The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial

Abstract

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

Systematic review and meta‐analysis showed that complementary and alternative medicines were not effective for infantile colic

“…Two studies presented a high risk of bias and two reported an unclear risk of bias due to missing outcome data 11,35,36,38 . All the studies appeared to have an unclear risk of bias when it came to selecting the results that were reported 11,35–38 . The results of the assessments carried out using the Cochrane risk‐of‐bias tool are shown in Figure 2.…”

“…In addition, adverse effects should be considered whenever manipulation techniques are performed 39 . Two of the studies did not report any adverse events, while another study withdrew one patient due to increased crying 37 . A patient being withdrawn or dropping out due to a worsened outcome variable could be considered an adverse effect and may lead to a risk of bias when the results are reported.…”

“…The Consolidated Standards of Reporting Trials and the Template for Intervention Description and Replication promote the need for information on treatment dosage, so that the results obtained by researchers and/or in the clinical fields can be reproduced. In the studies we reviewed, the intervention was applied after a subjective evaluation performed by an osteopath or a chiropractor 11,35–38 . The evaluation was based on the manual palpation of structures, in order to try and diagnose dysfunctions or impairments.…”

“…That is why the interventions were very heterogeneous. None of the studies showed anything measurable regarding the evaluation and/or treatment processes, 11,35–38 which contributed to research bias.…”

Prevalencia de cólico infantil: experiencia del grupo de trabajo en trastornos del eje cerebro-intestino de la Sociedad Latinoamericana de Gastroenterología, Hepatología y Nutrición Pediátrica (SLAGHNP)

“…Sin embargo, se desconoce la relación causal entre el efecto modulador de los probióticos sobre la microbiota y el sistema inmunitario. 26 Otros tratamientos como la terapia manual, quiropráctica y la reflexología [33][34][35][36] son controversiales. La evidencia es limitada en relación con los programas de formación para padres, 37 la manipulación de la dieta materna, la lactasa, la sacarosa, la glucosa, la simeticona, la diciclomina, el cimetroprio, las hierbas, la acupuntura y los inhibidores de la bomba de protones.…”