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Anticonvulsants for behavioral and psychological symptoms in dementia: protocol for a systematic review.

ABSTRACT:

Background

Behavioral and psychological symptoms of dementia (BPSD) are present in a majority of patients with dementia contributing to increased morbidity, health care costs, and caregiver burden. While there are no United States Food and Drug Administration (FDA)-approved medications for these symptoms, off-label use of medications such as antipsychotics have been shown to have significant adverse effects including increased mortality. The goal of this review is to examine the efficacy and safety of anticonvulsants in the treatment of BPSD.

Methods

We will systematically search for randomized trials of anticonvulsants compared to placebo or other treatments such as antidepressants and antipsychotics from the following sources: The Cochrane Library, MEDLINE (OVID SP) in Process and Other Non-Indexed Citations (latest version), EMBASE, clinicalTrials.gov , and the WHO Clinical Trials Registry. The studies will be limited to those published in English but the study location can be worldwide. We will include studies pertaining to individuals with dementia and symptoms of BPSD. The primary outcomes will be behavioral change as measured by validated scales and secondary outcomes will include caregiver burden, quality of life, placement in long term care facility, serious adverse effects, and treatment discontinuation due to adverse effects. Two sets of reviewers will independently screen select and extract data. We will narratively describe the major findings and conclusions from individual studies. Patients who are prescribed antiepileptic drugs (AEDs) for other indications, including seizures, will be excluded. Outcomes of interest will include a change in a validated scale that measures BPSD, serious adverse events, and caregiver quality of life outcomes. If the data are found to be appropriate for a meta-analysis, we will use a random effects model to compute summary estimates of treatment effects.

Discussion

This is a protocol for a systematic review addressing the anticonvulsant group of medications as a whole, and as such, our results will inform current clinical practice in the use of anticonvulsants for BPSD. It will also help clinicians and policy makers compare the efficacy of anticonvulsants compared to antidepressants and antipsychotics as well as identify areas which will need further study.

Systematic review registration

PROSPERO CRD42017079826.

SUBMITTER: Benjamin S

PROVIDER: S-EPMC6525967 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundDementia is a major mental health problem worldwide, and an optimal anti-dementia drug that could modify its core symptoms has not been developed yet. Behavioral and psychological symptoms of dementia (BPSD), an important clinical manifestation of dementia, is closely related to disease burden, caregiver burden, and consequent social burden. In general, many experts and international guidelines prefer non-pharmacological interventions, including psychosocial intervention, and complementary and integrative medicine in the management of BPSD. However, in clinical settings, psychotropic drugs are frequently used; therefore, the need to establish and actively use effective non-pharmacological interventions is emphasized. Therefore, in this systematic review, we will evaluate the effectiveness and safety of acupuncture, a promising non-pharmacological complementary and integrative medicine, for BPSD.Methods and analysisA comprehensive search will be conducted in 13 electronic medical databases. Regardless of its design, original clinical studies, such as randomized controlled clinical trials, nonrandomized controlled clinical trials, and before-after studies, will be included to assess the beneficial effects and safety of acupuncture on BPSD. The severity of BPSD symptoms assessed by the validated tool will be considered as a primary outcome. The secondary outcome included the total effective rate, daily living activities and quality of life of patients, burden and quality of life of caregiver, placement in a long-term care facility from home, and safety data. The study selection, data extraction, and quality assessment process were performed by 2 independent researchers. The methodological quality of the included studies will be assessed using validated tools according to its design, such as the Cochrane Collaboration's risk of bias tool. RevMan version 5.3 will be used to perform the meta-analysis, with mean differences for continuous outcomes and risk ratio for binary outcomes, and 95% confidence intervals. A fixed- or random-effects model will be used according to the heterogeneity and number of included studies.Ethics and disseminationAs this protocol is for a systematic review, ethical approval is not required. The results of the systematic review will be disseminated by the publication of a manuscript in a peer-reviewed journal or presentation at a relevant conference.Registration numberOSF (URL: https://osf.io/hu5ac), PROSPERO (CRD42020211005) (URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020211005).

Project description:Background: Identifying the characteristics of behavioral and psychological symptoms of dementia (BPSD) associated with different dementia types may be a promising strategy to effectively deal with BPSD. We aimed to synthesize the prevalence rates of BPSD characteristics in community-dwelling dementia patients. Methods: We searched Medline, EMBASE, and PsycARTICLES databases for original clinical studies published until December 2020 that enrolled at least 300 community-dwelling dementia patients. The methodological qualities of prevalence studies were assessed using the Joanna Briggs Institute's critical appraisal checklist. Results: Thirty studies were included. The prevalence of the BPSD characteristic ranged from 4 (elation and mania) to 32% (apathy) in the pooled samples. The prevalence of delusions, anxiety, apathy, irritability, elation and mania, and aberrant motor behavior in Alzheimer's disease patients was 1.72-2.88 times greater than that in vascular dementia (VD) patients, while the prevalence of disinhibition in VD patients was 1.38 times greater. The prevalence of anxiety, irritability, and agitation and aggression, delusion, hallucinations, apathy, disinhibition, and aberrant motor behavior tended to increase as the severity of dementia increased, while that of depression, eating disorder, sleep disorders, and elation and mania tended to stable. In community-dwelling patients with dementia, the pooled prevalence of apathy, depression, anxiety, irritability, agitation and aggression, sleep disorders, and eating disorder was higher than 20%, while that of disinhibition and elation and mania was lower than 10%. Conclusion: Overall, the pooled prevalence of apathy, depression, anxiety, irritability, agitation and aggression, sleep disorders, and eating disorder was generally high in patients with dementia. Also, the prevalence of some BPSD characteristics differed according to the type and the severity of dementia. The methodological quality of the included studies is not the best, and high heterogeneity may affect the certainty of the findings. However, the results of this review can deepen our understanding of the prevalence of BPSD. Systematic Review Registration: https://osf.io/dmj7k, identifier: 10.17605/OSF.IO/DMJ7K.

Project description:Background: Dementia is a global health concern, causing serious health and socioeconomic burdens with population aging. The associated symptoms of dementia, called behavioral and psychological symptoms of dementia (BPSD), are factors contributing to the socioeconomic burden of dementia. Recently, herbal medicine (HM) has attracted attention as a potential complementary therapy for BPSD. Therefore, this systematic review was aimed at analyzing the effectiveness (or efficacy), safety, and research status of HM in BPSD management through a comprehensive review. Methods: Thirteen electronic databases were searched comprehensively. Related clinical studies published until December 28, 2020, were collected. The methodological quality was evaluated using tools such as the Cochrane Collaboration's risk of bias tool according to the study design. The effectiveness (or efficacy) was analyzed for randomized controlled trials (RCTs) only, and when sufficient homogeneity was assured, effect estimates were presented as mean difference (MD) and risk ratio (RR), with 95% confidence interval (CIs), through a meta-analysis. Results: A total of 52 clinical studies, including 36 RCTs, were included in this review. As an adjunctive therapy, HM showed statistically significant benefits in BPSD severity assessed by the Behavior Pathology in Alzheimer's Disease Rating Scale (combined with psychotropic drugs: MD = -3.48, 95% CI: -3.96 to -2.99; with anti-dementia drugs: MD = -2.81, 95% CI: -3.17 to -2.45) and Neuropsychiatric Inventory (with anti-dementia drugs: MD = -3.23, 95% CI: -4.06 to -2.40). Adverse events were significantly less frequent in the HM group (RR = 0.50; 95% CI: 0.28 to 0.88). However, the methodological quality of the RCTs included in this systematic review was not optimal overall. Conclusion: According to the findings of this review, HM may be associated with additional benefits in BPSD treatment, particularly when used as an adjunct to conventional medications, including psychotropic and anti-dementia drugs. However, considering the methodological quality of the included RCTs, this clinical evidence is not robust. Nevertheless, dementia is a global health concern, and considering the limitations of conventional psychotropic drugs for BPSD, a major cause of the disease burden, HM appears to be a promising complementary therapy that warrants further research.

Project description:BackgroundDementia is causing a huge medical and socioeconomic burden. Along with strategies to delay cognitive decline in dementia, behavioral and psychological symptoms of dementia (BPSD) are major contributing factor to the burden of dementia, and have been an important clinical issue for successful management of dementia. However, pharmacological strategies such as antipsychotics raise concerns in terms of risk-to-benefit ratio in managing BPSD. Therefore, there is a need for an effective and safe alternative in BPSD management. From this point of view, various complementary and alternative medicines (CAMs) are attracting attention in BPSD management. Therefore, the overview will make it possible to evaluate the feasibility of using CAM as a potential treatment strategy for BPSD in terms of evidence-based medicine.Methods and analysisComprehensive searching will be performed in 13 bibliographic databases from their inception dates to November 2021. Systematic reviews and/or meta-analyses that examined the effectiveness and safety of CAM modalities including herbal medicine, acupuncture, acupressure, aromatherapy, meditation, and relaxation on BPSD, will be included. The methodological quality of included reviews will be assessed by using the A MeaSurement Tool to Assess systematic Reviews-2. Two independent researchers will conduct study search, study selection, data extraction, and quality assessment processes.ResultsThe results of overview will be disseminated by the publication of a manuscript in a peer-reviewed journal or presentation at a relevant conference.ConclusionThe findings of this overview will help to solve the major public health problem related to dementia, and will provide patients with dementia, their caregivers, clinicians, and health policy makers credible evidence in mitigating the burden of dementia.Ethics and disseminationAs this protocol is for an overview of systematic reviews and meta-analyses, ethical approval is not required.Protocol registration numberOpen Science Framework registry (https://osf.io/g5f3m).

Project description:BackgroundHigh-quality clinical practice guidelines (CPGs) are important for the effective treatment of behavioral and psychological symptoms of dementia (BPSD). However, recommendations provided by different quality guidelines may lead to varied clinical practice outcomes.ObjectiveTo assess the quality of available CPGs for the management of BPSD and summarize the best recommendations for treating BPSD.MethodsThis was a systematic review of CPGs for the management of BPSD with data obtained from electronic databases and evaluated using the Appraisal of Guidelines for Research and Evaluation II instrument, consisting of six domains: "Scope and purpose", "Stakeholder involvement", "Rigor of development", "Clarity of presentation", "Applicability", and "Editorial independence". The criteria for high-quality guidelines were set as: the score of high-quality guidelines in the "Rigor of development" domain should be ≥60% and as well as a score of >60% in at least three other domains. High-quality guidelines were selected for recommendation extraction, and the final recommendations were formed in combination with the latest meta-analysis and randomized clinical-trial results.ResultsIn term of median scores in each domain for the six included CPGs, "Scope and purpose" (87.5%) scored better than all others, whereas "Applicability" (46.5%) was the domain with the lowest score. Four CPGs (2015 APA, 2018 NICE, 2018 CANADA, 2020 EAN) met the criteria of high-quality guidelines and were used to extract recommendations. From these four CPGs, nine specific recommendations related to the management of BPSD were summarized, of which seven were related to pharmacological treatment and two to non-pharmacological treatment. These recommendations covered the applicability of antipsychotic drugs, medication recommendations, withdrawal times, and several suitable non-pharmacological therapies.ConclusionThe quality of CPGs for the management of BPSD requires improvement, especially for the "Applicability" domain. For psychotic-like symptoms in dementia, the use of antipsychotics should be based on the individual's risk-benefit ratio, and the use of atypical antipsychotics seems to be a better choice. Non-pharmacological treatments may be suitable for emotional symptoms and sleep disorders.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020209204.

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