| Methods |
Randomised, double‐blind, parallel group design.
Randomisation by computer generated random numbers.
Patients randomised 2:1, ropinirole: bromocriptine.
Intention‐to‐treat analysis.
Location: 66 sites, 11 European countries, Israel, South Africa, and Canada.
Duration: 25 weeks, titration phase maximum 13 weeks. |
| Participants |
Ropinirole: 367 patients with 68 drop‐outs (19%).
Bromocriptine: 188 patients with 36 drop‐outs (19%)
No details of terminations given.
Group B patients:
Ropinirole: 88
Bromocriptine: 51
Age (group B):
Ropinirole
63.5 years
Bromocriptine 65.1 years.
Hoehn and Yahr at baseline:
Ropinirole = 2.8
Bromocriptine = 2.9.
Inclusion criteria: IPD then divided into 3 groups:
Group A: low dose L‐dopa
Group B: high dose L‐dopa with motor complications
Group C: L‐dopa and dopamine agonists with motor complications.
Age over 30 years.
Exclusion criteria: Psychosis, dementia, severe systemic disease, history of hallucinations. |
| Interventions |
Therapy titrated over a maximum of 13 weeks, then optimal therapeutic dose maintained to end of study.
Ropinirole titrated to a maximum of 24mg/d, mean 10 mg/d.
Bromocriptine titrated to a maximum of 39.9mg/d, mean 18 mg/d.
Levodopa could be reduced. |
| Outcomes |
UPDRS motor score
Levodopa dose
On/Off charts
Clinicians global impression score (7 points)
Responders: Group A: 20% reduction in L‐dopa and 20% reduction in UPDRS.
Group B: 20% reduction in L‐dopa and 20% reduction in off time.
Group C: 20% reduction in L‐dopa and improved CGI.
Adverse events |
| Notes |
Only data from Group B (IPD with motor complications on high dose of l‐dopa) used in comparison. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
