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

Abstract

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. Design. A prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded. Setting. 13 GPs’ offices in Southern Norway. Intervention. Three days of bilateral needling of the acupuncture point ST36, with no treatment as control. Subjects. 113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed. Main outcome measures. 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. Conclusion. 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.

Key Words::

• Acupuncture
• acupuncture point
• general practice
• infantile colic
• Norway
• randomized controlled trial

Acknowledgements

The authors would like to thank Magne Thoresen, professor at the Department of Biostatistics, University of Oslo, for his invaluable help in the statistical analyses of this trial.

Ethical approval

Regional Ethics Committee of South-Eastern Norway, reference, S-08732b 2008/17889s.

Funding

The study was financed through a grant from the Norwegian Research Fund in General Practice (AMFF).

Trial Registry

Clinical Trial Registry Identifier: NCT00907621.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.