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Three Part Question

In [an otherwise healthy 6-week-old infant with typical colicky pain] is [chiropractic effective] in [reducing the severity of the colic, or the length of time spent crying]?

Clinical Scenario

Mrs A. presents with her 6-week-old baby complaining of his excessive and uncontrollable crying behaviour, particularly in the evening and at night. The child is otherwise healthy, thriving and has a normal weight gain. Following questions regarding the pattern of crying, and associated signs, it is apparent that the child is exhibiting typical colic behaviour. There are clear signs that the continual and excessive crying behaviour is impairing the mother-child relationship, and you consider the child might be at increased risk of harm (or neglect). In discussing the treatment options, Mrs A. tells you that her chiropractor has offered to treat her baby for the excessive crying behaviour. She herself has been treated by this chiropractor in the past for back pain, and it is obvious she has considerable confidence in him. She asks your advice.

Search Strategy

MEDLINE
''colic'' AND ''chiropractic'' and filter "therapy" - 3 articles, ((colic AND chiropractic) AND (randomized controlled trial [PTYP] OR drug therapy [SH] OR therapeutic use [SH:NOEXP] OR random* [WORD])) 2 articles - (both RCTs). Hand searching - abstract (Mercer and Nook).

Search Outcome

4 articles found.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Klougart N et al, 1989, UK	316 otherwise healthy infants (age 2-16 weeks) with symptoms of colic according to well-defined criteria, all treated with chiropractic spinal manipulation. Primary evaluation after two weeks of treatment (average of 3 treatment visits). Number of dropouts = 17.	Prospective single cohort observational study (2b)	Symptom improvement score estimated by parents	At day 14; 6% of sample no change or worse, 34% improved, 60% stopped colic symptoms.	Lack of blinding introduces considerable bias. Lack of randomisation and a control group prevents estimates of a placebo effect or natural course of the condition, which is known to improve with age. The study is however important because of the large number of infants recruited.
			Daily hours of crying using diary completed by parents	Mean no. of daily hours crying over 2 days before treatment (retrospective estimate): 5.2. At day 1: 2.5, and at day 14: 0.65 (74% reduction). Unclear whether infants had been treated on day 1.
Mercer C and Nook BC, 1999, Auckland, NZ	30 infants (0-8 weeks) suffering from infantile colic diagnosed by a paediatrician (criteria unclear). 15 infants treated by chiropractic spinal manipulation (experimental); 15 infants treated with a non-functional, de-tuned ultrasound machine (placebo). In both groups, a maximum of 6 treatments over two weeks. No information given on dropouts.	RCT (1b) Single blinded study	Subjective response to treatment by parents before treatment and at each subsequent consultation. Outcomes not defined.	Statistically significant difference (no data given) in response to treatment between 2 groups (assumed beneficial in experimental group). Complete resolution of symptoms in 93% of infants in (assumed) experimental group. No comparative data for placebo group.	This study was reported in abstract form. The small sample group without well defined inclusion data and the lack of detail in methodology and recorded data seriously undermines the contribution of this study to the evidence base. Nevertheless, it is reported for completeness, and does support the suggestion of a beneficial effect of chiropractic.
Wiberg JMM et al, 1999, Denmark	50 objectively healthy infants (age 2-10 weeks) with well defined colic. 25 treated with chiropractic spinal manipulation for two weeks (mean 3.8 treatments) and 16 with dimethicone for two weeks (9 dropouts).	RCT (1b) Single blinded study	Daily hours of crying using diary (completed by parents).	At 8-11 days, mean change in no. of hours crying: -1.0 (SE 0.4) dimethicone; -2.7 (0.3) spinal manipulation (p=0.004)	Parents reporting outcome knew the intervention. Dimethicone has been shown to be no better than placebo treatments No follow up period after treatment period so unsure whether observed effect is maintained.
Olafsdottir E et al, 2001, Norway	100 colicky infants (age 3-9 weeks) meeting strict entry criteria. 50 treated with chiropractic spinal manipulation for 3 visits (over 8 days) and 50 given placebo treatment (holding). (9 infants excluded (failure to meet entry criteria) and 5 drop outs leaving 86 completing trial).	RCT (1b) Double blinded study, randomised by sealed envelopes	Daily hours of crying using diary (completed by parents).	At third (last) visit (day 8), mean no. of hours crying: 3.1 (SD 2.7) spinal manipulation; 3.1 (SD 2.7) placebo (p=0.982)	No results given for follow up period after treatment finished. No CI or RR given in spite of reference to them in the methods. No results given for improvement after visits 1 and 2.
			Symptom improvement score 8-14 days after last visit (completed by parents).	No difference in symptom scores between spinal manipulation and placebo (p=0.743). NNT = 10 (95%CI 3 to infinity) NNH (95%CI 9 to infinity)

Comment(s)

The early prospective study is the first documented evidence to indicate a possible beneficial effect of chiropractic intervention in colic, and as such highlights the need for future RCTs. The RCT reported by Mercer and Nook is only published in abstract form, and the lack of detail prevents scrutiny of its methodology and data analysis. It is therefore not included in the best evidence available for the effectiveness of chiropractic for colic. Both RCTs (Wiberg et al. and Olafsdottir et al.) were comparable in design and of good quality. The major difference was in the blinding of parents who completed the crying diary (and the symptom improvement score) and therefore in the reduction of parents' bias. This strengthens the trial by Olafsdottir et al, and their conclusion that chiropractic offers no greater efficacy in treating infantile colic than placebo. On the other hand, the positive effects of spinal manipulation reported by Wiberg et al. are almost certainly not as beneficial as they would have been had an intention to treat analysis been carried out. All 9 dropouts in the dimethicone group were as a result of a worsening of symptoms (and not parents' bias against medication). There were no dropouts in the spinal manipulation group. The first study is a study of effectiveness - it is pragmatic. Parents taking their child to a chiropractor clearly report a significant improvement. By eliminating parental bias, the second study is an efficacy study of chiropractic intervention. Chiropractic itself does not appear to be efficacious. An alternative explanation for these disparate results is postulated by Grunnet-Nilsson and Wiberg who hypothesise a dose-response phenomenon. In the trial by Olafsdottir et al, a treatment protocol of a maximum of 3 sessions of spinal manipulation was used over 8 days, whereas the study by Wiberg et al relied on the clinical judgement of the chiropractor. All infants received 3 - 5 sessions of chiropractic over a 14-day period (64% greater than 3). Again this reflects the pragmatic nature of the study by Wiberg et al, and the investigation of effectiveness as opposed to efficacy of a treatment intervention.

Clinical Bottom Line

The evidence suggests that chiropractic has no benefit over placebo in the treatment of infantile colic. However, there is similarly good evidence that taking a colicky infant to a chiropractor will result in fewer reported hours of colic by the parents. In this clinical scenario where the family is under significant strain, where the infant may be at risk of harm and possible long-term repercussions, where there are limited alternative effective interventions, and where the mother has confidence in a chiropractor from other experiences, the advice is to seek chiropractic treatment.

Level of Evidence

Level 2 - Studies considered were neither 1 or 3.

References

1. Klougart N, Nilsson N, Jacobsen J. Infantile colic treated by chiropractors: a prospective study of 316 cases. J Manipulative Physiol Ther 1989;12(4):281-8.
2. Mercer C, Nook BC The efficacy of chiropractic spinal adjustments as a treatment protocol in the management of infantile colic. In: Haldeman S, Murphy B eds, 5th Biennial Congress of the World Federation of Chiropractic. Auckland 1999;170-1.
3. Wiberg JM, Nordsteen J, Nilsson N. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomised controlled trial with a blinded observer. J Manipulative Physiol Ther 1999;22(8):517-22.
4. Olafsdottir E, Forshei S, Fluge G, et al. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child 2001;84(2):138-141.
5. Grunnet-Nilsson N. and Wiberg JM. Infantile colic and chiropractic spinal manipulation. (Letter) Arch Dis Child 2001; 85(4):268.