Studies have suggested that a number of phytotherapeutic products derived from the pollen extract of a variety of plants are of value in treating men with benign prostatic hyperplasia. Most of these studies have used Cernilton, a pharmaceutical product composed of the pollen extract from several plants grown in Sweden. The two principal active constituents of Cernilton are a water soluble fraction and an acetone soluble fraction containing three betasterols. Animal studies using Cernilton have demonstrated a significant decrease in the size of the prostate associated with epithelial cell atrophy, a decline in total and prostatic acid phosphatase levels, and an increase in zinc concentrations within the prostate. In addition, the water soluble fraction of Cernilton has been shown to inhibit the immortal human cell line growth in culture derived from prostate carcinoma. Finally, it has been shown that the hormone-stimulated growth of benign prostatic hyperplasia tissue transplanted into nude mice is significantly inhibited by Cernilton extract.

Clinical studies with Cernilton have included a double-blind, randomized trial in which 60 men awaiting surgery for benign prostatic hyperplasia were randomized to receive Cernilton or placebo for 6 months. No adverse effects or changes in hematologic parameters were seen in patients treated with this plant extract. Based on a modified Boyarsky symptom score, men treated with Cernilton showed statistically significant improvement in subjective symptoms compared to men in the control group (69% versus 29%, respectively, p < .009). When analyzed by individual voiding symptoms, only nocturia and a sense of incomplete emptying significantly improved in the men treated with Cernilton compared to those receiving placebo. Although no change in peak urinary flow rate or voided volume was noted in either group of patients, residual urine volume declined significantly in those men treated with Cernilton (mean 145 cc to 102 cc after 6 months) compared to controls (p = .025). Finally, based on transrectal ultrasound measurements performed prior to treatment and after 6 months, a small but statistically significant decrease in prostate size in patients receiving Cernilton was noted compared to those in the placebo group (p = .025).

The use of Cernilton has also been studied in men with chronic prostatitis and prostatodynia. In a non-randomized, open-label investigation, 90 men who had had symptoms for 1 year or more and had no evidence of bacterial infection received the pollen extract for 6 months. Subjective assessment of perineal pain, frequency, and dysuria were assessed as well as the results of digital rectal examination, white blood cell counts in expressed prostatic secretions, complement levels in the seminal fluid, and uroflowmetry. There was a favorable response seen in 78% (56 of 72) of those without complicating factors such as urethral strictures or bladder neck contracture, and complete resolution of all symptoms and signs of prostatitis was noted in 36% (26 of 72). Results were poor in those with complicating factors, with only 1 of 18 (6%) showing any significant improvement in subjective or objective outcome measures. Although these results suggest that there may be a role for Cernilton in men with nonbacterial prostatitis and pelvic pain syndromes, the lack of placebo controls in this study makes it difficult to draw conclusions regarding the efficacy of this agent.

Finally, the results of a study comparing Cernilton with the Pygeum extract Tadenan in men with symptomatic benign prostatic hyperplasia have been reported. Superior improvements in voiding symptoms, urine flow rate, and postvoid residual volume were noted among men treated with Cernilton.

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