OBJECTIVES/HYPOTHESIS: To compare efficacy and outcome of daily saline irrigation versus saline/gentamicin for treating chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective, randomized, double-blinded study. METHODS:Forty children diagnosed with CRS were enrolled. Patients were randomized to once-daily irrigation with saline or saline/gentamicin for 6 weeks. Treatment outcomes were measured using 1) Lund-Mackay scoring system of pre- and post-treatment computer tomography (CT); and 2) Sinonasal Quality-of-Life Survey (SN-5) completed at baseline, and after 3 weeks and 6 weeks of irrigation. RESULTS: Thirty-four patients completed the study and follow-up. There were statistically significant improvements in quality-of-life (QoL) scores after 3 weeks of irrigation within both groups. However, there were no statistically significant differences in the SN-5 scores between the two treatment groups after 3 and 6 week (P = .067). CT scores for each sinus and total scores were reduced for both groups after 6 weeks, and the differences in scores were statistically significant within each group after treatment, but there were no differences between the two treatment groups. Only one patient required functional endoscopic sinus surgery due to persistent symptoms. Compliance was over 90% for once daily irrigation over the 6 week treatment period. CONCLUSIONS: Once-daily intranasal irrigation for 6 weeks is safe and equally effective in the treatment of pediatric CRS using saline or saline plus gentamicin, and QoL was significantly improved after 3 weeks of irrigation in both groups. High tolerance, compliance, and effectiveness of irrigation support its use as a first-line treatment for pediatric CRS before considering surgical intervention.
RCT Entities:
OBJECTIVES/HYPOTHESIS: To compare efficacy and outcome of daily saline irrigation versus saline/gentamicin for treating chronic rhinosinusitis (CRS). STUDY DESIGN: Prospective, randomized, double-blinded study. METHODS: Forty children diagnosed with CRS were enrolled. Patients were randomized to once-daily irrigation with saline or saline/gentamicin for 6 weeks. Treatment outcomes were measured using 1) Lund-Mackay scoring system of pre- and post-treatment computer tomography (CT); and 2) Sinonasal Quality-of-Life Survey (SN-5) completed at baseline, and after 3 weeks and 6 weeks of irrigation. RESULTS: Thirty-four patients completed the study and follow-up. There were statistically significant improvements in quality-of-life (QoL) scores after 3 weeks of irrigation within both groups. However, there were no statistically significant differences in the SN-5 scores between the two treatment groups after 3 and 6 week (P = .067). CT scores for each sinus and total scores were reduced for both groups after 6 weeks, and the differences in scores were statistically significant within each group after treatment, but there were no differences between the two treatment groups. Only one patient required functional endoscopic sinus surgery due to persistent symptoms. Compliance was over 90% for once daily irrigation over the 6 week treatment period. CONCLUSIONS: Once-daily intranasal irrigation for 6 weeks is safe and equally effective in the treatment of pediatric CRS using saline or saline plus gentamicin, and QoL was significantly improved after 3 weeks of irrigation in both groups. High tolerance, compliance, and effectiveness of irrigation support its use as a first-line treatment for pediatric CRS before considering surgical intervention.
Authors: Karen Head; Lee Yee Chong; Patorn Piromchai; Claire Hopkins; Carl Philpott; Anne G M Schilder; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2016-04-26