When Pollen Is Good: Prostatitis
Abstract & Commentary
By Russell H. Greenfield, MD, Editor
Synopsis: There is no agreed upon standard therapy for men experiencing inflammatory chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS). The results of this strong clinical trial suggest that a 12-week course of therapy with a specific pollen extract is significantly more effective than placebo in reducing the symptoms of CP/CPPS, especially pain.
Source: Wagenlehner ME, et al. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: A multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study. Eur Urol 2009;56:544-551.
To evaluate the safety and efficacy of a standardized pollen extract in the treatment of inflammatory CP/CPPS, a German research team devised a multicenter, prospective, randomized, double-blind, placebo-controlled phase 3 clinical trial that compared the therapeutic effects of Cernilton to placebo. Subjects were men aged 18-65 years with symptoms of pelvic pain for at least 3 of the prior 6 months before study entry, who also had a score in the pain domain of the German-validated portion of the NIH Chronic Prostatitis Symptoms Index (NIH-CPSI) ≥ 7, and leukocytes ≥ 10 in examination of post-prostatic massage urine (VB3). Men with acute or chronic bacterial prostatitis were excluded, as were those with high residual urine volumes.
A detailed medical history was obtained during the screening process that included responses to the NIH-CPSI, as well as to the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire. Routine labs were obtained and residual urine volume was determined via ultrasound examination to rule out bladder outlet obstruction. Subjects were pre-treated with azithromycin 250 mg every 6 hours for 1 day to eliminate atypical pathogens, and were then randomized to receive either the pollen extract (2 capsules every 8 hours, each containing 60 mg cernitin T60 and 3 mg cernitin GBX) or matched placebo. At 6 and 12 weeks, data were again obtained through standard urologic evaluation, as well as the NIH-CPSI, examination for the presence of leukocytes in the VB3, the IPSS, and the sexuality domain of a life satisfaction questionnaire.
Following 12 weeks of therapy, the mean change from baseline in the pain domain of NIH-CPSI was -4.50 in the pollen extract group and -2.92 in the placebo group, a statistically significant difference. There was also statistically significant improvement in total NIH-CPSI score for the pollen extract group as compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by a minimum of 25% or at least 6 points, was seen in 70.6% of those receiving the pollen extract vs. 50.0% in the placebo group. Mean IPSS improved in both groups. A trend toward greater improvement in the sexuality domain of the life satisfaction questionnaire was identified for the pollen extract group, as well as a nonstatistically significant improvement in mean changes in VB3 leukocytes per high power field. Adverse events occurred in both study groups but were of a minor nature, and both interventions were well tolerated. The authors concluded that 12 weeks of treatment with the standardized pollen extract Cernilton significantly improves symptoms in men with inflammatory CP/CPPS as compared with placebo, with the major impact being on pain.
Commentary
This is one of the first studies to apply strong comparative research methodology to a CAM therapy for CP/CPPS. Importantly, the treatment in question (a standardized pollen extract) had already been in use in Europe for the treatment of CP/CPPS for nearly 20 years with good clinical success, yet in contrast to the largely positive studies on Cernilton for the management of benign prostatic hyperplasia, few data existed for its inclusion in the treatment plan for male chronic pelvic inflammation. The results of the current trial are welcome news, as the efficacy of even the most commonly employed conventional means of addressing the disorder (alpha blockade and sometimes antibiotic therapy, although the latter is used more frequently in the setting of bacterial prostatitis) have reportedly come into question.
The symptoms of CP/CPPS, especially pain and dysfunctional voiding patterns, can markedly impact quality of life. When conventional medical means do not adequately provide relief, many patients turn to options such as Chinese medicine, mind/body therapies, and botanicals, with mixed success. Saw palmetto and stinging nettle have both been studied and used in clinical practice for the treatment of CP/CPPS, but the supportive data for pollen extract are far more compelling at present than for any other CAM therapy in this setting.
Study methodology was impressive. The sample size was well defined and sizable for such a disorder, and confounding factors were largely accounted for. Of note is the significant placebo response (upward of 50%, although still much lower than the response in the active treatment group). The difference in symptom relief became evident after 6 weeks, which the authors interpret to mean that a long duration of therapy is necessary with CP/CPPS, not unlike the approach espoused by most urologists. Although men in both groups experienced symptom improvement, only those men receiving Cernilton achieved levels of relief that meet the NIH-CPSI criteria for clinical improvement.
As noted earlier, Cernilton contains 63 mg of the defined extract fractions cernitin T60 (water-soluble) and cernitin GBX (fat-soluble). While the mechanism of action of this standardized pollen extract remains unknown, an anti-inflammatory effect has been postulated, with research data showing associated decreases in levels of pro-inflammatory cytokines.
For men with CP/CPPS and the health care practitioners caring for them, there has been relatively little clinical direction to guide successful treatment. This paper should help change that situation for the better.
There is no agreed upon standard therapy for men experiencing inflammatory chronic prostatitis/ chronic pelvic pain syndrome (CP/CPPS). The results of this strong clinical trial suggest that a 12-week course of therapy with a specific pollen extract is significantly more effective than placebo in reducing the symptoms of CP/CPPS, especially pain.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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