Management of Infantile Colic: A Review
Justine Cohen-Silver and Savithiri Ratnapalan
CLIN PEDIATR 2009 48: 14 originally published online 2 October 2008
The online version of this article can be found at:
can be found at: Clinical Pediatrics Additional services and information for Clinical Pediatrics Management of Infantile Colic: A Review
Justine Cohen-Silver, MD, MSc, andSavithiri Ratnapalan, MBBS, MEd
Infantile colic is an easily identified childhood entity
current concepts for management options of infantile
that has no clear treatment guidelines. The management
of infantile colic varies among physicians, and familiesare often frustrated by the medical community’s inability
Keywords: general pediatrics; colic; infantile colic;
to prescribe a cure for colic. This article reviews the
et al1 in 1954 as ‘‘crying for 3 hours a day, on atleast 3 days a week, for at least 3 weeks.’’
Based on the theory that infantile colic is a gastroin-
Although this definition has been since disputed,2
testinal pathologic condition, several groups have
the presence of colic and its effect on infants and fam-
examined diet modification to treat infantile colic.
ilies persist. Many studies have been conducted to
The main theory resides in the contribution of whey
determine the cause and management of colic. This
hydrosylate to infantile colic by causing excessive
article will review the current concepts for manage-
gas production from poor gut digestion.
A prospective randomized controlled trial among
Colic can begin anytime from early infancy to 4 to
275 infants looked at substituting standard formula
5 months of age.3 Crying associated with colic has
plus simethicone pharmacotherapy with a formula
been described as excessive, tends to occur in the eve-
of partially hydrolysed whey proteins, probiotic oligo-
nings, and has been reported to have a high-pitched
saccharides (OS), and a high beta-palmitic acid
quality.4,5 At times, colic has been associated with
content.7 Ninety-six infants who were fed the new
flushing of the face, drawing up of the legs, and
formula had a significant decrease in the number of
crying episodes per week (mean [SD], 1.76 [1.60]
episodes in the treatment group vs 3.32 [2.06] epi-
MEDLINE from 1950 to October 4, 2007. The key-
sodes in the control group; P < .001). A second trial
words infantile colic, colic, and therapeutics were com-
among 43 infants was a double-blind randomized
bined in the search. Publications were excluded if they
placebo-controlled trial that demonstrated a signifi-
were comments, case reports, or letters. Publications
cant reduction in crying time when infants were fed
were included if they were review articles or rando-
whey hydrosylate formula compared with standard
mized control trials. The published literature about
formula.8 Crying duration was decreased by 63
the treatment of colic is discussed under the following
(95% confidence interval, 1-127) min/d. A third
subheadings: diet change, pharmacologic treatments,
double-blind randomized placebo-controlled trial
alternative therapies, and behavior modification.
placed bottle-fed infants on a whey hydrosylateformula vs regular formula, and the mothers ofbreast fed infants were asked to consume a hypoaller-
From the Department of Pediatrics, Hospital for Sick Children,
genic diet (free of milk, egg, wheat, and nuts) or a
University of Toronto, Ontario, Canada.
control diet.9 Mothers measured infant distress
Address correspondence to: Savithiri Ratnapalan, MBBS, MEd,
levels using validated distress charts. After adjusting
Department of Pediatrics, Hospital for Sick Children, Universityof Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada;
for age and feeding mode, infants receiving the
e-mail: [email protected].
treatment diets had a 39% (95% confidence interval,
Management of Infantile Colic / Cohen-Silver, Ratnapalan
26%-50%) reduction in distress vs a 16% (95%
distension and discomfort due to excessive gas produc-
confidence interval, 0%-30%) reduction in distress
tion. Although the principle of reduction in discomfort
among control subjects (P = .01). One study10
makes inherent sense, studies11,12 demonstrated that
attempted to specifically classify whether bovine
simethicone was not superior to placebo in reducing
whey protein was responsible for infantile colic.
Twenty-four infants in a double-blind crossoverstudy were fed capsules of bovine whey protein (treat-
ment) or human albumin (placebo) within a hyperal-lergenic formula (Nutramigen; Mead Johnson Co,
Probiotics, Glucose, and Herbal Remedies
Evansville, Indiana). Daily crying durations were 3.2hours for the infants receiving whey protein and 1.0
Several alternative pharmacologic agents have been
hour for those receiving placebo (P < .001).
assessed for their ability to decrease symptoms of
Based on these studies, physicians recommend
infantile colic. A recent prospective randomized
changing to formulas containing whey hydrosylate
study13 assessed the effectiveness of Lactobacillus
for formula-fed infants, as well as maternal dietary
acidophilus vs simethicone in reducing colic in 90
modifications for breastfed infants. However, exclu-
breastfed infants. Daily median crying durations
sive hypoallergenic formula feeds should be reserved
were reduced from 159 minutes to 51 minutes in
for children with true allergy to cow’s milk protein,
the probiotic group and from 177 minutes to 145
and the parents of children with infantile colic
minutes in the simethicone group. No adverse effects
Another study14 assessed oral hypertonic glucose
solution vs sterile water for the treatment of colic in
25 infants in a randomized double-blind crossovertrial; results were measured using parents’ scores.
Several trials have examined pharmacotherapy as a
The group receiving glucose, 30%, had significantly
treatment of infantile colic. Pharmacologic agents
less colic than the placebo group (P = .03).
are aimed at reducing gastrointestinal discomfort,
Two studies assessed whether herbal remedies
which has been theoretically linked with infantile
were superior to placebo. In a study15 of 93 breastfed
colic. Anticholinergic medications such as dicyclo-
infants, a significant reduction in crying time of 85.4%
mine hydrochloride and dicycloverine have been
in the treatment group was observed vs 48.9% in the
shown to be effective in reducing the increased peri-
control group (P < .005). A randomized placebo-
staltic cholinergic activity of the gut.6 Unfortunately,
controlled study16 assessed whether fennel oil was
the adverse effect profile reported for these medica-
superior to placebo and found that 63% of infants in
tions is significantly morbid. Adverse effects include
the treatment group had a response to treatment vs
loose bowel movements, accidental overdose of the
23.7% of infants in the control group (P < .01).
medication, and the appearance of patients as dopey,
There were no reported adverse effects in these 2
A randomized double-blind placebo-controlled trial
revisited the concept of administering an alternative
anticholinergic to dicyclomine, namely, cimetropiumbromide.10 Ninety-seven infants were included in the
Evidence for the efficacy of spinal manipulation in
study. The mean (SD) duration of crying during crisis
treating infantile colic is inconclusive. A randomized
was 17.3 (12.6) minutes in the treatment group vs
controlled trial demonstrated that 32 of 46 infants
47.5 (28.5) minutes in the placebo group (P < .005).
(69.6%) in the treatment group and 24 of 40 infants
A placebo response was significant at P < .05. The
(60.0%) in the control group demonstrated a response
main adverse effect noted in the treatment group vs
to treatment, but the effect of spinal manipulation
the placebo group was increased sleepiness.
was statistically nonsignificant.17 Another study18 of
Simethicone is an alternative pharmacologic agent
50 patients randomized to spinal manipulation or
that acts as a detergent to facilitate gas bubbles within
dimethicone study groups demonstrated a reduction
the gut to coalesce, as well as to decrease abdominal
in crying duration by 1 hour in the dimethicone group
Clinical Pediatrics / Vol. 48, No. 1, January 2009
vs 2.7 hours in the spinal manipulation group
the self-limiting nature, the perceived pathogenesis,
(P = .004). Physicians should be cautious about spinal
and the concept of altered perception to normal
manipulation in infants and should discourage families
stimuli), as well as a discussion of the different treat-
from treating infantile colic with spinal manipulation.
ment options (including dietary modifications). Allparents should be counseled and encouraged to trybehavior modification, which would help reduce mater-
nal stress. Other treatment options such as probiotics,glucose water, or herbal remedies could be considered
Behavior modification for infantile colic is largely
in nonresponders with severe symptoms.
based on intervening with parents to provide reassur-ance and to offer alternative behavioral methods fortreating colic. A study19 examined the effectiveness
of instituting a home-based nursing intervention todecrease parental stress invoked from having an
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Parents in the treatment group reported significantly
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