Summary of findings for the main comparison.
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Antidepressants for the treatment of abdominal pain‐related functional gastrointestinal disorders in children and adolescents. | ||||||
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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] | |||||
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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 | |
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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 | ||
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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