Petrovic M, Pevernagie D, Mariman A, et al. Fast withdrawal from benzodiazepines in geriatric inpatients: a randomised double-blind, placebo-controlled trial. European Journal of Clinical Pharmacology 2002;57:759-64
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/11868796
Full text article: https://link.springer.com/article/10.1007%2Fs00228-001-0387-4
| Methods | Study design: Randomized double-blind placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 40 randomized, 26 completed
· Active deprescribing group: 20 randomized, 10 completed · Control group: 20 randomized, 16 completed Age: 81 ± 4.6 years, range 74 – 90 years Sex: 27 female, 13 male Participants with dementia: No Inclusion criteria: · Not reported Exclusion criteria: · Dementia · Severe psychiatric disorder Country: Belgium Setting: Hospital – Geriatric ward of a hospital |
| Interventions | Medicine: Benzodiazepine
Withdrawal schedule: One week of 1mg lormetazepam which was less than half the average daily benzodiazepine dose in the group Comparator: Placebo compared to continued treatment |
| Outcomes | Successful deprescribing
Pittsburgh Sleep Quality Index score Benzodiazepine Withdrawal Symptom Questionnaire |
| Dates | Dates: Not described
Follow-up duration: 12 months |
| Funding sources | Not described |
| Notes | Additional information sought, and received. |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Randomization stated, but no description. |
| Allocation concealment (selection bias) | Unclear risk | Randomization and blinding arestated, but no description of that process orallocation concealment. |
| Blinding of participants and personnel (performance bias) | Unclear risk | No description of the method.
“Administration of these compounds was randomized and double-blind.” |
| Blinding of outcome assessment (detection bias) | Unclear risk | As above |
| Incomplete outcome data (attrition bias) | High risk | Missing outcome data. Only reported intervention group results for some outcomes. |
| Selective reporting (reporting bias) | High risk | Pittsburgh Sleep Quality Index – YES Benzodiazepine Withdrawal Symptom Questionnaire – YES Difference in withdrawal toleranceNot all stated outcomes were reported for both control and intervention groups.e.g. Benzodiazepine Withdrawal Symptom Questionnaire and Pittsburgh Sleep Quality Index scores not reported with numbers (just that they were not statistically significantly different). |
| Other bias | High risk | Method described well for assessment methods, but very brief for other components.
The patients should have been stratified for diagnosis. As it was, the authors found a difference when anxiety was part of the patient’s profile, which is a primary indication for prescription of benzodiazepines. |
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