title: Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis.
abstract: 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 received placebo (23.8% and 24.5%, respectively; hazard ratio, 0.95; 95% confidence interval [CI], 0.77 to 1.18; P=0.66) or between those who received M. indicus pranii immunotherapy and those who received placebo (25.0% and 24.3%, respectively; hazard ratio, 1.03; 95% CI, 0.82 to 1.29; P=0.81). Prednisolone therapy, as compared with placebo, was associated with significant reductions in the incidence of constrictive pericarditis (4.4% vs. 7.8%; hazard ratio, 0.56; 95% CI, 0.36 to 0.87; P=0.009) and hospitalization (20.7% vs. 25.2%; hazard ratio, 0.79; 95% CI, 0.63 to 0.99; P=0.04). Both prednisolone and M. indicus pranii, each as compared with placebo, were associated with a significant increase in the incidence of cancer (1.8% vs. 0.6%; hazard ratio, 3.27; 95% CI, 1.07 to 10.03; P=0.03, and 1.8% vs. 0.5%; hazard ratio, 3.69; 95% CI, 1.03 to 13.24; P=0.03, respectively), owing mainly to an increase in HIV-associated cancer.
  
  
  CONCLUSIONS
  In patients with tuberculous pericarditis, neither prednisolone nor M. indicus pranii had a significant effect on the composite of death, cardiac tamponade requiring pericardiocentesis, or constrictive pericarditis. (Funded by the Canadian Institutes of Health Research and others; IMPI ClinicalTrials.gov number, NCT00810849.).
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Bongani M
authors.initials: BM
authors.lastname: Mayosi
authors.forename: Mpiko
authors.initials: M
authors.lastname: Ntsekhe
authors.forename: Jackie
authors.initials: J
authors.lastname: Bosch
authors.forename: Shaheen
authors.initials: S
authors.lastname: Pandie
authors.forename: Hyejung
authors.initials: H
authors.lastname: Jung
authors.forename: Freedom
authors.initials: F
authors.lastname: Gumedze
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.forename: Marek
authors.initials: M
authors.lastname: Smieja
authors.forename: Veronica
authors.initials: V
authors.lastname: Francis
authors.forename: Laura
authors.initials: L
authors.lastname: Joldersma
authors.forename: Kandithalal M
authors.initials: KM
authors.lastname: Thomas
authors.forename: Baby
authors.initials: B
authors.lastname: Thomas
authors.forename: Abolade A
authors.initials: AA
authors.lastname: Awotedu
authors.forename: Nombulelo P
authors.initials: NP
authors.lastname: Magula
authors.forename: Datshana P
authors.initials: DP
authors.lastname: Naidoo
authors.forename: Albertino
authors.initials: A
authors.lastname: Damasceno
authors.forename: Alfred
authors.initials: A
authors.lastname: Chitsa Banda
authors.forename: Basil
authors.initials: B
authors.lastname: Brown
authors.forename: Pravin
authors.initials: P
authors.lastname: Manga
authors.forename: Bruce
authors.initials: B
authors.lastname: Kirenga
authors.forename: Charles
authors.initials: C
authors.lastname: Mondo
authors.forename: Phindile
authors.initials: P
authors.lastname: Mntla
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Tsitsi
authors.forename: Ferande
authors.initials: F
authors.lastname: Peters
authors.forename: Mohammed R
authors.initials: MR
authors.lastname: Essop
authors.forename: James B W
authors.initials: JB
authors.lastname: Russell
authors.forename: James
authors.initials: J
authors.lastname: Hakim
authors.forename: Jonathan
authors.initials: J
authors.lastname: Matenga
authors.forename: Ayub F
authors.initials: AF
authors.lastname: Barasa
authors.forename: Mahmoud U
authors.initials: MU
authors.lastname: Sani
authors.forename: Taiwo
authors.initials: T
authors.lastname: Olunuga
authors.forename: Okechukwu
authors.initials: O
authors.lastname: Ogah
authors.forename: Victor
authors.initials: V
authors.lastname: Ansa
authors.forename: Akinyemi
authors.initials: A
authors.lastname: Aje
authors.forename: Solomon
authors.initials: S
authors.lastname: Danbauchi
authors.forename: Dike
authors.initials: D
authors.lastname: Ojji
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000328:Adult; D002305:Cardiac Tamponade / Q000209:etiology / Q000517:prevention & control; D003131:Combined Modality Therapy; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D015658:HIV Infections / Q000150:complications; D006801:Humans; D007167:Immunotherapy; D053208:Kaplan-Meier Estimate; D008297:Male; D009161:Mycobacterium / Q000276:immunology; D020519:Pericardiocentesis; D010494:Pericarditis, Constrictive / Q000209:etiology / Q000517:prevention & control; D010495:Pericarditis, Tuberculous / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone