Cytokine Inhibition in Chronic Fatigue Syndrome Patients
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Rationale: Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no
somatic or pharmacological treatment has been proven effective. Dysfunction of the cytokine
network has been suspected to play a role in the pathophysiology of CFS. Although
derangements of the cytokine network in CFS are controversial, a major problem is that many
studies did not use adequate controls. In addition, all studies have been performed on
peripheral venous blood of the patients. As cytokines mainly act in the tissues, e.g., the
brain, the information that can be derived from peripheral blood cells is limited. The only
information regarding the possible role of cytokines in the pathophysiology of CFS could come
from intervention studies in which pathogenetically important cytokines are inhibited. A
potentially relevant cytokine which can be blocked in humans without severe side effects is
IL-1. Although it is plausible that these cytokines play a role in CFS, there is limited
evidence for this.
Objective: To investigate the effect on symptomatology of interference with IL-1 in CFS
patients.
Study design: A randomized placebo controlled study will be performed to determine whether
interference with IL-1 is able to reduce fatigue and disabilities in CFS patients.
Study population: Female CFS patients without psychiatric co-morbidity will be included in
this study. Patients of the outpatient clinic of the Department of General internal medicine
and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study.
Patients will be asked to bring a healthy neighbourhood control to their first study visit.
Intervention: After inclusion patients will be randomized to receive one of the following
treatments:
- interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);
- placebo for 4 weeks (N=25).
Main study parameters/endpoints: The primary outcome measure will be fatigue severity
measured with the Checklist Individual Strength (CIS) at 4 weeks, measurement will be
repeated up to 26 weeks.
Secondary outcome measures will be:
- level of functional impairment measured with the Sickness Impact Profile (SIP8) total
score;
- physical and social functioning assessed with the subscale physical functioning and
social functioning of the SF-36;
- level of psychological distress assessed with the total score on the Symptom
Checklist-90 (SCL-90);
- pain severity assessed with a Visual Analog Scale (VAS);
- cytokine measurement in blood (plasma and blood in Pax-gene tubes) and saliva (at
protein and mRNA level);
- cortisol measurement in saliva and hair;
- microbiome determination in faeces;
- body temperature and pulse rate.