Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2): protocol for randomized controlled trial.

BACKGROUND: In a pilot study using both cannabidiol (CBD) and tetrahydrocannabinol (THC) as single agents in advanced cancer patients undergoing palliative care in Thailand, the doses were generally well tolerated, and the outcome measure of total symptom distress scores showed overall symptom benefit. The current study aims to determine the intensity of the symptoms experienced by breast cancer patients, to explore the microbiome profile, cytokines, and bacterial metabolites before and after the treatment with cannabis oil or no cannabis oil, and to study the pharmacokinetics parameters and pharmacogenetics profile of the doses. METHODS: A randomized, double-blinded, placebo-controlled trial will be conducted on the breast cancer cases who were diagnosed with breast cancer and currently receiving chemotherapy at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. Block randomization will be used to allocate the patients into three groups: Ganja Oil (THC 2 mg/ml; THC 0.08 mg/drop, and CBD 0.02 mg/drop), Metta Osot (THC 81 mg/ml; THC 3 mg/drop), and placebo oil. The Edmonton Symptom Assessment System (ESAS), Food Frequency Questionnaires (FFQ), microbiome profile, cytokines, and bacterial metabolites will be assessed before and after the interventions, along with pharmacokinetic and pharmacogenetic profile of the treatment during the intervention. TRIAL REGISTRATION: TCTR20220809001.

Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial.

OBJECTIVE: To compare the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia. DESIGN: Randomised, double blind controlled trial, with central randomisation. SETTING: Thai traditional medicine hospital, district hospital, and university hospitals in Thailand. PARTICIPANTS: Participants with a diagnosis of functional dyspepsia. INTERVENTIONS: The interventions were curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days. MAIN OUTCOME MEASURES: Functional dyspepsia symptoms on days 28 and 56 were assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events. RESULTS: 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (-4.83, -5.46 and -6.22), non-pain (-2.22, -2.32 and -2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (-7.19, -8.07 and -8.85), non-pain (-4.09, -4.12 and -3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred. CONCLUSION: Curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect. TRIAL REGISTRATION NUMBER: TCTR20221208003.

Prevalence and Factors Associated with Frailty and Cognitive Frailty Among Community-Dwelling Elderly with Knee Osteoarthritis.

Physical frailty and cognitive impairment are risk factors for adverse outcomes in older people with osteoarthritis of the knee (knee OA). This cross-sectional study was conducted to determine the prevalence and associated factors of frailty and cognitive frailty among community-dwelling older patients with knee OA in four representative cities of Thailand. Data composed of three parts, Part 1: Demographic data, Part 2: The assessment of frailty by Fried phenotype and cognitive function by MiniCog and Part 3: The assessment of factors associated with frailty. Of 780 elders (mean age, 69.4 ± 6.9 years) screened, 101 (12.9%) were classified to be frail, 511 (65.6%) pre-frail and 168 (21.5%) non-frail. The prevalence of cognitive frailty was 2.44%. The correlation between physical activity rated by the Global Physical Activity Questionnaire (GPAQ) and self-rated methods was high (kappa 0.721; p < 0.001). Self-rated physical activity yielded similar prevalence of frail (9.4%), pre-frail (69.1%) and non-frail (21.5%). In multivariate analysis, aging (OR 3.42; 95% CI 1.16-10.11), severe knee OA symptoms (OR 18.96; 95% CI 3.53-101.65), malnutrition (OR 2.50; 95% CI 1.23-5.09), and functional dependence (OR 3.94; 95% CI 1.19-13.03) were associated with frailty. The prevalence of frailty and pre-frailty was high in knee OA and associated with aging, severe knee OA symptoms, malnutrition, and functional dependence, whereas the prevalence of cognitive frailty was not uncommon in community-dwelling elderly. Physical activity rated by the GPAQ and self-rated methods were highly correlated. Self-rated physical activity may be used in community surveys of frailty.