Borrek 1997.
Study characteristics | ||
Methods | Design: randomised by draw, double‐blind, placebo‐controlled, cross‐over Duration: 20 to 24 weeks Interval of assessment: 4 to 3 weeks |
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Participants | Number randomised: 24 children and teenagers from 3 to 17 years of age Sex (M/F): 14/10 total Age of participants: 3 to 17 years (mean age = 10 years) Unit of allocation: single person Country and setting: Germany, 1 university pediatric clinic Inclusion criteria of the study
Exclusion criteria of the study
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Interventions |
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Outcomes |
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Notes | Concommitant treatment: permitted Assessment of compliance: unsure |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was by draw (entrance to study) |
Allocation concealment (selection bias) | Unclear risk | The trial did not specify this |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants from each group withdrew due to non‐compliance |
Selective reporting (reporting bias) | Low risk | The trial reported all prespecified outcomes |
Other bias | Low risk | Quote (page 101): "No difference between the two groups in the most important variables" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (page 101): "Patient and examiner were blinded with respect to after completion of the capsule contents" Comment: This was adequate (both blinded) |