The Journal of the American Osteopathic Association, 2012/08, 112(8):541. doi: 10.7556/jaoa.2012.112.8.529, type of study: ,rct,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Full text    (https://www.degruyter.com/document/doi/10.7556/jaoa.2012.112.8.529/html)

Keywords:

infants [211]
pediatrics [573]
placebo [41]
randomized controlled trial [947]
research [483]

Abstract:

Background: Placebo effect has been largely studied and debated in medicine. Interestingly, the majority of studies have focused on children and adults but not on newborns. In the field of osteopathic medicine, few studies documented this effect using sham therapy. A previous study showed the association between osteopathic manipulative treatment and length of stay (LOS) in newborns. However, no research has been conducted on the placebo effect on newborns treated with osteopathic medicine. Objective: To detect the association between placebo treatment and change in clinical outcome in newborns. Methods: A double-blinded randomized control trial was carried out on 250 preterm newborns without medical complications (gestational age, 29-37 weeks). After enrollment, all participants were randomly assigned to study (n=107) or control groups (n=143). All preterm newborns received routine pediatric care and osteopathic sham therapy was administered to the study group for the entire period of hospitalization. Primary outcome was to evaluate the effectiveness of sham therapy in reducing LOS. Results: At entry, univariate statistical analysis showed no differences between groups. At the end of the study, after adjusting for all potential confounders, generalized linear model analysis showed no difference in the primary outcome (mean difference, 2.444; 95% confidence interval, 0.447-5.337; P=.09). Conclusion: This study is the first in the field showing no effect of placebo treatment using sham therapy on newborns, raising questions about the age when placebo effect starts.