title: Controlled trial for long-term low-dose erythromycin after sinus surgery for chronic rhinosinusitis.
abstract: OBJECTIVE
  The efficacy of macrolides in chronic rhinosinusitis (CRS) is still under controversy. To date, only two double-blind, placebo-controlled studies have been published with differing results. None of these studies investigated the possible benefit of macrolides in the postoperative period. We conducted an investigator-initiated clinical trial using 250-mg erythromycin once a day over a period of 3 months, beginning the administration of either erythromycin or placebo 2 weeks after a surgical intervention for CRS.
  
  
  METHODS
  Randomized double-blind, placebo-controlled trial.
  
  
  METHODS
  The concentrations of eosinophilic cationic protein (ECP) and myeloperoxidase in nasal secretion were chosen as primary outcome measures. Additionally, as a secondary outcome measure, changes in the Sino-Nasal Outcome Test-20 score, olfaction, saccharin transit time, nasal endoscopy score, and self-rating of nasal health using a visual analogue scale were evaluated.
  
  
  RESULTS
  Sixty-seven patients after surgery for CRS with or without nasal polyps were screened, and 58 patients were randomized to the study groups. For the primary outcomes, the concentrations of ECP changed from 176.4 µl/l ± 79.0 to 226.1 µl/l ± 200.6 in the erythromycin group and from 186.9 µl/l ± 36.0 to 192.9 µl/l ± 189.2 in the placebo group; no statistical differences were found. Of the secondary outcomes, only the nasal endoscopy score showed a statistically significant improvement in the erythromycin group (from 2.6 ± 1.4 to 1.9 ± 1.5 points) compared to the placebo group (from 2.5 ± 1.3 to 2.6 ± 1.5 points). The subgroup of patients without nasal polyps in the erythromycin group showed a tendency to improvement in some secondary outcome criteria.
  
  
  CONCLUSIONS
  A general recommendation for long-term, low-dose erythromycin treatment after surgery for CRS cannot be given. In patients with CRS without nasal polyps, a tendency to improved parameters was detected.
  
  
  METHODS
  Ib.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, AMEOS Klinikum Haldensleben, Haldensleben, Germany; Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
authors.forename: Boris R
authors.initials: BR
authors.lastname: Haxel
authors.forename: Meike
authors.initials: M
authors.lastname: Clemens
authors.forename: Niki
authors.initials: N
authors.lastname: Karaiskaki
authors.forename: Uta
authors.initials: U
authors.lastname: Dippold
authors.forename: Lisanne
authors.initials: L
authors.lastname: Kettern
authors.forename: Wolf J
authors.initials: WJ
authors.lastname: Mann
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004917:Erythromycin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013517:Otorhinolaryngologic Surgical Procedures; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D004917:Erythromycin
keywords: CRS; Macrolides; evidence-based medicine; sinus surgery