Numerous hypotheses have been generated and possible etiologies have been proposed to explain infant colic, leading to a variety of possible treatments. The authors provide a general overview of the therapeutic options for the treatment of infant colic.
EXPLANATIONS AND REASSURANCE
Infant colic is one of the most frequent reasons that parents seek medical advice for babies between 1 and 4 months old. Parents are tired because they sleep little, are anxious and feel unable to calm their baby. Physician reassurance and empathy seem to be the key factors for successful management. Meticulous clinical examination and discussion of the differential diagnosis with the parents is the first step and such medical consultations should not be hurried. One of the most important interventions is to make parents realize that crying is not always related to pain, but also is a means of communication. Advice to increase carrying and holding does not seem to be effective (1); however, other authors have shown that parental counseling may be more effective than changes in infant nutrition (2). Having periods of rest is essential for all family members, although challenging to achieve in many circumstances. Advice to calm the infant is often given—take a walk, take a car trip, listen to music, rock the baby, and diminish aerophagia (adapted nipple size, slow feeding, and dummy when it helps)—which allows the parents to feel helpful and less guilty (3). All of these considerations can be conceptualized as a triangle, with the baby, the environment, and the colic at each corner. Parents can actually draw a triangle at each medical consultation and place their child on the triangle. This diagram can serve as a marker of progress for the parents, and it may be become easier for them to understand the factors involved and feel less stress about the symptoms. As a result, sometimes babies continue to have colic, but their crying is better tolerated (4).
No medication has definitively proved beneficial in treating infant colic. Two randomised placebo-controlled trials have shown that simethicone is not more effective than placebo (5,6). In spite of the lack of positive results, simethicone is still widely used by physicians. Several antispasmodic agents have been used in an attempt to “relax” the bowel in infants with colic. Dicyclomine hydrochloride (anticholinergic) has shown encouraging results, but because of its adverse effects profile (respiratory symptoms, seizures, syncope, pulse rate fluctuations, muscular hypotonia, and even coma), there has been the suggestion that its use in infants is contraindicated (7). A study showed that an antimuscarinic compound with antispasmodic activity, cimetropium bromide, may be effective, but its use is associated with significant adverse effects (eg, sleepiness) (8). Not much is known about the benefit of trimebutine, a drug with antimuscarinic and weak mu-opioid agonist effects, which is widely used in the treatment of infant colic. Thus, these studies suggest that for the time being, pharmacological management of colic is not evidence based and other therapies must be considered.
Cow's-Milk Protein Hypothesis
Sensitivity to cow's-milk protein is sometimes mentioned as a possible cause of the occurrence of colic. As reviewed by Heine in this supplement, this hypothesis is disputed, notably because the incidence of infant colic is similar in bottle-fed formula and breast-fed infants (9). To resume providing milk without bovine proteins could be attempted, particularly in cases of familial or personal history of atopy, but it is not an efficient treatment in the absence of cow's-milk allergy.
Hypoallergenic Diet in Breast-Feeding Mothers
Some proteins present in the mother's diet are excreted into breast milk, and it has been proposed that cow's proteins excreted in breast milk may have an influence on colic symptoms. In small-sample-size studies, special diets in breast-feeding mothers seem to make a difference on the incidence of colic. In a nonblinded study, exclusion of cow's milk from the breast-feeding mother's diet resulted in the disappearance of colic in 13 of 18 infants (10). In another study, colic disappeared in 35 of 66 breast-feeding mothers who were given a cow's-milk–free diet (11). Two studies assessed the effect of more extensive low-allergen diets. Hill et al (12) found a 39% reduction in distress in infants of mothers receiving the hypoallergenic diet (milk, egg, wheat, and nut free) compared with 16% receiving the control diet. In a similar study on 90 breast-fed infants, Hill et al (13) found a reduction of at least 25% in the duration of crying/fussing in infants with a maternal diet that excluded dairy, soy, eggs, peanuts, tree nuts, and fish. The mothers’ subjective assessments were not different between groups, however.
Some data support the hypothesis that proteins excreted in breast milk may play a role in colic; however, the results of these studies are not sufficiently conclusive to recommend hypoallergenic diets in all breast-feeding mothers of colicky infants. In addition, it has been shown that there is no association between the prevalence of colic and the source of nutrition (14).
Soy-based formulae also are frequently mentioned as a means to treat infant colic. Iacono et al found that symptoms disappeared in 50 of 70 (71%) cow's-milk formula–fed colicky infants who were fed soy milk formula (15). All 50 infants redeveloped symptoms in 2 successive nonblinded challenges. In a randomized crossover trial for two 6-day periods involving 19 colicky infants, the median duration of symptoms, noted by the parents, was 5 hours overall when infants were fed soy formula compared with 20 hours when cow's-milk formula was used (16). Lothe et al showed that only 11 of 60 colicky infants receiving cow's milk improved when fed with soy formula and that among 32 infants who did not improve with soy formula, their symptoms disappeared with casein hydrolysate formula (17).
The above studies involved a small number of infants and the results may be related to the elimination of cow's milk rather than to the beneficial use of soy formula. Soy formula, therefore, may improve some bottle-fed infants, but because soy protein is considered a common allergen in infancy, contains high concentrations of phytate, aluminum, and phytoestrogens, and should not be used before the age of 6 months, its widespread use cannot be recommended. The Canadian Paediatric Society advised physicians to limit the use of soy-based formulae in infants with galactosemia or in those who cannot consume dairy-based products for cultural or religious reasons (18). The same recommendations have been published by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Committee on Nutrition, which emphasised “There is no evidence supporting the use of soy protein formulae for the prevention or management of infantile colic, regurgitation, or prolonged crying” (19).
Some authors took an interest in the role of lactase in the treatment of colicky infants, but considering the divergent conclusions of the studies, the use of lactase or lactose-free formula cannot be recommended in the management of infant colic.
Human milk contains a large amount of prebiotic oligosaccharides and probably some probiotics. Probiotics are oral supplements composed of a sufficient number of viable microorganisms (generally, certain strains of Lactobacillus, Bifidobacterium, or Streptococcus) that are supposed to be beneficial for health. The expected benefit of such bacteria has led to their study in various gastrointestinal disorders, including infant colic. Most of the studies related to the use of probiotic supplements have found no significant differences between the probiotic-supplemented group and the control group (20); however, a prospective randomised nonblinded study suggested that L reuteri (strain 55730) may be beneficial for the treatment of infant colic (21). The authors examined the effect of L reuteri oral supplementation (108 colony-forming units once per day) versus simethicone administration for 28 days in the treatment of infant colic in 90 breast-fed infants. To avoid confounding factors, cow's milk was eliminated from all mothers diets in both groups. In that study, the administration of L reuteri diminished the duration of infant crying within 1 week of treatment compared with simethicone therapy.
The same authors published a randomised double-blind placebo-controlled trial comparing the efficacy of L reuteri DSM 17938 (naturally derived from the 55730 strain) versus placebo in colicky infants (22). Fifty breast-fed infants with colic were enrolled, 24 in the probiotic group and 21 in the placebo group, respectively. At day 21, the authors observed a significant reduction in the daily crying time in the probiotics-treated group. This was associated with a higher rate of L reuteri in faecal samples and a lower proportion of Escherichia coli, suggesting that L reuteri improved digestive symptoms through a reduction in E coli colonisation. These studies provide fertile ground for innovative research aimed at an improved understanding of the physiopathology of infant colic and its treatment. Szajewska et al showed similar results (23). In their study, 80 colicky infants (younger than 5 months) were enrolled and blinded randomised to receive orally L reuteri DSM 17938 (108 colony-forming units per day) or placebo. The included babies were exclusively or predominantly breast-fed. At day 7, the number of responders (reduction in the daily average crying-duration time of >50%) compared with the baseline (day 0) was significantly higher in the L reuteri group compared with the placebo group (P = 0.026). At days 14 and 21, the difference between the 2 groups was significantly greater (P < 0.001). These results, obtained by 2 independent teams, argued for the efficacy of L reuteri in treating infant colic. A systematic review based on 12 trials (1825 infants) (24) showed contrasting results: 6 of the studies suggested that probiotics reduce crying and 6 did not.
The efficacy of probiotics is, therefore, not convincing, especially in formula-fed infants. In any case, the interpretation of this systematic review is difficult because of the variability in the study populations, type and delivery, and mode/dose of probiotic supplementation. Additional multicentric studies performed on larger sample sizes and independently replicated are necessary before the use of probiotics can be recommended in exclusively breast-fed or formula-fed colicky infants (20).
COMPLEMENTARY AND ALTERNATIVE MEDICINE
Complementary and alternative medicine, generally considered to be harmless, also has been promoted for the treatment of infants with colic (25).
Several studies have investigated the effect of herbal therapies such as fennel, chamomile, and vervain for the treatment of infant colic. These plants may have an antispasmodic action. Two well-conducted trials reported the possible benefit of fennel extract or herbal tea (also containing fennel with chamomile, vervain, licorice, and balm-mint) versus placebo in reducing the crying time of the enrolled infants (26,27). Another study provided comparable results using an herbal formula, ColiMil, that also contained fennel (28). In these studies, no adverse effects were reported. Chinese star anise (Illicium verum), used in some countries for the treatment of infant colic, has been associated with neurological impairments, emphasising the potential toxicity of some herbal therapies (29).
The effect of chiropractic care in the treatment of colic has been studied. For some authors its efficacy has not been convincingly demonstrated, but others have reached contradictory conclusions; however, there are no well-designed and reproducible studies from which to draw definitive conclusions (30–33).
Spinal manipulation involves quick, controlled techniques that are adapted for different ages and conditions. Force is applied by hand, suddenly rather than strongly, which moves the joint over a small range. The spinal manipulation of infants is performed in an outpatient setting without the use of special equipment and usually involves >1 visit. Wiberg et al found a significant reduction in mean hours of crying with spinal manipulation compared with simethicone at days 4 to 7 and days 8 to 11 of the study (34), but the data were available only for 41 of 50 subjects and the methodology of the study is questionable. Another trial studied the impact of cranial osteopathy compared with no treatment (only therapeutic time) (35). The results indicated a significant reduction in crying and a significantly greater increase in sleeping time in the intervention group compared with the control group.
Of all of the studies of spinal manipulation, that of Olafsdottir et al is the most reliable because the parents were not aware of the treatment (36). In the treatment group the chiropractor palpated infants’ spinal articulations with respect to areas of dysfunction. Dysfunctional articulations were manipulated and mobilised using light fingertip pressure. The treatment was given 3 times, at intervals of 2 to 5 days, for a period of 8 days. This trial showed no differences in outcome according to parents’ reports or hours of crying recorded in parent diaries. Based on the available evidence (few studies conducted using different techniques and with methodological problems), it is not possible to recommend the use of chiropractic for the management of infant colic.
The use of reflexology is another modality that has been used to treat colicky infants. Bennedbaek and colleagues assessed the impact of specific and nonspecific reflexology on colicky infants (37). Nonspecific reflexology did not target the areas of the feet considered to be therapeutic for colic, whereas colic-specific reflexology targeted the points related to the spine, digestion, colon, spleen, lungs, urinary tract, solar plexus, and endocrine system. They found a significant effect on colic in the 2 reflexology groups, but there was no difference between specific and nonspecific reflexology groups. Based on the available evidence (few studies conducted using different techniques and with methodological problems), it is not possible to recommend the use of reflexology for the management of infant colic.
Because of the outcome of infant colic is always favorable, its treatment is based mostly on physicians reassuring parents. An appropriate medical consultation that provides empathy and reassurance is essential for the management of colicky babies and their parents. The distress caused by this functional disorder sometimes leads parents to explore other therapeutic options, however. The results of pharmacological studies do not provide support for the routine use of drugs. Drug therapies are not effective, maternal cow's milk exclusion in case of breast-feeding is questionable, and lactase-enriched milks have not clearly proved beneficial. Milk without bovine proteins could be attempted, herbal therapies could sometimes help, and probiotics therapies may be effective, but mid- and long-term data are missing.
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