into an Australian study investigating immunological biomarkers filled out a questionnaire assessing the medicines they were taking. Evidence from randomised clinical trials was sought in biomedical databases.

RESULTS: The 94 CFS patients used 474 different medicines and supplements. The most commonly used medicines were antidepressants, analgesics, sedatives, and B vitamins. We identified 20 randomised controlled trials studying these medicines in CFS patients.

DISCUSSION: While conventional and complementary medicines are widely used by CFS patients, the evidence for effectiveness in CFS is very limited.

 

Source: Kreijkamp-Kaspers S, Brenu EW, Marshall S, Staines D, Van Driel ML. Treating chronic fatigue syndrome – a study into the scientific evidence for pharmacological treatments. Aust Fam Physician. 2011 Nov;40(11):907-12. http://www.racgp.org.au/download/documents/AFP/2011/November/201111kkaspers.pdf (Full article)

 

Serotonergic descending inhibition in chronic pain: design, preliminary results and early cessation of a randomized controlled trial

Abstract:

AIM: We examined whether activation of serotonergic descending pathways improves pain inhibition during exercise in patients with chronic fatigue syndrome (CFS) and comorbid fibromyalgia (FM) in comparison with rheumatoid arthritis (RA) and sedentary, healthy controls in a double-blind randomized controlled trial with cross-over design.

PATIENTS AND METHODS: Three female CFS/FM patients, one female RA patient and two healthy women were randomly allocated to the experimental group (2 ml of citalopram intravenously) or the placebo group (2 ml of 0.9% NaCl intravenously). Participants performed a submaximal exercise protocol, preceded and followed by an assessment of endogenous pain inhibition. Seven days later, groups were crossed over.

RESULTS: Significant side-effects were observed in all, but one participant immediately after intravenous administration of citalopram. One CFS/FM patient withdrew because of severe post-exertional malaise.

CONCLUSION: It was decided that proceeding with the study would be unethical. No conclusion could be made regarding pain inhibition during exercise in CFS/FM compared to RA and controls.

 

Source: Meeus M, Ickmans K, De Clerck LS, Moorkens G, Hans G, Grosemans S, Nijs J. Serotonergic descending inhibition in chronic pain: design, preliminary results and early cessation of a randomized controlled trial. In Vivo. 2011 Nov-Dec;25(6):1019-25. https://www.ncbi.nlm.nih.gov/pubmed/22021700

 

The effect of homework compliance on treatment outcomes for participants with myalgic encephalomyelitis/chronic fatigue syndrome

Abstract:

PURPOSE: This study examined the relationship between level of treatment engagement through completion of homework on treatment outcomes within nonpharmacological interventions for participants with ME/CFS.

METHOD: A sample of 82 participants with ME/CFS was randomly assigned to one of four nonpharmacological interventions. Each intervention involved 13 sessions over the course of 6 months. Change scores were computed for self-report measures taken at baseline and 12-month follow-up. Homework compliance was calculated as the percentage of completed assignments across the total number of sessions and grouped into three categories: minimum (0-25%), moderate (25.1-75%), or maximum (75.1-100%).

RESULTS: Findings revealed that after controlling for treatment condition, those who completed a maximum amount of homework had greater improvement on a number of self-report outcome measures involving role, social, and mental health functioning. There were no differential improvements in physical and fatigue functioning based on level of homework compliance.

IMPLICATIONS: Findings from this study suggest homework compliance can have a positive influence on some aspects of physical, social, and mental health functioning in participants with ME/CFS. It should be emphasized that these interventions do not cure this illness. The lack of significant changes in physical functioning and fatigue levels suggests a need for more multidisciplinary treatment approaches that can elicit improvement in these areas.

 

Source: Hlavaty LE, Brown MM, Jason LA. The effect of homework compliance on treatment outcomes for participants with myalgic encephalomyelitis/chronic fatigue syndrome. Rehabil Psychol. 2011 Aug;56(3):212-8. doi: 10.1037/a0024118. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3166212/ (Full article)

 

Chronic fatigue syndrome in the media: a content analysis of newspaper articles

Abstract:

OBJECTIVES: Although cognitive behavioural therapy and graded exercise treatment are recognized evidence-based treatments for chronic fatigue syndrome/myalgic encephalomyelitis (ME), their use is still considered controversial by some patient groups. This debate has been reflected in the media, where many patients gather health information. The aim of this study was to examine how treatment for chronic fatigue syndrome/ME is described in the newspaper media.

DESIGN: Content analysis of newspaper articles.

SETTING: The digitalized media archive Atekst was used to identify Norwegian newspaper articles where chronic fatigue syndrome/ME was mentioned.

PARTICIPANTS: Norwegian newspaper articles published over a 20-month period, from 1 January 2008 to 31 August 2009.

MAIN OUTCOME MEASURES: Statements regarding efficiency of various types of treatment for chronic fatigue syndrome/ME and the related source of the treatment advice. Statements were categorized as being either positive or negative towards evidence-based or alternative treatment.

RESULTS: One hundred and twenty-two statements regarding treatment of chronic fatigue syndrome/ME were identified among 123 newspaper articles. The most frequent statements were positive statements towards alternative treatment Lightning Process (26.2%), negative statements towards evidence-based treatments (22.1%), and positive statements towards other alternative treatment interventions (22.1%). Only 14.8% of the statements were positive towards evidence-based treatment. Case-subjects were the most frequently cited sources, accounting for 35.2% of the statements, followed by physicians and the Norwegian ME association.

CONCLUSIONS: Statements regarding treatment for chronic fatigue syndrome/ME in newspapers are mainly pro-alternative treatment and against evidence-based treatment. The media has great potential to influence individual choices. The unbalanced reporting of treatment options for chronic fatigue syndrome/ME in the media is potentially harmful.

 

Source: Knudsen AK, Omenås AN, Harvey SB, Løvvik CM, Lervik LV, Mykletun A. Chronic fatigue syndrome in the media: a content analysis of newspaper articles. JRSM Short Rep. 2011 May;2(5):42. doi: 10.1258/shorts.2011.011016. Epub 2011 May 25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3105457/ (Full article)

 

Chronic fatigue syndrome

Abstract:

INTRODUCTION: Chronic fatigue syndrome (CFS) affects between 0.006% and 3% of the population depending on the criteria of definition used, with women being at higher risk than men.

METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for chronic fatigue syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

RESULTS: We found 46 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: antidepressants, cognitive behavioural therapy (CBT), corticosteroids, dietary supplements, evening primrose oil, galantamine, graded exercise therapy, homeopathy, immunotherapy, intramuscular magnesium, oral nicotinamide adenine dinucleotide, and prolonged rest.

 

Source: Reid S, Chalder T, Cleare A, Hotopf M, Wessely S. Chronic fatigue syndrome. BMJ Clin Evid. 2011 May 26;2011. pii: 1101. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3275316/ (Full article)

 

Amitriptyline and prochlorperazine inhibit proinflammatory mediator release from human mast cells: possible relevance to chronic fatigue syndrome

CFS a complex disorder characterized by unexplained severe fatigue for over 6 months with a broad range of additional symptoms involving the nervous, endocrine and immune systems, and an estimated prevalence of 1%1. Tricyclic antidepressants (TCAs) are prescribed off label for a number of painful diseases that are often comorbid, such as chronic fatigue syndrome (CFS), fibromyalgia, interstitial cystitis, and irritable bowel syndrome, the symptoms of which are worsened by stress2. However, there is no known mechanism to explain the apparent beneficial action of TCAs3.

Mast cells and their mediators have been implicated in inflammatory diseases4, including CFS5. Mast cells are located perivascularly in close proximity to neurons in the thalamus and hypothalamus, especially the median eminence6, where they are juxtaposed to corticotropin-releasing hormone (CRH)-positive nerve processes7. CRH activates mast cells to release vascular endothelial growth factor (VEGF)8, which could participate in neurogenic inflammation and contribute to the pathogenesis of CFS. Such mediators may be released locally in the brain or may cross the blood-brain-barrier (BBB), which can be disrupted by stress, subsequent to mast cell activation9. Given the above, we hypothesized that TCAs may be helpful through inhibition of mast cell release of pro-inflammatory mediators.

You can read the rest of this letter here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3498825/

 

Source: Clemons A, Vasiadi M, Kempuraj D, Kourelis T, Vandoros G, Theoharides TC. Amitriptyline and prochlorperazine inhibit proinflammatory mediator release from human mast cells: possible relevance to chronic fatigue syndrome. J Clin Psychopharmacol. 2011 Jun;31(3):385-7. doi: 10.1097/JCP.0b013e3182196e50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3498825/ (Full article)

 

The role of changes in activity as a function of perceived available and expended energy in nonpharmacological treatment outcomes for ME/CFS

Abstract:

Nonpharmacological interventions for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) often emphasize gradual increases in activity to promote improvement in physical functioning and fatigue. The energy envelope theory may provide a framework for understanding the relationship between changes in activity level and outcomes for patients with ME/CFS. This study examined the relationship between energy envelope and changes in activity after nonpharmacological interventions in a sample of 44 adults with ME/CFS.

Results showed that those who were within their energy envelope before treatment showed more improvement in physical functioning and fatigue compared with those outside of their energy envelope. These findings suggest that an assessment of perceived available and expended energy could help guide the development of individualized nonpharmacological interventions for people with ME/CFS.

© 2010 Wiley Periodicals, Inc.

 

Source: Brown M, Khorana N, Jason LA. The role of changes in activity as a function of perceived available and expended energy in nonpharmacological treatment outcomes for ME/CFS. J Clin Psychol. 2011 Mar;67(3):253-60. doi: 10.1002/jclp.20744. Epub 2010 Oct 25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3164291/ (Full article)