| Methods |
Randomised double‐blind parallel group design.
Randomised according to a computer generated randomisation list. Patients received progressive randomistion numbers according to their temporal entry into the study.
Method of data analysis unclear.
Location: 5 sites, Spain.
Duration: 6‐10 week titration period followed by a 4 week stable dose period (on 3‐4mg/day) if the patient had a >30% reduction in off hours. |
| Participants |
Cabergoline: 23 patients with 5 drop‐outs (22%)
Placebo: 20 patients with 6 drop‐outs (30%)
Details of terminations given.
Mean age of patients, cabergoline 60 (SD8.9), placebo 62 (SD10.2).
Inclusion criteria: IPD with motor fluctuations on l‐dopa, l‐dopa stable for 4 weeks, no other dopamine agonist for 4 weeks.
Exclusion criteria: Other CNS or degenerative disorders, severe depression or dementia, cardiopathies, history of psychiatric disturbances on other dopamine agonists, renal or hepatic impairment, child‐bearing potetial. |
| Interventions |
Cabergoline initial dose 0.75mg/d. For 6 Cabergoline & 9 placebo; titrated over 6 weeks to a maximum of 2mg/d. For 12 cabergoline & 5 placebo; titrated over 10 weeks to maximum of 3mg/d.
L‐dopa reduction allowed but only occured in 3 cabergoline and 1 placebo patient |
| Outcomes |
Primary: >30% reduction in off hours
Secondary: UPDRS, all subsections
Schwab & England
Hoehn & Yahr
Adverse events |
| Notes |
Only data to end of titration phase used as after that the population was selected for those who responded to the Cabergoline.
Allowed withdrawals due to lack of efficacy after titration phase. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
