Colic

I was stunned to read in 2011 that no alternative medicine treatments had any effect on colic. But the review (Ernst, April Pediatrics Journal) itself showed that out of fifteen trials “eleven trials indicated a significant result in favor of complementary and alternative medicines.” The reviewers’ commentary, not the facts, was taken out of context. A previous Pediatrics review (2000) found alternative medicine had: “some effective therapies for infant colic.”

In looking through the medical literature, breast feeding is superior to formula feeding in terms of the softening stool. Prebiotics caused more diarrhea and rashes. Probiotics were helpful in five studies. In a trial for cramping, Spascupreel was comparable to hyoscine butylbromide. When compared to the drug, the homeopathic Sprascupreel is nontoxic. One of its ingredients is chamomile.

The biggest factor confirmed in colic is reactivity to diet. Older studies have shown a direct relationship to cow’s milk, with elimination of symptoms in the majority of infants. Other studies have found significant benefit only in those infants shown to be allergic. Using soy formula does not show significant benefit, possibly because soy is another common allergen.

Parents should keep journals of symptoms and consult with their pediatricians. Colic can often be lessened by addressing lifestyle and dietary choices within the family. Simply waiting for the children to grow up is a prescription for grey hair.

We begin with the “negative” review:

Nutritional Supplements and Other Complementary Medicines for Infantile Colic: A Systematic Review

Rachel Perry, MPhil, MA, BAa, Katherine Hunt, PhD, MSc, BN, RNa, Edzard Ernst, PhD, MD, FMedSci, FSB, FRCPa

aDepartment of Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Plymouth, United Kingdom

Background Complementary and alternative medicines often are advocated for infantile colic, yet there has been no synthesis of the evidence to inform current practice about their use.

Objective To critically evaluate all randomized clinical trials of nutritional supplements and other complementary and alternative medicines as a treatment for infantile colic.

Methods Five electronic databases were searched from their inception to February 2010 to identify all relevant randomized clinical trials of complementary and alternative medicines and supplements for infantile colic. Reference lists of retrieved articles were hand searched. Data were extracted by two independent reviewers, and methodological quality was assessed using the Jadad score and key aspects of the Cochrane risk of bias.

Results Fifteen randomized clinical trials met the inclusion criteria and were included. Thirteen studies were placebo controlled. Eight were of good methodological quality. Eleven trials indicated a significant result in favor of complementary and alternative medicines. However, none of these randomized clinical trials were without flaws. Independent replications were missing for most modalities.

Conclusions Some encouraging results exist for fennel extract, mixed herbal tea, and sugar solutions, although it has to be stressed that all trials have major limitations. Thus, the notion that any form of complementary and alternative medicine is effective for infantile colic currently is not supported from the evidence from the included randomized clinical trials. Additional replications are needed before firm conclusions can be drawn.

PEDIATRICS Vol. 106 No. 1 Supplement July 2000, pp. 184-190

EARLY CHILDHOOD: COLIC, CHILD DEVELOPMENT, AND POISONING PREVENTION:

A Systematic Review of Treatments for Infant Colic

Received Oct 25, 1999; accepted Feb 10, 2000.

Michelle M. Garrison* and Dimitri A. Christakis*,

From the * Child Health Institute, University of Washington; and Department of Pediatrics, University of Washington, Seattle, Washington.

Objective: To conduct a systematic review of rigorously evaluated treatments for infant colic.

Methods. Online bibliographic databases were searched for the term "colic" in articles classified as clinical trials or randomized controlled trials and conducted in infants. Reference lists from review articles, meta-analyses, and the selected articles were also reviewed for potential studies. The abstracts or full-text articles of 57 relevant studies were examined, of which 22 met the selection criteria. The methodology and findings of all retrieved articles were critically evaluated. Data were extracted from each article regarding study methods, intervention studied, outcomes measured, and results.

Results. Four of the interventions studied had data of adequate quality and statistically significant numbers needed to treat (NNT): hypoallergenic diet (NNT = 6), soy formula (NNT = 2), reduced stimulation (NNT = 2), and herbal tea (NNT = 3).

Conclusions. There are some effective therapies for infant colic, but additional rigorous studies of existing and alternative therapies are needed.

Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial

Francesco Savino, MD, PhDa, Lisa Cordisco, PhDb, Valentina Tarasco, MDa, Elisabetta Palumeri, MDa, Roberto Calabrese, BSca, Roberto Oggero, MDa, Stefan Roos, PhDc, Diego Matteuzzi, PhDb

a Department of Pediatrics, Regina Margherita Children Hospital, University of Turin, Turin, Italy;

b Department of Pharmaceutical Sciences, University of Bologna, Bologna, Italy; and

c Department of Microbiology, Swedish University of Agricultural Sciences, Uppsala, Sweden

OBJECTIVE To test the efficacy of Lactobacillus reuteri on infantile colic and to evaluate its relationship to the gut microbiota.

STUDY DESIGN Fifty exclusively breastfed colicky infants, diagnosed according to modified Wessel's criteria, were randomly assigned to receive either L reuteri DSM 17 938 (108 colony-forming units) or placebo daily for 21 days. Parental questionnaires monitored daily crying time and adverse effects. Stool samples were collected for microbiologic analysis.

RESULTS Forty-six infants (L reuteri group: 25; placebo group: 21) completed the trial. Daily crying times in minutes/day (median [interquartile range]) were 370 (120) vs 300 (150) (P = .127) on day 0 and 35.0 (85) vs 90.0 (148) (P = .022) on day 21, in the L reuteri and placebo groups, respectively. Responders (50% reduction in crying time from baseline) were significantly higher in the L reuteri group versus placebo group on days 7 (20 vs 8; P = .006), 14 (24 vs 13; P = .007), and 21 (24 vs 15; P = .036). During the study, there was a significant increase in fecal lactobacilli (P = .002) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only (P = .001). There were no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to the supplementation were observed.

CONCLUSION L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of infantile colic and was well tolerated and safe. Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement.

J Fam Health Care. 2010;20(6):206-9.

Infantile colic: practicalities of management, including dietary aspects.

Shergill-Bonner R.

Great Ormond Street Hospital, London.

Abstract

The incidence of infantile colic is between 5-20%. It occurs equally in breast- and bottle-fed infants, and in both sexes. The aetiology is unknown. The elimination of cow's milk protein and using extensively hydrolysed protein formula have been shown to be effective treatments for infantile colic. Partially hydrolysed milk has also been shown to be helpful and can be a useful option in the community when a cow's milk allergy is not considered to be an underlining cause of the colic. If symptoms persist the situation should be reassessed, as further investigations and treatment may be necessary. Certain behavioural interventions, such as reassurance, making changes to the parents' responsiveness to the infant, using motion/sound to calm the infant and reducing stimuli to the infant have also been shown to be effective treatments for infantile colic. There is some evidence to suggest that the use of prebiotic oligosaccharides, to restore normal healthy gut flora, can be beneficial. Soya milk is not recommended as a treatment.

PMID: 21319674

Asia Pac J Clin Nutr. 2010;19(4):473-80.

Effect of a whey-predominant starter formula containing LCPUFAs and oligosaccharides (FOS/GOS) on gastrointestinal comfort in infants.

Vivatvakin B, Mahayosnond A, Theamboonlers A, Steenhout PG, Conus NJ.

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. BOOSBA.V@CHULA.AC.TH

Abstract

Development of new infant formulas aims to replicate the benefits of breast milk. One benefit of breast milk over infant formulas is greater gastrointestinal comfort. We compared indicators of gastrointestinal comfort in infants fed a whey-predominant formula containing long-chain polyunsaturated fatty acids, galacto-oligo-saccharides and fructo-oligosaccharides, and infants fed a control casein-predominant formula without additional ingredients. The single-centre, prospective, double-blind, controlled trial randomly assigned healthy, full-term infants (n=144) to receive exclusively either experimental or control formula from 30 days to 4 months of age. A group of exclusively breast-fed infants served as reference (n=80). At 1, 2, 3, and 4 months, infants' growth parameters were measured and their health assessed. Parents recorded frequency and physical characteristics of infants' stool, frequency of regurgitation, vomiting, crying and colic. At 2-months, gastric emptying (ultrasound) and intestinal transit time (H2 breath test) were measured, and stool samples collected for bacterial analysis. Compared to the control (n=69), fewer of the experimental group (n=67) had hard stools (0.7 vs 7.5%, p<0.001) and more had soft stools (90.8 vs 82.3%, p<0.05). Also compared to the control, the experimental group's stool microbiota composition (mean % bifidobacteria: 78.1 (experimental, n=17), 63.7 (control, n=16), 74.3 (breast-fed, n=20), gastric transit times (59.6 (experimental, n=53), 61.4 (control, n=62), 55.9 (breast-fed, n=67) minutes) and intestinal transit times (data not shown) were closer to that of the breast-fed group. Growth parameter values were similar for all groups. The data suggest that, in infants, the prebiotic-containing whey-based formula provides superior gastrointestinal comfort than a control formula.

PMID: 21147707

J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):359-64.

Term infants fed formula supplemented with selected blends of prebiotics grow normally and have soft stools similar to those reported for breast-fed infants.

Ziegler E, Vanderhoof JA, Petschow B, Mitmesser SH, Stolz SI, Harris CL, Berseth CL.

Department of Pediatrics, University of Iowa Hospital and Clinic, Iowa City, IA, USA.

Abstract

OBJECTIVES: The present study was designed to evaluate the effect of 2 different combinations of prebiotic ingredients, polydextrose (PDX), galactooligosaccharides (GOS), and lactulose (LOS), at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age.

PATIENTS AND METHODS: Healthy, formula-fed, term infants (n = 226) were randomly assigned to 1 of 3 study formula groups: control group (n = 76), PG4 group (control formula supplemented with 4 g/L of a prebiotic blend, n = 74), or PGL8 group (control formula supplemented with 8 g/L of a prebiotic blend, n = 76). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age, and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30, 60, 90, and 120 days of age. Adverse events were recorded throughout the study.

RESULTS: There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point. Significant differences in stool consistency were detected among the 3 formula groups at 30, 60, and 90 days of age (P < 0.001, P = 0.025, P = 0.004, respectively), with the supplemented formula groups having looser stools than the control group. The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age (P = 0.021 and P = 0.017, respectively), but all of the groups were similar at 60, 90, and 120 days of age. A statistical difference was detected among the formula groups in 3 categories of adverse events: diarrhea (control vs PG4, 4% vs 18%, P = 0.008), eczema (PG4 vs control, 18% vs 7%, P = 0.046; PG4 vs PGL8, 18% vs 4%, P = 0.008), and irritability (control vs PGL8, 4% vs 16%, P = 0.027).

CONCLUSIONS: Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula. A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics.

PMID: 17325558

Appl Environ Microbiol. 2009 Feb;75(4):1121-8. Epub 2008 Dec 16.

Molecular ecological analysis of fecal bacterial populations from term infants fed formula supplemented with selected blends of prebiotics.

Nakamura N, Gaskins HR, Collier CT, Nava GM, Rai D, Petschow B, Russell WM, Harris C, Mackie RI, Wampler JL, Walker DC.

Division of Nutritional Sciences, Institute for Genomic Biology, University of Illinois at Urbana-Champaign, 1207 W. Gregory Drive, Urbana, IL 61801, USA. nnakamur@illinois.edu

Abstract

Supplementation of infant formulas with prebiotic ingredients continues the effort to mimic functional properties of human milk. In this double-blind, controlled, 28-day study, healthy term infants received control formula (control group; n = 25) or control formula supplemented with polydextrose (PDX) and galactooligosaccharide (GOS) (4 g/liter) (PG4 group; n = 27) or with PDX, GOS, and lactulose (LOS) (either 4 g/liter [PGL4 group; n = 27] or 8 g/liter [PGL8 group; n = 25]). A parallel breast-fed group (BF group) (n = 30) was included. Stool characteristics, formula tolerance, and adverse events were monitored. Fecal bacterial subpopulations were evaluated by culture-based selective enumeration (Enterobacteriaceae), quantitative real-time PCR (Clostridium clusters I, XI, and XIV, Lactobacillus, and Bifidobacterium), and fluorescence in situ hybridization (FISH) (Bifidobacterium). Fecal bacterial community profiles were examined by using 16S rRNA gene PCR-denaturing gradient gel electrophoresis. The daily stool consistency was significantly softer or looser in the BF group than in all of the groups that received formula. The formulas were well tolerated, and the incidences of adverse events did not differ among feeding groups. Few significant changes in bacterial subpopulations were observed at any time point. The bacterial communities were stable; individual profiles tended to cluster by subject rather than by group. Post hoc analysis, however, demonstrated that the bacterial community profiles for subjects in the BF, PG4, PGL4, and PGL8 groups that first received formula at a younger age were less stable than the profiles for subjects in the same groups that received formula at an older age, but there was no difference for the control group. These data indicate that formulas containing PDX, GOS, and LOS blends are more likely to influence gut microbes when administration is begun in early infancy and justify further investigation of the age-related effects of these blends on fecal microbiota.

PMID: 19088307

Ann Saudi Med. 2010 Nov-Dec;30(6):468-70.

Predictive value of the cow's milk skin prick test in infantile colic.

Moravej H, Imanieh MH, Kashef S, Handjani F, Eghterdari F.

Department of Pediatrics, Shiraz University of Medical Sciences, Shiraz, Iran. hmoravej@sums.ac.ir

Abstract

BACKGROUND AND OBJECTIVES: Infantile colic is a common problem among young infants. Cow's milk allergy has been suggested as one of the causes. We aimed to investigate the value of the cow's milk skin test for the diagnosis of cow's milk allergy in exclusively breast-fed infants with infantile colic.

METHODS: Exclusively breast-fed infants with infantile colic were enrolled in this study. On the first visit, the average hours of crying of the infant in a 24-h period were recorded and the cow's milk skin test was performed. If the infant had a positive skin test, elimination of cow's milk from the mothers' diet was advised. Infants with negative skin tests were divided into case and control groups. Cow's milk was eliminated from the diet of mothers in the case group. After 2 weeks, the number of hours of crying were recorded again. The reduction in the crying hours was compared between the two groups using the chi-square test.

RESULTS: Skin tests were positive in 3 of 114 cases (2.6%) of infantile colic. All three cases recovered completely following elimination of cow's milk from the mother's diet. Among the 111 patients with negative skin tests, 77 patients completed the study: 35 in the case group and 42 in the control group. The reduction in crying hours in infants in the case group was not significantly different from that in the control group.

CONCLUSION: Elimination of cow's milk from the mothers' diet is not beneficial for infants with a negative skin test. Infants with a positive skin test may benefit from this management.

PMID: 21060160

Pediatrics. 1983 Feb;71(2):268-71.

Cow's milk proteins cause infantile colic in breast-fed infants: a double-blind crossover study.

Jakobsson I, Lindberg T.

Abstract

Sixty-six mothers of 66 breast-fed infants with infantile colic were put on a diet free from cow's milk. The colic disappeared in 35 infants; it reappeared on at least two challenges (cow's milk to mother) in 23 infants (35%). A double-blind crossover trial with cow's milk whey protein was performed in 16 of these 23 mothers and infants. Six infants had to be taken out of the study for various reasons; of the remaining ten infants, nine reacted with colic after their mothers' intake of whey protein-containing capsules. Sequential analysis showed a high correlation between infantile colic in breast-fed infants and their mothers' consumption of cow's milk protein. A diet free of cow's milk is suggested for the mothers as a first trial of treatment of infantile colic in breast-fed infants.

PMID: 6823433

Pediatrics. 1989 Feb;83(2):262-6.

Cow's milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study.

Lothe L, Lindberg T.

Department of Pediatrics, University of Lund, Malmö General Hospital, Sweden.

Erratum in:

Pediatrics 1989 Jul;84(1):17.

Comment in:

Pediatrics. 1989 Nov;84(5):938-9.

Abstract

There are several causes of infantile colic. The aim of this study was to evaluate, under controlled conditions, whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants. The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks. In 24 of 27 infants with severe colic, the symptoms disappeared when they were given a cow's milk-free diet (Nutramigen). These 24 infants were entered into a double-blind crossover study. The infants (receiving cow's milk-free diet) were given the contents of identical capsules with each meal during day 6. The same procedure was repeated on day 10. The capsules contained either whey protein powder (with Nutramigen added) or human albumin powder (with Nutramigen added). Eighteen infants receiving the whey protein-containing capsules reacted with colic, two infants receiving placebo reacted with colic (P less than .001), and four infants did not react at all. Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow's milk-free diet-fed infants (P less than .001). Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo (P less than .001). In conclusion, bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants.

PMID: 2913556

Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003664.

Formulas containing hydrolysed protein for prevention of allergy and food intolerance in infants.

Osborn DA, Sinn J.

Westmead Hospital, Neonatal Unit, Hawkesbury Road, Westmead, New South Wales, Australia.

Update of:

Cochrane Database Syst Rev. 2003;(4):CD003664.

Abstract

BACKGROUND: Allergies and food reactions are common and may be associated with foods including adapted cow's milk formula. Formulas containing hydrolysed proteins have been used to treat infants with allergy or food intolerance. However, it is unclear whether hydrolysed formula can be advocated for prevention of allergy and food intolerance in infants without evidence of allergy or food intolerance.

OBJECTIVES: To determine the effect of feeding hydrolysed formulas on allergy and food intolerance in infants and children compared to adapted cow's milk or human breast milk. If hydrolysed formulas are effective, to determine what type of hydrolysed formula is most effective including extensively and partially hydrolysed formulas. To determine which infants benefit, including infants at low or high risk of allergy and infants receiving early, short term or prolonged formula feeding.

SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. The review was updated with searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), MEDLINE (1966-March 2006), EMBASE (1980-March 2006) and CINAHL (1982-March 2006) and previous reviews including cross references.

SELECTION CRITERIA: Randomised and quasi-randomised trials that compare the use of a hydrolysed infant formula to human milk or cow's milk formula. Trials with >80% follow up of participants were eligible for inclusion.

MAIN RESULTS: Two trials compared early, short term hydrolysed formula to human milk feeding. No significant difference in infant allergy or childhood cow's milk allergy (CMA) were reported. No eligible trial compared prolonged hydrolysed formula to human milk feeding. Two trials compared early, short term hydrolysed formula to cow's milk formula feeding. No significant benefits were reported. One large quasi-random study reported a reduction in infant CMA of borderline significance in low risk infants (RR 0.62, 95% CI 0.38, 1.00). Ten eligible studies compared prolonged feeding with hydrolysed formula versus cow's milk formula in high risk infants. Meta-analysis found a significant reduction in infant allergy (seven studies, 2514 infants; typical RR 0.79, 95% CI 0.66, 0.94), but not in the incidence of childhood allergy (two studies, 950 infants; typical RR 0.85, 95% CI 0.69, 1.05). There was no significant difference in infant eczema (eight studies, 2558 infants, typical RR 0.84, 95% CI 0.68, 1.04), childhood eczema incidence (two studies, 950 infants, typical RR 0.83, 95% CI 0.63, 1.10), childhood eczema prevalence (one study, 872 infants; RR 0.66, 95% CI 0.43, 1.02), or infant or childhood asthma, rhinitis and food allergy. One study reported a significant reduction in infants with CMA with confirmed atopy (RR 0.36, 95% CI 0.15, 0.89). Subgroup analysis of trials blinded to formula found no significant difference in infant allergy (four studies, 2156 infants; typical RR 0.87, 95% CI 0.69, 1.08) or childhood allergy incidence (one study, 872 infants; RR 0.91, 95% CI 0.73, 1.14). No eligible trial examined the effect of prolonged hydrolysed formula feeding on allergy beyond early childhood. There is evidence that preterm or low birthweight infants fed a hydrolysed preterm formula have significantly reduced weight gain, but not in other growth parameters (head circumference or length). Studies in term infants report no adverse effects on growth. Subgroup analysis of trials of partially hydrolysed versus cow's milk formula found a significant reduction in infant allergy (six studies, 1391 infants; typical RR 0.79, 95% CI 0.65, 0.97) but not childhood allergy, or infant or childhood asthma, eczema or rhinitis. Methodological concerns were the same as for the overall analysis. Analysis of trials of extensively hydrolysed formula versus cow's milk formula found no significant differences in allergy or food intolerance. Infants fed extensively hydrolysed formula compared with partially hydrolysed formula had a significant reduction in food allergy (two studies, 341 infants; typical RR 0.43, 95% CI 0.19, 0.99), but there was no significant difference in all allergy or any other specific allergy incidence. Comparing extensively hydrolysed casein containing formula with cow's milk formula, one study (431 infants) reported a significant reduction in childhood allergy incidence (RR 0.72, 95% CI 0.53, 0.97). Meta-analysis found a significant reduction in infant eczema (three studies, 1237 infants; typical RR 0.71, 95% CI 0.51, 0.97). One study reported a significant reduction in childhood eczema incidence (RR 0.66, 95% CI 0.44, 0.98) and prevalence (RR 0.50, 95% CI 0.27, 0.92).

AUTHORS' CONCLUSIONS: There is no evidence to support feeding with a hydrolysed formula for the prevention of allergy compared to exclusive breast feeding. In high risk infants who are unable to be completely breast fed, there is limited evidence that prolonged feeding with a hydrolysed formula compared to a cow's milk formula reduces infant and childhood allergy and infant CMA. In view of methodological concerns and inconsistency of findings, further large, well designed trials comparing formulas containing partially hydrolysed whey, or extensively hydrolysed casein to cow's milk formulas are needed.

PMID: 17054180

Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003741.

Soy formula for prevention of allergy and food intolerance in infants.

Osborn DA, Sinn J.

Westmead Hospital, Neonatal Unit, Hawkesbury Road, Westmead, New South Wales, Australia.

Update of:

Cochrane Database Syst Rev. 2004;(3):CD003741.

Abstract

BACKGROUND: Allergies and food reactions in infants and children are common and may be associated with a variety of foods including adapted cow's milk formula. Soy based formulas have been used to treat infants with allergy or food intolerance. However, it is unclear whether they can help prevent allergy and food intolerance in infants without clinical evidence of allergy or food intolerance.

OBJECTIVES: To determine the effect of feeding adapted soy formula compared to human milk, cow's milk formula or a hydrolysed protein formula on preventing allergy or food intolerance in infants without clinical evidence of allergy or food intolerance.

SEARCH STRATEGY: The standard search strategy of the Cochrane Neonatal Review Group was used. Updated searches were performed of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), MEDLINE (1966-March 2006), EMBASE (1980-March 2006), CINAHL (1982-March 2006) and previous reviews including cross references.

SELECTION CRITERIA: Randomised and quasi-randomised trials that compare the use of an adapted soy formula to human milk, an adapted cow's milk or a hydrolysed protein formula for feeding infants without clinical allergy or food intolerance in the first six months of life. Only trials with > 80% follow up of participants and reported in group of assignment were eligible for inclusion.

DATA COLLECTION AND ANALYSIS: Eligibility of studies for inclusion, methodological quality and data extraction were assessed independently by each review author. Primary outcomes included clinical allergy, specific allergies and food intolerance. Where no heterogeneity of treatment effect was found, the fixed effect model was used for meta-analysis. Where significant or apparent heterogeneity was found, results were reported using the random effects model and potential causes of the heterogeneity were sought.

MAIN RESULTS: Three eligible studies enrolling high risk infants with a history of allergy in a first degree relative were included. No eligible study enrolled infants fed human milk. No study examined the effect of early, short term soy formula feeding. All compared prolonged soy formula to cow's milk formula feeding. One study was of adequate methodology and without unbalanced allergy preventing co-interventions in treatment groups. One study with unclear allocation concealment and 19.5% losses reported a significant reduction in infant allergy, asthma and allergic rhinitis. However, no other study reported any significant benefits from the use of a soy formula. Meta-analysis found no significant difference in childhood allergy incidence (2 studies; typical RR 0.73, 95% CI 0.37, 1.44). No significant difference was reported in one study in infant asthma (RR 1.10, 95% CI 0.86, 1.40), infant eczema (RR 1.20, 95% CI 0.95, 1.52), childhood eczema prevalence (RR 1.10, 95% CI 0.73, 1.68), infant rhinitis (RR 0.94, 95% CI 0.76, 1.16) or childhood rhinitis prevalence (RR 1.20, 95% CI 0.73, 2.00). Meta-analysis found no significant difference in childhood asthma incidence (3 studies, 728 infants; typical RR 0.71, 95% CI 0.26, 1.92), childhood eczema incidence (2 studies, 283 infants; typical RR 1.57, 95% CI 0.90, 2.75) or childhood rhinitis incidence (2 studies, 283 infants; typical RR 0.69, 95% CI 0.06, 8.00). One study reported no significant difference in infant CMPI (RR 1.09, 95% CI 0.45, 2.62), infant CMA (RR 1.09, 95% CI 0.24, 4.86), childhood soy protein allergy incidence (RR 3.26, 95% CI 0.36, 29.17) and urticaria. No study compared soy formula to hydrolysed protein formula.

AUTHORS' CONCLUSIONS: Feeding with a soy formula cannot be recommended for prevention of allergy or food intolerance in infants at high risk of allergy or food intolerance. Further research may be warranted to determine the role of soy formulas for prevention of allergy or food intolerance in infants unable to be breast fed with a strong family history of allergy or cow's milk protein intolerance.

PMID: 17054183

Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006475.

Probiotics in infants for prevention of allergic disease and food hypersensitivity.

Osborn DA, Sinn JK.

Abstract

BACKGROUND: The composition of the intestinal microflora may be different in individuals with atopic eczema from those without this condition, and such differences may precede the development of eczema. Probiotics are live bacteria that colonize the gastrointestinal tract and provide a health benefit to the host. Probiotics added to infant feeds have the potential to prevent sensitisation of infants to dietary allergens.

OBJECTIVES: To determine the effect of probiotics given to infants for the prevention of allergic disease or food hypersensitivity.

SEARCH STRATEGY: This included searches of the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (1966 - February 2007), EMBASE, PREMEDLINE, abstracts of conference proceedings and citations of published articles, and expert informants.

SELECTION CRITERIA: Randomised and quasi-randomised controlled trials that compare the use of a probiotic to no probiotic; or the use a specific probiotic compared to a different probiotic; or a probiotic with added prebiotic to control.

DATA COLLECTION AND ANALYSIS: Assessment of trial quality, data extraction and synthesis of data were performed using standard methods of the Cochrane Neonatal Review Group.

MAIN RESULTS: Twelve studies were eligible for inclusion. Allergic disease and / or food hypersensitivity outcomes were assessed by 6 studies enrolling 2080 infants, but outcomes for only 1549 infants were reported. Studies generally had adequate randomisation, allocation concealment and blinding of treatment. However, the findings of this review should be treated with caution due to excess losses in patient follow-up (17% to 61%). Meta-analysis of five studies reporting the outcomes of 1477 infants found a significant reduction in infant eczema (typical RR 0.82, 95% CI 0.70, 0.95). However, there was significant and substantial heterogeneity between studies. One study reported that the difference in eczema between groups persisted to 4 years age. When the analysis was restricted to studies reporting atopic eczema (confirmed by skin prick test or specific IgE), the findings were no longer significant (typical RR 0.80, 95% CI 0.62, 1.02). All studies reporting significant benefits used probiotic supplements containing L. rhamnosus and enrolled infants at high risk of allergy. No other benefits were reported for any other allergic disease or food hypersensitivity outcome.

AUTHORS' CONCLUSIONS: There is insufficient evidence to recommend the addition of probiotics to infant feeds for prevention of allergic disease or food hypersensitivity. Although there was a reduction in clinical eczema in infants, this effect was not consistent between studies and caution is advised in view of methodological concerns regarding included studies. Further studies are required to determine whether the findings are reproducible.

PMID: 17943912

J Altern Complement Med. 2010 Jan;16(1):69-79.

The use of homeopathic products in childhood: data generated over 8.5 years from the Avon Longitudinal Study of Parents and Children (ALSPAC).

Thompson EA, Bishop JL, Northstone K.

Bristol Homeopathic Hospital, Bristol, United Kingdom. Elizabeth.Thompson@UHBristol.nhs.uk

Abstract

BACKGROUND: Very little is known about the use of homeopathic products (HP) in children. The Avon Longitudinal Study of Parents and Children (ALSPAC), a population-based cohort in the South-West of England, has collected homeopathic data through self-completion questionnaires posted to the mother at regular time points throughout childhood. The aim of this article is to describe the use of these products in a large cohort of children from birth to 8.5 years of age.

METHODS: Questions asked about the use of HP within a preceding time period at seven time points from birth to 8.5 years of age. Additional questions at 18 and 81 months asked about the conditions treated and at 81 months who had prescribed the HP.

RESULTS: Eleven and eight-tenths percent (11.8%) of this cohort used a HP at least once up to 8.5 years of age. Chamomilla for teething and Arnica for soft-tissue bruising were the most commonly used products. The most frequently prescribed products were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. Parents were most likely at 81 months to prescribe HP for their children (46.3% of all prescription sources) and 10% of products were prescribed by general practitioners. Confusion about what constituted a HP was present in nearly 10% of answers.

CONCLUSIONS: No other study, to our knowledge, has been able to map the use of HP over such a long time period in such a large cohort of children. The amount of HP use reflects a significant minority of the population who use complementary and alternative medicine treatments to manage the health of their family. Health care professionals should be aware of the confusion surrounding HP and have knowledge around some of the more commonly used HP. Parents and carers are using homeopathy wisely with appropriate remedies consistently used for acute problems. Research could focus on greater information delivery to the community and monitoring of potential health and cost benefits, or side-effects of the use of HP for acute and chronic conditions in children.

PMID: 20105063

BMC Fam Pract. 2008 Jan 30;9:8.

Complementary or alternative? The use of homeopathic products and antibiotics amongst pre-school children.

Wye L, Hay AD, Northstone K, Bishop J, Headley J, Thompson E.

Academic Unit of Primary Health Care, Community Based Medicine, University of Bristol, Cotham House, Cotham Hill, Bristol, UK. lesley.wye@bristol.ac.uk

Abstract

BACKGROUND: Any intervention to reduce the inappropriate use of antibiotics for infections in children has the potential to reduce the selective pressure on antimicrobial resistance and minimise the medicalisation of self-limiting illness. Little is known about whether homeopathic products might be used by some families as an alternative to antibiotics or the characteristics of such families. We used the Avon Longitudinal Study of Parents and Children (ALSPAC) observational dataset to explore the hypothesis that the use of homeopathic products is associated with reduced antibiotic use in pre-school children and to identify characteristics of the families of pre-school children given homeopathic products.

METHODS: Questionnaires data were completed by the parents of 9723 children while aged between 3-4.5 years in Bristol UK. Univariable and multivariable analyses were used to explore the relationships between antibiotic and homeopathic product use.

RESULTS: Six percent of children had received one or more homeopathic products and 62% one or more antibiotics between the ages of 3 and 4.5 years. After adjustment for factors associated with antibiotic use, there was no association between homeopathic product and antibiotic use (adjusted OR = 1.02, 95% CI 0.84, 1.24). Factors independently associated with child homeopathic product use were: higher maternal education, maternal use of homeopathic products, maternal lack of confidence in doctors, mothers reporting that they were less likely to see doctor when the child was ill, children being given vitamins, watching less television and suffering from wheeze and food allergies.

CONCLUSION: In this observational study, the use of homeopathic products was not associated with decreased antibiotic consumption, suggesting the use of homeopathic product complements rather than competes with the use of antibiotics in pre-school children. The characteristics of mothers giving homeopathic products to their children are similar to those associated with adult self-administration.

PMID: 18234084

Pediatr Int. 2007 Jun;49(3):328-34.

Effects of Spascupreel versus hyoscine butylbromide for gastrointestinal cramps in children.

Müller-Krampe B, Oberbaum M, Klein P, Weiser M.

Abstract

BACKGROUND: Gastrointestinal spasms and cramps are common in children as well as in adults. Alternative medical practices such as chiropractic and homeopathy are becoming increasingly popular in Europe and the USA. The effectiveness and tolerability of the homeopathic preparation Spascupreel was compared with that of hyoscine butylbromide treatment in children <12 years of age.

METHODS: An observational cohort study in 204 children <12 years was conducted over a 1 week treatment period. The efficacy of the respective therapies were evaluated on the effect on severity of spasms and clinical symptoms (pain/cramps, sleep disturbances, distress, eating or drinking difficulties and frequent crying). Compliance was evaluated on a four-point scale from 'very good' to 'low'. Evaluation was done by the practitioner based on information given by the patient or minder.

RESULTS: The analysis showed comparative improvements with the homeopathic preparation and hyoscine butylbromide therapy on severity of spasms, pain/cramps, sleep disturbances, eating or drinking difficulties, and frequent crying, all as evaluated by the practitioner. Both treatments were very well tolerated.

CONCLUSIONS: For patients opting for a homeopathic therapy, Spascupreel seems to be an effective and well tolerated alternative to conventional therapies in children suffering from gastrointestinal spasms.

PMID: 17532830

http://en.wikipedia.org/wiki/Butylscopolamine

Br J Clin Pharmacol. 2005 Jun;59(6):743-9.

Paediatric homoeopathy in general practice: where, when and why?

Ekins-Daukes S, Helms PJ, Taylor MW, Simpson CR, McLay JS.

Department of Medicine and Therapeutics, The University of Aberdeen, Polwarth Buildings, Foresterhill, Aberdeen, AB25 2ZD.

Abstract

AIMS: To investigate the extent of homoeopathic prescribing in primary care for childhood diseases and assess GP attitudes towards the use of homoeopathy in children.

METHODS: Homoeopathic prescribing in primary care was assessed in 167 865 children aged 0-16 years for the year 1999-2000. Computerized prescribing data were retrieved from 161 representative general practices in Scotland. Medical attitudes towards homoeopathic prescribing to children were also assessed via a questionnaire survey.

RESULTS: During the year 1999-2000 22% (36) of general practices prescribed homoeopathic medicines to 190 (1.1/1000 registered) children. The majority of such prescriptions were issued to children under 1 year of age (8.0/1000 registered children). The most frequently prescribed medicines were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. A total of 259 completed questionnaires were returned by GPs, giving a response rate of 75%. GPs who frequently prescribed homoeopathic medicines to children (more than 1 per month) were more likely to claim an interest in homoeopathy, have had a formal training and keep up to date in the discipline, and refer on to a homoeopath (P < 0.001 for all variables) than those GPs who prescribed less than once a month or never. The majority of GPs who prescribed homoeopathic medicines did so when conventional treatments had apparently failed (76%), while 94% also perceived homoeopathy to be safe. Frequent prescribers reported a more positive attitude towards homoeopathic medicines than those who prescribed less frequently. Non-prescribers reported a lack of proven efficacy and lack of training as the main reasons for not prescribing homoeopathic medicines (55% and 79%, respectively). However non-prescribers from within homoeopathic prescribing practices reported a more favourable attitude in general towards homoeopathy and less resistance towards prescribing in the future than non-prescribers from practices where none of the partners practiced homoeopathy.

CONCLUSIONS: In primary care paediatric prescribing of homoeopathic medicines most commonly occurs for self-limiting conditions in infants less than 1 year of age. Although the current level of homoeopathic prescribing is low, the widespread use in the community suggests that at least some knowledge of the main indications for homoeopathy and the preparations used would be of benefit to registered medical practitioners.

PMID: 15948942