By Darren M. Lynch, MD
Benign prostatic hyperplasia (BPH) is a common disorder, with increasing incidence reported with advancing age. Population studies show the frequency of moderate-to-severe BPH symptoms to be 8-31% of men in the fifth decade and up to 44% of men in the seventh decade.1 Treatment options for symptoms include medications, surgery, and botanical treatments, the latter being most common in Europe but enjoying increasing popularity in the United States. Use of plant extracts for the treatment of BPH was described as far back as 15th century BC Egypt.2
Diagnosis and Treatment Guidelines
Clinical practice guidelines for BPH were published in 1994 by the Agency for Health Care Policy and Research.3 Diagnosis is presumptive and is based on a constellation of both obstructive and irritative voiding symptoms. Obstructive symptoms include decreased force of or interrupted urinary stream, straining to void, sensation of incomplete emptying, and urinary hesitancy. Irritative symptoms include urinary frequency, nocturia, and urgency. Interestingly, prostatic enlargement is not necessary for the diagnosis of BPH, as prostate size has not been found to correlate with degree of obstruction or severity of symptoms.4
Chronic nonbacterial prostatitis and prostatodynia are difficult entities to treat. Chronic nonbacterial prostatitis has an unknown etiology and may represent a non-infectious inflammatory disorder. Diagnosis is based on symptoms in the absence of infectious etiology, including irritative voiding symptoms and perineal or suprapubic discomfort. Prostatodynia is a non-inflammatory disorder affecting young and middle-aged men with symptoms similar to chronic prostatitis, as well as hesitancy and possibly interruption of flow. According to Watson and Irwin, the term prostatodynia is used to designate any unexplained complaints of chronic pelvic pain associated with nonspecific voiding symptoms and/or pain located in or around the groin, genitalia, or perineum, or the absence of pyuria and bacteriuria, with or without excess white cells or bacteria, on results from Gram stain and culture of expressed prostatic secretions in male patients.5 Voiding dysfunction or pelvic floor muscular impairment may be the underlying pathophysiology. Both illnesses present viable opportunities for use of botanical treatments, like rye grass pollen, as conventional medical therapies have not proven to be wholly effective.
Constituents and Formulation
The most commonly used and studied rye grass pollen extract product for BPH is Cernilton, prepared from the Swedish rye grass pollen Secale cereale. Cernilton is used by millions of men worldwide and is a registered pharmaceutical product throughout Western Europe, Japan, Korea, and Argentina. The extract is prepared through microbial digestion of rye grass pollen, followed by water and acetone extraction. Cernilton is composed of 60 mg of a water-soluble fraction (Cernitin T60) and 3 mg of an acetone-soluble fraction (Cernitin GBX) per tablet. Pollen extracts have been found to contain at least 21 amino acids, as well as enzymes, coenzymes, sterols, minerals, trace elements, and all known vitamins. Gas chromatography studies found the Cernitin GBX fraction to contain phytosterols and fatty acids, including alpha-linoleic acid.
Mechanism of Action
The mechanism of action of rye grass pollen is not completely understood, although a number of mechanisms have been proposed regarding its beneficial effects on the prostate. In vitro studies have shown the water-soluble fraction T60 to inhibit the growth of prostate cancer cell lines and primary cultures from BPH specimens.6 Other in vitro data raise the possibility of anti-prostaglandin and anti-leukotriene actions by inhibiting the arachidonic acid cascade.7 Animal studies have demonstrated a significant reduction in rat prostate size following three weeks of therapy,8 as well as a contractile effect on the bladder and a relaxing effect on the urethra in mice and pigs.9
Clinical Studies
Two systematic reviews of rye grass pollen for BPH have been published. A 2002 Cochrane Systematic Review of rye grass pollen for BPH found human trials to be limited by short duration, limited number of enrollees, gaps in reported outcomes, and unknown quality of the preparations utilized.10 However, the authors concluded that the available evidence suggests rye grass pollen is well-tolerated and modestly improves urologic symptoms including nocturia. Additional randomized controlled trials were deemed necessary to evaluate long-term clinical effectiveness and safety of rye grass pollen. These findings echoed those published in the initial systematic review a few years earlier.1
Two published trials supporting the use of rye grass pollen in BPH are not available in English and, therefore, were not fully reviewed by the author. The first was a German double-blind, placebo-controlled study of 103 patients followed for 12 weeks, with findings of statistically significant improvements in nocturia and post-void residual urine.11 The second was a double-blind Japanese trial comparing two proprietary brands of rye grass pollen, Cernilton and Paraprost, the latter being a pharmacological treatment for BPH used primarily in Japan and containing a mixture of amino acids. The investigators found statistically significant self-reported improvement of symptoms in the Cernilton group.12
The most rigorous English language double-blind, placebo-controlled study of rye grass pollen for BPH was published in 1990.13 Sixty patients awaiting operative treatment for outflow obstruction due to benign prostate enlargement were entered into the six-month study. The study dose was 2 tablets of Cernilton twice daily. Subjective assessment was based on the Boyarsky scoring scale for symptoms of frequency, urgency, hesitancy, intermittency, incomplete emptying, terminal dribbling, and dysuria, with a score of 0-3 for each of these symptoms. Objective criteria for the evaluation of outflow obstruction were urine flow rate, voided volume, ultrasound measurement of residual urine, and transrectal ultrasound measurement of prostate size. Fifty-three patients were evaluated at the end of the six-month trial, 29 in the Cernilton arm and 24 in the placebo arm, with findings of statistically significant subjective improvement in 69% of patients. Significant decreases were noted in both residual urine volume and ultrasound determined antero-posterior diameter of the prostate. No significant differences were detected in flow rate and voided volume.
Subsequent papers also report positive effects of rye grass pollen on BPH. One open study included 79 patients with mild or moderate symptomatic BPH.14 Subjective assessment was based on the same Boyarsky scoring scale for symptoms, with an average baseline score of 9.6. Maximum flow rate, average flow rate, residual volume, and mean prostatic volume on transrectal ultrasonography were other measured baseline characteristics. The dose of Cernilton pollen extract was 2 tablets three times daily for more than 12 weeks, with substantial improvement noted in nearly all irritative symptoms, no changes in prostatic volume or urine volume, and no adverse reactions reported. Twenty-eight patients who achieved good results with short-term treatment continued treatment for more than a year, with subsequent findings of decreased prostatic volume and further reductions in symptom score and residual volume. The results of this study are difficult to extrapolate, however, as no statistical analysis was performed and there was no control group.
Another study involved 89 BPH patients, 51 of whom received Cernilton and 38 who received Tadenan (Pygeum africanum, traditionally used in Europe for BPH) over a four-month period.15 The two groups were compared using a subjective symptoms score devised by the author and objective evaluation by physical exam, uroflowmetry, and ultrasound determination of residual urine and prostate size. Subjective improvement was found in 78% of the Cernilton group compared to 55% of the Tadenan-treated group. Improvements also were noted in urine flow rate, residual urine volume, and prostate size. Again, no statistical analysis was performed, raising questions about the significance of the study. It is interesting that Cernilton outperformed a more widely recognized botanical BPH treatment.
Two studies have evaluated the treatment of chronic prostatitis and prostatodynia with pollen extract. The first was an open trial of 15 patients with either diagnosis suffering with symptoms for periods ranging from five months to seven years.16 Nearly all complained of irritative urinary symptoms, mainly dysuria and frequency, and all complained of pain or discomfort. Duration of treatment lasted from one to 18 months. Complete resolution of symptoms was found in seven of 15 patients and another six patients were markedly improved. Most patients (11/15) did not experience improvement in signs and symptoms until three months after starting treatment.
A larger study of 90 patients treated with 1 tablet of Cernilton three times daily for six months was subsequently conducted.17 The patients were divided into two groups: those without associated complicating factors (n = 72) and those with complicating factors, such as urethral strictures, prostatic calculi, and bladder neck sclerosis (n = 18). This division was employed because of significant differences at initial presentation and in response to treatment. Subjective symptoms of discomfort, nocturia, frequency, and dysuria, as well as findings from digital rectal prostate exams and uroflowmetry, were recorded at baseline, three months, and six months. Other measurements included urine leukocyte counts and measurement of complement C3/ceruloplasmin in the ejaculate, regarded as an extremely sensitive index of inflammation within the prostate.
Patients with associated complicating factors responded poorly to treatment. Both symptoms and urine flow measurements improved in the group without complicating factors; there was an overall positive clinical response in 56 of 72 of these patients. Complement C3/ceruloplasmin levels were reduced as well, suggesting an anti-inflammatory mechanism. Again, lack of statistical analysis and absence of a control group make the results of this study difficult to apply widely.
Adverse Effects
Adverse effects were not reported in any of the aforementioned studies.
Dosage
Dosing was different in nearly every study mentioned, but Graminex, the manufacturer of Cernilton, lists 6 tablets daily as the recommended dose for prostate conditions.
Conclusion
Rye grass pollen extract appears to be a safe, well-tolerated, and moderately effective botanical treatment for use in prostate disorders, with some studies following patients for as long as 12 months. More extensive evidence supports its use for BPH than for chronic prostatitis or prostatodynia, though the relative lack of effective treatments for these latter conditions makes the use of rye grass pollen extract compelling. The effect of rye grass pollen on development of urinary retention or need for surgery with BPH has yet to be determined. More rigorous controlled studies are needed to fully assess the efficacy of rye grass pollen extract in prostate disorders.
Recommendation
Rye grass pollen can be an effective, evidence-based herbal treatment for prostate disorders; however, long-term safety data are lacking.
Dr. Lynch is a Fellow in Integrative Medicine, Continuum Center for Health and Healing, Beth Israel Medical Center, New York, NY.
References
1. MacDonald R, et al. A systematic review of Cernilton for the treatment of benign prostatic hyperplasia. Br J Urol Int 1999;85:836-841.
2. Lowe FC, Ku JC. Phytotherapy in treatment of benign prostatic hyperplasia: A critical review. Urology 1996; 48:12-20.
3. McConnell JD. Benign prostatic hyperplasia: Diagnosis and treatment. Benign Prostatic Hyperplasia Guideline Panel. Clinical practice guideline no. 8, publication no. 94-0582. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, 1994.
4. Dull P, et al. Managing benign prostatic hyperplasia. Am Fam Physician 2002;66:77-84.
5. Watson RA, Irwin RJ. Prostatodynia. Available at: www.emedicine.com. Accessed Sept. 1, 2003.
6. Habib FK, et al. In vitro evaluation of the pollen extract, cernitin T-60, in the regulation of prostate cell growth. Br J Urol 1990;66:393-397.
7. Loschen G, Ebeling L. Inhibition of arachidonic acid cascade by extract of rye pollens [in German]. Arzneimittelforschung 1991;41:162-167.
8. Ito R, et al. Cernitin pollen extract (Cernilton); antiprostatic hypertrophic action of Cernitin pollen extract (Cernilton). Pharmacometrics 1986;31:1-11.
9. Kimura M, et al. Micturition activity of pollen extract: Contractile effects on bladder and inhibitory effects on urethral smooth muscle of mouse and pig. Planta Medica 1986;2:148-151.
10. Wilt T, et al. Cernilton for benign prostatic hyperplasia. Cochrane Database Syst Rev 2003;(1): CD001423.
11. Becker H, Ebeling L. Konservative therapie der benignen prostata-hyperplasie (BPH) mit Cernilton N. Urologe B 1988;28:301-306.
12. Maekawa M, et al. Clinical evaluation of Cernilton on benign prostatic hypertrophy—a multiple center double-blind study with Paraprost. Hinyokika Kiyo 1990;36:495-516.
13. Buck AC, et al. Treatment of outflow tract obstruction due to benign prostatic hyperplasia with the pollen extract, cernilton. A double-blind, placebo-controlled study. Br J Urol 1990;66:398-404.
14. Yasumoto R, et al. Clinical evaluation of long-term treatment using cernitin pollen extract in patients with benign prostatic hyperplasia. Clin Ther 1995; 17:82-87.
15. Dutkiewicz S. Usefulness of Cernilton in the treatment of benign prostatic hyperplasia. Int Urol Nephrol 1996;28:49-53.
16. Buck AC, et al. Treatment of chronic prostatitis and prostatodynia with pollen extract. Br J Urol 1989;64: 496-499.
17. Rugendorff EW, et al. Results of treatment with pollen extract (Cernilton N) in chronic prostatitis and prostatodynia. Br J Urol 1993;71:433-438.
Lynch DM. Rye grass pollen for benign prostatic hyperplasia, protatitis, and prostatodynia. Altern Med Alert 2003;6(10):109-112.
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