A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis.
OBJECTIVE
The antiinflammatory effect of macrolide antibiotics has been well-established, as has their role in the treatment of certain disorders of chronic airway inflammation. Several studies have suggested that long-term, low-dose macrolides may be efficacious in the treatment of chronic rhinosinusitis; however, these studies have lacked a control group. To date, this effect has not been tested in a randomized, placebo-controlled study.


METHODS
The authors conducted a double-blind, randomized, placebo-controlled clinical trial on 64 patients with chronic rhinosinusitis. Subjects received either 150 mg roxithromycin daily for 3 months or placebo. Outcome measures included the Sinonasal Outcome Test-20 (SNOT-20), measurements of peak nasal inspiratory flow, saccharine transit time, olfactory function, nasal endoscopic scoring, and nasal lavage assays for interleukin-8, fucose, and a2-macroglobulin.


RESULTS
There were statistically significant improvements in SNOT-20 score, nasal endoscopy, saccharine transit time, and IL-8 levels in lavage fluid (P<.05) in the macrolide group. A correlation was noted between improved outcome measures and low IgE levels. No significant improvements were noted for olfactory function, peak nasal inspiratory flow, or lavage levels for fucose and a2-macroglobulin. No improvement in any outcome was noted in the placebo-treated patients.


CONCLUSIONS
These findings suggest that macrolides may have a beneficial role in the treatment of chronic rhinosinusitis, particularly in patients with low levels of IgE, and supports the in vitro evidence of their antiinflammatory activity. Additional studies are required to assess their place in clinical practice.
Wallwork
Ben
B
School of Biomolecular and Biomedical Science, Griffith University, and Princess Alexandria Hospital, Brisbane, Australia. benwallwork@hotmail.com
Coman
William
W
Mackay-Sim
Alan
A
Greiff
Lennart
L
Cervin
Anders
A
D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D006801:Humans; D007073:Immunoglobulin E; D018942:Macrolides / Q000627:therapeutic use*; D012220:Rhinitis / Q000188:drug therapy* / Q000276:immunology; D015575:Roxithromycin / Q000627:therapeutic use; D012852:Sinusitis / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D018942:Macrolides; D015575:Roxithromycin; D007073:Immunoglobulin E