ABSTRACT
BACKGROUND: Placebo-controlled evidence from ORBITA-2 found that percutaneous cutaneous intervention (PCI) in stable coronary artery disease with little or no antianginal medication relieved angina, but residual symptoms persisted in many. The reason for this was unclear. OBJECTIVES: ; This ORBITA-2 secondary analysis investigates the relationship between presenting symptoms and disease severity (anatomic, non-invasive, and invasive ischemia) and the ability of symptoms to predict the placebo-controlled efficacy of PCI. METHODS: Pre-randomization symptom severity and nature were assessed using the ORBITA smartphone application and symptom and quality of life questionnaires including the Rose angina questionnaire. Disease severity was assessed using quantitative coronary angiography (QCA), stress echocardiography, fractional flow reserve (FFR), and instantaneous wave-free ratio (iFR). Bayesian ordinal regression was used. RESULTS: At pre-randomization, the median number of daily angina episodes was 0.8 (0.4-1.6), 64% had Rose angina, QCA diameter stenosis 61 (49-74), stress echocardiography score 1.0 (0.0-2.7), FFR 0.63 (0.49-0.75), and iFR 0.78 (0.55-0.87). There was little relationship between symptom severity and nature and disease severity: angina symptom score with QCA ordinal correlation coefficient 0.06 (95% CrI 0.00 to 0.08); stress echocardiography 0.09 (95% CrI 0.02 to 0.10); FFR 0.04 (95% CrI -0.03 to 0.07); and iFR 0.04 (95% CrI -0.01 to 0.07). However, Rose angina and guideline-based typical angina were strong predictors of placebo-controlled PCI efficacy (angina symptom score: OR 1.9, 95% CrI 1.6 to 2.1, Pr(Interaction)=99.9% and OR 1.8, 95% CrI 1.6 to 2.1, Pr(Interaction)=99.9%, respectively). CONCLUSIONS: Although symptom severity and nature were poorly associated with disease severity, the nature of symptoms powerfully predicted the placebo-controlled efficacy of PCI.
ABSTRACT
BACKGROUND: A pilot study was conducted to determine the effects of Spirulina (Arthrospira platensis) on Cretan patients with non-alcoholic fatty liver disease (NAFLD). Spirulina is a filamentous cyanobacterium taken as a dietary supplement. METHODS: Fifteen adult Cretan outpatients (13 men), median age 48 (range: 29-62) years, with NAFLD were orally supplemented with 6 g of Spirulina (Greek production) per day for six months. Anthropometric characteristics (height, weight, waist circumference), systolic and diastolic blood pressure, complete blood count, biochemical assessments, homeostasis model assessment of insulin resistance (HOMA-IR) index, health-related quality of life and abdominal sonographic findings were recorded and measured, before and after Spirulina supplementation. RESULTS: At the end of the 6-month intervention period, the mean levels of aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, triglycerides, low-density lipoprotein-cholesterol, total cholesterol, and the ratio of total cholesterol to high-density lipoprotein cholesterol were significantly decreased: 38.5%, 37.5%, 26.7%, 24.8%, 9.6%, 9.1%, and 13.5% respectively, whereas the mean levels of high-density lipoprotein-cholesterol and hemoglobin were significantly increased: 4.2% and 4.1% respectively. Spirulina supplementation resulted also in a significant reduction in weight and HOMA-IR index (8.1% and 19.6% respectively) and a significant improvement in health-related quality of life scale. No changes in sonographic findings were observed. CONCLUSION: Spirulina supplementation at a high dosage of 6 g daily in NAFLD patients has strong and multiple beneficial metabolic effects and improves their health-related quality of life.
