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. 2016 Nov 7;2016(11):CD010690. doi: 10.1002/14651858.CD010690.pub2

Pellecchia 2004.

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

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

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
  • Levodopa SR 25/100 mg once/d orally, doubled to a maximum of 50/200 mg once/d after 2 weeks, for a period of 6 weeks


Co‐interventions
  • None

Outcomes
  • Reduction in severity of RLS scores (IRLSSG: 0 to 24) at baseline, 6 weeks and at end of study

  • Adverse events

Notes
  • Funding source not reported

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