Mortality Rates and a Clinical Predictive Model for the Elderly on Maintenance Hemodialysis: A Large Observational Cohort Study of 17,354 Asian Patients.

INTRODUCTION: Mortality following hemodialysis initiation may influence the decision to initiate hemodialysis in elderly patients. Our objective is to demonstrate mortality following hemodialysis initiation in elderly patients (≥70 years) and to derive a prediction risk score based on clinical and laboratory indicators to determine risk of all-cause mortality in patients aged ≥80 years. METHODS: We identified elderly patients (≥70 years) who initiated maintenance hemodialysis between January 2005 and December 2016 using data from the Thai Renal Replacement Therapy (TRT) registry. The mortality rate was determined based on age categories. A predictive risk score for all-cause mortality was created for 4,451 patients aged ≥80 years by using demographics, laboratory values, and interview-based parameters. Using a flexible parametric survival analysis, we predicted mortality 3 months, 6 months, 1 year, 5 years, and 10 years after hemodialysis initiation. RESULTS: 17,354 patients (≥70 years) were included, mean age 76.9 ± 5.1 years, 46.5% male, and 6,309 (36.4%) died. Patients aged <80 years had a median survival time of 110.6 months. A 9-point risk score was developed to predict mortality in patients aged ≥80 years: age >85 years, male, body mass index <18.5 kg/m2, hemoglobin <10.0 g/dL, albumin <3.5 g/dL, substantial assistance required in daily living (1 point each), and Karnofsky Performance Status (KPS) score <50 (3 points). C-statistic of 0.797 indicated high model discrimination. Internal validation demonstrated good agreement between observed and anticipated mortalities. CONCLUSIONS: Hemodialysis is appropriate for patients aged 70-80 years. A risk score for mortality in patients aged ≥80 years has been developed. The score is based on seven readily obtainable and evaluable clinical characteristics.

Psychometric evaluation of the multidimensional Uraemic Pruritus in Dialysis patients (UP-Dial) scale: comparison of haemodialysis and peritoneal dialysis patients with chronic pruritus.

BACKGROUND: High-quality patient-reported outcome (PRO) measures for dialysis patients with chronic pruritus are urgently needed. However, no known, well-validated multidimensional tools have been investigated to measure pruritus symptoms in dialysis patients. OBJECTIVES: To examine the psychometric properties of a multidimensional tool of chronic pruritus, the Uraemic Pruritus in Dialysis patients (UP-Dial) 14-item scale, by comparing haemodialysis and peritoneal dialysis modality. METHODS: This validation study used data from the Thai Renal Outcomes Research-Uraemic Pruritus, a prospective, multicentre, longitudinal study. Data for this study were collected from 1 February 2019 to 31 May 2022. The adult sample of 226 haemodialysis and 327 peritoneal dialysis patients fulfilled the criteria of chronic pruritus based on the International Forum for the Study of Itch. Psychometric properties of the UP-Dial included validity and reliability, as measured across haemodialysis and peritoneal dialysis patients. Patients completed a set of anchor-based measurement tools, including global itching, Dermatology Life Quality Index (DLQI), EuroQoL-5 dimension-5 level (EQ-5D-5L), Kidney Disease Quality of Life-36 (KDQOL-36), Pittsburgh Sleep Quality Index (PSQI), global fatigue, Somatic Symptom Scale-8 (SSS-8) and Patient Health Questionnaire-9 (PHQ-9). RESULTS: From the patient's perspective, face validity was satisfactory for both dialysis samples. Psychometric analyses of the UP-Dial for each dialysis sample had good convergent validity. Spearman rho correlations indicate a positively strong correlation (0.73-0.74) with global itching, a positively moderate correlation (0.33-0.58) with DLQI, PSQI, global fatigue, SSS-8 and PHQ-9, and a negatively moderate correlation (-0.39 to -0.58) with EQ-5D-5L and KDQOL-36. The discriminant validity was satisfactory with a group of moderate and severe burden of pruritus for both dialysis samples. For scale reliability, the UP-Dial revealed excellent internal consistency (Cronbach's α = 0.89 and McDonald's ω = 0.90) and reproducibility (intraclass correlation 0.84-0.85) for both dialysis samples. Regarding psychometric properties, no statistically significant differences between dialysis samples were observed (all P > 0.05). CONCLUSIONS: The findings reaffirm good measurement properties of the UP-Dial 14-item scale in haemodialysis and peritoneal dialysis patients with chronic pruritus. These suggest a transferability of the UP-Dial as a PRO measure in clinical trial and practice settings.

Itch is a common symptom in chronic kidney disease, especially for people experiencing end-stage kidney disease and receiving dialysis. Itching among dialysis patients can present and affect any part of the body. Although there has been improvement in dialysis treatment over time, chronic itching (itching lasting more than 6 weeks) remains under-recognized in dialysis patients. In recent years, a specific clinical tool called the Uraemic Pruritus in Dialysis patients (UP-Dial) has been developed to assess the severity and burden of itching in dialysis patients. However, a comprehensive tool for evaluating itching symptoms has yet to be tested in a large dialysis population (haemodialysis and peritoneal dialysis). We examined and validated the measurement properties of the UP-Dial scale in an adult sample of 226 haemodialysis and 327 peritoneal dialysis patients with chronic itching. Our study found that the UP-Dial had good measurement properties for evaluating the burden of itching symptoms among haemodialysis and peritoneal dialysis patients with chronic itching. Our findings support the use of UP-Dial to compare treatments for chronic itching clinical trials and track treatment responses in daily practice.

Survival rates in comprehensive conservative care compared to dialysis therapy in elderly end-stage kidney disease patients: a propensity score analysis.

Initiating dialysis therapy in elderly patients with end-stage kidney disease (ESKD) is a challenging decision. We aimed to examine the mortality rates among elderly patients who underwent hemodialysis, peritoneal dialysis, or comprehensive conservative care. This retrospective cohort study included elderly patients (≥70 years) with ESKD who selected their treatment options from January 2008 to December 2018. Patients were categorized into three groups: hemodialysis, peritoneal dialysis, and comprehensive conservative care. The outcome of interest was all-cause mortality analyzed using flexible parametric survival models. Propensity score analysis with inverse probability treatment weighting technique was performed, incorporating age, Charlson Comorbidity Index score, and estimated glomerular filtration rate. The study included 719 elderly ESKD patients with mean age of 78.2 ± 4.9 years, 52.3% were male, and 60.1% died during the median follow-up period of 22.1 months. In a fully adjusted model, patients receiving comprehensive conservative care (n = 50) had higher mortality rates than those receiving hemodialysis (n = 317) (adjusted hazard ratio [HR] 5.60; 95% CI 2.26-13.84, p < 0.001). However, patients who received peritoneal dialysis (n = 352) had a similar mortality rate when compared to those who received hemodialysis (adjusted HR 1.38; 95% CI 0.78-2.44, p = 0.275). The higher mortality rate in the comprehensive conservative care group remained significantly higher than in the hemodialysis group among patients aged ≥80 years (adjusted HR 4.97; 95% CI 1.32-18.80, p = 0.018). Among elderly patients (≥70 years), treatment with dialysis was associated with longer survival rates. This survival advantage persisted in patients aged ≥80 years who chose hemodialysis or peritoneal dialysis over comprehensive conservative care.

Cost-effectiveness analysis of pharmacist interventions in patients with heart failure in Thailand.

INTRODUCTION: Patients with heart failure (HF) are likely to have multiple diseases with complex therapy regimens. Pharmacist intervention in HF treatment can reduce all-cause mortality and hospitalization, but the economic outcome is not known. OBJECTIVE: This study aimed to assess the cost-effectiveness of pharmacist contribution in HF setting compared with usual care. METHODS: A decision analytical model was developed to estimate the cost and outcome from a health care system perspective in Thailand. Clinical inputs were obtained from literature review. Pharmacist costs, hospitalization cost for HF, risk of hospitalization death, risk of nonhospitalization death, and readmission rate were based on data from Thailand. The cost and outcome were discounted at 3% annually. OUTCOME MEASURES: The incremental cost-effectiveness ratio (ICER) was calculated and presented for the year 2020. A series of sensitivity analysis was also performed. RESULTS: Pharmacist intervention incurred higher total costs than usual care, because total cost of pharmacists was 186,040 THB (5936 USD) whereas usual care cost was 151,654 THB (4839 USD). It also provided more quality-adjusted life years (QALYs) than usual care, from 2.4 to 2.8. In addition, patient life years (LY) were increasing from 3.3-3.8. This yielded an ICER of 77,398 THB/LY (2467 USD/LY) or 103,037 THB/QALYs (3288 USD/QALYs). This ICER is considered to be cost-effective at the willingness-to-pay level of 160,000 THB/QALY (5191.87 USD). CONCLUSION: At this current situation in Thailand, pharmacists may represent good value for the nation's limited health care resources. The information should be used in national policies to plan for pharmacist work force implementation and production line in the near future.

Association of job loss, income loss, and financial burden with adverse mental health outcomes during coronavirus disease 2019 pandemic in Thailand: A nationwide cross-sectional study.

BACKGROUND: Economic crises during the coronavirus disease (COVID-19) pandemic severely impacted mental health outcomes. However, there is limited evidence on this issue in Thailand. We aimed to evaluate the association of economic burden during the first phase of the pandemic and the risk of adverse mental health outcomes in the Thai population. METHODS: We recruited 2,303 participants aged 18 years or above with employment/full-time jobs before the national lockdown in April-May 2020. The measures of economic burden were job loss, income loss, and financial problems related to the outbreak. The outcomes included depressive symptoms, anxiety, and perceived stress. The association between economic burden and adverse mental health outcomes was evaluated using multivariable logistic regression models. RESULTS: Individuals who lost their jobs during the COVID-19 pandemic had a higher risk of perceived stress compared to those who maintained their job (adjusted odds ratio [OR], 2.40; 95% confidence interval [CI], 1.28-4.51; p = .006). A higher risk of anxiety was observed in individuals with a monthly income loss of 50% (adjusted OR, 1.42; 95% CI, 1.03-1.99; p = .035; individuals without income loss, reference group) or over. Self-reported financial problems were significantly associated with adverse mental health outcomes (nonexperienced financial problems, reference group): Adjusted ORs of 1.84 (95% CI, 1.34-2.51; p < .001) for depressive symptoms, 2.00 (95% CI, 1.48-2.71; p < .001) for anxiety, and 2.12 (95% CI, 1.51-2.95; p < .001) for perceived stress. CONCLUSIONS: Economic burden, especially self-reported financial problems, was associated with adverse mental health outcomes. However, long-term studies are needed to address the mental health consequences of COVID-19 and economic downturns.

Exposure to COVID-19-Related Information and its Association With Mental Health Problems in Thailand: Nationwide, Cross-sectional Survey Study.

BACKGROUND: The COVID-19 pandemic has had a negative impact on both the physical and mental health of individuals worldwide. Evidence regarding the association between mental health problems and information exposure among Thai citizens during the COVID-19 outbreak is limited. OBJECTIVE: This study aimed to explore the relationship between information exposure and mental health problems during the COVID-19 pandemic in Thailand. METHODS: Between April 21 and May 4, 2020, we conducted a cross-sectional, nationwide online survey of the general population in Thailand. We categorized the duration of exposure to COVID-19-related information as follows: <1 h/day (reference group), 1-2 h/day, and ≥3 h/day. Mental health outcomes were assessed using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 scale, the Perceived Stress Scale-10, and the Insomnia Severity Index for symptoms of depression, anxiety, perceived stress, and insomnia, respectively. Multivariable logistic regression models were used to evaluate the relationship between information exposure and the risk of developing the aforementioned symptoms. An ancillary analysis using multivariable multinomial logistic regression models was also conducted to assess the possible dose-response relationship across the severity strata of mental health problems. RESULTS: Of the 4322 eligible participants, 4004 (92.6%) completed the online survey. Of them, 1481 (37.0%), 1644 (41.1%), and 879 (22.0%) participants were exposed to COVID-19-related information for less than 1 hour per day, 1 to 2 hours per day, or 3 or more hours per day, respectively. The major source of information related to the COVID-19 pandemic was social media (95.3%), followed by traditional media (68.7%) and family members (34.9%). Those exposed to information for 3 or more hours per day had a higher risk of developing symptoms of depression (adjusted odds ratio [OR] 1.35, 95% CI 1.03-1.76; P=.03), anxiety (adjusted OR 1.88, 95% CI 1.43-2.46; P<.001), and insomnia (adjusted OR 1.52, 95% CI 1.17-1.97; P=.001) than people exposed to information for less than 1 hour per day. Meanwhile, people exposed to information for 1 to 2 hours per day were only at risk of developing symptoms of anxiety (adjusted OR 1.35, 95% CI 1.08-1.69; P=.008). However, no association was found between information exposure and the risk of perceived stress. In the ancillary analysis, a dose-response relationship was observed between information exposure of 3 or more hours per day and the severity of mental health problems. CONCLUSIONS: These findings suggest that social media is the main source of COVID-19-related information. Moreover, people who are exposed to information for 3 or more hours per day are more likely to develop psychological problems, including depression, anxiety, and insomnia. Longitudinal studies investigating the long-term effects of COVID-19-related information exposure on mental health are warranted.

Efficacy of Furosemide, Oral Sodium Chloride, and Fluid Restriction for Treatment of Syndrome of Inappropriate Antidiuresis (SIAD): An Open-label Randomized Controlled Study (The EFFUSE-FLUID Trial).

RATIONALE & OBJECTIVE: First-line therapy for syndrome of inappropriate antidiuresis (SIAD) is fluid restriction. Additional treatment for patients who do not respond to fluid restriction are water restriction with furosemide or water restriction with furosemide and salt supplementation. However, the efficacy of these treatments has never been tested in a randomized controlled study. The objective of this study was to investigate whether, combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation was more effective than fluid restriction alone in the treatment of hyponatremia in SIAD. STUDY DESIGN: Open-label randomized controlled study. SETTING & PARTICIPANTS: Patients with serum sodium concentrations ([Na+]) ≤ 130mmol/L due to SIAD. INTERVENTION(S): Random assignment to 1 of 3 groups: fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl). Strictness of fluid restriction (<1,000 or<500mL/d) was guided by the urine to serum electrolyte ratio. Furosemide dosage was 20 to 40mg/d. NaCl supplements were 3g/d. All treatments were continued for 28 days. OUTCOMES: The primary outcome was change in [Na+] at days 4, 7, 14, and 28 after randomization. RESULTS: 92 patients were recruited (FR, n=31; FR+FM, n=30; FR+FM+NaCl, n=31). Baseline [Na+] was 125±4mmol/L, and there were no significant differences between groups. Mean [Na+] on day 4 in all treatment groups was significantly increased from baseline by 5mmol/L (P<0.001); however, the change in [Na+] was not significantly different across groups (P=0.7). There was no significant difference in percentage of patients or time to reach [Na+] ≥ 130 or≥135mmol/L across the 3 groups. Acute kidney injury and hypokalemia (potassium≤3.0mmol/L) were more common in patients receiving furosemide. LIMITATIONS: Open-label treatment. CONCLUSIONS: In patients with SIAD, furosemide with NaCl supplement in combination with fluid restriction did not show benefits in correction of [Na+] compared with treatment with fluid restriction alone. Incidences of acute kidney injury and hypokalemia were increased in patients receiving furosemide. FUNDING: None. TRIAL REGISTRATION: Registered at the Thai Clinical Trial Registry with study number TCTR20170629004.

The association between proton pump inhibitor use and the risk of adverse kidney outcomes: a systematic review and meta-analysis.

Background: Existing epidemiological studies illustrate that proton pump inhibitors (PPIs) may be related to adverse kidney outcomes. To date, no comprehensive meta-analysis has been conducted to evaluate and quantify this association. Methods: We performed a systematic review and meta-analysis of studies to assess the association between PPI use and the risk of adverse kidney outcomes. We searched MEDLINE, Embase, SCOPUS, Web of Science, CINAHL, Cochrane Library and grey literature with no language restrictions (through 31 October 2016). Adverse kidney outcomes were acute interstitial nephritis (AIN), acute kidney injury (AKI), chronic kidney disease (CKD) and end-stage renal disease (ESRD). The risk ratios (RRs) and confidence intervals (CIs) were pooled using a random effects model. The strength of evidence (SOE) for each outcome was assessed using the Grading of Recommended Assessment, Development and Evaluation system. Results: Of 2037 identified studies, four cohort and five case-control studies with ∼2.6 million patients were included. Of these, 534 003 (20.2%) were PPI users. Compared with non-PPI users, PPI users experienced a significantly higher risk of AKI [RR 1.44 (95% CI 1.08-1.91); P = 0.013; SOE, low] and CKD [RR 1.36 (95% CI 1.07-1.72); P = 0.012; SOE, low]. Moreover, PPIs increased the risk of AIN [RR 3.61 (95% CI 2.37-5.51); P < 0.001; SOE, insufficient] and ESRD [RR 1.42 (95% CI 1.28-1.58); P < 0.001; SOE, insufficient]. Conclusion: PPI usage was associated with adverse kidney outcomes; however, these findings were based on observational studies and low-quality evidence. Additional rigorous studies are needed for further clarification.

Effect of iron supplementation during early pregnancy on the development of gestational hypertension and pre-eclampsia.

OBJECTIVE: To investigate the association between iron supplementation during early pregnancy and the presence of de novo hypertension after 20 weeks' gestation (either gestational hypertension or pre-eclampsia). STUDY DESIGN: Retrospective cohort study. METHODS: This study retrospectively reviewed the medical records of non-anemic pregnant women who received first antenatal care at the Department of Obstetrics and Gynecology, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand, during the June 2009-December 2010 study period. All included women had blood pressure and urine albumin level data that were recorded at each antenatal visit. The study population was divided into one of the two following groups: iron supplementation starting at gestational age (GA) < 16 weeks (study group) or GA ≥ 16 weeks (control group). A comparison of the proportion of de novo hypertension arising after 20 weeks' gestation was then performed between groups. RESULTS: Four hundred non-anemic pregnant women were included, with 200 patients allocated to each groups. The overall incidence of de novo hypertension after 20 weeks' gestation was 10% (40/400), with significantly higher prevalence in the study group than that in the control group [13.5% (27/200) vs. 6.5% (13/200); relative risk: 2.14, 95%, CI 1.22-3.73; p = 0.008]. None of the women in this study developed anemia at time of delivery. There was no significant difference between groups for GA at delivery, birth weight, or birth asphyxia. CONCLUSION: In our study population, iron supplementation before 16 weeks' GA was significantly associated with increased risk of developing de novo hypertension after 20 weeks' gestation.

Cost and Cost-Effectiveness of the Management Strategies of Chronic Urticaria: A Systematic Review.

Importance: Although treatment for chronic urticaria (CU) has improved over the past decades, evidence regarding costs and net benefits associated with these treatment strategies have yet to be comprehensively characterized and synthesized. Objective: To summarize the cost and cost-effectiveness of CU management strategies. Evidence Review: An extensive systematic literature search of 6 databases (MEDLINE, Embase, PubMed Cochrane, Scopus, and CINAHL) and gray literature sources, without language restriction, was conducted and updated to March 23, 2024. Articles that performed cost analysis or full economic evaluation among patients with CU were included. Two reviewers independently extracted data, such as annual costs of health care services or incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY). All monetary values were converted and inflated to 2023 US dollars. Evidence-based synthesis for health benefit was judged using the Evidence Rating Matrix by the Institute for Clinical and Economic Review. Findings: Seventeen unique studies (11 cost analysis studies and 6 full economic evaluations) were included. With the wide variation in health care resources, services that included biologic omalizumab utilization had higher annual health care cost estimations for CU management than services that did not include omalizumab prescription (median [IQR] cost, $6933 [$5988-$8717] vs $5621 [$2488-$8754]). The biologic omalizumab, 300 mg, for H1 antihistamine-refractory chronic spontaneous urticaria (CSU) (3 studies) was found to have a median (IQR) ICER of $89 005 ($36 058-$145 694) per QALY (evidence rating as incremental or better; moderate certainty with substantial net health benefit). Routine laboratory testing among patients with CSU with otherwise normal histories and physical examination findings (1 study) had ICERs ranging from $1 427 928 to $1 950 524 per QALY (evidence rating as comparable or inferior; moderate certainty that the net health benefit is inferior). Conclusions and Relevance: With limited evidence of cost-effectiveness, biologic omalizumab, 300 mg, for H1 antihistamine-refractory CSU was found to be cost-effective in US health care services at the willingness to pay threshold of $150 000 per QALY. Meanwhile, routine laboratory testing among patients with CSU without compelling indication was not cost-effective. Future studies in more diverse CU populations and resource settings are needed to fill evidence gaps.

Effect of Curcuminoids on Contrast-Induced Acute Kidney Injury after Elective Coronary Angiography or Intervention: A Pilot Randomized, Double-Blind, Placebo-Controlled Study.

INTRODUCTION: The role of curcuminoids, a striking antioxidant, in prevention of contrast-induced acute kidney injury (CI-AKI) remains unknown. We aimed to evaluate the efficacy and safety of curcuminoids in preventing CI-AKI in patients undergoing elective coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). METHODS: We randomized 114 patients who were undergoing elective CAG and/or PCI to receive curcuminoids, 4 g/day (1 day before and 1 day after the procedure, n = 56), or placebo (n = 58). Serum creatinine was assessed at baseline, 12, 24, and 48 h after contrast exposure. The primary endpoint was development of CI-AKI defined as serum creatinine increase ≥0.3 mg/dL within 48 h after contrast exposure. The secondary endpoint was the occurrence of kidney injury defined by >30% increase in urine neutrophil gelatinase-associated lipocalin (NGAL). RESULTS: Baseline characteristics were comparable between the two groups. Seven (12.7%) in curcuminoids group and eight (14.0%) in placebo group developed CI-AKI (p = 0.84). The incidence of increased urine NGAL was comparable in the placebo and curcuminoids group (39.6% vs. 50%, respectively; p = 0.34). None in both groups had drug-related adverse events. CONCLUSION: This is a pilot study to demonstrate the safety and tolerability of curcuminoids in patients undergoing elective CAG and/or PCI. Curcuminoids have no protective effects against kidney injury after elective CAG and/or PCI.

Evaluation of Pharmacological Treatments for Acute Urticaria: A Systematic Review and Meta-Analysis.

BACKGROUND: The effectiveness and safety of pharmacological treatments for acute urticaria remain unclear. OBJECTIVE: To systematically review and meta-analyze the efficacy and safety of pharmacological treatments for acute urticaria in emergency department (ED) and non-ED settings. METHODS: We searched electronic databases and gray literature up to July 8, 2023, without language restrictions. Randomized clinical trials (RCTs) relating to pharmacological interventions in patients with acute urticaria, regardless of age, were eligible for inclusion. The relevant outcomes of interest were the treatment efficacy and safety profiles. The results are presented as standardized mean differences (SMDs) or odds ratios (ORs). RESULTS: We identified 8 RCTs comprising 680 patients. Regarding the ED setting (2 trials, n = 118), intramuscular first-generation H1-antihistamine (fgAH) was more efficacious in decreasing pruritus symptoms (SMD, -0.38; 95% confidence interval [CI], -0.75 to -0.02) but had higher sedative effects than H2-blockers. With comparable pruritus symptom improvement (2 trials, n = 295), intravenous second-generation H1-antihistamine (sgAH) had favorable clinical outcomes compared with intravenous fgAH in the ED setting with a lower risk of return to any ED/clinic (OR, 0.31; 95% CI, 0.12-0.83) and lower risk of any adverse event (OR, 0.24; 95% CI, 0.09-0.63). The efficacy of adjunctive therapy with a short course of systemic glucocorticosteroids in ED and non-ED settings remains unclear. No serious concerns regarding the safety profiles were observed in any of the treatment comparisons. CONCLUSIONS: H1-antihistamine is a crucial and effective component of acute urticaria treatment, and intravenous sgAH is preferred as an initial treatment option.

Randomized Trial on the Effects of Dialysate Potassium Concentration on Intradialytic Hypertension.

Introduction: Intradialytic hypertension is not an uncommon condition during chronic hemodialysis. It is associated with unfavorable cardiovascular outcomes, including hospitalization and mortality. Several small studies have demonstrated the contradictory effects of different dialysate potassium concentrations on intradialytic blood pressure. This study is a randomized crossover trial aiming to evaluate the effects of different dialysate potassium concentrations on intradialytic hypertension. Methods: A 24-week, 2-treatment, 4-sequence, multicenter, double-blinded, randomized, crossover study was conducted at Maharaj Nakorn Chiang Mai Hospital and Lampang Hospital in Thailand among stable patients receiving chronic hemodialysis who experienced intradialytic hypertension >30% of their sessions over the past 3 months. Each participant was randomly assigned to 1 of 4 treatment sequences. During each intervention period, patients were dialyzed with dialysate potassium of either 2 mmol/l (D-K2) or 3 mmol/l (D-K3) for 4 weeks according to their preassigned sequence, separated by a 2-week washout period. The primary outcome was the incidence of intradialytic hypertension. Results: Forty eligible patients were recruited. The mean age was 61.4 ± 14.2 years and the mean systolic blood pressure (SBP) was 146.6 ± 11.2 mm Hg. Of the 40 patients, 95.5% had hypertension and their average number of antihypertensive drugs was 2.8 ± 1.9. A total of 1380 dialysis sessions were included in the analysis (695 sessions for D-K2 and 685 sessions for D-K3). The incidence of intradialytic hypertension was not significantly different between different dialysate potassium concentrations (D-K2 54.7% vs. D-K3 53.1%, P = 0.788). The changes in SBP, diastolic blood pressure (DBP), and mean arterial pressure (MAP) were not different between the 2 dialysate potassium groups. Conclusion: Dialysate potassium concentration of 2 or 3 mmol/l did not affect the incidence of intradialytic hypertension in patients receiving chronic hemodialysis who frequently developed intradialytic hypertension.

Comparative Safety Profiles of Individual Second-Generation H1-Antihistamines for the Treatment of Chronic Urticaria: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The comparative safety and/or dosing regimens of individual second-generation H1-antihistamines (sgAHs) in patients with chronic urticaria (CU) remain poorly elucidated. OBJECTIVE: To compare the safety profiles of individual sgAHs and/or dosing regimens in adolescents or adult patients with CU using a systematic review and network meta-analysis of all available evidence. METHODS: With limited English publications, electronic databases and gray literature were searched for randomized clinical trials from inception, with searches last updated on January 20, 2023. Relevant safety outcomes included treatment unacceptability (all-cause discontinuation), tolerability (discontinuation due to any adverse events), adverse events, serious adverse events, central nervous system (CNS) side effects, and anticholinergic side effects. Regarding the network estimates, the probability of being associated with the highest adverse outcome risk was estimated for each treatment comparison. RESULTS: Fifty-one randomized clinical trials with 14 individual sgAHs and different dosing regimens, involving 7502 participants, were included. On the basis of the findings from network meta-analyses, variations in sgAH treatment comparisons were observed regarding the unacceptability of treatment, tolerability, adverse events, and CNS side effects. There were no statistically significant differences between the results of sgAH treatment for serious adverse events and those for anticholinergic side effects. On the basis of the ranking of safety profiles, emedastine 4 mg, mizolastine 10 mg, and cetirizine 10 mg were the top 3 ranked treatments with unfavorable safety profiles associated with CNS side effects and any adverse events. CONCLUSIONS: These findings suggest evidence of variations in safety profiles among sgAHs for CU treatment, particularly in terms of adverse events and CNS side effects.

Efficacy and safety of metformin for melasma treatment: a systematic review and meta-analysis.

Objective: Metformin has recently been demonstrated to have an anti-melanogenic activity. Nevertheless, clinical evidence of the effectiveness of metformin in melasma is lacking. The objective of this study was to assess the efficacy and safety of metformin in the treatment of melasma. Methods: MEDLINE, Embase, PubMed, Cochrane Library (CENTRAL), Scopus, CINAHL, and grey literature databases were searched to 4 October 2022 and updated on 26 February 2023. Randomized controlled trials (RCTs), quasi-RCTs, observational studies, case series, and case reports investigating the efficacy and safety of metformin for melasma were included. The Melasma Area Severity Index (MASI) scores that changed from baseline were pooled using fixed-effects model and expressed as standardized mean differences (SMDs) and 95% confidence intervals (CIs). Results: Three RCTs including 140 patients with melasma were included. The results demonstrated that after 8 weeks, 15% topical metformin significantly reduced the Melasma Area Severity Index (MASI) score compared to placebo (1 trial; n = 60; MD, -0.56; 95% CI, -1.07 to -0.04; p = 0.034). Furthermore, when compared to triple combination cream (TCC), 30% topical metformin demonstrated similar efficacy in reducing the MASI score after 8 weeks (2 trials; n = 80; MD, 0.19, 95% CI, -0.25 to 0.63; p = 0.390). Patients using 30% topical metformin had fewer adverse events compared to TCC users, although no statistical difference was found. Conclusion: Topical metformin was as effective as triple combination cream (TCC) in decreasing changes in the MASI score in patients with melasma, with minimum adverse events. Further studies with larger sample sizes, longer follow-up times, and well-designed trials are required. Systematic Review Registration: Identifier PROSPERO (CRD42022351966).

Evidence Gaps in Clinical Trials of Pharmacologic Treatment for H1-Antihistamine-Refractory Chronic Spontaneous Urticaria: A Systematic Review and Future Perspectives.

No data addressing issues concerning disparities in participant and trial characteristics and trial outcome reporting have been established in clinical trials for H1-antihistamine-refractory chronic spontaneous urticaria (CSU). To better harmonize and compare the different treatment interventions, we systematically evaluated the overall landscape of pharmacological treatments for H1-antihistamine-refractory CSU clinical trials published between 2000 and 2021. This systematic review included 23 randomized clinical trials involving 2480 participants from 22 countries. We found significant increases in the number of globally published and newly tested drugs, especially biologic drugs. Regarding relatively small trials, we found that people living with H1-antihistamine-refractory CSU who were identified as members of minority groups (non-white population), populations of regions other than North America/Europe, and populations of low- to lower/upper-middle-income countries are underrepresented. Most trials were designed to evaluate treatment efficacy and safety profiles; however, less than half of the included trials reported the patient's perspective in terms of patient-reported outcomes. Disparities in outcome reporting, including clinimetric tools for assessing treatment response and outcome sets, were observed. To close the evidence gap in H1-antihistamine-refractory CSU trials, strategies for improving trial and participant enrollment and standardizing core outcome sets for trial reporting are needed.

Prevalence of chronic kidney disease stages 3-5 in low- and middle-income countries in Asia: A systematic review and meta-analysis.

Chronic kidney disease (CKD) is a major public health problem in low- and middle-income countries (LMICs). Although CKD prevalence has been rapidly increasing in LMICs, particularly in Asia, quantitative studies on the current epidemiology of CKD in this region are limited. This study aimed to identify the prevalence of CKD stages 3-5 in LMICs in Asia, by subregion, country economy classification, identification of CKD, traditional and non-traditional risk factors. A systematic review and meta-analysis of observational studies was conducted through a literature search of seven electronic databases and grey literature search published until November 2021. The Newcastle-Ottawa quality assessment scale (NOS) was used to assess the risk of bias of each study. A random-effects model was used to estimate pooled prevalence. The protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42019120519). Of 4,548 potentially relevant records, 110 studies with moderate and high quality were included with 4,760,147 subjects. The average prevalence (95% CI) of CKD stages 3-5 in 14 LMICs in Asia was 11.2% (9.3-13.2%). The prevalence of CKD stages 3-5 was varied among subregions and country economic classification. CKD prevalence was 8.6% (7.2-10.2%) in east Asia, 12.0% (7.7-17.0%) in south-east Asia, 13.1% (8.7-18.2%) in western Asia, and 13.5% (9.5-18.0%) in south Asia. CKD prevalence was 9.8% (8.3-11.5%) in upper-middle-income countries and 13.8% (9.9-18.3%) in lower-middle-income countries. Prevalence of CKD stage 3-5 in LMICs in Asia is comparable to global prevalence. High level of heterogeneity was observed. Study of factors and interventions that lead to the delay of CKD progression is needed.

Disparities and Factors Associated with Coronavirus Disease-2019-Related Public Stigma: A Cross-Sectional Study in Thailand.

Coronavirus disease 2019 (COVID-19)-related public stigma is a major challenge, with scarce available evidence. This study aimed to determine the disparities and factors associated with COVID-19-related public stigma in the Thai population. We conducted a cross-sectional study involving a voluntary online survey in Thailand from 21 April 2020 to 4 May 2020. We invited 4004 participants to complete a series of questionnaires, including the validated COVID-19 public stigma scale and questions on relevant COVID-19-related psychosocial issues. Multinomial logistic regression was performed to investigate the factors associated with COVID-19-related public stigma. The prevalence of COVID-19-related public stigma was 24.2% (95% confidence interval [CI], 22.2-26.2) for no/minimal, 35.5% (95% CI, 33.4-37.6) for moderate, and 40.3% (95% CI, 38.2-42.4) for high. We observed disparities in the prevalence of COVID-19-related public stigma according to participant characteristics and psychosocial factors. Using the no/minimal group as a reference group, the six predominant risk factors significantly associated with a moderate and high degree of COVID-19-related public stigma were middle-aged or older adults, male, divorced/widowed/separated, current quarantine status, moderate/severe fear of COVID-19, and medium/high perceived risk of COVID-19. Additional risk factors significantly related to a high degree of COVID-19-related public stigma were religion (Buddhist), region of residence (non-capital city), and exposure to COVID-19-related information. Disparities in COVID-19-related public stigma due to sociodemographic and psychosocial issues are frequent in the Thai population. To reduce public stigmatization, early identification of vulnerable groups and the development of tailored mitigation strategies should be implemented during the pandemic.