To evaluate the efficacy of dexamethasone for treatment of primary supratentorial intracerebral hemorrhage, we studied 93 patients 40 to 80 years old, using a double-blind randomized block design. After the subjects were stratified according to their level of consciousness (Glasgow Coma Scale), those with objectively documented primary supratentorial intracerebral hemorrhage were randomly assigned to either dexamethasone or placebo. For ethical reasons, three interim analyses were planned, to permit early termination of the trial if one study group did better than the other. During the third interim analysis, the death rate at the 21st day was identical in the two groups (dexamethasone vs. placebo, 21 of 46 vs. 21 of 47; chi-square = 0.01, P = 0.93). In contrast, the rate of complications (mostly infections and complications of diabetes) was much higher in the dexamethasone group (chi-square = 10.89, P less than 0.001), leading to early termination of the study. In the light of the absence of a demonstrable beneficial effect and the presence of a significant harmful effect, current practices of using dexamethasone for treatment of primary supratentorial hemorrhage should be reconsidered.
This article has been cited by other articles:
Bardutzky, J., Schwab, S.
(2007). Antiedema Therapy in Ischemic Stroke. Stroke
38: 3084-3094
[Abstract][Full Text]
Broderick, J., Connolly, S., Feldmann, E., Hanley, D., Kase, C., Krieger, D., Mayberg, M., Morgenstern, L., Ogilvy, C. S., Vespa, P., Zuccarello, M.
(2007). REPRINT: Guidelines for the Management of Spontaneous Intracerebral Hemorrhage in Adults: 2007 Update: A Guideline From the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists.. Circulation
116: e391-e413
[Abstract][Full Text]
Broderick, J., Connolly, S., Feldmann, E., Hanley, D., Kase, C., Krieger, D., Mayberg, M., Morgenstern, L., Ogilvy, C. S., Vespa, P., Zuccarello, M.
(2007). Guidelines for the Management of Spontaneous Intracerebral Hemorrhage in Adults: 2007 Update: A Guideline From the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists.. Stroke
38: 2001-2023
[Abstract][Full Text]
Juvela, S., Kase, C. S.
(2006). Advances in Intracerebral Hemorrhage Management. Stroke
37: 301-304
[Full Text]
Kase, C. S.
(2005). Hemostatic Treatment in the Early Stage of Intracerebral Hemorrhage: The Recombinant Factor VIIa Experience. Stroke
36: 2321-2322
[Full Text]
Davis, S. M., Donnan, G. A.
(2004). Steroids for Stroke: Another Potential Therapy Discarded Prematurely?. Stroke
35: 230-231
[Full Text]
Poungvarin, N.
(2004). Steroids Have No Role in Stroke Therapy. Stroke
35: 229-230
[Full Text]
Mayer, S. A.
(2003). Ultra-Early Hemostatic Therapy for Intracerebral Hemorrhage. Stroke
34: 224-229
[Abstract][Full Text]
PROVENCIO, J. J., BLECK, T. P., CONNORS, A. F. Jr.
(2001). Critical Care Neurology. Am. J. Respir. Crit. Care Med.
164: 341-345
[Full Text]
Qureshi, A. I., Tuhrim, S., Broderick, J. P., Batjer, H. H., Hondo, H., Hanley, D. F.
(2001). Spontaneous Intracerebral Hemorrhage. NEJM
344: 1450-1460
[Full Text]
Hemphill, J. C. III, Bonovich, D. C., Besmertis, L., Manley, G. T., Johnston, S. C., Tuhrim, S.
(2001). The ICH Score : A Simple, Reliable Grading Scale for Intracerebral Hemorrhage Editorial Comment: A Simple, Reliable Grading Scale for Intracerebral Hemorrhage. Stroke
32: 891-897
[Abstract][Full Text]
Bereczki, D., Liu, M., Prado, G. F. d., Fekete, I.
(2000). Cochrane Report : A Systematic Review of Mannitol Therapy for Acute Ischemic Stroke and Cerebral Parenchymal Hemorrhage. Stroke
31: 2719-2722
[Abstract][Full Text]
Hickenbottom, S. L., Grotta, J. C., Strong, R., Denner, L. A., Aronowski, J., Macdonald, R. L.
(1999). Nuclear Factor-{kappa}B and Cell Death After Experimental Intracerebral Hemorrhage in Rats • Editorial Comment. Stroke
30
: 2472-2478
[Abstract][Full Text]
Zuccarello, M., Brott, T., Derex, L., Kothari, R., Sauerbeck, L., Tew, J., Van Loveren, H., Yeh, H.-S., Tomsick, T., Pancioli, A., Khoury, J., Broderick, J.
(1999). Early Surgical Treatment for Supratentorial Intracerebral Hemorrhage : A Randomized Feasibility Study. Stroke
30: 1833-1839
[Abstract][Full Text]
Zazulia, A. R., Diringer, M. N., Derdeyn, C. P., Powers, W. J.
(1999). Progression of Mass Effect After Intracerebral Hemorrhage. Stroke
30: 1167-1173
[Abstract][Full Text]
Broderick, J. P., Adams, H. P. Jr, Barsan, W., Feinberg, W., Feldmann, E., Grotta, J., Kase, C., Krieger, D., Mayberg, M., Tilley, B., Zabramski, J. M., Zuccarello, M.
(1999). Guidelines for the Management of Spontaneous Intracerebral Hemorrhage : A Statement for Healthcare Professionals From a Special Writing Group of the Stroke Council, American Heart Association. Stroke
30: 905-915
[Full Text]
DESAI, P, PRASAD, K
(1998). Dexamethasone is not necessarily unsafe in primary supratentorial intracerebral haemorrhage. J. Neurol. Neurosurg. Psychiatry
65: 799a-801
[Full Text]
Mayer, S. A., Lignelli, A., Fink, M. E., Kessler, D. B., Thomas, C. E., Swarup, R., Van Heertum, R. L.
(1998). Perilesional Blood Flow and Edema Formation in Acute Intracerebral Hemorrhage : A SPECT Study. Stroke
29: 1791-1798
[Abstract][Full Text]
Brott, T., Broderick, J., Kothari, R., Barsan, W., Tomsick, T., Sauerbeck, L., Spilker, J., Duldner, J., Khoury, J.
(1997). Early Hemorrhage Growth in Patients With Intracerebral Hemorrhage. Stroke
28: 1-5
[Abstract][Full Text]
Bigio, M. R. D., Yan, H.-J., Buist, R., Peeling, J., del Zoppo, G. J.
(1996). Experimental Intracerebral Hemorrhage in Rats: Magnetic Resonance Imaging and Histopathological Correlates. Stroke
27: 2312-2320
[Abstract][Full Text]
