Saw Palmetto/Astaxanthin Prostate Complex [Discontinued] by Swanson Ultra

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults over 40 years of age with mild forgetfulness shows that taking a specific combination supplement (BGG Japan Co.) containing astaxanthin 9 mg and tocotrienols 50 mg daily for 12 weeks might improve composite and verbal memory when compared with placebo (105099). This study was funded by the supplement manufacturer.
• Age-related macular degeneration (AMD). Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with non-advanced AMD shows that a specific combination product (Azyr, Sifi S.p.A.) containing astaxanthin 4 mg, lutein, zeaxanthin, vitamin E, vitamin C, zinc, and copper, taken daily for 12 months, improves selective dysfunction in the central retina, but does not improve dysfunction in the peripheral retinal areas, when compared with baseline (19196). The validity of this finding is limited by the lack of a comparator group.
• Aging skin. Small studies suggest that oral and topical astaxanthin may be beneficial in aging skin; however, there is conflicting evidence regarding its effects on wrinkles. Details: Small studies in middle-aged adults show that taking astaxanthin (Astavita Astaxanthin, Astavita; AstaReal Oil 50F, Fuji Chemical Industry Co., Ltd.) 2-3 mg orally twice daily for 6-8 weeks improves elasticity, fine lines, wrinkles, and skin moisture when compared with placebo (19561,91734). However, a meta-analysis of small clinical studies in healthy adults shows that taking oral astaxanthin 2-12 mg daily for 4-16 weeks modestly improves moisture content and skin elasticity, but has no effect on wrinkle depth, when compared with placebo (107961). The validity of this meta-analysis is limited due to the population heterogeneity and variety of astaxanthin formulations utilized. In addition to oral astaxanthin, one study also used topical astaxanthin 0.094% (AstaTROL-Hp, Fuij Chemical Industry Co., Ltd.) 1 mL applied twice daily (91734). A systematic review of two very small, nonblinded studies in healthy adults suggests that topical application, either in combination with oral astaxanthin or alone, might have anti-aging skin effects when used for 2-3 weeks (107961).
• Alzheimer disease. Although there is interest in using oral astaxanthin for Alzheimer disease, there is insufficient reliable information about the clinical effects of astaxanthin for this condition.
• Athletic performance. Small studies suggest that oral astaxanthin may improve some aspects of athletic performance. Details: Two small studies in trained cyclists show that taking astaxanthin (Fuji Health Science, Inc. or AstaReal) 4-12 mg daily for 1 or 4 weeks decreases the time to complete a 20-40 km cycling trial by about 50-100 seconds when compared with placebo (91735,105096). However, a larger study in trained cyclists shows that taking astaxanthin (BioReal) 20 mg, vitamin C 300 mg, and vitamin E 50 mg daily for 4 weeks does not decrease time needed to complete a predetermined amount of cycling work (a timed trial) when compared with placebo (91738). Reasons for the discrepancies are not clear but may relate to the fitness level of the athletes in the studies or the differences in timed trial protocols used in the studies.
• Carpal tunnel syndrome. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of astaxanthin 4 mg, lutein, beta-carotene, and vitamin E (BioAstin, Cyanotech) orally 3 times daily for 8 weeks does not reduce the rate or duration of pain due to carpal tunnel syndrome when compared with placebo (19164).
• Diabetes. It is unclear if oral astaxanthin is beneficial for diabetes. Details: A small clinical trial in adults with diabetes shows that taking astaxanthin (Nature Vision) 8 mg daily for 8 weeks does not reduce levels of cholesterol or fasting blood glucose or reduce diastolic blood pressure when compared with placebo. However, there were some modest beneficial effects on visceral fat, triglyceride level, and systolic blood pressure (109778).
• Dry eye. It is unclear if oral astaxanthin is beneficial for dry eye syndrome. Details: A clinical study in adults and elderly patients with mild to moderate dry eye syndrome shows that taking oral astaxanthin 6 mg twice daily for 30 days improves symptom severity, tear break-up time, fluorescein break-up time, and meibomian gland dysfunction, but not visual acuity or intraocular pressure, when compared with baseline (107962). The validity of these findings is limited by the lack of a comparator group.
• Dyspepsia. It is unclear if oral astaxanthin improves symptoms of dyspepsia. Details: One clinical study in adults with functional dyspepsia with or without Helicobacter pylori infection shows that taking astaxanthin (AstaCarox, AstaReal AB) 16 mg or 40 mg daily for 4 weeks does not reduce indigestion, pain, or H. pylori counts when compared with placebo. However, astaxanthin 40 mg daily may reduce reflux in H. pylori-positive patients (19165).
• Exercise-induced muscle damage. Small clinical studies in trained athletes suggest that oral astaxanthin may not improve markers of muscle damage from exercise. Details: A small study in professional male soccer players shows that taking astaxanthin 4 mg daily for 90 days does not seem to reduce exercised-induced biomarkers of muscle damage, such as creatinine kinase, when compared with placebo (91739). Taking a combination of astaxanthin 4 mg and lutein 480 mg (BioAstin, Cyanotech) daily for 3 weeks also did not reduce creatinine kinase levels after exercise in trained athletes when compared with placebo (safflower oil) (19199).
• Exercise-induced muscle soreness. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in resistance trained athletes shows that taking a combination of astaxanthin 4 mg and lutein 480 mg (BioAstin, Cyanotech) daily for 3 weeks does not reduce muscle soreness or improve muscle performance 96 hours after exercise when compared with placebo (safflower oil) (19199).
• Fatigue. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in healthy patients shows that taking a specific combination product (ASTOTS, Fujifilm Co.) containing astaxanthin 6 mg and sesamin 10 mg after breakfast daily for 4 weeks does not improve overall fatigue after completion of mental and physical tasks when compared with placebo (98769).
• Heart failure. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with heart failure with reduced left ventricular ejection fraction (LVEF) shows that taking a specific supplement containing astaxanthin 12 mg, tocotrienol 40 mg, and L-ascorbic acid 2-glucoside 30 mg (AstaReal ACT, AstaReal Co., Ltd.) daily for 3 months may increase LVEF from 34% to 38% and modestly increase exercise tolerance as measured by the six-minute walk test when compared with baseline (105097). The validity of these findings is limited by the lack of a comparator group. Furthermore, this study was funded by the supplement manufacturer.
• Hyperlipidemia. Small clinical studies suggest that oral astaxanthin is not beneficial for reducing cholesterol levels. Details: One small clinical study in adults with mild hyperlipidemia shows that taking astaxanthin (AstaReal Astaxanthin, Fuji Chemical Industry) 12 mg or 18 mg daily for 12 weeks reduces triglyceride levels, while taking 6 mg or 12 mg daily increases high-density lipoprotein (HDL) cholesterol levels, when compared with placebo. However, total cholesterol and low-density lipoprotein (LDL) cholesterol levels were not affected (19167). Meta-analyses of small clinical studies mostly in adults without hyperlipidemia have also been conducted. One shows that taking astaxanthin 4-18 mg daily for up to 12 weeks does not reduce total or LDL cholesterol levels, but may increase HDL cholesterol levels, when compared with control (105100). A more recent analysis shows that taking astaxanthin 4-20 mg daily for up to 6 months has no beneficial effects on blood lipid levels and might actually increase levels of LDL cholesterol (109776).
• Hypertension. It is unclear if oral astaxanthin reduces blood pressure. Details:A meta-analysis of four small clinical trials shows that taking astaxanthin does not have a clinically beneficial effect on systolic or diastolic blood pressure (109776). However, none of the trials were conducted in patients with hypertension.
• Impaired glucose tolerance (prediabetes). It is unclear if oral astaxanthin is beneficial in patients with prediabetes. Details: A small clinical study in healthy adults and adults with prediabetes shows that taking oral astaxanthin 12 mg daily for 12 weeks improves glycated hemoglobin (HbA1c) when compared with baseline, but not when compared with placebo. Insulin sensitivity and postprandial glucose levels were also improved when compared with baseline, but no statistical comparison to the placebo group was conducted (107965). The validity of this study is limited due to unclear reporting.
• Infertility. It is unclear if oral astaxanthin improves reproductive outcomes in patients with infertility due to endometriosis or polycystic ovary syndrome (PCOS). Details: A small clinical study in adults with infertility secondary to moderate or severe endometriosis undergoing assisted reproductive therapy in Iran shows that taking astaxanthin (AstaReal, AstaReal Co.) 6 mg daily for 12 weeks improves the numbers of oocytes retrieved, mature oocytes, and high-quality embryos but not the quantity of immature oocytes, fertilization rate, number of transferred embryos, or clinical pregnancy rate when compared with placebo (112434). Similarly, a small clinical study also conducted in Iran in patients with infertility due to PCOS undergoing assisted reproductive therapy shows that taking astaxanthin (Algalife Pure astaxanthin) 8 mg daily for 40 days prior to egg retrieval modestly improves the high-quality embryo rate, but not the total number of embryos or the clinical pregnancy rate, when compared with placebo (109775).
• Male infertility. It is unclear if oral astaxanthin improves male infertility. Details: A small low-quality clinical study in males with infertility who are participating in intra-uterine insemination shows that taking astaxanthin (AstaCarox, AstaReal AB) 16 mg daily for 3 months does not seem to increase sperm count and quality, but might result in a higher total pregnancy rate of 23% compared with a 3.6% rate in the placebo group (19197). The validity of this finding is limited by poor study methodology and differences between treatment groups. Another small clinical study in males with infertility and oligospermia shows that taking astaxanthin (Astasan, Sensilab) 16 mg daily does not increase sperm concentration or sperm motility when compared with placebo (105098).
• Menopausal symptoms. Although there is interest in using oral astaxanthin for menopausal symptoms, there is insufficient reliable information about the clinical effects of astaxanthin for this purpose.
• Metabolic syndrome. Although there is interest in using oral astaxanthin for metabolic syndrome, there is insufficient reliable information about the clinical effects of astaxanthin for this condition.
• Nonalcoholic fatty liver disease (NAFLD). Although there is interest in using oral astaxanthin for NAFLD, there is insufficient reliable information about the clinical effects of astaxanthin for this condition.
• Osteoarthritis. Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with mild knee or hip osteoarthritis shows that taking a combination product containing astaxanthin 2 mg, krill oil, and hyaluronic acid daily for 12 weeks (FlexPro MD, Valensa) reduces joint pain and stiffness and improves objective and subjective measures of joint function but does not improve overall physical function when compared with placebo (112432). It is unclear if these effects are due to astaxanthin, other ingredients, or the combination.
• Obesity. Although there is interest in using oral astaxanthin for weight loss, there is insufficient reliable information about the clinical effects of astaxanthin for this purpose.
• Parkinson disease. Although there is interest in using oral astaxanthin for Parkinson disease, there is insufficient reliable information about the clinical effects of astaxanthin for this condition.
• Physical performance. It is unclear if oral astaxanthin improves physical performance in older adults. Details: A small clinical trial in healthy nursing home residents shows that taking astaxanthin (AstaReal) 12 mg twice daily for 16 weeks, in combination with vitamin E 40 mg and vitamin C 30 mg daily, increases the 6-minute walking distance by about 38 meters, a significant increase when compared with placebo containing vitamin E and vitamin C. However, there was no effect on muscle strength (109777). Another small clinical trial in healthy, older adults (aged 65-85 years) undergoing exercise endurance testing shows that a specific combination product (AstaReal; Fuji Health Science, Inc) containing astaxanthin 12 mg, tocotrienol 10 mg, and zinc 6 mg, taken as 2 capsules daily for 12 weeks, reduces the respiratory exchange ratio, but does not improve leg muscle endurance or perceived exertion, when compared with placebo. In a subgroup analysis of males, but not females, those taking astaxanthin had a greater total exercise efficiency when compared with placebo (107963).
• Rheumatoid arthritis (RA). Oral astaxanthin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with RA shows that taking a supplement containing astaxanthin 4 mg, lutein 40 mcg, vitamin A 65 IU, vitamin E 50 IU, and safflower oil 460 mg (BioAstin, Cyanotech) three times daily for 8 weeks reduces pain and improves satisfaction by approximately 40% when compared with placebo (94125).
• Stroke. Although there is interest in using oral astaxanthin for recovery from stroke, there is insufficient reliable information about the clinical effects of astaxanthin for this purpose.
• Sunburn. It is unclear if oral astaxanthin might help to prevent sunburn. Details: A very small clinical study in Japanese adults shows that taking astaxanthin (Astots, Fujifilm Corporation) 4 mg daily for 9 weeks might increase skin tolerance to ultraviolet (UV) light when compared with placebo (96884). It is unclear if this translates to a lower risk of sunburn. More evidence is needed to rate astaxanthin for these uses.

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POSSIBLY EFFECTIVE

• Transurethral resection of the prostate (TURP). Saw palmetto 320 mg daily seems to improve outcomes after TURP surgery in a dose-dependent manner. Details: Clinical research shows that taking saw palmetto (Permixon, Pierre Fabre Medicament) 320 mg daily for 2 months prior to TURP surgery reduces blood loss, the duration of surgery, the development of intraoperative complications, the duration of catheterization, and the length of hospitalization when compared with placebo (73323,73353). Although these studies found benefit, a small study using a lower dose of saw palmetto (Prostagood Mono, Abdi Ibrahim) 160 mg orally once daily for 5 weeks prior to TURP did not find any decrease in the risk of perioperative hemorrhage, or the density of prostate tissue (17202).

POSSIBLY INEFFECTIVE

• Benign prostatic hyperplasia (BPH). Although individual study results are conflicting, the overall body of evidence suggests that saw palmetto does not offer clinically meaningful improvements in BPH-related symptoms. Details: Research on the use of saw palmetto for improving symptoms of BPH is inconsistent and contradictory. To date, the best available evidence addressing the effectiveness of saw palmetto in patients with BPH comes from two high-quality clinical trials sponsored by the National Institutes of Health (NIH). In one of these trials, saw palmetto 160 mg twice daily for one year was ineffective for reducing moderate to severe symptoms of BPH when compared with placebo (14274). In the other trial, taking saw palmetto 320-960 mg daily for 72 weeks did not significantly improve symptoms when compared with placebo (17684). Additionally, meta-analyses of these trials and many of the small trials described below show that taking saw palmetto does not improve BPH-related signs and symptoms or International Prostate Symptom Scores (IPSS) (89441,102835). While several small, low-quality clinical trials and observational studies in patients with BPH suggest that saw palmetto provides some improvement in urinary symptoms, nocturia, urinary flow, and/or residual urine volume when compared with placebo or baseline (6750,6764,6772,73315,73383,73385,73387,89441,96570,110541), other studies show that saw palmetto has no clinically meaningful effect on BPH-related signs and symptoms, including prostate volume (5093,6752,11314,73343,96409). The validity of several of these studies is limited due to the use of per-protocol analyses and/or a lack of placebo control groups. Beyond this, reasons for these discrepant findings are unclear; however, the mixed results may be due to use of different saw palmetto products, varying study methodologies, different patient populations, and varying symptom scoring tools. Additionally, research shows significant variation in the chemical composition of commercially available saw palmetto extracts (17305,89441). Several clinical trials have compared saw palmetto to 5-alpha reductase inhibitors such as finasteride (Proscar) or dutasteride (Avodart). Some small studies suggest that it may be comparable to these medications for relieving BPH symptoms, but with less effect on prostate size or prostate-specific antigen (PSA) levels (6424,96570). It may also be better tolerated, with a positive effect on sexual dysfunction (6424,6763,18215,89441). Additionally, one observational study in patients with BPH has found that taking saw palmetto 320 mg with tamsulosin 0.4 mg daily for 6 months is associated with similar improvements in IPSS and quality of life scores, but also has a lower risk of reduced libido, when compared with tamsulosin plus dutasteride 5 mg or finasteride 0.5 mg daily (110542). Some research has also compared saw palmetto to alpha-adrenergic blockers. Alpha-adrenergic blockers appear to have a faster onset of symptom relief (2732,6750), and saw palmetto might be less effective than the alpha-adrenergic blocker prazosin (Minipress). Although some studies and a meta-analysis suggest it is similarly effective to tamsulosin (Flomax) after 6-12 months of treatment for improving various symptoms of BPH (6775,6776,11243,89441,96570,104804,107483), another meta-analysis found that alpha-blockers were more effective than saw palmetto for these outcomes (102835). Additionally, tamsulosin appears to be more effective than saw palmetto for reducing prostate volume (104802). However, some research suggests that saw palmetto may be better tolerated than tamsulosin (107483). It is unclear if taking saw palmetto with tamsulosin can improve BPH symptoms. Several low-quality studies and a meta-analysis of two of these studies show no additional benefit over using tamsulosin alone (8901,89443,89448,96410). However, one study suggests that a specific saw palmetto extract (Permixon, Pierre Fabre Medicament) 320 mg daily is associated with a 29% decrease in the IPSS when taken alone, compared with a 37% decrease when taken along with tamsulosin 0.4 mg daily for 6 months. Tamsulosin alone was associated with a 31% decrease (104802). Smaller, lower-quality studies of various combinations of saw palmetto with other ingredients have demonstrated some benefit for improving symptoms of BPH, and some have shown equivalence to finasteride, tamsulosin, or tadalafil (Cialis). These ingredients include stinging nettle root (PRO 160/120, Dr. Willmar Schwabe Pharmaceuticals) (6763,17307,73330,89441); cernitin, beta-sitosterol, and vitamin E (11241); selenium and lycopene (Profluss, Konpharma) (90354,97255); pygeum, lycopene, Epilobium parviflorum, and pumpkin seed oil (ProstateEZE Max, Caruso's Natural Health) (92164); and quercetin and beta-sitosterol (Difaprost, Difass International) (96784). Additionally, one study suggests that an enriched form of saw palmetto oil containing 3% beta-sitosterol seems to be more effective than standard saw palmetto oil containing 0.3% beta-sitosterol in reducing IPSS scores (104803).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Androgenic alopecia. It is unclear if oral or topical saw palmetto is beneficial in patients with androgenic alopecia. Details: Clinical research shows that a combination of saw palmetto extract 200 mg plus beta-sitosterol 50 mg taken twice daily for 18-24 months improves subjective scores of hair quantity and quality in males with androgenic alopecia (15550). However, other clinical research shows that taking saw palmetto extract 320 mg daily for 24 months is less effective for improving hair growth in males with androgenic alopecia when compared with finasteride 1 mg daily (89444). Some clinical research shows that saw palmetto lotion applied topically twice daily for 50 weeks improves hair density by 27% in people with androgenic alopecia. However, a 13% improvement was observed in the placebo group, and no between-group comparisons were made (73435). Additionally, a small clinical study in males with androgenic alopecia receiving platelet-rich plasma every 3 weeks shows that applying 1 mL of topical saw palmetto, redensyl, and biotin daily for 12 weeks modestly improves subjective hair loss scores and photographic assessment of hair growth when compared with 1 mL of topical Procapil daily (112176). However, it is unclear if this effect is due to saw palmetto, other ingredients, or the combination.
• Asthma. Although there has been interest in using oral saw palmetto for asthma, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic bronchitis. Although there has been interest in using oral saw palmetto for chronic bronchitis, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). It is unclear if oral saw palmetto is beneficial in patients with CP/CPPS. Details: Preliminary clinical research shows that oral saw palmetto 325 mg daily for one year does not significantly improve symptoms of CP/CPPS when compared with finasteride 5 mg once daily (11354). However, a clinical trial in patients with moderate to severe CP/CPPS shows that taking saw palmetto 160 mg orally twice daily for 12 weeks improves NIH Chronic Prostatitis Index (NIH-CPSI) score after two weeks of treatment in patients with moderate disease and after 4 weeks of treatment in patients with severe disease when compared with placebo. Independent of severity, 73% of patients taking saw palmetto report a 6-point reduction in NIH-CPSI total score, compared to 33% of patients taking placebo (107482). Saw palmetto extract has also been evaluated in combination with other ingredients. A preliminary clinical study shows that taking a combination of saw palmetto extract 320 mg, selenium 50 mcg, and lycopene oil extract 5 mg daily for 8 weeks improves symptoms and peak flow in patients with CP/CPPS when compared with baseline. However, these effects were not observed or were less significant in patients treated with saw palmetto alone (60442).
• Common cold. Although there has been interest in using oral saw palmetto for the common cold, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Hirsutism. Although there has been interest in using oral and topical saw palmetto for hirsutism, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Non-neurogenic lower urinary tract symptoms (LUTS). It is unclear if oral saw palmetto is beneficial in females with non-neurogenic LUTS. Details: A small clinical study in elderly Japanese females with LUTS shows that taking saw palmetto extract 320 mg daily for 12 weeks reduces daytime urinary frequency and might improve nocturia, but it does not seem to reduce urinary urgency, incontinence, straining, bladder pain, or urethral pain when compared with placebo (110540).
• Prostate cancer. Small preliminary studies suggest that saw palmetto does not reduce prostate cancer risk or symptoms associated with prostate cancer. Details: Population research shows that people who take saw palmetto supplements do not have a lower risk of developing prostate cancer (15217). Preliminary clinical research also shows that taking saw palmetto 960 mg daily before, during, and after radiation treatment for early prostate cancer does not significantly improve lower urinary tract symptoms when compared with placebo (96412).
• Prostatitis. Adding saw palmetto to antibiotic therapy seems to relieve some symptoms of bacterial prostatitis more effectively than antibiotics alone. Details: Preliminary clinical research in patients with bacterial prostatitis shows that taking saw palmetto extract daily for eight weeks, with prulifloxacin 600 mg daily for 15 days, reduces pain and urinary symptoms more than prulifloxacin alone, but the combination does not appear to improve bacterial eradication or sexual dysfunction more than the antibiotic alone (89442). One small clinical study in patients with chronic nonbacterial prostatitis shows that a specific saw palmetto extract (Prostamol Uno, Profluss) 320 mg daily improves symptoms when compared with no treatment (73329). Combinations of saw palmetto with other supplements have also been used with fluoroquinolone antibiotics, typically resulting in symptom improvement when compared with the antibiotic alone. These supplement combinations include saw palmetto, indole-3-carbinol, and epigallocatexin-3-gallate (Indigal Plus) 2 capsules twice daily for 3 months (73355); saw palmetto 160 mg, stinging nettle 120 mg, curcumin 200 mg, and quercetin 100mg (ProstaMEV plus FlogMEV) for 2 weeks (73346); and saw palmetto 320 mg, Bacillus coagulans 200 mg, and arbutin 100 mg (Lactorepens) daily for 30 days (96411).
• Sexual desire. Although there has been interest in using oral saw palmetto for sexual desire, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Sexual dysfunction. Although there has been interest in using oral saw palmetto for sexual dysfunction, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose. More evidence is needed to rate saw palmetto for these uses.

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LIKELY SAFE ...when used in amounts found in foods. Astaxanthin has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when taken orally and appropriately. Astaxanthin 4-18 mg daily has been used with apparent safety for up to 12 weeks. Doses of 40 mg daily have been used with apparent safety for up to 4 weeks (19165,19167,19197,32621,96884,105100).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those typically found in foods.

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LIKELY SAFE ...when used orally and appropriately. Saw palmetto has been safely used in clinical studies lasting up to 3 years (2735,6750,6752,6764,6772,6773,11354,14274,15550,17202,17306,17684,73315,73383,73384,73385,73389,89441,96410,96412,110540).

POSSIBLY SAFE ...when used rectally and appropriately. Saw palmetto has been used safely in clinical research at a dose of 640 mg once daily for 30 days (73387). However, the long-term safety of saw palmetto administered rectally is not known.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally. Saw palmetto has hormonal activity (6766); avoid using.

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CYTOCHROME P450 2B6 (CYP2B6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, astaxanthin may decrease levels of drugs metabolized by CYP2B6.  Details In vitro research shows that astaxanthin induces cytochrome CYP2B6 enzyme activity in human hepatocytes (32613). This effect has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, astaxanthin may decrease levels of drugs metabolized by CYP3A4.  Details In vitro research shows that astaxanthin induces CYP3A4 enzyme activity in human hepatocytes (32613). This effect has not been reported in humans.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Saw palmetto might increase the risk of bleeding with anticoagulant or antiplatelet drugs.  Details Saw palmetto is reported to prolong bleeding time (8659). Theoretically, it might increase the risk of bleeding when used concomitantly with anticoagulant or antiplatelet drugs.

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Saw palmetto might reduce the effectiveness of contraceptive drugs.  Details Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with contraceptive drugs taken concomitantly.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Saw palmetto might reduce the effectiveness of estrogens.  Details Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with estrogens taken concomitantly.

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General ...Orally, astaxanthin seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, red fecal color.

Gastrointestinal ...Orally, astaxanthin 6 mg daily has caused two cases of increased bowel movements and two cases of red fecal color (91736). A higher dose of astaxanthin (AstaCarox, AstaReal AB) 40 mg daily has caused severe stomach/abdominal pain in two patients (19165).

Ocular/Otic ...Canthaxanthin, another carotenoid substance that is chemically related to astaxanthin, has caused crystals in the retina and loss of visual acuity in one patient (8455). This effect has not been observed with astaxanthin, but patients who have visual changes while taking astaxanthin should stop taking it immediately.

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General ...Orally, saw palmetto is well tolerated and adverse effects are mild, infrequent, and reversible.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, decreased libido, diarrhea, dizziness, fatigue, headache, nausea, rhinitis, vomiting.

Cardiovascular ...Occasionally, cases of hypertension, postural hypotension, tachycardia, angina pectoris, arrhythmia, extrasystole, angiopathy, myocardial infarction, and congestive heart failure have been reported in patients using saw palmetto orally (6424,6484,6752,6772,17684,73388,89441). One case of severe bradycardia and second degree heart block was reported in a 64 year-old male taking an unknown amount of saw palmetto for a few weeks (96413).

Dermatologic ...A case report describes a 61-year-old male who developed a fixed drug eruption with localized blisters and erosions three days after starting oral saw palmetto. The lesions resolved when saw palmetto was stopped, but recurred when it was reintroduced six months later. Topical corticosteroid treatment was necessary and the patient was left with some residual hyperpigmented patches (104805). A combination of saw palmetto and beta-sitosterol has been associated with a single report of worsening acne (15550).

Endocrine ...Two case reports involving one 11-year-old female undergoing treatment for telogen effluvium and another 10-year-old female undergoing treatment for hirsutism, describe hot flashes and the onset of menarche associated with use of saw palmetto. One of these patients was consuming saw palmetto in a food supplement; the other was taking a supplement containing saw palmetto 320 mg daily (73361,96414). In both cases, the hot flashes resolved following treatment discontinuation. In one case, a rechallenge with saw palmetto caused a recurrence of hot flashes.

Gastrointestinal ...Gastrointestinal complaints such as nausea, vomiting, constipation, diarrhea, gastralgia, and halitosis are the most frequently reported adverse effects associated with saw palmetto (6484,6752,60442,73315,73320,73348,73354,73383,73385,73388,89441). Less often, cases of duodenal ulcer, dyspepsia, or heartburn have been reported (6772,73329,73354). Meteorism (intestinal gas accumulation) has also been reported with saw palmetto, although causality was unclear (60442).

Genitourinary ...Some clinicians are concerned that saw palmetto might cause erectile dysfunction, ejaculatory disturbance, or altered libido because of its potential effects on 5-alpha-reductase. Some preliminary clinical studies have reported sexual dysfunction, particularly ejaculatory dysfunction, erectile dysfunction, and reduced libido, in patients taking saw palmetto (5093,17202,17684,73383,89441). However, most of these patients were previously diagnosed with prostate disorders, so causality is unclear. Additionally, several clinical studies indicate that the occurrence of impotence in males taking saw palmetto is similar to placebo and tamsulosin (Flomax), and significantly less than finasteride (Proscar) (2732,6424,17306,107481). Rarely, cases of testicular pain, vesical tenesmus, and urinary tract infections have been reported in patients using saw palmetto extract orally (73388).

Hematologic ...Saw palmetto might have antiplatelet effects and potentially increase the risk of bleeding in some patients. There is one report of excessive intraoperative bleeding in a patient who took saw palmetto prior to surgery. Bleeding time normalized when saw palmetto was discontinued (8659). Also, one case of cerebral hemorrhage has been reported, but details are not available to determine causality (6772,73348). A case of retroperitoneal hematoma after bilateral inguinal hernia repair is reported in a male patient taking saw palmetto. The patient was discharged after a 3-day hospitalization in stable condition (112177).

Hepatic ...A case report describes a patient who developed acute hepatitis and pancreatitis while taking saw palmetto. Symptoms resolved when saw palmetto was discontinued, and reemerged upon re-challenge (14457). Other cases of acute hepatitis and pancreatitis, with elevated alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin have been reported in patients using saw palmetto orally (14457,73350,73351).

Musculoskeletal ...Orally, saw palmetto may cause fatigue, weakness, muscle pain, and back pain, although these adverse events are rare (6424,73388,89441). A case of saw palmetto-related rhabdomyolysis was reported in an 82-year-old male presenting with kidney dysfunction, increased C-reactive protein levels, and elevated serum creatine kinase (73358).

Neurologic/CNS ...Orally, saw palmetto can cause headaches, dizziness, insomnia, and fatigue (6750,6752,6772,11354,60442,73348,73385,73388,89441).

Ocular/Otic ...A case of intraoperative floppy-iris syndrome (IFIS) has been reported in a patient using saw palmetto orally (73340). However, no statistically significant association between saw palmetto and IFIS was found in a case series of 660 patients undergoing cataract surgery (73347).

Pulmonary/Respiratory ...Rhinitis is one of the more commonly reported adverse effects of saw palmetto (73348). One patient taking saw palmetto extract 160 mg twice daily reported "breathlessness" (73388). Two cases of respiratory depression have been reported in patients using saw palmetto extract (Permixon) 320 mg (6772).

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