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

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.

Decrease of nasal airway resistance and alleviations of symptoms after balloon sinuplasty in patients with isolated chronic rhinosinusitis: a prospective, randomised clinical study.

OBJECTIVES: The aim of this study was to evaluate and compare the clinical outcome of balloon sinuplasty and uncinectomy for patients suffering from isolated chronic rhinosinusitis of the maxillary sinus. DESIGN: A prospective, randomised, non-blinded, controlled trial was conducted. SETTING: The study was carried out at the Department of Otolaryngology, Tampere University Hospital, Finland. PARTICIPANTS: Adult patients with symptomatic isolated chronic or recurrent rhinosinusitis without severe findings in the sinuses, as documented in the sinus' Computer Tomography scan and clinical examination, were randomised into two groups: uncinectomy and balloon sinuplasty. MAIN OUTCOME MEASURES: The variables in our study are the Sinonasal Outcome Test-22 (SNOT 22), acoustic rhinometry and rhinomanometry. These parameters were analysed preoperatively and postoperatively (after 3 and 6 months). RESULTS: The preliminary results of our study have been previously published. Both balloon sinuplasty and uncinectomy significantly improved almost all the parameters of SNOT22 (P < 0.05), with no significant difference being found between these two groups (P > 0.05). Based on rhinomanometry results, airway resistance decreased after treatment. Regarding adverse effects, balloon sinuplasty was significantly associated with a lesser risk of synechia. CONCLUSIONS: Both balloon sinuplasty and uncinectomy improved the quality of life and decreased upper airway resistance of patients with mild, isolated chronic or recurrent rhinosinusitis. The smaller risk of postoperative synechiae with balloon sinuplasty combined with its promising efficiency could partially compensate for its high material cost.

Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study.

OBJECTIVES: To conduct the first prospective randomized controlled trial that evaluates and compares the clinical outcome and impact of ballonsinuplasty and endoscopic sinus surgery (ESS) on the quality of life of patients suffering from chronic or recurrent rhinosinusitis (CRS) of the maxillary sinus. METHODS: Adult patients with symptomatic chronic or recurrent rhinosinusitis without severe findings in the sinuses, as documented in the sinus' Computer Tomography scan and clinical exam, were randomized in 2 groups: ESS and Balloon Sinuplasty.The main variable in our study is the Sinonasal Outcome Test-22 (SNOT 22) and its parameters. These parameters were analysed preoperatively and at 3 months, postoperatively. RESULTS: There was a subjective improvement in symptoms after surgery. We also noticed an objective improvement in the quality of life of our patients seen as a decrease in the total SNOT 22 score. Both balloon sinuplasty and ESS significantly improved almost all the parameters of SNOT22, with no significant difference being found between these two groups. CONCLUSION: Both balloon sinuplasty and endoscopic sinus surgery improved the quality of life of patients with mild chronic or recurrent rhinosinusitis. However, the remarkably higher material cost of balloon sinuplasty compared to ESS sets limits on its broad use. There is an obvious need for further study to find out if, as an office procedure, balloon sinuplasty could deliver cost-savings high enough to cover the higher material cost of balloon sinuplasty. Our study was, however, too small to enable firm conclusions to be drawn.