GLUCOCORTICOID TREATMENT FOR NASAL POLYPS - THE USE OF TOPICAL BUDESONIDE POWDER, INTRAMUSCULAR BETAMETHASONE, AND SURGICAL-TREATMENT

Background: The treatment of nasal polyps is controversial, and medica l treatment alone has been little investigated to our knowledge. Objec tive: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical remov al or intramuscular betamethasone. Design: Randomized, double-blind co mparison of 2 dosages and additional treatment, if therapy failed. Aft er 1 year, treatment with medication was stopped, and the demand for r enewed treatment was monitored for another year. Patients: Patients wi th bilateral nasal polyps who demanded treatment were consecutively en rolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients en tered the 2-year study. Interventions: In phase 1, randomized and doub le-blind treatment with a topical medication, budesonide powder, 800 m u g or 400 mu g daily, or a placebo was given for I month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 mu g or 400 mu g daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical rem oval or a single injection of sustained released betamethasone. In pha se 3, treatment with the medication was discontinued, and patients wer e monitored for another year. The time when treatment was required aga in was noted. The present article deals with phases 2 and 3. Main Outc ome Measures: Patients' scores of treatment efficacy as well as sympto ms and signs. Semiquantitative measurement of sense of smell and calcu lation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. Results: In all outcome measures, a comparison of th e data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was des cribed at the end of phase 2. About 85% of the patients, including tho se who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages i nvestigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The result s of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. Conclusio ns: The clinical course in this study showed that most patients with n asal polyps do well with medical treatment. Therefore, surgery was req uired in few patients. However, the potential of medical treatment sho uld be further explored in future studies.