scholarly journals Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Randomized Controlled Trials

2020 ◽  
Vol 9 (11) ◽  
pp. 3463
Author(s):  
Do-Young Kim ◽  
Jin-Seok Lee ◽  
Chang-Gue Son
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Fatigue Syndrome ◽  
Sf 36

Background: Due to its unknown etiology, the objective diagnosis and therapeutics of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) are still challenging. Generally, the patient-reported outcome (PRO) is the major strategy driving treatment response because the patient is the most important judge of whether changes are meaningful. Methods: In order to determine the overall characteristics of the main outcome measurement applied in clinical trials for CFS/ME, we systematically surveyed the literature using two electronic databases, PubMed and the Cochrane Library, throughout June 2020. We analyzed randomized controlled trials (RCTs) for CFS/ME focusing especially on main measurements. Results: Fifty-two RCTs out of a total 540 searched were selected according to eligibility criteria. Thirty-one RCTs (59.6%) used single primary outcome and others adapted ≥2 kinds of measurements. In total, 15 PRO-derived tools were adapted (50 RCTs; 96.2%) along with two behavioral measurements for adolescents (4 RCTs; 7.7%). The 36-item Short Form Health Survey (SF-36; 16 RCTs), Checklist Individual Strength (CIS; 14 RCTs), and Chalder Fatigue Questionnaire (CFQ; 11 RCTs) were most frequently used as the main outcomes. Since the first RCT in 1996, Clinical Global Impression (CGI) and SF-36 have been dominantly used each in the first and following decade (26.1% and 28.6%, respectively), while both CIS and Multidimensional Fatigue Inventory (MFI) have been the preferred instruments (21.4% each) in recent years (2016 to 2020). Conclusions: This review comprehensively provides the choice pattern of the assessment tools for interventions in RCTs for CFS/ME. Our data would be helpful practically in the design of clinical studies for CFS/ME-related therapeutic development.

scholarly journals Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Do-Young Kim ◽  
Jin-Seok Lee ◽  
Samuel-Young Park ◽  
Soo-Jin Kim ◽  
Chang-Gue Son
Keyword(s):  
Systematic Review ◽  
Chronic Fatigue Syndrome ◽  
Randomized Controlled Trials ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Controlled Trials ◽  
Pharmacological Interventions ◽  
Case Definitions ◽  
Randomized Controlled ◽  
Fatigue Syndrome

Abstract Background Although medical requirements are urgent, no effective intervention has been proven for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). To facilitate the development of new therapeutics, we systematically reviewed the randomized controlled trials (RCTs) for CFS/ME to date. Methods RCTs targeting CFS/ME were surveyed using two electronic databases, PubMed and the Cochrane library, through April 2019. We included only RCTs that targeted fatigue-related symptoms, and we analyzed the data in terms of the characteristics of the participants, case definitions, primary measurements, and interventions with overall outcomes. Results Among 513 potentially relevant articles, 56 RCTs met our inclusion criteria; these included 25 RCTs of 22 different pharmacological interventions, 29 RCTs of 19 non-pharmacological interventions and 2 RCTs of combined interventions. These studies accounted for a total of 6956 participants (1713 males and 5243 females, 6499 adults and 457 adolescents). CDC 1994 (Fukuda) criteria were mostly used for case definitions (42 RCTs, 75.0%), and the primary measurement tools included the Checklist Individual Strength (CIS, 35.7%) and the 36-item Short Form health survey (SF-36, 32.1%). Eight interventions showed statistical significance: 3 pharmacological (Staphypan Berna, Poly(I):poly(C12U) and CoQ10 + NADH) and 5 non-pharmacological therapies (cognitive-behavior-therapy-related treatments, graded-exercise-related therapies, rehabilitation, acupuncture and abdominal tuina). However, there was no definitely effective intervention with coherence and reproducibility. Conclusions This systematic review integrates the comprehensive features of previous RCTs for CFS/ME and reflects on their limitations and perspectives in the process of developing new interventions.

scholarly journals Correction to: Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Do-Young Kim ◽  
Jin-Seok Lee ◽  
Samuel-Young Park ◽  
Soo-Jin Kim ◽  
Chang-Gue Son
Keyword(s):  
Systematic Review ◽  
Chronic Fatigue Syndrome ◽  
Randomized Controlled Trials ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Fatigue Syndrome

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals What treatments work for anxiety in children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)? Systematic review

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015481 ◽  
Author(s):  
Sarah Victoria Ellen Stoll ◽  
Esther Crawley ◽  
Victoria Richards ◽  
Nishita Lal ◽  
Amberly Brigden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Fatigue Syndrome ◽  
Chronic Fatigue ◽  
Behavioural Therapy ◽  
Myalgic Encephalomyelitis ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Fatigue Syndrome ◽  
Diagnostic Status ◽  
Randomised Controlled

ObjectivesAnxiety is more prevalent in children with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) than in the general population. A systematic review was carried out to identify which treatment methods are most effective for children with CFS and anxiety.DesignSystematic review using search terms entered into the Cochrane library and Ovid to search the databases Medline, Embase and psychINFO.ParticipantsStudies were selected if participants were <18 years old, diagnosed with CFS/ME (using US Centers for Disease Control and Prevention, the National Institute for Health and Care Excellence or Oxford criteria) and had a valid assessment of anxiety.InterventionsWe included observational studies and randomised controlled trials.ComparisonAny or none.OutcomesChange in anxiety diagnostic status and/or change in anxiety severity on a validated measure of anxiety from pretreatment to post-treatment.ResultsThe review identified nine papers from eight studies that met the inclusion criteria. None of the studies specifically targeted anxiety but six studies tested an intervention and measured anxiety as a secondary outcome. Of these studies, four used a cognitive behavioural therapy (CBT)-type approach to treat CFS/ME, one used a behavioural approach and one compared a drug treatment, gammaglobulin with a placebo. Three of the CBT-type studies described an improvement in anxiety as did the trial of gammaglobulin. As none of the studies stratified outcomes according to anxiety diagnostic status or severity, we were unable to determine whether anxiety changed prognosis or whether treatments were equally effective in those with comorbid anxiety compared with those without.ConclusionWe do not know what treatment should be offered for children with both anxiety and CFS/ME. Further research is therefore required to answer this question.Trial registration numberThis review was registered on Prospective Register of Systematic Review Protocols (PROSPERO) and the protocol is available fromhttp://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016043488.

scholarly journals Physical activity measures in patients with myalgic encephalomyelitis/chronic fatigue syndrome: correlations between peak oxygen consumption, the physical functioning scale of the SF-36 questionnaire, and the number of steps from an activity meter

2020 ◽  
Author(s):  
C (Linda) MC van Campen ◽  
Peter C Rowe ◽  
Freek WA Verheugt ◽  
Frans C Visser
Keyword(s):  
Physical Activity ◽  
Chronic Fatigue Syndrome ◽  
Physical Functioning ◽  
Stress Test ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Peak Oxygen Consumption ◽  
Physical Functioning Scale ◽  
Fatigue Syndrome ◽  
Sf 36

Abstract Background most studies to assess effort intolerance in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) have used questionnaires. Few studies have compared questionnaires with objective measures like an actometer or an exercise test. Therefore three measures of physical activity in ME/CFS patients, being the physical functioning scale (PFS) of the SF-36, the number of steps/day (Steps) of an actometer and the %peak VO 2 of a cardiopulmonary stress test were compared. Methods female ME/CFS patients were selected from a clinical database if the three types of measurements were available, and the interval between measurements was ≤ three months. Data of the three measures were compared by linear regression. Results in 99 female patients the three different measures were linearly, significantly and positively correlated (PFS vs Steps, PFS vs %peak VO 2 and Steps vs %peak VO 2 : all P<0.001). Subgroup analysis showed that the relations between the three measures were not different in patients with versus without fibromyalgia and with versus without a maximal exercise effort (RER≥1.1). In 20 patients re-evaluated for symptom worsening, the mean of all three measures was significantly lower (P<0.0001), strengthening the observation of the relations between them. Despite the close correlation a large variation was observed between the three measures in individual patients. Conclusions given the large variation in ME/CFS patients, the use of only one type of measurement is inadequate. Integrating the three modalities may be useful for patient care by detecting overt discrepancies and may aid study designs aimed at improving exercise capacity.

Comparing active immunotherapy efficacy of PD-L1 ≥ 50% NSCLC patients: A systematic review and meta-analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21139-e21139
Author(s):  
Yi Hu ◽  
Xiaochen Zhao ◽  
Yuezong Bai ◽  
Longgang Cui ◽  
Fan Zhang
Keyword(s):  
Systematic Review ◽  
Overall Survival ◽  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Difference ◽  
Nsclc Patients

e21139 Background: Several therapies based on immune checkpoint inhibitors (ICIs) have been approved as the 1L standard of care for PD-L1≥ 50% advanced non-small cell lung cancer (NSCLC). However, little is known about the difference in efficacy between different strategies. We conducted a systematic review and meta-analysis to help clinicians choose more reasonable treatment options. Methods: We searched PubMed, Cochrane library, Embase and major conference proceedings from January 2010 to December 2020 for randomized controlled trials that had available subgroup hazard ratios (HRs) for overall survival according to PD-L1≥ 50%. Only drugs met primary outcome or approved by FDA were included for analysis. The primary outcome was the difference in overall survival (OS). HRs and 95% CI were calculated for the pooled OS using a random-effects model. p<0.05 was considered as statistical difference. Results: A total of 10 randomized controlled trials were included for this meta-analysis. The pooled HR and 95% CI for monotherapy, ICI plus chemotherapy and ICI plus ICI were 0.64 (0.55, 0.74), 0.64 (0.51, 0.79) and 0.70 (0.55, 0.90), respectively. There was no statistical differences between ICI monotherapy and ICI plus chemotherapy (HR 1.00, 95% CI 0.77- 1.30), between ICI monotherapy and ICI plus ICI (HR 0.91, 95% CI 0.69- 1.22) or between ICI plus chemotherapy and ICI plus ICI (HR 0.91, 95% CI 0.66- 1.27). Conclusions: For PD-L1≥ 50% NSCLC patients, active ICI monotherapies showed no different efficacy when compared with ICI combination therapies.

scholarly journals Physical activity measures in patients with myalgic encephalomyelitis/chronic fatigue syndrome: correlations between peak oxygen consumption, the physical functioning scale of the SF-36 questionnaire, and the number of steps from an activity meter

2020 ◽  
Author(s):  
C (Linda) MC van Campen ◽  
Peter C Rowe ◽  
Freek WA Verheugt ◽  
Frans C Visser
Keyword(s):  
Physical Activity ◽  
Chronic Fatigue Syndrome ◽  
Physical Functioning ◽  
Stress Test ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Peak Oxygen Consumption ◽  
Physical Functioning Scale ◽  
Fatigue Syndrome ◽  
Sf 36

Abstract Background most studies to assess effort intolerance in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) have used questionnaires. Few studies have compared questionnaires with objective measures like an actometer or an exercise test. Therefore three measures of physical activity in ME/CFS patients, being the physical functioning scale (PFS) of the SF-36, the number of steps/day (Steps) of an actometer and the %peak VO 2 of a cardiopulmonary stress test were compared. Methods female ME/CFS patients were selected from a clinical database if the three types of measurements were available, and the interval between measurements was ≤ three months. Data of the three measures were compared by linear regression. Results in 99 female patients the three different measures were linearly, significantly and positively correlated (PFS vs Steps, PFS vs %peak VO 2 and Steps vs %peak VO 2 : all P<0.001). Subgroup analysis showed that the relations between the three measures were not different in patients with versus without fibromyalgia and with versus without a maximal exercise effort (RER≥1.1). In 20 patients re-evaluated for symptom worsening, the mean of all three measures was significantly lower (P<0.0001), strengthening the observation of the relations between them. Despite the close correlation a large variation was observed between the three measures in individual patients. Conclusions given the large variation in ME/CFS patients, the use of only one type of measurement is inadequate. Integrating the three modalities may be useful for patient care by detecting overt discrepancies and may aid study designs aimed at improving exercise capacity.

scholarly journals Housebound versus nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome

2016 ◽  
Vol 12 (4) ◽  
pp. 292-307 ◽  
Author(s):  
Tricia Pendergrast ◽  
Abigail Brown ◽  
Madison Sunnquist ◽  
Rachel Jantke ◽  
Julia L Newton ◽  
...  
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Bodily Pain ◽  
Chronic Fatigue ◽  
Health Impact ◽  
Myalgic Encephalomyelitis ◽  
Mental Functioning ◽  
Immune Functioning ◽  
Illness Onset ◽  
Fatigue Syndrome ◽  
Sf 36

Objectives The objective of this study was to examine individuals with myalgic encephalomyelitis and chronic fatigue syndrome who are confined to their homes due to severe symptomatology. The existing literature fails to address differences between this group, and less severe, nonhousebound patient populations. Methods Participants completed the DePaul Symptom Questionnaire, a measure of myalgic encephalomyelitis and chronic fatigue syndrome symptomology, and the SF-36, a measure of health impact on physical/mental functioning. ANOVAs and, where appropriate, MANCOVAS were used to compare housebound and nonhousebound patients with myalgic encephalomyelitis and chronic fatigue syndrome across areas of functioning, symptomatology, and illness onset characteristics. Results Findings indicated that the housebound group represented one quarter of the sample, and were significantly more impaired with regards to physical functioning, bodily pain, vitality, social functioning, fatigue, postexertional malaise, sleep, pain, neurocognitive, autonomic, neuroendocrine, and immune functioning compared to individuals who were not housebound. Discussion Findings indicated that housebound patients have more impairment on functional and symptom outcomes compared to those who were not housebound. Understanding the differences between housebound and not housebound groups holds implications for physicians and researchers as they develop interventions intended for patients who are most severely affected by this chronic illness.

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