• Ann. Intern. Med. · Oct 1993

    Randomized Controlled Trial Clinical Trial

    Efficacy of psyllium in reducing serum cholesterol levels in hypercholesterolemic patients on high- or low-fat diets.

    • D L Sprecher, B V Harris, A C Goldberg, E C Anderson, L M Bayuk, B S Russell, D S Crone, C Quinn, J Bateman, B R Kuzmak, and L D Allgood.
    • University of Cincinnati, Ohio.
    • Ann. Intern. Med. 1993 Oct 1; 119 (7 Pt 1): 545-54.

    ObjectivesTo determine the efficacy of psyllium in reducing serum cholesterol levels in patients on high- or low-fat diets.DesignDouble-blind, placebo-controlled, 16-week parallel trial. The study included an 8-week baseline period and an 8-week treatment period.PatientsHealthy men and women, 21 to 70 years old, with primary hypercholesterolemia (total serum cholesterol > or = 5.7 mmol/L [220 mg/dL]). Thirty-seven participants followed a high-fat diet and 81 participants followed a low-fat diet.InterventionParticipants were randomly assigned to either psyllium, 5.1 g twice a day, or placebo.MeasurementsFasting lipid and apolipoprotein concentrations, including direct low-density lipoprotein (LDL) cholesterol quantification; nutritional analyses of 4 days of 7-day food records to monitor dietary compliance; and physical examinations, clinical chemistry and hematologic studies, and urinalysis to assess treatment safety.Main ResultsPsyllium recipients in both the high- and low-fat diet groups showed small but significant decreases (P < 0.05) in total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Total cholesterol and LDL cholesterol levels decreased 5.8% and 7.2%, respectively, in psyllium recipients on high-fat diets and 4.2% and 6.4%, respectively, in psyllium recipients on low-fat diets. No significant difference was seen in LDL cholesterol response when psyllium recipients on low- and high-fat diets were compared (P > 0.2). No significant reductions in lipid levels were observed in placebo recipients. Based on the National Cholesterol Education Program LDL cholesterol classification system, 39% of the psyllium recipients improved in LDL cholesterol classification (P < 0.0001) compared with 20.3% of placebo recipients (P > 0.2).ConclusionsPsyllium produces a modest but significant improvement in total cholesterol and LDL cholesterol levels in persons on either low-fat or high-fat diets. Psyllium, when added to a prescribed low-fat diet, may obviate the need for typical lipid-lowering medications or may prove to be a valuable adjunct to other treatments in patients with moderately elevated LDL cholesterol levels.

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