Tag: Karnofsky performance scale

Do people with ME/CFS and joint hypermobility represent a disease subgroup? An analysis using registry data

Abstract:

Background: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a chronic, multifaceted disease that affects millions globally. Despite its significant impact, the disease’s etiology remains poorly understood, and symptom heterogeneity poses challenges for diagnosis and treatment. Joint hypermobility, commonly seen in hypermobile Ehlers-Danlos Syndrome (hEDS), has been observed in ME/CFS patients but its prevalence and clinical significance within this population are not well-characterized.

Objective: To compare the characteristics of ME/CFS patients with and without joint hypermobility (JH+ and JH-) as assessed using the Beighton scoring system, and to explore whether JH+ ME/CFS patients exhibit distinct disease characteristics, comorbidities, and health-related quality of life (HRQOL).

Methods: The study used cross-sectional, self-reported data from 815 participants of the You + ME Registry. Participants were categorized as JH+ or JH- based on self–assessed Beighton scores and compared across demographics, comorbidities, family history, and symptoms. HRQOL was assessed using the Short Form-36 RAND survey and Karnofsky Performance Status.

Results: 15.5% (N = 126) of participants were classified as JH+. JH+ participants were more likely to be female, report Ehlers-Danlos Syndrome (EDS), Postural Orthostatic Tachycardia Syndrome (POTS), and a family history of EDS. They experienced worse HRQOL, particularly in physical functioning and pain, and a higher number of autonomic, neurocognitive, headache, gut, and musculoskeletal symptoms. Sensitivity analysis suggested that ME/CFS with concurrent JH+ and EDS was associated with more severe symptoms and greater functional impairment.

Conclusion: ME/CFS patients with joint hypermobility, particularly those with EDS, demonstrate distinct clinical characteristics, including more severe symptomatology and reduced HRQOL. These findings highlight the need for comprehensive clinical assessments of ME/CFS patients with joint hypermobility. Understanding these relationships could aid in subgroup identification, improving diagnosis, and informing targeted therapeutic approaches. Further research is warranted to explore these associations and their implications for clinical practice.

Source: Kathleen Mudie, Allison Ramiller, Sadie Whittaker, Leslie E. Phillips. Do people with ME/CFS and joint hypermobility represent a disease subgroup? An analysis using registry data. Front. Neurol., 12 March 2024, Sec. Autonomic Disorders, Volume 15 – 2024 | https://doi.org/10.3389/fneur.2024.1324879 https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1324879/full (Full text)

Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome

Abstract:

PURPOSE: To determine whether the reported therapeutic benefit of intravenous immunoglobulin in patients with chronic fatigue syndrome (CFS) is dose dependent.

PATIENTS AND METHODS: Ninety-nine adult patients, who fulfilled diagnostic criteria for CFS, participated in this double-blind, randomized, and placebo-controlled trial. Patients received intravenous infusions with either a placebo solution (1% albumin) or one of three doses of immunoglobulin (0.5, 1, or 2 g/kg) on a monthly basis for 3 months, followed by a treatment-free follow-up period of 3 months. Outcome was assessed by changes in a series of self-reported measures (quality-of-life visual analog scales, standardized diaries of daily activities, the profile of mood states questionnaire) and the Karnofsky performance scale. Cell-mediated immunity was evaluated by T-cell subset analysis and delayed-type hypersensitivity (DTH) skin testing.

RESULTS: No dose of intravenous immunoglobulin was associated with a specific therapeutic benefit. Adverse reactions, typically constitutional symptoms, were reported by 70% to 80% of patients, with no relationship to immunoglobulin treatment.

CONCLUSIONS: Intravenous immunoglobulin cannot be recommended as a therapy for the treatment of CFS. A better understanding of the pathophysiology of this disorder is needed before effective treatment can be developed.

 

Source: Vollmer-Conna U, Hickie I, Hadzi-Pavlovic D, Tymms K, Wakefield D, Dwyer J, Lloyd A. Intravenous immunoglobulin is ineffective in the treatment of patients with chronic fatigue syndrome. Am J Med. 1997 Jul;103(1):38-43. http://www.ncbi.nlm.nih.gov/pubmed/9236484

 

Cognitive behaviour therapy for the chronic fatigue syndrome. Patients were not representative of all patients with the syndrome.

Comment on: Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial. [BMJ. 1996]

 

EDITOR,-Michael Sharpe and colleagues conclude that cognitive behaviour therapy leads to a sustained reduction in functional impairment for patients with the chronic fatigue syndrome.1 The levels of disability of the 60 patients who took part in the study suggest, however, that these patients do not represent a comprehensive cross section of patients with the syndrome. The 60 patients scored 60-78 on the Karnofsky scale assessing disability and so represent a different population from the 143 patients reported on by Case History Research on ME (myalgic encephalomyelitis), who would have scored 30-60 (R Gibbons et al, first world congress on chronic fatigue syndrome and related disorders, Brussels, Nov 1995). Fifty nine of these 143 patients reported functional deterioration after sustained, incrementally increased physical exertion.

The authors did not assess other symptoms common in the chronic fatigue syndrome, such as pain, nausea, muscle weakness, or balance problems-a measure of the reduction of which was taken as a standard for “success” in an earlier trial.2 The lack of evidence of significant changes in other measures besides “the principal complaint of severe fatigue” in the authors’ study tends to diminish the validity of their conclusions.

You can read the full comment here:  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2350876/pdf/bmj00539-0052c.pdf

 

Source: Gibbons R, Macintyre A, Richards C. Cognitive behaviour therapy for the chronic fatigue syndrome. Patients were not representative of all patients with the syndrome. BMJ. 1996 Apr 27;312(7038):1096; author reply 1098. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2350876/

Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVE: To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with thechronic fatigue syndrome.

DESIGN: Randomised controlled trial with final assessment at 12 months.

SETTING: An infectious diseases outpatient clinic.

SUBJECTS: 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome.

INTERVENTIONS: Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care.

MAIN OUTCOME MEASURES: The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation.

RESULTS: Only two eligible patients refused to participate. All randomised patients completed treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69). Similar differences were observed in subsidiary outcome measures. The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy. Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone.

CONCLUSION: Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment.

Comment in:

Cognitive behaviour therapy for the chronic fatigue syndrome. Good general care may offer as much benefit as cognitive behaviour therapy. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Patients were not representative of all patients with the syndrome. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Cognitive behavior therapy should be compared with placebo treatments. [BMJ. 1996]

ACP J Club. 1996 May-Jun;124(3):71.

Cognitive behaviour therapy for the chronic fatigue syndrome. Use an interdisciplinary approach. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Patients’ beliefs about their illness were probably not a major factor. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Evening primrose oil and magnesium have been shown to be effective. [BMJ. 1996]

Cognitive behaviour therapy for the chronic fatigue syndrome. Essential elements of the treatment must be identified. [BMJ. 1996]

 

Source: Sharpe M, Hawton K, Simkin S, Surawy C, Hackmann A, Klimes I, Peto T, Warrell D, Seagroatt V. Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial. BMJ. 1996 Jan 6;312(7022):22-6. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349693/

Note: You can read the full article here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349693/pdf/bmj00523-0026.pdf

 

 

Chronic fatigue syndrome. Role of psychological factors overemphasised

Comment in: Chronic fatigue syndrome and myalgic encephalomyelitis. [BMJ. 1994]

Comment on: Longitudinal study of outcome of chronic fatigue syndrome. [BMJ. 1994]

 

Editor,-In concluding that psychological factors are more important than immunological ones in determining the long term outcome of myalgic encephalomyelitis or the chronic fatigue syndrome Andrew Wilson and colleagues seem overconfident of the validity of their findings. Although the use of self rated measures of outcome is necessary, the validity of the investigators’ treatment of such data is questionable. For example, the five point self rated global illness outcome was dichotomised such that an original response of “not improved at all” was recorded to “worsened”-a decision the investigators fail to justify. It is also dubious whether patients’ recall of their own premorbid psychological state is accurate, given that the average onset was 9 years before recall and the finding that memory of an event is affected by subsequent events.

You can read the rest of this comment here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2540179/pdf/bmj00440-0053a.pdf

 

Source: Blatch C, Blatt T. Chronic fatigue syndrome. Role of psychological factors overemphasised. BMJ. 1994 May 14;308(6939):1297. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2540179/

 

A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U), in chronic fatigue syndrome

Abstract:

Chronic fatigue syndrome (CFS) is a physically debilitating illness associated with immunologic abnormalities, viral reactivation, and impairment of cognition.

In a randomized, multicenter, placebo-controlled, double-blind study of 92 patients meeting the CFS case definition of the Centers for Disease Control and Prevention, the response of several laboratory and clinical variables to an antiviral and immunomodulatory drug, poly(I).poly(C12U), was determined.

Measures of clinical response included Karnofsky performance score, a cognition scale derived from a self-administered instrument assessing symptomatology (SCL-90-R), an activities of daily living scale, and exercise treadmill performance.

After 24 weeks, patients receiving poly(I).poly(C12U) had higher scores for both global performance and perceived cognition than did patients receiving placebo. In particular, patients given poly(I).poly(C12U) had increased Karnofsky performance scores (P < .03), exhibited a greater ability to do work during exercise treadmill testing (P = .01), displayed an enhanced capacity to perform the activities of daily living (P < .04), had a reduced cognitive deficit (P = .05), and required less use of other medications (P < .05).

 

Source: Strayer DR, Carter WA, Brodsky I, Cheney P, Peterson D, Salvato P, Thompson C, Loveless M, Shapiro DE, Elsasser W, et al. A controlled clinical trial with a specifically configured RNA drug, poly(I).poly(C12U), in chronic fatigue syndrome. Clin Infect Dis. 1994 Jan;18 Suppl 1:S88-95. http://www.ncbi.nlm.nih.gov/pubmed/8148460

 

Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial

Abstract:

PURPOSE: To evaluate the potential benefit of immunologic therapy with dialyzable leukocyte extract and psychologic treatment in the form of cognitive-behavioral therapy (CBT) in patients with chronic fatigue syndrome (CFS).

PATIENTS AND METHODS: Immunologic and psychologic treatments were administered to 90 adult patients who fulfilled diagnostic criteria for CFS in a double-blind, randomized, and placebo-controlled study. A four-cell trial design allowed the assessment of benefit from immunologic and psychologic treatment individually or in combination. Outcome was evaluated by measurement of global well-being (visual analogue scales), physical capacity (standardized diaries of daily activities), functional status (Karnofsky performance scale), and psychologic morbidity (Profile of Mood States questionnaire), and cell-mediated immunity was evaluated by peripheral blood T-cell subset analysis and delayed-type hypersensitivity skin testing.

RESULTS: Neither dialyzable leukocyte extract nor CBT (alone or in combination) provided greater benefit than the nonspecific treatment regimens.

CONCLUSIONS: In this study, patients with CFS did not demonstrate a specific response to immunologic and/or psychologic therapy. The improvement recorded in the group as a whole may reflect both nonspecific treatment effects and a propensity to remission in the natural history of this disorder.

Comment in:

Treatment for chronic fatigue syndrome. [Am J Med. 1994]

Cognitive behavior therapy for chronic fatigue syndrome. [Am J Med. 1995]

Cognitive behavior therapy for chronic fatigue syndrome. [Am J Med. 1995]

 

Source: Lloyd AR, Hickie I, Brockman A, Hickie C, Wilson A, Dwyer J, Wakefield D. Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial. Am J Med. 1993 Feb;94(2):197-203. http://www.ncbi.nlm.nih.gov/pubmed/8430715