Authors
Bongani M Mayosi, Mpiko Ntsekhe, Jackie Bosch, Shaheen Pandie, Hyejung Jung, Freedom Gumedze, Janice Pogue, Lehana Thabane, Marek Smieja, Veronica Francis, Laura Joldersma, Kandithalal M Thomas, Baby Thomas, Abolade A Awotedu, Nombulelo P Magula, Datshana P Naidoo, Albertino Damasceno, Alfred Chitsa Banda, Basil Brown, Pravin Manga, Bruce Kirenga, Charles Mondo, Phindile Mntla, Jacob M Tsitsi, Ferande Peters, Mohammed R Essop, James BW Russell, James Hakim, Jonathan Matenga, Ayub F Barasa, Mahmoud U Sani, Taiwo Olunuga, Okechukwu Ogah, Victor Ansa, Akinyemi Aje, Solomon Danbauchi, Dike Ojji, Salim Yusuf
Publication date
2014/9/18
Journal
New England Journal of Medicine
Volume
371
Issue
12
Pages
1121-1130
Publisher
Massachusetts Medical Society
Description
Background
Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered. We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis.
Methods
Using a 2-by-2 factorial design, we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo, administered in five injections over the course of 3 months. Two thirds of the participants had concomitant human immunodeficiency virus (HIV) infection. The primary efficacy outcome was a composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis.
Results
There was no significant difference in the primary outcome between patients who received prednisolone and those who …
Scholar articles
BM Mayosi, M Ntsekhe, J Bosch, S Pandie, H Jung… - New England Journal of Medicine, 2014