title: Do placebo effects associated with sham osteopathic procedure occur in newborns? Results of a randomized controlled trial.
abstract: BACKGROUND
  Placebo effect has been largely studied and debated in medicine. Research focused mainly on children and adults but not on newborns. In osteopathy, few studies documented this effect and no research has been conducted in newborns.
  
  
  OBJECTIVE
  To assess the presence of placebo effect in newborns using sham osteopathic manipulative treatment.
  
  
  METHODS
  Randomized control trial.
  
  
  METHODS
  Neonatal Intensive Care Unit in Italy.
  
  
  METHODS
  Two groups (103 patients each) of preterm infants aged 29-36 weeks without medical complications received routine pediatric care and osteopathic sham therapy was administrated to the study group only for the entire period of hospitalization.
  
  
  METHODS
  Primary end point was the mean reduction of length of stay at discharge. Secondary objective was the change in daily weight gain.
  
  
  RESULTS
  206 newborns entered the study. No difference between sham and control group was found for the primary outcome length of stay (30.0±20.3; 28.8±18.9; p=0.70). Multivariate analysis showed no difference between study and control group on length of stay. A negative association was found for gestational age (-2.33; 95% CI -3.81 to -0.85; p=0.002), birth weight (-0.01; 95% CI -0.02 to -0.01; p<0.001) and milk volume at study enrollment (-0.02; 95% CI -0.05 to -0.01; p=0.01).
  
  
  CONCLUSIONS
  To the best of our knowledge, this study is the first in the field showing no placebo effect on newborns. Further discussions are opened concerning the age when placebo effect starts.
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy; EBOM - European Institute for Evidence Based Osteopathic Medicine, viale Unità d'Italia 1, 66100 Chieti, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Martelli
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Cardinali
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy; EBOM - European Institute for Evidence Based Osteopathic Medicine, viale Unità d'Italia 1, 66100 Chieti, Italy.
authors.forename: Gina
authors.initials: G
authors.lastname: Barlafante
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy; EBOM - European Institute for Evidence Based Osteopathic Medicine, viale Unità d'Italia 1, 66100 Chieti, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Pizzolorusso
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy; EBOM - European Institute for Evidence Based Osteopathic Medicine, viale Unità d'Italia 1, 66100 Chieti, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Renzetti
authors.affiliation: AIOT - Accademia Italiana Osteopatia Tradizionale, via Prati 29, 65124 Pescara, Italy; EBOM - European Institute for Evidence Based Osteopathic Medicine, viale Unità d'Italia 1, 66100 Chieti, Italy. Electronic address: francesco.cerritelli@aiot.edu.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cerritelli
mesh_terms: D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007558:Italy / Q000453:epidemiology; D007902:Length of Stay; D008297:Male; D026301:Manipulation, Osteopathic / Q000379:methods*; D015999:Multivariate Analysis; D015990:Placebo Effect; D010919:Placebos / Q000627:therapeutic use*; D015430:Weight Gain / Q000502:physiology
chemical_list: D010919:Placebos
keywords: Osteopathic manipulative treatment; Placebo; Placebo effect; Sham