Manipulative therapies for infantile colic.

Background: Infantile colic is a common disorder, affecting around one in six families, and in 2001 was reported to cost the UK National Health Service in excess of £65 million per year (Morris 2001). Although it usually remits by six months of age, there is some evidence of longer-term sequelae for both children and parents.Manipulative therapies, such as chiropractic and osteopathy, have been suggested as interventions to reduce the severity of symptoms.

Objectives: To evaluate the results of studies designed to address efficacy or effectiveness of manipulative therapies (specifically, chiropractic, osteopathy and cranial manipulation) for infantile colic in infants less than six months of age.

Search Methods: We searched following databases: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 3 2012), EMBASE (1980 to 2012 Week 17), CINAHL (1938 to April 2012), PsycINFO (1806 to April 2012), Science Citation Index (1970 to April 2012), Social Science Citation Index (1970 to April 2012), Conference Proceedings Citation Index - Science (1990 to April 2012) and Conference Proceedings Citation Index - Social Science & Humanities (1970 to April 2012). We also searched all available years of LILACS, PEDro, ZETOC, WorldCat, TROVE, DART-Europe, ClinicalTrials.gov and ICTRP (May 2012), and contacted over 90 chiropractic and osteopathic institutions around the world. In addition, we searched CentreWatch, NRR Archive and UKCRN in December 2010.

Selection Criteria: Randomised trials evaluating the effect of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions for the treatment of infantile colic.

Data Collection And Analysis: In pairs, five of the review authors (a) assessed the eligibility of studies against the inclusion criteria, (b) extracted data from the included studies and (c) assessed the risk of bias for all included studies. Each article or study was assessed independently by two review authors. One review author entered the data into Review Manager software and the team's statistician (PP) reviewed the chosen analytical settings.

Main Results: We identified six studies for inclusion in our review, representing a total of 325 infants. There were three further studies that we could not find information about and we identified three other ongoing studies. Of the six included studies, five were suggestive of a beneficial effect and one found no evidence that manipulative therapies had any beneficial effect on the natural course of infantile colic. Tests for heterogeneity imply that there may be some underlying difference between this study and the other five.Five studies measured daily hours of crying and these data were combined, suggesting that manipulative therapies had a significant effect on infant colic - reducing average crying time by one hour and 12 minutes per day (mean difference (MD) -1.20; 95% confidence interval (CI) -1.89 to -0.51). This conclusion is sustained even when considering only studies with a low risk of selection bias (sequence generation and allocation concealment) (MD -1.24; 95% CI -2.16 to -0.33); those with a low risk of attrition bias (MD -1.95; 95% CI -2.96 to -0.94), or only those studies that have been published in the peer-reviewed literature (MD -1.01; 95% CI -1.78 to -0.24). However, when combining only those studies with a low risk of performance bias (parental 'blinding'), the improvement in daily crying hours was not statistically significant (MD -0.57; 95% CI -2.24 to 1.09).One study considered whether the reduction in crying time was clinically significant. This found that a greater proportion of parents of infants receiving a manipulative therapy reported clinically significant improvements than did parents of those receiving no treatment (reduction in crying to less than two hours: odds ratio (OR) 6.33; 95% CI 1.54 to 26.00; more than 30% reduction in crying: OR 3.70; 95% CI 1.15 to 11.86).Analysis of data from three studies that measured 'full recovery' from colic as reported by parents found that manipulative therapies did not result in significantly higher proportions of parents reporting recovery (OR 11.12; 95% CI 0.46 to 267.52).One study measured infant sleeping time and found manipulative therapy resulted in statistically significant improvement (MD 1.17; 95% CI 0.22 to 2.12).The quality of the studies was variable. There was a generally low risk of selection bias but only two of the six studies were evaluated as being at low risk of performance bias, three at low risk of detection bias and one at low risk of attrition bias.One of the studies recorded adverse events and none were encountered. However, with only a sample of 325 infants, we have too few data to reach any definitive conclusions about safety.

Authors' Conclusions: The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.There are inadequate data to reach any definitive conclusions about the safety of these interventions.