Tham TCK, Brown H, Taggart HM. Temazepam Withdrawal in Elderly Hospitalized-Patients – a Double-Blind Randomized Trial Comparing Abrupt Versus Gradual Withdrawal. Irish Journal of Medical Science 1989;158:294-96.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/2576423
Full text article: https://link.springer.com/article/10.1007%2FBF02942077
| Methods | Study design: Randomized double-blind placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 36 randomized, 31 completed
· Abrupt deprescribing group: 15 completed · Titrated deprescribing group: 16 completed Age: 81.7 ± 7.1 years, range 69 to 98 years Sex: 26 female, 5 male Participants with dementia: Unclear. Mild to moderate confusion for 70% of participants Inclusion criteria: Not described Exclusion criteria: Not described Country: Ireland Setting: Hospital – All patients in the Geriatric Medical Unit of the Belfast City Hospital |
| Interventions | Medicine: Temazepam
Withdrawal schedule and comparator: · Abrupt withdrawal (switched straight to a placebo for 10 days) · Gradual withdrawal (5mg temazepam for 4 days, 2mg temazepam for 4 days, placebo for 2 days) |
| Outcomes | Hours of sleep
Number of times awake |
| Dates | Dates: Not described
Follow-up duration: 17 days |
| Funding sources | Not disclosed |
| Notes | Limited detail |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Not described
“Patients were then randomized to either abrupt or gradual withdrawal of temazepam.” |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | Unclear risk | Text states that a placebo was used, but no additional information given.
“The patients in the abrupt withdrawal group were given placebo for 10 days while those in the gradual withdrawal group were given temazepam 5 mg for 4 days, 2mg for 4 days and then placebo for 2 days. The temazepam and placebo tablets were supplied by Farmitalia Carlo Erba.” |
| Blinding of outcome assessment (detection bias) | Unclear risk | As above |
| Incomplete outcome data (attrition bias) | High risk | Outcomes are assessed “as-treated” rather than intention-to-treat. The risk of bias is increased as: (a) we are not told which group the five drop-outs were in. (b) the drop-outs were “2 refused their medication most nights due to confusion and three were discharged from hospital earlier than expected”. It is plausible that these reasons are potentially related to the intervention. |
| Selective reporting (reporting bias) | Low risk | No pre- published protocol available. The stated objective was straight forward, and the outcome reported. |
| Other bias | Unclear risk | As thioridazine 12.5mg could have been given, its use should have been reported. Only one patient was mentioned as having required thioridazine,but this was in the context of no sleep at all. It was not stated how many patients required thiroidazine overall. Since this drug can be used for insomnia, this is an important possible confounding factor |
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