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Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice
Holgeir Skjeie1, Trygve Skonnord, Arne Fetveit
1Department of General Practice, Institute of Health and Society , University of Oslo , Norway.
Insights
Acupuncture did not show a significant or clinically relevant effect for treating infantile colic in a randomized controlled trial. Further research is recommended before widespread use in clinical practice.
Area of Science:
- Pediatrics
- Complementary Medicine
- Clinical Research
Background:
- Infantile colic is a common and distressing condition in early infancy.
- Acupuncture is utilized as a treatment for infantile colic in some regions, notably Scandinavia.
- The clinical effectiveness of acupuncture for infantile colic requires rigorous scientific evaluation.
Purpose of the Study:
- To test the hypothesis that acupuncture treatment offers a clinically relevant benefit for infantile colic.
- To evaluate the efficacy of acupuncture compared to a control group in reducing crying time in infants with colic.
Main Methods:
- A prospective, blinding-validated, randomized controlled multicentre trial was conducted across 13 general practices in Southern Norway.
- 90 infants diagnosed with colic were randomized into two groups: one receiving acupuncture at the ST36 point for three days, and a control group receiving no treatment.
- Blinding of research assistants and parents was validated, and outcomes were assessed through diaries and interviews focusing on changes in crying time.
Main Results:
- The blinding validation confirmed successful blinding of participants and researchers (p = 0.41 and 0.60).
- No statistically significant difference in crying time reduction was observed between the acupuncture and control groups (p = 0.26).
- A non-significant trend favored acupuncture, but the difference was not considered clinically relevant.
Conclusions:
- Acupuncture treatment for infantile colic demonstrated neither a statistically significant nor a clinically relevant effect in this trial.
- Based on current evidence, the use of acupuncture for infantile colic should be limited to controlled clinical trials.
- Further research may be needed to definitively establish the role, if any, of acupuncture in managing infantile colic.
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.