Background and Aims Placebo effect has been largely studied and debated in medicine. Interestingly the majority of studies 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 OMT and LOS on newborns. However, no research were conducted on the placebo effect on newborns osteopathically treated. Therefore the aim of this study is 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, GA >29 and <37w and free of medical complications. After enrollment, all subjects were randomly assigned to study (N=107) and control group (N=143). All preterms received routine pediatric care and osteopathic sham therapy was administered to the study group only 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 on the primary outcome (mean difference between study and control group: 2.444; 95%CI –0.447, 5.337; p=0.09).
Conclusion This study is the first in the field showing no effect of placebo treatment using sham therapy on newborns opening discussions about the age when placebo effect starts.