• Scand J Prim Health Care · Dec 2013

    Randomized Controlled Trial Multicenter Study

    Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice.

    • Holgeir Skjeie, Trygve Skonnord, Arne Fetveit, and Mette Brekke.
    • Department of General Practice, Institute of Health and Society , University of Oslo , Norway.
    • Scand J Prim Health Care. 2013 Dec 1; 31 (4): 190-6.

    ObjectiveInfantile 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.DesignA prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded.Setting13 GPs' offices in Southern Norway.InterventionThree days of bilateral needling of the acupuncture point ST36, with no treatment as control.Subjects113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed.Main Outcome MeasuresDifference in changes in crying time during the trial period between the intervention and control group.ResultsThe 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.ConclusionThis 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.

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