But results from Asia, Africa may not apply to patients in the West, experts say
WEDNESDAY, Dec. 12 (HealthDay News)-- Disappointing the hopes of researchers, new trials using a powerful steroid to treat deadly bacterial meningitis have shown little or no benefit from the drugs.
"It was a surprise," said Dr. Matthew Scarborough, a clinical lecturer in infectious diseases at the University of Malawi College of Medicine, and the lead author of one study. "Following publication of a European trial that showed benefits, our results showed none," he said.
The results of the two trials, which were conducted in Vietnam and in the south African nation of Malawi, are published in the Dec. 13 issue of the New England Journal of Medicine.
Despite the results, guidelines for the treatment of bacterial meningitis in the United States will almost certainly continue to recommend use of steroids, in part because of the positive results of the 2003 European trial, Scarborough said.
He noted that there were significant differences between the patients treated in that trial and the 465 participants in the Malawi trial.
"Ninety percent of the patients in Malawi had HIV co-infections," Scarborough said. "They also presented later in the disease. Also there was a high incidence of neurological complications. We don't know which of these factors explains the results."
Meningitis is an infection of the spinal fluid (meninges) that surrounds the spinal cord and brain. The illness can be caused by a virus (typically less severe) or, more rarely, by bacteria. Bacterial meningitis is considered much more dangerous, even lethal.
In the Malawi study, researchers gave participants suspected of having bacterial meningitis either the corticosteroid dexamethasone plus an antibiotic, ceftriaxone, or ceftriaxone alone.
Overall, there was no difference in the incidence of death, disability and severe complications between those who got the steroid and those who did not.
A trial of 435 patients with suspected bacterial meningitis patients treated in Vietnam showed similar results, with similar rates of death and disability at one and six months in groups that got steroids or did not. But a significantly lower rate of death and disability was found in patients where the suspected diagnosis of bacterial meningitis could be confirmed.
The Vietnam trial was led by Dr. Jeremy Farrar of the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
The studies suggest that different treatment approaches may be needed in different locales, Scarborough said.
"At the moment, I don't think there is any reason for a change of guidelines in Europe and America," Scarborough said. "In Europe and America, patients will still get steroids as adjuvant therapy. There is no evidence that in Africa or Asia, there is a benefit in children or adults. The guidelines will have to be separated."
"The results of the newly reported studies are not entirely unexpected," said Dr. Dean A. Blumberg, associate professor of pediatric infectious diseases at the University of California, Davis.
"The field has not been entirely clear," Blumberg said. "We have been looking at different patient populations, of different ages, some with a large proportion of HIV-infected individuals. Some have different pathogens."
While the two trials were "exceptionally well done," the relatively small number of participants makes it more difficult to interpret the results, Blumberg said.
"Steroids might be allowing someone to live who might otherwise have died," he said. "I don't think this will affect guidelines here. In less developed areas, it may lead to a change in recommendations there."
There's more on bacterial meningitis at the U.S. National Library of Medicine.
SOURCES: Matthew Scarborough, M.D., senior lecturer in infectious diseases, John Radcliffe Hospital, Oxford, England, and College of Medicine/Malawi-Liverpool-Wellcome Programme of Clincal Tropical Research, Blantyre, Malawi; Dean A. Blumberg, M.D., associate professor of pediatric infectious diseases, University of California, Davis; Dec. 13, 2007, New England Journal of Medicine
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