BACKGROUND: The treatment of nasal polyps is controversial, and medical treatment alone has been little investigated to our knowledge. OBJECTIVE: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical removal or intramuscular betamethasone. DESIGN: Randomized, double-blind comparison of 2 dosages and additional treatment, if therapy failed. After 1 year, treatment with medication was stopped, and the demand for renewed treatment was monitored for another year. PATIENTS: Patients with bilateral nasal polyps who demanded treatment were consecutively enrolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients entered the 2-year study. INTERVENTIONS: In phase 1, randomized and double-blind treatment with a topical medication, budesonide powder, 800 micrograms or 400 micrograms daily, or a placebo was given for 1 month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 micrograms or 400 micrograms daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical removal or a single injection of sustained released betamethasone. In phase 3, treatment with the medication was discontinued, and patients were monitored for another year. The time when treatment was required again was noted. The present article deals with phases 2 and 3. MAIN OUTCOME MEASURES: Patients' scores of treatment efficacy as well as symptoms and signs. Semiquantitative measurement of sense of smell and calculation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. RESULTS: In all outcome measures, a comparison of the data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was described at the end of phase 2. About 85% of the patients, including those who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages investigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The results of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. CONCLUSIONS: The clinical course in this study showed that most patients with nasal polyps do well with medical treatment. Therefore, surgery was required in few patients. However, the potential of medical treatment should be further explored in future studies.
RCT Entities:
BACKGROUND: The treatment of nasal polyps is controversial, and medical treatment alone has been little investigated to our knowledge. OBJECTIVE: To examine the efficacy of therapy using only topical budesonide powder and topical budesonide powder supplemented with surgical removal or intramuscular betamethasone. DESIGN: Randomized, double-blind comparison of 2 dosages and additional treatment, if therapy failed. After 1 year, treatment with medication was stopped, and the demand for renewed treatment was monitored for another year. PATIENTS: Patients with bilateral nasal polyps who demanded treatment were consecutively enrolled in a hospital outpatient clinic or specialty private practice. During a 15-month period from 1990 to 1992, a total of 126 patients entered the 2-year study. INTERVENTIONS: In phase 1, randomized and double-blind treatment with a topical medication, budesonide powder, 800 micrograms or 400 micrograms daily, or a placebo was given for 1 month. In phase 2, randomized and double-blind treatment with budesonide powder, 800 micrograms or 400 micrograms daily, was given. At the end of phase 1, failed therapy was supplemented by randomly assigned treatment of either surgical removal or a single injection of sustained released betamethasone. In phase 3, treatment with the medication was discontinued, and patients were monitored for another year. The time when treatment was required again was noted. The present article deals with phases 2 and 3. MAIN OUTCOME MEASURES: Patients' scores of treatment efficacy as well as symptoms and signs. Semiquantitative measurement of sense of smell and calculation of peak expiratory flow rate index based on nasal and oral peak expiratory flow. RESULTS: In all outcome measures, a comparison of the data before treatment with the corresponding figures during phase 2 showed statistically significant efficacy. The clinical course was described at the end of phase 2. About 85% of the patients, including those who received additional therapy because the initial therapy failed, rated total or substantial control over the symptoms. The 2 dosages investigated showed equal results. These findings were consistent with the signs recorded and the peak expiratory flow rate index. The results of phase 3 showed that 50% of patients had demanded treatment after 4 months, while 34% managed without medication after 1 year. CONCLUSIONS: The clinical course in this study showed that most patients with nasal polyps do well with medical treatment. Therefore, surgery was required in few patients. However, the potential of medical treatment should be further explored in future studies.
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; R Weber; K Hörmann Journal: HNO Date: 2012-02 Impact factor: 1.284
Authors: B A Stuck; C Bachert; P Federspil; W Hosemann; L Klimek; R Mösges; O Pfaar; C Rudack; H Sitter; M Wagenmann; K Hörmann Journal: HNO Date: 2007-10 Impact factor: 1.284