Intranasal budesonide or fluticasone for allergic rhinitis. (Patient-Oriented Evidence that Matters).
Clinical question Which intranasal steroid, budesonide or fluticasone, is more effective in controlling symptoms of perennial allergic rhinitis?
Background Allergic rhinitis affects from 10% to 30% of the population of the United States. Intranasal corticosteroids have become more popular in the treatment of allergic rhinitis because of their ability to affect multiple steps of the inflammatory process while maintaining a large margin of safety. A study comparing the efficacy of aqueous formulations of budesonide and fluticasone had not been previously done.
Population studied A total of 375 subjects from Canada and Spain, aged 18 years and older, with at least a 1-year history of allergic perennial rhinitis were enrolled in this study. Participants were required to exhibit at least 2 of 3 symptoms of rhinitis (blocked nose, runny nose, or sneezing) during at least 8 days of an 8- to 14-day baseline period, and to have a positive skin prick response to 1 or more perennial allergens. Approximately 90% were allergic to dust mites.
Exclusion criteria included systemic or intranasal corticosteroid treatment within 2 months before enrollment, inhaled steroids for asthma >1000 [micro]g per day, nasal abnormalities that could interfere with efficacy assessment, pregnancy or breastfeeding, and not using effective contraception (for women of childbearing age).
Study design and validity The study was an adequately designed randomized placebo-controlled trial. Groups were given either budesonide (n = 111), fluticasone (n = 109), or placebo (n = 53). Treatment allocation was double-blind for budesonide and single-blind (to the healthcare provider) for fluticasone. During the 6-week treatment period, patients were instructed to administer 2 doses of the study medication to each nostril every morning (64 [micro]g budesonide aqueous spray for a total of 256 [micro]g; 50 [micro]g fluticasone propionate spray for a total of 200 [micro]g; or placebo using the same dosage vehicle as budesonide). Loratidine 10 mg was used as rescue medication throughout the study, when subjects considered symptoms intolerable. A high dropout rate of 27% (102 of the 375 randomized subjects) weakens the study somewhat, especially since explanation was lacking. The manufacturer of budesonide funded the study.
Outcomes measured The principal outcome measure was patient assessment of 3 symptoms: blocked nose, runny nose, and sneezing. Each symptom was self-scored on a 4-point scale, where 0 = no symptom and 3 = severe symptom. Secondary outcomes were patient assessment of overall treatment effectiveness (substantial/total control, minor control, aggravated/no control), nasal examination by rhinoscopy, use of rescue medication, and adverse events.
Results The reduction in the combined nasal symptom score was statistically significant for both budesonide and fluticasone when compared with placebo (P < .001 and P = .001, respectively). Of the 3 nasal symptoms assessed, nasal blockage was significantly more decreased with budesonide compared with fluticasone (0.75 vs 0.5 points, P = .009). Patient assessment of overall treatment efficacy was not statistically different between the 2 medications at 3 and 6 weeks after beginning treatment. Both were effective compared with placebo. The use of rescue medication was reduced in both active treatment groups with no difference between the 2 groups. Bloody nasal discharge was more common in the budesonide group (18%) versus the fluticasone group (7%).
Recommendations for clinical practice Intranasal budesonide and fluticasone propionate are both effective in relieving symptoms of perennial rhinitis. Although symptom reduction scores were better for budesonide, especially for nasal blockage, patients considered overall symptom control to be substantial or complete for both equally. For patients annoyed by bloody nasal discharge, fluticasone performs better. At the doses used in this study, the costs of the 2 treatments are comparable.
Sri Kala Yedavally-Yellayi, DO Linda French, MD Oakwood Healthcare System Dearborn, Michigan E-mail: firstname.lastname@example.org
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|Author:||Yedavally-Yellayi, Sri Kala; French, Linda|
|Publication:||Journal of Family Practice|
|Article Type:||Brief Article|
|Date:||Apr 1, 1999|
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