| Methods |
Randomised, double blind, parallel group design.
Intention to treat analysis only for clinicians global impression score, all other data analysed on a per protocol basis.
Location: 67 sites throughout Europe, Israel and Latin America.
Duration: Titration phase 13 weeks maximum (mean 2 months), if the patients showed minimal improvement or better there followed a 3 month stable dose phase. Patients in whom improvement was maintained entered a follow‐up treatment period carried out in double‐blind conditions until completion of last patient in each country, and subsequently in open conditions. |
| Participants |
Cabergoline: 181 patients with 23 drop‐outs (13%) after titration phase.
Bromocriptine: 185 patients with 21 drop‐outs (11%) after titration phase.
Age: Cabergoline = 61.0 years (SD9.8), Bromocriptine = 60.9 years (SD9.3).
Hoehn and Yahr score at baseline, 'On' state: cabergoline 2.1, bromocriptine 2.1; 'Off' state: cabergoline 3.4, bromocriptine 3.5.
Inclusion criteria: IPD with motor fluctuations
Exclusion criteria: History of intolerance of dopamine agonists, severe depression, other CNS disorders, serious cardiac disease, liver or renal impairment. |
| Interventions |
Drugs titrated over 15 weeks, 8 dose levels, increments applied at weekly/biweekly intervals.
Cabergoline: initial dose = 0.5mg/d, maximum = 6mg/d, mean 4.4mg/d.
Bromocriptine: initial dose = 5mg/d, maximum = 40mg/d, mean 28.7 mg/d
Levodopa could be reduced. |
| Outcomes |
Primary: Clinicians global impression score (7 points)
Secondary: Off/On diaries
UPDRS
Hoehn and Yahr
Schwab and England
Adverse Events |
| Notes |
Only data from the end of titration phase was used in this review as patients were subsequently selected for on the basis of their response to the drugs. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
