Corticosteroids for pulmonary sarcoidosis.

BACKGROUND: Pulmonary sarcoidosis is a common condition with an unpredictable course. Oral or inhaled steroids are widely used in its treatment, but there is no consensus about when and in whom therapy should be initiated, what dose should be given and for how long. Corticosteroids given for several months have deleterious side-effects so it is important to know whether they have any maintained benefit in pulmonary sarcoidosis.

OBJECTIVES: To determine the randomised controlled trial (RCT) evidence for the benefit of corticosteroids (oral or inhaled) in the treatment of pulmonary sarcoidosis.

SEARCH STRATEGY: The Cochrane Airways Group interstitial lung disease RCT register was searched using the terms: sarcoidosis and (steroid* OR corticosteroid* OR prednisolone OR prednisone OR beclomethasone OR budesonide OR fluticasone). Bibliographies of retrieved RCTs and reviews were searched for additional RCTs. Pharmaceutical companies and authors of identified RCTs were contacted for other published and unpublished studies.

SELECTION CRITERIA: Two reviewers independently assessed full text articles for inclusion based upon the following criteria: the study had to be a RCT or controlled clinical trial in adults with histological evidence of pulmonary sarcoidosis.

DATA COLLECTION AND ANALYSIS: Study quality was assessed and data extracted independently by two reviewers. Outcomes were analysed as continuous and dichotomous outcomes, using standard statistical techniques.

MAIN RESULTS: Eight RCTs were identified, two had insufficient data for any analysis. There were 338 patients in the four usable trials of oral steroids, and 66 patients in two trials of inhaled steroids. The oral steroid dose was equivalent to prednisolone 15-40 mg/day. The inhaled steroid was budesonide 0.8 - 1.2 mg/day. Outcomes were symptoms, chest X-ray (CXR) changes, lung function and global scores (a combination of all three outcomes). Oral steroids improved the CXR over 6-24 months. One study showed no improvement in lung function, in another there was an improvement in diffusing capacity in the treated group. Global scores improved in patients with stage 2 and 3 disease but not with stage 1 disease. There were no data on side-effects. Inhaled steroids had no effect on CXR. In one study diffusing capacity improved. In another, symptoms improved at the end of six months of treatment.

REVIEWER'S CONCLUSIONS: Oral steroids improved the chest X-ray and a global score of CXR, symptoms and spirometry over 6-24 months. There is little evidence of an improvement in lung function. There are no data beyond 2 years to indicate whether oral steroids have any modifying effect on long-term disease progression. Oral steroids are indicated for patients with Stage 2 and 3 disease with moderate - severe or progressive symptoms or CXR changes. The available data provide no guidance for the management of this disease after 2 years. Short term (less than six months) of inhaled steroids may improved symptoms, perhaps in patients who mainly have cough.