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
| Autor: | Monique Leclercq, Jos W. M. van der Meer, L. M. Kampschreur, Corine E Delsing, Tom Sprong, Hans Knoop, Michel van den Berg, Rogier Donders, Stephan P. Keijmel, Gijs Bleijenberg, Marrigje H. Nabuurs-Franssen, Chantal P. Bleeker-Rovers |
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| Přispěvatelé: | APH - Mental Health, Medical Psychology |
| Rok vydání: | 2017 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Randomization medicine.medical_treatment lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine 030212 general & internal medicine business.industry Other Research Radboud Institute for Health Sciences [Radboudumc 0] Chronic fatigue Guideline Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] Confidence interval Clinical trial Cognitive behavioral therapy lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] Infectious Diseases Physical therapy business 030217 neurology & neurosurgery |
| Zdroj: | Clinical Infectious Diseases, 64, 998-1005 Clinical infectious diseases, 64(8), 998-1005. Oxford University Press Clinical Infectious Diseases, 64, 8, pp. 998-1005 |
| ISSN: | 1058-4838 |
| DOI: | 10.1093/cid/cix013 |
| Popis: | Contains fulltext : 174731.pdf (Publisher’s version ) (Closed access) 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. |
| Databáze: | OpenAIRE |
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