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PEDIATRICS “THE GRIPE”: AN INTEGRATIVE APPROACH TO INFANT COLIC Lawrence D. Rosen, MD

abies cry. In fact, crying is consid- Karp speculates that some babies have a colic will fade by the time newborns are 12 ered part of normal infant devel- more difficult time adjusting to what he to 16 weeks of age. There is encouraging opment. Noted psychologist terms the “fourth trimester,” a three- evidence that parenting intervention can B Gwen Gustafson offers this scien- month period of time in which infants reduce crying time in colicky babies.10,11 tific explanation: “Neonatal crying is a must cope with potentially overwhelming Many families, though, seeking a more ac- -specific behavior which achieves sensory stimuli.6 Just like adults, babies tive role in reducing infants’ distress, turn its likely evolutionary function (infant sur- vary in how well they integrate these exter- to complementary and alternative medical vival) by reliably eliciting responses from nal stimuli, and colic may well represent (CAM) therapies. Surveys of CAM use in caregivers.”1 The great behavioral observer an adjustment disorder—the far end of an culturally diverse populations indicate Charles Darwin described his own baby’s infant irritability syndrome. Most parents that colic is a common reason for use of distress in superb biological detail: “With claim that their colicky babies seem to suf- and nutritional therapies in early 12,13 one of my own infants, from his eighth fer abdominal pain, and interestingly, childhood. Even in the 1950s, Wessel day and for some time afterwards, I often there is now mounting evidence that the noted that among the most prevalent observed that the first sign of a screaming- may be involved in treatments used by parents were dietary fit, when it could be observed coming on colic via neuroimmune connections. In modifications and various soothing regi- 4 gradually, was a little frown, owing to the fact, babies with food allergy and other mens, sometimes today termed as CAM. contraction of the corrugators of the atopic disorders are more likely to be diag- But are these therapies actually alterna- 7 brows; the capillaries of the naked head nosed with colic. Exposure to cigarette tive? In the case of colic, it is difficult to and face becoming at the same time red- smoking, a known link to colic for quite distinguish conventional from unconven- dened with blood.”2 Harvard develop- some time, is thought to exacerbate dis- tional approaches, as culture and geogra- tress by a connection to gastroesophageal phy play such a large role in what is com- mentalist T. Berry Brazelton observed that 8 the typical baby cries up to 2.25 hours reflux. A recently published 10-year pro- monly used. spective study challenges a commonly The largest systematic review to date of daily,3 supporting current speculation that held view that there are no long-term treatments for colic found little evidence crying, like most things, exists along a health-related issues in children who had to support many conventional therapies, spectrum. Yet, there are those babies (and colic in infancy.9 Approximately 100 in- including the widely used simethicone, their families) that seem to suffer more fants were evaluated at one to three while noting that several nutritional and than most; these infants in Darwin’s En- months of age, and then again at the age of botanically based approaches were indeed gland were said to have “the gripe.” Today 10 years. There was an association noted evidence based.14 An integrative ap- we call it colic. We have widely accepted between infantile colic and later recurrent proach, combining the best conventional the “Rule of 3s” definition first offered by abdominal pain, atopic disease, and sleep and CAM prevention and treatment strat- pediatrician Morris Wessel in 1954.4 Dr disorders. This association does not, of egies, is a wonderful paradigm for the Wessel, who studied infant crying behav- course, prove causation, but suggests that management of infantile colic. Integrative ior as part of the Yale Rooming-In Project, whatever processes are involved in the de- medicine, with its focus on family-cen- defined colic as paroxysmal fussing in in- velopment of colic may also predispose tered and culturally sensitive holistic care, fancy for more than three hours per day, at children to subsequent health concerns. provides practitioners and families with least three days per week, for at least three We need to evaluate these potential links the best opportunities for successful out- weeks duration. Surveys indicate that up closely, as any connection would support comes. to 26% of infants are diagnosed with col- actively working with families to prevent 5 ic, making the condition one of the most and treat excessive infant irritability. common reasons for infant visits to pri- SPECIFIC THERAPIES mary care practitioners today. The integrative management of colic de- We know colic when we see it, but we RATIONALE FOR AN INTEGRATIVE mands consideration of every tool in the still do not know what causes it. The most APPROACH practitioner’s toolbox. Individualization popular conventional medical theory is There is no widely accepted conventional of treatment, as is typical in integrative that colic is an extreme variant of infant treatment for colic. Practitioners will offer practice, is crucial in these cases. Some ap- irritability, perhaps related to neural regu- families psychological support, with the proaches work quite well for some families lation differences. Pediatrician Harvey hope that with time—as is often the case— and not at all for others. An integrative

Pediatrics EXPLORE July/August 2007, Vol. 3, No. 4 417 primary care practitioner will openly dia- The power of touch is quite apparent and amounts of . This practice should logue with families and collaborate with remarkable in colicky infants. A recent Co- be discouraged. It is important to ask fam- various CAM therapists as warranted. The chrane Database Systematic Review of mas- ilies specifically about the use of gripe wa- most commonly used therapies, including sage intervention in infants acknowledges ter and other herbal blends, and to figure mind-body medicine, infant massage, bo- that there is “evidence of benefits on out which substances are being ingested tanical and homeopathic remedies, nutri- mother-infant interaction, sleeping and by the baby. The Natural Medicines Com- tional modulation, and probiotics, will all crying, and on hormones influencing prehensive Database lists five separate be discussed in the following sections. stress levels.”19 Infant massage is effective products labeled as “gripe water,” and all in reducing excessive crying in even the have different constituents.25 Mind-Body Medicine most vulnerable of infants, including pre- Other available botanical products are mature babies and cocaine-exposed neo- marketed as gastrointestinal soothers and Perhaps no period of relative wellness in a 20,21 family’s life is more stressful than the first nates. Families can be taught to use used by parents for colic symptom relief. few months of infancy. Even typical infant simple and safe massage techniques, and Some of these carry the same name, are crying and sleep patterning is disruptive they appreciate the power of this self-care made by different companies, but have approach. This effect seems to be superior radically different ingredients. For exam- and unsettling. The entire family dynamic 22 to simple vibration devices and may be ple, Chinese star ()isa is shifted, and caregivers may experience 23 severe mood lability and tension. Wessel enhanced by the use of essential oils. used in many cultures for infantile believed it was this family tension that was Whether this latter effect is related to the colic. Although this specific is gener- responsible for colic symptoms in in- oil as or simply adds to the ally recognized as safe, its close relative, fants4; we now understand that stress can physical massage technique, or both, is Japanese star anise (Illicium anisatum), ab- indeed modulate neurological responses, unknown. For safety reasons, caution solutely is not. It contains constituents therefore supporting the need to promote should be taken with the application of with the potential for neurologic and gas- parental stress-coping mechanisms. There essential oils in children; they should not trointestinal toxicity, as noted in a case are clear links between maternal mood generally be used directly on the skin, but report of seven infants significantly af- states, including postpartum depression, mixed first in a carrier oil (eg, , al- fected by this herb.26 Of great concern, and the development of colic in infants.15 mong, or grape ). One must be careful these babies were given a Chinese star an- Screening for postpartum psychological about allergies and skin sensitivity as well ise product adulterated with Japanese star disorders is feasible in pediatric offices16 with these products. anise. In another report, a case of pseudo- and should be standard practice. Reducing monal bacterial sepsis in an infant was parenting stress is a proven method of Botanically Based Therapies linked to the use of an imported Indian helping families cope with irritable in- gripe water preparation.27 As with all 17 Many cultures have used botanical reme- fants, and there are many strategies to do dies for fussy babies for thousands of herbal supplements, one must be aware of so. Despite the lack of randomized con- years. There are as many used for regulatory and quality control issues. trolled trials proving efficacy or cost-effec- colic as there are babies with the condi- Herbs commonly found in today’s tiveness in colic management, practices tion. One of the more widely known ther- gripe water preparations include , fen- such as guided imagery, self-hypnosis, apies, gripe water, dates back to the 1850s, nel, , and . The first three mindfulness-based stress reduction, yoga, when it was developed by William Wood- herbs contain volatile oils that produce or energy healing techniques like Reiki ward, a British pharmacy apprentice.24 smooth muscle relaxation and an antispas- 25 may be helpful in reducing parental dis- Woodward borrowed the formula—a com- modic effect. Dill (Anethum graveolens), tress. Modulating infant stimulation may bination of dill seed oil, sodium bicarbon- from the Norwegian word meaning to lull, also prove effective, as demonstrated in has containing volatile oils rich in 18 ate and alcohol, among other substances— one randomized controlled trial. Dr from who were using solution carvone. ( vulgare) seeds Karp advocates a system of “five Ss” (suck- in the 1840s to treat babies with “fen fe- hold another volatile oil, , and ing, shushing sounds, side/stomach posi- ginger’s oil contains sesquiterpenes. Gin- 6 ver,” a form of malarial illness. It seemed tioning, swinging, and swaddling), which that these babies were soothed by the con- ger (Zingiber officinale) contains active con- many parents find useful to enhance their coction and reportedly found relief from stituents known as gingerol, gingerdione, infants’ calming reflexes. Karp advises gastrointestinal troubles (known at that and shogaol, responsible for a myriad of side/stomach positioning only while time as “watery gripes”). Woodward sub- effects, including antipyretic, analgesic, holding the baby, not for sleep position- sequently sold his formula, and over the antitussive, anti-inflammatory, sedative, ing; one must be careful to promote the years, gripe water has become not one antibiotic, weak antifungal, and other back-sleeping position for sudden infant standard recipe but a recipe that contains properties. German chamomile (Matri- death syndrome prevention. any number of purportedly soothing caria recutita) contains multiple active con- herbs and substances. The large amount of stituents, including , , Infant Massage alcohol in the original formulation has and coumarins, and the essential oils ma- Therapeutic infant massage is one of the been removed from most contemporary tricin, chamazulene, alpha bisaboloid, most widely studied CAM therapies in pe- commercially available preparations, but and bisaboloid oxides. Some of these diatrics. It is also a terrific way to improve some families will make their own ver- components may have anti-inflammatory the parent-child bond in stressful times. sions, which can contain significant and antispasmodic activity.

418 EXPLORE July/August 2007, Vol. 3, No. 4 Pediatrics There have been several published stud- specific in extraction and delivery meth- matherapy may be a useful tool to help ies of herbal remedies for colic. A group ods. Each dose of ColiMil consisted of the families cope with colicky babies. from evaluated an Italian following standardized : sweet fen- is also widely used by preparation (Calma-Bebi) containing cha- nel powdered standardized to many Western European and American momile, vervain, licorice, fennel, and 0.05% to 0.1% , chamomile parents for colic treatment. These consist balm.28 In the trial, 68 colicky in- flower powdered extract standardized to of both single remedies and blends of var- fants aged two to eight weeks were ran- 0.3% apigenin, essential oil ious highly diluted herbs, including cha- domized to receive either tea or placebo standardized to 2% , 0.85 momila (chamomile), colocynthis (bitter for seven days. Colic diagnosis was based mg of B1, 3.24 mg of pan- apple), dioscorea (wild yam), fennel, gin- on the Wessel definition according to par- tothenate, and 1.20 mg of vitamin B6. Pla- ger, , , aloe, and lemon ent description of behavior. Infants were cebo consisted of reverse osmosis filtered balm. If one buys a commercially available allowed to have the liquid up to three water, fructose, pineapple flavoring, citric blend, note that just as in the case of gripe times per day at a volume of up to 150 mL acid, and potassium sorbate. Diagnosis of water, there are products with the same (five ounces). The average intake during colic was according to Wessel criteria, and name but containing different constitu- the study was actually far less, at two serv- infants were enrolled at age three to nine ents. Some families like to use homeopa- ings per day, for a cumulative total of weeks. Each infant received an exact stan- thy as a self-care regimen, whereas others about three ounces per day. Infants who dardized dose of 2 mL/kg per day twice prefer to consult with a classical homeo- received the tea were much more likely to daily before breast feeding for seven days. path. Given its very low risk for adverse improve than those receiving placebo (a At the end of the trial, a statistically and reactions, homeopathy is generally con- powdered mixture of glucose and unspec- clinically significant reduction of crying sidered safe for treatment of colic. ified natural flavorings); 57% of babies in time was observed in 85.4% of patients One of the most intriguing potential nat- the treatment group versus 26% of those receiving ColiMil and in 48.9% of infants ural health products for colic therapy is the in the placebo group. Although this differ- receiving the placebo. Average daily cry- neurohormone, melatonin, or 5-methoxy- ence was statistically and clinically signifi- ing time was reduced from about 200 min- N-acetyltryptamine. In humans, melatonin cant, it is worthwhile noting the marked utes/day to 76.9 minutes/day in the treat- is produced by pinealocytes in the pineal placebo effect. No significant adverse ef- ment group, and from 200 minutes/day to gland and also by the retina and gastrointes- fects were reported. Unfortunately, this only 169.9 minutes/day in the placebo tinal tract. In fact, there is least 400 times study is hampered by so many unknowns group. Notably, crying was still reduced at more melatonin in the gastrointestinal tract 31 that it is impossible to generalize advice 2 weeks after the end of the trial in the than in the pineal gland. Furthermore, based on its results. The amounts and ColiMil treatment group. Neither group melatonin receptors are abundant through- types of each herb, the volume each infant reported adverse side effects. It seems that out the gastrointestinal tract, and many bio- received, and the exact nature of the pla- individual fennel seed oil or blends of the logical effects of melatonin are produced cebo are all unspecified variables that may aforementioned herbs may be quite effec- through activation of these receptors. It has been hypothesized that because endoge- have had an impact on colic resolution. tive and safe in treating colic in infants. nous melatonin production does not ma- A second study, from a group in Russia, Interestingly, there is a consistent placebo ture until infants are 12 weeks old, when was much more specific. Alexandrovich et effect and a reassuring lack of reported ad- colic generally resolves, that abnormal circa- al29 compared the effect on colic of a 0.1% verse effects. As long as parents are in- dian melatonin rhythms may be implicated water emulsion of fennel seed oil and structed how to use herbal teas and solu- in colic development.32 Why some infants 0.4% polysorbate-80 with that of a poly- tions wisely, including limiting beverage are excessively irritable may have to do with sorbate-only placebo. One hundred twen- temperature and avoiding potentially differences in melatonin or receptor physi- ty-five infants aged from 2 to 12 weeks harmful botanicals and contaminants, ology, and perhaps administration of exog- were diagnosed with colic according to the these products offer potential therapeutic enous melatonin would be an effective colic Wessel definition and randomized to one benefit. treatment. Of course, both safety and effi- of the two groups. The groups were al- Another botanically based colic therapy cacy studies need to be done before general lowed 5 to 20 mL of solution up to four is aromatherapy. Many of the same herbs recommendations can be made. Of note, times per day, but actually ingested an av- listed above, along with lavender and most commercially available melatonin is erage of two to three doses per day, for a other soothing scents, are used by families synthesized in the laboratory, based on the total of less than two ounces per day. After to cope with infant distress. Aroma- endogenous pineal gland substance, but in the one-week trial, colic was eliminated in therapy is often delivered by the use of rare cases, it is derived from animal pineal 65% of the treatment group versus 23.7% essential oil extracts, either aerosolized or gland extracts, which should be avoided due of the placebo group. Again, this is a sta- by incorporation into a massage-oil base. to the possibility of contamination. tistically and clinically significant finding, Although historical use suggests a positive but with a notable placebo effect. effect of aromatherapy on infant and par- Finally, a third trial, from Savino et al,30 ent stress, and therefore colic, there are no Nutritional Modulation compared a standardized extract (ColiMil) published trials to date evaluating such Nutritional modulation is one of the few of three herbs (chamomile, fennel, and claims. Still, as long as essential oil safety preventive and therapeutic options for in- lemon balm) with a placebo in 93 breast- guidelines are observed (eg, keep out of fants with colic. It does not appear that fed colicky infants. This study was quite reach of children to avoid ingestion), aro- breast feeding exclusively prevents colic,33

Pediatrics EXPLORE July/August 2007, Vol. 3, No. 4 419 but it has been historically observed that of this finding are unknown at present, but ing fewer overall lactobacilli in breast-fed certain foods either ingested by breast- one can speculate that docosahexaenoic colicky infants versus noncolicky infants. feeding mothers or by formula-fed infants acid supplementation both prenatally and A follow-up study found that one type of lead to fussy periods in infancy. We can postnatally may prevent or lessen colic. lactobacillus species (Lactobacillus aci- therefore speculate that avoiding highly In infants who are partially or fully for- dophilus) was less prevalent, and two other allergenic or irritating foods may prevent mula fed, the choice of formula may play types (Lactobacillus brevis and Lactobacillus colic in at-risk infants (eg, those with fam- a role in colic development. There have lactis) were more prevalent in infants with ily histories of atopy) or treat colic in ex- been no prospective studies of colic pre- colic.46 It is likely that some strains of lac- cessively fussy babies. Although there is vention in formula-fed babies, but if one tobacilli confer protection against gastro- no clear consensus on avoidance of these extrapolates from allergy research, avoid- intestinal neuroimmune disruption and foods for allergy prevention despite exten- ing cow’s milk or soy formulas in infants at subsequent pain, whereas others contrib- sive study,34 there does seem to be mount- high risk of atopy is warranted. These in- ute to disorder and disease. Most recently, ing evidence in support of food avoidance fants seem to have fewer atopic symptoms the Italian group published results of a 39 for babies with colic. when fed with hydrolyzed formulas ; gas- trial of Lactobacillus reuteri in comparison The most recently published trial by troesophageal reflux and perhaps colic with simethicone in the treatment of in- Hill et al35 from found that ex- may also be prevented with this same ap- fantile colic.47 Simethicone, while a com- clusion of certain allergenic foods (cow’s proach in these select infants. There is ev- monly used antigas agent used by families milk, soy, wheat, eggs, peanuts, tree nuts, idence, however, supporting the use of hy- for infants with colic, has been found pre- and fish) was positively associated with a drolyzed formulas for reducing colic viously to be ineffective in this regard.14 In reduction in colic in breast-fed infants.35 symptoms in those infants already exhib- this trial, 90 exclusively breast-fed colicky One hundred seven infants presenting iting excessive irritability. Both extensive infants between ages 21 and 90 days were with excessive irritability (average crying casein hydrolysates (eg, Alimentum, Nu- randomized to one of two groups: they time over 300 minutes per day) aged under tramigen, both more prevalent in the either received L reuteri once daily at a six weeks were randomized to a one week ) and whey hydrolysates (eg, dose of 108 CFU, or simethicone 30 mg/ trial of maternal low-allergen diet versus Nutrilon Pepti, available predominantly dose twice daily, for 28 days. Mothers were control (nonelimination) diet. At the in Western ) have been demon- instructed to avoid all sources of cow’s completion of the trial, 74% of treated in- strated to be more effective than nonhy- milk during the trial. At the start of the fants versus 37% of control infants experi- drolyzed cow’s milk formulas in reducing study, both groups of infants were report- 40,41 enced significant reduction in crying time crying times in colicky babies. edly crying for approximately 200 minutes (about 200 minutes per day less compared Though some families and practitioners per day. The probiotic treatment group with 100 minutes less per day on average, will consider soy and partially hydrolyzed had a significantly reduced crying time respectively). These differences are both formulas as alternatives for colic treat- (minutes/day) by only seven days into the statistically and clinically significant; just ment, there is no evidence to support this trial (159 vs 177 in the simethicone practice.42,43 If an infant with colic pre- ask any parents of a colicky infant. Still, group), a disparity that widened at weeks sents with additional atopic symptoms there is a notable placebo effect. Which of two, three, and four (51 vs 145). At the (eczema, wheezing, allergic rhinitis, and these foods was primarily responsible (if endpoint of the study, 95% of the probi- gastroesophageal reflux), one must con- any in isolation was responsible for the otic treatment group were responders (did sider avoiding food allergens in formula or change) is unknown. In practice, it may be not meet Wessel criteria) versus only 7% in breast milk as a treatment priority. more feasible to advise single food group of the simethicone group. Of note, both elimination trials (for one week per food), infants with and without a family history or if avoidance of all foods is initially ad- Probiotics of atopy demonstrated equally significant vised, one can add back one food group Probiotics have been defined as “a prepa- benefits. Is there something unique about per week at a time to evaluate clinical ef- ration of or a product containing viable, L reuteri as opposed to other probiotics in fect. It is important to maintain appropri- defined microorganisms in sufficient this regard? We can’t yet say, but it is likely ate maternal and infant intake of essential numbers, which alter the microflora (by that supplementation with other strains and minerals (eg, calcium, vita- implantation or colonization) in a com- (Lactobacillus acidophilus, L. GG) could min D, and ) during this period. Ad- partment of the host and by that exert ben- achieve similar results. How best to deliver ditionally, some researchers have found eficial health effects in this host.”44 These the probiotics is another question. Some that other food types may contribute to microorganisms colonize the intestinal researchers have investigated whether in- colic in breast-fed babies, including cruci- tracts of infants during the birth process fant formulas can safely and effectively be ferous vegetables and chocolate.36,37 New and shortly thereafter, and they have been supplemented with probiotics or prebiot- research indicates that maternal essential implicated in promoting immunological ics (nutrients that support probiotic fatty acid status also may be linked to in- balance and digestive health. Savino et growth). Two such trials have looked at fant distress and sleep patterning.38 Babies al,45 in Italy, have published several fasci- colic reduction in this regard. Saavedra et of mothers with higher docosahexaenoic nating papers on the nature of probiotic al48 from Johns Hopkins University led a acid concentrations at birth had a signifi- balance in infants and the relationship to randomized controlled trial of a cow’s cantly higher quiet sleep to active sleep colic. They initially described quantitative milk formula containing two probiotics ratio on day two of life. The implications differences in lactobacillus species, find- (Bifidobacterium lactis and Streptococcus ther-

420 EXPLORE July/August 2007, Vol. 3, No. 4 Pediatrics mophilus). This was not technically a REFERENCES 17. Keefe MR, Kajrlsen KA, Lobo ML, Kotzer study of colic, as the infants were older 1. Gustafson GE, DeConti KA. Infants’ cries AM, Dudley WN. Reducing parenting (3-24 months), but the findings were no- in the process of normal development. stress in families with irritable infants. Nurs table in that consumption of the for- Early Child Devel Care. 1990 65:45-56. Res. 2006;55:198-205. 18. McKenzie S. Troublesome crying in in- mula supplemented with B lactis and S 2. Darwin C. The Expression of Emotion in Man and Animals. New York, NY: D. Appleton fants: effect of advice to reduce stimula- thermophilus was well tolerated and re- and Company; 1898. tion. Arch Dis Child. 1991;66:1416-1420. sulted in reduced reporting of colic or 3. Brazelton TB. Crying in infancy. Pediatrics. 19. van Sleuwen BE, L’hoir MP, Engelberts irritability. In the second study, Savino 1962;29:579-588. 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