Effectiveness of treatments for infantile colic: systematic review

BMJ 1998; 316 doi: http://dx.doi.org/10.1136/bmj.316.7144.1563 (Published 23 May 1998)
Cite this as: BMJ 1998;316:1563

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The article by Lucassen et al(1) analyses the efficacy of drug and dietary treatments for infantile colic by assessing the methodological quality of the trials. They scored the adequacy of randomisation, double -blinding, and the completeness of follow up. These attributes are necessary but not sufficient to fully evaluate the dietary trials. They ascribed significant dietary interventions with soy and hypoallergenic formula milks to elimination of cow's milk protein. Both of these formulas have very reduced lactose content compared with standard formulas. None of the reported trials were controlled for the associated change in carbohydrate. The possibility of lactose intolerance as well as protein intolerance needs to be considered.

The article studied two low lactose trials, and both used oral lactase as the intervention. Miller et al(2) reported that lactase drops, given directly into the baby's mouth, had no significant effect on the duration of crying in breast fed infants. In that trial the optimal pH for the lactase drops used (Kluveromyces Lactis), was 6.3 to 6.9. They admit that the lactase may not have survived passage through the stomach and note that the intervention did not influence breath hydrogen. In defence they point to the effectiveness of oral lactase in older children (3), but that trial used lactase tablets with a different source (Aspergillus) and a lower optimum pH of 4.4. The second study(4) reported no difference in crying time between four milks with and without lactase. These babies had a mean age at intervention of 12 weeks, which is old for evaluation of classical infant colic.

We reported (5) a randomised, double-blind, crossover trial in the management of infant colic, which showed a reduction in crying time when milk formulas were incubated for 24 hours with lactase drops. There was no change in infant formulas. The only variable was the addition of lactase or placebo to the milk. Studies of dietary measures in colic are difficult. The issues of blinding, definitions, washout periods and the need for repeat challenges in a limited time frame pose practical problems. We agree with Lucassen et al1 that a parallel design is preferable to a crossover trial.


1 Lucassen PLBJ, Assendelft WJJ, Gubbels JW, van Eiijk JTM, van Geldrop WJ, and Knuistingh Neven A. Effectiveness of treatments for infantile colic: systematic review. BMJ 1998;316:1563-9.

2 Miller JJ, McVeagh P, Fleet GH, Petocz P, and Brand JC. Effect of yeast lactase enzyme on "colic" in infants fed human milk. J Pediatr 1990;17:261-3.

3 Medow MS, Thek KD, Newman LJ, Berezin SB, Glassman MS, and Schwarz SM. b-Galactosidase tablets in the treatment of lactose intolerance in Pediatrics. Am J Dis Child 1990;144:1261-4.

4 Stahlberg MR, and Savilahti E. Infantile colic and feeding. Arch Dis Child 1986;61:1232-3.

5. Kearney PJ, Malone AJ, Hayes T, Cole M, and Hyland M. A trial of lactase in the management of infant colic. J Hum Nutr and Dietetics 1998;11:281-6.

Competing interests: None declared

Peter J Kearney, Professor of Paediatrics

University College Cork, Ireland

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Editor - The review by Lucassen et al looking at the effectiveness of interventions to treat infantile colic concentrates mainly on bottle fed infants and therefore may not be helpful to healthcare workers aiming to support mothers who choose to breast-feed their babies. (1)

Colic in breast-fed infants may be part of an increasingly recognized syndrome of frequent feeding , symptoms of hunger between feeds , excess wind , loose watery stools and failure to thrive in extreme cases. The syndrome usually results from incorrect latching of the baby on the breast leading to ineffective emptying but other causes include switching the baby to the second breast before the feed on the first breast is complete and a vigorous milk rejection reflex in the mother allowing the baby to feed without actively 'stripping' the breast of milk. All of these factors lead to the frequent consumption of high volume , low calorie feeds with a low fat and high lactose concentration which results in increased fermentation in the colon with colic, excessive wind and explosive watery stools. (2)

Simple manipulations, therefore, such as careful attention to correct attachment of the infant at the breast and advice on feed patters may be all that is needed to considerably improve troublesome colic and its associated symptoms in breast-fed infants. This approach also has relevance to those who strive to improve not only breast-feeding rates on discharge from hospital, but more important , the continuation of successful breast-feeding in the community.

Dr FJ Thompson Consultant Paediatrician Northampton General Hospital Northampton NN1 5BD

Chloe Fisher Infant Feeding Specialist John Radcliffe Hospital Oxford OX3 9DU

1. Lucassen PLBJ, Assendelft WJJ, Gubbels JW, van Eijk JTM, van Geldrop WJ, Knuitstingh Neven A. Effectiveness of treatments for infantile colic : Systematic Review. BMJ 1998;316:1563-9 (23 May)

2. Woolridge MW, Fisher C . Colic, 'Overfeeding' , and symptoms of lactose malabsorption in the breastfed baby: A possible artifact of feed management. Lancet 1988;2:382-4 (13 Aug)

Competing interests: None declared

F J Thompson

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EDITOR-The pooled outcomes shown in this review are not reported with their level of heterogeneity, but it appears that the three trials dealing with Soy formula milk are heterogeneous as the confidence limits do not overlap. It may therefore be more useful to look at the differences between the three trials rather than pool the results. Excluding the trial of lower methodological quality does not seem to eliminate the heterogeneity.

I notice that the trial showing the large effect size (Campbell 1989) is reported as having no babies as partially or totally breast fed, whilst the trial with the least effect (Evans 1981) has all breast fed babies. I wonder if this might explain the difference in outcomes.

The same reservation about pooling the results would apply to the two trials of Hypoallergenic formula milk. Although there appears to be no statistical heterogeneity between the trials one is shown as 67% breast fed (Hill 1995) and the other 0% breast fed (Forsyth 1989). Pooling results from diet trials with such diverse levels of breast feeding may not make clinical sense; surely results from breast-fed and bottle fed infants would be better analysed separately?

Competing interests: None declared

Chrisopher Cates, GP

Manor View Practice, Bushey Health Centre, London Road, Bushey, Herts

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It is encouraging to see a subject that troubles so many parents put through the rigours of a systematic review to find effective treatments. However I have some concerns, firstly that this review could be more explicit in that it concentrates on colicky babies fed on artificial formula. Secondly that the two trials considering hypoallergenic milks on which the conclusions are based are small.

The Forsyth study (ref 17) seems to have a drop out rate of 47% with only 17 babies accounted for. The babies, who were all bottle-fed, were given feeds over four day periods alternating between a standard formula and hypoallergenic milk and the mothers kept a diary of crying episodes caused by colic. It was reported in the MEDLINE abstract that only in one subject had a clinically meaningful response been reported in all three formula changes. This article concluded that the effect (of hypoallergenic milk) diminishes with time and only infrequenly is the effect reproducible. The Hill study (ref 18) had 38 bottle-fed babies, and 77 breastfed babies whose mothers were all treated with an artificial colour free, preservative free diet and a treatment group which also excluded milk, eggs, wheat and nuts. The statistical results seem to include both these groups of babies together, were they seperated for this systematic review?

I am concerned that the recommendation of a one-week trial of hypoallergenic milk, as a treatment for infantile colic for babies on cows milk formula is not supported by strong enough evidence. Other recommendations listed are less debatable; listening and supporting parents, offering reassurance, etc, although the suggestion to avoid carrying and holding for long periods would seem contrary to instinct. A discussion on treatments for breastfed babies with colic would be useful.

Competing interests: None declared

Phyll Buchanan, Breastfeeding Supporter


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Where are the breastfeeding babies? Q. Who paid for this study? A. Formula manufacturers? Breastfeeding, the forgotten art, the forgotten gold brand of milk, the best way to feed a human baby. Huge health benefits for baby which continue all through life, huge health benefits to woman who breastfeeds her children. We forget this at our peril. We continue to sacrifice breastfeeding on the altar of ignorance. So sad, so sad.

Competing interests: None declared

Helen M Woodman, Breastfeeding Counsellor

From home

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The article about infantile colic has provoked much thought into the need for consistent advice from Health care professionals. Differing advice between HV and GP seems to exarcebate a stressful situation.

Competing interests: None declared

Ashraf Bakhat, GP


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Colic is a word used to describe a very uncomfortable baby and no one seems sure the exact cause. There are a number of helpful suggestions that can be tried. Successful solutions for one family will be different from solutions for another family. Some breastfeeding mothers find it helpful to change the manner in which they breastfeed. Changing to more upright positions is somewhat helpful. Letting the baby "finish the first side first" as Chloe Fisher describes is one of the most helpful suggestions. This way the baby gets plenty of hindmilk to help digest the foremilk more slowly. Rushing to artificial milks for a solution is one of the least helpful and most potentially dangerous solutions in terms of the baby's short and long term health. Paying attention to "how" the baby is fed is important.

Competing interests: None declared

Audrey Trenholme, IBCLC


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