title: Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial.
abstract: OBJECTIVE
  The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias.
  
  
  METHODS
  Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups.
  
  
  RESULTS
  One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively).
  
  
  CONCLUSIONS
  In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.
authors.affiliation: Anglo-European College of Chiropractic, Bournemouth, UK. jmiller@aecc.ac.uk
authors.forename: Joyce E
authors.initials: JE
authors.lastname: Miller
authors.forename: David
authors.initials: D
authors.lastname: Newell
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Bolton
mesh_terms: D003085:Colic / Q000175:diagnosis / Q000628:therapy*; D016001:Confidence Intervals; D003448:Crying; D005260:Female; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D008297:Male; D026882:Manipulation, Chiropractic / Q000379:methods*; D016017:Odds Ratio; D012016:Reference Values; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom