Graminex - Products containing Flower Pollen Extract - Cernilton ® For the Treatment of Prostatic Congestion

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For the Treatment of Prostatic Congestion

Cernilton ® in a few words

Composition: 1 tablet contains: Graminaceae flower pollen extract - T60 (water-soluble extract) 60 mg, GBX (fat-soluble extract) 3 mg. Excipients

Indication: Acute and chronic irritation in the urogenital area with voiding difficulties:
Benign prostatic hypertrophy, acute and chronic non-bacterial prostatitis, prostatodynia, prostatovesciculitis, urethritis.

Effect: Cernilton ® inhibits the formation of edema and inflammation in the prostate by its decongestive effect. The prostate shrinks, residual urine decreases and urinary flow rate shows marked improvement.

Efficacy: Results of clinical studies with Cernilton ® demonstrate in patients with BPH a marked reduction in residual urine and prostate volume. The voiding difficulties are improved permanently.

Dosage: In chronic diseases, long-term therapy with 3x1 tablet Cernilton ® per day is recommended. If the symptoms become temporarily more severe, the daily dose should be increased to 3x2 tablets Cernilton ®.

Side effects and contraindications: None reported.

Presentation: Original packs of 80 tablets.

Cernilton ® - Mechanism of action:
Anticongestive effects I

Prostatic congestion: The cause of voiding difficulties

Inflammation of the prostate results in edema of the interstitial stromal tissue surrounding the acini and ducts of the gland leading to congestion and poor secretory drainage. The swelling of the prostate gland that ensues from this pathological process, which can affect the normal as well as the hyperplastic gland, causes difficulty with voiding, dysuria, frequency and nocturia. It accounts for the discomfort and pain of chronic non-bacterial prostatitis and prostatodynia.

Inhibition of the arachidonic acid cascade

The anticongestive action of Cernilton ® is based on the inhibition of the prostaglandin and leukotriene biosynthesis: the activities of both the 5-lipoxygenase and cyclo-oxygenase enzymes are markedly reduced and the arachidonic acid cascade is interrupted.

Inhibition of prostaglandin and leukotriene biosynthesis

Dose-dependent reduction of the prostaglandin and leukotriene synthesis in sheep seminal vesicle microsomes or RBL-1 cell cultures by the fat-soluble pollen extract fraction of Cernilton ® (7)

Cernilton ® - Mechanism of action:
Anticongestive effects II

The inhibition of the arachidonic acid cascade by Cernilton ® prevents intraprostatic tissue edema and fibrosis, and leads to a significant reduction in clinical symptoms (1-6, 8).

Inhibition of prostaglandin and leukotriene biosynthesis

Cernilton ® inhibits the cyclo-oxygenase and the 5-lipoxygenase and thus reduces the biosynthesis of prostaglandins and leukotrienes from arachidonic acid (7).

Prostatic congestion in BPH
Therapeutic success with Cernilton ®

Enlargement and congestion of the prostate gland are the principal factors responsible for the obstructive symptoms in patients with BPH. Histological examination of the gland shows that interstitial edema with an inflammatory cell infiltrate is a major contributory factor. The anti-inflammatory action of Cernilton ® is therefore, a pharmacologically effective therapeutic principle.

Anticongestive effect of Cernilton ®

The anticongestive effect of Cernilton ® leads to a marked reduction in prostate volume in stage II and III of BPH (Vahlensieck).

Shrinkage of the prostate

Transrectal ultra sonography of the prostate before and after six months treatment with Cernilton ®. Marked reduction of the circumference, transverse and a-p diameter of the prostate (4).

Voiding Difficulties in BPH
Therapeutic success with Cernilton ®

In BPH patients the decongestive effect of Cernilton ® leads to a lasting improvement of voiding difficulties. High response rates are also obtained in one of the main symptoms of BPH, namely nocturia.
Residual urine decreases, on average, by 47%; the superiority of Cernilton ® in comparison with placebo is significant.

Significant superiority of Cernilton ®

Parameter Active Drug Placebo Significance
P value

Clinical symptom

Response (%)

Nocturia 66.7 37.2 0.011

Frequency 6.9 37.0 0.023

Symptom-free (%)

Frequency 45.2 15.2 0.003

Sensation of incomplete emptying 38.2 3.8 0.005

Urodynamics

Volume

Residual urine

-- before therapy (ml: x ± s) 54.5 ± 24.9 51.9 ± 32.0

-- after therapy (ml: x ± s) 28.9 ± 19.7 44.9 ± 28.6 0.001

-- reduction (%) 47.0 13.5

Results of the double-blind study: Significant differences in favor of Cernilton ® in clinical symptomatology and urodynamics (2).

Urodynamics in BPH
Therapeutic success with Cernilton ®

The anticongestive effect of the Graminaceae pollen extract leads to marked improvement of the difficulties of micturition. The residual urine volume decreases significantly (1, 2, 4). The therapeutic evaluation confirms the superiority of the Cernilton ® therapy (1).

Reduction of the residual urine volume

Positive evaluation of therapeutic response

Course of the residual urine volume (ml) in BHP stage III. Significantly different and continuous decrease in the residual urine volume under treatment with pollen extract (1).

Significantly better evaluation of therapeutic response by clinician and patient in the pollen extract group (1).

Prostatic congestion in chronic non-bacterial
prostatitis: Therapeutic success with Cernilton ®

Prostatodynia

In most patients (60%) with symptoms of prostatitis the diagnosis of exclusion is prostatodynia. Discomfort and pain in the urogenital area and dysuria are the dominant symptoms. Expressed prostatic secretions and post-massage urine are free from leukocytes and bacteria.

High cure rate in prostatodynia

Cernilton ® leads to a marked improvement of the symptoms in 78% (average) of the patients, and to a complete cure in an average of 60% (8).

Marked improvement of the symptoms in prostatodynia (8) due to Cernilton ® (n=30)

Symptom Symptom-free Improved

Pain 52.4 % 76.2 %

Dysuria
60.0 %
76.7 %

Nocturia 57.1 % 92.9 %

Frequency 63.3 % 63.3 %

Discomfort 61.5 % 80.8 %

Chronic prostatitis

Chronic, non-bacterial prostatitis is the most common form of prostatic inflammatory diseases (80%). Chronic bacterial prostatitis is rare. Bacteria are detected in only 20% of all cases. The therapeutic effect of Cernilton ® in chronic prostatitis has been documented in various open as well as controlled studies. (3, 5, 6, 8).

Clinical findings in chronic prostatitis:
Therapeutic success with Cernilton ®

In patients with chronic prostatitis, normalization of the inflammatory condition and marked improvement of the voiding difficulties and the urinary flow rate are obtained with Cernilton ®.

Marked reduction of
the leukocyte count

Leukocyte count per ml of post-massage urine VB3 (median values) in patients with chronic non-bacterial prostatitis (without complicating factors) before, during and after six months' treatment with Cernilton ® (8).

Continuous increase of
the peak urinary flow rate

Peak urinary flow rate (x ± SEM) in patients with chronic non-bacterial prostatitis before, during and after 6 months' treatment with Cernilton ® (with and without consideration of complicating factors, n = 23, n = 6) (8).

Therapeutic spectrum of Cernilton ®
in prostatic congestion

In BPH, Cernilton ® is indicated primarily in stages II and III (with regular controls), after Vahlensieck. Cernilton ® can also be used in stage I for the prophylactic treatment of the congestion.
In patients with symptoms of prostatitis and positve evidence of pathogen(s), an antibacterial therapy is always indicated. Treatment with Cernilton ® is particularly successful if the expressed prostatic secretions and post-massage urine are free from bacteria and if no complicating factors (urethral structure, bladder neck sclerosis, large prostatic calculi) are present (8).

Differential diagnosis and treatment of patients with prostatic congestion

BPH Stage
(after Vahlensieck)
Peak flow rate
(ml) Residual Urine
(ml) Therapy

I.   Subclinical stage >15 - (Cernilton ®)

II.   Irritative stage
10-15
<50 Cernilton ®

III. Residual urine stage <10 >50 Cernilton ®

IV. Decompensation stage <10 >100 Surgery

Chronic prostatitis
Prostatodynia Expressed prostatic
secretions
(Post-massage urine)
Leukocytosis Pathogen(s)
in expressed secretions Therapy

Chronic bacterial prostatitis:
-- acute recurrence + + Antibacterial

--in the infection-free interval
   *with complicating factors + - Surgery, if necessary

*without complicating factors + - Cernilton ®

Chronic non-bacterial prostatitis:
-- with evidence of pathogen(s) + + Antibacterial

-- without evidence of pathogen(s)
   *with complicating factors + - Surgery, if necessary

   *without complicating factors + - Cernilton ®

-- Prostatodynia - - Cernilton ®

Summary

Cernilton ® is a standardized, allergen-free whole extract of selected Graminaceae pollen.
Cernilton ® is suitable for the long-term treatment of prostatic congestion in BPH, chronic prostatitis and prostatodynia.
Cernilton ® reduces prostatic volume and residual urine volume, and continually improves the voiding difficulties and the urinary flow rate in patients with BPH.
Cernilton ® leads to marked improvement in symptoms and clinical findings in 87.7% and 83.3% of patients with chronic non-bacterial prostatitis and prostatodynia, respectively. Discomfort and pain are eliminated and the number of leukocytes in the EPS (expressed prostatic secretion) and post-massage urine VB3 are significantly reduced.
Cernilton ®'s clinical effectiveness is scientifically documented by many long-term clinical studies.

Literature

Cernilton Studies

Becker H, Ebeling L, Konservative Therapie der benignen Prostata-Hyperplasie (BPH) mit CerniltonN. Urologe B28, 301-306,1988
Becker H, Ebeling L, Phytotherapie der BPH mit CerniltonN - Ergebnisse einer kontrollierten Verlaufsstudie. Urologe B31, 113-116,1991
Buck AC et al., Treatment of chronic prostatitis and prostatodynia with pollen-extract. British Journal of Urology 64, 496-499, 1989
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. British Journal of Urology, 66, 398-404,1990
Ebeling L, The therapeutic results of defined pollen extract in patients with chronic prostatitis or BPH accompanied by chronic prostatitis. In: Schmiedt E, Aiken JE, Bauer HW (eds) Therapy of Prostatitis. Zuckschwerdt Verlag, MOnchen, S. 154-160,1986
Leander G, A preliminary investigation on the therapeutic effect of CerniltonN in chronic prostatovesiculitis. Svenska Ldkartidningen 59 (45), 3296,1962
Loschen G, Ebeling L, Hemmung der Arachidons,;~ure-Kaskade durch einen Extrakt aus Roggenpollen. Arzneimittelforschung 41 (1), 162-167,1991
Rugendorff E et al., Results of Treatment with Pollen Extract (CerniltonN) in Prostatodynia and Chronic Prostatitis. British Journal of Urology, 1992 (in press)

Further Literature

Barbalias GA et al., Prostatodynia: Clinical and urodynamic characteristics. Journal of Urology 130 (3), 514-517,1983
Barbalias GA, Prostatodynia or painful male urethral syndrome? Urology 36 (2), 146-153, 1990
Boyarsky S et al., A new look at bladder neck obstruction by the Food and Drug Administration regulators: guide lines for investigation of benign prostatic hypertrophy. Transactions of the American Association of Genito-Urinary Surgeons 68, 29-32, 1977
Di Tranpani D et al., Chronic prostatitis and prostatodynia: Ultrasonographic alterations of the prostate, bladder neck, seminal vesicles and periprostatic venous plexus. European Urology 15 (3-4), 230-234,1988
Greenberg RN et al., Chronic prostatitis: Comments on infectious etiologies and antimicrobial treatment. Prostate 6 (4), 445-448, 1985
Habib F et al., Androgen metabolism in the epithelial and stromal components of the human hyperplastic prostate. Journal of Endocrinology 91, 23-32, 1981
Hinman F jr (ed), Benign prostatic hypertrophy. Springer-Verlag New York, Heidelberg, Berlin, 1983
Ireton RC, Berger RE, Prostatitis and epididymitis. Urologic Clinics of North America 11 (1), 83-94,1984
Krieger JN et al., Diagnostic considerations and interpretation of microbiological findings of evaluation of chronic prostatitis. Journal of Clinical Microbiology 27 (10), 2240-2244, 1989
Lancet, Medical treatment of benign prostatic hyperplasia. Lancet 1, 1083-1084, 1988
Orland SM et al., Prostatitis, prostatosis, and prostatodynia. Urology 25 (5), 439-459, 1985
Riedasch G et al., Antibody-coated bacteria in ejaculate in bacterial prostatitis. Urology 23 (3), 252-255,1984
Shortliffe LM, Prostatitis: Still a diagnostic and therapeutic dilemma. Western Journal of Medicine 139 (4), 542-544,1983
Thin RN, Simmons PD, Chronic bacterial and non-bacterial prostatitis. British Journal of Urology 55 (5), 513-518,1983
Vahlensieck W, Dworak 0, Abgrenzung der rezidivierenden Prostatakongestion von der chronischen Prostatitis (Delimination between recurrent congestion of the prostate and chronic prostatitis. Helvetica Chirurgica Acta 555 (3), 293-296,1988
Vahlensieck W, Rutishauser G (eds), Benign prostate diseases. G.Thieme-Verlag, Stuttgart, New-York, 1992
Weidner W et al., Chlarnydia trachomatis in 'abacterial' prostatitis: Microbiological, cytological and serological studies. Urologia Internationalis 28 (3), 146-149,1983
Weidner W, Moderne Prostatitisdiagnostik. Klinische und experimentelle Urologie 7,1-211, 1984
Wilson JD, The pathogenesis of benign prostatic hyperplasia. American journal of Medicine 68, 745-756,1980

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