The Journal of Allergy and Clinical Immunology
Volume 118, Issue 1 , Pages 128-133, July 2006

Short course of systemic corticosteroids in sinonasal polyposis: A double-blind, randomized, placebo-controlled trial with evaluation of outcome measures

  • Pravin Hissaria, DM

      Affiliations

    • From the Department of Human Immunology, Institute of Medical and Veterinary Sciences
  • ,
  • William Smith, PhD

      Affiliations

    • Departments of Immunology and Allergy
    • Corresponding Author InformationReprint requests: William Smith, PhD, Clinical Immunology and Allergy, Ward R8, Royal Adelaide Hospital, North Terrace, Adelaide, South Australia 5000.
  • ,
  • Peter J. Wormald, MD

      Affiliations

    • Department of Surgery–Otorhinolaryngology Head & Neck Surgery, Universities of Adelaide and Flinders
  • ,
  • James Taylor, FRANZCR

      Affiliations

    • Radiology, Royal Adelaide Hospital
  • ,
  • Mathew Vadas, PhD

      Affiliations

    • From the Department of Human Immunology, Institute of Medical and Veterinary Sciences
  • ,
  • David Gillis, FRCPA

      Affiliations

    • From the Department of Human Immunology, Institute of Medical and Veterinary Sciences
  • ,
  • Frank Kette, PhD

      Affiliations

    • Departments of Immunology and Allergy

Received 9 December 2005; received in revised form 9 March 2006; accepted 14 March 2006. published online 22 May 2006.

Adelaide, Australia

Background

Topical and systemic corticosteroids are the first choice in medical treatments for sinonasal polyposis, but surprisingly, there is no high-level evidence for the efficacy of oral corticosteroids.

Objective

The aim of this study was to establish the efficacy of a short course of oral prednisolone in ameliorating the symptoms of sinonasal polyposis, as well as reducing mucosal inflammation assessed by means of nasendoscopy and magnetic resonance imaging (MRI). A secondary aim was to evaluate the relationship between outcome measures.

Methods

Subjects with symptomatic endoscopically diagnosed sinonasal polyposis received 50 mg of prednisolone daily for 14 days or placebo. Outcome was quantified by using the modified 31-item Rhinosinusitis Outcome Measure questionnaire, physician's assessment, nasendoscopy with photography, and MRI.

Results

There were 20 subjects in each treatment group. Only the prednisolone-treated group showed significant improvement in nasal symptoms (P < .001). The Rhinosinusitis Outcome Measure score improved in both groups, but the prednisolone-treated group had significantly greater improvement than the placebo group (P < .001). Objectively, there was significant reduction in polyp size, as noted with nasendoscopy (P < .001) and MRI (P < .001), only in the prednisolone-treated group. The outcome measures correlated with each other; the highest level of correlation was between the objective measures of nasendoscopy and MRI (R2 = 0.76, P < .001). There were no significant adverse events.

Conclusion

This trial clearly establishes clinically significant improvement in the symptoms and pathology of sinonasal polyposis with a short course of systemic corticosteroids. MRI scanning and quantitative nasendoscopic photography are objective and valid tools for assessing the outcome of treatment in this condition.

Clinical implications

A 14-day course of 50 mg of prednisolone is safe and effective therapy for symptomatic nasal polyposis.

Key words: Nasal polyps, corticosteroids, medical treatment, 31-item rhinosinusitis outcome measure, endoscopy, magnetic resonance imaging, outcome, randomized, double blind, placebo controlled

Abbreviations used: CT, Computed tomography, MRI, Magnetic resonance imaging, RSOM-31, Thirty-one–item rhinosinusitis outcome measure

 

 Disclosure of potential conflict of interest: P. Wormwald receives royalties from Medtronic Xomed for instruments designed. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(06)00655-5

doi:10.1016/j.jaci.2006.03.012

The Journal of Allergy and Clinical Immunology
Volume 118, Issue 1 , Pages 128-133, July 2006