Conservative Treatment of Benign Prostatic Hyperplasia (BPH) with Cernilton ®N
Results of a Placebo-Controlled Double-Blind Study
H. Becker, L. Ebeling
Summary (For the full study Click Here)
The efficacy and tolerance of the pollen extract preparation, Cernilton ®N, were investigated in a double-blind, placebo-controlled study carried out over a treatment period of 12 weeks in 6 urological practices, in a total of 103 patients suffering from benign prostatic hyperplasia (BPH) in stages 11 and 111. The investigational parameters were the disturbances of micturition classified according to the FDA recommendation, residual urine volume, palpation findings, uroflow as well as the global assessment of the therapy by the physician and by the patient. Under the pollen extract, nocturia, the principal symptom of BPH, improved in 68.8 % of the cases, compared with 37.2 % under the placebo medication (p < 0.005). Notable differences were observed in frequency and in sensation of residual urine, which were statistically significant as regards absence of these symptoms after the treatment, between the active treatment (AT) and placebo (PI) (p = 0.010 and p = 0.016, respectively). Observation of the course of the symptoms after 6 weeks and 12 weeks showed higher rates of improvement under the active treatment, for all the individual symptoms. In the case of the urodynamic study parameters, similar changes were observed in the findings for all the uroflow parameters, whereby the differences between the comparative groups were unremarkable. At the control examination after 6 weeks a continuous increase in the peak urine flow rate was observed, averaging 3.3 ml / sec under active treatment and 0.9ml/sec under placebo (p=0.060). The difference in the average decrease in the residual urine volume in the course of the treatment was statistically significant (AT/Pl: 24.3 ml / 3.7ml; p = 0.006). The pollen extract led to a continuous reduction, whereas in the placebo group the residual urine after 12 weeks had increased in comparison with the value recorded after 6 weeks. Significant differences in the residual urine volumes before and after the treatment, in favor of the pollen extract, were observed also in the patients in BPH stage III (p = 0.042). Prostate size and congestion showed higher response rates, in the sense of reduction in size and decongestion, as detected by palpation, under the active treatment, with a marked trend (AT/Pl: 88.5%/69.0%; p=0.155). Nausea was recorded under active treatment in one case. In accordance with their positive experiences with the treatment, the investigating physicians and the patients assessed the therapeutic result under the pollen extract as very good or good significantly more often than that obtained under placebo (p = 0.001). The results of the study prove the efficacy of the pollen extract in patients with BPH in stages II and III, in regard to clinical symptornatology, urodynamics and global assessment, and demonstrate the good tolerability of the drug, which permits long-term therapy with little risk of side effects.