These common agents are not US Food and Drug Administration (FDA) approved but are available through health food stores and other commercial outlets. Phytotherapies and other supplements are under study, but few have undergone trials in the United States. Most have not demonstrated any significant efficacy. Many of these products are sold as part of combination therapies, and they are sold under many trade names. There have been growing concerns about the potential toxicities of these products and their interactions with standard pharmaceuticals. According to the FDA, manufacturers of dietary supplements can make claims about how their products affect the structure or function of the body, but they may not claim to prevent, treat, cure, mitigate, or diagnose a disease without prior FDA approval.
African Plum (Pygeum africanum)
The extract, tadenan, is derived from the bark of the African plum tree and is taken for the treatment of benign prostatic hypertrophy (BPH) and lower urinary tract symptoms (LUTS). Pygeum is usually found in most combination prostate health formulations. Its mode of action is thought to be via inhibition of fibroblast growth and anti-inflammatory effects. Some inconclusive data show a decrease in symptoms and an increase in flow rate. However, the T-IPSS study, a randomized double-blind placebo-controlled trial using tadenan was completed but never released or published. Only some minor gastrointestinal side effects have been noted with this product.
Bazoton (Radix urticae)
This plant extract has been used in the treatment of BPH. The active ingredients are thought to include its steroid-glycoside composition. It is an inhibitor of sex-steroid binding globulin. There is a paucity of clinical data that show it decreases symptom scores, and it has little effect on flow rates. Side effects are minor and usually related to its smell and taste.
Capsaicin is the main pungent ingredient of hot peppers. It has been used as an intravesical therapy for overactive bladder. The mode of action is by the selective activation of sensory nerve fibers and by a neurotoxic effect on C afferent fibers. Multiple studies have documented its efficacy in terms of symptom improvement and urodynamic changes. Adverse effects include suprapubic pain, hematuria, and incontinence, which are all self-limiting.
Cranberries (Vaccinum macrocarpon) Juice and Supplements
Cranberry is widely used to prevent UTIs; it was originally believed that this fruit acidified the urine. However, cranberry appears to work by inhibiting the adhesion of type I and P-fimbriated uropathogens (eg, uropathogenic E. coli) to the uroepithelium, thus impairing colonization and subsequent infection. It contains a unique blend of organic acids—quinic, malic, and citric—as well as nondialyzable polymeric compounds that provide this antibacterial adherence effect.
Studies using cranberry juice, cranberry-lingonberry juice, and cranberry tablets compared with placebo for preventing UTIs, bacteruria, or pyuria concluded that cranberry juice and cranberry products significantly reduced UTIs among women with recurrent infections. Recommended doses range from 90–480 mL of cranberry cocktail twice daily or 15–30 mL of unsweetened 100% cranberry juice daily. The frozen concentrate has almost 30 times the strength of the juice, and 30–45 mL b.i.d. has been used. Capsule doses range between 1 and 6 capsules of 300–400 mg concentrated extract b.i.d. High pediatric doses of >300 mL daily have been associated with adverse effects such as hypersensitivity or gastrointestinal distress such as diarrhea.
The findings of several reviews support the potential use of cranberry products in the prophylaxis of recurrent UTIs in young and middle-aged women, but it should not be used as a substitute for antibiotics, as it is an ineffective treatment for established infections. Patients with a history of nephrolithiasis should avoid the use of cranberry products (possible increases in urinary calcium and oxalate concentration). Due to the heterogeneity of clinical study designs and the lack of consensus regarding the dosage regimen and formulation to use, cranberry products cannot be broadly recommended for the prophylaxis of recurrent UTIs at this time. May potentiate anticoagulant effects of warfarin.
Primarily used for memory deficits, dementia, and neurologic dysfunction, ginkgo biloba is also promoted as a treatment for impotence and selective serotonin reuptake inhibitor (SSRI)-induced sexual dysfunction, with a recommended dose range of 60–80 mg standardized dry extract orally b.i.d.–t.i.d. Studies have shown small cognition benefits with dementia, but no other demonstrated benefit in healthy adults. Use cautiously with aspirin (ASA), salicylates, warfarin.
Heather (Calluna vulgaris)
The medicinal portion of common heather consists of the entire herb (leaves, flower, roots) ground and boiled to create a product that is taken for its diuretic properties in the treatment of kidney ailments and BPH/LUTS. Active compounds are thought to include flavonoids and sitosterols. The claimed efficacy has never been documented. No clinical trials are available.
Horny Goat Weed (Epimedium)
Epimedium is a Chinese herbal remedy promoted as a safe and natural alternative to sildenafil citrate (Viagra). However, extracts of epimedium are strongly estrogenic due to the presence of novel potent phytoestrogens of the prenyl-flavone family. It has been reported to cause tachyarrhythmias.
This product is no longer commercially available because of issues associated with quality control. It was found to be tainted with diethylstilbestrol, warfarin, and alprazolam. It was used for treatment of prostate cancer, particularly in hormone-refractory patients. It consisted of 7 Chinese herbs (Chrysanthemum, Isatis, licorice, Ganoderma lucidium, Panax pseudo-ginseng, Rabdosia rubescens, Scutellaria [skullcap], and saw palmetto berry). It had potent antiestrogenic effects. Its use was associated with deep venous thrombosis, breast tenderness, loss of libido, and decreased prostate-specific antigen (PSA) and testosterone levels. Other companies have made similar combinations but have not achieved as widespread usage.
This product has been used for numerous indications in traditional Chinese medicine. It is frequently used for decreased libido and erectile dysfunction in the urologic arena. It reportedly has androgenic effects and stimulation, although improvements in penile endothelial L-arginine–nitric oxide activity have been suggested.
Clinical trials are not conclusive of its effectiveness.
Permixon (Serenoa repens)
This is the branded saw palmetto extract produced in France. It is the lipido-sterolic extract of the dried fruit (berry) of the dwarf palm. It is the most widely studied of all phytotherapies for the treatment of BPH/LUTS. From in vitro studies, it has been postulated to have many mechanisms of action including antiprostaglandin, antiandrogenic, and antiestrogenic effects. It has almost no effect upon prostate size and no effect upon PSA levels. There are no known significant health risks or adverse effects.
Pumpkin Seed (Cucurbita pepo)
Fresh and dried seeds are taken whole or ground for the treatment of BPH or overactive bladder. Active compounds are thought to be phytosterols. There are no recent clinical trials and therefore no evidence establishing its efficacy. There are no known side effects.
Rye Pollen (Secale cereale)
A pollen extract obtained by microbial digestion and extraction by water and organic solvents. Cernilton is the branded product. Active ingredients are thought to be β-sitosterols. It is used for the treatment of BPH and prostatitis and chronic pelvic pain syndrome (CPPS). In vitro inhibition of epithelial and stromal cell growth has been demonstrated. No long-term conclusive clinical studies exist. Side effects are reportedly minimal.
Saw Palmetto Berry (Serenoa repens, Sabal serrulata)
There are many different extraction processes and therefore many different brands of saw palmetto. The composition of these brands are variable. A recent National Institutes of Health (NIH)-sponsored double-blind, placebo-controlled study using the Indena brand showed no statistical difference between placebo and saw palmetto berry for treatment of BPH/LUTS. Permixon brand is the most widely studied product (see “Permixon” above). Minimal side effects are associated with saw palmetto. Saw palmetto berry extract (SPBE) compounds are also sold for “prostate health.” SPBE includes ingredients such as beta-sitosterol and stigmasterol with no reliable clinical data to support their use.
A trace mineral that may prevent the development of prostate cancer. Epidemiologic studies suggest a chemo-preventative effect. One study of patients with high-grade prostatic intraepithelial neoplasia suggested that selenium reduced the incidence of prostate cancer on subsequent biopsy. The National Cancer Institute-sponsored SELECT trial was a 10-yr prospective trial that begin in 2001 of over 35,000 men studying the prostate cancer chemopreventive effects of selenium and vitamin E alone and in combination. The data monitoring safety board (DMSB) halted the trial in the fall of 2008. Their concerns were that the supplements did not appear to offer any benefit. In particular, there was a nonstatistically significant trend to increasing prostate cancer with vitamin E alone and increased diabetes risk in men on selenium alone.
South African Star Grass (Hypoxis roperi)
This extract is taken for BPH/LUTS. The active compound is thought to be β-sitosterols, which are thought to induce apoptosis by transforming growth factor (TGF)-β1; this is unproven clinically. Initial studies showed dramatic improvements in symptom scores and flow rates; however, confirmatory studies are still needed. Adverse effects are believed to be minimal.
Stinging Nettle (Urtica dioca, Urticae radix)
Bazoton is a branded form of this extract; see above. The clinical evidence of the effectiveness of nettle root is based primarily on open studies, and the significance of this must be confirmed. Minimal toxicity is associated with stinging nettle use.
Yohimbine (Pausinystalia yohimbe) Yocon, Yohimex
An extract of the bark of the yohim tree has been used for erectile dysfunction and decreased libido. The mechanism of action is as an α-adrenergic antagonist. Conflicting studies show both positive and no effect when compared to placebo. It appears to have greatest utility for men with psychogenic impotence. Despite the advent of phosphodiesterase 5 (PDE5) inhibitors, there is still widespread utilization of this over-the-counter product. Side effects include anxiety, tremors, dizziness, hypertension, and tachycardia. Do not use with antidepressants (eg, MAOIs or similar agents)