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Six versus 2 weeks treatment with doxycycline in European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blinded, randomised and placebo-controlled trial

Journal of neurology, neurosurgery and psychiatry, 2022-07, Vol.93 (11), p.1222-1228 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2022 ;ISSN: 0022-3050 ;EISSN: 1468-330X ;DOI: 10.1136/jnnp-2022-329724 ;PMID: 35896378

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  • Title:
    Six versus 2 weeks treatment with doxycycline in European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blinded, randomised and placebo-controlled trial
  • Author: Solheim, Anne Marit ; Lorentzen, Åslaug Rudjord ; Dahlberg, Audun Olav ; Flemmen, Heidi Øyen ; Brune, Synne ; Forselv, Kristine Johanne Nordstrøm ; Pripp, Are Hugo ; Bø, Margrete Halvorsen ; Eikeland, Randi ; Reiso, Harald ; Mygland, Åse ; Ljøstad, Unn
  • Subjects: Antibiotics ; borrelia ; Clinical medicine ; Encephalitis ; Hospitals ; infectious diseases ; lyme disease ; Neuroinfection ; Patients ; Sample size
  • Is Part Of: Journal of neurology, neurosurgery and psychiatry, 2022-07, Vol.93 (11), p.1222-1228
  • Description: BackgroundThere is limited evidence regarding optimal duration of antibiotic treatment in neuroborreliosis. We aimed to compare efficacy and safety of oral doxycycline for 2 and 6 weeks in European Lyme neuroborreliosis (LNB).MethodsThe trial had a randomised, double-blinded, placebo-controlled, non-inferiority design. Patients with LNB were recruited from eight Norwegian hospitals and randomised to doxycycline 200 mg once daily for 2 weeks, followed by 4 weeks of placebo, or doxycycline 200 mg once daily for 6 weeks. The primary endpoint was clinical improvement as measured by difference in a Composite Clinical Score (0–64 points) from baseline to 6 months. The non-inferiority margin was predetermined to 0.5 points.ResultsOne hundred and twenty-one patients were included. Fifty-two treated for 2 weeks and 53 for 6 weeks were included in the intention-to-treat analyses, and 52 and 51 in per-protocol analysis. Mean difference in clinical improvement between the groups was 0.06, 95% CI −1.2 to 1.2, p=0.99 in the intention-to-treat population, and −0.4, 95% CI −1.4 to 0.7, p=0.51 in the per-protocol population and non-inferiority could not be established. There were no treatment failures and no serious adverse events. The groups did not differ in secondary outcomes including clinical scores at 10 weeks and 12 months, cerebrospinal fluid data and patient-reported outcome measures. Patients receiving 6 weeks doxycycline reported slightly more side effects in week 5.ConclusionOur results strongly indicate that there are no benefits of doxycycline treatment beyond 2 weeks in European LNB.Trial registration number2015-001481-25.
  • Publisher: England: BMJ Publishing Group Ltd
  • Language: English
  • Identifier: ISSN: 0022-3050
    EISSN: 1468-330X
    DOI: 10.1136/jnnp-2022-329724
    PMID: 35896378
  • Source: ProQuest One Psychology
    BMJ Journals
    ProQuest Central
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