Averbuch‐Heller 1997.
Methods | Pharmacological interventions for acquired pendular and jerk nystagmus Allocation: double‐masked Masking: double‐masked Exclusions: 0 Losses: 1 Design: cross‐over RCT |
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Participants |
Country: 4 sites in USA and Germany Number of participants randomised: 21 (15 with pendular nystagmus and 6 with jerk nystagmus) Age: 25‐73 years Gender: 10 female, 11 male Aetiologies: multiple sclerosis (9), degeneration (1), cerebellar atrophy (1), stroke (5), idiopathic (2), encephalitis (1), tonsillar herniation (1), AIDS (1) Ocular motility condition: acquired pendular nystagmus and horizontal jerk nystagmus Inclusion criteria: adult nystagmus Exclusion criteria: not specified |
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Interventions |
Intervention 1: gabapentin Dose: 300 mg up to 900 mg/day Intervention 2: baclofen Dose: 10 mg up to 30 mg/day Duration: 2 weeks of intervention, 1‐2 weeks for wash‐out period, 2 weeks of intervention |
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Outcomes |
Measurements: Landolt C, eye movement recordings, perceived motion of target, drug effects by participant recall Timepoints: Baseline, 2 weeks, 4 weeks and 6 weeks Adverse events: Drug intolerance, Increased ataxia |
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Notes |
Health economic costs: not reported Quality of life measures: not reported Funding: USPHS grant E706717, Office of Research and development, Medical research Service, Department of Veteran Affairs and Evenon Arlington Fund and Deutsche Forschungsgemeinschaft Declaration of interests: Parke‐Davis Co provided transport and participant insurance fees in Germany Dates of study: not specified Trial registration ID: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomly assigned to [gabapentin or baclofen]; these drugs were administered in opaque capsules that were identical in appearance, and both the primary investigators and the patients were blinded as to their identify". Judgment comment: primary investigators were masked which suggests that the allocation was concealed. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients were randomly assigned to [gabapentin or baclofen]; these drugs were administered in opaque capsules that were identical in appearance, and both the primary investigators and the patients were blinded as to their identify". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Patients were randomly assigned to [gabapentin or baclofen]; these drugs were administered in opaque capsules that were identical in appearance, and both the primary investigators and the patients were blinded as to their identify". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 21 people were recruited and 20 completed both 2‐week test periods. The one person who dropped out did so because of an unrelated condition. |
Selective reporting (reporting bias) | Unclear risk | No access to study protocol or trials registry entry. |
Other bias | High risk |
Additional 'Risk of bias' assessment for cross‐over study Was the cross‐over design suitable: probably Was there a carry‐over effect: uncertain, no analysis done. Was only first period data available: no, first period data were not available Was the analysis correct: unclear, no estimates of effect reported Comparability of results with those from parallel‐group trials: no parallel group trials. |