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. 2011 Jul 6;2011(7):CD008013. doi: 10.1002/14651858.CD008013.pub2

Summary of findings for the main comparison.

Antidepressants for the treatment of abdominal pain‐related functional gastrointestinal disorders in children and adolescents.
 
Patient or population: adolescents with newly diagnosed irritable bowel syndrome according to Rome II criteria
Settings: Outpatients at private practice clinic
Intervention: amitriptyline
Comparison: 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
[placebo] [amitriptyline]
Patients' overall assessment of satisfactory relief
[Overall, how do you feel your problem is? Answers: better, same, or worse]
[4 weeks]
53% (95% CI not reported) of children reported feeling better 59% (95% CI not reported) of children reported feeling better (P not reported) RR 1.12 (0.77, 1.63) 90
[1]
low1,2
Quality of life
[IBS ‐ QOL Questionnaire]
13 weeks
The mean change of IBS‐QOL scores was 1.9 points (95% CI not reported) in the control group The mean change of IBS‐QOL scores in the intervention groups was 16.8 points (95% CI not reported);
14.9 points higher than control group; P = 0.013
33 [1] low1,2
Adverse events
[methods of adverse effects assessment not reported]
2% (95% CI not reported) of children reported at least one adverse event 4% (95 CI not reported) of children reported at least one adverse event RR 1.91 (0.18, 20.35) 90
[1]
very low1,2,3
*The basis for the assumed risk (e.g. the 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; RR: Risk Ratio; IBS‐QOL: Irritable Bowel Syndrome‐Quality of Life scale;
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.

1Unclear risk of bias

2 Imprecision of results

3 High probability of outcomes reporting bias