Saw Palmetto With Lycopene by Natural Factors HerbalFactors

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.

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POSSIBLY INEFFECTIVE

• Bladder cancer. Consuming tomatoes and tomato-based products does not appear to reduce the risk of bladder cancer. Details: Observational studies have found no association between tomato and tomato-based product intake and the risk of bladder cancer (2407).
• Breast cancer. Consuming tomatoes and tomato-based products does not appear to reduce the risk of breast cancer. Details: Observational studies have found no association between tomato or tomato-based product intake and risk of breast cancer (15747).
• Diabetes. Consuming tomatoes and tomato-based products does not appear to prevent the development of type 2 diabetes or improve glycemic control in patients with type 2 diabetes. Details: Observational studies have found that increasing intake of tomato or tomato-based products does not significantly decrease the risk of developing type 2 diabetes (14004,14361). Additionally, a small clinical study in non-smoking male patients with type 2 diabetes shows that consuming raw tomato 200 grams daily for 8 weeks does not improve plasma glucose levels when compared to baseline (102477). The validity of this finding is limited by the lack of comparator group.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if tomato improves skin appearance. Details: A small study of females aged 35-55 shows that taking a certain tomato pulp product (Lumenato, Lycored) 1 capsule daily for 12 weeks improves patient reported skin appearance scores when compared to baseline (110523). The interpretation of this result is limited by the lack of a placebo group.
• Benign prostatic hyperplasia (BPH). Oral tomato powder has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients with BPH shows that taking 5 grams of a whole tomato food supplement consisting of tomato powder and polyphenols extracted from olives daily for 2 months improves quality of life and reduces lower urinary tract symptoms including urinary frequency, urinary urgency, and nocturia when compared to baseline. No improvements in these symptoms were reported with placebo (106656). It is unclear if these findings are due to tomato, olive polyphenols, or the combination.
• Cardiovascular disease (CVD). It is unclear if consuming tomato-based foods reduces the risk of cardiovascular events. Details: Observational research has found that increased consumption of tomato-based foods is associated with an insignificant trend towards a reduced risk of myocardial infarction, stroke, and other cardiovascular events (10418,102178).
• Cataracts. It is unclear if consuming tomatoes reduces the risk of cataracts. Details: Observational research has found that eating more than 3 servings of tomatoes each week may decrease the risk of developing cataracts (9439).
• Cervical cancer. It is unclear if consuming tomatoes reduces the risk of cervical cancer. Details: Observational research has found that increased tomato intake is associated with a decreased risk of cervical cancer (2407).
• Colorectal cancer. Research on the benefits of consuming tomatoes or tomato-based products for the prevention of colorectal cancer is conflicting and limited to observational studies only. Details: Some observational research has found that increasing tomato or tomato-based product intake is associated with a reduced risk of colorectal cancer (2404,2407). However, higher quality observational research has found that tomato-based product intake is not associated with risk of colorectal cancer (15747).
• Exercise-induced asthma. It is unclear if oral tomato extract is beneficial in patients with exercise-induced asthma. Details: A small clinical study in patients with exercise-induced asthma shows that taking a specific tomato extract (Lyc-O-Mato, LycoRed Ltd) 30 mg daily for 1 week seems to reduce exercise-induced asthma when compared with placebo. The tomato extract seems to prevent decreases in forced expiratory volume (FEV1) in response to exercise (7898).
• Gastric cancer. Research on the benefits of consuming tomatoes or tomato-based products for the prevention of gastric cancer is conflicting and limited to observational studies only. Details: Some observational studies have found that increasing tomato or tomato-based product intake is associated with a reduced risk of gastric cancer in some subgroups of patients (2407,15747,102480). However, other observational research has found that tomato-based product intake is not associated with risk of gastric cancer (15747). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim regarding tomatoes and gastric cancer risk. However, the FDA concludes that it is highly unlikely that tomatoes reduce the risk of gastric cancer (102375).
• Hyperlipidemia. Small clinical studies suggest that consuming tomato sauce or semi-dried tomatoes may modestly reduce low-density lipoprotein (LDL) cholesterol levels in patients with hyperlipidemia. Details: One small, open-label clinical trial in patients with hyperlipidemia shows that consuming a specific vine-ripened tomato sauce (OsteoCol, C.G. Food, SRL) 150 mL daily for 6 weeks reduces total cholesterol and LDL cholesterol levels when compared to baseline. Patients adherent to the tomato sauce regimen showed an 11 mg/dL and 12 mg/dL reduction in total and LDL cholesterol, respectively, while those consuming a sterol-enriched yogurt saw total and LDL cholesterol levels decrease by 18 mg/dL and 16 mg/dL, respectively. Patients with a baseline LDL cholesterol level of greater than 152 mg/dL saw the greatest benefit from this tomato sauce (106653). Another 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 a tomato without lycopene (102180). This suggests that any benefit of tomato on blood lipid levels is likely due to its lycopene content.
• Hypertension. Small clinical studies and observational research suggest that oral tomato extract or dietary tomato consumption may modestly reduce blood pressure in patients with hypertension. Details: Several small clinical trials in patients with hypertension show that taking a specific tomato extract product (Lyc-O-Mato, LycoRed, Ltd.), providing lycopene 15-30 mg daily, for 6-8 weeks, reduces systolic blood pressure by around 7-13 mmHg and diastolic blood pressure by around 4-6 mmHg when compared to baseline (14287,60415,102182). The validity of these findings is limited by the lack of a comparator group. Additionally, a large observational study, conducted over 3 years, suggests that moderate consumption of tomato-based products (i.e., 44-82 grams daily) is associated with marginally lower blood pressure when compared with higher and lower consumption in older adults with grade 1 hypertension. However, this association is not seen in patients with grade 2 or 3 hypertension (113145). Interpretation of these results is limited by self-reported data and lack of generalizability outside of confounders relating to a Mediterranean lifestyle. Evidence on the use of tomato in patients with pre-hypertension is mixed. One small clinical study in patients with pre-hypertension shows that taking a specific tomato extract (Fruitflow, Provexis Plc, UK.) 150 mg as a single dose seems to modestly reduce blood pressure over a 24-hour period when compared with placebo (102478). This study is limited by its small size and short duration. Another small clinical study in pre-hypertensive patients shows that taking a specific tomato extract (Lyc-o-Mato, LycoRed Ltd) containing lycopene 15 mg daily for 8 weeks does not reduce blood pressure when compared with placebo (42079). The impact of dietary tomato consumption on preventing hypertension has also been evaluated. A large prospective observational study in Chinese adults without a history of smoking or myocardial infarction suggests moderate dietary intake of tomatoes (i.e. up to 33.3 grams daily) is associated with a 49-58% reduction in the risk of developing new onset hypertension when compared with no consumption after about 6 years' follow up. However, the associated risk reduction was less with higher consumption (110525). These results may not apply to patients in countries where dietary trends are different, and the validity of these findings is limited by the potential for confounding. Another large observational study, conducted over 3 years in older adults at high cardiovascular risk, suggests that higher consumption (i.e., at least 1 large-sized tomato daily) is associated with reduced risk of hypertension by 36% when compared with moderate and lower consumption (113145). However, interpretation of these results is limited by self-reported data, and lack of generalizability outside of confounders relating to a Mediterranean lifestyle.
• Lung cancer. It is unclear if consuming tomatoes reduces the risk of lung cancer; the available research is conflicting. Details: Some observational studies have found an association between increased tomato and tomato-based product consumption and a reduced risk of lung cancer; however, many of these studies were not stratified based on the patient's smoking status. Higher quality, large-scale observational studies have not found any association between tomato product intake and lung cancer risk (15747).
• Muscle strength. It is unclear if consuming tomatoes improves muscle strength or attenuates declines in muscle strength. Details: A small observational study in Japanese adults 22-68 years of age found that more frequent tomato consumption (2 or more times weekly) is associated with an attenuated rate of handgrip strength decline over 3 years when compared with less frequent tomato consumption (102473).
• Ovarian cancer. Research on the benefits of consuming tomatoes or tomato-based products for the prevention of ovarian cancer is conflicting and limited to observational studies only. Details: Some observational research has found that increased tomato or tomato juice intake is not associated with risk of ovarian cancer; however, consuming tomato sauce two or more times weekly is associated with a decreased risk (2407). Other observational research has found that increased dietary intake of lycopene, particularly from tomato sauce, is associated with a reduced risk of ovarian cancer in premenopausal patients (10133). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim regarding tomato sauce and ovarian cancer risk. However, the FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer (102375).
• Pancreatic cancer. Research on the benefits of consuming tomatoes or tomato-based products for the prevention of pancreatic cancer is conflicting and limited to observational studies only. Details: A large-scale observational study have found that that tomato or tomato-based product intake is not associated with a decreased risk of pancreatic cancer (15747). However, other observational studies have found that raw tomato intake, and high tomato intake in general, is associated with a reduced risk of pancreatic cancer (2407,15747,15750). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim regarding tomatoes and pancreatic cancer risk. However, the FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer (102375).
• Prostate cancer. Consuming tomatoes or tomato-based products may slightly lower the risk of prostate cancer; however, observational research is mixed and high-quality clinical trials addressing tomato intake and prostate cancer risk are lacking. Details: Some observational studies have found that consuming tomato products, including tomatoes, tomato sauce, pizza, or tomato juice, one time or more per week, is associated with a modest reduction in the risk of prostate cancer (2406,7772,7895,12878,15747,102476). However, other observational research has found that tomato consumption is not associated with a reduced risk of prostate cancer (14125,15172,15747,92171). One small clinical study in patients with high-grade prostatic intraepithelial neoplasia shows that taking tomato extract capsules containing lycopene 30 mg daily for 6 months does not impact benign tissue endpoints when compared with placebo (102471). In 2005, the US Food and Drug Administration (FDA) approved a qualified health claim stating that one-half to one cup of tomatoes or tomato sauce weekly may reduce the risk of prostate cancer. However, the FDA concludes that there is little scientific evidence to support this claim (102375).
• Radiation dermatitis. It is unclear if drinking tomato juice is beneficial in patients with radiation dermatitis. Details: One small, uncontrolled clinical trial in patients undergoing radiotherapy for breast cancer shows that drinking tomato juice 160 mg daily for 6 months after radiotherapy improves the severity of dermatitis within 1 month of treatment when compared to baseline (106654). The lack of a comparator group limits the validity of these findings; it is unclear how tomato juice consumption compared with the natural resolution of radiation dermatitis. More evidence is needed to rate tomato 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 the ripe or unripe tomato fruit or its products are consumed in amounts found in foods (2406,9439,10418,106653,106654). ...when tomato leaf is consumed in regular food amounts (18).

POSSIBLY SAFE ...when a tomato extract is used orally for medicinal purposes. A specific tomato extract (Lyc-O-Mato, LycoRed Ltd) has been used with apparent safety in clinical studies lasting up to 8 weeks (7898,14287,102182).

POSSIBLY UNSAFE ...when the tomato leaf or unripe green tomato fruit is used orally in excessive amounts. Tomato leaf and unripe green tomatoes contain tomatine, which has been associated with toxicity when consumed in large quantities (18,102957). There is insufficient reliable information available about the safety of the tomato vine.

PREGNANCY AND LACTATION: LIKELY SAFE
when the tomato fruit or its products are consumed in typical food amounts. There is insufficient reliable information available about the safety of tomato extracts when used during pregnancy or lactation; 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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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, tomato leaves and ripe or unripe tomato fruit are well tolerated in typical food amounts. Tomato extracts also seem to be well tolerated. Tomatine, a glycoalkaloid found in tomato leaves and unripe green tomatoes, can cause serious side effects when consumed in excessive amounts.
Serious Adverse Effects (Rare):
Orally: Bradycardia, diarrhea, respiratory disturbances, spasms, vomiting, and death with excessive consumption of tomatine, a glycoalkaloid found in tomato leaves and unripe green tomatoes.

Cardiovascular ...Orally, the glycoalkaloid tomatine in tomato leaf or green tomatoes can cause bradycardia when consumed in excessive amounts (18,102957).

Gastrointestinal ...Orally, the glycoalkaloid tomatine in tomato leaf or green tomatoes can cause severe mucous membrane irritation, vomiting, diarrhea, and colic when consumed in excessive amounts (18,102957).

Immunologic ...In a case report, a 31-year-old female working in the supermarket developed an airborne allergy to tomato stem proteins with symptoms of severe rhinoconjunctivitis. This woman did not have a food allergy to tomato fruit (102467).

Neurologic/CNS ...Orally, the glycoalkaloid tomatine in tomato leaf or green tomatoes can cause dizziness, stupor, headache, and mild spasms when consumed in excessive amounts (18,102957).

Pulmonary/Respiratory ...Orally, the glycoalkaloid tomatine in tomato leaf or green tomatoes can cause respiratory disturbances when consumed in excessive amounts. In severe cases, death by respiratory failure might occur (18,102957).

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