Summary of findings for the main comparison. Simethicone versus placebo for infantile colic.
| Simethicone versus placebo for infantile colic | ||||||
| Patient or population: infants with infantile colic Settings: university primary care centre (Sweden) and general paediatric practices (USA) Intervention: simethicone versus placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Simethicone vs placebo | |||||
| Reduction in crying duration Difference between final values (hours per day of crying) Follow‐up: mean 7 days | Mean crying duration in control groups was 4.37 hours/d | Mean crying duration in intervention groups was 0.13 lower (1.4 lower to 1.14 higher) | MD ‐0.13 (‐1.40 to 1.14) | 27 (1 study) | ⊕⊝⊝⊝ Very lowa,b | ‐ |
| Responders Number of infants who improved after treatment Follow‐up: mean 7 days | Study population | RR 0.95 (0.73 to 1.23) | 110 (2 studies) | ⊕⊕⊝⊝ Lowa,c | ‐ | |
| 591 per 1000 | 561 per 1000 (431 to 727) | |||||
| Moderate | ||||||
| 604 per 1000 | 574 per 1000 (441 to 743) | |||||
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; GRADE: Grades of Recommendation, Assessment, Development and Evaluation; MD: mean difference; RR: risk ratio. | ||||||
| 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. | ||||||
aHigh risk of selection, attrition and reporting bias. bOnly one study with 27 infants. cOnly two studies with 110 infants.