Tabloski PA, Cooke KM, Thoman EB. A procedure for withdrawal of sleep medication in elderly women who have been long-term users. Journal of gerontological nursing 1998;24:20-8; quiz 50-1.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/9814275
| Methods | Study design: Open-label randomized placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 20 randomized
· Active deprescribing group: 10 randomized · Control group: 10 randomized Age: 77.5 ± 7.9 years, range 64 to 91 years Sex: 20 female, 0 male Participants with dementia: No Inclusion criteria: · Female · Chronic user of sleep medication (used sleeping or sedating medication at least five nights per week for a period of at least six months) Exclusion criteria: · Centrally-acting drugs such as antidepressants, antihistamines for allergies, beta-blockers, narcotic pain relievers, and neuroleptic medications Concomitant medicines: Various including antihypertensives, diuretics, digitalis, non-steroidal anti-inflammatory agents, and anti-ulcer drugs Country: United States of America Setting: Community – recruited from regional senior citizens’ centers |
| Interventions | Medicine: Diphenhydramine 25mg n=2, diphenhydramine 50mg n=1, lorazepam 0.5mg n=2, lorazepam 1mg n=2, flurazepam 30mg n=1, nortriptyline 20mg n=1, triazolam 0.125mg n=1
Withdrawal schedule: Week 1: Dose reduced by half Week 2: Cease Comparator: Placebo compared to continued treatment Method to identify targets: Patient-specific intervention Investigator-led intervention: Intervention by the researchers who identified deprescribing targets and undertook the deprescribing process Tool to identify deprescribing targets: pre-specified list of medications |
| Outcomes | Sleep complaints
Time in Bed (minutes) Sleep latency (minutes) Total Sleep Time (minutes) Sleep (minutes) Sleep Efficiency (score) Longest Sleep Period (minutes) Number of wakes Wake After Sleep Onset (minutes) |
| Dates | Dates: Not described
Follow-up duration: Five weeks |
| Funding sources | University of Connecticut Research Foundation |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | “Then the subjects were randomly assigned to either a drug withdrawal group or a non-drug withdrawal group.” |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) | High risk | Placebos were provided,but these were not identical to their sleep medications.
“using a placebo capsule instead of a nightly sleeping pill.” “During the 2 weeks of total withdrawal, the subjects in the drug withdrawal group were provided with transparent sugar-filled gelatin capsules, with the instruction to take one each night before bedtime in lieu of their habitual sleeping pill. Because there were no brittle diabetics in the study, a small gelatin capsule was filled with 1/16 of a teaspoon of sugar. This inert capsule was designed to enable the subjects to preserve the bedtime ritual of pill taking. They were told of the contents of the capsule and that it might or might not affect their sleep.” “These statements were made despite the fact that the subjects were told very precisely that there was only sugar in the small capsules.” |
| Blinding of outcome assessment (detection bias) | High risk | As above |
| Incomplete outcome data (attrition bias) | Low risk | It appears to be 100% follow-up. |
| Selective reporting (reporting bias) | Unclear risk | There was no evidence of a pre-specified protocol, so it is uncertain if the authors followed a pre-specified data-analysis plan. However, the stated objectives are reported. |
| Other bias | Low risk |
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