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Effect of placebo on ambulatory blood pressure monitoring in children

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Abstract

Background

Ambulatory blood pressure monitoring (ABPM) has been proposed as a useful tool for more accurately diagnosing hypertension (HTN) and evaluating blood pressure (BP) response in pediatric anti-hypertensive trials. ABPM captures multiple BP measurements during routine daily activities and is thus an excellent method for identifying white-coat HTN. Additionally, ABPM measurements in adults do not demonstrate the placebo effect commonly seen with casual BP measurements, although this has yet to be evaluated in children. Therefore,, the aim of this study was to assess the effect of placebo on ABPM measurements in children.

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.

Results

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.

Conclusion

Having confirmed HTN at baseline did not affect the impact of placebo on mean BP. If confirmed, this lack of placebo effect on ABPM measurements may allow for the design of direct comparison pediatric anti-hypertensive trials without a placebo arm.

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Abbreviations

ABPM:

Ambulatory blood pressure monitoring

BP:

Blood pressure

DBP:

Diastolic blood pressure

FDA:

Food and Drug Administration

HTN:

Hypertension

SBP:

Systolic blood pressure

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Sources of funding

The Network of Pediatric Pharmacology Research Units is funded by the National Institutes of Child Health and Human Development (5U10HD031324-152; 3U10 HD 021324-15S12; 5U10 HD 031323-154; U10 HD0459345; U10 HD0459866)

K.R. is funded in part by the UAMS Translational Research Institute KL2 scholars program (KL2RR029883), the Arkansas Children’s Hospital Research Institute, and the Arkansas Biosciences Institute, the major research component of the Tobacco Settlement Proceeds Act of 2000.

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Authors and Affiliations

  1. Division of Pediatric Nephrology, Department of Pediatrics, University of Arkansas for Medical Sciences & Arkansas Children’s Hospital, Little Rock, AR, USA

    Karen Redwine & Thomas Wells

  2. Section of Clinical Pharmacology and Toxicology, Department of Pediatrics, University of Arkansas for Medical Sciences & Arkansas Children’s Hospital, Little Rock, AR, USA

    Lee Howard, Laura James & Thomas Wells

  3. Section of Quantitative Health Sciences, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA

    Pippa Simpson, Shun-Hwa Li & Ke Yan

  4. Department of Pediatrics, University of Toledo, Toledo, OH, USA

    Jeffrey Blumer

  5. Division of Pediatric Critical Care, Department of Pediatrics and Pharmacology and Toxicology, Kosair Charities Pediatric Clinical Research Unit, University of Louisville, Louisville, KY, USA

    Janice Sullivan

  6. Department of Pediatrics, Division of Neonatology and Division of Pediatric Pharmacology, University of Utah, Salt Lake City, UT, USA

    Robert Ward

  7. Division of Pediatric Nephrology, University of Arkansas for Medical Sciences, 1 Children’s Way, Mail Slot 512-14, Little Rock, AR, 72202, USA

    Karen Redwine

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  1. Karen Redwine
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Correspondence to Karen Redwine.

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Redwine, K., Howard, L., Simpson, P. et al. Effect of placebo on ambulatory blood pressure monitoring in children. Pediatr Nephrol 27, 1937–1942 (2012). https://doi.org/10.1007/s00467-012-2191-z

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  • DOI: https://doi.org/10.1007/s00467-012-2191-z

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