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A prospective, randomized clinical study comparing drug eluting stent therapy and intranasal corticoid steroid therapy in the treatment of patients with chronic rhinosinusitis.

Rhinology 2017 September 2
OBJECTIVES: To conduct the first prospective, randomized controlled clinical trial comparing the efficacy of a drug-eluting stent (DES) (the Relieva StratusTM MicroFlow Spacer) and topical intranasal corticosteroid therapy in patients with chronic rhinosinusitis (CRS).

METHODS: Sixty-three adult patients with ethmoiditis were randomized into either the DES group (n=34) or nasal spray group (n=29). The main outcome variable was the Sinonasal Outcome Test 22, Visual Analogue Scale, nasal endoscopy, rhinometric measurements were performed at the beginning of the study, after three months and six months of follow-up.

RESULTS: Both treatments significantly improved quality of the life with no significant difference being found between the two groups. The VAS score decreased in both groups: improvements were significant at three and six months in the nasal spray group, but in the DES group a significant difference was noted only at three months. There was a statistically significant increase in total nasal cavity volumes in the corticosteroid spray group, but not in the DES group.

CONCLUSION: We found that patients benefitted from DES and the corticosteroid nasal spray. We could not find any significant difference between the treatments, except the greater increase in the total nasal cavity volumes favouring the nasal spray group. Because of the very good results for the nasal spray and the much higher material and operating room costs associated with DES, we cannot recommend the use of DES over nasal spray as a monotherapeutic treatment for CRS.

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