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. 2016 Nov 1;2016(10):CD011579. doi: 10.1002/14651858.CD011579.pub2

Summary of findings 2. Different doses or dose regimens of hydroxyurea compared.

Different doses or dose regimens of hydroxyurea compared
Patient or population: people with non‐transfusion dependent beta thalassaemia
Settings: specialised outpatient clinic
Intervention: 20 mg/kg/day hydroxyurea versus 10 mg/kg/day
Outcomes Illustrative comparative risks* (95% CI) Relative effect
(95% CI) No of Participants
(studies) Quality of the evidence
(GRADE) Comments
Assumed risk Corresponding risk
10 mg/kg/day 20 mg/kg/day
Frequency of transfusion Outcome not reported.
Major adverse effects ‐ Neutropenia Study population RR 9.93 
(1.34 to 73.67) 61
(1 trial) ⊕⊝⊝⊝
very low1,2,3 Not downgraded for lack of blinding because outcome considered to be objective.
31 per 1000 310 per 1000
(42 to 1000)
Major adverse effects ‐ Thrombocytopenia Study population RR 3.68 
(1.12 to 12.07) 61
(1 trial) ⊕⊝⊝⊝
very low1,2,3 Not downgraded for lack of blinding because outcome considered to be objective.
94 per 1000 345 per 1000
(105 to 1000)
Quality of life Outcome not reported
Mean Hb F at 24 weeks (g/dL) The mean Hb F at 24 weeks (g/dL) in the intervention group was 1.5 lower (1.83 to 1.17 lower) 61
(1 trial) ⊕⊕⊝⊝
low1,2 Not downgraded for lack of blinding because outcome considered to be objective.
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; Hb F: foetal haemoglobin; RR: risk ratio.
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.

1 Downgraded one level for unclear allocation concealment 
2 Downgraded one level because conclusions based on one small trial
3 Downgraded one level for extremely wide CI