Browsing by Author "Numthavaj P."

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    A network meta-analysis of efficacy and safety of adjuvant targeted therapy or immunotherapy in non-small cell lung cancer
    (2025-12-01) Sa-nguansai S.; Rattanasiri S.; Pornsuriyasak P.; Numthavaj P.; McKay G.J.; Attia J.; Thakkinstian A.; Sa-nguansai S.; Mahidol University
    The integration of targeted therapy and immunotherapy into adjuvant treatments for early-stage non-small cell lung cancer (NSCLC) remains challenging. This study aimed to compare the efficacy and safety of all available adjuvant treatment options. Randomized controlled trials (RCTs) published up to August 15, 2023, were identified from MEDLINE, Scopus, and Cochrane CENTRAL. RCTs were included if they studied early-stage NSCLC and compared any adjuvant systemic targeted therapy or immunotherapy with adjuvant chemotherapy/placebo. This study was registered with PROSPERO, CRD42022351290. Individual patient data were generated based on data extracted from Kaplan–Meier curves. A parametric survival model was used to estimate the median time for disease-free survival (DFS) and overall survival (OS). A two-stage network meta-analysis (NMA) was applied to estimate the hazard ratio (HR) for DFS and OS, in addition to the risk ratio (RR) of severe adverse events (SAE). Nineteen RCTs (n = 9,438) were included for assessing the effects of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), vascular endothelial growth factor (VEGF) inhibitors, immune checkpoint inhibitor (ICI) immunotherapy, and non-ICI immunotherapy. DFS in EGFR-TKIs and ICI immunotherapy was longer than chemotherapy/placebo, with a median time of 69.24, 53.47, and 39.49 months, respectively. EGFR-TKIs had a 46% significantly lower risk of recurrence [HR = 0.54 (95% CI: 0.38, 0.77)] than chemotherapy/placebo. Both EGFR-TKIs and ICI immunotherapy appeared to improve OS compared to chemotherapy or placebo, but both treatments also had an increased risk of SAE; however, neither result was statistically significant. This study indicates that EGFR-TKIs might be the best treatment regimen for reducing recurrence with an intermediate risk of SAE.
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    An Umbrella Review of Systematic Reviews and Meta-analyses of Randomized Controlled Trials Investigating the Effect of Curcumin Supplementation on Lipid Profiles
    (2025-08-01) Unhapipatpong C.; Julanon N.; Shantavasinkul P.C.; Polruang N.; Numthavaj P.; Thakkinstian A.; Unhapipatpong C.; Mahidol University
    Context Dyslipidemia is a major risk factor for atherosclerotic cardiovascular disease (ASCVD), and curcumin may help improve lipid metabolism. Objective This umbrella review and updated meta-analysis assessed the effects of curcumin supplementation on lipid profiles. Data Sources Electronic databases (Medline, Scopus, Cochrane, and Google Scholar) were searched through March 31, 2023, without language restrictions. Data Extraction Two independent authors selected eligible randomized controlled trials (RCTs) involving curcumin supplementation compared with placebo, measuring total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-c), high-density-lipoprotein cholesterol (HDL-c), and triglyceride (TG) levels. Data Analysis This study identified 26 systematic reviews and meta-analyses (MAs) that met the inclusion criteria for the umbrella review. Of these, 53 RCTs, with a corrected coverage area of 9.76% indicating a moderate degree of overlap, were included for re-pooling. Additionally, this study found 19 more RCTs, bringing the total number of studies for the updated MAs to 72. Results Curcumin significantly reduced TC, LDL-c, and TG, with mean differences (MDs) of -7.76 mg/dL (95% CI: -11.29, -4.22; I2 = 97%), -5.84 mg/dL (95% CI: -11.63, -0.05; I2 = 98%), and -13.15 mg/dL (95% CI: -17.31, -8.98; I2 = 94%), respectively, and increased HDL-c by 2.4 mg/dL (95% CI: 1.22, 3.57; I2 = 94%). The reductions in LDL-c and TG reached the minimally clinically important differences (MCIDs). However, the reduction in TC and increase in HDL-c did not meet their respective MCIDs. Subgroup analysis showed greater lipid improvements in patients with metabolic-related diseases, particularly type 2 diabetes. Enhanced bioavailability forms of curcumin, supplementation for at least 8 weeks, and exercise yielded additional benefits. Conclusion The study confirmed that curcumin has an anti-lipidemic effect on patients with noncommunicable diseases. A form of curcumin with enhanced bioavailability is preferred, and supplementation for at least 8 weeks, along with exercise, may be used as an accessible approach to reduce the risk of ASCVD.
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    Causal association pathways between fetuin-A and kidney function: a mediation analysis
    (2022-04-01) Bassey P.E.; Numthavaj P.; Rattanasiri S.; Sritara P.; McEvoy M.; Ongphiphadhanakul B.; Thakkinstian A.; Mahidol University
    Objective: Body mass index (BMI), uric acid, diabetes mellitus, and hypertension are risk factors for reduced kidney function and are associated with fetuin-A levels, but their causal pathways remain unclear. The objective of this study was to investigate this knowledge gap. Methods: A repeated cross-sectional design was used to assess causal pathway effects of fetuin-A on the estimated glomerular filtration rate (eGFR), which is mediated through BMI, uric acid, diabetes mellitus, and hypertension. Results: Among 2305 participants, the mean eGFR at baseline decreased from 98.7 ± 23.6 mL/minute/1.73 m2 in 2009 to 92.4 ± 22.9 mL/minute/1.73 m2 in 2014. Fetuin-A was significantly associated with eGFR, suggesting that increasing fetuin-A levels predict a decrease in eGFR. Additionally, the indirect effect of fetuin-A on eGFR, as assessed through BMI, was also significant. The effects of fetuin-A on eGFR through other mediation pathways showed variable results. Conclusions: Our study revealed a possible role of fetuin-A in the etiology of declining renal function through mediating body mass index, uric acid, diabetes mellitus, and hypertension via complex causal pathways. Further studies to clarify these mediated effects are recommended.
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    Comparative cardiovascular outcomes of novel drugs as an addition to conventional triple therapy for heart failure with reduced ejection fraction (HFrEF): a network meta-analysis of randomised controlled trials
    (2023-11-08) Suebsaicharoen T.; Chunekamrai P.; Yingchoncharoen T.; Tansawet A.; Issarawattana T.; Numthavaj P.; Thakkinstian A.; Mahidol University
    Background Currently, there is no head-to-head comparison of novel pharmacological treatments for heart failure with reduced ejection fraction (HFrEF). A network meta-analysis aimed to compare effects of both conventional and alternative drug combinations on time to develop primary composite outcome of cardiovascular death or heart failure hospitalisation (PCO). Methods Randomised controlled trials (RCTs) were identified from Medline, Scopus up to June 2021. The RCTs were included if comparing any single or combination of drugs, that is, ACE inhibitors (ACEI), angiotensin receptor blockers, beta-blockers (BB), mineralocorticoid receptor antagonists (MRA), ivabradine (IVA), angiotensin receptor blocker/neprilysin inhibitors (ARNI) and sodium-glucose cotransporter-2 inhibitors (SGLT2i), soluble guanylyl cyclase and omecamtiv mecarbil and reporting PCO. Data were extracted from Kaplan-Meier curves, individual patient data were generated. A mixed-effect Weibull regression was applied. Median time to PCO, HRs with 95% CI were estimated accordingly. Our findings suggested that ACEI+BB+MRA+SGLT2i, BB+MRA+ARNI, and ACEI+BB+MRA+IVA had lower probability of PCOs than the conventional triple therapy (ACEI+BB+MRA). Results Median time to PCOs of ACEI+BB+MRA was 57.7 months whereas median times to those new combinations were longer than 57.7 months. In addition, the three new regimens had a significantly lower PCO risks than ACEI+BB+MRA, with the HRs (95% CI) of 0.51 (0.43 to 0.61), 0.55 (0.46 to 0.65) and 0.56 (0.47 to 0.67), accordingly. Conclusion This study suggested that SGLT2i, ARNI and IVA in addition to ACEI+BB+MRA may be better in prolonging time to develop PCO in HFrEF patients.
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    Cost-effectiveness analysis of isolation strategies for asymptomatic and mild symptom COVID-19 patients
    (2023-12-01) Suthutvoravut U.; Kunakorntham P.; Semayai A.; Tansawet A.; Pattanaprateep O.; Piebpien P.; Numthavaj P.; Thakkinstian A.; Atiksawedparit P.; Mahidol University
    Background: Management of COVID-19 patients with mild and moderate symptoms could be isolated at home isolation (HI), community isolation (CI) or hospitel. However, it was still unclear which strategy was more cost-effective. Therefore, this study was conducted to evaluate this. Methods: This study used data from patients who initially stayed at HI, CI, and hospitel under supervision of Ramathibodi Hospital between April and October 2021. Outcomes of interest were hospitalisation and mortality. An incremental cost-effectiveness ratios (ICER) was calculated based on hospital perspective using home isolation as the reference. Results: From 7,077 patients, 4,349 2,356, and 372 were admitted at hospitel, HI, and CI, respectively. Most patients were females (57.04%) and the mean age was 40.42 (SD = 16.15). Average durations of stay were 4.47, 3.35, and 3.91 days for HI, CI, and hospitel, respectively. The average cost per day for staying in these corresponding places were 24.22, 63.69, and 65.23 US$. For hospitalisation, the ICER for hospitel was at 41.93 US$ to avoid one hospitalisation in 1,000 patients when compared to HI, while CI had more cost, but less cases avoided. The ICER for hospitel and CI were at 46.21 and 866.17 US$ to avoid one death in 1,000 patients. Conclusions: HI may be cost-effective isolated strategy for preventing hospitalisation and death in developing countries with limited resources.
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    Cross-Cultural Adaptation and Psychometric Properties of Tinnitus Functional Index for Thai Patients
    (2023-01-01) Premkraisorn V.; Lertsukprasert K.; Numthavaj P.; Tiravanitkul R.; Jariengprasert C.; Premkraisorn V.; Mahidol University
    OBJECTIVE This study aims to cross-culturally translate the Tinnitus Functional Index (TFI) questionnaire into Thai, and to determine the psychometric properties of Thai version (TFI-Th). METHODS TFI was translated into a Thai version (TFI-Th) using a forward-backward translation procedure. All participants completed the following questionnaires in random order: TFI-Th, Visual analog scales, Tinnitus Handicap Inventory Thai Version (THI-T), and Thai Hospital Anxiety and Depression Scales (Thai HADS). RESULTS The content validity index (CVI) of the TFI-Th was high. The TFI-Th showed adequate convergent and divergent validity. The correlation between TFI-Th and other measurements were calculated and showed a high correlation with THI-T (r = 0.82), a moderate-to-high correlations with each items of VAS (r = 0.66-0.86), and a moderate correlation with depression (r = 0.58) and anxiety (r = 0.62) of Thai HADS. The internal consistency reliability of TFI-Th was excellent (μ = 0.97). CONCLUSIONS The results of the present study revealed that the cross-cultural TFI-Th had similar reliability and validity to the original TFI and suitable for the evaluation of Thai tinnitus patients.
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    Delayed versus primary closure to minimize risk of surgical-site infection for complicated appendicitis: A secondary analysis of a randomized trial using counterfactual prediction modeling
    (2023-01-01) Tansawet A.; Siribumrungwong B.; Techapongsatorn S.; Numthavaj P.; Poprom N.; McKay G.J.; Attia J.; Thakkinstian A.; Mahidol University
    Objective: To evaluate the risk of surgical site infection (SSI) following complicated appendectomy in individual patients receiving delayed primary closure (DPC) versus primary closure (PC) after adjustment for individual risk factors. Design: Secondary analysis of randomized controlled trial (RCT) with prediction model. Setting: Referral centers across Thailand. Participants: Adult patients who underwent appendectomy via a lower-right-quadrant abdominal incision due to complicated appendicitis. Methods: A secondary analysis of a published RCT was performed applying a counterfactual prediction model considering interventions (PC vs DPC) and other significant predictors. A multivariable logistic regression was applied, and a likelihood-ratio test was used to select significant predictors to retain in a final model. Factual versus counterfactual SSI risks for individual patients along with individual treatment effect (iTE) were estimated. Results: In total, 546 patients (271 PC vs 275 DPC) were included in the analysis. The individualized prediction model consisted of allocated intervention, diabetes, type of complicated appendicitis, fecal contamination, and incision length. The iTE varied between 0.4% and 7% for PC compared to DPC; ∼38.1% of patients would have ≥2.1% lower SSI risk following PC compared to DPC. The greatest risk reduction was identified in diabetes with ruptured appendicitis, fecal contamination, and incision length of 10 cm, where SSI risks were 47.1% and 54.1% for PC and DPC, respectively. Conclusions: In this secondary analysis, we found that most patients benefited from early PC versus DPC. Findings may be used to inform SSI prevention strategies for patients with complicated appendicitis.
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    Development and Validation of a Literature Screening Tool: Few-Shot Learning Approach in Systematic Reviews
    (2024-01-01) Wiwatthanasetthakarn P.; Ponthongmak W.; Looareesuwan P.; Tansawet A.; Numthavaj P.; McKay G.J.; Attia J.; Thakkinstian A.; Wiwatthanasetthakarn P.; Mahidol University
    Background: Systematic reviews (SRs) are considered the highest level of evidence, but their rigorous literature screening process can be time-consuming and resource-intensive. This is particularly challenging given the rapid pace of medical advancements, which can quickly make SRs outdated. Few-shot learning (FSL), a machine learning approach that learns effectively from limited data, offers a potential solution to streamline this process. Sentence-bidirectional encoder representations from transformers (S-BERT) are particularly promising for identifying relevant studies with fewer examples. Objective: This study aimed to develop a model framework using FSL to efficiently screen and select relevant studies for inclusion in SRs, aiming to reduce workload while maintaining high recall rates. Methods: We developed and validated the FSL model framework using 9 previously published SR projects (2016-2018). The framework used S-BERT with titles and abstracts as input data. Key evaluation metrics, including workload reduction, cosine similarity score, and the number needed to screen at 100% recall, were estimated to determine the optimal number of eligible studies for model training. A prospective evaluation phase involving 4 ongoing SRs was then conducted. Study selection by FSL and a secondary reviewer were compared with the principal reviewer (considered the gold standard) to estimate the false negative rate. Results: Model development suggested an optimal range of 4-12 eligible studies for FSL training. Using 4-6 eligible studies during model development resulted in similarity thresholds for 100% recall, ranging from 0.432 to 0.636, corresponding to a workload reduction of 51.11% (95% CI 46.36-55.86) to 97.67% (95% CI 96.76-98.58). The prospective evaluation of 4 SRs aimed for a 50% workload reduction, yielding numbers needed to screen 497 to 1035 out of 995 to 2070 studies. The false negative rate ranged from 1.87% to 12.20% for the FSL model and from 5% to 56.48% for the second reviewer compared with the principal reviewer. Conclusions: Our FSL framework demonstrates the potential for reducing workload in SR screening by over 50%. However, the model did not achieve 100% recall at this threshold, highlighting the potential for omitting eligible studies. Future work should focus on developing a web application to implement the FSL framework, making it accessible to researchers.
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    Development of Symbolic Signal Processing and Transformer Models for Predicting Respiratory System Mechanics in Mechanical Ventilation
    (2023-01-01) Junwei Y.; Numthavaj P.; Pattanateepapon A.; Puttanawarut C.; Junhasavasdikul D.; Mahidol University
    This paper focuses on the assessment of respiratory mechanics, i.e., compliance (C) and resistance (R) on the analysis of respiratory signals. Inspired by the growing use and success of the transformer model in fields such as natural language processing, image recognition, and signal analysis, we have devised an innovative method that leverages automatic feature extraction via transformers to predict C and R. While the use of transformers in respiratory signals has not been widely studied yet, we demonstrate their efficacy for extracting relevant features from respiratory signals in this paper. As transformers require a lot of memory, we have developed a symbolic approach to process the signal, which significantly reduces the size of input data and results in a more compact model. Our experimental findings showed that the proposed algorithm achieved mean absolute errors of 6.91 mL/cmH2O and 3.01 cmH2O.s/L, as well as mean absolute percentage errors of 15% and 20.6% when determining respiratory C and R respectively. These results demonstrated the potential of the proposed method for developing a new generation of ventilation monitoring techniques that could enhance the care given to specific intensive care unit patients.
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    Early subcutaneous basal insulin with intravenous insulin infusion for diabetic ketoacidosis management: A systematic review and meta-analysis of randomised controlled trials
    (2025-01-01) Thammakosol K.; Vongtangton P.; Numthavaj P.; Auttara-atthakorn A.; Sriphrapradang C.; Thammakosol K.; Mahidol University
    Aims: To evaluate the effectiveness and safety of early initiation of subcutaneous (SC) basal insulin in combination with intravenous insulin infusion (IVII), compared with IVII alone, for the management of diabetic ketoacidosis (DKA). Materials and Methods: A systematic search of PubMed, Embase, Scopus, and the Cochrane Library was conducted to identify randomised controlled trials (RCTs) comparing early initiation of long- or ultra-long-acting basal insulin plus IVII versus IVII alone in DKA management. Studies published up to 6 September 2025, were included. Meta-analysis was performed using mean difference (MD) for continuous outcomes and risk ratio for dichotomous outcomes, both with a 95% confidence interval (CI). The primary outcome was time to DKA resolution. Secondary outcomes included total intravenous insulin use, rebound hyperglycemia, hypoglycemia, hypokalemia, length of hospital stay (LOS), and mortality. A one-stage individual participant data meta-analysis was also conducted when individual-level data were available. Results: Eight RCTs including 468 participants (256 receiving early SC basal insulin plus IVII; 212 receiving IVII alone) were included. Baseline characteristics were comparable across studies. Early SC basal insulin significantly reduced time to DKA resolution (MD −4.02 h, 95%CI −5.52 to −2.52, p <0.001) and total intravenous insulin dose until DKA resolution (MD −19.2 units, 95%CI −28.99 to −9.26, p <0.001). No significant differences were observed between groups for rebound hyperglycemia, safety outcomes, LOS, or in-hospital mortality. Conclusions: Early SC basal insulin in combination with IVII significantly accelerates DKA resolution and reduces total IVII requirements, without increasing the risk of adverse events, including hypoglycemia or hypokalemia.
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    Effectiveness of Prophylactic Central Neck Dissection in Intermediate-Risk Papillary Thyroid Cancer
    (2026-04-01) Marpukdee V.R.; Numthavaj P.; Mahathanaruk N.; Marpukdee V.R.; Mahidol University
    Objective: The role of prophylactic central neck dissection is still controversial in patients with papillary thyroid carcinoma with intermediate risk, especially those without evidence of metastasis. We therefore aimed to assess its impact on locoregional and survival outcomes. Methods: A retrospective cohort study was conducted at the Department of Otolaryngology Head and Neck Surgery of a tertiary-care hospital. Results: Of 469 patients with confirmed papillary thyroid carcinoma, 157 patients underwent prophylactic central neck dissection and 312 patients did not. The recurrence-free survival time was 2.14 years in the group that underwent central neck dissection and 3.58 years in the other, under the mean follow-up time of 5.8 years (SD 2.6), showing no statistical significance. Of the 82 patients with recurrence, 35.3% underwent central neck dissection while 64.6% did not have the operation. Although the difference between the two groups was statistically insignificant, the number of recurrences seems to be higher in those who did not undergo prophylactic central neck dissection. Conclusion: The study reveals no superiority of prophylactic central neck dissection over no central neck dissection in terms of both recurrence-free survival time and recurrence outcomes. Future studies are needed to refine more effective treatment strategies and develop impactful guidelines. Level of Evidence: 2.
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    Effects of electrical and magnetic stimulation on upper extremity function after stroke: A systematic review and network meta-analysis
    (2025-01-01) Keesukphan A.; Suntipap M.; Thadanipon K.; Boonmanunt S.; Numthavaj P.; McKay G.J.; Attia J.; Thakkinstian A.; Keesukphan A.; Mahidol University
    Objectives: To pool and rank the efficacy of various stimulation therapies, including repetitive peripheral magnetic stimulation (rPMS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES), transcranial magnetic stimulation (TMS), and combinations of these interventions on upper extremity function, activities of daily living (ADL), and spasticity after stroke relative to sham/conventional rehabilitation. Literature Survey: MEDLINE, Scopus, Physiotherapy Evidence Database, Cochrane Central Register of Controlled Clinical Trials, and Google Scholar were searched from inception to July 2022. Methodology: Randomized controlled trials comparing any of the interventions mentioned above (rPMS, NMES, FES, TMS, NMES+rPMS, NMES+TMS, FES+TMS, and conventional rehabilitation) on upper extremity function, ADL, or spasticity from five databases were systematically reviewed and collected. Two-stage network meta-analysis was applied. Synthesis: Thirty-four studies involving 1476 patients reporting upper extremity function with the Fugl-Meyer Assessment were pooled. NMES combined with rPMS, NMES, NMES combined with TMS, TMS, and FES showed significantly higher improvement than conventional rehabilitation, with pooled mean differences (95% confidence intervals) of 14.69 (9.94–19.45), 9.09 (6.01–12.18), 6.10 (2.51–9.69), 4.07 (0.33–7.81), and 3.61 (0.14–7.07) respectively. NMES combined with rPMS had the highest probability for improving upper extremity function. NMES plus TMS had the highest probability for improving ADL, but none of the interventions showed significant differences in spasticity. Conclusions: NMES plus rPMS might be the best intervention to improve upper extremity functions, with NMES plus TMS most likely to lead to improved ADL but the quality of the evidence is low.
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    Efficacy and safety of urate-lowering agents in asymptomatic hyperuricemia: systematic review and network meta-analysis of randomized controlled trials
    (2022-12-01) Sapankaew T.; Thadanipon K.; Ruenroengbun N.; Chaiyakittisopon K.; Ingsathit A.; Numthavaj P.; Chaiyakunapruk N.; McKay G.; Attia J.; Thakkinstian A.; Mahidol University
    Background: Asymptomatic hyperuricemia was found to be associated with increased cardiovascular disease risk but the potential benefits of urate-lowering therapy (ULT) remain controversial. We conducted a systematic review and network meta-analysis (NMA) with frequentist model to estimate the efficacy and safety of ULT in asymptomatic hyperuricemia. Methods: MEDLINE, Embase, and Scopus were searched without language restrictions. Randomized controlled trials (RCT) of adults with asymptomatic hyperuricemia were eligible if they compared any pair of ULTs (i.e., allopurinol, febuxostat, probenecid, benzbromarone, sulfinpyrazone, rasburicase, lesinurad, and topiroxostat) and placebo or no ULT, and had outcomes of interest, including composite renal events, major adverse cardiovascular events, serum urate levels, estimated glomerular filtration rate (eGFR), systolic blood pressure, and adverse events. Results: NMA with frequentist approach was applied to estimate relative treatment effects, i.e., risk ratio (RR) and mean difference (MD). A total of 23 RCTs were eligible. NMA identified beneficial effects of ULT on composite renal events and eGFR but not for other outcomes. Allopurinol and febuxostat had significantly lower composite renal events than placebo (RR 0.39, 95% confidence interval [CI] 0.23 to 0.66, and RR 0.68, 95% CI 0.46 to 0.99, respectively). Both treatments also resulted in significantly higher eGFR than placebo (MD 3.69 ml/min/1.73 m2, 95% CI 1.31 to 6.08, and MD 2.89 ml/min/1.73 m2, 95% CI 0.69 to 5.09, respectively). No evidence of inconsistency was identified. Conclusions: Evidence suggests that allopurinol and febuxostat are the ULTs of choice in reducing composite renal events and improving renal function. Trial registration. This study was registered with PROSPERO: CRD42019145908. The date of the first registration was 12th November 2019.
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    Efficacy of migraine prophylaxis treatments for treatment-naïve patients and those with prior treatment failure: a protocol for systematic review and network meta-analysis of randomised controlled trials
    (2024-03-01) Numthavaj P.; Anothaisintawee T.; Attia J.; McKay G.; Thakkinstian A.; Numthavaj P.; Mahidol University
    Introduction Migraine headache is a significant health problem affecting patients' psychological well-being and quality of life. Several network meta-analyses (NMAs) have compared the efficacy of migraine prophylaxis medications. However, some have focused exclusively on oral medications, while others were limited to injectable medications. Moreover, none of these NMAs conducted a stratified analysis between treatment-naïve patients and those with prior treatment failure. Therefore, this systematic review and NMA will compare the efficacy among all treatments for migraine prophylaxis, stratified by the treatment status of patients (ie, treatment-naïve and previous treatment failure). Methods and analysis Randomised-controlled trials that included patients with chronic or episodic migraine, assessed the efficacy of oral or injectable treatments for migraine prophylaxis and measured the outcomes as monthly migraine day, monthly headache day, migraine-related disability, health-related quality of life or adverse drug events will be eligible for inclusion in this review. Relevant studies will be searched from Medline, Scopus, the US National Institutes of Health Register, and the World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) databases since inception through 15 August 2023. Risk of bias assessment will be performed using a revised tool for assessing the risk of bias in randomised trials. Two-stage NMA will be applied to compare relative treatment effects among all treatments of migraine prophylaxis. Surface under the cumulative ranking curve will be applied to estimate and rank the probability to be the best treatment. Consistency assumption will be assessed using a design-by-treatment interaction model. Publication bias will be assessed by comparison-adjusted funnel plot. All analyses will be stratified according to patients' status (ie, treatment-naïve and prior treatment failure). Ethics and dissemination This study is a systematic review protocol collecting data from published literature and does not require approval from an institutional review board. Results from this systematic review will be published in a peer-reviewed journal.
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    Efficacy of Treatment for Metastatic Hormone-Sensitive Prostate Cancer: An Umbrella Review of Systematic Reviews and Meta-Analyses
    (2023-12-01) Sirisreetreerux P.; Poprom N.; Numthavaj P.; Rattanasiri S.; Thakkinstian A.; Sirisreetreerux P.; Mahidol University
    Purpose: This umbrella review focused on evaluating the efficacy and adverse events of the metastatic hormone-sensitive prostate cancer patients receiving any treatment regimens, including ADT alone or combination treatments. Methods: This study conducted an umbrella review following the PRISMA 2020 checklist, aiming to summarize the available studies to evaluate the efficacy of medical treatments for metastatic hormone-sensitive prostate cancer. A literature search was performed to identify systematic reviews and meta-analyses (SRMAs) that included only randomized controlled trials (RCTs) up to September 2023. This study summarized their findings, evaluated overlapping data (i.e., the same RCTs were included in >one SRMA), tested for excessive significance (i.e., observed number of statistically significant studies > expected number by chance) and assessed the quality of the studies. Results: A total of 4191 studies were identified, but only 27 were included. Among those 27 studies, 12 were network meta-analyses and 15 were direct meta-analyses. Most studies showed no statistically significant difference in overall mortality among GnRH agonists, antagonists and bilateral orchiectomy. Combination treatment is more beneficial than ADT alone in both OS and PFS outcomes with more adverse events. Nevertheless, there is no OS advantage of any combination regimen over the others. Conclusion: Combination treatments demonstrated clear benefits in OS and PFS over ADT alone with more AEs. Further studies are needed to compare among combination treatments.
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    Ethnicity-specific associations between the promoter region G-308A polymorphism (rs1800629) of the TNF-α gene and the development of end-stage renal disease: An evidence-based meta-analysis and trial sequential analysis
    (2025-01-01) Anumas S.; Tansawet A.; Numthavaj P.; Pattharanitima P.; Pabalan N.; Jarjanazi H.; Mongkolrob R.; Tasanarong A.; Tharabenjasin P.; Anumas S.; Mahidol University
    Tumor necrosis factor-alpha (TNF-α), is partly attributed to pathogenesis of end-stage renal disease (ESRD). Inconsistency of reported associations between TNF-α G-308A polymorphism (rs1800629) and ESRD prompted a meta-analysis to obtain more precise estimates. Eleven case-control studies from 11 articles were included. Pooled odds ratios (OR) and 95% confidence intervals (95% CIs) were estimated to evaluate the association. Subgroup analysis was based on ethnicity (Caucasian and Asian). Multiple comparisons were Bonferroni-corrected. Trial sequential analysis (TSA) was implemented to ascertain the reliability of results. Sensitivity analyses and publication bias tests were performed on significant results. There were no significant association (pa >0.05) in the overall and ethnic subgroup. Indians, three significant pool ORs (pa < 0.01-0.03) showed increased susceptibility to ESRD in homozygous (OR, 6.57; 95% CI, 1.45 to 29.75; pa = 0.01), recessive (OR, 6.75; 95% CI, 1.44 to 31.56; pa = 0.02), and codominant (OR, 2.06; 95% CI, 1.08 to 3.94; pa = 0.03) models. TSA indicated the robustness of such association in the Indian population. The main outcomes were robust without evidence of publication bias. This study showed associations between TNF-α G-308A and ESRD are confined to Indians, which are susceptible to ESRD up to approximately 7 times.
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    External validation and revision of Penn incisional hernia prediction model: A large-scale retrospective cohort of abdominal operations
    (2023-01-01) Tansawet A.; Numthavaj P.; Teza H.; Pattanateepapon A.; Piebpien P.; Poprom N.; Techapongsatorn S.; McKay G.; Attia J.; Sumritpradit P.; Thakkinstian A.; Mahidol University
    Background: Incisional hernia (IH) manifests in 10%–15% of abdominal surgeries and patients at elevated risk of this complication should be identified for prophylactic intervention. This study aimed to externally validate the Penn hernia risk calculator. Methods: The Ramathibodi abdominal surgery cohort was constructed by linking relevant hospital databases from 2010 to 2021. Penn hernia risk scores were calculated according to the original model which was externally validated using a seven-step approach. An updated model which included four additional predictor variables (i.e., age, immunosuppressive medication, ostomy reversal, and transfusion) added to those of the three original predictors (i.e., body mass index, chronic liver disease, and open surgery) was also evaluated. The area under the receiver operating characteristic curve (AUC) was estimated, and calibration performance was compared using the Hosmer–Lemeshow goodness-of-fit method for the observed/expected (O/E) ratio. Results: A total of 12,155 abdominal operations were assessed. The original Penn model yielded fair discrimination with an AUC (95% confidence interval (CI)) of 0.645 (0.607, 0.683). The updated model that included the additional predictor variables achieved an acceptable AUC (95% CI) of 0.733 (0.698, 0.768) with the O/E ratio of 0.968 (0.848, 1.088). Conclusion: The updated model achieved improved discrimination and calibration performance, and should be considered for the identification of high-risk patients for further hernia prevention strategy.
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    Fascial Dehiscence and Incisional Hernia Prediction Models: A Systematic Review and Meta-analysis
    (2022-12-01) Tansawet A.; Numthavaj P.; Techapongsatorn T.; Techapongsatorn S.; Attia J.; McKay G.; Thakkinstian A.; Mahidol University
    Background: Fascial dehiscence (FD) and incisional hernia (IH) pose considerable risks to patients who undergo abdominal surgery, and many preventive strategies have been applied to reduce this risk. An accurate predictive model could aid identification of high-risk patients, who could be targeted for particular care. This study aims to systematically review existing FD and IH prediction models. Methods: Prediction models were identified using pre-specified search terms on SCOPUS, PubMed, and Web of Science. Eligible studies included those conducted in adult patients who underwent any kind of abdominal surgery, and reported model performance. Data from the eligible studies were extracted, and the risk of bias (RoB) was assessed using the PROBAST tool. Pooling of C-statistics was performed using a random-effect meta-analysis. [Registration: PROSPERO (CRD42021282463)]. Results: Twelve studies were eligible for review; five were FD prediction model studies. Most included studies had high RoB, especially in the analysis domain. The C-statistics of the FD and IH prediction models ranged from 0.69 to 0.92, but most have yet to be externally validated. Pooled C-statistics (95% CI) were 0.80 (0.74, 0.86) and 0.81 (0.75, 0.86) for the FD (external-validation) and IH prediction model, respectively. Some predictive factors such as body mass index, smoking, emergency operation, and surgical site infection were associated with FD or IH occurrence and were included in multiple models. Conclusions: Several models have been developed as an aid for FD and IH prediction, mostly with modest performance and lacking independent validation. New models for specific patient groups may offer clinical utility.
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    Fine Particulate Matter Exposure and Risk of Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Post-Percutaneous Coronary Intervention (PCI) Patients: A Thai PCI Registry-Based Cohort Study
    (2026-01-01) Suppasilp C.; Angkananard T.; Rodis Wabina R.S.; Roongsangmanoon W.; Numthavaj P.; Charatcharoenwitthaya P.; Ingsathit A.; Vareesangthip K.; Srimahachota S.; Limpijankit T.; Sansanayudh N.; Thakkinstian A.; Suppasilp C.; Mahidol University
    Background: Major adverse cardiac and cerebrovascular events (MACCE) are critical clinical outcomes in patients undergoing percutaneous coronary intervention (PCI); however, evidence regarding the impact of fine particulate matter (PM2.5) on these outcomes remains limited. Methods: This retrospective cohort study included 22,188 Thai adults who underwent PCI to investigate the association between PM2.5 exposure and the incidence of MACCE. Baseline demographic, clinical characteristics, and comorbidities, with angiographic and procedural data, were collected. Cumulative PM2.5 exposure was estimated using satellite-derived data based on patients' residential locations over a 12-month follow-up period. The primary outcome was a composite MACCE endpoint. A multilevel survival model was employed to assess the association between PM2.5 exposure and MACCE, adjusting for potential confounding variables. Results: During the median follow-up of 11.97 months (ranging from 0.03 to 12 months), 6,382 patients (28.8%) experienced at least one MACCE. PM2.5 levels in Thailand exhibit a distinct seasonal pattern, peaking around February (Quarter 1; Q1) and reaching their lowest levels in Q3. In the final multivariable model, a 1 μg/m³ increase in PM2.5 exposure was associated with MACCE (adjusted hazard ratio (HR) 1.45 (95% CI: 1.37, 1.54)). The adjusted HR for PM2.5 comprising quarterly seasonal variations was as follows: 1.015 (95% CI: 1.005, 1.024) in Q4, 1.222 (95% CI: 1.132, 1.319) in Q1, 1.177 (95% CI: 1.096, 1.265) in Q2, and 1.500 (95% CI: 1.381, 1.629) in Q3. Conclusion: The study's findings suggested that higher seasonal PM2.5 exposure is associated with MACCE in patients who underwent PCI. These results underscore the urgent need for public health policies that focus on reducing PM2.5 to improve health outcomes and reduce the burden of the disease.
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    Frailty as a mediator of postoperative delirium in older adults undergoing orthopedic surgery: A causal mediation analysis
    (2024-12-01) Roopsawang I.; Aree-Ue S.; Thompson H.; Numthavaj P.; Roopsawang I.; Mahidol University
    Background: Postoperative delirium has a high prevalence in hospitalized older adults. Frail older adults have an increased risk for developing it. Preoperative pain—a common symptom in older adults with orthopedic conditions—shows a connection with frailty through an inflammatory process. However, an association among preoperative pain, frailty, and postoperative delirium remains unexplored among older adults undergoing orthopedic surgery. Objectives: To examine the magnitude, direction, and mediation effect of frailty on the association between preoperative pain and postoperative delirium among older adults undergoing orthopedic surgery. Design: A secondary analysis of a prospective cohort study. Setting and participants: A cohort of 200 older adults (60 years and older) who underwent major orthopedic surgery at a university hospital in Thailand was recruited for the study. Methods: Participants responded to the Demographic and Health Information Form, the Reported Edmonton Frailty Scale-Thai version, and the Thai version of the 4 A's test. Analyses were conducted using a causal mediation analysis with 95 % confidence intervals. Results: We found that 12.5 % of participants developed postoperative delirium. For the direct paths associated with postoperative delirium, statistically significant effects were observed for frailty, preoperative pain, and comorbidity. Considering frailty as a mediator of postoperative delirium, a significant positive indirect effect was identified from preoperative pain. Controlling for age and comorbidities, frailty mediated the association between preoperative pain and postoperative delirium in a statistically significant manner; the average direct effect was 0.014 (95 % confidence interval: 0.008–0.020), the average causal mediating effect was 0.002 (95 % confidence interval: 0.000–0.010), the total effects was 0.017 (95 % confidence interval: 0.010–0.020), and the probability mediation accounted for 14 % (95 % confidence interval: 0.031–0.300). Conclusion: Integrating the concept of age-related decline and frailty assessment may offer opportunities to provide disease-specific care and strengthen precision perioperative care, which ultimately enhance quality of life in older adults undergoing orthopedic surgery.