Ruths S, Straand J, Nygaard HA, et al. Effect of antipsychotic withdrawal on behavior and sleep/wake activity in nursing home residents with dementia: a randomized, placebo‐controlled, double‐blinded study The Bergen District Nursing Home Study. Journal of the American Geriatrics Society 2004;52(10):1737-43.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/15450054
Ruths S, Straand J, Anygaard H, et al. Stopping antipsychotic drug therapy in demented nursing home patients: a randomized, placebo-controlled study––The Bergen District Nursing Home Study (BEDNURS). International Journal of Geriatric Psychiatry 2008;23(9):889–95-89–95.
PubMed link:https://www.ncbi.nlm.nih.gov/pubmed/18306150
Full text article: https://onlinelibrary.wiley.com/doi/abs/10.1002/gps.1998
| Methods | Study design: Randomized double-blind placebo-controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 30 randomized, 30 completed
· Active deprescribing group: 15 randomized, 15 completed · Control group: 15 randomized, 15 completed Age: 83.4 ± 6.9 years Sex: 24 female, 6 male Participants with dementia: All (inclusion criteria) Inclusion criteria: · Taking antipsychotic medications (risperidone, olanzapine, or haloperidol) for non-psychotic indications for at least 3 months before the study as standing medication and in stable dose · Aged 65 and older · Dementia diagnosis according to the clinical criteria of International Classification of Diseases, 10th Revision · Residence in the facility for at least 3 months before inclusion to ensure that nursing staff knew the patients well enough to assess their symptoms Exclusion criteria: · Antipsychotics prescribed for a primary diagnosis of major psychotic disorder · Mental retardation · Terminal illness with life expectancy judged to be shorter than 3 months · Recent major changes in health status Country: Norway Setting: Residential aged care facilities – nine facilities in Norway |
| Interventions | Medicine: Antipsychotics – duration of use an average 14 months (range 3–44)
· Typical antipsychotics (haloperidol, n=4) · Atypical antipsychotics (olanzapine n=4, risperidone n=22) Withdrawal schedule: Abrupt discontinuation Comparator: Placebo compared to continued treatment |
| Outcomes | Medication use
Sleep / Wake Activity Neuropsychiatric Index |
| Dates | Dates: September and October 2002
Follow-up duration: Four weeks |
| Funding sources | Not described |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | An independent researcher randomly assigned the study participants to antipsychotic withdrawal (intervention group) or continued antipsychotic drug treatment (reference group). |
| Allocation concealment (selection bias) | Low risk | Assignment was achieved using random permuted-blocks of four. Randomization was concealed to patients, NH staff, and the research team. Sealed envelopes, containing details of study medication for all patients, were available in case of serious health events. All envelopes remained unopened until the end of the study. |
| Blinding of participants and personnel (performance bias) | Low risk | For four consecutive weeks, the intervention group received inert placebo drugs consisting of lactose. To ensure double blindness, study medications (placebo and antipsychotics) were administered as identical-looking capsules and given at the same dose and frequency as baseline antipsychotics. |
| Blinding of outcome assessment (detection bias) | Low risk | As above |
| Incomplete outcome data (attrition bias) | Low risk | There does not appear to be missing data. However, it is an intention-to-treat analysis.
Two people lost from follow-up for each group. The reasons for drop-outs are not given. |
| Selective reporting (reporting bias) | Low risk | Outcomes described are reported on. The outcomes are not described in much detail, so it makes it difficult to tell if they are all reported on. However, there are no obvious exclusions from the paper. |
| Other bias | High risk | Combining of data from typical and atypical antipsychotics could potentially blur the outcomes.
This study assumes that the three antipsychotics studied are equal and that the non-psychotic reasons for prescription are equal. The differences between drugs are substantial. Analysis between drugs should have done. Reasons for prescription should also be discriminated. |
Leave a Reply