Alprazolam para el temblor esencial
References
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en espera de evaluación
Referencias adicionales
Characteristics of studies
Characteristics of included studies [ordered by study ID]
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| Study characteristics | ||
| Methods | Randomised parallel study, double‐blind, placebo‐controlled | |
| Participants | 24 randomly assigned participants (12 alprazolam, 12 placebo); mean age 60.2 years (range 27 to 73 years); 12 men and 12 women, with baseline clinical rating of 2.17 (standard deviation (SD) 0.8) | |
| Interventions | Alprazolam vs placebo; 0.75 to 3 mg/d; follow‐up 2 weeks | |
| Outcomes | Clinical rating, investigator global assessment; participant global assessment | |
| Notes | Exclusion criteria not specified; 1‐week washout period with no other anti‐tremor medication before baseline evaluation | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Trial is described as 'randomised', but random sequence generation is not reported |
| Allocation concealment (selection bias) | High risk | Not reported |
| Blinding of participants and personnel (performance bias) | High risk | Trial is described as 'double‐blind', but blinding for participants and personnel is not reported |
| Blinding of outcome assessment (detection bias) | High risk | Presence of a blinded rater is not specified |
| Incomplete outcome data (attrition bias) | Low risk | None |
| Selective reporting (reporting bias) | Unclear risk | Numbers of adverse events in the placebo group are not reported |
| Other bias | High risk | Diagnostic criteria for essential tremor and patient exclusion and inclusion criteria are not reported; validation process of the clinical scale used to assess the primary outcome (tremor severity) is not reported; short duration of follow‐up is described |
Characteristics of excluded studies [ordered by study ID]
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| Study | Reason for exclusion |
| Non‐randomised study using neurophysiological parameters only to assess outcomes |
Characteristics of studies awaiting classification [ordered by study ID]
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| Methods | Double‐blind, cross‐over, placebo‐controlled trial |
| Participants | 22 participants randomly assigned; 19 analysed (3 dropped out before study end); mean age 51.5 years (range 18 to 83 years); 4 men and 15 women; mean tremor duration 24.2 years; baseline functional score 8.00 (standard deviation (SD) 2.36) |
| Interventions | Participants with essential tremor received, in random order, alprazolam (starting dose 0.125 mg/d), acetazolamide (starting dose 62.5 mg/d), primidone (starting dose 62.5 mg/d) and placebo for 4 weeks, with a 2‐week washout period between treatments |
| Outcomes | Functional score (including writing a sentence, drawing spirals, feeding, engaging in social activity); participant‐rated global improvement score (0 to 3) |
| Notes | Only final scores were reported (very high risk of carry‐over effect), and data from the first treatment phase after randomisation were not available. We contacted the corresponding author of this paper in an attempt to obtain further information and are still awaiting a reply |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Clinical rating scale Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | ‐0.75 [‐0.83, ‐0.67] |
| Analysis 1.1  Comparison 1: Comparison for efficacy, Outcome 1: Clinical rating scale | ||||
Flowchart of the literature search on alprazolam and essential tremor.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Comparison for efficacy, Outcome 1: Clinical rating scale
| Alprazolam for essential tremor | ||||||
| Patient or population: patients with essential tremor | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control | Alprazolam | |||||
| Tremor severity | Mean tremor severity in control groups was | Mean tremor severity in intervention group was | 24 | ⊕⊝⊝⊝ | ||
| Withdrawals due to adverse events Follow‐up: 2 weeks | None | None | 24 (1 study) | ⊕⊝⊝⊝ | ||
| Quality of life Investigator global assessment Scale from 1 to 7 Follow‐up: 2 weeks | Mean score in the control group was 3.83 points | Mean score in the intervention group was 1.16 lower (0.17 to 2.15 lower) | 24 (1 study) | ⊕⊝⊝⊝ | ||
| Quality of life Investigator global assessment Scale from 1 to 7 Follow‐up: 2 weeks | Mean score in the control group was 3.5points | Mean score in the intervention group was 0.67 lower (0.27 to 1.61 lower) | 24 (1 study) | ⊕⊝⊝⊝ | ||
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded by 2 levels for very serious risk of bias: allocation and blinding methods not described (selection bias); number of adverse events in the placebo group not reported (reporting bias); essential tremor diagnostic criteria applied to participants not reported; patient exclusion and inclusion criteria not specified. An arbitrary, not validated, clinical rating scale for tremor severity was used for assessment of tremor. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Clinical rating scale Show forest plot | 1 | 24 | Mean Difference (IV, Fixed, 95% CI) | ‐0.75 [‐0.83, ‐0.67] |
