Silva 1997.
Methods | RCT. Cross‐over design. Location: single tertiary centre in Brazil. Duration: 6 months per treatment arm, but washout period was not stated in paper. |
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Participants | 26 participants randomised. Age, median (range): 45.3 months (3.6 months to 15 years). Gender split: 8 males, 18 females. Diagnosis: CAH due to 21OH deficiency. |
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Interventions |
Group 1: HC 15 mg/m² 1x daily and FC 0.1 mg/day for 6 months. Group 2: HC 25 mg/m² 1x daily and FC 0.1 mg/day for 6 months. |
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Outcomes | 17 OHP, androstenedione, testosterone, GH, IGF‐1, growth pattern (height and weight). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Treatment randomly assigned, but paper does not state how sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation of concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Each child was examined by the same physician who was blinded to the HC dosing schedule. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Each child was examined by the same physician who was blinded to the HC dosing schedule. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rate was not reported. |
Selective reporting (reporting bias) | High risk | We did not have any access to the original trial protocols to definitely confirm whether this occurred and we attempted to contact the investigators but have not received a response. |
Other bias | Unclear risk | We did not have any access to the original trial protocols to definitely confirm this but there was no washout period described in the paper for this cross‐over trial. |