Methods |
Study design: open‐label crossover RCT
Study duration: not reported
Study follow‐up period: 14 weeks including 1 week screening and 1 week washout period
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Participants |
Country: Italy
Setting: outpatient HD centre
Health status: stable adult HD patients receiving 3 times/wk dialysis with a diagnosis of RLS established according to IRLSSG criteria; patients agreed not to take any psychotropic drug (e.g. levodopa SR, dopamine agonists, antidepressants, and neuroleptics) at least 1 month before baseline evaluation
Number: 11
Mean age ± SD: 56.2 ± 8.7 years
Sex (M/F): 7/4
Exclusion criteria: patients with clinically significant orthostatic hypotension; unstable medical condition including serious cardiovascular, pulmonary, hepatic, or psychiatric disease; concurrent or past diagnosis of malignant melanoma
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Interventions |
Treatment group
Ropinirole, 0.25 mg/d orally doubled every 5 days to a maximum dose of 2 mg/d for a period of 6 weeks
1 week washout period before switch to alternate therapy
Control group
Co‐interventions
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Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer generated randomisation |
Allocation concealment (selection bias) |
Unclear risk |
Open label |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open label |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open label |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Adverse events were clearly stated |
Selective reporting (reporting bias) |
Low risk |
No evidence of selective reporting |
Other bias |
Unclear risk |
Funding source not reported |