Dietary modifications for infantile colic.

BACKGROUND: Infantile colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. This condition appears to be more frequent in the first six weeks of life (prevalence range of 17% to 25%), depending on the specific location reported and definitions used, and it usually resolves by three months of age. The aetiopathogenesis of infantile colic is unclear but most likely multifactorial. A number of psychological, behavioural and biological components (food hypersensitivity, allergy or both; gut microflora and dysmotility) are thought to contribute to its manifestation. The role of diet as a component in infantile colic remains controversial. OBJECTIVES: To assess the effects of dietary modifications for reducing colic in infants less than four months of age. SEARCH METHODS: In July 2018 we searched CENTRAL, MEDLINE, Embase , 17 other databases and 2 trials registers. We also searched Google, checked and handsearched references and contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of dietary modifications, alone or in combination, for colicky infants younger than four months of age versus another intervention or placebo. We used specific definitions for colic, age of onset and the methods for performing the intervention. We defined 'modified diet' as any diet altered to include or exclude certain components. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was duration of crying, and secondary outcomes were response to intervention, frequency of crying episodes, parental/family quality of life, infant sleep duration, parental satisfaction and adverse effects. MAIN RESULTS: We included 15 RCTs involving 1121 infants (balanced numbers of boys and girls) aged 2 to 16 weeks. All studies were small and at high risk of bias across multiple design factors (e.g. selection, attrition). The studies covered a wide range of dietary interventions, and there was limited scope for meta-analysis. Using the GRADE approach, we assessed the quality of the evidence as very low.Low-allergen maternal diet versus a diet containing known potential allergens: one study (90 infants) found that 35/47 (74%) of infants responded to a low-allergen maternal diet, compared with 16/43 (37%) of infants on a diet containing known potential allergens.Low-allergen diet or soy milk formula versus dicyclomine hydrochloride: one study (120 infants) found that 10/15 (66.6%) breastfed babies responded to dicyclomine hydrochloride, compared with 24/45 (53.3%) formula-fed babies. There was little difference in response between breastfed babies whose mother changed their diet (10/16; 62.5%) and babies who received soy milk formula (29/44; 65.9%).Hydrolysed formula versus standard formula: two studies (64 infants) found no difference in duration of crying, reported as a dichotomous outcome: risk ratio 2.03, 95% confidence interval (CI) 0.81 to 5.10; very low-quality evidence. The author of one study confirmed there were no adverse effects. One study (43 infants) reported a greater reduction in crying time postintervention with hydrolysed formula (104 min/d, 95% CI 55 to 155) than with standard formula (3 min/d, 95% CI -63 to 67).Hydrolysed formula versus another hydrolysed formula: one study (22 infants) found that two types of hydrolysed formula were equally effective in resolving symptoms for babies who commenced with standard formula (Alimentum reduced crying to 2.21 h/d (standard deviation (SD) 0.40) and Nutramigen to 2.93 h/d (SD 0.70)).Hydrolysed formula or dairy- and soy-free maternal diet versus addition of parental education or counselling: one study (21 infants) found that crying time decreased to 2.03 h/d (SD 1.03) in the hydrolysed or dairy- and soy-free group compared with 1.08 h/d (SD 0.7) in the parent education or counselling group, nine days into the intervention.Partially hydrolysed, lower lactose, whey-based formulae containing oligosaccharide versus standard formula with simethicone: one study (267 infants) found that both groups experienced a decrease in colic episodes (secondary outcome) after seven days (partially hydrolysed formula: from 5.99 episodes (SD 1.84) to 2.47 episodes (SD 1.94); standard formula: from 5.41 episodes (SD 1.88) to 3.72 episodes (SD 1.98)). After two weeks the difference between the two groups was significant (partially hydrolysed: 1.76 episodes (SD 1.60); standard formula: 3.32 episodes (SD 2.06)). The study author confirmed there were no adverse effects.Lactase enzyme supplementation versus placebo: three studies (138 infants) assessed this comparison, but none reported data amenable to analysis for any outcome. There were no adverse effects in any of the studies.Extract of Foeniculum vulgare, Matricariae recutita, and Melissa officinalis versus placebo: one study (93 infants) found that average daily crying time was lower for infants given the extract (76.9 min/d (SD 23.5), than infants given placebo (169.9 min/d (SD 23.1), at the end of the one-week study. There were no adverse effects.Soy protein-based formula versus standard cows' milk protein-based formula: one study (19 infants) reported a mean crying time of 12.7 h/week (SD 16.4) in the soy formula group versus 17.3 h/week (SD 6.9) in the standard cows' milk group, and that 5/10 (50%) responded in the soy formula group versus 0/9 (0%) in the standard cows' milk group.Soy protein formula with polysaccharide versus standard soy protein formula: one study (27 infants) assessed this comparison but did not provide disaggregated data for the number of responders in each group after treatment.No study reported on our secondary outcomes of parental or family quality of life, infant sleep duration per 24 h, or parental satisfaction. AUTHORS' CONCLUSIONS: Currently, evidence of the effectiveness of dietary modifications for the treatment of infantile colic is sparse and at significant risk of bias. The few available studies had small sample sizes, and most had serious limitations. There were insufficient studies, thus limiting the use of meta-analysis. Benefits reported for hydrolysed formulas were inconsistent.Based on available evidence, we are unable to recommend any intervention. Future studies of single interventions, using clinically significant outcome measures, and appropriate design and power are needed.

Pain-relieving agents for infantile colic.

BACKGROUND: Infantile colic is a common disorder in the first months of life, affecting somewhere between 4% and 28% of infants worldwide, depending on geography and definitions used. Although it is self limiting and resolves by four months of age, colic is perceived by parents as a problem that requires action. Pain-relieving agents, such as drugs, sugars and herbal remedies, have been suggested as interventions to reduce crying episodes and severity of symptoms. OBJECTIVES: To assess the effectiveness and safety of pain-relieving agents for reducing colic in infants younger than four months of age. SEARCH METHODS: We searched the following databases in March 2015 and again in May 2016: CENTRAL, Ovid MEDLINE, Embase and PsycINFO, along with 11 other databases. We also searched two trial registers, four thesis repositories and the reference lists of relevant studies to identify unpublished and ongoing studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of pain-relieving agents given to infants with colic. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures of The Cochrane Collaboration. MAIN RESULTS: We included 18 RCTs involving 1014 infants. All studies were small and at high risk of bias, often presenting major shortcomings across multiple design factors (e.g. selection, performance, attrition, lack of washout period).Three studies compared simethicone with placebo, and one with Mentha piperita; four studies compared herbal agents with placebo; two compared sucrose or glucose with placebo; five compared dicyclomine with placebo; and two compared cimetropium - one against placebo and the other at two different dosages. One multiple-arm study compared sucrose and herbal tea versus no treatment. Simethicone. Comparison with placebo revealed no difference in daily hours of crying reported for simethicone at the end of treatment in one small, low-quality study involving 27 infants. A meta-analysis of data from two cross-over studies comparing simethicone with placebo showed no difference in the number of of infants who responded positively to treatment (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.73 to 1.23; 110 infants, low-quality evidence).One small study (30 participants) compared simethicone with Mentha piperita and found no difference in crying duration, number of crying episodes or number of responders. Herbal agents. We found low-quality evidence suggesting that herbal agents reduce the duration of crying compared with placebo (mean difference (MD) 1.33, 95% CI 0.71 to 1.96; three studies, 279 infants), with different magnitude of benefit noted across studies (I² = 96%). We found moderate-quality evidence indicating that herbal agents increase response over placebo (RR 2.05, 95% CI 1.56 to 2.70; three studies, 277 infants). Sucrose. One very low-quality study involving 35 infants reported that sucrose reduced hours spent crying compared with placebo (MD 1.72, 95% CI 1.38 to 2.06). Dicyclomine. We could consider only one of the five studies of dicyclomine (48 infants) for the primary comparison. In this study, more of the infants given dicyclomine responded than than those given placebo (RR 2.50, 95% CI 1.17 to 5.34). Cimetropium bromide. Data from one very low-quality study comparing cimetropium bromide with placebo showed reduced crying duration among infants treated with cimetropium bromide (MD -30.20 minutes per crisis, 95% CI -39.51 to -20.89; 86 infants). The same study reported that cimetropium increased the number of responders (RR 2.29, 95% CI 1.44 to 3.64).No serious adverse events were reported for all of the agents considered, with the exception of dicyclomine, for which two of five studies reported relevant adverse effects (longer sleep 4%, wide-eyed state 4%, drowsiness 13%). AUTHORS' CONCLUSIONS: At the present time, evidence of the effectiveness of pain-relieving agents for the treatment of infantile colic is sparse and prone to bias. The few available studies included small sample sizes, and most had serious limitations. Benefits, when reported, were inconsistent.We found no evidence to support the use of simethicone as a pain-relieving agent for infantile colic.Available evidence shows that herbal agents, sugar, dicyclomine and cimetropium bromide cannot be recommended for infants with colic.Investigators must conduct RCTs using standardised measures that allow comparisons among pain-relieving agents and pooling of results across studies. Parents, who most often provide the intervention and assess the outcome, should always be blinded.

Effectiveness of bibliographic searches performed by paediatric residents and interns assisted by librarians. A randomised controlled trial.

BACKGROUND: Considerable barriers still prevent paediatricians from successfully using information retrieval technology. OBJECTIVES: To verify whether the assistance of biomedical librarians significantly improves the outcomes of searches performed by paediatricians in biomedical databases using real-life clinical scenarios. METHODS: In a controlled trial at a paediatric teaching hospital, nine residents and interns were randomly allocated to an assisted search group and nine to a non-assisted (control) group. Each participant searched PubMed and other online sources, performing pre-determined tasks including the formulation of a clinical question, retrieval and selection of bibliographic records. In the assisted group, participants were supported by a librarian with ≥5 years of experience. The primary outcome was the success of search sessions, scored against a specific assessment tool. RESULTS: The median score of the assisted group was 73.6 points interquartile range (IQR = 13.4) vs. 50.4 (IQR = 17.1) of the control group. The difference between median values in the results was 23.2 points (95% CI 4.8-33.2), in favour of the assisted group (P-value, Mann-Whitney U test: 0.013). CONCLUSIONS: The study has found quantitative evidence of a significant difference in search performance between paediatric residents or interns assisted by a librarian and those searching the literature alone.