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The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial
Lise Vilstrup Holm1,2, Dorte Ejg Jarbøl2, Henrik Wulff Christensen1
1The Chiropractic Knowledge Hub, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark.
Insights
Chiropractic care showed a slight reduction in infant colic crying time, but the effect was not statistically significant after adjustments. Further research is needed to identify potential subgroups that may benefit from this intervention.
Area of Science:
- Pediatrics
- Complementary and Alternative Medicine
- Clinical Trials
Background:
- Infantile colic is a common condition in newborns, often leading to parental distress.
- Chiropractic care is frequently sought for infant colic, yet robust clinical evidence is limited.
- Large, blinded trials are necessary to ascertain the efficacy of chiropractic interventions for infantile colic.
Purpose of the Study:
- To evaluate the effectiveness of chiropractic care in treating infantile colic.
- To assess the impact of chiropractic treatment on crying duration and other colic-related symptoms in infants.
Main Methods:
- A multicenter, single-blind randomized controlled trial involving infants aged 2-14 weeks with unexplained excessive crying.
- Participants were randomized to receive either chiropractic care or a control (no treatment) over a two-week period.
- Parental diaries and questionnaires were used to collect data on crying duration, sleep, and gastrointestinal symptoms.
Main Results:
- The chiropractic group experienced a mean reduction of 1.5 hours of crying, compared to 1 hour in the control group (unadjusted P=0.026).
- After adjusting for baseline crying, age, and clinic, the difference in crying reduction between groups was not statistically significant (P=0.066).
- A clinically significant reduction in crying (≥1 hour) was observed in 63% of the chiropractic group versus 47% of the control group (P=0.037), with a Number Needed to Treat (NNT) of 6.5.
Conclusions:
- Chiropractic care did not demonstrate a statistically significant reduction in infantile colic crying time after adjustments.
- While a clinically relevant proportion of infants improved, the mean difference was small, suggesting potential benefits for specific subgroups.
- Further investigation is warranted to identify subgroups of infants, such as those with musculoskeletal issues, who might benefit more from chiropractic care.
Background:
Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic.
Method:
This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015-2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2-14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child's allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire.
Results:
Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference - 0.6, 95% CI - 1.1 to - 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes.
Conclusion:
Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care.
Trial Registration:
Clinical Trials NCT02595515 , registered 2 November 2015.
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