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Randomized, placebo-controlled, double blind clinical trial of b-sitosterol in patients with benign prostatic hyperplasia
This is a randomized, double blind, placebo-controlled, multi-center study of 200 men with BPH (benign prostatic hyperplasia) treated with the phytosterol, B-sitosterol. Two hundred men were selected and followed for 6 months using a variety of lab tests, and subjective and objective symptom indicators for BPH. Half the group received the active treatment, 20 mg B-sitosterol three times daily and the other half received the placebo. The results indicate that the group treated with B-sitosterol improved in both subjective symptoms of BPH and the objective measurement of improved urine flow. These results occurred independent of a reduction in actual prostate size. Only minor side effects were observed with the phytosterol treatment group compared to the more toxic side effects associated with the 5-alpha-reductase inhibitor drugs such as finasteride. No mechanism for the effects of B-sitosterol on the prostate has been elucidated as yet. This study indicates that traditional herbal treatment of BPH with saw palmetto; pygeum africanus and pumpkin seeds may be attributable to the phytosterol content of these herbs. A German herbal preparation sold for the last 20 years under the trade name Harzol for the treatment of BPH contains a mixture of phytosterols including B-sitosterol.
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