Information provided from:
Journal of American Medical Association (JAMA)

Contempo 1999
Updates Linking Evidence and Experience

Urology
For the specialty of urology, 1998 was the year of the penis. Last spring the field of urology was taken by storm with the Food and Drug Administration's (FDA's) approval of oral sildenafil citrate (Viagra) forthe treatment of male erectile dysfunction. The identification of nitric xide as a penile neurotransmitter1 paved the way for sildenafil, a selective cyclic guanosine monophosphate (GMP)-specific phosphodiesterase inhibitor that increases cyclic GMP levels, thus enhancing the effect of nitric oxide in response to sexual stimulation.

Benign prostatic hyperplasia (BPH), the most common prostate disease, continues to provide a source of controversy. Despite a previous report3 questioning the short-term efficacy of finasteride (Proscar) for obstructive voiding symptoms, McConnell et al4 demonstrated that, when used for 4 years by symptomatic men with enlarged prostates, finasteride caused a 2-fold decrease in the incidence of urinary retention, a 2-fold decrease in the need for prostate surgery, a mild decrease in urinary symptoms, and a mild increase in urinary flow rates. Finasteride caused occasional erectile dysfunction, decreased libido, and decreased ejaculatory volume but did not decrease the incidence of prostate cancer. Yet despite these statistically significant findings, most clinicians agree that the effectiveness of finasteride for urinary obstruction is modest and limited to men with palpably larger glands.

Meanwhile, patient demand for alternative medicines for BPH has created a huge market for herbal preparations, most of which are ineffective or untested. The most frequently used is an extract of the plant Serenoa repens, known to patients as saw palmetto. In a large systematic review of the published world literature on saw palmetto, Wilt et al5 reported that the herb does appear to have a mild salutary effect on obstructive voiding symptoms. In randomized placebo-controlled trials, men taking Saw Palmetto were 1.7 (95% confidence interval [CI], 1.2-2.4) times more likely to report overall improvement in their urinary symptoms. Compared with placebo, patients taking Saw Palmetto scored an average of 3.5 points lower on the International Prostate Symptom Scale (range, 0-35), 2.2 mL/s higher in mean urinary flow rates, and 22 mL lower in postvoid residual volumes. Nonetheless, the most important message this year for men with BPH is that treatment decisions should focus not only on symptoms but also on the degree of bother and impact on quality of life.

BPH: A Common Part of Aging
Why BPH Occurs
Symptoms
Diagnosis
Treatment

Saw Palmetto is used to treat benign prostatic hyperplasia (BPH), an enlargement of the prostate gland that affects about half of all men older than fifty. BPH is a noncancerous growth of the prostate gland. If the prostate grows in mature men, it pinches the urethra, or urine tube, and problems begin, including painful urination and frequent nighttime trips to the bathroom. Researchers estimate that BPH affects about ten million men in the United States -- some in their forties, half of all men older than fifty, and four out of every five men older than eighty.

Research conducted in Europe since the beginning of the 1980's shows that Saw Palmetto reduced by nearly 50 percent the number of times BPH sufferers had to get up to go to the bathroom during the night and significantly reduced painful, difficult urination. More recently, researchers compared a saw palmetto extract with finasteride, the conventional BPH drug. The study involved 1,098 men diagnosed with BPH, and researchers concluded that both treatments relieved BPH symptoms in about two-thirds of the men. But while the finasteride reduced the prostate size it also decreased sex drive and potency.

Saw Palmetto has become very popular in the United States and it is the fifth top-selling phytomedicine on the market, according to a 1998 survey by Whole Foods magazine. In Europe, medical doctors for years have prescribed Saw Palmetto and other herbs to treat mild to moderate cases of BPH. Today in Germany alone, the sale of BPH products total 90 percent of sales which are using Saw Palmetto as their number one source.

BPH: A Common Part of Aging

It is common for the prostate gland to become enlarged as a man ages. Doctors call the condition benign prostatic hyperplasia (BPH), or benign prostatic hypertrophy.

It is not clear whether certain groups face a greater risk of getting BPH. Studies done over the years suggest that BPH occurs more often among married men than single men and is more common in the United States and Europe than in other parts of the world. However, these findings have been debated, and no definite information on risk factors exists.

Why BPH Occurs

The cause of BPH is not well understood. For centuries, it has been known that BPH occurs mainly in older men and that it doesn't develop in men whose testes were removed before puberty. For this reason, some researchers believe that factors related to aging and the testes may spur the development of BPH.

Throughout their lives, men produce both testosterone, an important male hormone, and small amounts of estrogen, a female hormone. As men age, the amount of active testosterone in the blood decreases, leaving a higher proportion of estrogen. Studies done with animals have suggested that BPH may occur because the higher amount of estrogen within the gland increases the activity of substances that promote cell growth.

Another theory focuses on dihydrotes-tosterone (DHT), a substance derived from testosterone in the prostate, which may help control its growth. Most animals lose their ability to produce DHT as they age. However, some research has indicated that even with a drop in the blood's testosterone level, older men continue to produce and accumulate high levels of DHT in the prostate. This accumulation of DHT may encourage the growth of cells. Scientists have also noted that men who do not produce DHT do not develop BPH.

Some researchers suggest that BPH may develop as a result of "instructions" given to cells early in life. According to this theory, BPH occurs because cells in one section of the gland follow these instructions and "reawaken" later in life. These "reawakened" cells then deliver signals to other cells in the gland, instructing them to grow or making them more sensitive to hormones that influence growth.

Symptoms

Many symptoms of BPH stem from obstruction of the urethra and gradual loss of bladder function, which results in incomplete emptying of the bladder. The symptoms of BPH vary, but the most common ones involve changes or problems with urination, such as

A hesitant, interrupted, weak stream.
Urgency and leaking or dribbling.
More frequent urination, especially at night.

The size of the prostate does not always determine how severe the obstruction or the symptoms will be. Some men with greatly enlarged glands have little obstruction and few symptoms while others, whose glands are less enlarged, have more blockage and greater problems.

Sometimes a man may not know he has any obstruction until he suddenly finds himself unable to urinate at all. This condition, called acute urinary retention, may be triggered by taking over-the-counter cold or allergy medicines. Such medicines contain a decongestant drug, known as a sympathomimetic. A potential side effect of this drug may be to prevent the bladder opening from relaxing and allowing urine to empty. When partial obstruction is present, urinary retention also can be brought on by alcohol, cold temperatures, or a long period of immobility.

It is important to tell your doctor about urinary problems such as those described above. In 8 out of 10 cases, these symptoms suggest BPH, but they also can signal other, more serious conditions that require prompt treatment. These conditions, including prostate cancer, can be ruled out only by a doctor's exam.

Severe BPH can cause serious problems over time. Urine retention and strain on the bladder can lead to urinary tract infections, bladder or kidney damage, bladder stones, and incontinence. If the bladder is permanently damaged, treatment for BPH may be ineffective. When BPH is found in its earlier stages, there is a lower risk of developing such complications.

Diagnosis

You may first notice symptoms of BPH yourself, or your doctor may find that your prostate is enlarged during a routine checkup. When BPH is suspected, you may be referred to a urologist, a doctor who specializes in problems of the urinary tract and the male reproductive system. Several tests help the doctor identify the problem and decide whether surgery is needed. The tests vary from patient to patient, but the following are the most common.

Prostate Specific Antigen (PSA) Blood Test

In order to rule out cancer as a cause of urinary symptoms, your doctor may recommend a PSA blood test. PSA, a protein produced by prostate cells, is frequently present at elevated levels in the blood of men who have prostate cancer. The U.S. Food and Drug Administration has approved a PSA test for use in conjunction with a digital rectal exam to help detect prostate cancer in men age 50 or older and for monitoring prostate cancer patients after treatment. However, much remains unknown about the interpretation of PSA levels, the test's ability to discriminate cancer from benign prostate conditions, and the best course of action following a finding of elevated PSA.

Because many unanswered questions surround the issue of PSA screening, the relative magnitude of its potential risks and benefits is unknown. Both PSA and ultrasound tests enhance detection when added to DRE screening. But they are known to have relatively high false-positive rates, and they may identify a greater number of medically insignificant tumors. Thus, PSA screening might lead to treatment of unproven benefit that could result in morbidity (including impotence and incontinence) and mortality. It cannot be determined from earlier studies whether PSA screening will reduce prostate cancer mortality. Ongoing studies are addressing this issue.

Urine Flow Study
Sometimes the doctor will ask a patient to urinate into a special device which measures how quickly the urine is flowing. A reduced flow often suggests BPH.

Treatment

Men who have BPH with symptoms usually need some kind of treatment at some time. However, a number of recent studies have questioned the need for early treatment when the gland is just mildly enlarged. These studies report that early treatment may not be needed because the symptoms of BPH clear up without treatment in as many as one-third of all mild cases. Instead of immediate treatment, they suggest regular checkups to watch for early problems. If the condition begins to pose a danger to the patient's health or causes a major inconvenience to him, treatment is usually recommended.

Since BPH may cause urinary tract infections, a doctor will usually clear up any infection with antibiotics before treating the BPH itself. Although the need for treatment is not usually urgent, doctors generally advise going ahead with treatment once the problems become bothersome or present a health risk.

The following section describes the types of treatment that are most commonly used for BPH.

Vitamin Supplement Treatment

Saw Palmetto 320mg dosage daily to promote prostate health.

Drug Treatment
Over the years, researchers have tried to find a way to shrink or at least stop the growth of the prostate without using surgery. Recently, several new medications have been tested in clinical trials, and the Food and Drug Administration (FDA) has approved four drugs to treat BPH. These drugs may relieve common symptoms associated with an enlarged prostate.

Finasteride (marketed under the name Proscar), FDA-approved in 1992, inhibits production of the hormone DHT, which is involved with prostate enlargement. Its use can actually shrink the prostate in some men.

Information provided from:
Journal of American Medical Association (JAMA)

Saw Palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. Feb. 10th 1999

Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C

Department of Veterans Affairs Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies, Minneapolis Veterans Affairs Medical Center, Minn 55417, USA. wilt.timothy@minneapolis.va.gov

OBJECTIVE: To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the Saw Palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hperplasia (BPH). DATA SOURCES: Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies.

STUDY SELECTION: Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days.

DATA EXTRACTION: Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies.

DATA SYNTHESIS: A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively.

CONCLUSIONS: The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications.