Clinical Topic A-Z Clinical Speciality

Colic - infantile

Colic - infantile
D003085Colic
D007223Infant
Child healthGastrointestinal
2012-08-01Last revised in August 2012

Colic - infantile - Summary

Infantile colic is defined for clinical purposes as repeated episodes of excessive and inconsolable crying in an infant that otherwise appears to be healthy and thriving.

The underlying cause is unknown.

Estimates of prevalence range from 5–20% of infants, depending on the definition used.

Infantile colic can cause significant distress and suffering to the parents.

Typically:

Colic starts in the first weeks of life and resolves by around 4 months of age.

Crying most often occurs in the late afternoon or evening.

The baby draws its knees up to its abdomen, or arches its back when crying.

The history and examination should include the:

General health of the baby.

Antenatal and perinatal history.

Onset and length of crying.

Nature of the stools.

Feeding assessment.

Mother's diet if breastfeeding.

Family history of allergy.

Parent's response to the baby's crying.

Factors which lessen or worsen the crying.

The most useful intervention is support for parents and reassurance that infantile colic will resolve.

Holding the baby through the crying episode may be helpful. Other strategies include:

Gentle motion (e.g. pushing the pram, rocking the crib).

'White noise' (e.g. vacuum cleaner, hairdryer, running water).

Bathing in a warm bath.

Parents should be encouraged to look after their own well-being by:

Resting when possible.

Asking family and friends for support. CRY-SIS is a support group for families (www.cry-sis.org.uk).

Meeting other parents with babies of the same age.

Health visitors will also provide advice and support.

Medical treatments should only be tried if parents feel unable to cope despite advice and reassurance. The options for medical treatments are:

A 1-week trial of simeticone drops (breastfed or bottle-fed).

A 1-week trial of diet modification to exclude cow's milk protein — breastfed babies: dairy-free diet for the mother; bottle-fed babies: hypoallergenic formula.

A 1-week trial of lactase drops (breastfed or bottle-fed).

Treatment should only be continued if there is a response (i.e. the duration of crying shortens). If no response, another treatment can be considered.

Breastfeeding mothers should take a calcium supplement if they are on a dairy-free diet long term.

If the baby responds to lactase or a hypoallergenic diet, the parents should be reassured that this does not necessarily mean that they are lactose intolerant or allergic to cow's milk.

If there is a response to treatment: after the age of 3 months (and by 6 months of age at the latest), treatment can be weaned off over a period of about 1 week.

Advice from a paediatrician is required if:

The parents are not coping.

There is diagnostic doubt.

It is not possible to wean the baby off treatment by the age of 6 months.

Have I got the right topic?

0months6monthsBoth

This CKS topic covers the management of infantile colic.

This CKS topic does not cover the management of other forms of colic.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care.

How up-to-date is this topic?

How up-to-date is this topic?

Changes

Last revised in August 2012

August 2012 — reviewed. A literature search was conducted in July 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of the topic. No major changes to clinical recommendations have been made.

Previous changes

March 2011 — technical update. The management section of this topic has been simplified to improve clarity and navigation. There have been no changes to the clinical content or meaning of the recommendations with two minor exceptions: information about the history and examination was added to Diagnosis, and the choice of hypoallergenic infant formulae has been revised. Issued in June 2011.

March 2011 — minor update. Minor text correction. Issued in March 2011.

November 2010 — minor update. Pregestimil® and Nutramigen 1® have been re-branded as Pregestimil LIPIL®, and Nutramigen 1 LIPIL®. Issued in November 2010.

October 2009 — minor update. Description of use of lactase as an off-label indication for unproven lactose intolerance has been removed. Lactase drops are not a medicinal product and therefore have no licensed indications. Issued in October 2009.

May to September 2007 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. There are no major changes to the recommendations.

October 2005 — minor technical update. Issued in November 2005.

June 2004 — reviewed. Validated in September 2004 and issued in November 2004.

June 2001 — reviewed. Validated in November 2001 and issued in April 2002.

September 1998 — written.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 July 2012.

HTAs (Health Technology Assessments)

No new HTAs since 1 July 2012.

Economic appraisals

No new economic appraisals relevant to England since 1 July 2012.

Systematic reviews and meta-analyses

Systematic reviews published since the last revision of this topic:

Anabrees, J., Indrio, F., Paes, B., and Alfaleh, K. (2013) Probiotics for infantile colic: a systematic review. BMC Pediatrics 13(1), 186. [Abstract] [Free Full-text]

Dobson, D., Lucassen, P.L.B.J., Miller, J.J., et al. (2012) Manipulative therapies for infantile colic (Cochrane Review). The Cochrane Library. Issue 12. John Wiley & Sons, Ltd. www.thecochranelibrary.com [Free Full-text]

Sung, V., Collett, S., de Gooyer, T., et al. (2013) Probiotics to prevent or treat excessive infant crying: systematic review and meta-analysis. JAMA Pediatrics 167(12), 1150-1157. [Abstract]

Primary evidence

Randomized controlled trials published since the last revision of this topic:

Skjeie, H., Skonnord, T., Fetveit, A. and Brekke, M. (2013) Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scandinavian Journal of Primary Health Care 31(4), 190-196. [Abstract] [Free Full-text]

Sung, V., Hiscock, H., Tang, M.L.K., et al. (2014) Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ 348, g2107. [Free Full-text]

New policies

No new national policies or guidelines since 1 July 2012.

New safety alerts

No new safety alerts since 1 July 2012.

Changes in product availability

No changes in product availability since 1 July 2012.

Goals and outcome measures

Goals

To reduce parental anxiety and stress

To provide strategies to help soothe a crying baby

Background information

Definition

What is it?

Infantile colic is defined for clinical purposes as repeated episodes of excessive and inconsolable crying in an infant that otherwise appears to be healthy and thriving [National Collaborating Centre for Primary Care, 2006].

Researchers use more specific definitions, often that of Wessel and colleagues: 'paroxysms of irritability, fussing or crying lasting for a total of three hours a day and occurring on more than three days in any one week for a period of three weeks in an infant who is otherwise healthy and well-fed' [Wessel et al, 1954].

Causes

What causes it?

The underlying cause of infantile colic is unknown.

Suggested underlying causes include:

Transient intolerance to the protein in cow's milk or to lactose.

Gastrointestinal causes (for example gastro-oesophageal reflux).

Parenting factors (for example overstimulating the baby, misinterpreting cries).

Others have suggested that colic is just the extreme end of normal crying, or that it is due to the baby's temperament (for example a high-need baby with a sensitive temperament).

[Lucassen et al, 1998; Crotteau and Wright, 2006]

Prevalence

How common is it?

Estimates of prevalence range from 5–20% of infants, depending on the definition used for colic [Lucassen et al, 2001].

Complications

What are the complications?

Infantile colic can cause significant distress and suffering to the parents.

Stress on the parents may affect their relationships with the child.

Breastfeeding might be stopped earlier, or weaning on to solid foods begun sooner, than would otherwise have happened.

Prognosis

What is the prognosis?

Babies usually 'grow out' of infantile colic by 3–4 months of age, and by 6 months at the latest.

There is conflicting evidence on whether or not infantile colic is associated with later development of allergies (e.g. eczema, asthma, allergic rhinitis):

In an 11-year study of infants followed from birth, infantile colic was not associated with later development of allergies (for example atopy, asthma, allergic rhinitis). Infants with infantile colic (n = 90) did not have a significantly increased prevalence of allergic rhinitis or eczema compared with infants who did not have infantile colic (n = 893) [Castro-Rodriguez et al, 2001].

A 10-year study of infants hospitalised for severe colic (n = 52) or hospitalised for a cause unrelated to infantile colic (n = 51) found an association between infantile colic and allergic disorders (allergic rhinitis, conjunctivitis, asthmatic bronchitis, pollenosis, atopic eczema, or food allergy) (p < 0.05) [Savino et al, 2005].

Diagnosis

Diagnosis of infantile colic

Diagnosis

How do I know my patient has it?

Diagnose infantile colic when the history and examination and consideration of the differential diagnosis reveal no abnormality other than inconsolable crying. Typically:

Colic starts in the first weeks of life and resolves by around 4 months of age.

Crying most often occurs in the late afternoon or evening.

The baby draws its knees up to its abdomen, or arches its back when crying.

The history and examination should include the:

General health of the baby.

Antenatal and perinatal history.

Onset and length of crying.

Nature of the stools.

Feeding assessment.

Mother's diet if breastfeeding.

Family history of allergy.

Parent's response to the baby's crying.

Factors which lessen or worsen the crying.

Basis for recommendation

Basis for recommendation

These recommendations reflect guidelines developed by the National Institute for Health and Care Excellence (NICE) [National Collaborating Centre for Primary Care, 2006] and an expert review [Reust and Blake, 2000].

NICE based their recommendations on expert opinion because their systematic review found no relevant clinical trials.

Differential diagnosis

What is the differential diagnosis of infantile colic?

If symptoms started suddenly and recently, consider:

Intussusception, volvulus, strangulated hernia.

Torsion of the testis.

Corneal abrasion (such as from a scratch from the baby's nails).

Non-accidental injury.

For more persistent crying, consider:

Discomfort.

Hunger or thirst (assess feeding technique: is the baby feeding often enough?).

Too hot or too cold (assess suitability of clothing, keep room temperature at around 18°C if possible).

Too itchy (for example eczema, or itchy clothes or clothes labels).

Nappy rash.

Wind (inadequate burping: try sitting a bottle-fed baby upright when feeding to reduce air intake).

Woman's diet if breastfeeding (for example too much coffee, tea, or soft drinks that contain caffeine, or too much alcohol or spicy food).

Constipation.

Gastro-oesophageal reflux disease (GORD).

Normal infants have a high prevalence of reflux symptoms such as daily regurgitation, arching of the back, crying for more than an hour per day, or hiccups.

However, infants with significant GORD are more likely to have greater than five episodes of regurgitation per day, to refuse feeding, to have episodes of apnoea, or to have problems gaining weight.

Transient cow's milk intolerance.

Transient intolerance to cow's milk protein occurs in infants when large molecules (such as cow's milk protein) pass through the infant's permeable gastrointestinal tract and are absorbed rather than broken down.

As the infant's gastrointestinal tract matures, fewer whole proteins get through, and symptoms resolve.

Transient lactose intolerance.

Parental depression or anxiety, or inability to interact normally with the baby.

Rare, serious causes such as:

Seizures; infantile spasms.

Cerebral palsy.

Chromosomal abnormalities.

Basis for recommendation

Basis for recommendation

These recommendations reflect guidelines developed by the National Institute for Health and Care Excellence (NICE) [National Collaborating Centre for Primary Care, 2006] and expert reviews [Reust and Blake, 2000].

In the absence of relevant evidence from clinical trials, the recommendations are based on expert opinion — [Reust and Blake, 2000] for the differential diagnosis in general and [Ewing and Allen, 2005] for information on cow's milk intolerance.

Management

Management

Scenario: Management : covers the management of infantile colic, including advice for parents, treatment, and indications for referral.

Scenario: Management

Scenario: Management of infantile colic

0months6monthsBoth

Advice for parents

What advice should I give to the parents?

Reassure the parents that their baby is well, they are not doing something wrong, the baby is not rejecting them, and that colic is common and is a phase that will pass within a few months.

Holding the baby through the crying episode may be helpful. However, if there are times when the crying feels intolerable, it is best to put the baby down somewhere safe (such as their cot) and take a few minutes' 'time out'.

Other strategies that may help to soothe a crying infant include:

Gentle motion (for example pushing the pram, rocking the crib).

'White noise' (for example vacuum cleaner, hairdryer, running water).

Bathing in a warm bath.

Encourage parents to look after their own well-being:

Ask family and friends for support — parents need to be able to take a break.

Rest when the baby is asleep.

Meet other parents with babies of the same age.

CRY-SIS is a support group for families with excessively crying, sleepless, and demanding children. Their helpline is available every day from 9 a.m. to 10 p.m. Tel: 08451 228 669. The CRY-SIS website (www.cry-sis.org.uk) also contains useful information.

Health visitors are also a useful source of advice and support for parents of excessively crying babies.

Basis for recommendation

Basis for recommendation

These recommendations reflect guidelines developed by the National Institute for Health and Care Excellence (NICE) [National Collaborating Centre for Primary Care, 2006].

Reassurance, peer support, and holding the baby through the crying episode

The good practice recommendations on reassurance, peer support, and holding the baby through the crying episode are taken from the NICE guideline [National Collaborating Centre for Primary Care, 2006].

Soothing motion

Soothing motion (for example pushing the pram), 'white noise' (for example vacuum cleaner, hairdryer, running water), or reducing stimulation have not been studied adequately, but professional opinion is they may be worth trying as they are safe, inexpensive, and involve the parents [Hiscock, 2006].

Support from Health visitors

The advice to seek advice and support from Health visitors is based on expert opinion in a qualitative study [Long and Johnson, 2001].

Treatment considerations

When should treatment for infantile colic be considered, and with what?

The most useful intervention is support for parents and reassurance that infantile colic will resolve.

Only consider trying medical treatments if parents feel unable to cope despite advice and reassurance. The options for medical treatments are:

A 1-week trial of simeticone drops (breastfed or bottle-fed).

A 1-week trial of diet modification to exclude cow's milk protein:

Breastfed babies: dairy-free diet for the mother.

Bottle-fed babies: hypoallergenic formula.

A 1-week trial of lactase drops (breastfed or bottle-fed).

Only continue treatment if there is a response (such as the duration of crying shortens).

If there is no response to one medical treatment, consider trying another.

Breastfeeding mothers should take a calcium supplement if they are going to remain on a dairy-free diet long term.

If the baby does respond to lactase or hypoallergenic diet, reassure the parents that this does not necessarily mean that they are lactose intolerant or allergic to cow's milk. These are rare conditions that affect very few babies with infantile colic.

For further information on how to use lactase drops, and which hypoallergenic formulas are available on the NHS, see Prescribing information.

Basis for recommendation

Basis for recommendation

These recommendations are in line with guidelines developed by the National Institute for Health and Care Excellence (NICE) [National Collaborating Centre for Primary Care, 2006].

Quality of evidence

Although there are many studies of interventions for infantile colic, most are of poor methodological quality, making it difficult to evaluate the effectiveness of any treatment. No treatment has been clearly shown to be of substantial benefit (apart from antimuscarinics, which have serious adverse effects and are therefore not recommended). See Supporting evidence.

Simeticone

Although studies of simeticone have not provided evidence of benefit in infantile colic, CKS suggests that a 1-week trial as a placebo may still be worth a try because simeticone is easily available, licensed for this indication, and cheap. It has no reported adverse effects, and the simple act of being able to give their baby something may help parents cope better with the crying.

Hypoallergenic diet

There is limited evidence that switching to a hypoallergenic formula for bottle-fed babies, or to a hypoallergenic diet for breastfeeding mothers (free of milk, eggs, wheat, and nuts) may help ease the symptoms of colic [Evans et al, 1981; Hill et al, 1995; Lucassen et al, 2000].

The randomized controlled trials with whey hydrolysate are of better quality than those evaluating casein hydrolysate. However, both casein and whey hydrolysate are probably effective in cases of true intolerance to cow's milk protein or lactose.

A dairy-free diet is recommended as a pragmatic strategy for a trial of diet modification in primary care [Hiscock, 2006]. Advice should be sought from a dietitian before a stricter hypoallergenic diet is considered.

The Chief Medical Officer recommends that soya infant milk formulas should not be the first choice of treatment for cow's milk sensitivity or lactose intolerance [CMO, 2004]. This is because they have a high phytoestrogen content, and this may pose a risk to future fertility and sexual development [Committee on Toxicity, 2003].

Lactase

The available evidence suggests that lactase drops may help ease symptoms for some babies, providing that the lactase is given some time to incubate in the feed before it is given [Kearney et al, 1998; Kanabar et al, 2001]. However, the studies are small and require confirmation by studies independent of industry.

Low-lactose formula not recommended

There is no reliable evidence on effectiveness of switching to a low-lactose formula. Two systematic reviews [Lucassen et al, 1998; Garrison and Christakis, 2000] and CKS found no studies of low-lactose formula with adequate methodology.

There are theoretical reasons to suggest that a lactose-free formula may not be beneficial in the longer term: lactase is an inducible enzyme and requires the presence of some lactose in the intestine for optimal development [Shulman et al, 2005].

When to stop treatment

When should I consider stopping treatment?

If there is no response to the trial of treatment stop it.

If there is a response to treatment: after the age of 3 months (and by 6 months of age at the latest), wean off treatment over a period of about 1 week.

Basis for recommendation

Basis for recommendation

These are pragmatic recommendations from CKS. We found no review articles from experts that discussed this aspect of care.

Referral

When should I refer a baby with infantile colic?

Seek advice from a paediatrician if:

The parents are not coping despite advice, reassurance, and primary care interventions.

There is diagnostic doubt (for example the baby is not thriving; crying is not starting to get better or is getting worse after 4 months of age; significant gastro-oesophageal reflux is suspected).

Unable to wean off treatment by the age of 6 months.

Basis for recommendation

Basis for recommendation

These are pragmatic recommendations from CKS. We found no review articles from experts that discussed this aspect of care.

Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the electronic Medicines Compendium (eMC) (http://medicines.org.uk/emc), or the British National Formulary (BNF) (www.bnf.org).

Hypoallergenic infant formulas

Which hypoallergenic infant formulas are available on the NHS?

Hypoallergenic infant milk formulas are made from hydrolysed cow's milk protein (casein or whey) or from other sources of protein such as soya.

Hypoallergenic infant milk formulas are also low in, or free of, lactose.

The following hypoallergenic infant milk formulas are available on the NHS:

Casein hydrolysate — Nutramigen 1 LIPIL ®

Whey hydrolysate — Aptamil Pepti®.

The prescription must be endorsed ACBS.

Pepti-Junior® and Pregestimil LIPIL® are also available but, because they contain medium chain triglycerides, they are less well tolerated.

The Chief Medical Officer recommends that soya infant milk formulas should not be the first choice of treatment for cow's milk sensitivity or lactose intolerance [CMO, 2004]. This is because they have a high phytoestrogen content, and this may pose a risk to future fertility and sexual development [Committee on Toxicity, 2003].

Lactase drops

What should I be aware of when prescribing lactase drops?

Offer advice on using the drops:

Breastfeeding: express a few tablespoons of foremilk into a sterile container; add four drops of lactase; give the foremilk with the lactase to the baby using a sterilized plastic teaspoon and then breastfeed as usual.

Bottle feeding: make up the feed as usual; add four drops of lactase to the warm feed; shake gently and leave to stand for half an hour (shaking occasionally); feed the baby as normal, checking that the feed is at the correct temperature.

[Crosscare, 2011]

Simeticone

What should I be aware of when prescribing simeticone?

Simeticone is well tolerated: there are no contraindications or adverse effects listed in the manufacturer's summary of product characteristics [ABPI Medicines Compendium, 2011].

Simeticone may interact with levothyroxine if given concurrently, leading to possible under-treatment of hypothyroidism [ABPI Medicines Compendium, 2011].

Evidence

Evidence

Supporting evidence

Although there are many studies of interventions for infantile colic, most are of poor methodological quality.

Hypoallergenic milk formula

Evidence on hypoallergenic milk formula

There is some evidence that whey hydrolysate formula can improve infantile colic, and limited evidence that casein hydrolysate formula may improve infantile colic. Studies of soya formula also suggest some benefit, but are of even poorer methodological quality.

Whey hydrolysate formula

One randomized double-blind study of whey hydrolysate formula in 43 infants reduced crying by 101 minutes per day compared with control formula (95% CI 24 to 179 minutes) [Lucassen et al, 2000]. However, the authors reported that the blinding may not have remained concealed because of differences in the smell and colour of the two formulae, and differences in stools passed.

A more recent randomized controlled study of 267 infants compared a new infant formula (containing hydrolyzed whey proteins and prebiotic oligosaccharides, with a high beta-palmitic acid content) to a standard formula with simeticone [Savino et al, 2006]. Analysis of the 199 infants who completed the study found that infants receiving the whey-based formula had fewer episodes of colic (3.32 +/– 2.06) than those receiving standard formula with simeticone (1.76 +/– 1.60) (p < 0.0001; CI –1.0 to –2.1).

Casein hydrolysate formula

One randomized controlled trial of 122 infants comparing hypoallergenic diet (casein hydrolysate formula or maternal hypoallergenic diet [free of milk, eggs, wheat, and nut products]) with control diet (standard formula or usual maternal diet) [Hill et al, 1995], found that the hypoallergenic diet reduced infant distress: 61% of babies receiving a hypoallergenic diet (33 out of 54) had reductions in distress (as measured by parents on a validated chart) compared with 43% (26 out of 61) receiving the control diet (odds ratio 2.12; 95% CI 1.00 to 4.46; p = 0.047). However, results for both bottle-fed and breastfed infants were pooled together for analysis by hypoallergenic diet or control in this study, limiting its usefulness.

Evidence on the effectiveness of casein hydrolysate from crossover studies [Forsyth, 1989; Jakobsson et al, 2000] has not been included because infantile colic improves spontaneously over time, limiting the usefulness of a crossover design.

Soya formula

One randomized study of soya formula in 19 infants also showed some benefit compared with cow's milk formula [Campbell, 1989]. However, other authors have questioned the adequacy of the double-blinding in this study [Garrison and Christakis, 2000].

Infant soya milk is not recommended in the UK because of concerns that the phytoestrogen content may pose a risk to future fertility and sexual development [Committee on Toxicity, 2003; CMO, 2004].

Low-lactose milk formula

Evidence on low-lactose milk formula

The effect of switching to a low-lactose formula is unknown; CKS found no published randomized controlled trials on the effect of low-lactose formula on infantile colic.

Two systematic reviews searching for papers published before May 1999 did not identify any studies of low-lactose formula of adequate methodology for inclusion [Lucassen et al, 1998; Garrison and Christakis, 2000].

CKS found no randomized controlled studies of low-lactose formula published after May 1999.

Adding lactase to milk

Evidence on adding lactase to milk (bottle or breast)

Using lactase to lower the lactose content of breast milk or formula may be of some benefit if the lactase is given time to incubate in the milk before the feed is given.

In one double-blind crossover study, 12 breastfed infants were given either lactase or placebo within 5 minutes of starting the feed [Miller et al, 1990]. There was no significant difference in total daily crying time between treatments.

Another crossover study gave 10 bottle-fed infants cow's milk formula or pooled breast milk that had been pre-treated (and then frozen) with lactase or placebo [Stahlberg and Savilahti, 1986]. There was no significant difference between lactase and placebo in the number of days when colic was present. The duration of each colic episode was not reported.

One randomized double-blind crossover study (funded by industry) of 13 bottle-fed infants found that lactase (added to the feed 24 hours before it was given) reduced daily crying time by about 1 hour compared with placebo [Kearney et al, 1998].

A further randomized double-blind crossover study (funded and co-authored by industry) enrolled 53 infants [Kanabar et al, 2001]. For bottle-fed babies, two drops of lactase (or placebo) were added to bottle feed 4 hours before it was given. For breastfed babies, mothers were instructed to express a small amount of milk into a sterile container before starting a feed. Four drops of lactase (or placebo) were added to the expressed milk, the baby was breastfed as usual, and the treated milk was given to the baby at the end of the feed. Intention-to-treat analysis of the 46 infants with available data did not show a significant difference in crying time between babies given lactase or placebo. However, a significant difference was found when the 14 babies whose mothers were non-compliant were excluded from the analysis.

Hypoallergenic diet in breastfeeding

Evidence on hypoallergenic diet taken by breastfeeding mother

Data regarding the effectiveness of hypoallergenic diets for breastfeeding mothers are inconclusive, but suggest that there may be some benefit.

One randomized controlled trial of 122 infants comparing hypoallergenic diet (casein hydrolysate formula milk or maternal hypoallergenic diet [free of milk, eggs, wheat, and nuts]) with control diet (standard formula or usual maternal diet) [Hill et al, 1995], found that the hypoallergenic diet reduced infant distress: 61% of babies receiving a hypoallergenic diet (33 out of 54) had reductions in distress (as measured by parents on a validated chart) compared with 43% (26 out of 61) receiving the control diet (odds ratio 2.12; 95% CI 1.00 to 4.46; p = 0.047). However, results for both bottle-fed and breastfed infants were pooled together for analysis by hypoallergenic treatment or control in this study, limiting its usefulness.

A previous randomized study of 17 infants found that elimination of cow's milk from the mother's diet did not have a significant effect on the symptoms of colic [Evans et al, 1981]. However, this study has several methodological weaknesses (small sample size, inadequate power, very subjective inclusion criteria) that make it difficult to draw firm conclusions [Garrison and Christakis, 2000].

Simeticone

Evidence on simeticone

Studies of simeticone have not demonstrated benefit in infantile colic.

Two trials in a total of 110 babies showed no significant difference between simeticone and placebo, while a third trial in 26 babies (with methodological limitations) found a small improvement in the number of crying attacks on days 4–7 of treatment [Garrison and Christakis, 2000].

Meta-analysis of these studies found no significant difference between simeticone and placebo for infantile colic [Lucassen et al, 1998].

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of infantile colic.

Search dates

2007 - July 2012

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

exp Colic/, infantile colic.tw., colic$ ADJ2 infant$.tw.

Table 1 . Key to search terms.
Search commands Explanation
/ indicates a MeSh subject heading with all subheadings selected
.tw indicates a search for a term in the title or abstract
exp indicates that the MeSH subject heading was exploded to include the narrower, more specific terms beneath it in the MeSH tree
$ indicates that the search term was truncated (e.g. wart$ searches for wart and warts)
Sources of guidelines

National Institute for Health and Care Excellence (NICE)

Scottish Intercollegiate Guidelines Network (SIGN)

Royal College of Physicians

Royal College of General Practitioners

Royal College of Nursing

NICE Evidence

Health Protection Agency

World Health Organization

National Guidelines Clearinghouse

Guidelines International Network

TRIP database

GAIN

NHS Scotland National Patient Pathways

New Zealand Guidelines Group

Agency for Healthcare Research and Quality

Institute for Clinical Systems Improvement

National Health and Medical Research Council (Australia)

Royal Australian College of General Practitioners

British Columbia Medical Association

Canadian Medical Association

Alberta Medical Association

University of Michigan Medical School

Michigan Quality Improvement Consortium

Singapore Ministry of Health

National Resource for Infection Control

Patient UK Guideline links

UK Ambulance Service Clinical Practice Guidelines

RefHELP NHS Lothian Referral Guidelines

Medline (with guideline filter)

Driver and Vehicle Licensing Agency

NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

The Cochrane Library :

Systematic reviews

Protocols

Database of Abstracts of Reviews of Effects

Medline (with systematic review filter)

EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

NIHR Health Technology Assessment programme

The Cochrane Library :

NHS Economic Evaluations

Health Technology Assessments

Canadian Agency for Drugs and Technologies in Health

International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

The Cochrane Library :

Central Register of Controlled Trials

Medline (with randomized controlled trial filter)

EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Bandolier

Drug & Therapeutics Bulletin

TRIP database

Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

Department of Health

Health Management Information Consortium (HMIC)

Patient experiences

Healthtalkonline

BMJ - Patient Journeys

Patient.co.uk - Patient Support Groups

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

British National Formulary (BNF)

electronic Medicines Compendium (eMC)

European Medicines Agency (EMEA)

LactMed

Medicines and Healthcare products Regulatory Agency (MHRA)

REPROTOX

Scottish Medicines Consortium

Stockley's Drug Interactions

TERIS

TOXBASE

Micromedex

UK Medicines Information

References

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