title: Lack of efficacy of long-term, low-dose azithromycin in chronic rhinosinusitis: a randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
authors: Department of Otorhinolaryngology, Academic Medical Centre, Amsterdam, the Netherlands.
authors: W J
authors: WJ
authors: Videler
authors: L
authors: L
authors: Badia
authors: R J
authors: RJ
authors: Harvey
authors: S
authors: S
authors: Gane
authors: C
authors: C
authors: Georgalas
authors: F W
authors: FW
authors: van der Meulen
authors: D J
authors: DJ
authors: Menger
authors: M T
authors: MT
authors: Lehtonen
authors: S K
authors: SK
authors: Toppila-Salmi
authors: S I
authors: SI
authors: Vento
authors: M
authors: M
authors: Hytönen
authors: P W
authors: PW
authors: Hellings
authors: L
authors: L
authors: Kalogjera
authors: V J
authors: VJ
authors: Lund
authors: G
authors: G
authors: Scadding
authors: J
authors: J
authors: Mullol
authors: W J
authors: WJ
authors: Fokkens
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004724:Endoscopy; D005260:Female; D006801:Humans; D018942:Macrolides / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012220:Rhinitis / Q000188:drug therapy* / Q000601:surgery; D012852:Sinusitis / Q000188:drug therapy* / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D018942:Macrolides; D017963:Azithromycin