Initial Use of Oral Steroids May Improve Chronic Rhinosinusitis With Polyposis

Laurie Barclay, MD

March 02, 2011

March 2, 2011 — Initial treatment with oral corticosteroids may alleviate symptoms of chronic rhinosinusitis (CRS) with polyposis, according to the results of a parallel randomized trial reported in the March 1 issue of the Annals of Internal Medicine.

"Chronic rhinosinusitis with nasal polyposis is a common problem resulting in nasal blockage, facial pain, and hyposmia," write Sriram Vaidyanathan, MBBS, from Ninewells Hospital and University of Dundee, Dundee, United Kingdom, and colleagues. "Responses to therapy are frequently incomplete, and relapses are common. Although oral steroids are recommended only when specialty care is required, little is known about their efficacy."

Radiograph of CRS with polyposis

The goal of the study was to assess the effectiveness and safety of a 2-week regimen of oral steroid therapy followed by 26 weeks of sequential topical steroid maintenance therapy.

At a specialty rhinology clinic in Tayside, Scotland, 60 adults with CRS and moderate-sized or larger nasal polyps who were referred by their primary physicians for specialty care were randomly assigned by computer-generated block randomization and central allocation to receive oral prednisolone, 25 mg/day, or placebo for 2 weeks. Both groups then received 8 weeks of treatment with fluticasone propionate nasal drops, 400 μg twice daily, followed by fluticasone propionate nasal spray, 200 μg twice daily, for 18 weeks.

Patients as well as investigators were blinded to group allocation. The main study endpoint was polyp grading, and secondary outcomes were hyposmia score, quality of life, symptoms, nasal patency, adrenal function, and bone turnover.

From baseline to 2 weeks, the mean decrease in polyp grade was 2.1 ± 1.1 units in the prednisolone group vs 0.1 ± 1.0 unit in the placebo group (mean difference between groups, −1.8 units; 95% confidence interval [CI], −2.4 to −1.2 units; P < .001). At 10 weeks, the between-group difference was −1.08 units (95% CI, −1.74 to −0.42 unit; P = .001); at 28 weeks, it was −0.8 unit (95% CI, −1.8 to 0.2 unit; P = .11).

From baseline to 2 weeks, the mean decrease in hyposmia score was 31.12 ± 30.1 mm in the prednisolone group and 1.41 mm ± 30.6 in the placebo group (mean between-group difference, −28.33 mm; 95% CI, −42.71 to −13.96 mm; P = .002). At 10 weeks, the between-group difference was −16.06 mm (95% CI, −30.99 to −1.13 mm; P = .03); at 28 weeks, it was −12.13 mm (95% CI, −30.55 to 6.29 mm; P = .19).

Patients receiving prednisolone had transient suppression of adrenal function and increase in bone turnover after 2 weeks, but these returned to baseline at 10 and 28 weeks.

"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," the study authors write.

Limitations of this study include setting at a single-center rhinology clinic, limiting generalizability; and lack of serial measurements of nasal inflammation markers, such as nitric oxide or cytokine levels.

In an accompanying editorial, Joaquim Mullol, MD, PhD, and Isam Alobid, MD, PhD, from the Rhinology Unit and Smell Clinic, Hospital Clínic i Universitari in Barcelona, Spain, call this a "carefully executed study" despite its small size.

"Yet, clinicians must temper their enthusiasm for oral therapy with recognition of potential systemic adverse effects on the HPA [hypothalamic-pituitary-adrenal] axis and bone metabolism," Drs. Mullol and Alobid write. "These adverse effects are likely to be greatest among elderly patients, postmenopausal women, and those who receive repeated courses of oral therapy. Thus, we believe that oral steroid therapy should be initiated only when patients with chronic rhinosinusitis with nasal polyps have an unsatisfactory response to at least 3 months of treatment with intranasal corticosteroids. We advocate an initial daily dose of 0.5 to 1 mg/kg that is tapered after 2 weeks, followed by intranasal corticosteroid therapy."

Chief Scientist Office, Scotland; National Health Service Tayside Small Grants Scheme; and an Anonymous Trust grant from University of Dundee supported this study. Disclosures of the study authors can be viewed at this particular Web site of the Annals of Internal Medicine. Disclosures of the editorialists can be viewed at this particular Web site of the Annals of Internal Medicine.

Ann Intern Med. 2011;154:293-302, 365-367. Full text Excerpt

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