ProstaCol by Vitamin Research Products

POSSIBLY EFFECTIVE

• Prostate cancer. Early findings suggests that oral lycopene might have a small benefit in preventing the development or recurrence of prostate cancer. Details: While some observational studies have found a reduced risk for prostate cancer from increased dietary lycopene intake (2405,2406,7772,7773,7895,12878,60304,60448,109432), others have found no significant association (34635,60334,60449,60457,60547). The most recent meta-analysis of these and other observational studies has found an overall modest benefit, suggesting that the risk of developing prostate cancer decreases by 1% for each additional 2 mg of daily dietary lycopene intake, and decreases by 3.5% for each 10 mcg/dL increase in plasma lycopene levels (98824). A subgroup analysis of some population research also suggests that the benefits from increased dietary lycopene may be limited to non-Hispanic White subjects (109432). Furthermore, a small clinical study in patients at high risk for developing prostate cancer with high-grade prostate intraepithelial neoplasia shows that taking lycopene (Lyc-O-Mato, LycoRed Natural Product Industries) 4 mg twice daily for one year might delay progression to prostate cancer when compared with no supplementation (14126). Numerous small heterogeneous studies have examined the effect of lycopene on serum prostate specific antigen (PSA) levels. One meta-analysis of 6 controlled clinical trials in patients with non-metastatic prostate cancer or prostatic intraepithelial neoplasia shows that taking lycopene 15-45 mg daily for 4 months does not reduce PSA levels when compared with control. However, in patients with a higher baseline PSA of over 6.5 mg/L, lycopene supplementation seems to reduce PSA levels when compared with control (105573). Other small, uncontrolled studies in patients in remission or with recurrent or metastatic prostate cancer suggest that taking lycopene (LycoRed, Jagsonpal Pharmaceuticals; Lyc-O-Mato, LycoRed Natural Product Industries Ltd.) 10-30 mg daily, or tomato products providing a mean of 43 mg lycopene daily, for 3-6 months reduces PSA levels when compared to baseline (60353,60397,60403,60417). Lycopene might also be beneficial in patients receiving surgical interventions. Small clinical studies in patients receiving orchiectomy for metastatic prostate cancer or radical prostatectomy show that taking lycopene 4 mg daily for 6 months or 30 mg daily for 3 weeks seems to reduce and normalize PSA levels when compared with baseline or control (7771,60328,60342). However, not all research has been positive. Two small clinical studies in patients with relapsed or androgen-independent prostate cancer show that taking lycopene 15-120 mg daily for up to one year does not affect PSA levels when compared with baseline (60372,60384). Many of these findings are limited due to a lack of a placebo control.

POSSIBLY INEFFECTIVE

• Bladder cancer. Dietary lycopene does not seem to affect the risk of bladder cancer. Details: Epidemiological research and population studies have not established a link between dietary intake of lycopene or lycopene serum levels and the risk of bladder cancer (2407,60411,60496,60533).
• Diabetes. Increased dietary lycopene intake does not seem to reduce the risk of diabetes or diabetic complications. Details: Population research has found that increasing intake of dietary lycopene does not decrease the risk of developing type 2 diabetes (14004,14361). Other epidemiological research in patients with type 2 diabetes has found that an increased serum concentration of lycopene is not associated with reduced cardiovascular mortality over 14 years (109768).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related macular degeneration (AMD). It is unclear if oral lycopene is beneficial in patients with AMD; the available evidence is conflicting. Details: Some observational research has found that lycopene serum levels in the lowest quintile are associated with an almost two-fold increased risk for AMD when compared with levels in the highest quintile (6110). However, other population research has found no association between lycopene serum levels or dietary lycopene intake and the risk of developing AMD (5922,10902,14007,60585).
• Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease). It is unclear if dietary lycopene helps to prevent ALS. Details: Population research has found that the highest quintile of total dietary carotenoid intake is associated with a 25% lower risk of ALS when compared with the lowest quintile. However, no association was found for lycopene intake alone (90412).
• Asthma. It is unclear if oral lycopene reduces asthma exacerbations or prevents asthma. Details: Some preliminary clinical research in adults with stable asthma shows that taking a specific tomato extract product (Lyc-O-Mato, LycoRed Natural Products Industries, Ltd.) providing lycopene 15 mg three times daily orally for up to 14 weeks does not reduce asthma exacerbations when compared with placebo (60482). However, other observational research has found that a higher dietary intake of lycopene is associated with at least a 20% lower odds of having asthma when compared with a lower dietary intake (109765). The effects of lycopene supplements are unclear.
• Atherosclerosis. It is unclear if oral lycopene is beneficial in patients with atherosclerosis. Details: Some observational research has found that higher serum lycopene levels are associated with a lesser degree of aortic or carotid atherosclerosis (1446,60329,60463). Some observational research has also found that higher serum lycopene levels are associated with a lower risk of coronary heart disease and myocardial infarction in people with atherosclerosis (7897,60538). However, there does not seem to be a link between serum lycopene levels and the risk of ischemic stroke (1449).
• Benign prostatic hyperplasia (BPH). Small studies suggest that lycopene products might improve BPH symptoms. Details: While epidemiological evidence has not found an association between dietary lycopene and the development of BPH (60365), clinical research suggests that lycopene might improve BPH-related symptoms. One small clinical study in patients with BPH shows that taking lycopene (LycoVit powder, BASF) 15 mg daily for 6 months slows the progression of BPH and improves symptom scores when compared to baseline (60399). This finding is limited by the lack a statistical comparison to the control group. Research also suggests that combination products containing lycopene might improve BPH symptoms. These products have combined lycopene 2.1 mg with pumpkin seed oil 160 mg, small-flowered willow herb 500 mg, pygeum 15 grams, and saw palmetto 660 mg (ProstateEZE Max, Caruso's Natural Health) once daily for 3 months (92164); and lycopene 5 mg with saw palmetto 320 mg and selenium 50 mcg (Profluss, KonPharma) daily for 1 year (90354).
• Brain tumor. It is unclear if oral lycopene is beneficial for various types of brain tumor. Details: A small clinical study in patients with glioblastoma multiforme or anaplastic astrocytoma shows that taking lycopene 8 mg orally daily for 3 months does not improve the response to radiotherapy and paclitaxel when compared with placebo (60441).
• Breast cancer. It is unclear if oral lycopene reduces the risk of breast cancer. Details: Some observational research has found that higher levels of lycopene in the blood and breast adipose tissue are associated with reduced breast cancer risk (10132,34634,60549,60555). However, other epidemiological research has found that neither dietary lycopene intake nor lycopene serum levels are associated with breast cancer risk (10823,15751,60344,60468,60541). Also, some population research has found that there is a possible relationship between low serum lycopene levels and an increased risk of breast cancer in Black females, but not White females (60325).
• Cardiovascular disease (CVD). It is unclear if oral lycopene reduces the risk of CVD. Details: Most epidemiological research has found that higher serum levels of lycopene and increased dietary lycopene intake are associated with modestly reduced risk of adverse cardiovascular events, including reduced incidence of coronary heart disease, myocardial infarction, stroke, and mortality (7897,9594,10418,15749,60538,102178,109434). However, evidence from clinical trials shows that lycopene may not improve most risk factors for CVD. Meta-analyses of clinical research in healthy adults or patients with at least one cardiovascular risk factor show that taking lycopene 1.44 to 75 mg daily does not improve blood pressure, lipid levels, or endothelial function when compared with control (95777,105575). These findings are limited by the heterogeneity of the included trials.
• Cataracts. It is unclear if oral lycopene is beneficial for reducing the risk of cataracts. Details: One epidemiological study has found that serum lycopene levels are inversely associated with the risk of developing cataracts (60203). However, other population studies have found no association between lycopene serum levels or dietary intake of lycopene and the development of cataracts (3219,3220,60299).
• Cervical cancer. It is unclear if oral lycopene reduces the risk of cervical cancer. Details: Epidemiological research has found that higher serum lycopene levels or higher dietary lycopene intake is associated with a reduced risk of cervical intraepithelial neoplasia and invasive cervical cancer (60429,60430,60439,60566). However, other studies have not shown this association (60388,60517,60521).
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with prostatitis and chronic pelvic pain syndrome shows that taking a specific combination of lycopene 5 mg with selenium 50 mcg and saw palmetto 320 mg (Profluss, KonPharma) daily for 8 weeks reduces pain scores by 52%, compared with a 26% reduction with saw palmetto alone (60442). It is unclear if this effect is due to lycopene, the other ingredients, or the combination.
• Cognitive function. It is unclear if oral lycopene is beneficial for improving cognitive function and memory. Details: Observational research in healthy adults has found that consuming more lycopene in the diet over 22 years is associated with lower odds of poor cognitive function (104468).
• Colorectal cancer. It is unclear if lycopene reduces the risk for colorectal cancer; the available research is conflicting. Details: Some population research has found that the highest tertile of dietary lycopene intake is associated with a 50% reduced risk for colorectal cancer when compared with the lowest tertile (2407,38845). However, other epidemiological research has found no association between dietary lycopene intake and the risk of colorectal cancer, regardless of smoking status, drinking status, geographical location, gender, and tumor location (3962,34542,95778).
• Esophageal cancer. It is unclear if oral lycopene is beneficial for preventing esophageal cancer. Details: A meta-analysis of population research has found that high dietary intake of lycopene is associated with a 25% reduced odds of developing esophageal squamous cell carcinoma when compared with low dietary intake of lycopene (91159).
• Exercise-induced asthma. It is unclear if oral lycopene is beneficial for preventing exacerbations of exercise-induced asthma. Details: One very small clinical trial in children and adults with exercise-induced asthma shows that taking a specific tomato extract product (Lyc-O-Mato, LycoRed Natural Products Industries, Ltd.) providing lycopene 30 mg daily for 1 week seems to reduce the incidence of exercise-induced asthma exacerbations, but does not improve certain measures of lung function, when compared to baseline (7898). However, another very small study in adolescent athletes with exercise-induced asthma shows that taking the same product and dose for 1 week does not improve post-exercise lung function or reduce exacerbations when compared with placebo (60358). This study may have been underpowered to detect a difference between groups.
• Exercise-induced muscle damage. Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adult long-distance runners shows that taking a combination product (Lycored Ltd.) containing lycopene 5 mg, other carotenoids 4 mg, folic acid 0.1 mg, tocopherols 4 mg, and rosemary extract orally once daily for 4 weeks reduces muscle damage associated with a 2-hour run when compared with placebo (98825).
• Gastric cancer. It is unclear if oral lycopene reduces the risk of gastric cancer. Details: Preliminary observational research in adult males has found that high dietary intake of lycopene is associated with 0.87 lower odds of having stomach cancer when compared with low dietary intake (109436).
• Gingivitis. Small studies suggest that ingesting or injecting oral lycopene products might improve gingivitis. Details: Preliminary clinical research shows that taking a specific oral lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 8 mg daily for 2 weeks, or receiving a single injection of lycopene gel 2 mg into the gums, reduces gingivitis when compared with placebo (60400,60473). However, using a combination product (Lycotas, Intas Pharmaceuticals) containing lycopene 2 mg, vitamin C 50 mg, vitamin A 2500 units, zinc sulfate 20.6 mg, and chromium picolinate 75 mcg orally twice daily for 2 weeks does not improve moderate gingivitis or mild to moderate periodontitis when compared with placebo in people who have also undergone scaling and root planning (92172).
• Helicobacter pylori. It is unclear if oral lycopene helps to eradicate H. pylori. Details: A small clinical study in patients diagnosed with H. pylori shows that adding lycopene 30 mg daily for 1 month to standard therapy with metronidazole, amoxicillin, omeprazole, and bismuth does not increase the rate of H. pylori elimination when compared with standard therapy alone (60480).
• Human papillomavirus (HPV). It is unclear if oral lycopene is beneficial in patients with HPV. Details: Epidemiological research in females has found that higher plasma levels of lycopene are associated with a faster rate of oncogenic HPV clearance, with an average of 8.5 months, when compared with lower levels of plasma lycopene, with an average of 11-12 months (12177).
• Hyperlipidemia. Most research shows that oral lycopene doesn't reduce low-density lipoprotein (LDL) cholesterol levels; however, effects on other lipid levels are unclear. Details: A subgroup meta-analysis of 3 small clinical studies in adults with hyperlipidemia shows that taking lycopene 7-15 mg daily or tomato juice containing lycopene 2.5 mg 4 times weekly for 8 weeks does not improve LDL cholesterol levels when compared with control (105575). Another subgroup meta-analysis of 9 studies in adults without hyperlipidemia shows that consuming lycopene, in supplements or in tomato products, also does not seem to reduce LDL cholesterol levels when compared with both active and inactive controls (105575). This finding is limited by the heterogeneity of interventions and patient populations. In contrast, one small clinical study in Japanese patients with borderline high cholesterol shows that taking 50 grams of a semi-dried tomato containing lycopene 22-27.8 mg daily for 12 weeks modestly reduces LDL cholesterol levels, but does not affect high-density lipoprotein (HDL) cholesterol levels, when compared with taking 50 grams of tomato without lycopene (102180). Subgroup meta-analyses also show that taking lycopene does not reduce triglyceride levels or improve HDL cholesterol levels (105575). However, a meta-analysis of 14 small clinical trials including healthy subjects and subjects with metabolic disorders shows that taking lycopene 6-75 mg orally daily for 1 week to 6 months moderately improves both HDL cholesterol and triglyceride levels when compared with control. A subgroup analysis suggests lycopene may improve lipid levels in unhealthy, but not healthy, subjects. However, the validity of this study is limited by high heterogeneity and the exclusion of LDL cholesterol levels from the analysis (109431). Also, a clinical study in patents with ischemic heart failure shows that taking lycopene 25 mg daily for 8 weeks modestly reduces levels of triglycerides (109773). In postmenopausal females, taking a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 4 mg orally twice daily for 6 months also modestly increases triglyceride levels (109694). However, there was no effect on other lipid levels in either of these studies (109694,109773).
• Hypertension. Small clinical studies suggest that some lycopene products might reduce blood pressure in patients with hypertension. However, lycopene does not seem to reduce the risk for hypertension. Details: Observational research has found no link between serum lycopene levels and the risk for hypertension (60419). Additionally, lycopene supplements do not seem to reduce blood pressure in patients without hypertension or with pre-hypertension (42079,105572,105575). However, some clinical research suggests that lycopene may be beneficial for lowering blood pressure in people with hypertension. A network meta-analysis of 4 small clinical trials in patients with hypertension shows that taking standardized tomato extract containing lycopene 10-30 mg daily for 4-12 weeks reduces systolic and diastolic blood pressure by about 8 mmHg and 4 mmHg, respectively, when compared with placebo. This benefit was not seen with supplements containing only lycopene or tomato products without standardized lycopene content (105572). Specific tomato extract products (Lyc-O-Mato or Tomato Nutrient Complex, LycoRed, Ltd.), were used in some studies (60415,102182).
• Lung cancer. It is unclear if oral lycopene is beneficial in patients with lung cancer. Details: Some epidemiological research has found that higher dietary lycopene intake or serum levels are linked to a decreased risk of lung cancer (2595,60332,60363,60550). However, other epidemiological research has found no association between dietary intake or blood levels of lycopene and lung cancer risk (60316,60520,60522,60554).
• Male infertility. It is unclear if oral lycopene is beneficial in male patients with infertility. Details: A small clinical study in males with idiopathic infertility shows that taking lycopene 2 mg orally twice daily for 3 months improves sperm concentration, motility, and morphology when compared with baseline (60340). The validity of this finding is limited by the lack of a control group.
• Melasma. Topical lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with melasma shows that applying a sunscreen cream containing lycopene 0.05% and wheat bran extract 3.45% twice daily for 12 weeks seems to modestly reduce the severity of melasma, but not the area of affected skin, when compared with a placebo cream (105569).
• Menopausal symptoms. Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with menopausal symptoms shows that taking a specific oral combination of lycopene with calcium, vitamin D3, astaxanthin, and citrus bioflavonoids (Cor.Con. International) daily for 8 weeks reduces hot flashes, incontinence, joint pain, anxiety, and depression when compared with no treatment (19198). It is not clear if this effect is due to lycopene, other ingredients, or the combination.
• Obesity. It is unclear if a diet high in lycopene helps to reduce weight. Details: A small clinical study in obese adults shows that ingesting a drink with a carrot paste containing lycopene 7.6-8.6 mg, along with either high-lutein kale paste or low-lutein cabbage paste, daily for 8 weeks does not reduce body weight or waist circumference, but seems to modestly reduce the amount of visceral fat, when compared with baseline (105574). This finding is limited due to a lack of comparison to the control group, which consumed a carrot paste containing no lycopene.
• Oral leukoplakia. It is unclear if oral lycopene is beneficial in patients with oral leukoplakia. Details: A small clinical study in patients with oral leukoplakia shows that taking a specific lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 2-4 mg orally twice daily for 3 months improves clinical and histological symptoms in a dose-dependent manner when compared with placebo (15748). Preliminary clinical research also shows that taking lycopene 6 mg, along with vitamin E 400 IU and selenium 200 mcg twice daily, for 3 months has a large beneficial effect on lesion size when compared with placebo (109772).
• Oral submucous fibrosis. Small studies suggest that oral lycopene might slightly improve mouth opening in patients with oral submucous fibrosis. It is unclear if lycopene reduces pain or burning sensation. Details: A meta-analysis of 5 small clinical studies in patients with oral submucous fibrosis, usually from chewing betel nuts and/or tobacco, shows that taking lycopene 4-8 mg twice daily for 1-3 months seems to improve maximal mouth opening, but not pain, when compared with control (105570). Clinical studies reported an average mouth opening increase of 3.5-4 mm when compared to baseline (60381,98823,102181). It is unclear if this improvement is clinically significant. Furthermore, although two clinical studies using specific tomato extracts (LycoRed, Jagsonpal Pharmaceuticals; MintovitL by Obsurge Biotech Limited) show that lycopene also reduces the burning sensation in the mouth (98823,102181), the meta-analysis did not confirm this benefit (105570). All of the available studies have been conducted in India and Saudi Arabia; it is unclear if these results are generalizable to other locations.
• Osteoporosis. It is unclear if oral lycopene reduces the risk of osteoporosis. Details: Population research in adults at least 50 years of age has found that high dietary intake of lycopene is not associated with bone mineral density or osteoporosis risk when compared with low dietary intake (107289).
• Ovarian cancer. It is unclear if oral lycopene reduces the risk of ovarian cancer. Details: Some epidemiological evidence has found that a diet rich in carotenoids, including lycopene, is associated with a decreased risk of premenopausal ovarian cancer (10133). However, other epidemiological research has found no association (60373,60534).
• Overall mortality. It is unclear if oral lycopene reduces the risk of overall mortality. Details: Preliminary observational research in adults undergoing cancer screening has found that moderate dietary intake of lycopene, defined as 5.61-8.43 mg daily, is associated with a lower risk of overall mortality and cardiovascular disease-related mortality when compared with low dietary intake of lycopene, defined as less than 2.79 mg daily. However, higher dietary intake of lycopene of 8.44 mg or greater was not associated with mortality risk (109434).
• Pancreatic cancer. It is unclear if oral lycopene helps to prevent pancreatic cancer. Details: Epidemiological research has found that high dietary intake of lycopene is associated with a reduced risk of pancreatic cancer. Intake in the highest quartile was associated with a 31% reduction in risk when compared with the lowest quartile (15750).
• Parkinson disease. It is unclear if oral lycopene helps to prevent Parkinson disease. Details: Epidemiological research has found that neither dietary intake nor blood levels of lycopene is associated with the risk of developing Parkinson disease (91164).
• Polymorphous light eruption (PMLE). Oral lycopene has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with PMLE shows that taking a combination of lycopene 2.5 mg, beta-carotene 4.7 mg, and Lactobacillus johnsonii 500 million CFU (Inneov Sun Sensitivity, Laboratoires Innéov) daily for 12 weeks reduces skin lesion severity after a single exposure to light when compared with placebo (90276). It is not clear if this effect is due to lycopene, other ingredients, or the combination.
• Pre-eclampsia. It is unclear if oral lycopene is beneficial in patients with pre-eclampsia. Details: Epidemiological research has found that the highest intake of lycopene during pregnancy is associated with 45% reduced odds of having pre-eclampsia when compared with the lowest intake (109762). However, results from clinical research are mixed. One clinical study in healthy primigravidae shows that taking a specific oral lycopene supplement (LycoRed, Jagsonpal Pharmaceuticals) 2 mg twice daily, starting between weeks' 16 and 20 of pregnancy and continuing until delivery, lowers mean diastolic blood pressure and reduces the incidence of pre-eclampsia, intra-uterine growth retardation, and preterm labor when compared with placebo (60337). However, another clinical study in this same population shows that taking this same lycopene supplement only once daily, starting between weeks' 12 and 20 of pregnancy, does not reduce the incidence of pre-eclampsia when compared with placebo. Furthermore, the rates of preterm labor and low birth weight were higher in those taking lycopene when compared with placebo (60428). The reasons for these conflicting findings are unclear; larger, high-quality studies are needed to clarify these findings.
• Renal cell carcinoma. It is unclear if oral lycopene reduces the risk for renal cell carcinoma. Details: Observational research has found no association between dietary lycopene intake and the risk of developing renal cell carcinoma (60379).
• Sunburn. Small studies suggest that consuming tomato paste with oral lycopene might prevent sunburn. Details: Small clinical studies in healthy volunteers shows that taking lycopene 10-16 mg daily for 12 weeks, in the form of tomato paste or a tomato extract (Lyc-O-Mato), may provide some protection against experimentally-induced sunburn when compared to baseline or control (23012,60324,60452). More evidence is needed to rate lycopene for these uses.

(Read more about LYCOPENE)

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 orally and appropriately in amounts commonly found in foods (2406,7772,7773). ...when used orally in supplemental doses. Lycopene supplements have been used safely in doses of 15-45 mg daily for 4 to 6 months (60389,60399,60482,102180,102182,109431). Some limited evidence suggests that 120 mg daily is safe for up to one year (60372).

PREGNANCY: LIKELY SAFE
when consumed in amounts commonly found in foods. There is insufficient reliable information available about the safety of lycopene supplements during pregnancy. Small, low-quality clinical studies have shown conflicting results about the safety of using lycopene 2-4 mg daily during pregnancy (60337,60428).

LACTATION: LIKELY SAFE
when consumed in amounts commonly found in foods. There is insufficient reliable information available about the safety of lycopene supplements during lactation; 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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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking lycopene with anticoagulant or antiplatelet drugs might increase the risk of bleeding.  Details In vitro research shows that lycopene has antiplatelet effects (60360,60375,92177).

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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, lycopene is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal complaints, skin rash.

Cardiovascular ...A case of chest pain has been reported in a pregnant patient who was taking a specific lycopene product (LycoRed, Jagsonpal Pharmaceuticals) 2 mg daily (60428). The role of lycopene in this event has not been determined.

Dermatologic ...Orally, lycopene supplements have been reported to cause allergic skin reactions in some clinical studies (60409,60417). Skin rash also occurred in a pregnant patient who was taking a specific lycopene product (LycoRed, Jagsonpal Pharmaceuticals) (60428).
There is at least one case report of carotenoderma, with a yellow-orange coloration in the stratum corneum of the skin, in a 26-year-old female who consumed 20-30 cherry tomatoes and 180 mL tomato juice, as well as other carotenoid-rich foods, daily for up to 10 years. Plasma levels of carotenoids, mainly lycopene, were elevated (109774).

Gastrointestinal ...Orally, gastrointestinal side effects associated with use of lycopene supplements include diarrhea, flatulence, abdominal distension, nausea, vomiting, dyspepsia, and anorexia (60372,60384,60417,60433,60464).

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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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