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Evid Based Nurs 4:77 doi:10.1136/ebn.4.3.77
  • Treatment

Chiropractic spinal manipulation did not lead to an improvement in infantile colic or reduce crying


 
 QUESTION: Is chiropractic spinal manipulation effective in the treatment of infantile colic?

Design

Randomised {allocation concealed}*, blinded (paediatrician, parents, and outcome assessor), placebo controlled trial with 8–14 days of follow up.

Setting

{Outpatient ward in a paediatric department in Bergen, Norway.}*

Patients

100 thriving infants (3–9 wks) who cried ⩾3 hours/day, 3 days/week for the previous 3 weeks with no sign of lactose intolerance, no previous chiropractic treatment, and who were non-responsive to a cows' milk free diet in the mothers who breast fed or to casein hydrolysed formula for those who were bottle fed. The infants were recruited from public health clinics, the paediatric outpatient clinic at the university hospital, general practitioners, chiropractors, and maternity units. 9 infants (9%) did not meet the inclusion criteria and were excluded; 5 infants did not complete the trial. Of the 86 who completed the trial, 55% were boys and the mean birth weight was 3690 g.

Intervention

46 infants were allocated to spinal manipulation and 40 to the control group. Infants in the spinal manipulation group were brought by a nurse to the chiropractor who used a very light, modified fingertip mobilisation form of spinal manipulation (no joint “cracks”). The treatment was given 3 times, at intervals of 2–5 days, for a period of 8 days. Infants in the control group did not receive spinal manipulation but were held by the nurse for 10 minutes.

Main outcome measures

The primary outcome was amount of improvement reported by the parent on a 5 point scale. The secondary outcome was amount of crying (h/d).

Main results

The groups did not differ for parent reported improvement or for amount of crying time. 32 of 46 infants (70%) showed some improvement in the treatment group, whereas 24 of 40 (60%) showed improvement in the control group (p=0.4). Crying time was reduced by a similar amount in the treatment and control groups (treatment group 5.1 h/d at baseline to 3.1 h/d at follow up v control group 5.4 h/d at baseline to 3.1 h/d, p=0.98).

Conclusion

Chiropractic spinal manipulation did not lead to an improvement in infantile colic or reduce infants' crying time.

Commentary

  1. Mary Lou Walker, RN, MHSc
  1. Family Health Program Manager, Toronto Public Health Toronto, Ontario, Canada

      Infantile colic is common during the first months of life and, despite extensive study, its cause remains unclear. This is reflected in the numerous approaches to treatment that have been recommended and studied. Although its symptoms usually resolve by 4–5 months of age, colic causes appreciable distress to parents and creates needs for teaching and counselling by nurses. It is therefore an important issue for antepartum and postpartum nurses working in hospital and community settings.

      The 2 studies presented here used the same diagnostic definition of infantile colic.1 The infants in both studies and in both groups, however, had very high levels of crying (>4.5 h/d compared with the diagnostic cut off of >3 h/d, for >3 d/wk). This initially high crying time made it more difficult to achieve large enough reductions to meet one of the outcome criteria: a reduced proportion of infants meeting the diagnostic definition of colic. The high crying time among study participants also may reflect the presence of other confounding factors.

      In the study of chiropractic treatment by Olafsdottir et al, there was reduced infant crying and parents reported an improvement in both the intervention and placebo groups, with no statistically significant differences between them. The similar improvement may be the result of a placebo effect (ie, the counselling and support provided to parents in both groups) and/or the natural course of infantile colic. The lack of effect from spinal manipulation differs from other trial results, possibly because this study had the critical methodological strength of blinding the parents to the intervention, minimising the potential for bias arising from parental expectations. These findings are important in locales where chiropractic treatment is an accepted treatment for colic and nurses are asked for advice about this treatment.

      The study of whey hydrolysate by Lucassen et al presents results that are consistent with findings from a systematic review of treatments for colic, which concluded that replacement of cows' milk protein with a hydrolysate is effective.2 It is not clear, however, how much formula the infants in this study consumed because the inclusion criterion was at least 1 formula feeding a day, and the amount of breast feeding in the sample group, before and during the study, was not reported. It is important to know the extent of breast feeding in the 2 groups as this may have affected the differences in outcomes. It is also not stated whether only formula feedings, or breast milk feedings as well, were replaced with whey hydrolysate. This limits the generalisability of results, and does not provide any evidence to support replacement of breast milk with whey hydrolysate formula.

      The study sample size was much smaller than anticipated: over a 2 year period, 38 completed the trial although the anticipated sample size was 150. This speaks to the challenges of recruitment, particularly when there is a strict definition of colic and a measurement instrument to be completed by parents who are already overburdened with coping with a colicky infant. The high average crying time in recruited infants may be related to their parents' motivation to enter the study. With such a small number of infants in the trial, it is not surprising that the treatment and control groups differed in age, sex, crying and crying/fussing levels, and the presence of a food allergy at baseline. As a result, we must rely on the adjusted analysis which just achieves statistical significance with a p value of 0.05.

      The findings from these 2 studies have important implications for nurses in clinical practice and research. When providing anticipatory guidance to prospective parents, and when counselling parents of newborns about infant crying, nurses need to present parents with realistic expectations, common causes, and practical relief measures. If crying is consistently in excess of 3 hours/day, then a detailed assessment is required. Other disorders need to be ruled out. Reassurance, teaching, counselling, and support always should be the first intervention measures. The evidence from these studies supports a switch from cows' milk formula to whey hydrolysate formula in formula fed infants with colic, but not the use of spinal manipulation. Nurses have an important part to play in educating new parents and other health professionals in this area.

      This evidence highlights the continuing need for research on the causes of infantile colic and the effectiveness of dietary and alternative treatments, particularly with the increasing interest in complementary medicine. Attention must be paid to the role of breast feeding with any dietary interventions. Studies need to replicate the strong methodology here, with sufficient sample size, placebo control, and blinding. The influence of social factors on colic is another potential area of research. Nurses have a responsibility to advocate for, and participate in, rigorous studies on infantile colic, and to disseminate their findings.

      References

      Footnotes

      • Source of funding: Norwegian Research Council.

      • For correspondence: Dr E Olafsdottir, Department of Paediatrics, University of Bergen, 5021 Bergen, Norway. Fax +47 559 75159.

      • * Information provided by author.

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