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Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial
Joyce E Miller1, David Newell, Jennifer E Bolton
1Anglo-European College of Chiropractic, Bournemouth, UK. jmiller@aecc.ac.uk
Insights
Chiropractic manual therapy significantly reduced crying time in infants with colic. Parental awareness of treatment did not influence the positive outcomes, suggesting the therapy
Area of Science:
- Pediatric care
- Manual therapy
- Infant health
Background:
- Infant colic, characterized by unexplained persistent crying, affects numerous infants.
- The efficacy of various interventions for infant colic remains a subject of research.
- Parental reporting bias can influence the perceived effectiveness of treatments.
Purpose of the Study:
- To evaluate the effectiveness of chiropractic manual therapy for infants experiencing unexplained crying.
- To investigate the potential impact of parental awareness of treatment on study outcomes.
Main Methods:
- A randomized controlled trial involving 104 infants younger than 8 weeks with persistent crying.
- Three groups were established: treated with parent aware, treated with parent unaware, and not treated with parent unaware.
- Daily crying duration was recorded by parents over 10 days; data analyzed using analysis of covariance.
Main Results:
- Chiropractic manual therapy demonstrated a statistically significant improvement in crying time by day 8 and day 10 in blinded parents.
- The number needed to treat was 3, indicating a substantial clinical effect.
- No significant difference in treatment outcomes was observed between blinded and non-blinded parents.
Conclusions:
- Chiropractic manual therapy is effective in improving crying behavior in infants diagnosed with colic.
- The study suggests that parental knowledge of treatment allocation does not bias the observed positive effects.
- The results indicate that chiropractic manual therapy offers a viable treatment option for infant colic, independent of parental reporting bias.
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.
