| Methods |
Randomised, double‐blind, parallel group design.
A computerized randomisation list was generated. Treatments were balanced within blocks of 4 cases. The study medication was prepared and labelled with corresponding patient numbers. In each centre patients were to recieve progressive randomisation numbers according to theri temporal entry into the study.
Data analysed on a per protocol basis.
Location: 12 sites.
Duration: Titration phase of 13 weeks, if the patients showed minimal improvement or better there followed a 3 month stable dose phase. |
| Participants |
Cabergoline: 22 patients with 3 drop‐outs (14%) at end of titration phase.
Bromocriptine: 20 patients with 5 drop‐outs (25%) at end of titration phase.
Age: Cabergoline = 61.4 years (SD 6.4), Bromocriptine = 59.6 years (SD 9.6)
Hoehn and Yahr at baseline, 'On' state: Cabergoline 2.3, Bromocriptine 2.5, 'Off' state: Cabergoline 3.2, bromocriptine 3.4.
Inclusion criteria: IPD with motor fluctuations. Other dopamine agonists stopped 2 weeks prior to trial.
Exclusion criteria: Other CNS degenerative disorders, severe depression or dementia, cardiopathies, history of severe psychiatric disorder with previous dopamine agonists, renal or hepatic impairment, child bearing potential. |
| Interventions |
Drugs titrated over 13 weeks, increments applied at weekly/fortnightly intervals.
Cabergoline: initial dose = 0.5mg/d, maximum = 4.0mg/d
Bromocriptine: initial dose = 5.0mg/d, maximum = 40mg/d
Levodopa could be reduced. |
| Outcomes |
Primary: Clinicians Global Impression score (7 points)
Secondary: Off hours
UPDRS parts II and III
Hoehn and Yahr
Swab and England
Adverse Events |
| Notes |
Only data from the end of the titration phase was used in this review as patients were subsequently selected 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 |
