| Methods |
Randomised open parallel group design.
Method of randomisation not stated.
Data analysed on a per protocol basis.
Location: 1 site, South Korea.
Duration: 16 weeks. |
| Participants |
Ropinirole: 37 patients with 5 drop‐outs (14%).
Bromocriptine: 39 patients with 6 drop‐outs (15%). Details of terminations given.
Age: Ropinirole 63.5 (SD 10.8); Bromocriptine 60.0 (SD 8.3).
Hoehn and Yahr score at baseline: Ropinirole 2.5; Bromocriptine 2.4.
Inclusion criteria: IPD >40 years old, Hoehn & Yahr stage 2‐4, on l‐dopa with motor complications or on a dopamine agonist (not bromocripitine) as an adjunct to l‐dopa.
Exclusion criteria: Late stage advance patients, severe orthostatic hypotension, severe systemic disease, arthritis, dementia, neurosis, psychosis, history of alcoholism or drug dependancy, on > 5mg/day pergolide or lisuride, hypersensitivity or contraindications to ergot alkaloids including bromocriptine. |
| Interventions |
Therapy titrated over 8 weeks, then optimal therapeutic dose continued until end of study.
Ropinirole: Initial dose 0.75 mg/d, minimum dose 4.5 mg/d, maximum dose 9mg/d.
Bromocriptine: Initial dose 1.25mg/d, minimum dose 10mg/d, maximum dose 17.5mg/d.
L‐dopa reduction allowed after optimal dose of study drug achieved. |
| Outcomes |
Primary: >20% reduction in l‐dopa.
Secondary: reduction in l‐dopa.
>20% increase in UPDRS motor score.
>20% reduction in off hours.
Improvement in CGI
Adverse events. |
| Notes |
1 drop‐out in bromocriptine group due to lack of efficacy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
