Medical Research: What are the main findings of this study?
Dr. Mayosi: In those with definite or probable tuberculous pericardial effusion:
(1) Prednisolone for 6 weeks and Mycibacterium indicus pranii for three months had no significant effect on the combined outcome of death from all causes, cardiac tamponade requiring pericardiocentesis or constrictive pericarditis.
(2) Both therapies were associated with an increased risk of HIV-associated malignancy.
(3) However, use of prednisolone reduced the incidence of constrictive pericarditis and hospitalization.
(4) The beneficial effects of prednisolone on constriction and hospitalization were similar in HIV-positive and HIV-negative patients
Medical Research: Were any of the findings unexpected?
Dr. Mayosi: The two findings that were unexpected were
(1) The neutral effect of steroids on death, and
(2) The increase in incidence of cancer in HIV infected patients.
Medical Research: What should clinicians and patients take away from your report?
Dr. Mayosi: A selective approach to the use of adjunctive steroids in tuberculous pericarditis is required, as follows:
(1) Adjunctive steroids should be avoided in patients with HIV-associated tuberculous pericardial effusion because of the risk of cancer;
(2) Adjunctive steroids may be used in HIV negative patients for the beneficial effect on constrictive pericarditis and hospitalization.
There is no role for M. indicus pranii in patients with tuberculous pericardial effusion.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Mayosi: The impact of adjunctive steroids in HIV positive patients on anti-retroviral therapy is unknown.
Bongani M. Mayosi, M.B., Ch.B., D.Phil., Mpiko Ntsekhe, M.D., Ph.D., Jackie Bosch, Ph.D., Shaheen Pandie, M.Med. (Med.), Hyejung Jung, M.Sc., Freedom Gumedze, Ph.D., Janice Pogue, Ph.D., Lehana Thabane, Ph.D., Marek Smieja, M.D., Ph.D., Veronica Francis, R.N., Laura Joldersma, B.Sc., Kandithalal M. Thomas, M.B., B.S., Baby Thomas, M.B., B.S., Abolade A. Awotedu, M.B., B.S., Nombulelo P. Magula, M.B., Ch.B., Datshana P. Naidoo, M.B., Ch.B., Ph.D., Albertino Damasceno, M.D., Ph.D., Alfred Chitsa Banda, M.B., Ch.B., Basil Brown, M.B., Ch.B., Pravin Manga, M.B., B.Ch., Bruce Kirenga, M.B., Ch.B., Charles Mondo, M.B., Ch.B., Ph.D., Phindile Mntla, M.B., Ch.B., Jacob M. Tsitsi, M.B., B.Ch., Ferande Peters, M.B., B.Ch., Mohammed R. Essop, M.B., B.Ch., James B.W. Russell, M.B., Ch.B., James Hakim, M.D., Jonathan Matenga, M.B., Ch.B., Ayub F. Barasa, M.B., Ch.B., Mahmoud U. Sani, M.B., B.S., Taiwo Olunuga, M.B., B.Ch., Okechukwu Ogah, M.B., Ch.B., Victor Ansa, M.B., Ch.B., Akinyemi Aje, M.B., Ch.B., Solomon Danbauchi, M.B., Ch.B., Dike Ojji, M.B., B.S., Ph.D., and Salim Yusuf, M.B., B.S., D.Phil. for the IMPI Trial Investigators