METHODS AND ANALYSIS: This 12-week randomised double-blind, placebo-controlled, parallel-group study aims to evaluate the efficacy of the standardised water extract of EL known as Physta in increasing the quality of life of perimenopausal and postmenopausal women. The study involves 150 women aged 40-55 years who score more than 61 on the Menopause-Specific Quality of Life (MENQOL) assessment. These participants will be randomised into three groups, receiving Physta at either 50 mg or 100 mg or a placebo. The outcomes measures include mood state, quality of life, fatigue, sleep quality, sexual function and pain score assessed using Profile of Mood State, MENQOL, Chalder Fatigue Scale, Pittsburgh Sleep Quality Index, Female Sexual Function Index and the Brief Pain Inventory questionnaires, respectively. The secondary outcome of the study includes full blood analysis, urine analysis, female reproductive hormone profiling, inflammatory and oxidative stress biomarkers analysis.
ETHICS AND DISSEMINATION: The research protocol of the study was reviewed and approved by the Research Ethics Committee of Universiti Kebangsaan Malaysia (UKM/PPI/111/8/JEP-2021-898). The findings will be disseminated to participants, healthcare professionals and researchers via conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER: ACTRN12622001341718.
MATERIALS AND METHODS: Full-text articles of case report, case control, cohort and cross-sectional studies that were published from 1st January 2012 until 30th June 2022, were searched using PubMed, CINAHL and Scopus. Periodontal related diseases were excluded in this review due to its wellknown associated disease with P. gingivalis. A comparison studies of detection methods were also excluded in this review.
RESULTS: Out of 612 articles that were screened, only 106 met the eligibility criteria to be selected for further review. Risk of bias was performed using FEAT principles and reviewers' discussion. A total of 21 final articles that were reviewed showed significant correlation with P. gingivalis and were classified into several clinical domains. Twelve out of 13 detection methods showed high sensitivity and specificity with short duration analysis.
CONCLUSION: Due to asymptomatic periodontal disease and the high prevalence of P. gingivalis-associated clinical diseases, this review suggests the need for oral public health awareness and early screening for the bacterium detection especially among elderly groups to maintain their quality of life.
MATERIALS AND METHODS: The present study is a retrospective cohort study using hospital medical records (patient files) from October 2019 to November 2021 (for 2 years). This study was performed in Malaysian women (n=53) suffering from advanced stages of POP, in which Gellhorn pessaries of diameter (44-76mm) were inserted by trained personnel. Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) were used to measure patients' symptoms and quality of life before and after Gellhorn pessary fitting. Patients were reassessed every three months for two years and their satisfaction scores were recorded.
RESULTS: We observed a significant difference in pre-test (pre-fitting) and post-test (three months post-fitting) scores on all three subscales and the PFIQ-7 total score. Twentyeight (52.83%) patients continued the use of Gellhorn pessary for at least 24 months, whereas 25 (47.20%) patients discontinued during this period. A retrospective analysis of the patients who discontinued Gellhorn pessary showed that 13 (24.52%) patients gave up the use of pessary for definitive surgery. It is noteworthy to mention here that only one out of the 13 patients who were awaiting surgery, chose surgery and the remaining 12 changed their mind after being fitted with the Gellhorn pessary. Seven (13.20%) patients declined reinsertion due to discomfort and voiding difficulties and refused further intervention, whereas three (5.66%) patients requested a ring pessary. Two (3.77%) patients, requested the removal of pessary due to vesicovaginal fistula and rectovaginal fistula (caused by an impacted pessary). The rate of continued use was 79.24% (42 patients) after 1st year and 52.83% (28 patients) at the end of two years.
CONCLUSION: In the current study, the Gellhorn pessary was used to treat stage 3 and 4 POP with significant symptom reduction post-fitting. More than half of the patients continued to use the pessary after 24 months of fitting. Therefore, the Gellhorn pessary can be used as a treatment strategy for stage 3 and 4 POP with reasonable acceptance in the Malaysian population.
METHODS: A cross-sectional study was conducted to establish a psychometric instrument validation. A total of 389 participants aged 55 years and above were included. The study was conducted in Sarawak, Malaysia, from November 2021 to January 2022 in two phases, translation of the PMT Scale, cross-cultural adaptation, face validation and pre-testing of the PMT Scale. The participants were selected using multistage random sampling in a primary healthcare clinic. Data entry and statistical analysis were performed using IBM SPSS version 26 for exploratory factor analysis and SmartPLS version 3.3.7 for confirmatory factor analysis using partial least square structural equation modelling.
RESULTS: The Kaiser-Meyer-Olkin value was 0.760, Bartlett's sphericity test was significant and the total variance explained was 61%. It identified 31 items within eight dimensions of the Protection Motivation Theory scale. The Higher Order Constructs' measurement model indicates that the convergent and discriminant validity were established (Cronbach's alpha and composite reliability: ≥ 0.740; average variance extracted: 0.619 to 0.935 and Henseler's Heterotrait-Monotrait criterion for all constructs' discriminant validity:
METHODS: This multicentre, randomised, placebo-controlled, phase 2b trial was done at 60 hospitals and clinics in 20 countries. Eligible study participants were aged between 12 and 75 years with a documented history of GPP as per the European Rare and Severe Psoriasis Expert Network criteria, with a history of at least two past GPP flares, and a GPP Physician Global Assessment (GPPGA) score of 0 or 1 at screening and random assignment. Patients were randomly assigned (1:1:1:1) to receive subcutaneous placebo, subcutaneous low-dose spesolimab (300 mg loading dose followed by 150 mg every 12 weeks), subcutaneous medium-dose spesolimab (600 mg loading dose followed by 300 mg every 12 weeks), or subcutaneous high-dose spesolimab (600 mg loading dose followed by 300 mg every 4 weeks) over 48 weeks. The primary objective was to demonstrate a non-flat dose-response curve on the primary endpoint, time to first GPP flare.
FINDINGS: From June 8, 2020, to Nov 23, 2022, 157 patients were screened, of whom 123 were randomly assigned. 92 were assigned to receive spesolimab (30 high dose, 31 medium dose, and 31 low dose) and 31 to placebo. All patients were either Asian (79 [64%] of 123) or White (44 [36%]). Patient groups were similar in sex distribution (76 [62%] female and 47 [38%] male), age (mean 40·4 years, SD 15·8), and GPP Physician Global Assessment score. A non-flat dose-response relationship was established on the primary endpoint. By week 48, 35 patients had GPP flares; seven (23%) of 31 patients in the low-dose spesolimab group, nine (29%) of 31 patients in the medium-dose spesolimab group, three (10%) of 30 patients in the high-dose spesolimab group, and 16 (52%) of 31 patients in the placebo group. High-dose spesolimab was significantly superior versus placebo on the primary outcome of time to GPP flare (hazard ratio [HR]=0·16, 95% CI 0·05-0·54; p=0·0005) endpoint. HRs were 0·35 (95% CI 0·14-0·86, nominal p=0·0057) in the low-dose spesolimab group and 0·47 (0·21-1·06, p=0·027) in the medium-dose spesolimab group. We established a non-flat dose-response relationship for spesolimab compared with placebo, with statistically significant p values for each predefined model (linear p=0·0022, emax1 p=0·0024, emax2 p=0·0023, and exponential p=0·0034). Infection rates were similar across treatment arms; there were no deaths and no hypersensitivity reactions leading to discontinuation.
INTERPRETATION: High-dose spesolimab was superior to placebo in GPP flare prevention, significantly reducing the risk of a GPP flare and flare occurrence over 48 weeks. Given the chronic nature of GPP, a treatment for flare prevention is a significant shift in the clinical approach, and could ultimately lead to improvements in patient morbidity and quality of life.
FUNDING: Boehringer Ingelheim.
METHODS: An international cross-sectional study was conducted in 30 countries across six World Health Organization regions from July 2020 to August 2021, with 16 512 adults self-reporting changes in 18 lifestyle factors and 13 interim health outcomes since the pandemic.
RESULTS: Three networks were computed and tested. The central variables decided by the expected influence centrality were consumption of fruits and vegetables (centrality = 0.98) jointly with less sugary drinks (centrality = 0.93) in the lifestyles network; and quality of life (centrality = 1.00) co-dominant (centrality = 1.00) with less emotional distress in the interim health outcomes network. The overall amount of exercise had the highest bridge expected influence centrality in the bridge network (centrality = 0.51). No significant differences were found in the network global strength or the centrality of the aforementioned key variables within each network between males and females or health workers and non-health workers (all P-values >0.05 after Holm-Bonferroni correction).
CONCLUSIONS: Consumption of fruits and vegetables, sugary drinks, quality of life, emotional distress, and the overall amount of exercise are key intervention components for improving overall lifestyle, overall health and overall health via lifestyle in the general population, respectively. Although modifications are needed for all aspects of lifestyle and interim health outcomes, a larger allocation of resources and more intensive interventions were recommended for these key variables to produce the most cost-effective improvements in lifestyles and health, regardless of gender or occupation.
AIM: The study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol-rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.
METHODS: We conducted a 12 weeks, prospective, open-label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM-2019-274 (NMMR-19-1588-49234).
RESULTS: Thirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week-12, significant reduction of investigator global assessment (63.4%), Patient-Oriented Scoring Atopic Dermatitis Index (PO-SCORAD) (65%), and SCORAD (52.3%) was noted (p Life Index and Children's Dermatology Life Quality Index were found to improve significantly compared to baseline (p
METHODS: We did a systematic review and meta-analysis to evaluate characteristics associated with symptomatic benefit of testosterone treatment versus placebo in men aged 18 years and older with a baseline serum total testosterone concentration of less than 12 nmol/L. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and the Cochrane Central Register of Controlled Trials) and clinical trial registries for reports published in English between Jan 1, 1992, and Aug 27, 2018. Anonymised individual participant data were requested from the investigators of all identified trials. Primary (cardiovascular) outcomes from this analysis have been published previously. In this report, we present the secondary outcomes of sexual function, quality of life, and psychological outcomes at 12 months. We did a one-stage individual participant data meta-analysis with a random-effects linear regression model, and a two-stage meta-analysis integrating individual participant data with aggregated data from studies that did not provide individual participant data. This study is registered with PROSPERO, CRD42018111005.
FINDINGS: 9871 citations were identified through database searches. After exclusion of duplicates and publications not meeting inclusion criteria, 225 full texts were assessed for inclusion, of which 109 publications reporting 35 primary studies (with a total 5601 participants) were included. Of these, 17 trials provided individual participant data (3431 participants; median age 67 years [IQR 60-72]; 3281 [97%] of 3380 aged ≥40 years) Compared with placebo, testosterone treatment increased 15-item International Index of Erectile Function (IIEF-15) total score (mean difference 5·52 [95% CI 3·95-7·10]; τ2=1·17; n=1412) and IIEF-15 erectile function subscore (2·14 [1·40-2·89]; τ2=0·64; n=1436), reaching the minimal clinically important difference for mild erectile dysfunction. These effects were not found to be dependent on participant age, obesity, presence of diabetes, or baseline serum total testosterone. However, absolute IIEF-15 scores reached during testosterone treatment were subject to thresholds in patient age and baseline serum total testosterone. Testosterone significantly improved Aging Males' Symptoms score, and some 12-item or 36-item Short Form Survey quality of life subscores compared with placebo, but it did not significantly improve psychological symptoms (measured by Beck Depression Inventory).
INTERPRETATION: In men aged 40 years or older with baseline serum testosterone of less than 12 nmol/L, short-to-medium-term testosterone treatment could provide clinically meaningful treatment for mild erectile dysfunction, irrespective of patient age, obesity, or degree of low testosterone. However, due to more severe baseline symptoms, the absolute level of sexual function reached during testosterone treatment might be lower in older men and men with obesity.
FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.
CONCLUSIONS: We have provided an overview of current evidence and expert-agreed recommendations for the definition, investigation, and management of OD. As for our original Position Paper, we hope that this updated document will encourage clinicians and researchers to adopt a common language, and in so doing, increase the methodological quality, consistency, and generalisability of work in this field.
METHODS: A cross-sectional online survey was carried out among all pharmacy staff in public healthcare facilities throughout Sarawak. Burnout was measured using the Copenhagen Burnout Inventory. Multiple logistic regression analysed demographic and work characteristics associated with burnout. Open-ended replies on burnout causes, impact, coping strategies and employer's role were coded and thematically analysed.
KEY FINDINGS: A total of 329 responses were received. The prevalence of personal, work and patient-related burnout was 54.7, 47.1 and 35.3%, respectively. Respondents facing problems with child support were 8.26 and 3.62 times more likely to suffer from personal and work-related burnout. Working in areas with potential exposure to COVID-19 patients increased the odds of patient and work-related burnout by 2.80 and 1.86 times, respectively. Burnout symptoms affected their quality of life; nevertheless, self-reported coping strategies were mostly positive. Respondents emphasised the need for organisational interventions, including increased resource allocation, better workload distribution and promotion of work-life balance, to mitigate burnout.
CONCLUSIONS: A significant percentage of public sector pharmacy staff continue to experience burnout two years into the pandemic. Regular well-being assessments and supportive policies are recommended to help them cope with increased stress. Additional training for supervisors may be necessary to effectively manage staff and workload during a pandemic.
METHODS: This retrospective, cross-sectional analysis included adults with T2DM from 11 Asian countries/regions prospectively enrolled in the Joint Asian Diabetes Evaluation (JADE) Register (2007-2019) with available EuroQol-5D (EQ-5D-3L) data.
RESULTS: Of 47,895 included patients, 42,813 were treated with OGLDs + lifestyle modifications (LSM) and 5,082 with LSM only. Among those treated with OGLDs, 60% received sulphonylureas (SUs), of whom 47% received gliclazide. The OGLD + LSM group had a lower mean EQ-5D-3L index score than the LSM-only group (p
METHODS: A cross-sectional study design was conducted on 162 breast cancer survivors from various breast cancer support groups in Malaysia. Psychological distress status was assessed based on depression and anxiety scores by applying the Malay version of Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder (GAD-7). Both instruments were self-administered along with a set of questionnaires comprising demographic, medical history, quality of life, and upper extremity function assessment. Outcomes from the PHQ-9 and GAD-7 were analyzed for severity level of psychological distress, and its association with relevant variables, arm morbidity symptoms, as well as the duration of cancer survivorship.
RESULTS: The univariate analysis showed that breast cancer survivors with arm morbidities after breast surgery had a higher score of depression (5.0 vs 4.0, p = 0.011) and anxiety (3.0 vs 1.0, p = 0.026) than those who did not. Besides that, receiving fewer post-rehabilitation treatments (p = 0.049) and having a family history of cancer (p = 0.022) were correlated with higher anxiety level. The level of depression and anxiety was inversely proportionate with quality of life and positively correlated with greater disability of the arm function (p
METHODOLOGY: The Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed (1985-January 2022) and trial registries for relevant randomised clinical trials were used. Relevant and published randomised clinical trials were reviewed and evaluated. The primary outcomes were anthropometry measurements, which were weight, waist circumference, body mass index (BMI), and body fat percentages. The secondary outcomes were changes in quality of life, psychological impact, lipid profile measurement, presence of adverse events, and changes in blood pressure and blood glucose. We assessed the data for risk of bias, heterogeneity, sensitivity, reporting bias, and quality of evidence.
RESULTS: 15 studies are included, involving 1161 participants. The analysis performed is based on three comparisons. For the first comparison between yoga and control, yoga reduces the waist circumference (MD -0.84, 95% CI [-5.12 to 3.44]), while there is no difference in body weight, BMI, or body fat percentages. In the second comparison between yoga and calorie restriction, yoga reduces body weight (MD -3.47, 95% CI [-6.20 to -0.74]), while there is no difference in waist circumference, BMI, or body fat percentage. In the third comparison between yoga and exercise, yoga reduces the body weight (MD -7.58, 95% CI [-11.51 to -3.65]), while there is no difference in waist circumference or BMI. For the secondary outcomes, yoga intervention reduces total cholesterol (MD -17.12, 95% CI [-32.24 to -2.00]) and triglycerides (MD -21.75, 95% CI [-38.77 to -4.73]) compared to the control group, but there is no difference compared to the calorie restriction and exercise group. There is no difference in the rest of the outcomes, which are LDL, HDL, quality of life, psychological impact, adverse events, blood pressure, and blood glucose. However, findings are not robust due to a high risk of bias and low-quality evidence.
CONCLUSION: From our review, there were methodological drawbacks and very low to moderate quality of evidence across all comparisons, and hence, it is inconclusive to say that yoga can significantly improve anthropometric parameters. More well-designed trials are needed to confirm and support the beneficial effects of yoga.
SUMMARY: Cockroach allergy is an important risk factor for allergic rhinitis in the tropics, that disproportionately affects children and young adults and those living in poor socio-economic environments. Immunotherapy would provide long-lasting improvement in quality of life, with reduced medication intake. However, the present treatment regime is long and has a risk of adverse effects. In addition, cockroach does not seem to have an immuno-dominant allergen, that has been traditionally used to treat allergies from other sources. Future trends of cockroach immunotherapy involve precision diagnosis, to correctly identify the offending allergen. Next, precision immunotherapy with standardized allergens, which have been processed in a way that maintains an immunological response without allergic reactions. This approach can be coupled with modern adjuvants and delivery systems that promote a Th1/Treg environment, thereby modulating the immune response away from the allergenic response.
METHODS: A cross-sectional study involving translation and validation of the English version of EBPQ. The original questionnaire, contained 51 items extracted into six domains was translated in Malay using forward and backward translation, pre-tested and validated among conveniently sampled female healthcare personnel. Vegetarians, pregnant ladies and women in confinement were excluded due to special daily dietary plans. Construct validity, reliability and feasibility were analyzed using Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA).
RESULTS: During translation, item modifications were made and subjected to field testing among 394 women. The original questionnaire was used as a reference to identify the positioning of items in constructs. Fifteen items were removed due to poor correlation with items within constructs. Seven factors were extracted using Varimax rotation with Kaiser-Meyer-Olkin (KMO) value range from 0.725-0.872 and significant Bartlett's test of Sphericity (p