Norris 1967.
Methods | Randomised, double‐blind cross‐over study of methixene vs placebo. Randomisation method not stated. 1 site (U.K.) Duration: 7 weeks, each period: 3 weeks. |
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Participants | 16 patients: 2 drop‐outs not included in report, 7 female, 7 male. Age: 47‐89 (mean: 67) years. Disease duration: not stated. Disease severity: not specified. Inclusion criteria: Persistent and marked tremor. "Aetiology varied", but not drug‐induced. |
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Interventions | Cross‐over design:
3 weeks active drug / placebo ‐ 1 week wash‐out ‐ 3 weeks placebo / active drug. Dose increased over 1 week to maximum 3 times 15 mg = 45 mg. Mean dose: apparently 45 mg in all patients. Other antiparkinsonian drugs continued, kept stable. |
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Outcomes | Tremor activity, measured with own accelerometer, measure: percentage of change. Trend in favour of mehixene, not statistically significant (p>0.1). No definite subjective difference. Neuropsychiatric AE: none. Drop‐outs: 1 unspecified AE on placebo, 1 error in randomisation. |
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Notes | Tremor only parkinsonian feature studied. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |