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.
Key Indexing Terms
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Article info
Publication history
Accepted:
July 4,
2012
Received in revised form:
June 30,
2012
Received:
January 20,
2012
Identification
Copyright
© 2012 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.
