| Methods |
Randomised, double‐blind, parallel group design.
Included a third placebo arm (see Cochrane pramipexole v placebo review). Study was not powered to examine differences between pramipexole and bromocriptine.
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 < or = 36 weeks. |
| Participants |
Pramipexole ‐ 79 patients with 16 drop outs (20%).
Bromocriptine ‐ 84 patients with 17 drop outs (20%).
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. |
| Interventions |
Blind titration to maximum of 1.5 mg tds of pramipexole and 10 mg tds of bromocriptine.
Titration phase < or = 12 weeks.
Maintenance = 24 weeks.
Dose reduction = 1 week.
Mean dose of pramipexole in active arm 3.36 mg/d.
Mean dose of bromocriptine in active arm 22.64 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 |
