1. Short summary / abstract
545 patients over 14years old from two centres in Vietnam randomly allocated to dexamethasone or placebo in conjunction with standard quadruple antituberculous chemotherapy for TB meningitis.
No significant difference between groups in primary outcome (death or severe disability at 9 months)
Significantly reduced mortality in dexamethasone group (most marked in those with mild disease at entry)
Only significant secondary outcome was reduced time to fever clearance in steroid group
Mortality significantly higher amongst HIV-infected adults but no significant benefit from dexamethasone treatment
Significantly fewer adverse drug reactions to antituberculous therapy in dexamethasone group
2. What question is the document addressing?
Does adjunctive corticosteroid therapy in conjunction with antituberculous chemotherapy reduce the risk of disability or death in adults with tuberculous meningitis?
3. Type of study
Randomised, double-blind, placebo-controlled trial
4. Methods valid & appropriate?
Enrolled good number of patients Well validated outcome measures (albeit used primarily in stroke trials)
5. Results / recommendations reliable?
Yes. Not generalisable to areas with lower rates of resistance to antituberculous drugs and/or access to additional antituberculous drugs. Not generalisable to HIV-infected individuals with access to antiretroviral therapy
6. Any major problems and biases?
Included patients without definite tuberculous meningitis High levels of resistance to first line antituberculous drugs (approx. 42% resistant to at least one drug) yet standard quadruple antituberculous chemotherapy was used throughout Different dexamethasone regimens used depending on severity of disease at presentation None of the HIV-infected adults received antiretroviral therapy despite severe immunosuppression
7. Any other important / relevant studies which confirm or contradict?
Cochrane systematic review 2004 found reduced incidence of death and severe disability with corticosteroids but trials mainly in children so no clear evidence of benefit in adults. Also provided no evidence about use of steroids for TB meningitis in the context of HIV infection
Meningitis Tuberculosis Steroids
*** Note: These are the views of a professional expert rather than an official statement from his or her society, organisation or advisory committee.
(Society / Organisation / Advisory Committee):
|BIS, ESCMID, BHIVA|