Controlled trial for long‐term low‐dose erythromycin after sinus surgery for chronic rhinosinusitis. (25th November 2014)

• Record Type: Journal Article
• Authors: Haxel, Boris R.; Clemens, Meike; Karaiskaki, Niki; Dippold, Uta; Kettern, Lisanne; Mann, Wolf J.
• Is Part Of: Laryngoscope. Volume 125:Number 5(2015:May)
• Page Start: 1048
• Page End: 1055
• Publication Date: 2014-11-25
• Subjects: Otolaryngology -- Periodicals; 617.51005
• DOI: 10.1002/lary.25052
• Languages: English
• ISSNs: 0023-852X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="lary25052-sec-0001" sec-type="section"> <title>Objectives/Hypothesis</title> <p>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.</p> </sec> <sec id="lary25052-sec-0002" sec-type="section"> <title>Study Design</title> <p>Randomized double‐blind, placebo‐controlled trial.</p> </sec> <sec id="lary25052-sec-0003" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="lary25052-sec-0004" sec-type="section"> <title>Results</title> <p>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.</p> </sec> <sec id="lary25052-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> <sec id="lary25052-sec-0006" sec-type="section"> <title>Level of Evidence</title> <p>Ib. <italic>Laryngoscope</italic>, 125:1048–1055, 2015</p> </sec> </abstract>