Amphotericin B irrigation for the treatment of chronic rhinosinusitis without nasal polyps: a randomized, placebo-controlled, double-blind study.
BACKGROUND
Fungus-driven inflammation is proposed to play an important role in the pathogenesis of chronic rhinosinusitis (CRS). Previous studies tested the efficacy of intranasal antifungal agents for patients with nasal polyps. The purpose of this study was to evaluate the efficacy of intranasal amphotericin B (AMB) in patients who have CRS without nasal polyps (CRSsNP).


METHODS
Patients diagnosed with CRSsNP were enrolled in this study. They were assigned randomly to receive irrigation with AMB solution (20 mg of AMB in 500 mL of normal saline) or placebo (yellowish dye in 500 mL of normal saline) for 4 weeks. The outcome measures included the Chinese version of the Rhinosinusitis Outcome Measure 31 (CRSOM-31), nasal endoscopy, and bacterial and fungal cultures.


RESULTS
Seventy patients were enrolled and 64 patients completed this study. There was significant improvement in the AMB group (n = 32) both in endoscopic (p = 0.013) and CRSOM-31 scores (p < 0.0001). The placebo group (n = 32) showed significant improvement in CRSOM-31 scores (p < 0.0001). CRSOM-31 scores were significantly lower in the AMB group than in the placebo group after 2-week treatment (p = 0.018) and remained lower after 4-week treatment, although the difference was not significant (p = 0.091). There were no significant differences in endoscopic scores and bacterial or fungal culture rates between two groups after treatment.


CONCLUSIONS
Our results showed that AMB irrigation improved symptoms and endoscopic scores but did not show superiority to saline irrigation alone in patients who have CRSsNP.
Liang
Kai-Li
KL
Department of Otolaryngology, Taichung Veterans General Hospital, Taichung, Taiwan.
Su
Mao-Chang
MC
Shiao
Jiun-Yi
JY
Tseng
Hung-Cheng
HC
Hsin
Chung-Han
CH
Lin
Jen-Fu
JF
Jiang
Rong-San
RS
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D004311:Double-Blind Method; D004724:Endoscopy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009298:Nasal Polyps / Q000175:diagnosis; D012189:Retrospective Studies; D012220:Rhinitis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D012852:Sinusitis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D007507:Therapeutic Irrigation; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000666:Amphotericin B