“Colic”—Primary Excessive Crying as an Infant-Environment Interaction

Symposium on Recurrent Pain in Childhood

"Colic"-Primary Excessive Crying as an Infant-Environment Interaction William B. Carey, M.D.*

"COLIC"-A CONFUSING PROBLEM "Colic" ranks with "hyperactivity" among the most confusing subjects in behavioral pediatrics today. Since there is no standard definition of "colic," theoretical discussions and studies of causes and management undoubtedly involve a heterogeneous group of infants with a variety of problems or no problem at all. One study cannot accurately be compared with another. The subject has attracted strongly partisan arguments for single intrinsic and extrinsic causes in spite of the compelling wisdom of the prevailing interactionist view of child development and behavior. Research on the subject of "colic" has too frequently been guilty of faulty design, which should have kept many of the studies from being published. For example, in an area where placebo effects are particularly strong, their role in the outcome of various forms of management has been frequently overlooked. The result of all this has been a professional literature that is insufficiently informative and reliable. No survey of American child care professionals' management theories and techniques is available but informal conversations with fellow pediatric practitioners reveal either bewilderment or intense loyalty to overly simple plans such as putting all infants with "colic" on soy milk formulas. The confusion and pessimism of many practitioners is readily communicated to the parents of infants who are crying excessively, thereby compounding their problem. This article aims to assemble the best previous thinking on the problem of "colic" and to redirect research and management of the problem. We shall begin with an attempt to clarify the definition, an absolutely necessary step if there is to be any progress. We shall review the various theories of single causes of "colic" or excessive crying and then propose

*Clinical Associate Professor of Pediatrics, University of Pennsylvania School of Medicine; Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

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that these be replaced by an interactional model. Suggestions for management are based on this expanded conceptualization. The final part of the article will present some recommendations as to how future research might avoid the confusions mentioned above. This review will not attempt to include every paper written on the subject, only enough to serve the purposes of the article.

DEFINITION: EXCESSIVE CRYING

Etymology. Much of the problem in discussing "colic" is that there is no standard definition of the phenomenon. Part of the difficulty here is the term itself. The word "colic" is derived via French and Latin from the Greek kolikos, the adjective of kolon, meaning the large intestine. 26 Use of the term, therefore, implies that something is amiss with the infant's colon. While this may at times be true, there is no evidence available to establish or even suggest that the great majority of infants who cry a great deal have any problem in that area. Furthermore, the traditional assumption has been that the infant is crying because of pain. Although this volume is devoted to recurrent pain in children, it should be acknowledged at the outset that for most infants who are "colicky," it is not at all certain that they are experiencing pain. They do appear distressed but infants look much the same when they are sufficiently tired, hungry, or frightened. They cannot tell us whether they are experiencing pain; they can only report their distress by crying. When we speak of a child as having a "cold," we often forget that we are using an obsolete word, one which carries the ancient belief that an acute viral respiratory infection is caused by exposure to a low temperature. An erroneous theory of causation has become fixed in the language. Those using the term "colic" should be aware that they are probably doing the same. Current Definitions. Although there is no standard definition for "paroxysmal fussing in infants," 34 "infantile colic," 25 "evening colic,"l6 or "three months' colic," 17 most pediatric texts and books of advice for parents mention such a phenomenon and describe it somewhat as follows: The condition begins soon after the baby comes home from the hospital and is likely to persist until he is three or four months of age. The crying is described as intense, lasting for up to several hours at a time and usually occurring in the late afternoon and evening. The affected infant is typically pictured as drawing up his knees against his abdomen and expelling much flatus. He may appear hungry but is not quieted for long either by feeding or other attempts at soothing. Nevertheless, the infant is otherwise well and grows normally. This typical description of "colic" is inadequate for several reasons. 8 l. Without a more precise definition of the intensity, duration, and frequency of the crying, it can be extended to almost all young infants at one time or another. It allows study popu1ations to vary from almost all infants down to almost none. Therefore, figures on incidence of "colic" are of little value.

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2. Such imprecision makes most studies of the phenomenon of questionable value. Writers on the subject often express strong convictions about favorite theories of causation and management that can neither be refuted nor verified because the infants studied are so poorly identified. 3. Telling parents that their child has "colic" is not particularly informative. 4. Studies of the treatment of "colic" are likely to be meaningless. Furthermore, if one cannot define precisely when the problem is present, it is also difficult to decide when it has ceased to exist, and the therapy has been presumably effective. The best definition available at this time is the one used by Wessel et al. 34 that such a young infant is "one who, otherwise healthy and well fed, had paroxysms of irritability, fussing or crying lasting for a total of more than three hours a day and occurring on more than three days in any one week." The excessive crying is identified in terms of intensity, duration, and frequency. The formulation becomes clearer if the word "paroxysm" is interpreted as crying at full force, not just any degree of fussing. Even this version, however, is applied with difficulty at times. A More Rigorous Definition. Since it is evident that young infants who cry a great deal do not have any particular organ system involved consistently and are not necessarily experiencing pain, it makes sense to define "colic" in terms of excessive crying. It is certainly the crying that bothers parents and induces them to seek help from the physician. A reduction in crying is generally regarded as a therapeutic success. Furthermore, the criterion of excessive flatus is not helpful, since it may be the consequence rather than the cause of the crying. The flexion of the legs onto the abdomen is a nonspecific response to distress seen with various noxious stimuli, such as a pinprick on the foot. A redefinition of "colic" in terms of the crying must include criteria as to the intensity, duration, and frequency and must distinguish the crying from normal crying and that resulting from various known physical causes. A reasonable classification system divides infant crying into: (1) normal or physiologic crying, (2) excessive crying secondary to disease, and (3) excessive crying with no known cause. 1. Normal or physiological crying is observed in all infants. The determination of the upper limit of normal depends on a knowledge of the expected range. Brazelton6 assessed crying patterns in a middle class sample of 80 infants. Crying lasted about two hours a day at two weeks, increased to a peak of almost three hours by six weeks, and then gradually decreased to about one hour by three months. The upper quartile of babies were crying three and one half hours per day at six weeks. Throughout these three months the principal time for all infants was in the evening. These amounts seem reasonable as a standard, but subsequent studies may demonstrate social class, cultural, or racial differences. It is important to stress at this point that the amount of parental complaining about crying, whether normal or excessive, is not necessarily proportional to the extent of crying. 2. Secondary excessive crying seems a plausible way to describe crying in excess of the expected normal range and due to some physical disorder

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in the infant. If milk allergy, lactose intolerance, or transmission of poorly tolerated substances via breast milk are conclusively demonstrated as the cause of the crying, these conditions would be included under this heading. Several other situations producing excessive crying are commonly cited in articles on "colic:" hunger, otitis media, intestinal cramping with diarrhea, corneal abrasion, and incarcerated hemia. However, these problems are usually relatively easily detected and solved and are not likely to lead to prolonged crying. 3. Primary excessive crying is a term that can be reserved for describing those infants in the first four months of life who are well nourished and otherwise healthy, but who cry substantially more than the mean amount for their age. The crying should be at full force and last for over three hours per day for four days or more in any week. Thus, these infants represent the extremes of the normal distribution in intensity, frequency, and duration of crying. There is no evidence to date that they are qualitatively different, in terms of any pathologic process, from those who cry less. This third group is the one to which one might apply the term "colic" if one felt the need to keep alive the archaic usage. In order to detach the word from its derivation from the Greek word for the large intestine, one could remake it into an acronym such as Cause Obscure Lengthy Infant Crying. Since the difference between normal and excessive crying seems to be only a quantitative one, there are some infants who fall into a "gray zone" between the two. Clinically the classification can be facilitated by asking the parent to report exact day histories for the recent days, and estimates of intensity of crying can be verified by comparison with that displayed in the physician's office. Research projects should use written records by the parents, as done by Brazelton' s6 population, or perhaps by electronic recording. Although even the above diagnostic criteria are not as precise as one might wish, they are about as exact as one can be at present. Failure to use such standards means dealing with populations selected only by parental complaints or referrals from various other child care professional persons.

SIMPLE THEORIES OF EXCESSIVE INFANT CRYING The theories of the causes of "colic" or excessive crying in young infants fall into three groups: (1) feedings, (2) extrinsic problems in the psychosocial environment, and (3) intrinsic problems in the infant. Feeding is a combination of extrinsic and intrinsic factors in that food from the environment is reacted to by the infant's body. These three groups of theories will be described briefly without attempting an exhaustive review of the literature. Feedings The technique of feeding is commonly cited as a cause of excessive crying in the infant. The infant may be underfed or overfed or may swallow excessive amounts of air or not be adequately burped.

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While some earlier papers recommended introduction of solid foods to combat "colic," a more recent study reported more "colic" (undefined) in infants fed solids in the first three months.I 4 No allowance was made for the possibility of more irritable babies being fed solids at an earlier age because their mothers hoped it would help quiet them. The iron in iron-fortified formulas has been blamed by some for excessive crying, but this possibility was not supported by a controlled study by Oski. 24 Irritant substances such as caffeine ingested via breast milk from the mother are implicated by clinical anecdote but not yet by double-blind study. Lactose intolerance in the infant was discarded as a cause of "colic" (loosely defined) by Liebman, 20 but Barret al. 4 have presented some evidence that duration (but not frequency) of crying in the second month may be related to "transient physiologic incomplete absorption of lactose." The older studies of milk allergy can be reviewed elsewhere.2. 12 The most recent ones deserve our critical attention here. A report by Lothe et al. 21 concluded that "cow's milk seems to be a major cause of infantile colic in formula-fed infants." In their study, 43 of 60 (72 per cent) of the infants were thought to have cow's milk or soy "dependent" colic because they cried less within 48 hours after being changed to soy formula or Nutramigen. Half of these infants (22 of 43) became symptomatic again when "challenged" with a cow's milk formula one month later. The other 17 of 60 (28 per cent) were judged to have a "spontaneous recovery" because they improved while still drinking the cow's milk formula. Methodologic problems include inadequate definition, use of a referred hospital population, and insufficient allowance for placebo and "challenge" (antiplacebo) effects. In the only part of the study that was double-blind there was no evidence of cow's milk allergy, in that fewer infants improved on soy formula (18 per cent) than did on cow's milk formula (28 per cent). A later report for the same group 1B claimed that "cow's milk proteins cause infantile colic in breast-fed babies." This study, equally encumbered by methodologic problems, is inconclusive. Meanwhile, Evans et al. 11 reported that removal of cow's milk from the mother's diet "did not reduce the rate of infantile colic in their babies in a double-blind placebocontrolled cross-over study." The need for better research on the matter of cow's milk allergy is highlighted by the realization that the recent recommendations of the Committee on Nutrition of the American Academy of Pediatrics1 on the use of soy-protein formulas cited these papers as resources. In view of the dearth of evidence favoring cow's milk allergy as a major cause of excessive crying in infants, one wonders why the possibility enjoys such popularity among physicians. Undoubtedly it is occasionally the correct interpretation. However, a more likely explanation is the persistence of untried traditional attitudes, the relative ease of manipulation of feedings as a way of dealing with the problem, and the apparent competence of this technique due to the temporary improvement with nonspecific placebo effects. In any case, if allergy is established as the cause of the crying, then the classification system suggested here requires the use of the description of secondary rather than primary excessive crying.

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Extrinsic Problems in Psychosocial Environment One theoretical approach to an explanation of excessive crying in infants is to blame an overstimulating or otherwise noxious environment. Reports dealing with this point of view have been reviewed elsewhere. 9 The serious limitations of these studies supporting it include evaluation of maternal anxiety only after the excessive crying had begun 19· 31 and inadequate assessment of the anxiety. The two investigations claiming to disprove the significance of parental feelings suffer from the same problems or from conclusions that do not agree with the data. 25· 29 Only one study has attempted to determine maternal anxiety systematically immediately postpartum and define "colic" rigorously. This one showed a significant relationship between the two but acknowledged that there must be other factors at work too, possibly intrinsic ones in the infant. 9 Experience with institutionalized infants 30 and with rapid recovery on hospitalization of infants with excessive crying3 leave no doubt that the environment is a factor of consequence. Intrinsic Problems in the Infant The old pediatric texts confidently blamed "colic" on such conditions as immaturity of the gastrointestinal tract or the central nervous system, although no proof was ever offered to support these opinions. One also finds references to "hypertonia of infancy," in which the high muscle tonus in the smooth and striped muscles is accompanied by the behavioral symptoms-irritability, sleeplessness, and overactivity .13 Deficiency of progesterone was offered 21 years ago as "one cause of colic." 10 This possibility was not further explored until Weissbluth and Green33 recently found no differences in progesterone levels. Again our understanding is hampered by the fact that the earlier study failed to define "colic" or describe how the sample was selected. As the next section will explain in greater detail, the intrinsic factors in primary excessive crying are probably usually physiologic or temperamental variables rather than pathologic conditions.

THE INTERACTION MODEL The last two decades have seen an increased acceptance of the interactional model to explain children's development and behavior. 32 The battles between nature and nurture, heredity and environment, and intrinsic and extrinsic factors have been resolved. As Scarr and Weinberg28 expressed it in the title of a paper "Calling all camps! The war is over." It is time to make sure that news of this armistice and reconciliation reaches clinicians and parents dealing with "colic" or excessive crying in young infants. The concept of interaction here is not a new one. In 1951 Rene Spitz30 wrote, "we may advance a two-factor hypothesis in which the infants' congenital hypertonicity would represent a bodily compliance, to which the mothers' overpermissiveness would have to be added to result in the "three-months colic." A few other authors have carried the theme in

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the intervening years, 9• 27 • 35 yet some of the most recent comprehensive reviews have failed to recognize the value of this interpretation. 2• 12 This article proposes that there may be various intrinsic and extrinsic factors interacting to produce excessive crying in the infant. If the intrinsic factor is some physical problem such as milk allergy, the term secondary excessive crying would apply. However, in the more likely event that it is a normal physiologic or temperamental predisposition, such as a low sensory threshold or difficult temperament, 7 we might refer to it as primary excessive crying. The extrinsic factors appear to be those environmental stimuli that interact with the infant's characteristics to produce more crying and less soothing. Inappropriate handling by the parents, suggested originally by Spitz, 30 seems the most likely cause, and the reasons for it may be various, including inexperience, anxiety, depression, and anger. 9 The developmental changes causing excessive crying to decrease by about three months, no matter how it may be conceptualized and managed, are a poorly understood element of the interaction. A possible role of the nonhuman environment, such as lighting or sounds, awaits systematic exploration. A typical interaction might proceed as follows: The one-month-old infant has just had a generous feeding and feels full and tired. Having a low sensory threshold for gastric distension and tending to express himself intensely, he cries in a way that is hard to ignore. Left alone for five or ten minutes, he would probably drop off to sleep, but his mother thinks there is something wrong with him. She picks him up, tries to burp him, offers him more milk, and carries him around on her shoulder. He quiets briefly but then resumes crying because of increasing fatigue. After further attempts at bouncing and rocking, the infant quiets momentarily. The mother puts him back in the crib and the cycle begins again. This model of interaction appears to be the best interpretation of the reliable data available on excessive crying in young infants. It is certainly not proven beyond any doubt. We await studies that will measure longitudinally and simultaneously infant predispositions, parental attitudes and feelings, and the resulting interactions and their consequences. EFFECTIVE MANAGEMENT OF THE INTERACTION PROBLEM If one conceives of a clinical problem as being due to a single factor, a rational approach to management entails merely altering that one element. Most traditional management of "colic" has been along these linesfor example, to change the formula or give the baby more sucking with a pacifier. However, when the problem is viewed as an interaction between organismic and environmental factors, the plan of treatment must be more complex. Before providing a specific outline for management, it is important to consider these theoretical complexities. First, when dealing with an interaction involving variable involvement from the individual and the environment, how does the clinician determine the relative contribution of the two? Such data will determine the emphasis of the treatment plan and the

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prognosis. For example, if the infant crying excessively has a difficult temperament profile, the amount of crying may be decreased by successful management but the infant will still have the low adaptability, negative mood, and other difficult characteristics. At present the clinician can only estimate the relative size of the contributing factors, since there is no temperament scale suitable for use in the one- to three-month period, and evaluation of the environment and interaction must depend primarily on interviewing and on brief observations. The second theoretical question is how to alter the environmental factors and their impact on the child. The sensitive, well-trained physician might attempt to persuade parents to alter self-defeating interactions. Ideally he or she could also recognize and deal appropriately with the underlying parental problems in the interaction. This is not always easily done. Finally comes the question of whether intrinsic factors can and should be altered. In the rare cases of established milk allergy and other physical problems, the procedure is clearer. On the other hand, physiologic or temperamental characteristics are not easily altered and perhaps we should not try. However, modification by pharmacologic agents for long enough to establish healthy interaction patterns and reduce the crying is easily justified. A recent textbook article describes several steps for the successful management of excessive crying in infants. 8 These are recapitulated here. History. One must begin by obtaining an adequate history. The first step is to define accurately the symptom: the intensity, duration, and frequency of the crying. The chief complaint offered by parents is often that the baby is too gassy, too hungry, or not sleeping well, although the real problem is the excessive crying. A detailed narration of the baby's typical day is a good way to make the parents' description more precise. Information about the baby's temperament must be based entirely on interview data and observations for lack of an appropriate rating scale for this age group. Having parents describe and demonstrate their soothing techniques should be helpful in revealing practices requiring modification. The rest of the history should be obtained in the usual manner but augmented so as to include parental concerns about the recent pregnancy and the child, anxieties related to their own experience as children or with rearing previous children, or inadequate family supports or other stresses. 9 Physical Examination. Although the physical examination seldom reveals anything useful in the management of excessive crying, it is an absolutely necessary part of the care of an infant with this problem. Most parents are unconvinced by reassurance that is not preceded by a careful assessment of the infant. Laboratory tests, however, are seldom indicated. Counselling. Most articles dealing with the management of "colic" or excessive crying are unreasonably pessimistic about the effectiveness of professional intervention. This defeatism is unjustified; appropriate management is usually successful in reducing the crying to acceptable amounts. The "he'll grow out of it" approach is obsolete. A genuine sense of accomplishment rewards the physician who consistently intervenes successfully using steps such as the following.

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1. The clinician should begin by reassuring the parents that the physical examination has not uncovered any problem with the infant's physical or neurologic health. 2. An appropriate next step is to acknowledge, if this is so, that the infant does appear at present to be crying more than the average and that this is an unpleasant burden for most people. Little is gained, however, by awarding the child with the vague diagnosis of "colic." If the amount of crying is not excessive, it may be helpful for the parents to receive some information about how much the average infant of the particular age cries. 3. Parental anxiety must be dealt with. It may be a factor in promoting the excessive crying, or it may be a reaction to it, or both. In any case, consideration of feelings about the baby or the various pertinent psychosocial stresses often reveals the basis for inappropriate handling of the infant. 9 4. Parental handling of the infant may require alteration. Parents with fussy infants are often doing too much and need to modify their tactics. They usually will be successful if they soothe more, as by a pacifier or heating pad or hot water bottle, and stimulate less, as by decreasing the picking up and feeding. A quiet environment with a minimum of unnecessary handling and correction of any faulty feeding techniques without changing the composition of the feedings seem helpful. The physician may be able to demonstrate better methods during the office visit. Some writers, particularly psychologists, have urged that a crying baby should always be picked up. This recommendation is usually based on the view that a cry is always a call for help that should not be ignored or that greater parental attentiveness in early months makes for happier babies later on. 5 One can agree that infants need attention and affection, but, if they have received enough or too much already, their paramount need is a withdrawal of environmental stimulation. 5. The use of medication is controversial but has a definite place in management. Most often recommended are phenobarbital elixir, one-half teaspoon (10 mg) three times daily; or dicyclomine hydrochloride (Bentyl syrup), one-half teaspoon (5 mg) three times daily or one teaspoon (10 mg) before an anticipated evening fussy spell. Treatment for one week is usually sufficient. If excessive crying returns after that, the medication can be given for a second week. There may be some placebo effect in the administration of these substances but it is likely that there is also a pharmacologic effect. 16 This is probably why the use of a drug alone without other measures is not likely to be effective, as was demonstrated in a recent report. 23 Medication, when indicated, should be made optional since some parents want to try first to lessen the crying without it. 6. An expression of optimism about the immediate outcome of these measures is justified and improves chances of success. Although acknowledging with the parents that excessive crying in young infants is a poorly understood phenomenon, the clinician is on firm ground in telling parents that, if the recommended steps are followed, there is a high probability that the crying will diminish considerably in the next two or three days and remain that way. This sanguine prophecy is based on experience and

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is usually correct. 9 On the contrary, telling parents that the excessive crying will go away by three months, which may be seen as a condemnation to two months or more of further screaming, is not comforting and is likely to be counterproductive. 7. Close follow-up of the excessively fussy baby is important. A telephone call every two or three days until there is substantial improvement is a convenient method. On rare occasions it is necessary to re-evaluate the infant and the management after about a week. 8. Under very extraordinary circumstances and as a last resort, separation of the infant from the parents by a brief period of hospitalization can be dramatically effective in reducing the infant's crying. If, however, parental feelings and handling are not dealt with appropriately before the parents are reunited with their infant, the old pattern of interaction and crying is likely to resume. 3 This author has taken this step only once in 26 years. 9. Several unsuitable forms of treatment should be mentioned, if only to discourage their use. Changes in the composition of feedings from one formula to another are seldom appropriate solutions. Almost any feeding change, in fact almost any altered procedure offered and executed with conviction, is likely to be followed by a temporary reduction in crying because of the placebo effect. However, the crying is likely to return after several days. Although the use of rectal manipulation and enemas is widely supported by tradition, there is no published evidence of their value.

PROGNOSIS Despite the therapeutic nihilism expressed by many pediatric texts and most books of advice for parents, the outlook is good. Clinical experience and some reported studies9 indicate that excessive crying in young infants can be sharply reduced within a few days in most instances if appropriate steps are taken. Some babies and some situations take longer but virtually all respond to suitable management. It is not necessary simply to try one ineffective solution after another until the crying slows down spontaneously at three or four months. Furthermore, with inappropriate care the fussing may even extend beyond that time. The long-term prognosis for individuals who cried excessively as young infants will depend on the nature of the intrinsic and extrinsic factors that produced the problem and whether they continue to operate. For example, if a low sensory threshold or difficult temperament are involved, these characteristics are likely to continue to affect the way the infant and probably the older child interacts with his environment. No longitudinal studies of the eventual outcome of infants who cried excessively (whether with or without adequate definition) can be found. Any statement that these infants become more "adventurous, driving, independent, active people" 15 may be intriguing but must be acknowledged as pure speculation.

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PREVENTION Lack of data compels us merely to consider theoretical possibilities as to how "colic" or primary excessive crying can be prevented. When the predisposing physiologic or temperamental factors are identified with greater certainty, it may be possible to screen for individual infants who are particularly liable to develop the problem. In the meanwhile, it is reasonable to educate parents, starting even prenatally, about infant crying and soothing. Some inexperienced parents need to be informed that even completely normal infants cry some every day. Some parents are unaware that one of the commonest reasons for crying is fatigue and that an infant usually does better if not picked up at those times. The sensitive clinician deals with parental anxieties whenever they are expressed. Concerns revealed prenatally or in the newborn period may lead to inappropriate handling of the infant if not resolved satisfactorily. Once a stressful interaction has begun, it may be possible, even by a brief telephone conversation, to advise revisions of management sufficient to keep the crying from becoming excessive.

BETTER RESEARCH NEEDED By this point, the reader may share the author's view that there is a great need for more and better research on the problem of excessive crying in young infants. Considering the possible incidence of 10 per cent of the population, the great anguish experienced by the families involved, and inconclusiveness of the available literature, one cannot avoid the conviction that research on the problem should be assigned a much higher priority. The fact that infants do not die or become handicapped as a result may make research funds harder to obtain but should not distract our interest from this important topic. An absolutely essential starting point is a standard definition of the phenomenon being studied. Earlier in this chapter a new one, based on that developed by Wessel et al., 34 was offered. Since it is admittedly not perfect, any improvement would be welcomed. Until there is general agreement as to the diagnostic criteria, studies of incidence, etiology, and management will not be comparable and will be of little use theoretically or clinically. It seems reasonable to suggest that subsequent studies should be obliged to have documentation of the amount of crying either by contemporaneous written parental records or by electronic measurements. Parental complaints that the infant cries too much or referrals with vague diagnoses of "colic" are insufficient means to define a coherent study population. The acceptance of the interactional model of infant behavior should restrain the unwarranted enthusiasm of proponents of single causes for excessive crying. Studies should be regarded as incomplete if they do not consider organismic and environmental factors and their interactions.

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Better research technique is urgently needed. Intrinsic and extrinsic factors must be measured. Interactions could be videotaped and studied in detail. If milk allergy or other food intolerances are suspected, their role should be more rigorously tested by established procedures. 22 The doubleblind method is indispensable in evaluation of treatment in view of the prominent placebo effects, and care must be taken to make certain that any study is as blind as the author claims it to be. One must avoid the antiplacebo effect of using a "challenge"21 or of saying or implying to parents that probably none of the unknown drugs being offered is likely to help. Treatment based on the interactional model and accompanied by optimism will make use of both real and placebo effects and should usually be successful.

SUMMARY Most articles on "colic" have been confusing because of inadequate definition of the problem, partisan arguments for single causes, and faulty research methods, including failure to recognize placebo effects in management. This chapter defines "colic" as primary excessive crying in young infants and suggests some specific diagnostic criteria. The three main theories of single causes are reviewed: feedings, psychosocial environment, and problems in the infant. In place of these oversimplified explanations this article proposes an interactional model that considers both intrinsic and extrinsic factors. Recommendations for management, being based on this view, include suggestions for handling the infant, the environment, and their interaction. This plan has proven generally successful in reducing the crying to acceptable amounts. Finally, some suggestions are offered for improving the quality of future research.

REFERENCES l. American Academy of Pediatrics, Committee on Nutrition: Soy-protein formulas: Recommendations for use in infant feeding. Pediatrics, 72:359-363, 1983. 2. Asnes, R. S., and Mones, R. L.: Infantile colic: A review. J. Dev. Behav. Pediatr., 4:57-

62, 1982. 3. Barbero, G. J., Rigler, D., and Rose, J. A.: lnlantile gastrointestinal disturbances: A pilot study and design for research. Am. J. Dis. Child., 94:532, 1957. 4. Barr, R. G., Hanley, J., and Patterson, D.: Does incomplete lactose absorption predispose to crying in normal infants? Paper presented at meeting of Society for Research in Child Development, Detroit, Michigan, April 1983. 5. Bell, S. M., and Ainsworth, M. D. S.: Infant crying and maternal responsiveness. Child Dev., 43:1171-1190, 1972. 6. Brazelton, T. B.: Crying in infancy. Pediatrics. 29:579--588, 1962. 7. Carey, W. B.: Clinical applications of infant temperament measurements. J. Pediatr., 81:823--828, 1972. 8. Carey, W. B.: "Colic" or excessive crying in young infants. In Levine, M. D., Carey, W. B., Crocker, A. C., and Gross, R. T. (eds.): Developmental-Behavioral Pediatrics. Philadelphia, W. B. Saunders Company, 1983, pp. 518-521. 9. Carey, W. B.: Maternal anxiety and infantile colic. Is there a relationship? Clin. Pediatr., 7:590--595, 1968.

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