Lack of efficacy of long-term, low-dose azithromycin in chronic rhinosinusitis: A randomized controlled trial

W. J. Videler, L. Badia, R. J. Harvey, S. Gane, C. Georgalas, F. W. Van Der Meulen, D. J. Menger, M. T. Lehtonen, S. K. Toppila-Salmi, S. I. Vento, M. Hytönen, P. W. Hellings, L. Kalogjera, V. J. Lund, G. Scadding, J. Mullol, W. J. Fokkens*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

156 Citations (Scopus)

Abstract

Background: In persistent chronic rhinosinusitis (CRS), conventional treatment is often insufficient. Long-term, low-dose administration of macrolides has been suggested as a treatment option. The MACS (Macrolides in chronic rhinosinusitis) study is a randomized placebo-controlled trial evaluating the efficacy of azithromycin (AZM) in CRS. Methods: We describe a group of patients with recalcitrant CRS with and without nasal polyps unresponsive to optimal medical and (in 92% also) surgical treatment. Patients were treated with AZM or placebo. AZM was given for 3 days at 500 mg during the first week, followed by 500 mg per week for the next 11 weeks. Patients were monitored until 3 months post-therapy. The assessments included Sino-Nasal Outcome Test-22 (SNOT-22), a Patient Response Rating Scale, Visual Analogue Scale (VAS), Short Form-36 (SF-36), rigid nasal endoscopy, peak nasal inspiratory flow (PNIF), Sniffin' Sticks smell tests and endoscopically guided middle meatus cultures. Results: Sixty patients with a median age of 49 years were included. Fifty per cent had asthma and 58% had undergone revision sinus surgery. In the SNOT-22, Patient Response Rating Scale, VAS scores and SF-36, no significant difference between the AZM and the placebo groups was demonstrated. Nasal endoscopic findings, PNIF results, smell tests and microbiology showed no relevant significant differences between the groups either. Conclusion: At the investigated dose of AZM over 3 months, no significant benefit was found over placebo. Possible reasons could be disease severity in the investigated group, under-dosage of AZM and under-powering of the study. Therefore, more research is urgently required.

Original languageEnglish
Pages (from-to)1457-1468
Number of pages12
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume66
Issue number11
DOIs
Publication statusPublished - Nov 2011
Externally publishedYes

Keywords

  • antibiotic treatment
  • azithromycin
  • chronic rhinosinusitis
  • long-term low dose
  • nasal polyps
  • nose diseases
  • oral administration
  • paranasal sinus diseases
  • randomized controlled trial
  • sinusitis

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