OBJECTIVE: To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants, compared with placebo.
STUDY DESIGN: A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (10(8) colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.
RESULTS: Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P = .045). On day 21, a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P = .035; relative risk, 3.3; 95% CI, 1.55-7.03).
CONCLUSION: Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic.
Infant colic, excessive crying of unknown cause, is a major burden to families and effects about 10-30 % of infants. Despite decades of research, the exact cause and treatment of infant colic has remained elusive. The use of Lactobacillus reuteri (DSM 17938) in infant colic is somewhat controversial and hence, we designed this study to evaluate its efficacy in infantile colic. We recruited predominantly or exclusively breastfed infants, aged less than 4 months in a placebo controlled observational randomized study. Participants' were assigned to receive L. reuteri at a dose 10(8) colony forming units (n = 21) and placebo (n = 21). Placebo was an identical formulation without live micro-organisms. Treatment was given to subjects for 21 days and they were followed for 4 weeks. Treatment success (primary outcome), daily reduction in crying time, parent satisfaction and reduction in maternal depression (secondary outcomes) were assessed at the end of study period. Treatment success was observed in all infants (100 %) of the probiotic group while it was seen in 15.7 % of the placebo group. Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day (P < 0.01) from 200.9 ± 6.3 min/day in the probiotic group as compared to the placebo group (120.6 ± 20.0 min/day). Moreover, throughout the study period, parent's satisfaction and improvement in maternal depression (Edinburgh postnatal depression scale) was also significantly higher in the probiotic group. In our study population, reduction in crying time was significant (P < 0.01) even during first week of initiation of therapy. We conclude that L. reuteri (DSM 17938) reduces daily crying time and maternal depression during infantile colic. We suggest L. reuteri may be a safe and efficacious option for reducing infant colic.
OBJECTIVE: To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
DESIGN: Double blind, placebo controlled randomised trial.
SETTING: Community based sample (primary and secondary level care centres) in Melbourne, Australia.
PARTICIPANTS: 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
INTERVENTIONS: Oral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.
MAIN OUTCOMES MEASURES: The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
RESULTS: Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
CONCLUSIONS: L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN95287767.
OBJETIVO: Para determinar se a administração de Lactobacillus reuteri (L reuteri) DSM 17938 é benéfico em crianças amamentadas com cólica infantil.
FORMA DE ESTUDO: Oitenta crianças com idade <5 meses com cólica infantil (definidos como episódios de choro com duração de três ou mais horas por dia e que ocorram pelo menos 3 dias por semana no prazo de 7 dias antes da matrícula), que eram exclusiva ou predominantemente (> 50%) amamentavam foram aleatoriamente designados para receber L reuteri DSM 17938 (10 (8), unidades formadoras de colónias) (n = 40) ou um placebo idêntico aparecendo e degustação (n = 40), ambos por via oral, em 5 gotas, 1 vez ao dia, durante 21 dias. As medidas de resultados primários foram o sucesso do tratamento, definida como a percentagem de crianças atingindo uma redução no tempo médio diário choro ≥ 50%, e a duração do choro (minutos por dia) aos 7, 14, 21, e 28 dias após a randomização .
RESULTADOS: A taxa de respondedores ao tratamento foi significativamente maior no grupo de probióticos, em comparação com o grupo placebo no dia 7 (P = 0,026), no dia 14 (risco relativo (RR) de 4,3, IC de 95% 2,3-8,7), em dia 21 (RR 2,7, IC de 95% 1,85-4,1), e no dia 28 (RR 2,5, IC de 95% 1,8-3,75). Além disso, durante todo o período de estudo, o tempo de choro mediano foi significativamente reduzida no grupo de probióticos, em comparação com o grupo de controlo.
CONCLUSÃO: crianças amamentadas exclusivamente ou predominantemente com cólica infantil benefício da administração de L reuteri DSM 17938 em comparação com placebo.
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.
BACKGROUND AND AIM: Many mothers consult physicians because of frequent infant regurgitation. Guidelines recommend reassurance and dietary treatment as first approaches. The aim of the present study was to test and compare the efficacy of 2 antiregurgitation formulae (ARF).
METHODS: A prospective, double-blind, randomized cross-over trial was performed for a 1-month period in 115 formula-fed infants (ages 2 weeks-5 months) comparing 2 ARF (ARF-1: nonhydrolyzed protein, locust bean gum; ARF-2: specific whey hydrolysate, locust bean gum, specially treated starch). The primary endpoint was the incidence of regurgitation.
RESULTS: At inclusion, mean age was 9.1 weeks; anthropometric parameters did not differ between the groups. According to the intention-to-treat analysis, the mean number of episodes of regurgitation decreased from 8.25 to 2.32 with ARF-1 and to 1.89 with ARF-2 (statistically significant difference between both ARF, P = 0.0091). The mean score of regurgitated volume decreased significantly more with ARF-2 than with ARF-1 (P = 0.0265). There was no significant difference in stool frequency and consistency between both groups.
CONCLUSIONS: The efficacy of both ARF was demonstrated by the decreased number and volume of regurgitations. ARF-2 was statistically more effective than ARF-1. Comparative trials enable the selection of the best therapeutic option.
The aim of this paper was to investigate the effect of aromatherapy massage using lavender oil as a possible treatment for this condition. This research was carried out on a group of 40 infants between 2 and 6 weeks of age with a gestational age of 38-42 weeks and normal development and growth. All the infants weighed between 2500 and 4000 g at birth and all exhibited the signs of colic. Infants in the treatment group received abdominal massage by their mothers using lavender oil, while those in the control group were not subject to an intervention. The infants in both control and treatment groups were monitored once a week by the researchers, in total five times. The effect of the massage was measured in terms of changes in the length of time the infants cried per week. The use of aromatherapy massage using lavender oil was found to be effective in reducing the symptoms of colic.
Abstract: OBJECTIVE: The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias. METHODS: Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups. RESULTS: One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively). CONCLUSIONS: In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.
OBJETIVOS: Estimar o efeito da osteopatia craniana sobre a saúde geral e bem-estar, incluindo o funcionamento físico, de crianças com paralisia cerebral.
PROJETO: Pragmatic estudo randomizado controlado.
PARTICIPANTES: 142 crianças a partir de Greater London e do Sudoeste de Inglaterra, com idades entre 5-12 anos com paralisia cerebral.
INTERVENÇÃO: Os participantes foram distribuídos aleatoriamente para seis sessões de osteopatia craniana com um osteopata registada ou uma lista de espera com controle de atenção parcial (pais convidados a participar de duas entrevistas semi-estruturadas).
As variáveis principais: A avaliação cega da função motora por fisioterapeutas que utilizam o Gross Motor Function Measure-66 (GMFM-66) e qualidade de vida usando o PF50 Child Health Questionnaire (CHQ) em 6 meses.
Desfechos secundários: avaliação dos Pais da saúde global e dormir em 6 meses, dor e sono diários em 10 semanas e 6 meses, CHQ PF50 em 10 semanas e qualidade de vida do cuidador principal (Short Form 36) em 10 semanas e 6 meses .
RESULTADOS: Em comparação com as crianças do grupo controle, as crianças do grupo osteopatia demonstraram diferenças estatisticamente significativas no GMFM-66 (diferença de 4,9 significa, IC 95% -4,4 a 14,1), CHQ Resumo Física Score (diferença média de 2,2, IC 95% -3,5 a 8,0) ou CHQ Resumo Psychological Score (diferença média de 3,4, IC 95% -0,8 a 7,7). Não houve diferenças significativas entre os grupos em relação à dor; dormir (ou "tempo dormindo" ou "hora de dormir"); ou a qualidade do cuidador principal da vida. Em comparação com as crianças do grupo controle, os cuidadores de crianças que receberam a osteopatia craniana foram quase duas vezes mais propensas a relatar que a saúde global do seu filho havia "melhorado" em 6 meses, em vez de 'diminuição' ou 'permaneceu o mesmo "(38% vs 18% ; odds ratio de 2,8, IC 95% 1,1-6,9).
CONCLUSÕES: Este estudo não encontrou nenhuma evidência estatisticamente significativa de que a osteopatia craniana leva à melhoria sustentada da função motora, dor, sono e qualidade de vida em crianças de 5-12 anos com paralisia cerebral, nem na qualidade de vida de seus cuidadores.
To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants, compared with placebo.
STUDY DESIGN:
A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (10(8) colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a structured diary, and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events.
RESULTS:
Total average crying and fussing times throughout the study (from baseline to day 21) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group (1719 ± 750 minutes [29 ± 13 hours] vs 2195 ± 764 minutes [37 ± 13 hours]; P = .028) (relative risk, 0.78; 95% CI, 0.58-0.98). Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo (median, 60 minutes/day [IQR, 64 minutes/day] vs 102 minutes/day [IQR, 87 minutes/day]; P = .045). On day 21, a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50% crying time reduction compared with infants given placebo (17 vs 6, P = .035; relative risk, 3.3; 95% CI, 1.55-7.03).
CONCLUSION:
Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic.
