Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial

Sriram Vaidyanathan, Martyn Barnes, Peter Williamson, Pippa Hopkinson, Peter T. Donnan, Brian Lipworth (Lead / Corresponding author)

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    Background: Chronic rhinosinusitis (CRS) with nasal polyposis is common. The long-term efficacy and safety of approaches to medical management are not well-known.

    Objective: To evaluate the efficacy and safety of a 2-week regimen of oral steroid therapy followed by 26 weeks of sequential topical steroid maintenance therapy.

    Design: Parallel randomized trial with computer-generated block randomization and central allocation. Patients and investigators were blinded to group assignment. ( registration number: NCT00788749)

    Setting: A specialty rhinology clinic in Tayside, Scotland.

    Patients: 60 adults with CRS and moderate-sized or larger nasal polyps who were referred by their primary physicians for specialty care.

    Interventions: Patients were randomly assigned in a 1: 1 ratio to receive oral prednisolone, 25 mg/d, or placebo for 2 weeks, followed in both groups by fluticasone propionate nasal drops, 400 mu g twice daily, for 8 weeks and then fluticasone propionate nasal spray, 200 mu g twice daily, for 18 weeks.

    Measurements: Polyp grading (primary outcome), hyposmia score, quality of life, symptoms, nasal patency, adrenal function, and bone turnover.

    Results: The mean decrease in polyp grade from baseline to 2 weeks was 2.1 units (SD, 1.1) in the prednisolone group and 0.1 unit (SD, 1.0) in the placebo group (mean difference between groups, -1.8 units [95% CI, -2.4 to -1.2 units]; P < 0.001). The difference between groups was -1.08 units (CI, -1.74 to -0.42 unit; P = 0.001) at 10 weeks and -0.8 unit (CI, -1.8 to 0.2 unit; P = 0.11) at 28 weeks. The mean decrease in hyposmia score from baseline to 2 weeks was 31.12 mm (SD, 30.1) in the prednisolone group and 1.41 mm (SD, 30.6) in the placebo group (mean difference between groups, -28.33 mm [CI, -42.71 to -13.96 mm]; P = 0.002). The difference between groups was -16.06 mm (CI, -30.99 to -1.13 mm; P = 0.03) at 10 weeks and -12.13 mm (CI, -30.55 to 6.29 mm; P = 0.19) at 28 weeks. Prednisolone therapy resulted in transient suppression of adrenal function and increase in bone turnover after 2 weeks, with a return to baseline at 10 and 28 weeks.

    Limitations: Patients were referred from primary care to a single-center rhinology clinic, which limits the generalizability of results. Serial measurements of surrogates of nasal inflammation (such as nitric oxide or cytokine levels) were not performed.

    Conclusion: Initial oral steroid therapy followed by topical steroid therapy seems to be more effective over 6 months than topical steroid therapy alone in decreasing polyp size and improving olfaction in patients referred for specialty care of CRS with at least moderate nasal polyposis.

    Original languageEnglish
    Pages (from-to)293-302
    Number of pages12
    JournalAnnals of Internal Medicine
    Issue number5
    Publication statusPublished - 2011


    • Quality of life
    • Glucocorticoid receptor
    • Double blind
    • Rhinitis
    • Fluticasone
    • Budesonide
    • Spray
    • Standardization
    • Management
    • Diagnosis

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