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Randomized Controlled Trial
. 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

Stephan P Keijmel  1   2 , Corine E Delsing  3 , Gijs Bleijenberg  4 , Jos W M van der Meer  1   2 , Rogier T Donders  5 , Monique Leclercq  6 , Linda M Kampschreur  7 , Michel van den Berg  8 , Tom Sprong  2   9 , Marrigje H Nabuurs-Franssen  10 , Hans Knoop  4   11 , Chantal P Bleeker-Rovers  1   2
Affiliations
Randomized Controlled Trial

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

Stephan P Keijmel et al. Clin Infect Dis. .

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.

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Comment in

  • Q Fever: Confusion Between Chronic Infection and Chronic Fatigue.
    Raoult D. Raoult D. Clin Infect Dis. 2017 Sep 15;65(6):1054-1055. doi: 10.1093/cid/cix469. Clin Infect Dis. 2017. PMID: 28520862 No abstract available.
  • Reply to Raoult.
    Keijmel SP, Bleijenberg G, van der Meer JWM, Knoop H, Bleeker-Rovers CP. Keijmel SP, et al. Clin Infect Dis. 2017 Sep 15;65(6):1055-1056. doi: 10.1093/cid/cix470. Clin Infect Dis. 2017. PMID: 28520868 No abstract available.

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