| Methods |
Randomised, double blind, parallel group design.
Computerised randomisation list generated. Treatments were balanced within blocks of 4 patients.
Intention to treat analysis only for clinicians global impression score, all other data analysed on a per protocol basis.
Location: 69 sites in 13 countries
Duration: Titration phase of 15 weeks maximum (mean 10 weeks), 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 (mean 10 months) carried out in double‐blind conditions until completion of last patient in each country, and subsequently in open conditions. Median duration, cabergoline = 444 days, bromocriptine = 455 days. |
| Participants |
Cabergoline: 191 patients with 28 drop‐outs (15%) at the end of the titration phase.
Bromocriptine: 193 patients with 34 drop‐outs (18%) at the end of the titration phase.
Age: Cabergoline = 62.3 years (SD9.1), Bromocriptine = 61.7 years (SD8.4)
Hoehn and Yahr scale at baseline: 2 or 2.5 in 111/191 of the patients in the cabergoline group, 123/193 in the bromocriptine group.
Inclusion criteria: IPD with motor fluctuations
Exclusion criteria: history of intolerance of dopamine agonists, severe depression, other CNS disorders, serious cardiac disease, kidney or liver 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, median = 4mg/d.
Bromocriptine: initial dose = 5mg/d, maximum = 40mg/d, median = 25mg/d.
Levodopa could be reduced. |
| Outcomes |
Primary: Clinicians global impression scale (7 points).
Secondary: Off hours
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 |
