Table 3.
Findings from included studies by similar outcomes
| Author, year (quality rating) | Participants, n and age | Outcomes and findings/results (parent-reported outcomes unless otherwise stated) | Magnitude or direction of effect: moderate to high-quality studies only |
| Reduction in crying: overall strength of evidence: moderate | |||
| Miller et al,34 2012* (high) |
n=104 Age: <8 weeks |
Mean crying times of all groups decreased by day 10, mean decrease was: treatment blinded (TB): 44.4% (P<0.001), treatment not blinded (TNB): 51.2% (P<0.001) and no treatment blinded (NTB): 18.6% (P<0.05). (1) TB versus NTB: using cut-off of 2 or less hours of crying per day and more than 30% change, respectively. Day 10: 12.0 (95% CI 2.1 to 68) and 3 (95% CI 0.8 to 9). (2) TB versus NTB: reduction −1.4 hours of mean crying time (95% CI −2.5 to −0.3) at day 10. (3) TB versus TNB: no significant difference between blinded treatment groups. Adjusted ORs: 0.7 (95% CI 0.2 to 2.0) and 0.5 (95% CI 0.1 to 1.6) at days 8 and 10, respectively. |
Significant favourable effect in the treatment group of 1.4 hours less crying |
| Browning and Miller,32 2008* (high) |
n=43 Age: <8 weeks |
At 4-week post-trial, there was complete resolution of colic symptoms (includes crying) in 18/22 infants in the spinal manual therapy (SMT) group and in 14/21 in the occipital decompression group (OSD) as perceived by the parent (rate ratio of 1.23 (95% CI 0.86 to 1.76)). Infants treated with SMT were 20% more likely to resolve compared with infants treated with OSD. Not statistically significant. | No difference between groups; both treatment groups improved. Head-to-head trial. |
| Hayden and Mullinger33 2006* (moderate) | n=28 Age: 10–83 days |
There was a statistically significant difference between the two groups in the mean reduction in crying time of 1.0 (95% CI 0.14 to 2.19) hours/24 hours. Overall reduction in crying time from weeks 1 to 4 was 63% in the treatment compared with 23% in the control group. |
Significant favourable effect in treatment group of 1 less hour of crying. |
| Olafsdottir et al,36 2001* (moderate) | n=100 Age: 3–9 weeks |
There was no difference between those treated and not treated (Student’s t-test, P=0.982). A reduction in crying hours per day in both groups was seen during the study, from a mean of 5.1 to 3.1 hours per day in the treatment group and from 5.4 to 3.1 hours in the control group. | No difference between groups; both treatment groups improved. |
| Wiberg and Wiberg,45 2010 (moderate) | n=276 Age: 0–3 months |
No apparent link between the clinical effect of chiropractic treatment and a natural decline in crying was found. | No clinical difference between treatment and natural decline. |
| Wiberg et al,37 1999* (low) | n=45 Age: mean 5.4 weeks |
There was a significantly larger reduction in colic symptoms from pretreatment to days 8–11 in the manipulation group (−1.0 hour/day, ±0.4 SE) compared with the dimethicone group (−2.7 hour/day, ±0.3 SE). | Inconclusive (low quality). |
| Sleeping time: overall strength of evidence: moderate | |||
| Herzhaft-Le Roy et al,38 2017* (high) | n=97 Age: mean 15 days |
16.5% of mothers in the osteopathic treatment group reported that their infants slept better, appeared soothed or better enjoyed lying on their back in the days that followed treatment. | Inconclusive: favourable outcome but only reported in the treatment group. |
| Browning and Miller,32 2008* (high) |
n=43 Age: <8 weeks |
At day 14, the mean hours of sleep per day were significantly increased in both groups (SMT, by 1.66 hours/day, P<0.01; OSD, by 1.03 hours day, P<0.01). | No difference between groups; both treatment groups improved. |
| Hayden and Mullinger,33 2006* (moderate) | n=28 Age: 10–83 days |
There was a significant difference between treated and control groups: mean increase in sleeping time of 1.17 hours/24 hours more (95% CI 0.29 to 2.27) (P<0.05). Overall improvement in sleeping time by week 4 was 11% for the treated group and less than 2% in the control group (mean % change). |
Significant favourable effect in treatment group of 1.17 hours of more sleeping. |
| Parent–child relations: overall strength of evidence: moderate | |||
| Neu et al,35 2014*(high) | n=43 Age: 4–12 weeks |
Effect size (ES) massage group relative to the non-massage group for sensitivity to cues, social-emotional growth fostering, cognitive growth and fostering (0.24 to 0.56: small to moderate. Not significant). Response to distress (ES −0.18) in unintended direction (not significant). |
Inconclusive: non-significant favourable effects in the treatment group. |
| Hayden and Mullinger,33 2006* (moderate) | n=28 Age: 10–83 days |
The mean difference in contact time between weeks 1 and 4 for the treated group was 1.3 hours (P<0.015) and 2 hours for the control group. | Significant favourable effects with less contact time required for the treated group compared with control. |
| Global improvement/resolution of symptoms: overall strength of evidence: moderate | |||
| Miller et al,34 2012*(high) | n=104 Age: <8 weeks |
Treatment group blinded versus non-blinded treatment group (adjusted OR (95% CI), 44.3 (7.7 to 253)). | Significant favourable effect in change with treatment. |
| Browning and Miller,32 2008* (high) | n=43 Age: <8 weeks |
At 4-week post-trial, there was complete resolution of colic symptoms in 18/22 infants in the SMT group and in 14/21 in the OSD group as perceived by the parent (rate ratio of 1.23 (95% CI 0.86 to 1.76). Infants treated with SMT were 20% more likely to resolve compared with infants treated with OSD. Not statistically significant. | No difference between groups; both treatment groups improved. |
| Davies and Jamison,39 2007 (moderate) | n=52 Age: median 7 weeks |
45 of 52 improved. One in four infants required only one adjustment (treating chiropractor reported data). |
Inconclusive: favourable descriptive statistics only. No control group. |
| Olafsdottir et al,36 2001*(moderate) | n=100 Age: 3–9 weeks |
69.9% of treatment groups versus 60% control showed some degree of improvement (Fisher’s exact test, P=0.374). | No difference between groups; both treatment groups improved. |
| Improvement in feeding: overall strength of evidence: low | |||
| Herzhaft-Le Roy et al,38 2017* (high) | n=97 Age: mean 15 days |
Ability to latch improved more in the treatment group (time 3, mean score=9.22, SD=0.92) than in the control group (time 3, mean score=8.18, SD=1.60); P=0.001. | Significant favourable effect in those having osteopathic treatment. |
| Miller et al,49 2016 (moderate) |
n=85. Age: <4 weeks |
7% (n=5) reported no difference in feeding after attending the clinic. 86% reported exclusive breastfeeding at follow-up (compared with the 26% at start of the study). Relative RR of exclusive breastfeeding after attending the clinic was 3.6 (95% CI 2.4 to 5.4). |
Significant favourable effect in those attending the clinic. |
| Miller et al,42 2009 (moderate) | n=114 Age: 2 days–12 weeks |
All showed improvement. 78% (n=89) were able to be exclusively breastfed after 2–5 treatments, within a 2-week time period. 20% (n=23) required at least some bottle-feeding. | Inconclusive descriptive statistics only. No control group. Favourable findings. |
| Cornall,50 2015 (high) | n=13 Mothers/osteopath dyads Age: mothers: median=32 years and newborns |
Findings support optimal breastfeeding through a progressive, transitional cycle process, which is supported by four interrelated categories: (1) connecting; (2) assimilating; (3) rebalancing; and (4) empowering. The findings outline contextual determinants that shaped women’s views and experiences, osteopaths’ professional identity and healthcare as a commodity. | Qualitative data affirming the need for a structured yet creative and individualised approach to infant manual therapy, with the goal of helping the mother to achieve optimal breastfeeding. |
| Maternal satisfaction: overall strength of evidence: low | |||
| Miller et al,49 2016 (moderate) | n=85. Age: <4 weeks. |
98% (n=83) planned to continue breastfeeding their baby and would recommend the clinic to friends. | Inconclusive: favourable descriptive statistics only. No control group. |
| Nipple pain: overall strength of evidence: low | |||
| Herzhaft-Le Roy et al,38 2017* (high) | n=97 Age: mean 15 days |
VAS mean scores over time (P=0.713). No statistical difference between groups. | No difference between groups. |
| Adverse events | |||
| Miller and Benfield,43 2008 (moderate) | n=697 Age: 75% <12 weeks |
7/697 of those attending treatment at clinic reported adverse reactions to treatment, 5 of these were treated for colic. Reactions reported were mild, transient and no medical care required. | Adverse events are minimal and transient. |
*Randomised controlled trials.
VAS, visual analogue scale.