Benign Prostatic Hyperplasia (BPH)
Reference: Berges RR, Windeler J, Trampisch HJ, et al. Randomized, placebo-controlled, double-blind clinical trial of ß-sitosterol in patients with benign prostatic hyperplasia. Lancet 1995; 345(8964):1529-32.
Study: In this double-blind clinical trial, 200 male patients (average age 65 years) with symptoms of benign prostatic hypertrophy, were randomized to receive 20 mg ß-sitosterol plus 0.2 mg ß-sitosterol glucoside or placebo three times a day for 6 months. The product employed in the trial was HarzolTM (distributed by Hoyer GmbH and Co, Germany) with each capsule containing 10 mg ß-sitosterol and 0.1 mg ß-sitosterol glucoside. Primary assessment of the study's outcomes was performed using a modified Boyarsky scale at monthly intervals. Secondary outcomes including International Prostate Symptom Score (IPSS), urine flow, residual urine volume, and other parameters of urinary flow plus prostate size were measured at 3 and 6 months. Laboratory values such as PSA, complete blood cell counts and a urine culture were performed at baseline and the conclusion of the study.
Results: Those patients employing ß-sitosterol and its glucoside had a significant reduction in their Boyarsky scores with an average decrease of 6.7 points compared to only 2.1 points in the placebo group after 6 months of therapy. IPSS scores also decreased in a similar fashion with average reductions of 7.4 and 2.1 points in the active and placebo groups respectively. This reduction in Boyarsky and IPSS scores were paralleled by the changes in urinary flow characteristics. For example, those patients employing HarzolTM not only had an increase in peak urinary flow from 9.9 to 15.2 ml/s but also experienced a reduction in mean residual urinary volume from 65.8 to 30.4 ml/s after 180 days of treatment. In addition, average voiding time decreased by 15.5 seconds in those utilizing HarzolTM compared to 2.8 seconds in the placebo group. Prostate volume was not affected in either group.
Clinical Summary: Both the HarzolTM and Moducare® products have their origins with the company Essential Sterolin Products in Midrand, South Africa. The HarzolTM product employed in this study by Berges et al contains the same active ingredients as found in Moducare®, namely ß-sitosterol and ß-sitosterol glucoside in a 100:1 ratio. However, unlike HarzolTM, each Moducare® capsule contains twice as much of the active ingredient (e.g. 20 mg ß-sitosterol and 0.2 mg ß-sitosterol glucoside). Thus patients with BPH may experience a significant change in their symptoms (e.g. better urinary flow, less urinary retention, and fewer night time awakenings) by employing the product Moducare® at a dose of one capsule three times a day for at least 6 months.
