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Effectiveness of fludrocortisone and salt in preventing syncope recurrence in children: a double-blind,
Mubadda A Salim1, Thomas G Di Sessa
1Division of Pediatric Cardiology, Department of Pediatrics, the University of Tennessee, Memphis, USA. msalim@peds.umaryland.edu
Insights
Fludrocortisone and salt did not prevent syncope recurrence in children compared to placebo. This suggests a significant placebo effect in syncope pharmacologic therapy.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
- Syncope Management
Background:
- Intravascular volume expansion with fludrocortisone and salt is a reported treatment for pediatric syncope.
- Limited pediatric placebo-controlled data exist for this therapeutic approach.
Purpose of the Study:
- To evaluate the efficacy of salt and fludrocortisone versus placebo in preventing syncope recurrence in children.
- To assess the potential for a placebo effect in pharmacologic syncope treatment.
Main Methods:
- A double-blind, randomized trial involving 33 children with syncope or presyncope.
- Participants received either fludrocortisone (0.1 mg/day) and salt (1 g/day) or placebo for one year.
- All children had a positive head-up tilt test prior to enrollment.
Main Results:
- Syncope recurred in 10 of 18 children on fludrocortisone and salt, versus 5 of 14 on placebo (p < 0.04).
- Children on placebo remained asymptomatic until study medication discontinuation.
- Demographics and baseline syncopal episodes were similar between groups.
Conclusions:
- The study suggests that fludrocortisone and salt are not more effective than placebo in preventing pediatric syncope recurrence.
- A significant placebo effect may contribute to the perceived efficacy of pharmacologic treatments for syncope.
- Further research is warranted to understand the role of placebo in syncope management.
Objectives:
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.
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