Abstract
Benign prostatic hyperplasia (BPH) is the pathological cellular progression of glandular proliferation associated with aging. Current available treatment options for BPH have limitations and various adverse effects. Equol is a polyphenolic/isoflavonoid molecule derived from intestinal metabolism, dairy and dietary plant sources. It has the unique characteristic to bind specifically 5α-dihydrotestosterone (5α-DHT) by sequestering 5α-DHT from the androgen receptor, thus decreasing androgen hormone actions to improve prostate health by acting as a selective androgen modulator (SAM). It also has affinity for estrogen related receptor gamma (ERR-γ) and estrogen receptor beta (ER-β) within the prostate that is known to improve male health via selective estrogen receptor modulatory (SERM) activities to decrease inflammation, cellular proliferation and carcinogenesis. We investigated the possible clinical efficacy of equol on the symptoms associated with benign prostatic hyperplasia (BPH) in this study. Materials and Methods: We performed a pilot intervention study evaluating the effects of low dose oral equol supplement (6 mg, twice a day with meals) for 4 weeks in a total of 18 men (49 - 60 years old) with moderate or severe BPH. Subjects included in the study: gave informed consent, underwent a physical examination and verified their BPH symptoms as measured by the International Prostate Symptom Scores (IPSS) and then were assigned to the moderate or severe BPH groups based upon their total IPSS index. All adverse events were reported. The primary efficacy measure was the IPSS parameters comparing baseline to 2 and 4 week IPSS indices. Blood samples were collected at the baseline and 4th week visits that served as secondary efficacy parameters that included testosterone, 5α-DHT and general blood chemistries along with cardiac and hepatic function panels. Results: Low dose equol positively improved moderate to severe BPH symptoms according to the IPSS indices. In moderately symptomatic men (n = 10) 5 out of 7 of the IPSS parameters significantly improved by 4 weeks of equol treatment. In severely symptomatic men (n = 8) all 7 of the IPSS parameters significantly improved with 4 weeks of equol treatment. There were no significant changes in androgen levels, general blood chemistries or cardiac and hepatic function parameters. Although, 5α-DHT levels declined by 21% in severely symptomatic men (from baseline vs. 4 week values). Conclusion: These findings suggest that equol may provide a well tolerated and rapid beneficial therapy for BPH that can be used alone or in combination with current pharmaceutical therapies. The beneficial clinical efficacy of equol observed in this study may be due to the multiple positive biological actions that are not present in current pharmaceutical treatments.
Highlights
Benign prostatic hyperplasia (BPH) is the pathological progression of epithelial and stromal proliferation in the prostate gland and the most common benign neoplasm in American men [1]
Subjects included in the study: gave informed consent, underwent a physical examination and verified their BPH symptoms as measured by the International Prostate Symptom Scores (IPSS) and were assigned to the moderate or severe BPH groups based upon their total IPSS index
There were no significant changes within or across the moderately symptomatic BPH or severely symptomatic groups for: albumin, sex hormone binding globulin, total protein/bilirubin, alkaline phosphatase, ALT & AST when baseline values were compared to 4 week levels for these parameters (Table 2)
Summary
BPH, such as nocturia (the most common, causing poor quality of sleep), incomplete emptying, urinary hesitancy, weak stream, frequency, and urgency can have a significant negative impact on the quality of life [1,2,6]. Interest in complementary and alternative medicines (CAM) for BPH increased after epidemiological and traditional hypothesis-driven scientific studies showed a lower incidence of BPH and prostate cancer in Asians compared to persons in Western countries [9,10,11,12] This caused a paradigm-shift to explore other known and/or previously unknown “natural” treatments for BPH that have reduced side effects. Equol is a polyphenolic or isoflavonoid molecule derived from intestinal metabolism, dairy and dietary plant sources [18,19,20,21] It is well established in human populations approximately 30% to 50% of individuals can produce equol at relatively low concentrations compared to animals [18,20]. Equol is currently used in skin treatments and has many positive influences on dermal gene and protein expression (e.g., anti-aging, anti-inflammatory and anti-oxidant properties) [27], but a recent proposal suggests equol may have beneficial applications for improvement in prostate health [25]
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