A Cochrane review [Abstract] 1 included 3 RCTs with a total of 212 patients with chronic rhinosinusitis (CRS). The patients had had sinusitis symptoms for more than 12 weeks and there was endoscopic or radiological evidence of sinusitis. In one trial functional endoscopic sinus surgery (FESS) combined with sinus irrigation and medical treatment (loracarbef 400 mg td for 10 days) was compared with sinus irrigation and medical treatment; in another trial FESS only was compared with conventional inferior meatal antrostomy. In the third trial FESS combined with medical treatment (2-week course of erythromycin 500 mg td, DRS and alkaline nasal douche followed by 3-month course of 100 µg of fluticasone propionate intranasal spray td and alkaline nasal douche) was compared with medical treatment only (12-week course of erythromycin, alkaline nasal douche and intranasal corticosteroid preparations). The median follow-up time was 12 months in all trials. The primary outcome measure was a change in clinical status or a reduction in symptoms score. The evidence available does not demonstrate that FESS is superior to medical treatment with or without sinus irrigation in patients with chronic rhinosinusitis (OR 1.63; 95% CI 0.58 to 4.53 in the other trial, WMD 1.20; 95% CI -11.89 to 14.29 in another trial). Middle meatal antrostomy, fashioned by FESS, was not superior to an inferior meatal antrostomy, a traditional sinus surgery technique (WMD 1.37; 95% CI -3.77 to 6.51). In one study there was a relapse rate of 2.4% in the FESS and sinus irrigation group compared to 5.6% in the sinus irrigation only group. The relapse rates were not mentioned in the other studies. There were no major complications, such as orbital injury or cerebrospinal fluid leak, reported in any of the included trials.
Comment: The quality of evidence is downgraded by study quality (inadequate allocation concealment), indirectness (differences between the interventions) and inconsistence (heterogeneity in population, outcomes and interventions).
Another Cochrane review [Abstract] 2 included one study with a total of 34 patients, although it was not yet a peer reviewed publication. The study randomised patients with chronic frontal sinusitis who had failed a prolonged course of medical treatment into two groups: balloon dilatation of the frontal recess (plus conventional FESS of other involved sinuses) versus conventional FESS (Draf type 1/2a procedures on the frontal sinuses). At 12 months follow up there was no statistically significant difference in radiological resolution of frontal sinuses between the two groups. The percentages of directly observed patent frontal recesses at 12 months were 75% in the balloon dilation group versus 63% in the FESS-only group. The authors state that this was statistically significant but details of the analysis were not presented.No major complications were reported. Three patients in the FESS-only group required further revision frontal sinus surgery compared to one in the balloon dilation group, although synechiae were more common in the latter.
Comment: The quality of evidence is downgraded by indirectness (not a published article) and imprecise results (one study with few patients).
An RCT 3 with a total of 92 patients compared outcomes between office balloon dilation and FESS.Adults with CRS, including those with anterior ethmoid disease, who failed medical management, underwent either standalone balloon dilation or FESS and were followed through a minimum of 1 year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was noninferior to FESS (-1.65; p < 0.001). The standardized effect size was large, showing clinically significant improvement for both interventions. Ostial patency was 96.7 and 98.7% after balloon dilation and FESS, respectively, and each group reported significant reductions (p < 0.0001) in rhinosinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS). Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved (p < 0.001) in both groups. There were no complications and revision surgery rate was 2% in each arm through 1 year.
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