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No effect of high‐dose inhaled steroids in pulmonary sarcoidosis: a double‐blind, placebo‐controlled study
Author(s) -
MILMAN N.,
GRAUDAL N.,
GRODE G.,
MUNCH E.
Publication year - 1994
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1111/j.1365-2796.1994.tb00798.x
Subject(s) - medicine , placebo , budesonide , sarcoidosis , pulmonary function testing , prednisolone , gastroenterology , corticosteroid , surgery , pathology , alternative medicine
Abstract. Objective. To evaluate whether inhaled steroids in high doses might be of therapeutic value in pulmonary sarcoidosis. Design. Randomized, double blind and placebo controlled parallel study. Setting. The out‐patient clinic of the Department of Pulmonary Medicine, Gentofte Hospital, Copenhagen, Denmark. Subjects. Twenty‐one untreated patients (17 males, 4 females, median age 33 years, range 21–65) and eight patients treated with systemic prednisolone. All patients had biopsy proven pulmonary sarcoidosis radiological stage I‐III. Interventions. Treatment with either inhaled budesonide 1.2 mg day −1 ‐2.0 mg day −1 ( n = 9) or placebo ( n = 12) for 12 months. Main outcome measures. Clinical (cough, chest pain, dyspnoea) and paraclinical variables (chest X‐ray, gallium scintigraphy, pulmonary function tests, and biochemical markers of disease activity: blood leukocytes, lymphocytes, serum (S‐) angiotensin converting enzyme (ACE), S‐1,25‐OH‐cholecalciferol, plasma (P‐) calcium, P‐immunoglobulins) were recorded before treatment, every three months during treatment, and 6 months after treatment had been discontinued. Results. There were no significant differences between the recorded variables in the budesonide and placebo groups. In general, a regression of disease activity was observed in both groups. Two patients in the treatment group, treated with 2.0 mg budesonide/ day, and two in the placebo group had progression in disease and were put on systemic steroids. Conclusion. Inhaled budesonide in doses of 1.2‐2.0 mg day −1 had no recognizable therapeutic effect on pulmonary sarcoidosis.