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Possibilities and Limitations of Phytotherapy for Benign Prostatic Flower Pollen Extract and its Effect on the Prostate Possibilities and Limitations of Phytotherapy for Benign Prostatic Hyperplasia (BPH) Results of Treatment with Cernilton® N for Stages 1-3 according to Alken (or II-IV according to Vahlensieck) D. Bach, L. Ebeling Introduction The importance of phytotherapeutic drugs with a low side effect profile has Surgical treatment (transurethral resection consequently increased in regard to the or open surgical enucleation of the conservative treatment of BPH, which at adenoma) of benign prostatic hyperplasia least in Germany is mainly the responsibility (BPH) is still the only curative therapy and of nonhospital-affiliated physicians. In recent therefore the "gold standard" for the years a standardized pollen extract treatment of BPH. Other treatment (Cernilton ®N1 ) has been investigated modalities have to be judged according to (5,6,9) and utilized. This pollen extract has this standard. Despite all improvements in also been utilized to treat prostatic surgical technique and modern congestion and/or prostatodynia and non- anesthesiology, a perioperative mortality bacterial prostatitis without proven rate of 0.2% and an increased delayed pathogens (8). The anticongestive effect of mortality due to cardiovascular diseases the pollen extract in the treatment of BPH remains a significant risk factor (19). should be considered as a clinically relevant Furthermore, other possible complications of therapeutic principle. surgery such as urinary incontinence, erectile impotence, or retrograde ejaculation To examine the value of treatment of BPH are not acceptable to some patients. with phytotherapeutic drugs in clinical practice, a study was conducted in BPH Despite extensive investigation into the patients to determine efficacy and tolerance endocrinological control of the growth of the of the pollen extract in the various stages of prostate, the etiology of the pathological disease. enlargement of this gland has not yet been definitely resolved. As a target organ for Patients and Methods male steroid hormones, the prostate is under the influence of dihydrotestosterone Patients and 17ß-estradiol, which act in particular synergistically on the growth of the Over the course of one year, 208 practicing fibromuscular stroma. This explains why physicians documented their treatment antiandrogens may be useful in the experiences using Cernilton® N in 1,933 treatment of BPH (4,20). Because of the patients with BPH. Because of missing adverse effects of antiandrogens such as follow-up examinations or premature disturbances of libido and erectile function termination of either treatment or as well as gynecomastia, this therapeutic documentation not related to the treatment ® principle has thus far not been utilized with Cernilton , data on only 1,894 patients widely, and is only used for certain patients were available for analysis. An additional 96 such as those at prohibitive surgical risk. cases which were not classified in regard to Other treatment attempts such as the the stage of the disease were also excluded inhibition of the enzyme 5alpha-Reductase from the analysis. In seven of these patients require further studies concerning efficacy treatment was terminated after the 12th and adverse effects (14). week. 24 weeks of treatment. Irritative and The patient material included therefore 1,798 patients with consecutive treatment obstructive symptoms (nocturia, frequency, over 24 weeks (2 tablets orally 3 times feeling of incomplete emptying, urgency, delayed voiding, prolonged voiding time, daily). In 1,661 patients pretreatment weak urinary stream, and post-void evaluations and evaluations after 12 and 24 dribbling) were classified as either mild, weeks of treatment were available, while in moderate, or severe. 29 patients data were available for the pretreatment evaluation and after 24 weeks Size and congestion of the prostate were of treatment with Cernilton® N. In 51 patients evaluated by digital rectal examination the treatment was terminated because of (DRE). Residual urine volume was symptomatic improvement (N = 11), lack of determined by ultrasonography. The efficacy (N = 7), surgery (N = 27), untoward documentation of residual urine was side effects (N = 4) or urinary tract infections optional, and flow rate parameters were not (N = 2). In 57 cases treatment was documented at all since several of the terminated without a specified reason. participating physicians were family Overall, therefore, 108/ 1,798 (6%) of the physicians and general practitioners who patients terminated treatment prematurely in often did not have the means to perform the study population, as opposed to 115 / residual urine or, in particular, flow rate 1,894 (6.1 %) in the entire patient measurements. population. According to the design of the study, a The patients were staged according to statistical analysis was conducted using Alken. Nine hundred and ten patients minimum, maximum, median, and mean (50.6 %) were in stage 1, 770 patient (42.8 values, standard deviation (STD), and %) in stage 2, and 118 patients (6.6 %) in frequency distributions. To compare stage 3. The average age for these three frequency distribution across the various groups was 60.0, 67.6, and 71.6 years, stages of BPH, the X2 test was used. For the respectively. Overall, 59.1 % of patients had comparison of means, a simple analysis of been pretreated, usually with other variance was employed, and for the phytotherapeutic drugs used in BPH over an comparison of mean time effectiveness average duration of 21.2 (stage 1), 32.5 profiles, split plot variance analysis was (stage 2), and 46.8 months (stage 3). This utilized. pretreatment was judged as "successful" in 52.0 % of stage 1 patients, 42.6 % of stage Results 2 patients and 30.4 % of stage 3 patients. Concomitant diseases existed in 812 (45.2 Voiding Disturbances and Findings on %) of the patients. Cardiovascular diseases DRE (57.4%), endocrine and metabolic diseases (22.8%), and urological diseases (11.0 %) The distribution of obstructive and irritative were most common. Among the urological voiding symptoms at the time of entry into diseases, prostatitis and bladder cancer the study is tabularized in Table 1. Data were the most common. concerning age at first manifestation and type of voiding symptoms as well as their To further describe the voiding disturbances, course are listed in Table 2. While in stage 1 data such as age at the first manifestation, BPH nocturia and frequency are the specific symptoms (irritative versus dominating symptoms, prolonged voiding obstructive), intensity of the symptoms over time and a weak urinary stream are most time (constant versus variable, either common in stage 2, and in particular in increasing or decreasing), and incidence of stage 3 BPH. Post-void dribbling was of episodes of acute urinary retention were particular importance in patients with stage 3 documented. BPH. Prostatic congestion increased significantly with increasing stages. As Methods expected, a more pronounced enlargement of the prostate was found in patients with Clinical evaluation was conducted prior to stages 2 and 3. initiation of therapy as well as after 12 and 2 | P a g e Possibilities and Limitations of Phytotherapy for Benign Prostatic Hyperplasia (BPH) Tab. 1 Moderate to severe intensity of voiding symptoms and findings at digital rectal examination (DRE) in 1,798 patients with BPH. [The frequency of symptoms and DRE findings differ significantly between the three stages. (p<0.001).] Of interest was the significantly different average age at the first manifestation of the found, while a symptom-free status was voiding symptoms. In patients with stage 1, found in 0 - 15% of patients (Table 3). it was eight years earlier than in stage 3. If one takes the average age of the patient into Unchanged positive symptoms and/or account, symptoms have been present prior prostatic congestions (Non-responder) were to treatment for 3.5 years in stage 1 found between 16.8% and 28.7% for patients, for 5.7 years in stage 2 patients, patients with stage 1, 19.8% and 31.2% for and for 7.1 years in stage 3 patients. If one patients with stage 2, and between 33.3% excludes the possibility that the data and 52.7% for patients with stage 3 BPH. obtained from older patients become Unchanged positive symptoms were found relatively imprecise, these results can only more commonly in the obstructive symptom be explained by an age-dependent dynamic category. Considering these findings, the course of progression of the disease comparison between the different stages process of BPH. yielded significant differences (p < 0.001) for all parameters, with a weaker effect in Irritative symptoms dominated in patients particular for stage 3 patients and in with stage 1, while in stages 2 and 3 comparing stage 1 with stage 2. Worsening obstructive symptoms were more common. of the status in up to 6.4% of the patients However, in the advanced stages, often both was found particularly in patients with stage irritative and obstructive symptoms were 3 BPH. found equally common. Fluctuation of the intensity of the symptoms was particularly An analysis of the time course showed for all characteristic for patients with stage 1 BPH, parameters - with the exception of the size while in patients with stages 2 and 3 a of the prostate - an increase in the rate of progression of the symptoms and a higher patients with a symptom-free status in incidence of episodes of acute urinary regard to voiding symptoms and prostatic retention was evident. congestions at 24-week evaluation in comparison with the 12-week evaluation. In regard to the findings on DRE and the The incremental rate of improvement voiding symptoms, the treatment with between 12 and 24 weeks of treatment was Cernilton ® N did not yield a significant 13 % to 24 % for stage 1, 10 % to. 25 % for difference in the response rates (range from stage 2, and 1 % to 17 % for stage 3. There 68% - 83%) between stages 1 and 2 (Table was no principle difference detected 3).
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