title: Effects of short-course oral corticosteroid therapy in early dengue infection in Vietnamese patients: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Patients with dengue can experience a variety of serious complications including hypovolemic shock, thrombocytopenia, and bleeding. These problems occur as plasma viremia is resolving and are thought to be immunologically mediated. Early corticosteroid therapy may prevent the development of such complications but could also prolong viral clearance.
  
  
  METHODS
  We performed a randomized, placebo-controlled, blinded trial of low-dose (0.5 mg/kg) or high-dose (2 mg/kg) oral prednisolone therapy for 3 days in Vietnamese patients aged 5-20 years admitted with dengue and fever for ≤72 hours, aiming to assess potential harms from steroid use during the viremic phase. Intention-to-treat analysis was performed using linear trend tests with a range of clinical and virological endpoints specified in advance. In addition to recognized complications of dengue, we focused on the are under the curve for serial plasma viremia measurements and the number of days after enrollment to negative viremia and dengue nonstructural protein 1 status.
  
  
  RESULTS
  Between August 2009 and January 2011, 225 participants were randomized to 1 of the 3 treatment arms. Baseline characteristics were similar across the groups. All patients recovered fully and adverse events were infrequent. Aside from a trend toward hyperglycemia in the steroid recipients, we found no association between treatment allocation and any of the predefined clinical, hematological, or virological endpoints.
  
  
  CONCLUSIONS
  Use of oral prednisolone during the early acute phase of dengue infection was not associated with prolongation of viremia or other adverse effects. Although not powered to assess efficacy, we found no reduction in the development of shock or other recognized complications of dengue virus infection in this study.
authors.affiliation: University of Medicine and Pharmacy of Ho Chi Minh City, Viet Nam.
authors.forename: Dong T H
authors.initials: DT
authors.lastname: Tam
authors.forename: Tran V
authors.initials: TV
authors.lastname: Ngoc
authors.forename: Nguyen T H
authors.initials: NT
authors.lastname: Tien
authors.forename: Nguyen T T
authors.initials: NT
authors.lastname: Kieu
authors.forename: Truong T T
authors.initials: TT
authors.lastname: Thuy
authors.forename: Lai T C
authors.initials: LT
authors.lastname: Thanh
authors.forename: Cao T
authors.initials: CT
authors.lastname: Tam
authors.forename: Nguyen T
authors.initials: NT
authors.lastname: Truong
authors.forename: Nguyen T
authors.initials: NT
authors.lastname: Dung
authors.forename: Phan T
authors.initials: PT
authors.lastname: Qui
authors.forename: Tran T
authors.initials: TT
authors.lastname: Hien
authors.forename: Jeremy J
authors.initials: JJ
authors.lastname: Farrar
authors.forename: Cameron P
authors.initials: CP
authors.lastname: Simmons
authors.forename: Marcel
authors.initials: M
authors.lastname: Wolbers
authors.forename: Bridget A
authors.initials: BA
authors.lastname: Wills
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D003715:Dengue / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D016037:Single-Blind Method; D016896:Treatment Outcome; D019562:Viral Load; D014766:Viremia; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D010919:Placebos