METHODS/DESIGN: The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment.
DISCUSSION: This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC.
TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900023451. Registered on 28 May 2019.
METHODS: This is an open-label randomized controlled trial with 60 participants divided into 2 study groups in a 1:1 ratio. The intervention group will receive 12 weeks of Guolin Qigong intervention with a 4-week follow-up while control will receive usual care under waitlist. The primary outcome will be feasibility measured based on recruitment and retention rates, class attendance, home practice adherence, nature, and quantum of missing data as well as safety. The secondary subjective outcomes of fatigue, sleep quality and depression will be measured at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention), and Week-16 (4 weeks post-intervention) while an objective 24-hour urine cortisol will be measured at Week-1 (baseline) and Week-12 (post-intervention). We will conduct a semi-structured interview individually with participants within 3 months after Week-16 (4 weeks post-intervention) to obtain a more comprehensive view of practice adherence.
DISCUSSION: This is the first mixed-method study to investigate the feasibility and effect of Guolin Qigong on breast, lung, and colorectal cancer survivors to provide a comprehensive understanding of Guolin Qigong's intervention impact and participants' perspectives. The interdisciplinary collaboration between Western Medicine and Chinese Medicine expertise of this study ensures robust study design, enhanced participant care, rigorous data analysis, and meaningful interpretation of results. This innovative research contributes to the field of oncology and may guide future evidence-based mind-body interventions to improve cancer survivorship.
TRIAL REGISTRATION: This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: 2022323-11092) and recognized by Western Sydney University Human Research Ethics Committee (RH15124).
METHOD: Potential miRNAs associated with NAFLD in HCC tumorigenesis were identified through a systematic review, and their roles were evaluated by data mining analysis. The biological function of the potential miRNA and its target genes in NAFLD and HCC were evaluated by bioinformatic analysis.
RESULT: MIR122 was identified as the potential miRNA associated with NAFLD and HCC. Then, MIR122 expression was significantly lower in HCC patients, and higher MIR122 levels were associated with significantly better overall survival. Next, the biological functions of MIR122 and target genes were predicted to be involved in inflammation, fibrosis, cell proliferation, invasion, metastasis, and apoptosis. In particular, the FOXO signaling pathway may regulate the above biological functions.
CONCLUSION: MIR122 was suggested to be involved in progressing from NAFLD to HCC through the PI3K/AKT/FOXO pathway.
SYSTEMATIC REVIEW REGISTRATION: PROSPERO, identifier: CRD 42024517940.
METHODS: We searched PubMed, Web of Science, Cochrane, Embase, and SPORTDiscus from database establishment to 5 February 2024 to identify randomized controlled trials (RCTs) evaluating the effects of different dietary supplements on athletic performance in soccer players. The risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials. A Bayesian network meta-analysis was performed using the R software and Stata 18.0. A subgroup analysis was conducted based on the competitive level of the athletes.
RESULTS: Eighty RCTs were included, with 1,425 soccer players randomly receiving 31 different dietary supplements or placebo. The network meta-analysis showed that compared with placebo, carbohydrate + protein (SMD: 2.2, very large), carbohydrate + electrolyte (SMD: 1.3, large), bovine colostrum (SMD: moderate) and caffeine (SMD: 0.29, small) were associated with a significant effect on increasing the distance covered. Kaempferia parviflora (SMD: 0.46, small) was associated with a significant effect on enhancing muscular strength. Beta-alanine (SMD: 0.83, moderate), melatonin (SMD: 0.75, moderate), caffeine (SMD: 0.37, small), and creatine (SMD: 0.33, small) were associated with a significant effect on enhancing jump height. Magnesium creatine chelate (SMD: -3.0, very large), melatonin (SMD: -1.9, large), creatine + sodium bicarbonate (SMD: -1.4, large), and arginine (SMD: -1.2, moderate) were associated with a significant effect on decreasing sprint time. Creatine + sodium bicarbonate (SMD: -2.3, very large) and caffeine (SMD: -0.38, small) were associated with a significant effect on improving agility. Sodium pyruvate (SMD: 0.50, small) was associated with a significant effect on increasing peak power. Magnesium creatine chelate (SMD: 1.3, large) and sodium pyruvate (SMD: 0.56, small) were associated with a significant effect on increasing mean power. Carbohydrate + electrolyte (SMD: -0.56, small) was associated with a significant effect on improving the rating of perceived exertion.
CONCLUSIONS: This study suggests that a range of dietary supplements, including caffeine, creatine, creatine + sodium bicarbonate, magnesium creatine chelate, carbohydrate + electrolyte, carbohydrate + protein, arginine, beta-alanine, bovine colostrum, Kaempferia parviflora, melatonin, and sodium pyruvate, can improve athletic performance in soccer players. This review provides evidence-based guidance for soccer coaches and nutritionists on using dietary supplements to enhance specific performance measures.