Tag: 2012

Test effort in persons with Chronic Fatigue Syndrome when assessed using the Validity Indicator Profile

Abstract:

The current study examined the potential contribution of suboptimal effort to the cognitive deficits that are associated with Chronic Fatigue Syndrome (CFS) using the Validity Indicator Profile (VIP). Unlike most tests of effort, the VIP distinguishes between intentional and unintentional poor performance and does not assess cognitive functions that are affected by CFS, thereby reducing the risk of mistakenly attributing genuinely poor performance to reduced effort.

The VIP was administered to 54 persons with CFS and 54 matched healthy community controls, and performance categorized into 1 of 4 response styles (valid: compliant; invalid: suppressed, irrelevant, inconsistent), based on the level of effort expended (high or low) and the intention to perform well or not. VIP performance was classified as valid for the majority of participants (CFS and controls), indicating high levels of effort and an intention to perform well.

Three participants in the CFS group and four in the control group showed low levels of effort but an intention to do well (invalid: inconsistent). No participant performed in a manner indicative of an intent to perform poorly (invalid: suppressed, inconsistent). These findings suggest that poor effort is unlikely to contribute to cognitive test performance of persons with CFS.

 

Source: Cockshell SJ, Mathias JL. Test effort in persons with Chronic Fatigue Syndrome when assessed using the Validity Indicator Profile. J Clin Exp Neuropsychol. 2012;34(7):679-87. doi: 10.1080/13803395.2012.668176. Epub 2012 Mar 23. https://www.ncbi.nlm.nih.gov/pubmed/22440059

 

Adolescent chronic fatigue syndrome; a follow-up study displays concurrent improvement of circulatory abnormalities and clinical symptoms

Abstract:

BACKGROUND: The pathophysiology of chronic fatigue syndrome (CFS) in adolescents is unknown, and the clinical course and prognosis is still questioned. Recent research indicates that abnormalities of autonomic cardiovascular control may play an important role. The aim of this research project was to perform a follow-up study of adolescents with chronic fatigue syndrome, focusing on clinical symptoms and autonomic cardiovascular control.

METHODS: 47 adolescents (12-18 years old) with CFS were recruited from the outpatient clinic at the Department of Pediatrics, Oslo University Hospital. In a primary visit and a follow-up visit (3-17 months later), we evaluated: a) a wide range of complaints and symptoms and b) cardiovascular variables at baseline and during a 20° head-up tilt-test (HUT).

RESULTS: At the second visit, patients reported significant improvement regarding functional impairments, fatigue severity, muscular pain, concentration problems, post-exertional malaise and the problem of non-relieving rest. Also, at the second visit, baseline heart rate (HR), blood pressure, total peripheral resistance index (TPRI) and LF/HF (low-frequency:high-frequency heart rate variability ratio, an index of sinus node sympathovagal balance derived from spectral analyses of heart rate) were significant lower, and the increases in HR, mean blood pressure (MBP), diastolic blood pressure (DBP) and TPRI during tilt were significantly less pronounced as compared to the first visit. There was a significant correlation between changes in autonomic symptom score, fatigue severity score and functional impairment score from the first to the second visit.

CONCLUSIONS: The majority of adolescents with CFS experienced an improvement over time in functional impairment, self-reported fatigue and additional symptoms, and a concurrent improvement of autonomic cardiovascular control. A possible connection between clinical symptoms and abnormal autonomic control in CFS might represent a focus for further research.

 

Source: Sulheim D, Hurum H, Helland IB, Thaulow E, Wyller VB. Adolescent chronic fatigue syndrome; a follow-up study displays concurrent improvement of circulatory abnormalities and clinical symptoms. Biopsychosoc Med. 2012 Mar 21;6:10. doi: 10.1186/1751-0759-6-10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3337799/ (Full article)

 

A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome

Abstract:

BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue. The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C(12)U), in patients with debilitating CFS/ME.

METHODS AND FINDINGS: A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET). Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36). Subjects receiving rintatolimod for 40 weeks improved intra-patient placebo-adjusted ET 21.3% (p = 0.047) from baseline in an intention-to-treat analysis. Correction for subjects with reduced dosing compliance increased placebo-adjusted ET improvement to 28% (p = 0.022). The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies. The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048). Placebo subjects crossed-over to receive rintatolimod demonstrated an intra-patient improvement in ET performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg twice weekly was generally well-tolerated.

CONCLUSIONS/SIGNIFICANCE: Rintatolimod produced objective improvement in ET and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes.

TRIAL REGISTRATION: ClinicalTrials.gov NCT00215800.

 

Source: Strayer DR, Carter WA, Stouch BC, Stevens SR, Bateman L, Cimoch PJ, Lapp CW, Peterson DL; Chronic Fatigue Syndrome AMP-516 Study Group, Mitchell WM.Collaborators (12). A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist rintatolimod in severe cases of chronic fatigue syndrome. PLoS One. 2012;7(3):e31334. doi: 10.1371/journal.pone.0031334. Epub 2012 Mar 14.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3303772/ (Full article)

 

Protocol for the “four steps to control your fatigue (4-STEPS)” randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

Abstract:

BACKGROUND: Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent, severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life. Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients. Based on the self-regulation (SR) theory of behaviour change, we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills, the “4-STEPS to control your fatigue” program.

METHODS/DESIGN: This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic Fatigue Syndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a self-regulation based physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3 months) and at 12 months follow-up. The primary outcome is fatigue severity.

DISCUSSION: The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves to be effective, it may be considered as an adjunctive treatment for these patients.

TRIAL REGISTRATION: ISRCTN: ISRCTN70763996.

 

Source: Marques M, De Gucht V, Maes S, Leal I. Protocol for the “four steps to control your fatigue (4-STEPS)” randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue. BMC Public Health. 2012 Mar 19;12:202. doi: 10.1186/1471-2458-12-202. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3359226/ (Full article)

 

Stress management skills, neuroimmune processes and fatigue levels in persons with chronic fatigue syndrome

Abstract:

OBJECTIVES: Stressors and emotional distress responses impact chronic fatigue syndrome (CFS) symptoms, including fatigue. Having better stress management skills might mitigate fatigue by decreasing emotional distress. Because CFS patients comprise a heterogeneous population, we hypothesized that the role of stress management skills in decreasing fatigue may be most pronounced in the subgroup manifesting the greatest neuroimmune dysfunction.

METHODS: In total, 117 individuals with CFS provided blood and saliva samples, and self-report measures of emotional distress, perceived stress management skills (PSMS), and fatigue. Plasma interleukin-1-beta (IL-1β, IL-2, IL-6, IL-10, and tumor necrosis factor-alpha (TNF-α), and diurnal salivary cortisol were analyzed. We examined relations among PSMS, emotional distress, and fatigue in CFS patients who did and did not evidence neuroimmune abnormalities.

RESULTS: Having greater PSMS related to less fatigue (p=.019) and emotional distress (p<.001), greater diurnal cortisol slope (p=.023) and lower IL-2 levels (p=.043). PSMS and emotional distress related to fatigue levels most strongly in CFS patients in the top tercile of IL-6, and emotional distress mediated the relationship between PSMS and fatigue most strongly in patients with the greatest circulating levels of IL-6 and a greater inflammatory (IL-6):anti-inflammatory (IL-10) cytokine ratio.

DISCUSSION: CFS patients having greater PSMS show less emotional distress and fatigue, and the influence of stress management skills on distress and fatigue appear greatest among patients who have elevated IL-6 levels. These findings support the need for research examining the impact of stress management interventions in subgroups of CFS patients showing neuroimmune dysfunction.

Copyright © 2012 Elsevier Inc. All rights reserved.

 

Source: Lattie EG, Antoni MH, Fletcher MA, Penedo F, Czaja S, Lopez C, Perdomo D, Sala A, Nair S, Fu SH, Klimas N. Stress management skills, neuroimmune processes and fatigue levels in persons with chronic fatigue syndrome. Brain Behav Immun. 2012 Aug;26(6):849-58. doi: 10.1016/j.bbi.2012.02.008. Epub 2012 Mar 6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3572196/ (Full article)

 

Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial

Abstract:

BACKGROUND: Chronic fatigue syndrome is characterised by persistent fatigue and severe disability. Cognitive behavioural therapy seems to be a promising treatment, but its availability is restricted. We developed Fatigue In Teenagers on the interNET (FITNET), the first dedicated internet-based therapeutic program for adolescents with this disorder, and compared its effectiveness with that of usual care.

METHODS: Adolescents aged 12-18 years with chronic fatigue syndrome were assigned to FITNET or usual care in a 1:1 ratio at one tertiary treatment centre in the Netherlands by use of a computer-generated blocked randomisation allocation schedule. The study was open label. Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires. Analysis was by intention to treat. Thereafter, all patients were offered FITNET if needed. This trial is registered, number ISRCTN59878666.

FINDINGS: 68 of 135 adolescents were assigned to FITNET and 67 to usual care, and 67 and 64, respectively, were analysed. FITNET was significantly more effective than was usual care for all dichotomised primary outcomes at 6 months-full school attendance (50 [75%] vs 10 [16%], relative risk 4·8, 95% CI 2·7-8·9; p<0·0001), absence of severe fatigue (57 [85%] vs 17 [27%], 3·2, 2·1-4·9; p<0·0001), and normal physical functioning (52 [78%] vs 13 [20%], 3·8, 2·3-6·3; p<0·0001). No serious adverse events were reported.

INTERPRETATION: FITNET offers a readily accessible and highly effective treatment for adolescents with chronic fatigue syndrome. The results of this study justify implementation on a broader scale.

FUNDING: Netherlands Organisation for Health Research and Development.

Copyright © 2012 Elsevier Ltd. All rights reserved.

 

Source: Nijhof SL, Bleijenberg G, Uiterwaal CS, Kimpen JL, van de Putte EM. Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial. Lancet. 2012 Apr 14;379(9824):1412-8. doi: 10.1016/S0140-6736(12)60025-7. Epub 2012 Mar 3. https://www.ncbi.nlm.nih.gov/pubmed/22385683

 

The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial

Abstract:

BACKGROUND: To evaluate the effectiveness of graded exercise therapy (GET), counselling (COUNS) and usual care plus a cognitive behaviour therapy (CBT) booklet (BUC) for people presenting with chronic fatigue in primary care.

METHOD: A randomized controlled trial in general practice. The main outcome measure was the change in the Chalder fatigue score between baseline and 6 months. Secondary outcomes included a measure of global outcome, including anxiety and depression, functional impairment and satisfaction.

RESULTS: The reduction in mean Chalder fatigue score at 6 months was 8.1 [95% confidence interval (CI) 6.6-10.4] for BUC, 10.1 (95% CI 7.5-12.6) for GET and 8.6 (95% CI 6.5-10.8) for COUNS. There were no significant differences in change scores between the three groups at the 6- or 12-month assessment. Dissatisfaction with care was high. In relation to the BUC group, the odds of dissatisfaction at the 12-month assessment were less for the GET [odds ratio (OR) 0.11, 95% CI 0.02-0.54, p=0.01] and COUNS groups (OR 0.13, 95% CI 0.03-0.53, p=0.004).

CONCLUSIONS: Our evidence suggests that fatigue presented to general practitioners (GPs) tends to remit over 6 months to a greater extent than found previously. Compared to BUC, those treated with graded exercise or counselling therapies were not significantly better with respect to the primary fatigue outcome, although they were less dissatisfied at 1 year. This evidence is generalizable nationally and internationally. We suggest that GPs ask patients to return at 6 months if their fatigue does not remit, when therapy options can be discussed further.

 

Source: Ridsdale L, Hurley M, King M, McCrone P, Donaldson N. The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial. Psychol Med. 2012 Oct;42(10):2217-24. doi: 10.1017/S0033291712000256. Epub 2012 Feb 28. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3435871/ (Free article)

 

Cervical neuro-muscular syndrome: discovery of a new disease group caused by abnormalities in the cervical muscles

Abstract:

Our previous study of whiplash injury found that abnormalities in the cervical muscles cause autonomic dystonia. Further research has found that abnormalities in the cervical muscles cause headache, chronic fatigue syndrome, vertigo, and dizziness. We named this group of diseases cervical neuro-muscular syndrome. Patients treated within a 2-year period from April 1, 2002 to March 31, 2004 reported good outcomes in 83.8% for headache, 88.4% for vertigo and dizziness, 84.5% for chronic fatigue syndrome, 88.0% for autonomic dystonia, and 83.7% for whiplash-associated disorder. A large number of outpatients present with general malaise, including many general physical complaints without identifiable cause. We propose that treatment of the cervical muscle is effective for general malaise.

 

Source: Matsui T, Ii K, Hojo S, Sano K. Cervical neuro-muscular syndrome: discovery of a new disease group caused by abnormalities in the cervical muscles. Neurol Med Chir (Tokyo). 2012;52(2):75-80. https://www.jstage.jst.go.jp/article/nmc/52/2/52_2_75/_pdf (Full article)

 

Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial

Abstract:

BACKGROUND: Cognitive behaviour therapy (CBT) for chronic fatigue syndrome (CFS) is an effective but intensive treatment, requiring trained therapists. A minimal intervention based on CBT for CFS, guided self-instruction, was shown to be an effective treatment when delivered in a tertiary treatment centre. Implementing this intervention in a community-based mental health centre (MHC) will increase the treatment capacity for CFS patients. This study evaluated the effectiveness of guided self-instruction for CFS implemented in an MHC, delivered by nurses.

METHOD: One hundred and twenty-three patients were randomly assigned to either guided self-instruction (n=62) or a waiting list (n=61). Randomization was computer generated, with allocation by numbered sealed envelopes. Group allocation was open to all those involved. Patients fulfilled US Centers for Disease Control and Prevention (CDC) criteria for CFS. Primary outcome variables were fatigue severity and physical and social functioning, measured with the Checklist Individual Strength (CIS) and the Medical Outcomes Survey Short Form-36 (SF-36) respectively.

RESULTS: After 6 months, patients who followed guided self-instruction reported a significantly larger decrease in fatigue compared to the waiting list [mean difference -8.1, 95% confidence interval (CI) -3.8 to -12.4, controlled effect size 0.70]. There was no significant difference in physical and social functioning. However, post-hoc analyses showed a significant decrease in fatigue and physical disabilities following the intervention in a subgroup of patients with physical disabilities at baseline (SF-36 physical functioning ⩽70).

CONCLUSIONS: Implementation of guided self-instruction in a community-based MHC was partially successful. The minimal intervention can be effectively implemented for CFS patients with physical impairments.

 

Source: Tummers M, Knoop H, van Dam A, Bleijenberg G. Implementing a minimal intervention for chronic fatigue syndrome in a mental health centre: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2205-15. doi: 10.1017/S0033291712000232. Epub 2012 Feb 21. https://www.ncbi.nlm.nih.gov/pubmed/22354999

 

Role of psychological aspects in both chronic pain and in daily functioning in chronic fatigue syndrome: a prospective longitudinal study

Abstract:

In addition to fatigue, many patients with chronic fatigue syndrome (CFS) experience chronic musculoskeletal pain. We aimed at examining the role of catastrophizing, coping, kinesiophobia, and depression in the chronic pain complaints and in the daily functioning of CFS patients.

A consecutive sample of 103 CFS patients experiencing chronic widespread musculoskeletal pain completed a battery of questionnaires evaluating pain, daily functioning, and psychological characteristics (depression, kinesiophobia, pain coping, and catastrophizing).

Thirty-nine patients participated in the 6-12-month follow-up, consisting of questionnaires evaluating pain and pressure pain algometry. Correlation and linear regression analyses were performed to identify predictors. The strongest correlations with pain intensity were found for catastrophizing (r = -.462, p < .001) and depression (r = -.439, p < .001). The stepwise multiple regression analysis revealed that catastrophizing was both the immediate main predictor for pain (20.2%) and the main predictor on the longer term (20.1%). The degree of depression was responsible for 10% in the observed variance of the VAS pain after 6-12 months.

No significant correlation with pain thresholds could be revealed. The strongest correlations with daily functioning at baseline were found for catastrophizing (r = .435, p < .001) and depression (r = .481, p < .001). Depression was the main predictor for restrictions in daily functioning (23.1%) at baseline. Pain catastrophizing and depression were immediate and long-term main predictors for pain in patients with CFS having chronic widespread musculoskeletal pain. They were also correlated to daily functioning, with depression as the main predictor for restrictions in daily functioning at baseline.

 

Source: Meeus M, Nijs J, Van Mol E, Truijen S, De Meirleir K. Role of psychological aspects in both chronic pain and in daily functioning in chronic fatigue syndrome: a prospective longitudinal study. Clin Rheumatol. 2012 Jun;31(6):921-9. doi: 10.1007/s10067-012-1946-z. Epub 2012 Feb 16. https://www.ncbi.nlm.nih.gov/pubmed/22349876