Meta AnalysisID 7637
抗胆碱酯酶药对帕金森病患者神经精神症状的作用：随机对照试验的系统评价与Meta分析方案
CRD42023465502
What is the effectiveness of anticholinesterases in treating neuropsychiatric symptoms like cognitive impairment, psychosis, and mood disorders in patients with Parkinson’s disease?
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Record Fields
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- Meta Analysis Id
- 7637
- Evidence Id
- 16195
- Core Evidence Id
- 16195
- Source Meta Analysis Id
- 7631
- Herb2 Meta Analysis Id
- HBMA007631
- Crd Id
- CRD42023465502
- Title
- Anticholinesterases for Neuropsychiatric Symptoms among Patients with Parkinson's Disease: A proposed systematic review and Meta-analysis of RCTs.
- Review Question
- What is the effectiveness of anticholinesterases in treating neuropsychiatric symptoms like cognitive impairment, psychosis, and mood disorders in patients with Parkinson’s disease?
- Study Type Included
- Only randomized controlled clinical trials comparing the efficacy of anticholinesterases will be included. RCTs are the preferred choice due to their robust design and methodological rigor. Randomly allocating participants into different groups and utilizing controlled conditions, RCTs establish causal relationships between interventions and outcomes while minimizing bias.
- Condition Being Studied
- Parkinson's disease is a complex neurological disorder primarily known for its motor symptoms, which include rest tremors, muscle rigidity, akinesia, and postural instability. These motor symptoms result from the degeneration of dopamine-producing neurons in the substantia nigra of the brain. However, the scope of PD extends well beyond the classic dopaminergic pathway, involving various neurotransmitter systems and brain regions resulting in non-motor symptoms of PD. These non-motor symptoms are diverse and play a significant role in the disease, significantly impacting the overall quality of life of individuals with PD. The spectrum of non-motor manifestations in Parkinson's disease includes sleep disturbances, autonomic dysfunction, sensory symptoms, pain, and neuropsychiatry symptoms, including cognitive decline, psychosis, depression, anxiety, apathy, and dementia
- Participant
- The inclusion criteria for this study encompass patients of any gender and age group who have been diagnosed with Parkinson's disease. Diagnosis may be based on either the clinical diagnostic criteria outlined by the UK Parkinson's Disease Society Brain Bank (UKBB) or through a clinically definite and probable Parkinson's disease diagnosis made by a healthcare professional using any of the available diagnostic tools. Additionally, the study will consider patients who have developed cognitive impairment or dementia after the Parkinson's disease diagnosis. Individuals with Parkinson's disease, irrespective of dementia, who exhibit other neuropsychiatric symptoms such as apathy, psychosis, visual hallucination, depression, or anxiety will also be included. Furthermore, the study will encompass Parkinson's patients receiving oral anticholinesterase medication and those with other comorbidities regardless of the dose.
- Animal
- Human Disease Modelled
- Intervention
- Parkinson's patients are orally administered anticholinesterase medications (rivastigmine, donepezil, galantamine) at any dose for treating neuropsychiatric symptoms, irrespective of the dose and duration of usage.
- Comparator Control
- The study will compare the intervention group of Parkinson's patients receiving orally administered anticholinesterase medications (rivastigmine, donepezil, galantamine) for neuropsychiatric symptom treatment and the placebo groups. The study will also compare anticholinesterases and active compounds, such as antipsychotics, antidepressants, anxiolytics, and medications employed in treating Alzheimer's disease for addressing neuropsychiatric symptoms.Additionally, the inclusion criteria will encompass studies involving a no-treatment group, where participants receive no specific intervention for neuropsychiatric symptoms of Parkinson’s.
- Main Outcome
- The primary efficacy outcomes to be assessed include cognition and behavioral disturbances. Changes in scores from baseline to the end of the study will serve as indicators of the drug's efficacy. Cognitive function will be gauged using established tools such as the Mini-Mental State Examination (MMSE) and the cognitive component of the Alzheimer's Disease Assessment Scale (ADAS‐Cog) Behavioral disturbances will be evaluated using the 12-item or 10-item Neuropsychiatry Inventory (NPI), or the Parkinson Psychosis Questionnaire (PPQ B) . Measures of effect The difference in mean change (MD) for or MMSE, ADAS-Cog, NPI, PPQ B and their corresponding standard deviations (SDs) between intervention and control group will be extracted from each study to be used as effect size for meta-analysis. Outcome measures will be grouped into three sections. The first group will include outcomes measured within 6 months, the second group will encompass outcomes measured between 6 months and 1 year, and the third group will consist of extension phase studies, i.e., studies beyond one year
- Outcome Measure
- Additional Outcome
- Secondary outcomes of the study will be Overall global assessment, disability, quality of life and adverse effects observed. The overall global assessment of change will be determined through the Clinician's Global Impression of Change (ADCS-CGIC or CGIC) or the Global impression of improvement, utilizing the Clinician's Interview-Based Impression of Change (CIBIC+) with input from caregivers or study partners. Disability will be quantified through the Activities of Daily Living (ADL) scale, offering insight into patients' functional independence. Additionally, the impact on the patient’s quality of life will be analyzed using the Parkinson's Disease Questionnaire (PDQ-8/39), shedding light on the treatment's influence on overall well-being. Studies that measure desired outcomes using a different questionnaire than the one mentioned above will also be included. Adverse effects in different studies will be noted down. Measures of effect The difference in mean change (MD) for or ADCS-CGI, CIBIC+, ADL, PDQ- 8/39 and their corresponding standard deviations (SDs) between intervention and control group will be extracted from each study to be used as effect size for meta-analysis.Furthermore, the safety outcomes will encompass the determination of the risk ratio in the number of adverse effect Outcome measures will be grouped into three sections. The first group will include outcomes measured within 6 months, the second group will encompass outcomes measured between 6 months and 1 year, and the third group will consist of extension phase studies, i.e., studies beyond one year
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- MeSH headings have not been applied to this record
- Contact
- Meena Kumari [email protected]
- Organisational Affiliation
- MANIPAL ACADEMY OF HIGHER EDUCATION
- Funding Source
- None Grant number(s) State the funder, grant or award number and the date of award NA
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- India
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-09-21
- Registration Date
- 2023-10-02
- Anticipated Start Date
- 2023-10-01
- Anticipated Completion Date
- 2024-06-01
- Title Cn
- 抗胆碱酯酶药对帕金森病患者神经精神症状的作用：随机对照试验的系统评价与Meta分析方案
- Title En
- Anticholinesterases for Neuropsychiatric Symptoms among Patients with Parkinson's Disease: A proposed systematic review and Meta-analysis of RCTs.
- Bilingual Status
- complete