PEDIATRICS Vol. 92 No. 1 July 1993, pp. 111-115
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Failure of High-Dose Methylprednisolone in Established Dengue Shock Syndrome: A Placebo-Controlled, Double-Blind Study

Sompon Tassniyom MD1, Sirijitt Vasanawathana MD2, Aroon Chirawatkul MSc3, and Suntharee Rojanasuphot BSc4

1 From the Department of Pediatrics and Clinical Epidemiology Unit, Faculty of Medicine, Khon Kaen University, Bangkok, Thailand
2 From the Department of Pediatrics, Khon Kaen Provincial Hospital, Ministry of Public Health, Bangkok, Thailand
3 From the Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University, Bangkok, Thailand
4 From the Virology Division, Department of Medical Science, Ministry of Public Health, Bangkok, Thailand

Objective. Steroids are widely used in Thailand and other dengue-endemic countries to treat severe dengue shock syndrome. This study was designed to determine whether a single high dose of methyiprednisolone will reduce mortality in children with dengue shock syndrome who did not respond to simple fluid and plasma replacement therapy.

Methods. A prospective, randomized, doubled-blind, controlled trial was conducted in two hospitals in Khon Kaen Thailand during June to September in 1987 and 1988. Sixty-three children with severe dengue shock syndrome were randomized into two groups; the first group received a single dose of methylprednisolone (30 mg/kg) and the second group received placebo.

Results. There was no significant difference in mortality between the two groups (P = .63). The mortality rate was 12.5% (4/32) in the steroid group and 12.9% (4/31) in the group that received placebo. The sequelae at 2 weeks among treatment and control survivors were not significantly different These two groups were comparable in age, sex, severity of illness, and duration of shock at the outset of the study. The two treatment groups were similar in subsequent hospital course as determined by maximum and minimum hematocrit level and bleeding severity. The numbers of patients in each group who had liver failure and evidence of disseminated intravascular clotting defect were also comparable. Complications such as occurrence of fever after shock, pneumonia, convulsion, cardiac arrest, pulmonary hemorrhage, and positive hemoculture were not significantly different in the treatment and control groups.

Conclusions. A single high dose of methylprednisolone does not reduce mortality in severe dengue shock syndrome which does not respond to conventional critical care.

Key Words: dengue hemorrhagic fever • dengue shock syndrome • steroids • randomization • double-blind method

Submitted on May 5, 1992
Accepted on February 22, 1993




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