Original Articles
The short-term effect of spinal manipulation in the treatment of infantile colic: A randomized controlled clinical trial with a blinded observer,☆☆,

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Abstract

Objective: To determine whether there is a short-term effect of spinal manipulation in the treatment of infantile colic. Design: A randomized controlled trial. Setting: A private chiropractic practice and the National Health Service's health visitor nurses in the uburb Ballerup (Copenhagen, Denmark). Subjects: Infants seen by the health visitor nurses, who fulfilled the diagnostic criteria for infantile colic. Intervention: One group received spinal manipulation for 2 weeks, the other was treated with the drug dimethicone for 2 weeks. Outcome Measure: Changes in daily hours of crying as registered in a colic diary. Results: By trial days 4 to 7, hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group (P = .04). On days 8 through 11, crying was reduced by 1 hour for the dimethicone group, whereas crying in the manipulation group was reduced by 2.7 hours (P = .004). From trial day 5 onward the manipulation group did significantly better that the dimethicone group. Conclusion: Spinal manipulation is effective in relieving infantile colic. (J Manipulative Physiol Ther 1999;22:517–22)

Introduction

Infantile colic was first described in 1894 as dyspepsia. Since then, different sets of diagnostic criteria have emerged, but there has never been complete agreement about any of these. However, the most accepted definition is: unexplainable and uncontrollable crying in babies from 0 to 3 months old, more than 3 hours a day, more than 3 days a week for 3 weeks or more, usually in the afternoon and evening hours. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17

Several studies have described a difference in the quality of crying in infants with colic compared with normal infants. Infants with colic have more hours of crying per day and more periods of crying per day, 1, 17, 18, 19, 20 and the crying in infantile colic has a higher frequency/pitch.10 Other studies describe motor unrest, typically with flexing of the knees against the abdomen, clenching of the fists, and extension or straightening of the trunk and extremities. Several studies conclude that infants with colic are perfectly normal but cry more than other infants. 21, 22, 23, 24, 25, 26, 27, 28 All studies agree that apart from the increased crying, these infants are otherwise healthy, thriving, and have a normal weight gain.

The incidence of infantile colic among newborns is estimated to be between 8% and 49% in different studies. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 17, 19, 29, 30, 31, 32, 33, 34, 35 An average of these estimates would put the incidence of infantile colic at 22.5%, and with a birth rate of 67,731 children in Denmark in 1992 this would mean that some 15,226 newborns would have infantile colic every year in a country with a population of 5 million (Statistisk månedsoversigt 1993:3:12).

Infantile colic is often described as a “benign self-limiting condition” that disappears spontaneously at 3 months of age. But a good observational study has shown that only 47% of infantile colic cases have disappeared at the age of 3 months, a further 41% disappeared before 6 months of age, and the remaining 12% of cases persevered until between the ages of 6 and 12 months.36

Although infantile colic may be regarded as a “benign self-limiting condition” that only results in a temporary delay in the development of child,33 several studies suggest that the effects of infantile colic may be more severe than that. Some studies have concluded that infantile colic can lead to a negative mother-child relationship, which may persist for up to 3 years after the disappearance of symptoms. 31, 32, 37, 38, 39, 40, 41, 42 Other studies conclude that these troublesome and screaming infants are in a high-risk group for ill treatment, for possible central nervous system damage, and even death from being shaken (shaken infant syndrome). 10, 21, 43, 44, 45, 46, 47, 48, 49, 50

The cause of infantile colic remains unknown. Many have pointed to increased air in the intestines as the cause. 51, 52, 53 But radiologic studies have shown that the amount of air in the intestines of infants with colic is the same as in normal infants. 6, 29, 54 Neither has it been possible to find constrictions in the intestines, and the gastrointestinal transit time in infants with colic is also normal. Others have investigated levels of intestinal hormones, fecal analysis, intestinal microflora, markers of intestinal damage, or occult blood in the stools and hydrogenion concentration in the breath, but none of these studies have convincingly identified abnormalities in infants with colic. 12, 34, 52, 55, 56, 57, 58, 59

Various modes of delivery (cesarean section, vaginal extraction, or vacuum extraction) have also been studied, but no differences could be identified in the incidence of colic in infants delivered by these three modes. 60, 61 Neither does the use of pudendal block, epidural analgesia, general anesthesia, or intravenous oxytocin seem to increase the risk of infantile colic.62

Numerous treatments for infantile colic have been advocated, but most of these, such as music and different sound or vibrations (car-simulating devices), have been shown to be without any effect. 3, 18, 63, 64 Treatment with sucrose seems to have a generalized analgesic effect in infants and may therefore also help in infantile colic.65

Different medical treatments for infantile colic have also been used. Dicyclomine hydrochloride 5, 15, 66 was often used with some effect until the mid 1980s, when reports about serious side effects stopped this treatment. 67, 68, 69, 70, 71, 72 Gripe-water, alcohol, atropine, skopyl, phenobarbital, meperidine, homatropine, and merbentyl have also been used with more or less convincing results. 29, 31, 73, 74, 75, 76, 77 Phenobarbital, homatropine, and alcohol have been studied in a double-blind design, which showed no effect compared with a placebo treatment,75 and most other preparations have had serious side effects. 78, 79, 80, 81, 82

One drug that is still used is dimethicone (Simethicone, Mylicon), and several good controlled studies have shown that this is no better than placebo treatment. 3, 67, 72, 83, 84

Chiropractors and others have for many years manually treated infants with colic symptoms with apparently good results. 4, 7, 30, 60, 61, 85, 86, 87, 88, 89, 90 The background for this has been the purely clinical observation that functional disturbances of the vertebral column may cause symptoms similar to those of infantile colic, and several studies seem to support this clinical observation. 7, 30, 61, 86, 87, 88, 89, 90, 91, 92

In 1985 a retrospective study was undertaken in Denmark on the chiropractic treatment of infantile colic,89 and this was followed in 1989 by a prospective multicenter study.7 Both studies suggest that there seems to be a positive effect of spinal manipulation for infantile colic, but because none of these studies had a control group, it is impossible to assess whether the effect observed was significantly better than placebo.

This trial is a prospective, randomized controlled clinical trial with a blinded observer for the purpose of studying whether any effect exists beyond placebo from spinal manipulation in the treatment of infantile colic.

Section snippets

Methods

Participants were recruited from April 1994 to July 1996 by health visitor nurses from the National Health Service in the suburb of Ballerup (Copenhagen, Denmark). The first 50 infants who fulfilled the inclusion criteria and whose parents consented were invited to take part in the study. The inclusion criteria were as follows.

  • 1.

    The age of the infant was 2 to 10 weeks.

  • 2.

    The infant did not show symptoms that could be a sign of any other disease than infantile colic.

  • 3.

    The infant had 1 or more violent

Results

Fifty-seven parents of infants were interviewed for the study; 50 were recruited for the trial, 25 were randomly assigned to the dimethicone treatment and 25 to the spinal manipulation group. All 25 in the manipulation group completed 13 days of treatment compared with only 16 in the dimethicone group. Of the 9 dropouts in the dimethicone group, 5 dropped out before the first week's diary was handed in, and therefore we have no objective registration of hours of crying for those 5 subjects.

Discussion

When we compare our results with those of the only other prospective trial on spinal manipulation in the treatment of infantile colic,7 we see that the results are virtually identical for our manipulation group. In the previous trial, mean daily hours with colic were reduced by 66% on day 12 of the trial, and in our trial we saw a reduction of 67% on day 12 in the manipulation group, whereas our dimethicone group only had a reduction in daily hours with colic of 38% by day 12. These

Conclusion

Spinal manipulation has a positive short-term effect on infantile colic.

Acknowledgements

We thank Birthel Hamann and the health visitor nurses, in particular Susanne Stage, in Ballerup and Ledøje-Smørum for their invaluable assistance.

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    Submit reprint requests to: Jesper M. M. Wiberg, DC, Hold an vej 5, 2750 Ballerup, Denmark.

    ☆☆

    Supported by the Danish Health Insurance Fund and the research committee of the Danish Chiropractors Association.

    The preliminary results from this study have been presented in Bürgenstock at the continuing education course of the Association of Swiss Chiropractors, September 11–13, 1997.

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