History of herbal therapies for benign prostatic hyperplasia

Historically, herbal therapy is considered to be the mainstay of complementary and alternative medicine for the treatment of benign prostatic hyperplasia (BPH). Millions of people worldwide, including in the United States, use herbal agents to treat symptoms of BPH and prevent its progression. Despite their widespread use for maintaining prostatic health in older men, the long-term efficacy and safety of over-the-counter phytotherapies for lower urinary tract symptoms (LUTS) attributable to BPH are not clear.

BPH is a common cause of morbidity among older men in the United States and other developed countries. Although BPH is a histologic process and its exact cause is unknown, this condition confers morbidity primarily through LUTS. Additionally, men with BPH, and particularly those with larger prostates as a result of BPH, are at an increased risk for complications, such as acute urinary retention, and may progress to requiring surgical treatment for BPH. In fact, although the availability of effective medical therapy has reduced the need for transurethral resection of the prostate (TURP), the traditional surgical treatment for BPH, the Centers for Disease Control’s National Hospital Discharge Survey reports that 132,000 TURP procedures were performed in the United States in 2000. Although a working epidemiologic definition of symptomatic BPH is still being debated, the clinical manifestations of BPH are generally agreed upon. Clinical BPH, defined as an American Urological Association Symptom Index (AUASI) score greater than 7 (moderate to severe LUTS) and a depressed peak uroflow rate (<15 mL/s), affects 17% of men aged 50 to 59 years, 27% of men aged 60 to 69 years, and 35% of men aged 70 to 79 years.

Men with bothersome LUTS caused by BPH can choose from a spectrum of traditional medical treatments, including alpha blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, TURP, and other surgical therapies. The Medical Treatment of Prostatic Symptoms trial tested finasteride and doxazosin, alone and in combination, for the prevention of BPH progression. BPH progression was defined as a confirmed increase in an AUASI score by at least 4 points, acute urinary retention, incontinence, urinary tract infection or urosepsis, or new renal insufficiency. Almost all progression events were in the first 2 categories. Finasteride is a 5-alpha reductase inhibitor that blocks the conversion of testosterone to dihydrotestosterone, the major intraprostatic androgen, and reduces prostate size. Doxazosin blocks alpha-adrenergic receptors in the lower urinary tract, resulting in a reduction in smooth muscle tone in the prostate and bladder neck. Alpha-blockers rapidly improve voiding symptoms and urinary flow rate, and the improvements are long lasting. Common side effects are dizziness, retrograde ejaculation, and postural hypotension. The 5-alpha reductase inhibitors reduce prostate volume and decrease the risk of urinary retention and the need for surgical intervention. The reduction in prostate volume takes months. Common side effects are decreased ejaculate volume and, rarely, erectile dysfunction. For men with severe symptoms and large prostates, combination therapy was more effective than either therapy alone, but was associated with a greater risk of side effects and greater cost. Combination finasteride and doxazosin therapy is an attractive option, given the different mechanisms of action.

Almost 30 phytotherapeutic compounds are currently available for the treatment of BPH. Those that have been studied most are extracts of the fruit of Serenoa repens , the saw palmetto dwarf palm that grows in the Southeastern United States. Second to saw palmetto is the extract of the bark of Pygeum africanum , the African plum tree. The proposed mechanisms of action for saw palmetto include 5-alpha reductase inhibition, intraprostatic androgen receptor blockage, and adrenergic receptor antagonism, as well as an antiinflammatory effect. In vitro studies have shown that Pygeum extracts have antiinflammatory and immunomodulatory properties, effects on bladder contractility, modulation of androgen production, and direct effects on the function of prostate epithelium. Although there is conflicting evidence in the literature concerning the efficacy and safety of saw palmetto in the treatment of men with LUTS secondary to BPH, a recent meta-analysis of saw palmetto conducted by the Cochrane Review committee concluded that there is no observed benefit of using saw palmetto in the treatment of LUTS related to BPH, compared with placebo.

Evidence of current use of saw palmetto and other herbal agents in treatment of benign prostatic hyperplasia

The use of herbal therapies by adults in the United States has increased significantly in the last decade. It is estimated that 1 in every 5 people in the United States uses an herb to treat a condition or promote health. Likewise, herbal therapy for BPH is rapidly gaining popularity in the Western world. A 2002 nationwide survey found that approximately 2.5 million men used saw palmetto for treatment of BPH in the United States. It is estimated that up to 90% of patients newly diagnosed with BPH have already tried an herbal treatment by the time they were referred to a urologist.

The trend in using phytotherapy for BPH can be partly explained by positive views of herbal therapies and personal values and beliefs. However, the published literature raises concerns about the safety and efficacy of herbal treatments for BPH.

Plant extracts are widely used by men with BPH in the United States and usually sold as dietary supplements. In Europe, these extracts are often prescription drugs. A nationwide German study reported that 50% of urologists preferred saw palmetto over pharmaceutical agents for treatment of BPH.

In a 2002 Cochrane meta-analysis of the effectiveness of saw palmetto extracts for men with BPH, 21 randomized trials 4 to 48 weeks in duration were identified, with 3193 total subjects. Data from the trials indicated that, compared with placebo, saw palmetto reduced nocturia by 0.76 times per night (10 trials), increased the odds of self-rated improvement 1.76 fold (6 trials), and improved peak flow rates by 1.86 mL/s (9 trials). Adverse effects were mild and infrequent. Methodological problems noted within the trials included lack of standardized symptom scores and short study durations. The most common dosage was 160 mg twice daily, but a comparative trial showed similar effectiveness with the more convenient dosage of 320 mg once daily.

There has been strong interest among numerous investigators, particularly urologists, to further examine the safety and efficacy of phytotherapy for BPH in the form of large multicenter clinical trials, such as the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) trial. If the results of these ongoing clinical trials show effectiveness at reducing LUTS, men with BPH might find herbal therapy preferable to medical therapy because of the appeal of naturalistic herbal therapy and minimal side effects.

Evidence of current use of saw palmetto and other herbal agents in treatment of benign prostatic hyperplasia

The use of herbal therapies by adults in the United States has increased significantly in the last decade. It is estimated that 1 in every 5 people in the United States uses an herb to treat a condition or promote health. Likewise, herbal therapy for BPH is rapidly gaining popularity in the Western world. A 2002 nationwide survey found that approximately 2.5 million men used saw palmetto for treatment of BPH in the United States. It is estimated that up to 90% of patients newly diagnosed with BPH have already tried an herbal treatment by the time they were referred to a urologist.

The trend in using phytotherapy for BPH can be partly explained by positive views of herbal therapies and personal values and beliefs. However, the published literature raises concerns about the safety and efficacy of herbal treatments for BPH.

Plant extracts are widely used by men with BPH in the United States and usually sold as dietary supplements. In Europe, these extracts are often prescription drugs. A nationwide German study reported that 50% of urologists preferred saw palmetto over pharmaceutical agents for treatment of BPH.

In a 2002 Cochrane meta-analysis of the effectiveness of saw palmetto extracts for men with BPH, 21 randomized trials 4 to 48 weeks in duration were identified, with 3193 total subjects. Data from the trials indicated that, compared with placebo, saw palmetto reduced nocturia by 0.76 times per night (10 trials), increased the odds of self-rated improvement 1.76 fold (6 trials), and improved peak flow rates by 1.86 mL/s (9 trials). Adverse effects were mild and infrequent. Methodological problems noted within the trials included lack of standardized symptom scores and short study durations. The most common dosage was 160 mg twice daily, but a comparative trial showed similar effectiveness with the more convenient dosage of 320 mg once daily.

There has been strong interest among numerous investigators, particularly urologists, to further examine the safety and efficacy of phytotherapy for BPH in the form of large multicenter clinical trials, such as the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) trial. If the results of these ongoing clinical trials show effectiveness at reducing LUTS, men with BPH might find herbal therapy preferable to medical therapy because of the appeal of naturalistic herbal therapy and minimal side effects.

Collection of relevant studies for this review

The authors performed PubMed ( www.pubmed.gov ), Web of Science ( www.isiwebofknowledge.com ), and Cochrane library ( www.cochrane.org ) world literature searches for articles in the English language. The search terms saw palmetto and BPH or herbal agent and BPH returned 35 studies published between 2000 and 2011 worldwide. Nineteen randomized clinical trials (RCT) were identified, but only 8 RCT were included (≥100 patients) ( Table 1 ); 4 meta-analysis studies (≥2 clinical studies) ( Table 2 ), 7 experimental basic scientific studies, 2 prospective studies, and 3 retrospective studies ( Table 3 ) were related to saw palmetto or herbs and BPH. Most of the world literature, in descending order, is from the United States, United Kingdom, Spain, Germany, Italy, France, Russia, Romania, Turkey, Australia, and Brazil. All large RCTs and meta-analyses were carefully selected and reviewed.

The current available herbal agents used in the treatment of benign prostatic hyperplasia

Table 4 lists most currently available herbal agents, dosages, and adverse effects. The current published evidence of using saw palmetto and other herbal agents is briefly discussed next.

Table 4

Summary of currently available herbal agents for benign prostatic hyperplasia

Herb	Scientific Name	Family	Dosage	Adverse Effects
Antiandrogenic
Saw palmetto	Serenoa repens	Arecaceae	Dried: 160 mg twice daily; Liquid: 0.6–1.5 mL or 0.5–1.0 g of berries in 150 mL of water 3 times daily	Nausea, vomiting, constipation, diarrhea, headache, hypertension, mild pruritus, decreased libido, and ejaculatory/erectile dysfunction
Antiproliferative
Pygeum	Pygeum africanum	Rosaceae	Dried: 50 mg twice daily	Nausea, gastric pain, constipation, diarrhea, dizziness, headache, insomnia, restlessness, and visual disturbance
Nettle root	Urtica dioica	Urtica ceae	Dried: 600–1200 mg daily Liquid: 1.5–7.5 mL daily	Mild gastric upset, allergic skin reactions, and sweating
Pumpkin seeds	Cucurbita pepo	Cucurbitaceae	Dried: 5 g twice daily	Potential electrolytes loss
African wild potato	Hypoxis hemerocallide	Hypoxidaceae	Dried: 60–130 mg divided into 2–3 doses daily	Nausea, vomiting, indigestion, diarrhea, constipation, anxiety, ventricular tachycardia, bone marrow suppression in patients with HIV disease, reduced absorption and blood levels of alpha- and beta-carotene and vitamin E
Beta-sitosterol	22,23-dihydrostigmasterol	Beta-sitosterol	Dried: 60–130 mg divided into 2–3 doses daily	Nausea, indigestion, diarrhea, constipation, erectile dysfunction, loss of libido, reduced absorption and blood levels of alpha- and beta-carotene and vitamin E
Lycopene	All-trans lycopene	Lycopene	Dried: 15 mg twice daily	Reduced plasma PSA level
Red Clover	Trifolium pratense	Fabaceae	Dried: 40–80 mg daily for 3 months	Rashlike reactions, myalgia, headache, nausea, and vaginal spotting; large amounts can induce bleeding
Antiinflammatory
Rye grass pollen	Secale cereale	Poaceae	Dried: 126 mg 3 times daily	Nausea, abdominal distention and heartburn
Nutrients
Selenium	Selenium	Selenium	For prostate cancer prevention, 200 mcg daily	Nausea, vomiting, abdominal pain, nail changes, fatigue, irritability, alopecia, and weight loss
Vitamin E	Alpha-tocopherol	Vitamin E	For prostate cancer prevention, 50–100 IU daily	Nausea, diarrhea, intestinal cramps, fatigue, weakness, headache, blurred vision, rash, gonadal dysfunction, and creatinuria
Miscellaneous
Garlic	Allium sativum	Alliaceae	NA	Mouth/breath odor, gastrointestinal irritation, heartburn, flatulence, nausea, vomiting, and diarrhea
Prickly pear cactus	Opuntia ficus-indica	Cactaceae	Dried: 500 mg 3 times daily for 2–8 mo	Mild diarrhea, nausea, increased stool volume, abdominal fullness, and headache
Saxifraga stolonifera Meerb	saxifraga	Chinese herb	NA	NA
Saireito	Saireito	Chinese herb	Dried: 5.4 g daily	NA
Green tea	Green tea	NA	NA	NA
Fengweicao granule	Fengweicao	Pteris multifida	Dried: 5 g twice daily	NA
Ganoderma lucidum	Ganoderma	NA	Dried: 6 mg daily	NA
Qianlie Sanyu	Qianlie	NA	NA	NA
Bushenhuoxue	Bushenhuoxue	NA	NA	NA

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