NEJM Saw Palmetto Study

NEJM Saw Palmetto Study - A Commentary ⁺

Saw Palmetto extract is widely used in the U.S. and Europe to treat symptoms of Benign Prostatic Hyperplasia (BPH). BPH is associated with age-related prostate gland enlargement. Over 2.5 million men in the U.S. reported using saw palmetto.¹ This popular herb is a first line therapy in Europe, where it is commonly prescribed by doctors. Saw Palmetto is considered safe, with only mild side effects, most commonly GI upset.²

A recent study, conducted in the U.S., concluded that saw palmetto did not improve symptoms or objective measurements of BPH.³The study was sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a branch of the National Institutes of Health(NIH), and published in the New England Journal of Medicine (NEJM). The study's conclusions are inconsistent with over twenty other studies of saw palmetto, involving over 3,000 men. Previous research demonstrated that saw palmetto produces improvement in men with mild to moderate symptoms of BPH.² One study compared saw palmetto to a commonly prescribed drug for BPH, called Proscar (finasteride). This study showed that saw palmetto was comparable in effectiveness to Proscar with significantly fewer sexual side effects.⁴

Possible Reason For Inconsistency

While acknowledging that the NCCAM/NEJM study was well designed, some experts do not believe that it is the final word on Saw Palmetto. ⁵The authors themselves cite possible reasons why this study is inconsistent with previous trials in the article's commentary. Expanding on the authors' discussion, additional arguments are presented in support for continued consideration of saw palmetto as a BPH treatment option.

Population Characteristics

Although authors of the NCCAM/NEJM study maintain that population characteristics and symptom scores of men in their clinical trial are comparable to those of men who participated in multiple international trials showing positive benefits, this premise has been disputed. Clinical scoring systems are used to quantify the severity of BPH. These scoring systems vary among the international trials evaluating the effectiveness of saw palmetto. Urologists in the U.S. use a scoring system developed by the American Urological Association, called the AUASI score. This system was not used in Europe to evaluate patients participating in many of the positive trials. According to a commentary in HerbClip™, a publication of the American Botanical Council, many patients in the European trials may have been classified as having mild BPH if scored by the AUASI, and therefore were not included in the NEJM study.⁶

In addition to equivalency of scoring symptoms, the issue of which patients are appropriate candidates for phytotherapy with saw palmetto comes into play. Participants in the NCCAM/NEJM study had symptom scores indicative of moderate to severe BPH. Based upon international clinical trials and experience, saw palmetto is recommended by government and professional groups, such as the German Commission E, the Canadian Natural Health Products Directorate, The European Scientific Cooperative on Phytotherapy, the World Health Organization, as safe and effective for mild to moderate symptoms of BPH.

Clinical experience with saw palmetto extract in the U.S is consistent with that in Europe in one center for complementary medicine. According to Dr. Aaron Katz, M.D., Director of The Center for Holistic Urology at Columbia University, approximately 70% of his patients with mild BPH respond within two months, often avoiding prescription medications and surgery.⁷

Properties of the Extract

No one has identified with certainty the active ingredients(s) of saw palmetto or the herb's mechanism of action. Saw palmetto extracts contain a variety of substances: fatty acids, fatty acid esters and phytosterols.² To complicate matters, various products are prepared using different extraction techniques and standardized to different potencies. The presence and concentration of any one specific ingredient may vary among preparations and extraction methods. It is therefore difficult to compare products used among various clinical trials. The New England Journal of Medicine, in an editorial appearing in the same issue as the the saw palmetto study, elaborated on this problem of saw palmetto product comparisons.⁸

Mechanism of Action

Multiple mechanisms of action have been proposed for saw palmetto. The herb appears to inhibit the "bad" male hormone, dihydrotestosterone (DHT), slows excessive growth of inner prostate tissue, and is anti-inflammatory. ^2,9 Because saw palmetto extract contains many active ingredients and probably exerts its effect in more than one way, the absence of one component in an extract may negatively impact clinical results.

In Europe, the gold standard product prescribed by doctors and used in several positive clinical trials is a brand name product called Permixon. Permixon compared favorable to the drug Proscar in a European trial (37% and 39% reduction in symptom scores respectively, with fewer sexual side effects for the herbal product)⁴ Permixon is not available in the U.S. and was not used in the NCCAM/NEJM study. The product used in the study was carefully selected by NCCAM and contained 92.1% fatty acids and 0.33% plant sterols, a formula that meets criteria for saw palmetto proposed by the U.S. Pharmacopeia (USP). The study's authors acknowledge that, despite rigorous screening for quality, the extract may not have been sufficient to produce a measurable effect.³

Dosage

Another factor may be the dosage used. The starting dosage for mild BPH is 160 mg twice a day. If the population of men in the trial suffered from moderate to severe symptoms, higher dosages may have been necessary. Some of the men in the trial may have passed the point where saw palmetto is effective for relieving symptoms and slowing disease progression, and were candidates for more aggressive traditional method of management.

The Bottom Line

Based upon the preponderance of evidence, saw palmetto is considered "likely effective: for symptoms of mild to moderate BPH.²Men with urinary tract symptoms, especially urinary retention, should consult a physician to rule out a more serious problem. After consultation between doctor and patient, saw palmetto remains an option for men with mild to moderate BPH. Other phyto-therapy options a beta-sitosterol, rye-grass pollen and pygeum.

References:

1) Barnes, PM, Powel-Griner E, et.al. Complementary and alternative medicine use among adults: United States, 2002. Adv Data 2004, 343:1-19

2) Natural Medicines Comprehensive Datebase, Therapeutic Research Center, 2006, Jeff Jellin, PharmD, Editor

3) Brent, S., Kane, C, et.al. Saw Palmetto For Benign Prostatic Hyperpoasia. NEJM:354; 6, Feb 9, 2006

4) Carraro JC, Raynaud JP, Koch G, et al. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate 1996; 29;231-40

5) The Pharmacits's Letter, March 2006, Volume 22, Therapeutic Research Center, Jeff Jellin, PharmD, Editor

6) HerbClip™, The American Botanical Council, Milot, B and Blumenthal, M, April 13, 2006

7) Dr. Katz's Guide to Prostate Health, From Conventional to Holistic Therapies, Dr. Aaron E. Katz, M.D., Freedom Press, 2006

8) Dipaola, R, Morton, R, Proven and Unproven Therapy for Benign Prostatic Hyperplasia, NEJM: 354:6 632-633, Feb 9, 2006

9) Nemecz, G Ph.D. Saw Palmetto, U.S. Pharmacist, Jan 1998

⁺ These statements have not been approved by the Food and Drug Administration. They are not intended to diagnose, treat, prevent or cure any disease.

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Saw Palmetto Study in New England Journal of Medicine NEJM



NEJM Saw Palmetto Study - A Commentary ⁺ Saw Palmetto extract is widely used in the U.S. and Europe to treat symptoms of Benign Prostatic Hyperplasia (BPH). BPH is associated with age-related prostate gland enlargement. Over 2.5 million men in the U.S. reported using saw palmetto.¹ This popular herb is a first line therapy in Europe, where it is commonly prescribed by doctors. Saw Palmetto is considered safe, with only mild side effects, most commonly GI upset.² A recent study, conducted in the U.S., concluded that saw palmetto did not improve symptoms or objective measurements of BPH.³The study was sponsored by the National Center for Complementary and Alternative Medicine (NCCAM), a branch of the National Institutes of Health(NIH), and published in the New England Journal of Medicine (NEJM). The study's conclusions are inconsistent with over twenty other studies of saw palmetto, involving over 3,000 men. Previous research demonstrated that saw palmetto produces improvement in men with mild to moderate symptoms of BPH.² One study compared saw palmetto to a commonly prescribed drug for BPH, called Proscar (finasteride). This study showed that saw palmetto was comparable in effectiveness to Proscar with significantly fewer sexual side effects.⁴ Possible Reason For Inconsistency While acknowledging that the NCCAM/NEJM study was well designed, some experts do not believe that it is the final word on Saw Palmetto. ⁵The authors themselves cite possible reasons why this study is inconsistent with previous trials in the article's commentary. Expanding on the authors' discussion, additional arguments are presented in support for continued consideration of saw palmetto as a BPH treatment option. Population Characteristics Although authors of the NCCAM/NEJM study maintain that population characteristics and symptom scores of men in their clinical trial are comparable to those of men who participated in multiple international trials showing positive benefits, this premise has been disputed. Clinical scoring systems are used to quantify the severity of BPH. These scoring systems vary among the international trials evaluating the effectiveness of saw palmetto. Urologists in the U.S. use a scoring system developed by the American Urological Association, called the AUASI score. This system was not used in Europe to evaluate patients participating in many of the positive trials. According to a commentary in HerbClip™, a publication of the American Botanical Council, many patients in the European trials may have been classified as having mild BPH if scored by the AUASI, and therefore were not included in the NEJM study.⁶ In addition to equivalency of scoring symptoms, the issue of which patients are appropriate candidates for phytotherapy with saw palmetto comes into play. Participants in the NCCAM/NEJM study had symptom scores indicative of moderate to severe BPH. Based upon international clinical trials and experience, saw palmetto is recommended by government and professional groups, such as the German Commission E, the Canadian Natural Health Products Directorate, The European Scientific Cooperative on Phytotherapy, the World Health Organization, as safe and effective for mild to moderate symptoms of BPH. Clinical experience with saw palmetto extract in the U.S is consistent with that in Europe in one center for complementary medicine. According to Dr. Aaron Katz, M.D., Director of The Center for Holistic Urology at Columbia University, approximately 70% of his patients with mild BPH respond within two months, often avoiding prescription medications and surgery.⁷ Properties of the Extract No one has identified with certainty the active ingredients(s) of saw palmetto or the herb's mechanism of action. Saw palmetto extracts contain a variety of substances: fatty acids, fatty acid esters and phytosterols.² To complicate matters, various products are prepared using different extraction techniques and standardized to different potencies. The presence and concentration of any one specific ingredient may vary among preparations and extraction methods. It is therefore difficult to compare products used among various clinical trials. The New England Journal of Medicine, in an editorial appearing in the same issue as the the saw palmetto study, elaborated on this problem of saw palmetto product comparisons.⁸ Mechanism of Action Multiple mechanisms of action have been proposed for saw palmetto. The herb appears to inhibit the "bad" male hormone, dihydrotestosterone (DHT), slows excessive growth of inner prostate tissue, and is anti-inflammatory. ^2,9 Because saw palmetto extract contains many active ingredients and probably exerts its effect in more than one way, the absence of one component in an extract may negatively impact clinical results. In Europe, the gold standard product prescribed by doctors and used in several positive clinical trials is a brand name product called Permixon. Permixon compared favorable to the drug Proscar in a European trial (37% and 39% reduction in symptom scores respectively, with fewer sexual side effects for the herbal product)⁴ Permixon is not available in the U.S. and was not used in the NCCAM/NEJM study. The product used in the study was carefully selected by NCCAM and contained 92.1% fatty acids and 0.33% plant sterols, a formula that meets criteria for saw palmetto proposed by the U.S. Pharmacopeia (USP). The study's authors acknowledge that, despite rigorous screening for quality, the extract may not have been sufficient to produce a measurable effect.³ Dosage Another factor may be the dosage used. The starting dosage for mild BPH is 160 mg twice a day. If the population of men in the trial suffered from moderate to severe symptoms, higher dosages may have been necessary. Some of the men in the trial may have passed the point where saw palmetto is effective for relieving symptoms and slowing disease progression, and were candidates for more aggressive traditional method of management. The Bottom Line Based upon the preponderance of evidence, saw palmetto is considered "likely effective: for symptoms of mild to moderate BPH.²Men with urinary tract symptoms, especially urinary retention, should consult a physician to rule out a more serious problem. After consultation between doctor and patient, saw palmetto remains an option for men with mild to moderate BPH. Other phyto-therapy options a beta-sitosterol, rye-grass pollen and pygeum. References: 1) Barnes, PM, Powel-Griner E, et.al. Complementary and alternative medicine use among adults: United States, 2002. Adv Data 2004, 343:1-19 2) Natural Medicines Comprehensive Datebase, Therapeutic Research Center, 2006, Jeff Jellin, PharmD, Editor 3) Brent, S., Kane, C, et.al. Saw Palmetto For Benign Prostatic Hyperpoasia. NEJM:354; 6, Feb 9, 2006 4) Carraro JC, Raynaud JP, Koch G, et al. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate 1996; 29;231-40 5) The Pharmacits's Letter, March 2006, Volume 22, Therapeutic Research Center, Jeff Jellin, PharmD, Editor 6) HerbClip™, The American Botanical Council, Milot, B and Blumenthal, M, April 13, 2006 7) Dr. Katz's Guide to Prostate Health, From Conventional to Holistic Therapies, Dr. Aaron E. Katz, M.D., Freedom Press, 2006 8) Dipaola, R, Morton, R, Proven and Unproven Therapy for Benign Prostatic Hyperplasia, NEJM: 354:6 632-633, Feb 9, 2006 9) Nemecz, G Ph.D. Saw Palmetto, U.S. Pharmacist, Jan 1998 ⁺ These statements have not been approved by the Food and Drug Administration. They are not intended to diagnose, treat, prevent or cure any disease. Jurisdiction Store policies © Copywrite 2006, Healthy Morning, LLC Saw Palmetto Study in New England Journal of Medicine NEJM		Buy ProstaPro ProstaPro by PhytoPharmica, the same standardized Saw Palmetto extract used in clinical studies, contains the required 80 to 95% fatty acids. Buy ProstaFlo ProstaFlow by Pure Encapsulations contains Cernitin™ Swedish Flower Pollen Extract. ProstaFlow Product Data Sheet Beta-sitosterol Beta-Sitosterol Product Data Sheet Shop Men's Health PureWeigh Weight Management Home News Bulletins