Lise Vilstrup Holm1,2, Dorte Ejg Jarbøl2, Henrik Wulff Christensen1, Jens Søndergaard2, Lise Hestbæk3,4. 1. The Chiropractic Knowledge Hub, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark. 2. Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J.B. Winsløws vej 9A, DK-5000, Odense C, Denmark. 3. The Chiropractic Knowledge Hub, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark. l.hestbaek@nikkb.dk. 4. Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense C, Denmark. l.hestbaek@nikkb.dk.
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.
RCT Entities:
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.
Authors: Francesco Savino; Andrea Quartieri; Angela De Marco; Maria Garro; Alberto Amaretti; Stefano Raimondi; Marta Simone; Maddalena Rossi Journal: Acta Paediatr Date: 2016-11-15 Impact factor: 2.299
Authors: Dawn Dobson; Peter L B J Lucassen; Joyce J Miller; Arine M Vlieger; Philip Prescott; George Lewith Journal: Cochrane Database Syst Rev Date: 2012-12-12
Authors: Judith Zeevenhooven; Pamela D Browne; Monique P L'Hoir; Carolina de Weerth; Marc A Benninga Journal: Nat Rev Gastroenterol Hepatol Date: 2018-08 Impact factor: 46.802