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 |