Phytosterols are a class of compounds that have been suggested to be the most important component of several phytotherapeutic products used for treating benign prostatic hyperplasia. Phytosterols are derived from a number of plants, including Hypoxis rooperi (South African star grass). There have been a variety of mechanisms proposed by which  phytosterols may improve voiding symptoms, including 5 a-reductase inhibition, anti-inflammatory effects, antiandrogenic actions, growth factor inhibition, antiestrogenic effects, and others. Beta-sitosterol has been suggested to be the most important phytosterol in treating voiding symptoms secondary to benign prostatic hyperplasia.

Harzol is a prescribable phytotherapeutic product manufactured in Germany. This agent is composed of a mixture of phytosterols that include primarily beta-sitosterol as well as smaller amounts of campesterol, stigmasterol, and other compounds. Although it has been suggested that beta-sitosterol is the most important active component of Harzol, it is not known which compounds are responsible for its effect on men with benign prostatic hyperplasia. Following initial study suggesting an improvement in urinary symptoms and flow rates in patients with benign prostatic hyperplasia treated with Harzol, Berges et al. published the results of a randomized, multicenter, placebo-controlled trial. In this study, 200 men with symptomatic benign prostatic hyperplasia were treated with Harzol or placebo three times per day for 6 months. Among men receiving Harzol, the International Prostate Symptom Score (IPSS) improved from a mean of 14.9 to 7.5 while those treated with placebo showed a mean symptom score improvement from 15.1 to 12.8 (p < .01). Similarly, mean peak urinary flow rate increased from 9.9 to 15.2 cc per second in the Harzol group, compared to 10.2 to 11.4 cc per second among controls (p < .01). There was also a significant decrease in postvoid residual urine volume seen in men treated with Harzol compared to controls. No severe adverse effects were noted secondary to Harzol, and there was no significant change in prostate volume.

Other studies concerning the use of phytosterol preparations composed primarily of beta-sitosterol have also been presented. Klippel et al. randomized 177 men with benign prostatic hyperplasia to receive Azuprostat, a phytosterol preparation marketed in Europe, or placebo for 6 months. In results presented at the 4th International Consultation on benign prostatic hyperplasia in 1997, there was a significant difference in IPSS improvement between men receiving Azuprostat and those receiving placebo (5.4 points, p < .01). In addition, the difference in peak urinary flow rate improvement (4.5 cc per second) and reduction in postvoid residual volume (33.5 cc) also indicated a significantly better response to the plant extract than to placebo.

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