Oxytocin treatment in children with Prader-Willi syndrome: A double-blind, placebo-controlled, crossover study

What Was Tested

This randomized controlled trial paper looks at Oxytocin.

Individuals with PWS have a deficit of oxytocin producing neurons in the paraventricular nucleus of the hypothalamus.

The researchers performed a double-blind, placebo-controlled, crossover study in 24 children with PWS at three academic institutions using 5 days of intranasal oxytocin (IN-OT) or 5 days of intranasal placebo spray, followed by a 4 week washout period, and then patients returned for 5 days of treatment with the alternate source.

Who Took Part

The abstract describes 24 children taking part.

PubMed indexes the participants as young children and children, both men and women.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and crossover study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Blinding on both sides kept the children and researchers unaware of who received Oxytocin.

The comparison arm used a placebo, so changes seen with Oxytocin could be set against what happens without it.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

The timeline in the abstract includes 5 days.

What Was Measured

Questionnaires, including the Aberrant Behavior Checklist, Social Responsiveness Scale, Repetitive Behavior Scale - Revised, and the Hyperphagia Questionnaire, as well as Clinical Global Impression scales were administered.

Blood testing for sodium, potassium, and glucose levels on days 2, 4, and 6, and a 24 hr diet recall.

The subject headings attached to it are Oxytocin, Potassium, Prader-Willi Syndrome, Quality of Life, Sodium and Surveys and Questionnaires.

Author keywords: hyperphagia.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin in 24 children over 5 days.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2017 (American journal of medical genetics. Part A), a journal based in United States.

More context: the Oxytocin compound page, all human trials.