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Clin Infect Dis. 2017 Apr 15;64(8):998-1005. doi: 10.1093/cid/cix013.

Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial.

Author information

1
Radboud Expertise Center for Q Fever, Nijmegen, The Netherlands.
2
Department of Internal Medicine, Division of Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
3
Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands.
4
Expert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
5
Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
6
Department of Internal Medicine, Bernhoven Hospital, Uden, The Netherlands.
7
Department of Internal Medicine, Medical Center Leeuwarden, The Netherlands.
8
Q-uestion, Foundation for Patients With Q Fever, Eindhoven, The Netherlands.
9
Department of Internal Medicine, Canisius-Wilhelmina Hospital, 6532 SZ Nijmegen, The Netherlands.
10
Department of Medical Microbiology and Infectious Diseases, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
11
Department of Medical Psychology, Academic Medical Center, University of Amsterdam, The Netherlands.

Abstract

Background:

Approximately 20% of patients with acute Q fever will develop chronic fatigue, referred to as Q fever fatigue syndrome (QFS). The objective of this randomized controlled clinical trial was to assess the efficacy of either long-term treatment with doxycycline or cognitive-behavioral therapy (CBT) in reducing fatigue severity in patients with QFS.

Methods:

Adult patients were included who met the QFS criteria according to the Dutch guideline: a new onset of severe fatigue lasting ≥6 months with significant disabilities, related to an acute Q fever infection, without other somatic or psychiatric comorbidity explaining the fatigue. Using block randomization, patients were randomized between oral study medication and CBT (2:1) for 24 weeks. Second, a double-blind randomization between doxycycline (200 mg/day, once daily) and placebo was performed in the medication group. Primary outcome was fatigue severity at end of treatment (EOT; week 26), assessed with the Checklist Individual Strength subscale Fatigue Severity.

Results:

Of 155 patients randomized, 154 were included in the intention-to-treat analysis (doxycycline, 52; placebo, 52; CBT, 50). At EOT, fatigue severity was similar between doxycycline (40.8 [95% confidence interval {CI}, 37.3-44.3]) and placebo (37.8 [95% CI, 34.3-41.2]; difference, doxycycline vs placebo, -3.0 [97.5% CI, -8.7 to 2.6]; P = .45). Fatigue severity was significantly lower after CBT (31.6 [95% CI, 28.0-35.1]) than after placebo (difference, CBT vs placebo, 6.2 [97.5% CI, .5-11.9]; P = .03).

Conclusions:

CBT is effective in reducing fatigue severity in QFS patients. Long-term treatment with doxycycline does not reduce fatigue severity in QFS patients compared to placebo.

Clinical Trials Registration:

NCT01318356.

KEYWORDS:

Coxiella burnetii; Q fever fatigue syndrome.; cognitive-behavioral therapy; doxycycline; placebo

PMID:
28329131
DOI:
10.1093/cid/cix013
[Indexed for MEDLINE]

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