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. 2002 Jul 22;2002(3):CD003735. doi: 10.1002/14651858.CD003735

Cantello 1986.

Methods Randomised, double‐blind cross‐over study of bornaprine vs placebo.
Randomisation method not stated.
Setting: 1 site (Italy).
Duration: 2 months, each period: 30 days.
Participants 30 patients: 17 female, 13 male.
Age: 50‐70 (mean: 65) years.
Disease duration: not stated.
Disease severity: 14 patients H&Y II, 13: III, 2: IV, 1: V.
Inclusion criteria: IPD with tremor; age 35‐70; stable dose of L‐dopa or bromocriptine "without adequate control of symptoms". 
 Exclusion criteria: Glaucoma, gastrointestinal stenosis, myocardial infarction in previous year, hyperkinetic cardiac arrhythmias, mental deterioration.
Interventions Cross‐over design: 
 30 days drug / placebo ‐ 30 days placebo / drug.
No wash‐out period.
Drug titrated to maximum of 12 mg/day if tolerated. Length of titration period not stated.
Mean dose: 8.25 mg/day (SD 2.8).
L‐dopa and /or bromocriptine kept stable, doses not stated. Other antiparkinsonian drugs allowed, not specified.
Outcomes Webster scale: 
 ‐ Tremor: most marked improvement: from 2.48 baseline to 1.18 on drug and 2.00 on placebo; both: p<0.01. 
 ‐Bradykinesia, rigidity, posture, facial expression, seborrhea, coping ability: all significantly (p<0.05) improved on drug; on placebo: less marked, but significant.
Subjective assessment by patients and investigators: 
 ‐Efficacy: significant (p<0.01) difference in favour of bornaprine. 
 ‐Tolerability: no significant difference.
Neuropsychiatric AE: 
 ‐Drug: "psychic disturbance" in 1 patient, insomnia in 2. 
 Placebo: none.
Drop‐outs: 3, failure to attend; allocation not stated.
Notes Not intention‐to‐treat.
No wash‐out period.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear