Skip to main content
. 2016 Nov 7;2016(11):CD010690. doi: 10.1002/14651858.CD010690.pub2

Thorp 2001.

Methods
  • Study design: double blind crossover RCT

  • Study duration: not reported

  • Study follow‐up period: 13 weeks (6 weeks of treatment with first agent, 1 week washout period and 6 weeks of treatment with second agent)

Participants
  • Country: USA

  • Setting: HD centre in Portland Veterans Affairs Medical centre, Portland, USA

  • Health status: stable chronic adult HD patients with RLS diagnosed according to criteria similar to the current IRLSSG criteria

  • Number: 16

  • Mean age ± SD: 64.1 ± 5.9 years

  • Sex (M/F): 15/1

  • Exclusion criteria: participants with other cause of leg discomfort on neurological examination

Interventions Treatment group
  • Gabapentin 300 mg orally at the end of dialysis (3 times/wk) for 6 weeks


Control group
  • Placebo similar to gabapentin administered orally at the end of dialysis (3 times/wk) for 6 weeks


Treatment administered under the direct supervision on nurse at the end of dialysis treatment. One week washout period between 2 treatments
Outcomes
  • RLS severity assessed by non‐validated Questionnaire at 0, 6, 13 weeks

Notes
  • Funding source: Drug was supplied by Pharmaceutical company

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No clear mention how randomised
Allocation concealment (selection bias) Unclear risk Method of concealment not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients, nurses, and physicians were blinded to treatment assignment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessments (questionnaires) were carried out while subjects and staff were still blinded to treatment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Clearly mention drop outs and withdrawals with specified reasons
Selective reporting (reporting bias) Unclear risk No study protocol but expected outcome (improvement in severity of RLS) is clearly discussed
Other bias High risk "Gabapentin was supplied by Parke‐Davis Pharmaceuticals"