Biagi 1994.
| Study characteristics | ||
| Methods | Design: double‐blind, placebo‐controlled using 2 different dosages Duration: 8 weeks Interval of assessment: start and end of study |
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| Participants | Number randomised: 48 (16 in each group) Sex (M/F): 24/27 total (this applied to the whole group; there was no separation for the active and placebo groups) Age of participants: children average 4.2 years (2.2 to 8.5 years) Unit of allocation: whole person Country and setting: Italy, single referral outpatient department 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 | Concomittent treatment: allowed continued emollients and topical steroids Compliance to treatment: unsure |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Children were randomised to receive either..." Comment: The trial gave no method of generation |
| Allocation concealment (selection bias) | High risk | The trial gave no details |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3/48 participants did not attend for follow up. The dropouts or losses to follow up by assignment group were unclear, as were the reasons |
| Selective reporting (reporting bias) | Low risk | The trial reported all prespecified outcomes |
| Other bias | Low risk | We contacted the author; there was no other bias |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "...all assessments were made double blind" Comment: This was adequate, but details were not given of who was blinded and how. This was probably done |