Prapokklao Hospital

BackgroundA traditional Thai cannabis-based multi-herbal formulation is legally recognized in Thailand for therapeutic use and clinical research. However, clinical evidence supporting its use for insomnia remains limited.Methods This Phase II randomized, double-blind, active-controlled non-inferiority trial compared the efficacy and safety of the Anti-Pom-Leung Fever medicine with lorazepam in patients with chronic insomnia. One hundred participants were randomized to receive either the herbal formulation or lorazepam for 4 weeks. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Non-inferiority was evaluated at week 4 using a predefined margin of 2.1 based on the upper bound of the two-sided 95% confidence interval for the mean PSQI difference (experimental minus comparator). Longitudinal changes were analyzed using repeated-measures analysis of variance, and safety was evaluated through clinical and laboratory assessments.Results Eighty-two participants completed the study (41 per group). Baseline characteristics were comparable between groups. Both treatments significantly improved sleep quality over 4 weeks. At week 4, mean PSQI scores were 3.44 in the experimental group and 4.78 in the comparator group, with a mean difference of -1.34 (95% CI: -2.99 to 0.31), demonstrating non-inferiority. A significant main effect of time on PSQI scores was observed, with no significant time-by-treatment interaction. Quality of life and stress improved in both groups, and safety profiles were comparable, with no clinically significant adverse effects.Conclusions The traditional Thai cannabis-based multi-herbal formulation demonstrated non-inferior efficacy to lorazepam and was well tolerated, supporting its use as a short-term alternative for chronic insomnia.

BACKGROUND:The survival outcomes among children with acute myeloid leukemia (AML) in low- and middle-income countries are still poor despite adopting modern treatment regimens from developed countries. The study aimed to identify additional potential determinant factors for relapse and death among children with AML in Thailand. METHODS:In all, data from 282 children newly diagnosed with AML between 2015 and 2019 across Thailand were retrospectively reviewed. Data, including initial white blood cell numbers, genetic analysis, post-induction minimal residual disease (MRD), hematopoietic stem cell transplantation, and supportive care, were analyzed. RESULTS:The probability of 5-year, event-free survival, overall survival, and cumulative incidence of relapse were 40.5%, 42.3%, and 47.4%, respectively. The risk of death was significantly increased among patients stratified as high-risk AML with an adjusted hazard ratio (HR) of 1.8 (95% confidence interval [CI]: 1.1-2.9, p = 0.01). The accessibility to MRD was significantly associated with the risk of death with an adjusted HR of 1.7 (95% CI: 1.1-2.5, p = 0.01). Patients with low-risk AML did carry a significant risk for both death, with an adjusted HR of 1.8 (95% CI: 1.1-3.0, p = 0.02), and relapse, with an adjusted HR of 2.6 (95% CI: 1.5-4.7, p < 0.001) for initial WBC greater than 100,000/mm3. CONCLUSION:Elevated initial WBC numbers and accessibility to MRD could be considered additional risk factors for unfavorable outcomes in childhood AML.

Background:The World Health Organization recommends dolutegravir (DTG) as the anchor antiretroviral therapy (ART) drug for children with HIV. Methods:The ODYSSEY randomized trial evaluated DTG-based ART vs non-DTG standard of care (SOC) over 96 weeks in children starting first-line ART or switching to second-line. Participant follow-up was extended to 240 weeks; ART in extended follow-up was per national guidelines. Flexible parametric survival models estimated the proportion of participants with treatment failure on randomized allocation, accounting for treatment switches through censoring and inverse probability of censoring weights. Adverse events were analyzed in the intention-to-treat population. Results:ODYSSEY enrolled 792 participants (392 DTG, 400 SOC): 311 started first-line (SOC, 92% efavirenz) and 396 second-line (SOC, 98% ritonavir-boosted protease inhibitors). The median (range) age at enrollment was 11.4 years (0.1-18.0); weight was 28.7 kg (3.4-85.0); and 89% were from Africa. Median follow-up on randomized allocation was 286 weeks (IQR, 230-310) for DTG and 204 weeks (168-240) for SOC. Among SOC participants, 23% switched to DTG before 192 weeks, 65% before 240 weeks. By 240 weeks, 74 participants on DTG and 131 on SOC had treatment failure (estimated, 19% vs 34%; difference [DTG-SOC], -15%; 95% CI, -21% to -9%; P < .001). Treatment effects were similar between first- and second-line (P = .10). The proportions of participants with serious adverse events (52 DTG vs 53 SOC, P = .92) or grade ≥3 adverse events (98 DTG vs 121 SOC, P = .09) were similar by arm over 192 weeks. Conclusions:DTG showed superior efficacy vs SOC over 240 weeks in children, with no safety concerns.

Meningovascular syphilis, a type of neurosyphilis, causes stroke and various types of myelopathy. In recent years, there has been an increase in the incidence of neurosyphilis. However, diagnosing neurosyphilis remains challenging due to the reliance on serum and cerebrospinal fluid (CSF) testing, which has low specificity and sensitivity. Magnetic resonance vessel wall imaging (MR-VWI), recently developed to identify vessel wall pathologies, may aid in diagnosing neurosyphilis. In this cross-sectional study, we performed systematic screening for syphilis in all 366 patients with acute ischemic stroke or transient ischemic attack admitted to our stroke unit. Further CSF analysis and MR-VWI were specifically conducted only on those with reactive serum venereal disease research laboratory (VDRL) or treponema pallidum particle hemagglutination assay (TPHA) tests to evaluate neurosyphilis. Serum screening was reactive in 5.7% (21/366) of patients; among these, the prevalence of likely neurosyphilis (defined by abnormal CSF pleocytosis or protein levels) was 2.2% (8/366). Within this group of eight patients, MR-VWI was technically feasible and thus performed in six cases. Although all CSF-VDRL tests were non-reactive, MR-VWI identified diagnostic evidence of meningovascular syphilis (concentric wall thickening and enhancement) in 33.3% (2/6) of symptomatic patients who underwent the scan. Neurosyphilis remains a critical, treatable cause of stroke that can affect older patients with established vascular risk factors. Our findings demonstrate that routine serum screening is essential, as traditional CSF-VDRL tests may yield false-negative results. MR-VWI serves as a valuable adjunct tool to provide objective evidence of active vasculitis, guiding the initiation of appropriate antibiotic therapy when laboratory results are inconclusive.