PARJUPAR 1996.
| Methods | G: Random number table C: central allocation of numbered medication packages in each centre Patients/doctors/assessors blind Not intention‐to‐treat | |
| Participants | Portugal 92 randomised patients included (exact number randomised unclear) 47 to selegiline and bromocriptine; 45 to bromocriptine Incl: untreated idiopathic PD, H&Y I ‐ II, age 30‐75 yrs Excl: severe tremor, depression Baseline mean UPDRS: seleg & bromo 31, bromo 31 | |
| Interventions | Treatment: selegiline 10 mg daily plus bromocriptine up to 30 mg daily Control: Bromocriptine up to 30 mg daily Duration of treatment: mean 1.7 yrs | |
| Outcomes | Deaths Time to levodopa & levodopa requirement Withdrawals due to side‐effects Total withdrawals | |
| Notes | Mean FU: 1.7 years (max 3 yrs) No washout | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "a table of random numbers, blocked in units of six" |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation was centralised. The centres received numbered medication packages". |
| Blinding (performance bias and detection bias) Doctors, All outcomes | Unclear risk | Quote: “Placebo were used in a double‐dummy way”. Unclear if identical placebos. |
| Incomplete outcome data (attrition bias) Mortality | Unclear risk | Unclear how many patients randomised in each group. 165 patients randomised in total to three groups (one group not eligible for this review) but 20 not analysed because had not reached time for first assessment and six excluded post‐randomisation because failed inclusion/exclusion criteria. No details given for which groups these patients were in. Rx: at least 47 randomised, 41 analysed: six lost to FU C: at least 45 randomised, 44 analysed: 1 lost to FU |
| Incomplete outcome data (attrition bias) Parkinsonian impairment & disability | Low risk | Not assessed |
| Incomplete outcome data (attrition bias) Participants requiring levodopa | Unclear risk | Rx: at least 47 randomised, 29 analysed: six lost to FU, 12 withdrawals (10 adverse events, 2 protocol violations) C: at least 45 randomised, 30 analysed: one lost to FU, 14 withdrawals (10 adverse events, 4 protocol violations) One year requirements estimated from Kaplan Meier curves |
| Incomplete outcome data (attrition bias) Motor fluctuations & dyskinesias | Low risk | Outcome not assessed |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | Low risk | |