Lee 2014.
Methods | Randomised, active‐comparator controlled trial | |
Participants | 30 participants with RLS, ages 20‐80, with serum ferritin 15‐50 ng/mL, enrolled at a single site (Korea) | |
Interventions | Intervention: oral ferrous sulfate, 325 mg bid, for 12 weeks Control: oral pramipexole at bedtime, starting dose 0.25 mg with dose increase as needed and tolerated |
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Outcomes | IRLS measured at baseline, weeks 2, 4, 8, and 12, ferritin, ESS score, Beck Depression Inventory, PSQI | |
Notes | The authors calculated that > 20 subjects would be needed per group for 80% power to detect an effect size of 0.8 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Block randomisation used |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation concealment; study unblinded |
Blinding (performance bias and detection bias) All outcomes | High risk | Study was unblinded to participants and study personnel |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Although last observation carried forward was used, there was a high dropout rate for treatment‐related reasons that differed between conditions (4/15 dropped out of pramipexole group because of side effects versus 1/15 from iron group for lack of efficacy; an additional 2/15 left the iron group for study inconvenience) |
Selective reporting (reporting bias) | Unclear risk | No mention of protocol registration |
Other bias | Low risk | No other risks identified |