Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice.
OBJECTIVE
Infantile colic is a painful condition in the first months of infancy. Acupuncture is used in Scandinavia as a treatment for infantile colic. A randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition.


METHODS
A prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded.


METHODS
13 GPs' offices in Southern Norway.


METHODS
Three days of bilateral needling of the acupuncture point ST36, with no treatment as control.


METHODS
113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed.


METHODS
Difference in changes in crying time during the trial period between the intervention and control group.


RESULTS
The blinding validation questions showed a random distribution with p = 0.41 and 0.60, indicating true blinding. We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals, nor in the main analysis of differences in changes over time (p = 0.26). There was a tendency in favour of the acupuncture group, with a non-significant total baseline-corrected mean of 13 minutes (95% CI -24 to + 51) difference in crying time between the groups. This was not considered clinically relevant, according to protocol.


CONCLUSIONS
This trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect. With the current evidence, the authors suggest that acupuncture for infantile colic should be restricted to clinical trials.
Department of General Practice, Institute of Health and Society , University of Oslo , Norway.
Holgeir
H
Skjeie
Trygve
T
Skonnord
Arne
A
Fetveit
Mette
M
Brekke
D015670:Acupuncture Therapy; D003085:Colic / Q000628:therapy*; D003448:Crying; D004311:Double-Blind Method; D005260:Female; D058006:General Practice / Q000379:methods*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009664:Norway; D011446:Prospective Studies; D036301:Qualitative Research; D013997:Time Factors; D016896:Treatment Outcome