Leonard S. Marks, M.D.

1st Quarter, 1999 -Alternative medical remedies, defined as those not traditionally taught in medical schools, have become extremely popular throughout the industrialized world. Included under the alternative therapy umbrella are herbs, massage, homeopathy, and other folk remedies. According to David Eisenberg and associates, writing in the November 11, 1998 issue of the Journal of the American Medical Association (JAMA), 42% of U.S. adults used at least one such therapy during 1997. Compared to a similar survey in 1990, annual patient visits to alternative medicine practitioners increased 47% to 629 million; and expenditures for these visits increased 45% to $21.2 billion. Thus, alternative medical remedies are widely used, their use is growing rapidly, and the cost of these remedies -- most of which is borne out-of-pocket by patients directly -- is enormous.

Urology has not escaped from the alternative medicine juggernaut, as documented by Glen Gerber and colleagues in a 1998 presentation before the American Urological Association (AUA). Prostate disorders -- which are often chronic, long-term problems, not immediately life-threatening and for which traditional medicine may not always have a perfect solution -- are often the subject of self-treatment with alternative remedies.

Two herbal remedies for the prostate, saw palmetto extract and PC-SPES, have recently been the subject of peer-reviewed articles: saw palmeto in JAMA (1998;280:1604-1609) and PC-SPES (PC for prostate cancer and SPES the Latin word for hope) in the New England Journal of Medicine (NEJM) (1998; 339:785-791). Saw palmetto extracts are widely used in Europe for treatment of symptomatic benign prostatic hyperplasia (BPH), and PC-SPES has been used in Asia and elsewhere as a treatment for prostate cancer (CaP). These two herbal products are both currently available in the U.S. without a doctor's prescription. Regulatory issues surrounding these and other herbal products are detailed on a pertinent website of the U.S. Food and Drug Administration.

In the JAMA article on saw palmetto, T.J. Wilt and associates performed a meta-analysis of 18 European trials in which the extract was used to treat men with symptomatic BPH. They found that, compared to placebo-treated men, men treated with saw palmetto extracts experienced decreased BPH symptoms and increased urinary flow. The results were not dramatic, but they were statistically significant. The JAMA article provides the most convincing evidence to date that this old folk remedy actually has therapeutic efficacy and virtually no side effects. However, the authors cautioned that additional trials, including long-term studies, were warranted.

In the NEJM article on PC-SPES, which is actually a combination of 8 different herbs, R.S. DiPaola and colleagues found that this product has major estrogenic actions. Serum testosterone and PSA levels were both lowered in the men studied, and all men in the study developed breast tenderness and loss of libido. One man developed venous thrombosis. The authors concluded that, "The use of this unregulated mixture of herbs may confound the results of standard or experimental therapies and may produce clinically significant adverse effects." In an accompanying editorial, the NEJM editors make a strong appeal for scientific testing of all therapies, both conventional and alternative.

The first U.S. randomized clinical trial of saw palmetto extract in treatment of men with symptomatic BPH was recently completed at the Los Angeles offices of USRF. Two abstracts from this trial have been submitted for presentation at the upcoming meeting of the AUA to be held in May, 1999 in Dallas, TX, and an editorial opinion on this subject will soon be published in Urolgy.

The AUA has recently appointed Dr. William R. Fair of Memorial Sloan-Kettering Hospital in New York to chair a committee to study alternative medical therapies relating to urology.