UK‐PDRG 2001.
Methods | G: random number tables C: central allocation Patients/doctors/assessors all unblinded Intention‐to‐treat | |
Participants | UK
520 randomised
271 to selegiline; 249 to control Incl: untreated idiopathic PD with incapacity requiring dopaminergic treatment Excl: dementia, previously failed to respond to dopaminergic drugs Baseline mean WRS: selegiline 11; control 11 |
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Interventions | Treatment: selegiline 5 mg twice a day Control: no selegiline Both groups received levodopa Mean mortality FU: 9.2 years |
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Outcomes | Deaths Mean levodopa dose Motor fluctuations Dyskinesias Withdrawals due to side‐effects Total withdrawals | |
Notes | Mean FU: 9.2 yrs (11.4 yrs for mortality) No washout | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "random number tables" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was carried out by an independent coordinator" Quote: "the investigators telephoned the coordinator for the treatment code, which was subsequently confirmed in writing." |
Blinding (performance bias and detection bias) Doctors, All outcomes | High risk | Quote: “An open, randomised trial” Comment: Not blinded. Unlikely to bias mortality data but may influence other more subjective outcomes. |
Blinding (performance bias and detection bias) Patients, All outcomes | High risk | |
Blinding (performance bias and detection bias) Outcome assessors, All outcomes | High risk | |
Incomplete outcome data (attrition bias) Mortality | Low risk | Rx: 271 randomised, 267 analysed (four lost to mortality FU) C: 249 randomised, 243 analysed (six lost to mortality FU) |
Incomplete outcome data (attrition bias) Parkinsonian impairment & disability | Low risk | Outcome not included in this review (assessed using Webster rating scale not UPDRS) |
Incomplete outcome data (attrition bias) Participants requiring levodopa | Low risk | Outcome not assessed |
Incomplete outcome data (attrition bias) Motor fluctuations & dyskinesias | Low risk | Rx: 271 randomised, 268 analysed (as rate per 1,000 person‐yrs FU). C: 249 randomised, 240 analysed (as rate per 1,000 person‐yrs FU) |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Different mean durations of FU: slightly longer in selegiline arm (3.8 vs 3.4 yrs). Quote: "sponsorship from Britannia Pharmaceuticals and Sandoz Products" |