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Infantile colic and the search for the holy grail.
Philippe Alliet°, Yvan Vandenplas* (philippe.alliet@jessazh.be)
°Jessa Hospital Hasselt; * UZ Brussel, Brussel
Use of nutritional supplements and other complemen- Infant crying or colic has always existed. The first reports of infants crying dur- ing evenings date back to ancient Egyptian times. Hieroglyphics from papyrus Despite the fact that many parents did state that they are satisfied by interventions rolls dating from 1500 BC, purchased by Georg Ebers in Luxor in 1876 and recommended by their paediatrician [11], they seek in up to 60 % of the cases still conserved in the university library of Leipzig, report babies crying from dusk until other treatment options [11]. Parenting magazines, internet and personal experience late at night [1,2]. Colic is characterized by paroxysms of excessive and inconsol- are frequently used information sources. The power of the evidence for these inter- able crying, often accompanied by flushing of the face, meteorism, drawing-up of ventions has to be evaluated before recommending them. The difficulty in evaluating the legs and flatulence and occur usually in the evening [3]. Crying usually peaks interventions for colic are the transient nature of the phenomenon, the still unknown around the age of 6-8 weeks and has subsided by 4-5 months. The widely used origin of the problem and the large placebo effect of any treatment.
and internationally accepted definition of infantile colic was published by Wessel A recent systematic review gives an overview and discusses most used alter- in 1954 and is often referred to as “Wessel’s rule of threes”: unexplained par- native interventions such as nutritional supplements and other complementary oxysmal bouts of fussing and crying that last more than 3 hours a day, for more medicines. Although often used in current practice, most of these are not criti- than 3 days a week and for more than 3 weeks ). A more practical definition is the cally validated [12].
“adapted Wessel definition” according to which the symptoms (crying for more than 3 hours a day for more than 3 days) should only exist for one week. [4,5] Crying is an aspecific sign that occurs in many different conditions during infancy Gripe water was introduced by William Woodward in 1851 [13]. It was in use as a such as gastro-oesophageal reflux (disease), cow’s milk protein allergy, urinary medication for “fen fever”. In the still water of the marshlands of Eastern England tract infection, corneal abrasion, … [1,6].
malaria was prevalent. He and others had noticed that the benefit of that treat-ment was not limited to the treatment of malaria. It seemed to be an effective soother of fretful infants and provided relief from gastrointestinal troubles. Gripe water was registered as a trade mark in 1876. Its exact formulation remained The aetiology of colic is still poorly understood. Four main hypotheses are pro- secret although it was known to contain alcohol (3.6 %), bicarbonate and sucrose. posed in literature [7,8]. Some authors state that that colicky babies are infants Although it first was thought that alcohol was the most important substrate re- with different pathologies in which crying is the primordial symptom. Others be- sponsible for the therapeutic effect, a study comparing an alcoholic solution with lieve that colic is still normal crying behaviour. The two most popular hypoth- placebo showed that alcohol was not more effective in relieving colic than the eses are gut- or behaviour-oriented. In the first one, painful gut contractions are placebo [14]. The soothing effect of gripe water is due to its sweet taste. The an- thought to be the central pathway leading to excessive crying. Causes such as algesic effect disappears when the sugar solution is given through a nasogastric cow’s milk protein allergy, lactose intolerance were hypothesized. According to the tube [15]. The effect is also observed if artificial sweeteners such as aspartame are behaviour hypothesis, an inadequate parent-infant interaction or a difficult infant administered. The knowledge that sugar has an analgesic effect dates back to temperament is considered as the cause of the crying.
ancient times. Gripe water was banned in the USA in 1982 due to the possible content of alcohol. It still exists in the United Kingdom, but without the alcohol. It is still possible to purchase the original formulation through the internet. There are no randomized controlled trials with gripe water. According to two systematic reviews, Lucassen and Garisson reported that there is no evidence to use soy milk, low lactose milk or exogenous lactase [7,8]. Di-cyclomine, an anticholinergic drug, had a clear beneficial effect on crying time. FennelHowever, this drug has been taken off the market because of side effects such as Fennel was already described in Eber’s papyrus rolls as a management of flatu- seizures, apnoeas, asphyxia, muscular hypotonia and coma in 5 % of the patients. lence. Fennel seeds were discovered in the tombs of the pharaohs. In more re- Trials with an extensive hydrolysate reach statistical significance and suggest that cent times, one well-conducted study reported a significant improvement of colic a cow’s milk free diet is useful in a subgroup of colicky infants [7,8]. However, it is symptoms in infants given herbal tea (containing camomile, verbena, liquorice, unclear how many of these infants did present other manifestations of cow’s milk fennel and balm-mint) [16]. Another study showed a significantly improved colic protein allergy such as atopic dermatitis or reflux. It seems fair to propose that score in infants given fennel extract compared to placebo. However, the recom-cow’s milk protein allergy should have been ruled out before the term “colicky mended efficacious intake is a major problem, since a mean consumption of 32 baby” is used. ml/kg/day seems to be needed [17]. It is beyond doubt, that this does have deleteri-ous nutritional effects on the babies. A systematic review of the behavioural interventions failed to show a reduction of crying time by increased infant carrying, car ride simulators or intensive parent training [8]. However, decreasing infant stimulation improved in 93 % of infants Chiropractic spinal manipulations crying time, as opposed to 50 % of those in the control group.[8] Randomized controlled trials collectively fail to demonstrate that osteopathy is an Gastro-esophageal reflux (disease) (GERD) is frequently considered to cause effective therapy for infantile colic. Given that spinal manipulation is not risk-free, distressed and crying babies, since according to the National Health Insurance experts even warn that physicians should be cautious about spinal manipulation System up to 14 % of the Belgian infants under 1 year of age were at least in infants and should discourage families from treating infantile colic with spinal once treated with proton pump inhibitors (website RIZIV/INAMI). However, pla- manipulation . Short episodes of apnoea during manual therapy were recorded cebo controlled trials did not show a benefit of acid reducing medication on in 22 percent of infants [18]. One case has been described in which such apnoea crying time [9,10]. Inhibition of gastric acid secretion is a risk factor for infectious resulted in death. In addition, the cost of osteopathic manipulation should be disease.
Journal du Pédiatre Belge • 2011 - Vol. 13 - Nr.3 49 Simethicone is advertised to manage intestinal air-trapping and flatulence. Al- 1. Barr R. Colic and crying syndromes in infants. Pediatrics 1998;102:e1282-6.
though recently re-introduced on the marked, pooled randomized controlled trials 2. Papyrus Ebers. http://nl.wikipedia.org/wiki/Papyrus_Ebers.
do not show any beneficial effect of this molecule on infantile colic [7,8].
3. Hyman P, Milla P, Benninga M, Davidson G, Fleisher D, Taminau J. Child- hood functional gastrointestinal disorders: neonate/toddler. Gastroenterology 4. Wessel M, Cobb J, Jackson E, Harris G, Detwiler A. Paroxysmal fussing in Savino published a prospective randomized trial comparing Lactobacillus reuteri infancy, sometimes called colic. Pediatrics 1954;14:421-35.
strain 55730, (5 drops 30 minutes after a feeding, once a day) versus simethi- 5. Buchanan P. Assessing the evidence: treatments for colic. The breastfeeding cone (15 drops twice per day after feeding) for 28 days in the treatment of colic in exclusively breastfed infants [20]. The commercially oil suspension of Lactobacillus 6. Shope T, RIeg T, Kathiria N. Corneal abrasions in young infants. Pediatrics reuteri was stable for 21 days at 2°C to 8°C, and has to be preserved in the refrigerator. Mothers were asked to follow a strict cow’s milk-free diet during 7. Lucassen P, Assendelft W, Gubbels J et al. Effectiveness of treatments for the study. Compliance of the diet was monitored. Probiotics, antibiotics and acid infantile colic: systematic review. BMJ 1998;316:1563-9.
blockers were prohibited during the course of the study. Parents were asked to 8. Garisson M, Christakis D. A systemic review of treatments for infant colic. record the daily average crying time and the number of colic episodes. Respond- ers were defined as those infants in whom a reduction of the daily average crying 9. Moore DJ. Double-blind placebo-controlled trial of omeprazole in irritable time of more than 50 % was obtained. After one week of treatment, infants infants with GER. J Pediatr 2003;143:219-23.
receiving L. reuteri were crying 18 minutes less than those receiving simethicone. 10. Orenstein S. Multicenter, double-blind, randomized, placebo-controlled After two, three and four weeks, the difference was respectively 58, 80 and 94 trial assessing the efficacy and safety of proton pump inhibor lansoprazole minutes. The authors concluded that L . reuteri was effective in the treatment of in infants with symptoms of gastroesophageal reflux disease. J Pediatr colic in 95 % of the infants compared with only 7 % in the simethicone group. However, drawbacks of the study are that it was not a double-blind placebo con- 11. De Wel A, Kerkhofs S, Hellinckx W, Onghena P, Gillis Ph, Raes M. Persistent trolled study, that the mothers had to follow simultaneously a strict cow’s milk free infant crying: a survey with sixty-eight families lead to the construction of an diet and that a clear effect was only seen after 2 weeks of treatment.
eclectic treatment manuel to manage “infant colic”. Tijdschr Belg Kinderarts 2008;10:8-12.
A double-blind placebo controlled trial with a similar design was more recently 12. Perry R, Hunt K, Ernst E. Nutritional supplements and other complementary published. The strain used was changed to Lactobacillus reuteri DSM17938. medicines for infantile colic: a systematic review. Pediatrics 2011;127:720-3.
because of plasmid transfer of antibiotic resistance to tetracycline and lincomy- 13. Blumenthal I. The gripe water story. J R Soc Med 2000;93:172-4.
cin [21]. The study compared the use of L reuteri DSM 17938 or placebo 5 drops/day in exclusively breastfed infants with mother’s on a cow’s milk free diet during 14. O’Donovan J, Bradstock A. The failure of conventional drug therapy in the management of infantile colic. Am J Dis Child 1979;133:999-1001.
21 days, 30 min after a feeding. A dramatic decrease in crying time was seen 15. Ramenghi L, Evans D, Leven M. “Sucrose analgesia”: absorptive mechanism in both groups after one week. The number of patients with a decrease of at least or taste perception. Arch Dis Child 1999;80:F146-7.
50 % of the crying time was statistically more important in the L reuteri group 16. Weizman Z, Alkrinawi S, Goldfarb D, Bitran C. Efficacy of herbal tea prepara- than in the placebo group (80 % vs 38 % responders after one week of treatment tion in infantile colic. J Pediatr 1993;122:650-2.
and 96 % vs 71 % after three weeks of treatment) – It is remarkable that there 17. Alexandrovich I, Rakovitskaya O, Kolmo E, Sidorova T, Shushunov S. The were almost no drop-outs in this study (none in the L reuteri group and 4 in the effect of fennel seed oil emulsion in infantile colic: a randomized, placebo- placebo group) although there was no demonstrated efficacy in 20 and 4% of controlled study. Altern Ther Health Med 2003;9:58-61.
the participating infants in the L reuteri group at one week and three week resp 18. Ernst E. Chiropractic spinal manipulation for infant colic: a systematic review and in resp 62 and 29 % of the placebo group. The relative high success rate of of randomized clinical trials. Int J Clin Pract 2009;63:1272-4.
the placebo strongly suggests that parental reassurance is a cornerstone in the 19. Brand P., Engelbert RH, Helders PJ et al. Systematic review of the effects of approach of infantile colic. The effect was only studied in exclusively breastfed in- therapy in infants with the KISS-syndrome (kinetic imbalance due to suboc- fants [22]. Today, there is no evidence for efficacy of L. reuteri in formula fed infants. cipital strain). Ned Tijdschr Geneeskd 2005;26:703-7.
20. Savino F, Pelle E, Palumeri E et al. Lactobacillus reuteri (American type culture collection strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics 2007;119:e124-30. The holy grail in treating colic still has to be discovered. Due to the definition, the 21. Rosander A, Connolly E, Roos S. Removal of antibiotic resistance gene- main problem remains that it is a transient phenomenon of unknown aetiology carrying plasmids from Lactobacillus reuteri ATCC 55730 and characteriza- and that the efficacy of placebo intervention is huge. Colic can best be regarded tion of the resulting daughter strain, L. reuteri 17938. Appl Environm Microbiol 2008;74:6032-40.
according to the triple risk model, addressing a vulnerable child in a critical period (first 3 months) as well as the coping mechanisms of the parents. Systematic 22. Savino F, Cordisco L, Tarasco V et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized,double-blind, placebo-controlled trial. Pediatrics reviews have shown a beneficial effect of extensively hydrolyzed formula and decreasing of infant stimulation. Not one study with proton pump inhibitors in distressed babies showed a decrease of the crying time. Although herbal tea was suggested to have some efficacy, the large volume needed needed makes this intervention not realistic. In exclusively breastfed babies, drops of L reuteri has a positive effect on colic. The approach in infantile colic has to be based on scientific evidence and focus on Hippocrates’ principle “primum non nocere”. Health care providers should evaluate the coping mechanisms of the parents to avoid dramatic events such as maltreatment of infants.
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