Effect of placebo on ambulatory blood pressure monitoring in children
Pediatric Nephrology, 05/30/2012
Redwine K et al. – Having confirmed hypertension (HTN) at baseline did not affect the impact of placebo on mean blood pressure (BP). If confirmed, this lack of placebo effect on ambulatory blood pressure monitoring (ABPM) measurements may allow for the design of direct comparison pediatric anti–hypertensive trials without a placebo arm.Methods
- A total of 141 children aged 5–16 years with elevated BP were randomized into a multi–center, single–blind, cross–over trial.
- Subjects received a placebo pill prior to wearing a 24–h ABPM device at one of two visits separated by 1–2 weeks.
- Study procedures were otherwise identical at both visits.
- Mean systolic and diastolic BP for all measured time periods were similar between visits, as was the number of children diagnosed with HTN at each visit.