Drimer T, Shahal B, Barak Y. Effects of discontinuation of long-term anticholinergic treatment in elderly schizophrenia patients. International Clinical Psychopharmacology 2004;19:27-29.
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/15101567
Methods | Study design: Before-and-after study
Number of groups: One group |
Participants | Number of participants: 27 enrolled, 21 completed
Age: 65.7 years (range 60 – 78) Sex: 14 female, 13 male Inclusion criteria: · In-patient status · Diagnosis of schizophrenia (DSM-IV criteria) · Aged 60 years or older · Receiving treatment with anticholinergic medicine for 1 year or longer Exclusion criteria: · Comorbid central nervous system disorder (e.g. Parkinson’s disease, dementia, cerebrovascular accident) · Receiving treatment with other psychotropic medications possessing anticholinergic effects (e.g. tricyclic antidepressants) · Recent history of alcohol or drugs abuse · Treated with electroconvulsive therapy in the three months preceding the study Concomitant medicine: Antipsychotics · Depot-administered antipsychotics, n=4 · Orally administered antipsychotics, n=17 Duration of illness: mean 22.3 years (range 11–38 years) Country: Israel Setting: Hospital |
Interventions | Medicine: Biperiden 2–6 mg/day
Withdrawal schedule: Tapered over three days – one-third of initial dose was withdrawn daily |
Outcomes | Adverse drug withdrawal effects
Mental status Alzheimer’s Disease Assessment Scale-Cognitive sub-scale results |
Dates | Dates: Not described
Follow-up duration: 10 days |
Funding sources | Not described |
Notes |
Risk of bias table
Bias | Authors’ judgment | Support for judgment |
Random sequence generation (selection bias) | High risk | Before-and-after study |
Allocation concealment (selection bias) | High risk | Open single-arm study |
Blinding of participants and personnel (performance bias) | 5 out of 5 | Open study and one group |
Blinding of outcome assessment (detection bias) | 1 out of 5 | The assessor was blindedthough the method is not described.
“The assessment was undertaken by a blinded examiner (T.D.).” |
Incomplete outcome data (attrition bias) | 5 out of 5 | Outcomes not adequately reported – no quantitative values given. |
Selective reporting (reporting bias) | 1 out of 5 | The two statedoutcomes are reported in the paper, but not sufficientquantitativedetail. |
Confounding (non-randomized) | 5 out of 5 | There was no concurrent control group.
Did not take account of all other drugs having anticholinergic effects, types of antipsychotics used, different anticholinergic drugs e.g. biperiden has low abuse potential |
Other bias | High risk | Limited detail to assess if there are other possiblesources of bias.
Methodological flaws – see confounders above. It is impossible to be confident that the intervention was responsible for the effects seen |
Newcastle-Ottawa scale | ||
Selection bias | Representativeness of the exposed cohort | Somewhat representative of the average older adults with schizophrenia and without other central nervous conditions (excluding dementia and Parkinson’s Disease). Limited detail to assess if the cohort is truly representative. |
Selection of the non-exposed cohort | There is no concurrent control group. | |
Ascertainment of exposure | Secure records were used to ascertain exposure. | |
Demonstration that outcome of interest was not present at start of study | They demonstrated that the outcome of interest was not present at the start of thestudy. | |
Comparability bias | Comparability of cohorts on the basis of the design or analysis | The studycontrols for deprescribing medication. There was no concurrent control group. |
Outcome bias | Assessment of outcome | Outcomes assessed independently. |
Was follow-up long enough for outcomes to occur | Follow-up was probably of probably too short in duration for outcomes to occur – one or two months would be more appropriate. | |
Adequacy of follow-up of cohorts | Follow-up of participants was adequate: 78% completion and those that withdrew were adequately described. |
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