Norway‐Denmark 1999.
Methods | G: unknown C: central allocation Patients/doctors/assessors blind Not intention‐to‐treat | |
Participants | Norway and Denmark 163 randomised 77 to selegiline; 86 to placebo Incl: untreated idiopathic PD or levodopa < 6 months, H&Y I ‐ III Excl: age <35 or >75, dementia, psychosis, unstable diseases Baseline mean UPDRS: selegiline 37; placebo 35 | |
Interventions | Treatment: selegiline 10 mg daily Control: placebo Both groups also received levodopa Duration of treatment: up to 5 years | |
Outcomes | Deaths
UPDRS
Mean levodopa dose
Motor fluctuations Dyskinesia Withdrawals due to side‐effects Total withdrawals |
|
Notes | Mean FU: selegiline 2.9 yrs; placebo 3.1 yrs 1 month washout | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomisation was done centrally by the study monitor in each country" Comment: Probably random |
Allocation concealment (selection bias) | Low risk | Quote: "randomisation was done centrally by the study monitor in each country" Comment: Central allocation. |
Blinding (performance bias and detection bias) Doctors, All outcomes | Unclear risk | Quote: “Double‐blind” Quote: "Sealed envelopes containing the treatment code were added to the study material. The code was broken by the data analyst after the analyses were done.” Unclear if envelopes were opaque and placebo identical. |
Incomplete outcome data (attrition bias) Mortality | Low risk | Rx: 77 randomised, 73 analysed C: 86 randomised, 81 analysed 9 excluded (three protocol violations, six not deemed to have Parkinson’s disease after one year FU). Data not given by randomised group. |
Incomplete outcome data (attrition bias) Parkinsonian impairment & disability | Unclear risk | Rx: 77 randomised, 62 analysed (reason for withdrawals unclear) C: 86 randomised, 73 analysed (reasons for withdrawlas unclear) |
Incomplete outcome data (attrition bias) Participants requiring levodopa | Low risk | Outcome not assessed |
Incomplete outcome data (attrition bias) Motor fluctuations & dyskinesias | High risk | Rx: 77 randomised, 65 analysed (reasons for withdrawal not given) C; 86 randomised, 72 analysed (reasons for withdrawal not given) |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Different mean durations of FU: slightly longer in control arm (2.9 vs 3.1 yrs). Quote: “supported by Orion Pharma” |