Natural Standard® Patient Monograph, Copyright © 2014 (www.naturalstandard.com). All Rights Reserved. Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions. Background Saw palmetto (Serenoa repens, Serenoa serrulata) is used popularly in Europe to treat symptoms of enlarged prostate. Although it is not considered the standard of care in the United States, it is the most popular herbal treatment for this condition. More than two million American men use saw palmetto for enlarged prostate, and it is commonly recommended as an alternative treatment by the U.S. Food and Drug Administration (FDA). Many studies report that saw palmetto may be as effective as the hormonal agent finasteride (Proscar®) and may cause fewer side effects when used to treat bladder problems. Most research has focused on the saw palmetto product Permixon®. However, results are still mixed, and further research is needed. Saw palmetto has also been used for low sperm count, low sex drive, hair loss, bronchitis, diabetes, inflammation, migraine, and prostate cancer, although there is limited evidence supporting its effectiveness for these conditions. Related terms American dwarf palm tree, American saw palmetto, Arecaceae (family), Bazoton®, Beltrax Uno®, cabbage palm, dwarf palm, dwarf palm plant, Elusan® Prostate, fatty acids, Harzol®, IDS 89, Libeprosta®, LSESR, myristoleic acid, PA 109, Palmae (family), palmetto scrub, palmier de l’ Amerique du nord (French), palmier nain (French), PC-SPES®, Permicaps®, Permixon®, Prostadyn®, Prostagood Mono®, Prostamen®, Prostamol Uno®, Prostasan®, Prostaserene®, Prostaserine®, ProstaX®, Remigeron®, sabal, Sabalfruchte (German), Sabal fructus, Sabal serrulata, Sabal serrulata (Michx.) Nutall ex. Schultes & Schultes, Sabal serrulatum, savpalme (Danish), saw palmetto berry, Serendar, Serenoa, Serona repens, Serenoa serrulata, Serenoa serrulata Hook F., Serenoae repentis fructus, SG 291, sterols, Strogen®, Strogen forte®, Tadenan®, Talso®, Urocaps®, Urogutt®, WS 1473, Zwegpalme. Select combination products: Cernitin®, Cerniton AF™, indigal plus, IPBTRE, PRO 160/120 (Prostagutt® forte), Profluss®, Prostagutt®, Prostataplex™. Note: Information on pygeum (Prunus africanum, Pygeum africanum) is available in a separate Natural Standard monograph. Dosing The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy. Adults (18 years and older) Saw palmetto has been taken as sterol and fatty acid extracts (such as LSESR), berries (ground, dried, whole, or pulp), tincture, fluid extract, or tea. Teas prepared from saw palmetto berries may be ineffective because the purported active constituents are water-insoluble. For enlarged prostate (benign prostatic hypertrophy), a range of 100-960 milligrams of sabal or Serenoa repens extract has been taken by mouth daily for up to 18 months. A dose of 320 milligrams of saw palmetto extract (e.g., Permixon®, Serendar, Talso®), in one dose or two divided doses (80-90% liposterolic content), by mouth daily for up to six months, has been taken in numerous studies. Dosing regimens of 160 milligrams of saw palmetto twice daily for eight weeks (PA109), nine weeks, and 12 weeks (Prostaserene®) have been taken by mouth. Reports suggest that 160 milligrams once daily by mouth may be as effective as twice daily by mouth. Libeprosta® has been taken as two 80 milligram tablets twice or three times daily by mouth. A dose of 640 milligrams of saw palmetto has also been taken by mouth daily for an unknown length of time. A dose of 640 milligrams of saw palmetto extract has been applied to the rectum once daily for 12 weeks. In preparation for surgery, pretreatment with 320 milligrams of Serenoa repens (Permixon®) has been taken by mouth daily for at least eight weeks before surgery. To treat prostate inflammation, 320 milligrams of prostamol (Sabal serrulata plant extract) has been taken by mouth. Also, 320 milligrams of Serenoa repens has been taken by mouth daily for eight weeks. Children (younger than 18 years) There is no proven safe or effective dose for saw palmetto in children. Safety The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects. Allergies Few allergic symptoms have been reported with saw palmetto. A study of people taking the combination product PC-SPES® (no longer commercially available), which includes saw palmetto and seven other herbs, reports that three out of 70 people developed allergic reactions. In one case, the reaction included throat swelling and difficulty breathing. Avoid in people who are allergic or sensitive to saw palmetto, any of its parts, or other members of the Arecaceae or Palmae family. Side Effects and Warnings Few severe side effects of saw palmetto are noted in the published scientific literature. A study found that there may be a lack of herb-drug interactions associated with saw palmetto. Overall, there appear to be few safety concerns with short-term use of saw palmetto. Saw palmetto appears to be well tolerated by most people for up to 3-5 years. LSESR, a particular extract of Serenoa repens, may be better tolerated, although this claim has not been confirmed. The most common complaints involve the stomach and intestines, and include stomach pain, nausea, vomiting, bad breath, constipation, diarrhea, gas, heartburn, and indigestion. Stomach upset caused by saw palmetto may be reduced by taking it with food. Some reports describe ulcers, liver damage, liver inflammation, and jaundice (yellowing of the skin), but the role of saw palmetto is not clear in these cases. Similarly, reports of headache, dizziness, insomnia, depression, chest pain, abnormal heart rhythm, heart attack, heart disease, heart failure, high or low blood pressure, respiratory tract problems (including breathing difficulties), and muscle pain have been reported but may not be clearly caused by saw palmetto. Saw palmetto may also cause or induce bloody urine, breast tenderness or enlargement, changes in blood chemistry, eye problems, flu-like symptoms, genital or urinary problems, hot flashes, inflammation of the pancreas, low energy, menstruation, mouth or teeth problems, physical injury, sexual dysfunction (such as ejaculation problems, erectile dysfunction, impotence, or low sex drive), skeletal muscle breakdown, skin reactions, and testicular pain. Use cautiously in people scheduled to undergo some surgeries or dental work, who have bleeding disorders, or who are taking drugs that may increase the risk of bleeding. Dosing adjustments may be necessary. Use cautiously in people who have high blood pressure, or those taking drugs or herbs and supplements that may affect blood pressure. Use cautiously in people who have liver disorders or those taking drugs for liver disorders. Use cautiously in patients with hormone-sensitive conditions or in those taking hormonal agents, due to possible hormonal effects of saw palmetto. Use cautiously in people who have stomach disorders. Use cautiously in combination with agents that may affect hemoglobin levels. Saw palmetto may reduce levels of hemoglobin, hematocrit, red blood cells, and platelets. Avoid saw palmetto in women who are or may potentially be pregnant, due to the risk of developmental problems in the baby and hormonal effects. Avoid saw palmetto when breastfeeding, due to a lack of available information. Avoid saw palmetto in children, due to a lack of available information. Avoid in people who are allergic or sensitive to saw palmetto, any of its parts, or other members of the Arecaceae or Palmae family. In theory, prostate-specific antigen (PSA) levels may be artificially lowered by saw palmetto, based on a proposed mechanism of action of saw palmetto (inhibition of 5-alpha-reductase). Therefore, there may be a delay in diagnosis of prostate cancer or interference with following PSA levels during treatment or monitoring in men with known prostate cancer. The combination product PC-SPES®, which contains saw palmetto and seven other herbs, has been found to contain prescription drugs including warfarin, a blood thinner. The U.S. Food and Drug Administration (FDA) has issued a warning not to use PC-SPES® for this reason, and it is no longer commercially available. Pregnancy and Breastfeeding Due to limited safety data, possible hormonal activity, and the risk of developmental problems in the baby, saw palmetto extract is not recommended for women who are or may potentially be pregnant, or women who are breastfeeding. Many tinctures contain high levels of alcohol and should be avoided during pregnancy. Interactions Interactions with Drugs Saw palmetto may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (blood thinners) such as warfarin (Coumadin®) or heparin, antiplatelet drugs such as clopidogrel (Plavix®), and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®). Some batches of the discontinued combination herbal preparation PC-SPES®, which contains saw palmetto and seven other herbs, has been found to contain several medications including the blood thinner warfarin. Saw palmetto may affect blood pressure. Caution is advised in people taking drugs that may affect blood pressure. Early research found that saw palmetto lacks effect on cytochrome P450 1A2, 3A4, 2E1, or 2D6 activity. Saw palmetto may also interact with agents that may affect hemoglobin levels, agents that may affect the immune system, agents that may affect the liver, agents that may lower seizure threshold, agents that may regulate heart rate, agents that may treat genitourinary tract disorders, agents that may treat impotence, agents that may treat stomach disorders, antibiotics, anticancer agents, anti-inflammatories, disulfiram (Antabuse®), and hormonal agents (such as androgens or antiandrogens). Interactions with Herbs and Dietary Supplements Saw palmetto may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba, and fewer cases with garlic. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases. Saw palmetto may affect blood pressure. Caution is advised in people taking herbs or supplements that affect blood pressure. Early research found that saw palmetto lacks effect on cytochrome P450 1A2, 3A4, 2E1, or 2D6 activity. Tannins in saw palmetto may prevent iron absorption. Saw palmetto may also interact with antibacterials, anticancer herbs and supplements, anti-inflammatories, cat’s claw, echinacea, herbs and supplements that may affect hemoglobin levels, herbs and supplements that may affect the immune system, herbs and supplements that may lower seizure threshold, herbs and supplements that may regulate heart rate, herbs and supplements that may treat genitourinary tract disorders, herbs and supplements that may treat impotence, herbs and supplements that may affect the liver, herbs and supplements that may treat stomach disorders, hormonal herbs and supplements (such as androgens, antiandrogens, or phytoestrogens), Pinus pinaster, and Urtica dioica.