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Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice.
Scand J Prim Health Care. 2013 Dec; 31(4):190-6.SJ

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.

Authors+Show Affiliations

Department of General Practice, Institute of Health and Society , University of Oslo , Norway.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24228748

Citation

Skjeie, Holgeir, et al. "Acupuncture for Infantile Colic: a Blinding-validated, Randomized Controlled Multicentre Trial in General Practice." Scandinavian Journal of Primary Health Care, vol. 31, no. 4, 2013, pp. 190-6.
Skjeie H, Skonnord T, Fetveit A, et al. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013;31(4):190-6.
Skjeie, H., Skonnord, T., Fetveit, A., & Brekke, M. (2013). Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scandinavian Journal of Primary Health Care, 31(4), 190-6. https://doi.org/10.3109/02813432.2013.862915
Skjeie H, et al. Acupuncture for Infantile Colic: a Blinding-validated, Randomized Controlled Multicentre Trial in General Practice. Scand J Prim Health Care. 2013;31(4):190-6. PubMed PMID: 24228748.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. AU - Skjeie,Holgeir, AU - Skonnord,Trygve, AU - Fetveit,Arne, AU - Brekke,Mette, Y1 - 2013/11/15/ PY - 2013/11/16/entrez PY - 2013/11/16/pubmed PY - 2014/2/20/medline SP - 190 EP - 6 JF - Scandinavian journal of primary health care JO - Scand J Prim Health Care VL - 31 IS - 4 N2 - 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. SN - 1502-7724 UR - https://www.unboundmedicine.com/medline/citation/24228748/full_citation DB - PRIME DP - Unbound Medicine ER -