Programme no. 441-OP
Acupuncture for infantile colic: A blinding-validated, randomized controlled multicentre trial in general practice
Holgeir Skjeie*1, Arne Fetveit2, Trygve Skonnord3, Mette Brekke4
1Department of General practice,University of Oslo,Oslo,Norway, 2Department of General practice,University of Oslo,Oslo,Norway, 3Department of General practice,University of Oslo,Oslo,Norway, 4Department of General practice,University of Oslo,Oslo,Norway
* = Presenting author
Objectives: A blinding-validated randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition. The results of the trial was published in Scandinavian Journal of Primary Health Care October 2013
Infantile colic is a painful condition in the first months of infancy. Acupuncture is used in Scandinavia as a treatment for infantile colic. Two scandinavian acupuncture treatment trials of children with infantile colic have been published(Reinthal et al 2008,Landgren et al 2010). Both studies concluded that acupuncture significantly reduced crying and pain-related behaviour without noticeable adverse effects. Effect sizes were small, and there was no blinding validation.
Results: 113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed. The blinding validation questions showed a random distribution with p= 0.41and 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 regression 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.
Material/Methods: A prospective, blinding-validated,randomized controlled multicentre trial in general practice. 13GP offices were involved. The intervention consisted of three days of standardized needle acupuncture on the acupuncture point ST36, with no treatment as control. Main outcome measure was difference in changes in crying time during the trial period between the intervention and control group
Conclusion: This trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect. With the current evidence, we suggest that acupuncture for infantile colic should be restricted to clinical trials.
Points for discussion:
Acupuncture in children is a potentially painful treatment. This is especially important in small children without competence of consent. Small children have no established anticipation/reward systems; it is the real effect of the needle that defines the relevance of acupuncture treatment. It would be unethical to treat in response to the parents ’ hope of improvement if the effect size does not outweigh the potential pain inflicted on the child. Our trial could not prove such a justification.