title: Effectiveness of fludrocortisone and salt in preventing syncope recurrence in children: a double-blind, placebo-controlled, randomized trial.
abstract: OBJECTIVE
  We sought to evaluate the effectiveness of salt and fludrocortisone versus placebo in the prevention of syncope recurrence in children.
  
  
  BACKGROUND
  Intravascular volume expansion with fludrocortisone and salt has been reported to be effective in the treatment of syncope in children. However, no pediatric placebo-controlled data are available on the effectiveness of this mode of therapy.
  
  
  METHODS
  Thirty-three children with syncope or severe presyncope were randomized in a double-blinded fashion to receive either fludrocortisone 0.1 mg/day and salt 1 g/day or placebo two capsules per day for one year. All children had a positive tilt test before enrollment.
  
  
  RESULTS
  Thirty-two children (20 female) had follow-up. Their age was (mean +/- SD) 13.9 +/- 2.5 years. The number of syncopal episodes before therapy was 4.4 +/- 4.8. Therapy was continued for 176 +/- 117 days, and follow-up including time after discontinuation of medications was 1.2 +/- 0.8 years. The demographics were similar in the 18 children treated with fludrocortisone and salt compared with the 14 children on placebo. Data for up to one year of randomization were included in analyses. Symptoms recurred in 10 of 18 children on fludrocortisone and salt and in 5 of 14 children on placebo (p < 0.04). Children on placebo had no symptoms until they discontinued their study medications.
  
  
  CONCLUSIONS
  These data, coupled with the reported comparable effect of many medications used in the treatment of syncope, raise the potential of a significant placebo effect with pharmacologic therapy.
authors.affiliation: Division of Pediatric Cardiology, Department of Pediatrics, the University of Tennessee, Memphis, USA. msalim@peds.umaryland.edu
authors.forename: Mubadda A
authors.initials: MA
authors.lastname: Salim
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Di Sessa
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005438:Fludrocortisone / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D012965:Sodium Chloride / Q000627:therapeutic use*; D013575:Syncope / Q000517:prevention & control*
chemical_list: D012965:Sodium Chloride; D005438:Fludrocortisone