Summary of findings for the main comparison. Summary of findings: dietary interventions for infantile colic versus placebo or other interventions.
Dietary interventions for infantile colic versus placebo or other interventions | |||
Patient or population: infants with colic defined by recognised criteria Settings: outpatient Intervention: any dietary intervention to treat infantile colic Comparison: placebo or any other intervention | |||
Outcomes | Impacts | Number of studiesa | Quality of the evidence (GRADE) |
Duration of crying | This was the most commonly reported outcome, but studies did so in an extremely heterogenous manner due to measurement tools used, as well as time and frequency of determination. There was no clear effect as regards the efficacy of any of the agents under study for reducing the duration of crying in affected infants. One study reported that the number of infants crying for less than 3 hours per day on at least 3 days a week following the intervention was 8 (out of 23) in the whey hydrolysate group versus 5 (out of 20) in the standard formula group (χ2 = 0.20, P = 0.65). Results from 3 individual studies found that a hydrolysed formula, herbal drops and soy protein‐based formula may reduce crying time at study end (continuous outcome). 1 study found no difference between 2 types of hydrolysed formulas. |
6 | ⊕⊝⊝⊝ Very lowb |
Number of responders in each group after treatment | There were mixed effects as regards the efficacy of the agents under study for improving the number of responders. Results from 2 individual studies showed that a low‐allergen maternal diet and a soy protein‐based formula may increase the number of responders. However, another study found no evidence in favour of a low‐allergen diet or soy‐milk formula but did find that dicyclomine hydrochloride may increase the number of breastfed babies who respond. | 3 | ⊕⊝⊝⊝ Very lowb |
Frequency of crying episodes per 24 h | Results from 2 individual studies showed that a hydrolysed or dairy‐ and soy‐free formula and a partially hydrolysed formula may reduce the frequency of crying episodes per 24 h. As this is very difficult to discern from normality and is not a key component of infantile colic diagnostic criteria or a necessary a goal of clinicians, the clinical relevance of this outcome is worth readers' consideration. | 2 | ⊕⊝⊝⊝ Very lowb |
Parental or family quality of life, including measures of parental stress, anxiety or depression | No data | ||
Infant sleep duration per 24 h at 7, 14 and 21 days from start of intervention | No data | ||
Parental satisfaction | No data | ||
Adverse effects to dietary modifications | This is a key outcome, given the population under study, which was poorly reported in many studies. 3 studies reported that there were no adverse effects. 3 authors (one of whom is an author on this review) of 3 other studies confirmed there were no adverse effects. The 9 remaining studies did not report on adverse effects. | 6 | ⊕⊝⊝⊝ Very lowb |
GRADE Working Group – grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. |
aParticipant numbers have not been included in the table as it contains multiple comparisons. bWe downgraded the quality of the evidence for all outcomes, across all studies, due to consistent issues with incomplete outcome data, selective reporting, the presence of extremely small sample sizes, drug and nutrition company involvement, and risk of bias. These issues were pervasive across the evidence base and must be considered when interpreting any of the reported findings.