OBJECTIVES: To assess the clinical effects, including adverse effects, of galantamine in people with probable or possible Alzheimer's disease or mild cognitive impairment, and to investigate potential moderators of effect.
SEARCH METHODS: We systematically searched the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 14 December 2022 using the term 'galantamine'. The Register contains records of clinical trials identified from major electronic databases (including CENTRAL, MEDLINE, and Embase), trial registries, grey literature sources, and conference proceedings. We manually searched reference lists and collected information from US Food and Drug Administration documents and unpublished trial reports. We imposed no language restrictions.
SELECTION CRITERIA: We included double-blind, parallel-group, randomised controlled trials comparing oral galantamine with placebo for a treatment duration exceeding four weeks in people with dementia due to Alzheimer's disease or with mild cognitive impairment.
DATA COLLECTION AND ANALYSIS: Working independently, two review authors selected studies for inclusion, assessed their quality, and extracted data. Outcomes of interest included cognitive function, change in global function, activities of daily living, functional disability, behavioural function, and adverse events. We used a fixed-effect model for meta-analytic synthesis, and presented results as Peto odds ratios (OR) or weighted mean differences (MD) with 95% confidence intervals. We used Cochrane's original risk of bias tool (RoB 1) to assess the risk of bias in the included studies.
MAIN RESULTS: We included 21 studies with a total of 10,990 participants. The average age of participants was 74 years, and 37% were male. The studies' durations ranged from eight weeks to two years, with 24 weeks being the most common duration. One newly included study assessed the effects of galantamine at two years, and another newly included study involved participants with severe Alzheimer's disease. Nineteen studies with 10,497 participants contributed data to the meta-analysis. All studies had low to unclear risk of bias for randomisation, allocation concealment, and blinding. We judged four studies to be at high risk of bias due to attrition and two due to selective outcome reporting. Galantamine for dementia due to Alzheimer's disease We summarise only the results for galantamine given at 8 to 12 mg twice daily (total galantamine 16 mg to 24 mg/day), assessed at six months. See the full review for results of other dosing regimens and assessment time points. There is high-certainty evidence that, compared to placebo, galantamine improves: cognitive function, as assessed with the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) (MD-2.86, 95% CI -3.29 to -2.43; 6 studies, 3049 participants; minimum clinically important effect (MCID) = 2.6- to 4-point change); functional disability, as assessed with the Disability Assessment for Dementia (DAD) scale (MD 2.12, 95% CI 0.75 to 3.49; 3 studies, 1275 participants); and behavioural function, as assessed with the Neuropsychiatric Inventory (NPI) (MD -1.63, 95% CI -3.07 to -0.20; 2 studies, 1043 participants) at six months. Galantamine may improve global function at six months, as assessed with the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus) (OR 1.58, 95% CI 1.36 to 1.84; 6 studies, 3002 participants; low-certainty evidence). Participants who received galantamine were more likely than placebo-treated participants to discontinue prematurely (22.7% versus 17.2%) (OR 1.41, 95% CI 1.19 to 1.68; 6 studies, 3336 participants; high-certainty evidence), and experience nausea (20.9% versus 8.4%) (OR 2.89, 95% CI 2.40 to 3.49; 7 studies, 3616 participants; high-certainty evidence) during the studies. Galantamine reduced death rates at six months: 1.3% of participants in the galantamine groups had died compared to 2.3% in the placebo groups (OR 0.56, 95% CI 0.33 to 0.96; 6 studies, 3493 participants; high-certainty evidence). Galantamine for mild cognitive impairment We summarise results, assessed at two years, from two studies that gave participants galantamine at 8 to 12 mg twice daily (total galantamine 16 mg to 24 mg/day). Compared to placebo, galantamine may not improve cognitive function, as assessed with the expanded ADAS-cog for mild cognitive impairment (MD -0.21, 95% CI -0.78 to 0.37; 2 studies, 1901 participants; low-certainty evidence) or activities of daily living, assessed with the Alzheimer's Disease Cooperative Study - Activities of Daily Living scale for mild cognitive impairment (MD 0.30, 95% CI -0.26 to 0.86; 2 studies, 1901 participants; low-certainty evidence). Participants who received galantamine were probably more likely to discontinue prematurely than placebo-treated participants (40.7% versus 28.6%) (OR 1.71, 95% CI 1.42 to 2.05; 2 studies, 2057 participants) and to experience nausea (29.4% versus 10.7%) (OR 3.49, 95% CI 2.75 to 4.44; 2 studies, 2057 participants), both with moderate-certainty evidence. Galantamine may not reduce death rates at 24 months compared to placebo (0.5% versus 0.1%) (OR 5.03, 95% CI 0.87 to 29.10; 2 studies, 2057 participants; low-certainty evidence). Results from subgroup analysis and meta-regression suggest that an imbalance in discontinuation rates between galantamine and placebo groups, together with the use of the 'last observation carried forward' approach to outcome assessment, may potentially bias cognitive outcomes in favour of galantamine.
AUTHORS' CONCLUSIONS: Compared to placebo, galantamine (when given at a total dose of 16 mg to 24 mg/day) slows the decline in cognitive function, functional ability, and behaviour at six months in people with dementia due to Alzheimer's disease. Galantamine probably also slows declines in global function at six months. The changes observed in cognition, assessed with the ADAS-cog scale, were clinically meaningful. Gastrointestinal-related adverse events are the primary concerns associated with galantamine use in people with dementia, which may limit its tolerability. Although death rates were generally low, participants in the galantamine groups had a reduced risk of death compared to those in the placebo groups. There is no evidence to support the use of galantamine in people with mild cognitive impairment.
METHODS: The translation, validation, and reliability assessment process followed guidelines from the World Health Organization, with adaptations from Sousa and Rojjanasrirat's recommendations. The process encompassed five steps: forward translation, harmonisation of the forward translation, backward translation, pretesting and cognitive interviews, and psychometric testing to assess the validity and reliability.
RESULTS: The Malay version of the MOQ (MOQ-M) demonstrated excellent item-level face validity index (I-FVI) and average scale-level face validity index (S-FVI/Ave), both scoring a perfect 1.00. Additionally, it exhibited excellent item-level content validity index (I-CVI) and average scale-level content validity (S-CVI/Ave), with scores ranging from 0.90 to 1.00 and 0.99 to 1.00, respectively. Internal consistency, measured using Cronbach's alpha, surpassed the minimum threshold for good reliability, with all three average scales in MOQ-M scoring between 0.84 and 0.99. Weighted average Cohen's Kappa coefficient revealed substantial agreement in the test-retest reliability across the three scales.
CONCLUSION: The MOQ-M is a valid and reliable instrument for assessing meaningful time use among Malay-speaking older persons in Malaysia.
CONSUMER AND COMMUNITY INVOLVEMENT: There was no consumer and community involvement in this study.
PLAIN LANGUAGE SUMMARY: This study aimed to translate the Modified Occupational Questionnaire (MOQ) into Bahasa Melayu (MOQ-M). The MOQ is a tool used by occupational therapists to understand how unemployed people spend their time and the reasons they are doing it. The translation was necessary because the original version of the MOQ was developed in an English-speaking country and might not be suitable for the Malay-speaking population in Malaysia due to cultural differences. A careful process was followed to make sure the translation was accurate and reliable. The translated version, MOQ-M, was then tested with older persons, most of whom were unemployed, to learn about their daily activities and the reasons for doing them. Understanding their daily routines is important for predicting their health and well-being. The results showed that the MOQ-M worked well, providing useful and consistent information. This means that the tool is reliable and can be trusted to measure how older persons spend their time and what activities are important to them. With this information, programmes can be created to better support older persons, helping them live healthier and happier lives as they age. However, it is important to note that most of the study participants were Malay, so this may not fully represent the different cultural groups in Malaysia.
METHODS: This is a 12-week, multicenter, randomized controlled trial involving 70 community-dwelling older adults aged 60-75, recruited from three Pusat Aktiviti Warga Emas (PAWE) (Activity Center for Older Adults) in the Northern region of Malaysia. Participants will be randomized to either the intervention group, receiving the PTICOPE module workbook and guided use, or the control group, receiving general IC information, healthcare education, and self-care management. The recruitment of participants for this study has not yet commenced. Recruitment is expected to start after completing the validation of the PTICOPE module, however, it is anticipated that the recruitment start date is in February 2025 and will end in August 2025. Primary outcomes, including locomotor, psychological, cognitive, vitality, visual, and hearing functions using validated scales, will be collected at baseline, 4th, 8th, and 12th week of the study period. Secondary outcomes will evaluate QoL, activities of daily living, urogenital health, and oral health at baseline and 12th week. The normality of data will be checked. The independent t-tests, Chi-square tests, paired t-tests, and Repeated measures ANOVA will be used for data analysis, with a significant level at p
METHODS: In this cross-sectional study, caregivers of adult PWE attending the neurology outpatient clinic at Hospital Canselor Tuanku Muhriz (HCTM) completed a comprehensive questionnaire comprising demographic data of participants and care recipients (adult PWE). Epilepsy-related data were obtained from the interview and medical records. Affiliate stigma among caregivers was assessed using Affiliate Stigma Scale (ASS), and psychological impacts were evaluated using Depression Anxiety Stress Scale 21 (DASS-21). The level of caregiver burden was evaluated with Zarit Burden Interview (ZBI).
RESULTS: A total of 119 caregivers participated in the study, and 35.2 % of them reported mild to moderate burden. The factors most strongly associated with higher caregiver burden were female caregivers, needs for assistance in activities of daily living (ADL), frequent seizures, polypharmacy, and affiliate stigma among caregivers. A statistically significant positive correlation was seen between caregiver burden and psychological impacts of depression (r 0.522, p
MATERIALS AND METHODS: Data were used from the Well-being of the Singapore Elderly (WiSE) study, a nationally representative, cross-sectional survey among Singapore residents aged 60 years and above. Caregiver dependence was ascertained by asking the informant (the person who knows the older person best) a series of open-ended questions about the older person's care needs.
RESULTS: The older adult sample comprised 57.1% females and the majority were aged 60 to 74 years (74.8%), while 19.5% were 75 to 84 years, and 5.7% were 85 years and above. The prevalence of caregiver dependence was 17.2% among older adults. Significant sociodemographic risk factors of caregiver dependence included older age (75 to 84 years, and 85 years and above, P <0.001), Malay and Indian ethnicity (P <0.001), those who have never been married (P = 0.048) or have no education (P = 0.035), as well as being homemakers or retired (P <0.001). After adjusting for sociodemographic variables and all health conditions in multiple logistic regression analyses, dementia (P <0.001), depression (P = 0.011), stroke (P = 0.002), eyesight problems (P = 0.003), persistent cough (P = 0.016), paralysis (P <0.001), asthma (P = 0.016) and cancer (P = 0.026) were significantly associated with caregiver dependence.
CONCLUSION: Various sociodemographic and health-related conditions were significantly associated with caregiver dependence. Dependent older adults will put greater demands on health and social services, resulting in greater healthcare expenditures. Hence, effective planning, services and support are crucial to meet the needs of dependent older adults and their caregivers.
DESIGN: Cross-sectional study.
SETTING: Three public primary care clinics in a district in Selangor, Malaysia.
PARTICIPANTS: Registered patients aged 55 years and above.
MEASUREMENTS: A face-to-face interview was conducted using a validated questionnaire of Medical Outcome Study 36-item short form health survey (SF-36). The outcome measure was the health related quality of life (HRQoL) and other factors measured were socio demography, physical activity, social support (Duke-UNC Functional Social Support Questionnaire), and presence of non-communicable diseases.
RESULTS: A total of 347 participants had non-communicable diseases which included hypertension (41.8%), type 2 diabetes (33.7%), asthma (4.8%), hyperlipidaemia (1.7%), coronary heart disease (1.2%), and osteoarthritis (0.2%). Age ≥ 65 years old (OR =2.23; 95%CI=1.42, 3.50), single (OR=1.75; 95%CI=1.06,2.90), presence of co-morbid condition (OR=1.66; 95%CI=1.06, 2.61), and poorer social support (OR=2.11; 95%CI=1.27, 3.51; p=0.002) were significant predictors of poorer physical component of HRQoL . In predicting lower mental health component of HRQoL, the significant predictors were women (OR=2.28; 95%CI=1.44, 3.62), Indian ethnicity (OR=1.86; 95%CI=1.08, 3.21) and poorer social support (OR=2.71; 95%CI=1.63, 4.51). No interactions existed between these predictors.
CONCLUSION: Older people with non-communicable diseases were susceptible to lower health related quality of life. Increasing age, single, presence of co-morbid conditions, and poorer social support were predictors of lower physical health component of HRQoL. While the older women, Indian ethnicity and poorer social support reported lower mental health component of HRQoL.
METHODS: The English version of Catquest-9SF questionnaire was translated and back translated into Malay and Chinese languages. The Malay and Chinese translated versions were self-administered by 236 and 202 pre-operative patients drawn from a cataract surgery waiting list, respectively. The translated Catquest-9SF data and its four response options were assessed for fit to the Rasch model.
RESULTS: The Catquest-9SF performed well in the Malay and Chinese translated versions fulfilling all criteria for valid measurement, as demonstrated by Rasch analysis. Both versions of questionnaire had ordered response thresholds, with a good person separation (Malay 2.84; and Chinese 2.59) and patient separation reliability (Malay 0.89; Chinese 0.87). Targeting was 0.30 and -0.11 logits in Malay and Chinese versions respectively, indicating that the item difficulty was well suited to the visual abilities of the patients. All items fit a single overall construct (Malay infit range 0.85-1.26, outfit range 0.73-1.13; Chinese infit range 0.80-1.51, outfit range 0.71-1.36), unidimensional by principal components analysis, and was free of Differential Item Functioning (DIF).
CONCLUSIONS: These results support the good overall functioning of the Catquest-9SF in patients with cataract. The translated questionnaire to Malay and Chinese-language versions are reliable and valid in measuring visual disability outcomes in the Malaysian cataract population.
DESIGN: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis.
PARTICIPANTS: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included.
INTERVENTION: Participants were randomly allocated to one of two groups at 4 (SD 1) days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions). The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions) for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks.
OUTCOME MEASURES: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded.
RESULTS: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI -0.2 to 2.3) and 12 weeks (MD 0.4, 95% CI -0.9 to 1.6) postoperatively. There were no statistically significant between-group differences in secondary outcomes.
CONCLUSION: Modified (ie, less restrictive) sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with traditional or modified sternal precautions.
TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN12615000968572. [Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D (2018) Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. Journal of Physiotherapy 64: 97-106].
METHODS: A parallel-group unblinded randomized controlled trial involving 300 patients was conducted in two hospital orthopedics clinics in Malaysia. Patients were randomly assigned to receive cognitive behavioral-based group therapy (n = 150) or no further intervention (n = 150). The primary outcome was the change from baseline in knee pain as determined by the Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 months. The data collected were analyzed by covariate-adjusted mixed design repeated measures analysis of variance. All analyses were performed under the terms of intention-to-treat.
RESULTS: At 6 months, mean change from baseline in the KOOS knee pain score was 0.6 points (95% CI -1.73 to 2.94) in the control group and 8.9 points (95% CI 6.62 to 11.23) (denoting less knee pain intensity) in the intervention group (significant treatment effect p < 0.0001). Patients treated with such an approach also experienced significant improvement in functional ability when performing activities of daily living and had improved ability to cope with depression, anxiety and pain catastrophizing.
CONCLUSION: The intervention module delivered by healthcare professionals had a sustained effect on knee OA pain and functionality over 6 months, thereby leading to an overall improvement in psychological well-being, thus benefitting most of the Malaysian knee OA patients.
METHODS: A total of 110 hospitalized geriatric patients aged 60 years and older were selected using convenience sampling method in a cross-sectional study. Sociodemographic data and medical history were obtained from the medical records. Questionnaires were used during the in-person semistructured interviews, which were conducted in the wards. Linear regression analyses were used to determine the predictors of each domain of quality of life.
RESULTS: Multiple regression analysis showed that activities of daily living, depression, and appetite were the determinants of physical health domain of quality of life (R(2)=0.633, F(3, 67)=38.462; P<0.001), whereas depression and instrumental activities of daily living contributed to 55.8% of the variability in psychological domain (R(2)=0.558, F(2, 68)=42.953; P<0.001). Social support and cognitive status were the determinants of social relationship (R(2)=0.539, F(2, 68)=39.763; P<0.001) and also for the environmental domain of the quality of life (R(2)=0.496, F(2, 68)=33.403; P<0.001).
CONCLUSION: The findings indicated different predictors for each domain in the quality of life among hospitalized geriatric patients with diabetes mellitus. Nutritional, functional, and psychological aspects should be incorporated into rehabilitation support programs prior to discharge in order to improve patients' quality of life.