Summary of findings 4. Cimetropium bromide versus placebo for infantile colic.
Cimetropium bromide versus placebo for infantile colic | ||||||
Patient or population: infants with infantile colic Settings: university hospital (Italy) Intervention: cimetropium bromide 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 | Cimetropium bromide vsplacebo | |||||
Reduction in crying duration Difference between final values (minutes per crisis of crying) Follow‐up: mean 3 days | Mean reduction in crying duration in control groups was 47.5 minutes per crisis of crying | Mean reduction in crying duration in intervention groups was 30.2 lower (39.51 to 20.89 lower) | MD ‐30.20 (‐39.51 to ‐20.89) | 86 (1 study) | ⊕⊝⊝⊝ Very lowa,b | ‐ |
Responders Number of infants who improved after treatment Follow‐up: mean 3 days | Study population | RR 2.29 (1.44 to 3.64) | 86 (1 study) | ⊕⊝⊝⊝ Very lowa,b | ‐ | |
326 per 1000 | 746 per 1000 (469 to 1000) | |||||
Moderate | ||||||
326 per 1000 | 747 per 1000 (469 to 1000) | |||||
*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. |
aOnly one study with 86 infants. bHigh risk of attrition bias.