Adjuvant corticosteroids for tuberculous pericarditis: promising, but not proven

Background: There is controversy regarding the effectiveness of corticosteroids in tuberculous pericarditis, particularly in patients who are immunocompromised by HIV. Aim: To determine the effectiveness of adjuvant corticosteroids in tuberculous pericarditis. Design: Systematic review of randomized controlled trials. Methods: We searched the Cochrane Infectious Diseases Group trials register (June 2002), the Cochrane Controlled Trials Register (Issue 2, 2002), MEDLINE (January 1966 to March 2003), EMBASE (1980 to May 2002), and the reference lists of existing reviews, for randomized and quasi-randomized controlled trials of adjuvant corticosteroids in the treatment of suspected tuberculous pericarditis. We also contacted organizations and individuals working in the field. Two reviewers independently assessed trial quality and extracted data. We used meta-analysis with a fixed effects model to calculate the summary statistics, provided there was no statistically significant heterogeneity, and expressed results as relative risk. Results: Four trials with a total of 469 participants met our criteria. Three (total n = 411) tested adjuvant steroids in participants with suspected tuberculous pericarditis in the pre-HIV era. Fewer participants died in the intervention group, but the potentially large reduction in mortality was not statistically significant (relative risk RR 0.65, 95%CI 0.36-1.16, n = 350; p = 0.14). One trial with 58 patients that enrolled HIV-positive individuals also showed a promising but non-significant trend on mortality (RR 0.50, 95%CI 0.19-1.28; p = 0.15). There was no significant beneficial effect of steroids on re-accumulation of pericardial effusion or progression to constrictive pericarditis. Patients with pericardial effusion were significantly more likely to be alive with no functional impairment at 2 years following treatment. However, the effect was not sustained in a sensitivity analysis that included patients who were lost to follow-up. Discussion: Steroids could have large beneficial effects on mortality and morbidity in tuberculous pericarditis, but published trials are too small to be conclusive. Large placebo-controlled trials are required, and should include sufficient numbers of HIV-positive and HIV-negative participants, and an adequate adjuvant steroid dose.