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. 2005 Jul 20;2005(3):CD004898. doi: 10.1002/14651858.CD004898.pub2

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
Interventions Treatment: selegiline 5 mg twice a day
Control: no selegiline 
 Both groups received levodopa 
 Mean mortality FU: 9.2 years
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"