Effect of Combining Psyllium Fiber With Simvastatin in Lowering Cholesterol: A clinical study
The present study was carried out to investigate the efficacy and safety of Combining Psyllium Fiber With Simvastatin in Lowering Cholesterol
Objective: Soluble fiber supplements are recommended to reduce levels of low-density lipoprotein cholesterol (LDL-C). We evaluated the LDL-C€“lowering effect of psyllium husk added to low-dose simvastatin therapy.
The study group comprised men (n = 40) and women (n = 28) aged 18 to 80 years, who met the NCEP ATP III criteria for drug treatment of hyperlipidemia and dietary intervention. All patients gave informed consent, and the Robert Wood Johnson Medical School Institutional Review Board approved the study. Patients were excluded if they had a body mass index (calculated as weight in kilograms divided by the square of height in meters) greater than 32, triglyceride levels greater than 400 mg/dL (>4.5 mmol/L), elevated liver enzymes aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the upper limit of normal, allergy to psyllium or known hypersensitivity to statins, or weight change within 5% of the baseline weight before randomization. Women with childbearing potential who were not using a birth control method and pregnant or lactating women were excluded. Patients taking medications that affect lipid levels, including corticosteroids, thiazides, Î²-blockers, estrogens, and progesterone, at doses that could not be stably maintained for the duration of the study were excluded. Patients using the calcium channel blocker verapamil hydrochloride and immunosuppressive drug therapy were excluded. Other exclusions were an active biliary disease, multiple lipid-lowering medications, myocardial infarction, coronary angioplasty, coronary artery bypass grafts, severe or unstable angina pectoris within 3 months before screening, uncontrolled hypertension, secondary causes of hyperlipidemia, type I or uncontrolled type II diabetes mellitus, unreliability as a study participant based on the investigator€™s prior knowledge of the subject, and any significant factor that compromised the patient€™s safety or compliance. Seventy-two patients were randomized to treatment, and 68 completed the study. One patient was excluded because of a protocol violation, and 3 patients withdrew consent.