A reboot for chronic fatigue syndrome research

Maxmen, Amy

doi:10.1038/d41586-017-08965-0

Cited by 24 publications

(23 citation statements)

References 9 publications

(8 reference statements)

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“…Since CFS was first shed light on and defined in the 1980s [71], numerous studies on its pathophysiology and treatment have been conducted. Nonetheless, CFS/ME is still poorly understood.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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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, 55 RCTs met our inclusion criteria; these included 25 RCTs of 22 different pharmacological interventions, 28 RCTs of 18 non-pharmacological interventions and 2 RCTs of combined interventions. These studies accounted for a total of 6316 participants (1568 males and 4748 females, 5859 adults and 457 adolescents). CDC 1994 (Fukuda) criteria were mostly used for case definitions (42 RCTs, 76.4%), and the primary measurement tools included the Checklist Individual Strength (CIS, 36.4%) and the 36-item Short Form health survey (SF-36, 30.9%). Eight interventions showed statistical significance: 3 pharmacological (Staphypan Berna, Poly(I):poly(C 12 U) and CoQ 10 + 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.

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“…Since CFS was first shed light on and defined in the 1980s [71], numerous studies on its pathophysiology and treatment have been conducted. Nonetheless, CFS/ME is still poorly understood.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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“…The present study is the first to examine the associations between rituximab serum concentrations, ADAs, and clinical responses among patients with ME/CFS. The results are complementary to a recent trial 16 that questions the benefit of rituximab among patients with ME/CFS and adds to the search for disease mechanisms, effective drug therapy, and mechanisms related to improvement of ME/CFS symptoms.…”

Section: Discussionmentioning

confidence: 79%

“…15 A recently completed (submitted) multicenter, randomized, double-blind Phase III trial investigating rituximab maintenance treatment versus placebo concluded that there were no significant differences in outcome measures between the rituximab and placebo groups. 16 This outcome casts doubt on the effects of rituximab intervention in ME/CFS in previous trials as well, 7,15 in which the improvements of ME/CFS symptoms could also have been caused by either placebo mechanisms or by natural variation over time. However, presently, we cannot exclude the possibility that selection mechanisms in previous trials could also be a relevant factor and that there may be a small subgroup of patients with ME/CFS with disease responsive to B-cell depletion.…”

Section: Discussionmentioning

confidence: 99%

“…15 However, we recently completed a multicenter, randomized, double-blind Phase III trial investigating rituximab maintenance treatment versus placebo (RituxME [B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab (Mabthera ® ) in Myalgic Encephalopathy/Chronic Fatigue Syndrome]; ClinicalTrials.gov identifier NCT02229942) and concluded that there were no significant differences in outcome measures between the rituximab and placebo groups (submitted). 16 The relationships between serum rituximab concentrations and efficacy have been studied in lymphomas 17e20 and in systemic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. 21e23 The associations of rituximab serum concentrations to effect, and the clinical relevance of antidrug antibodies (ADAs) against rituximab in ME/CFS, have not been described.…”

Section: Introductionmentioning

confidence: 99%

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Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome

Rekeland

Fluge

Alme

et al. 2019

Clinical Therapeutics

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Purpose: Previous Phase II trials indicated clinical benefit from B-cell depletion using the monoclonal anti-CD20 antibody rituximab in patients with myalgic encephalopathy/chronic fatigue syndrome (ME/CFS). The association between rituximab serum concentrations and the effect and clinical relevance of antidrug antibodies (ADAs) against rituximab in ME/ CFS is unknown. We retrospectively measured rituximab concentrations and ADAs in serum samples from patients included in an open-label Phase II trial with maintenance rituximab treatment (KTS-2-2010) to investigate possible associations with clinical improvement and clinical and biochemical data. Methods: Patients with ME/CFS fulfilling the Canadian criteria received rituximab (500 mg/m 2) infusions: 2 infusions 2 weeks apart (induction), followed by maintenance treatment at 3, 6, 10, and 15 months. The measured rituximab concentrations and ADAs in serum samples included 23 of 28 patients from the trial. Findings: There were no significant differences in mean serum rituximab concentrations between 14 patients experiencing clinical improvement versus 9 patients with no improvement. Female patients had higher mean serum rituximab concentrations than male patients at 3 months (P ¼ 0.05). There was a significant negative correlation between B-cell numbers in peripheral blood at baseline and rituximab serum concentration at 3 months (r ¼ −0.47; P ¼ 0.03). None of the patients had ADAs at any time point. Implications: Clinical improvement of patients with ME/CFS in the KTS-2-2010 trial was not related to rituximab serum concentrations or ADAs. This finding is also in line with a recent randomized trial questioning the efficacy of rituximab in ME/CFS. Rituximab concentrations and ADAs still offer supplemental information when interpreting the results of these trials.

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“…Moreover, patients with CFS are often dealt with a psychological problem or misdiagnosed as depression 12) . Above conflict facts between patients and clinicians have been an important medical issue and then USA government started to drive new policy via a report of Institute of Medicine (IOM) 13) .…”

Section: Introductionmentioning

confidence: 99%

Minireview for Chronic Fatigue Syndrome and its Medical Attention recently

Son

2019

J Korean Med

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Objectives: Chronic fatigue syndrome (CFS) is a debilitating illness impairing seriously quality of life, while CFS would be an optimized target disorder of Korean medicine. This study aims to present the recent information especially in aspect of medical policy and new diagnosis criteria for CFS. Methods: The literature survey was conducted using the terms of "chronic fatigue syndrome", "myalgic encephalomyelitis" and "fibromyalgia" in PubMed database and Google database in its entirety from January 2011 to February 2019. The in-depth review was made focusing on the changes in policy and medical perspective for CFS. Results: Recently large medical attentions and researches for CFS have been existed worldwide. By supporting of USA government, IOM made a report which leaded to a turning point in clinical practices and research in 2015. This report recommended a new name of CFS to systemic exertion intolerance disease (SEID), and new diagnostic criteria focusing on post-exertional malaise, unrefreshing sleep, cognitive impairment and orthostatic intolerance. The medical perspective also was changed into "a serious, chronic, complex, systemic disease" from a psychological-like disorder, and then UAS and EU governments sharply increased the research grants. Conclusions: This study provided practitioners in Korean medicine (KM) a core information about the recent changes in CFS-related perspectives. This review would be helpful for KM-derived researches or therapeutics development for CFS.

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A reboot for chronic fatigue syndrome research

Cited by 24 publications

References 9 publications

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

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

Rituximab Serum Concentrations and Anti-Rituximab Antibodies During B-Cell Depletion Therapy for Myalgic Encephalopathy/Chronic Fatigue Syndrome

Minireview for Chronic Fatigue Syndrome and its Medical Attention recently

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