Effect of placebo on ambulatory blood pressure monitoring in children.
Summary of "Effect of placebo on ambulatory blood pressure monitoring in children."
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.
Affiliation
Division of Pediatric Nephrology, Department of Pediatrics, University of Arkansas for Medical Sciences & Arkansas Children's Hospital, Little Rock, AR, USA, redwinekarenm@uams.edu.
Journal Details
This article was published in the following journal.
Name: Pediatric nephrology (Berlin, Germany)
ISSN: 1432-198X
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22623022
- DOI: http://dx.doi.org/10.1007/s00467-012-2191-z
Medical and Biotech [MESH] Definitions
Blood Pressure Monitoring, Ambulatory
Method in which repeated blood pressure readings are made while the patient undergoes normal daily activities. It allows quantitative analysis of the high blood pressure load over time, can help distinguish between types of HYPERTENSION, and can assess the effectiveness of antihypertensive therapy.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Monitoring, Physiologic
The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine.
Monitoring, Ambulatory
The use of electronic equipment to observe or record physiologic processes while the patient undergoes normal daily activities.
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.
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