2.3. Procedures
Adverse drug reactions, NMS
ADVERSE REACTIONS, NMS, ADVERSE EVENT, ADVERSE EFFECTS, BLOOD, ADVERSE DRUG REACTION
A total of 2300 volunteers were initially assessed at Jing Yuan County Hospital of Traditional Chinese Medicine, and 113 eligible patients were enrolled. Patients received oral natto and monascus capsules (975 mg twice daily, NMS (a fermented product containing nattokinase 2500 fibrinolytic units (FUs) derived from natto and lovastatin 7 mg derived from RYR, NMS group); or matching placebo (975 mg twice daily, main containing starch, placebo group) for 120 days (55 and 58, respectively). NMSs and placebo were identical in taste, smell, and appearance. All staff and researchers were blinded to the group assignments until the end of the experiment. Subjects were asked to return for a questionnaire (including food frequency and physical activity), physical examination, electrocardiogram (ECG), and fasting blood drawings at baseline and at two follow-up times. Carotid artery thickness B-ultrasound was completed at baseline and at 120 days. Blood samples were tested in the hospital laboratory. Biochemical analyses were performed using Beckman Coulter AU680 automatic biochemical analyzer or Mindray CL-2000i. Blood routines were tested in the Mindray BC-900. Coagulations were tested in Coatron 3000, Germany. Non-HDL-C = TC − HDL-C [The safety of our subjects during the study was monitored through laboratory assessments and physical examinations, including regular measurements of blood uric acid, aspartate transaminase (AST), alanine transaminase (ALT), coagulation, and other blood biochemical and routine data. Any adverse effects reported during interviews with professional researchers were also documented. Adverse drug reactions were judged by investigators according to Karch and Lasagna’s 5 criteria of adverse reactions. Adverse events were defined as those occurring after the first dose of the intervention.