| Methods |
Randomised, double‐blind, parallel group design.
Included a third arm for bromocriptine although the study was not powered to examine differences between pramipexole and bromocriptine (see Cochrane pramipexole v bromocriptine review).
Randomisation by computer generated random numbers. Medication allocated consecutively in blocks of 3 in centres.
Double‐dummy system for pramipexole and bromocriptine.
Location ‐ 34 multinational centres.
Intention‐to‐treat analysis using last observation carried forward method.
Duration of therapy < or = 36 weeks. |
| Participants |
Pramipexole ‐ 79 patients with 16 drop outs (20%).
Placebo ‐ 83 patients with 33 drop outs (40%).
Details of terminations given.
Patients comparable for age, sex, duration of disease and severity of disease at baseline.
Hoehn and Yahr scale at baseline not given.
Mean baseline levodopa dose not given. |
| Interventions |
Blind titration to maximum of 1.5 mg tds of pramipexole.
Titration phase < or = 12 weeks.
Maintenance = 24 weeks.
Dose reduction = 1 week.
Mean dose of pramipexole in active arm 3.36 mg/d.
Changes in levodopa dose allowed. |
| Outcomes |
Primary: UPDRS ADL (part II) as average of on and off scores and UPDRS motor (part III) in on phase only.
Secondary: UPDRS ADL on phase.
UPDRS ADL off phase.
UPDRS parts I and IV.
Off time.
Schwab and England scale in on and off phase.
Hoehn and Yahr in on and off phase.
Dyskinesia scale ‐ details not given.
Timed walking test.
Clinician's global impression scale.
EuroQol and Functional Status Questionnaires.
Adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
