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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. Although there has been interest in using oral deer velvet for anti-aging effects, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Anemia of chronic disease. Although there has been interest in using oral deer velvet for anemia of chronic disease, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Asthma. Although there has been interest in using oral deer velvet for asthma, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Athletic performance. It is unclear if oral deer velvet extract or powder is effective for improving athletic performance. Details: One small clinical study in active adult males participating in a strength training program shows that taking deer velvet extract 300 mg or deer velvet powder 1.5 grams daily for 10 weeks does not improve squat strength or aerobic capacity when compared with placebo. However, taking deer velvet might produce modest improvements in knee extension strength and endurance (47108).
• Cardiovascular disease (CVD). Although there has been interest in using oral deer velvet for CVD, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Cognitive function. Although there has been interest in using oral deer velvet to improve cognitive function, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Erectile dysfunction (ED). Although there has been interest in using oral deer velvet for ED, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Fatigue. Although there has been interest in using oral deer velvet for fatigue, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Hypertension. Although there has been interest in using oral deer velvet for hypertension, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Osteoporosis. Although there has been interest in using oral deer velvet for osteoporosis, there is insufficient reliable information about the clinical effects of deer velvet for this purpose.
• Sexual desire. It is unclear if oral deer velvet powder is effective for improving sexual desire. Details: One small clinical study in adult males shows that taking deer velvet powder 1 gram daily for 12 weeks does not improve sexual function or desire in males or their female partners when compared with placebo (47106).
• Uterine fibroids. Deer velvet has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of nine small clinical trials shows that taking traditional Chinese medicine decoctions containing deer velvet or ejiao, a gelatin product extracted from donkey skin, along with other herbal ingredients plus mifepristone reduces uterine fibroid volume and improves symptoms associated with uterine fibroids when compared with mifepristone alone (106850). It is unclear if these findings are due to deer velvet, other ingredients, or the combination.
• Wound healing. Although there has been interest in using oral deer velvet for wound healing, there is insufficient reliable information about the clinical effects of deer velvet for this purpose. More evidence is needed to rate deer velvet for these uses.

(Read more about DEER VELVET)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Bronchitis. Although there is interest in using oral horny goat weed for bronchitis, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Coronary heart disease (CHD). Although there is interest in using oral horny goat weed for CHD, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Erectile dysfunction (ED). Although there is interest in using oral horny goat weed for ED, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Fatigue. Although there is interest in using oral horny goat weed for fatigue, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Gulf war syndrome. It is unclear if oral horny goat weed is beneficial in patients with Gulf war syndrome. Details: A small clinical study in males with Gulf war syndrome shows that taking horny goat weed extract 250 mg or 500 mg twice daily, standardized to contain 50 mg or 100 mg of icariin per dose, respectively, for 30 days does not improve symptoms of Gulf war syndrome when compared with placebo (108311).
• Hepatitis. Although there is interest in using oral horny goat weed for hepatitis, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• HIV/AIDS. Although there is interest in using oral horny goat weed for HIV/AIDS, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Hypertension. Although there is interest in using oral horny goat weed for hypertension, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Male infertility. Although there is interest in using oral horny goat weed for male infertility, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Memory. Although there is interest in using oral horny goat weed for memory, there is insufficient reliable information about the clinical effects of horny goat weed for this purpose.
• Myocarditis. Although there is interest in using oral horny goat weed for myocarditis, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Osteoarthritis. Although there is interest in using oral horny goat weed for osteoarthritis, there is insufficient reliable information about the clinical effects of horny goat weed for this condition.
• Osteoporosis. Several small, low-quality clinical studies suggest that horny goat weed may modestly improve bone mineral density (BMD) in patients with osteoporosis. Details: A meta-analysis of 12 small, low-quality clinical studies in patients with osteoporosis shows that taking horny goat weed alone or in combination with conventional therapy improves BMD when compared with a control group. When added to conventional therapy, horny goat weed appears to have a large effect on BMD, while its effect is more modest when used alone. The most common formulations and doses used include granules 1 gram twice daily for 6 months, an extract 600 mg taken in divided doses daily for 6 months, and a decoction 50 mL taken 2-3 times daily for 3-6 months. The pooled analysis suggests that horny goat weed decoctions are more effective than other formulations (109578). Additionally, a small clinical study in postmenopausal patients not included in the analysis above shows that taking a specific extract of horny goat weed containing 60 mg icariin, 15 mg daidzein, and 3 mg genistein (Xianling Gubao; Tong Ji Tang Pharmacal Company) daily, in addition to calcium 300 mg daily, for 24 months attenuates loss of BMD of the lumbar spine and femoral neck when compared with placebo plus calcium. BMD increased by 1.6% and 1.3% at each site, respectively, compared with decreases of 1.8% and 2.4%, respectively, with placebo (14900).
• Postmenopausal conditions. It is unclear if oral horny goat weed is beneficial in patients with postmenopausal conditions. Details: Preliminary clinical research in postmenopausal patients shows that taking horny goat weed water extract 300 mL daily for 6 months slightly decreases triglyceride and total cholesterol levels and can increase estradiol levels when compared with placebo (55452). The clinical significance of these effects is unclear.
• Sexual dysfunction. Although there is interest in using oral horny goat weed for sexual dysfunction, there is insufficient reliable information about the clinical effects of horny goat weed for this condition. More evidence is needed to rate horny goat weed for these uses.

(Read more about HORNY GOAT WEED)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related testosterone deficiency. It is unclear if oral maca is beneficial for age-related testosterone deficiency. Details: A moderate-size clinical study in eugonadal males age 65 years on average with symptoms related to late-onset hypogonadism shows that taking maca 1.66 grams three times daily for 12 weeks improves physical, sexual, and psychological symptom scores when compared with placebo. However, maca did not lead to a significant difference in testosterone levels between groups (112012). The interpretation of these findings is limited by the use of patient-reported outcomes.
• Amenorrhea. Although there has been interest in using oral maca for amenorrhea, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Anemia of chronic disease. Although there has been interest in using oral maca for anemia of chronic disease, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Antidepressant-induced sexual dysfunction. It is unclear if oral maca is beneficial in patients with sexual dysfunction due to antidepressants. Details: Preliminary clinical research shows that taking maca 1.5 grams twice daily for 12 weeks modestly increases remission rates in females experiencing antidepressant-induced sexual dysfunction (90278).
• Athletic performance. It is unclear if oral maca is beneficial for athletic performance. Details: A small clinical study in male elite athletes shows that taking maca 2500 mg twice daily for 8 weeks may improve some measures of physical performance, including grip strength, power, or agility, when compared to baseline (112014). However, the interpretation of this study is limited by the lack of a control group, inconsistent results among the various types of athletes included in the study, and unreported habitual activities, such as diet, that may confound results.
• Chronic fatigue syndrome (CFS). Although there has been interest in using oral maca for CFS, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Depression. Although there has been interest in using oral maca for depression, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Fatigue. Although there has been interest in using oral maca for fatigue, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Leukemia. Although there has been interest in using oral maca for leukemia, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Male infertility. It is unclear if oral maca is beneficial for male infertility. Details: Clinical research shows that taking a specific maca product (Maca Gelatinizada La Molina, Laboratorios Hersil) 1.5-3 grams daily for 4 months increases semen volume, sperm count, and sperm motility in healthy males aged 22-44 years (18289). Conversely, a meta-analysis of 2 small clinical studies in males with infertility shows that taking 2-2.8 grams of maca daily for 12-16 weeks does not improve the concentration of semen when compared with placebo (112011). However, the interpretation of this finding is limited by the heterogeneity of the included studies.
• Memory. Although there has been interest in using oral maca for memory, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Osteoporosis. Although there has been interest in using oral maca for osteoporosis, there is insufficient reliable information about the clinical effects of maca for this purpose.
• Postmenopausal conditions. It is unclear if oral maca is beneficial for postmenopausal conditions. Details: Two small clinical trials show that taking powdered maca (Maca Power, Incan Food, Healthychoices) 3.3 or 3.5 grams daily as a single dose or in two divided doses for 6 weeks modestly reduces anxiety, depression, and sexual dysfunction when compared with placebo (90606,99792). However, these changes are generally small and of questionable clinical significance (90606).
• Sexual desire. It is unclear if oral maca improves male sexual desire; it has not been evaluated for female sexual desire. Details: Preliminary clinical research shows that taking a specific maca product (Maca Gelatinizada La Molina, Laboratorios Hersil), 1.5-3 grams daily in three divided doses for 12 weeks can increase subjective feelings of sexual desire in healthy males aged 21 to 57 years (9928).
• Tuberculosis. Although there has been interest in using oral maca for tuberculosis, there is insufficient reliable information about the clinical effects of maca for this purpose. More evidence is needed to rate maca for these uses.

(Read more about MACA)

LIKELY EFFECTIVE

• Coronary heart disease (CHD). A diet high in soluble fiber, such as that found in oats, reduces the risk of CHD. Details: Clinical research shows that a diet containing foods high in fiber, such as oats, oat bran, or whole oat flour, reduces the risk of CHD (2737,4960,4962,4963,4964,4965,4966,4967,4968). In 1993, the US Food and Drug Administration (FDA) approved a health claim stating that consuming at least 3 grams of soluble fiber per day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of CHD (102336). However, clinical studies show that at least 3.6 grams of soluble fiber daily is needed to reduce the risk of CHD (5786,5787,5788,5794,5795,5796).
• Hypercholesterolemia. A diet rich in soluble fiber, such as that found in oats, can reduce cholesterol by a moderate amount. Details: Oats, oat bran, and other soluble fibers can modestly reduce total and low-density lipoprotein (LDL) cholesterol when consumed as part of a diet low in saturated fat. Consuming 56-150 grams of whole oat products such as oatmeal and oat bran, containing 3.6-10 grams of soluble fiber daily, can significantly lower total and LDL cholesterol levels. For each gram of soluble fiber consumed, total cholesterol decreases by about 1.4 mg/dL and LDL by about 1.2 mg/dL. Eating 3-10 grams of soluble fiber daily can reduce total cholesterol by about 4-14 mg/dL (4976,4977,5786,5788,5792,5794,5795,8521,107749); however, doses greater than 10 grams daily don't seem to increase effectiveness (5788). Eating three bowls of oatmeal (28 gram servings) daily can decrease total cholesterol by about 5 mg/dL (4972,4973,4974,4975,4976,4977,5786,5788,6188). Oat bran products, such as oat bran muffins and oat bran flakes, may vary in their ability to lower cholesterol, depending on the total soluble fiber content and other dietary variables (6188). Whole oat products might be more effective for lowering LDL and total cholesterol than foods containing oat bran plus soluble fiber (10145).

POSSIBLY EFFECTIVE

• Diabetes. A diet rich in whole grains, such as oats, may help prevent diabetes or improve blood glucose control in patients with type 1, type 2, or gestational diabetes. Details: Population research shows that for every 16 gram daily serving of whole grains, including oats, there is a 7% to 11% lower risk of developing type 2 diabetes (100622). There is also evidence that consuming oats can decrease blood glucose and insulin levels, as well as lipid levels, in patients with diabetes. The glycemic effects of oats depend on the level of processing of the oat products. Consuming intact oat kernels or thick-cut oats (>0.6 mm) reduces postprandial blood glucose and insulin, but consuming thin-cut, or "quick", oats has no effect (105536). Clinical research shows that consuming oats and oat bran for 4-8 weeks decreases pre-prandial blood glucose, 24-hour plasma glucose, glycated hemoglobin (HbA1c), insulin levels, and low-density lipoprotein (LDL) cholesterol in people with type 2 diabetes (4980,4982,6266,103345). Various doses have been used, including 3 grams of soluble fiber daily, or bread providing 34 grams of total fiber daily (9 grams of soluble fiber) (4961,4980). Additional clinical research in obese adults with type 2 diabetes shows that eating whole grain oats 50-100 grams daily in place of other carbohydrates reduces postprandial blood glucose by 19-27 mg/dL when compared with other carbohydrates in a healthy diet. After 1 year, the groups consuming 50 grams and 100 grams of oats had an additional 0.48% and 0.64% reduction in HbA1c, respectively, when compared with the regular healthy diet group (97520). There is also some evidence that consuming oats 50 grams daily, containing 25 grams of soluble fiber, might be more effective for improving glycemic control and decreasing hyperinsulinemia than the standard moderate fiber diet recommended by the American Diabetes Association (ADA) (6266). Oats have also been evaluated in adolescents with type 1 diabetes. One very small clinical study shows that taking 50 grams of a specific oat product (Betaglucare), providing beta-glucans 6 grams, in three divided doses daily for one week is beneficial for glycemic control and variability when compared with a standard diet without beta-glucans or with taking only 25 grams of the product daily. Maximal, mean, and pre- and post-meal blood glucose levels were modestly lower, and minimal blood glucose levels were modestly higher. Most measures of glycemic variability were statistically different, although there were no differences in the duration of hypoglycemia or hyperglycemia between groups (105261). Oats have also been evaluated in patients with gestational diabetes. A randomized, controlled trial shows that taking 30 grams of a specific oat bran product (OAB; Golden Light Cup Company) orally twice daily at lunch and dinner for 4 weeks improves mean fasting blood glucose and two-hour postprandial glucose when compared with a control group. After 4 weeks, the mean fasting blood glucose and 2-hour postprandial glucose in the treatment group were 85 mg/dL and 104 mg/dL, respectively, compared with 93 mg/dL and 117 mg/dL, respectively, in the control group (107751). The validity of this study is limited by the short treatment duration and lack of follow-up.
• Gastric cancer. A diet rich in soluble fiber, such as that found in oats, might reduce the risk of gastric cancer. Details: Observational research has found that consuming a diet that includes cereal fiber, such as oats and oat bran, might reduce the incidence of gastric cancer (10435).

POSSIBLY INEFFECTIVE

• Colorectal cancer. Regular consumption of oats does not seem to reduce the risk of colorectal cancer. Details: Observational research has found that consuming oat bran or oats orally doesn't seem to reduce the risk of colon cancer. Additionally, consuming fiber, including oat-bran fiber, is not associated with a reduction in the risk for recurrence of colorectal adenomas (4820,5104).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical oats for acne, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Anxiety. Although there is interest in using oral oats for anxiety, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Atopic dermatitis (eczema). Topical colloidal oatmeal cream may be beneficial in patients with atopic dermatitis. Details: Preliminary clinical research shows that applying a cream containing colloidal oatmeal 1% daily for 2 weeks has a moderate effect on the severity of atopic dermatitis when compared with baseline (103344). The validity of this finding is limited by the lack of a comparator group. Other research suggests that colloidal oatmeal may be beneficial when used in combination with topical steroids. Clinical research shows that the benefits obtained from applying an ointment containing fluocinolone 0.025% to the hands for 2 weeks were better maintained in the patients who also used a cream containing colloidal oatmeal 1% during this time period and for an additional 4 weeks when compared with patients using fluocinolone and the cream base without colloidal oatmeal. Quality of life was also improved in the patients using colloidal oatmeal (103340).
• Breast cancer. Observational research suggests that regular oatmeal intake may be associated with reduced mortality from breast cancer. Details: Population research in postmenopausal patients has found that those who have eaten 50 grams of oatmeal daily prior to a breast cancer diagnosis have a 20% reduced risk of all-cause mortality in the 7 years following the diagnosis when compared with patients who have not eaten oatmeal. However, no benefit was seen when post-diagnostic oatmeal intakes were examined (103343).
• Burns. Although there is interest in using topical oats for burns, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral oats for CFS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Cognitive function. It is unclear if oral oats are beneficial in healthy adults with mild memory impairment. Details: Preliminary clinical research in healthy middle-aged adults with self-reported memory decline shows that consuming a specific wild green-oats extract (Neuravena, Frutarom) 800 mg as a single dose improves overall speed, but not overall accuracy, of cognitive performance when compared with placebo. However, a higher dose of 1600 mg was ineffective (97519).
• Dry skin. It is unclear if applying lotion containing colloidal oat extract improves dry skin to a greater extent than other lotion products. Details: Preliminary clinical research shows that applying a lotion containing colloidal oat extract (Aveeno Active Naturals Skin Relief 24Hr Moisturizing Lotion, Johnson & Johnson) twice daily for 2 weeks improves itchiness, cracking, scaling, dryness, and roughness when compared to baseline in females with dry skin (91458). Additional preliminary clinical research shows that applying a colloidal oatmeal lotion to the legs twice daily for three weeks reduces skin dryness and improves skin integrity when compared to baseline in adults with dry skin (97518). The validity of these findings is limited by the lack of a comparator group.
• Exercise-induced muscle soreness. It is unclear if oral oats are beneficial for exercise-induced muscle soreness. Details: A small clinical trial shows that eating two cookies containing oat flour 60 grams daily for 8 weeks reduces muscle soreness 48 or 72 hours after downhill running when compared with baseline (103341).
• Fat redistribution syndrome. It is unclear if oral oats are beneficial for fat redistribution syndrome. Details: Consumption of a high fiber diet, including oats, with adequate energy and protein might prevent fat deposition in patients with HIV. A one-gram increase in total dietary fiber may decrease the risk of fat deposition by 7% (12517).
• Gallbladder disease. Although there is interest in using oral oats for gallbladder disease, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Hypertension. It is unclear if oral oats are beneficial for hypertension. Details: Observational research has found that consumption of oats as oatmeal or oat cereal does not seem to reduce diastolic blood pressure (DBP) or systolic blood pressure (SBP) in males with minor elevations in blood pressure (2956). A randomized, controlled trial in patients with stage 1 hypertension receiving dietary guidance shows that taking 30 grams of oat bran, providing 8.9 grams of dietary fiber, once daily with breakfast or in between meals for 3 months improves various blood pressure measures when compared with dietary guidance alone. After 3 months of treatment, 24-hour maximum SBP and DBP decreased by 14 mmHg and 11 mmHg, respectively, and office SBP and DBP decreased by 15 mmHg and 10 mmHg, respectively. Oat consumption may also have impacted antihypertensive medication use. Two patients in the control group increased doses of antihypertensive medications, whereas 6 patients in the treatment group decreased doses and 1 patient discontinued use (107750). The effect of oral oat bran on patients with stage 2 hypertension or pre-hypertension is unknown.
• Irritable bowel syndrome (IBS). Although there is interest in using oral oats for IBS, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Metabolic syndrome. Limited research suggests that oats may not be beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that adding oat bran 40 grams daily for 6 weeks to a low-calorie diet does not reduce the incidence of metabolic syndrome. Oat bran also does not improve body weight, blood pressure, low-density lipoprotein (LDL) cholesterol, triglycerides, or blood glucose levels when compared with a low-calorie diet alone in patients with metabolic syndrome (103342).
• Osteoarthritis. Although there is interest in using oral oats for osteoarthritis, there is insufficient reliable information about the clinical effects of oats for this condition.
• Pruritus. Applying oat lotion topically may improve some types of pruritus. Details: Preliminary clinical research shows that applying an oat lotion (Espanol) twice daily for up to 2 weeks can decrease itching intensity by about 20% when compared to baseline in patients with pruritus associated with chronic kidney disease (uremic pruritus). This decrease is similar to the effects of applying vinegar 5% solution or taking hydroxyzine 10 mg orally. However, applying the oat lotion does not appear to decrease the frequency of itching (91457).
• Psoriasis. Although there is interest in using topical oats for psoriasis, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Rheumatoid arthritis (RA). Although there is interest in using oral oats for RA, there is insufficient reliable information about the clinical effects of oats for this purpose.
• Stroke. It is unclear if oral oats are beneficial for reducing the risk of stroke. Details: Population research suggests that consuming oatmeal for breakfast once weekly might reduce the incidence of stroke by a small amount when compared with consuming white bread or eggs for breakfast (103337).
• Ulcerative colitis. Oral oats have only been evaluated in combination with other ingredients; their effect when used alone is unclear. Details: Preliminary clinical research shows that taking a specific oat-based product (Profermin, Nordisk Rebalance) containing fermented oat flour, Lactobacillus plantarum, barley malt flour, and lecithin, 250 mL orally twice daily for 8 weeks, reduces disease activity and increases remission in about two-fold more patients with relapsing ulcerative colitis, when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).
• Wound healing. Although there is interest in using topical oats for wound healing, there is insufficient reliable information about the clinical effects of oats for this purpose. More evidence is needed to rate oats for these uses.

(Read more about OATS)

POSSIBLY EFFECTIVE

• Sexual dysfunction. Oral tribulus seems to improve sexual experience in females with hypoactive sexual desire disorder (HSDD) or sexual dysfunction. Some research also shows that oral tribulus improves sexual function in males. Details: Clinical research in premenopausal and postmenopausal patients with HSDD shows that taking tribulus 250 mg three times daily (Androsten, Herbarium) for 3 months improves overall satisfaction and lubrication, as well as pain, desire, sexual arousal, and ability to reach orgasm, when compared with placebo (92027,97331,97332). Other preliminary clinical research in females with HSDD shows that taking tribulus extract 7.5 mg daily for 4 weeks improves sexual desire, arousal, satisfaction, orgasm, pain, and lubrication when compared with placebo (92022). A nonblinded clinical study comparing tribulus dosing regimens shows that taking oral tribulus 280 mg, either once daily or in three divided daily doses, for 90 days results in similar improvements in sexual dysfunction, regardless of menopausal status. However, neither dosing schedule increases clitoral blood flow when compared with baseline (108551). Tribulus has also been studied in males. One clinical study in males with erectile dysfunction, with or without HSDD, shows that taking tribulus (Tribestan, Sopharma AD) 500 mg three times daily for 3 months improves sexual desire and intercourse satisfaction when compared with placebo (97330).

POSSIBLY INEFFECTIVE

• Athletic performance. Oral tribulus does not seem to improve athletic performance. Details: Small clinical studies in athletes show that taking tribulus orally, alone or in combination with other ingredients such as androstenedione, most often as 450-770 mg daily for 5-8 weeks, does not seem to enhance body composition or exercise performance when compared with placebo or a control group (7514,13255,92029,108552).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angina. It is unclear if oral tribulus is beneficial for angina. Details: Preliminary clinical research shows that taking a tribulus extract orally might reduce symptoms of angina when compared with a control (3931).
• Atopic dermatitis (eczema). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some preliminary clinical research shows that taking tribulus orally in combination with 9 other herbs (Zemaphyte) daily for 8 weeks reduces redness and skin lesions in adults and children with nonexudative atopic dermatitis (12627,12628). However, other research shows no effect (12630). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Bacterial vaginosis. Topical tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with bacterial vaginosis shows that using a specific vaginal suppository (Forzajeh) containing tribulus, myrtle, fennel, and tamarind daily for 1 week is as effective as metronidazole vaginal suppository for improving vaginal discharge volume and odor, pelvic pain, cervical inflammation, and vaginal pH (100339). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Benign prostatic hyperplasia (BPH). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with BPH shows that taking a combination supplement (Prostalyn, East India Pharmaceutical Works Ltd.) containing tribulus 600 mg and curry leaf (Murraya koenigii) 600 mg twice daily for 12 weeks improves prostate symptoms when compared to baseline, with no difference when compared to tamsulosin 400 mcg daily. This supplement also seems to reduce prostate volume by around 2 mL (92033).
• Cancer. Although there is interest in using oral tribulus for cancer, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral tribulus for CFS, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Diabetes. It is unclear if oral tribulus is beneficial for diabetes. Details: Preliminary clinical research in females with type 2 diabetes who are taking oral hypoglycemic agents shows that taking tribulus extract powder 500 mg twice daily for 3 months modestly reduces fasting glucose and postprandial glucose levels, but not glycated hemoglobin, when compared with placebo. However, the validity of these findings is limited by the difference in diabetes severity between groups at baseline (97327).
• Erectile dysfunction (ED). It is unclear if oral tribulus is beneficial for ED. Research is conflicting. Details: Clinical research in patients with ED shows that taking tribulus (Tribestan, Sopharma AD) 500 mg three times daily for 3 months does not provide a clinically beneficial improvement in erectile function when compared with placebo (97330). Other clinical research shows that taking tribulus 400 mg twice daily for 30 days does not improve erectile function when compared with placebo (92031). However, one preliminary clinical study in patients with partial androgen deficiency shows that taking tribulus 250 mg three times daily for 3 months improves erectile function when compared to baseline (92028). Tribulus has also been studied in combination with other ingredients. Preliminary clinical research shows that taking a combination supplement (Tradamix TX1000, Tradapharma Sagl) containing tribulus 450 mg, brown algae 300 mg, and chitosan 250 mg twice daily for 3 months improves sexual satisfaction, desire, ejaculation function, and sexual quality of life when compared with placebo in patients with mild-to-moderate ED (92030). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Exercise-induced muscle damage. It is unclear if oral tribulus is beneficial for exercise-induced muscle damage. Details: Clinical research in a small number of healthy, untrained males shows that taking tribulus 500 mg daily for 2 weeks prior to performing resistance exercise reduces markers of muscle damage, including creatine phosphokinase (CPK) and lactate dehydrogenase (LDH), but does not reduce levels of the inflammatory markers interleukin-6 (IL-6) or C-reactive protein (CRP), when compared with placebo (103236). However, another small clinical study in male CrossFit athletes shows that taking tribulus 770 mg capsules (Quamtrax Pharmaceuticals) daily for 42 days does not reduce CPK but does improve CRP and oxidant status when compared with placebo (111747). However, it is unclear whether any improvements are clinically significant. A very small crossover clinical study in trained male athletes shows that taking 20 mg/kg/day of tribulus in 3 divided doses 30 minutes before meals with 500 mL of water for 4 weeks does not reduce muscle soreness after intensive aerobic exercise when compared with placebo (111746).
• Gonorrhea. Although there is interest in using oral tribulus for gonorrhea, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Hypercholesterolemia. Although there is interest in using oral tribulus for hypercholesterolemia, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Hypertension. It is unclear if oral tribulus can lower blood pressure. Details: In patients with pre-hypertension, clinical research shows that taking powdered tribulus fruit 2 grams three times daily for 2 months reduces systolic and diastolic blood pressure by 6 and 5 mmHg, respectively, when compared with placebo (105245). It is unclear what effect Tribulus may have in patients with diagnosed hypertension.
• Kidney stones (nephrolithiasis). Although there is interest in using oral tribulus for kidney stones, there is insufficient reliable information about the clinical effects of tribulus for this purpose.
• Male infertility. It is unclear if oral tribulus is beneficial for male infertility; the available research is conflicting. Details: Case series suggest that taking a specific tribulus product (Tribestan, Sopharma) 250 mg three times daily for 30 days improves ejaculate volume, sperm concentration, and sperm motility in patients with infertility due to oligoasthenozoospermia (78865), and improves libido and erections in patients with primary hypogonadism (78868). Conversely, a small clinical study in patients with oligozoospermia shows that taking tribulus granules 6 grams daily for 60 days does not improve sperm count when compared with placebo (92032). In patients with idiopathic infertility, taking tribulus 250 mg three times daily for 3 months does not increase sperm concentration, sperm motility, serum testosterone levels, or luteinizing hormone levels (97328). The difference in these findings might be due to the small study sizes, as well as the variable etiology of infertility.
• Menopausal symptoms. Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination product containing tribulus 40 mg, ginger, saffron, and Ceylon cinnamon (Aphrodit, Goldaru Company) twice daily for 4 weeks improves mental and physical symptoms during menopause, but not genitourinary symptoms, when compared with placebo (97326). It is not clear if this effect is due to tribulus, the other ingredients, or the combination.
• Osteoporosis. Although there is interest in using oral tribulus for osteoporosis, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Polycystic ovary syndrome (PCOS). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study shows that taking tribulus extract (Tribulus forte, Mediherb, Integra Healthcare Ltd) 245 mg daily along with other ingredients and lifestyle modification during the follicular phase of the menstrual cycle for 3 months improves some symptoms of PCOS, including a 33% reduction in oligomenorrhea or amenorrhea and a 43-day reduction in the duration between menstrual cycles, when compared with lifestyle modification alone. Taking tribulus with other ingredients also improves quality of life by about 30% and reduces body mass index by 1 kg/m2 when compared with placebo. Although the conception rate increased 4-fold in patients taking the combination product, the live birth rate was similar to those taking placebo. (97216). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Premature ejaculation. Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination product containing tribulus, 5-HTP, winter savory, and chanca piedra (EiacuMev, Farmaceutica Mev) daily for 3 months improves time to ejaculation by 30 seconds and reduces symptoms related to premature ejaculation when compared to control (97016). More evidence is needed to rate tribulus for these uses.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Deer velvet powder has been used with apparent safety at a dose of 1-1.5 grams daily for up to 10-12 weeks (47106,47108).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about DEER VELVET)

POSSIBLY SAFE ...when horny goat weed extract is used orally and appropriately, short-term. A specific extract of horny goat weed containing 60 mg icariin, 15 mg daidzein, and 3 mg genistein (Xianling Gubao; Tong Ji Tang Pharmacal Company) has been used daily with apparent safety for up to 24 months (14900,97268). Another aqueous extract of horny goat weed containing up to 25.36% icariin has been used in a dose of 300 mL daily with apparent safety for up to 6 months (55452). Another horny goat weed extract has been used with apparent safety at doses up to 1000 mg daily (providing 200 mg icariin) for up to 30 days (108311).

POSSIBLY UNSAFE ...when used orally long-term or in high doses. Long-term use, or taking high doses of some species of horny goat weed, has been linked to serious adverse effects including respiratory arrest (10346).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Horny goat weed might have androgenic activity (10346). Theoretically, it might harm a developing fetus; avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about HORNY GOAT WEED)

LIKELY SAFE ...when maca is consumed in food amounts (9926).

POSSIBLY SAFE ...when used orally and appropriately, short term. Maca appears to be safe in doses up to 3 grams daily for 4 months (9928,10218,18289,90278,108603).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about MACA)

LIKELY SAFE ...when used orally and appropriately in food amounts (4960,4969,5792,5797). Oat bran has Generally Recognized as Safe (GRAS) status in the US (4912). Whole grain oats 50-100 grams daily have been used for up to 1 year without serious adverse effects (97520).

POSSIBLY SAFE ...when used topically and appropriately (12). Lotion containing colloidal oat 1% has been used topically without adverse effects for up to 6 weeks (97518,103340). There is insufficient reliable information available about the safety of oats when used orally in medicinal amounts.

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in food amounts (5792,5797).

(Read more about OATS)

LIKELY UNSAFE ...when the spine-covered fruit is used orally. There have been reports of bilateral pneumothorax and bronchial polyp after oral consumption of the spine-covered fruit (818).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Animal research suggests that tribulus might adversely affect fetal development (12674); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about TRIBULUS)

CONTRACEPTIVE DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, deer velvet might interfere with the effectiveness of contraceptive drugs.  Details Laboratory research shows that deer velvet contains small quantities of estradiol and testosterone (47110). While clinical research shows that taking deer velvet extract does not raise testosterone levels, estradiol levels were not measured (47108).

ESTROGENS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, deer velvet might increase the effects and side effects of estrogens.  Details Laboratory evidence shows that deer velvet contains small quantities of estradiol and testosterone (47110). While clinical research shows that taking deer velvet extract does not raise testosterone levels, estradiol levels were not measured (47108).

(Read more about DEER VELVET)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, horny goat weed might increase the risk of bleeding.  Details In vitro research and animal research shows that horny goat weed can inhibit platelet aggregation and thrombus formation (105832). This effect has not been reported in humans.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, horny goat weed might increase the risk of hypotension.  Details Laboratory research suggests that horny goat weed might have hypotensive effects (10346). This effect has not been reported in humans.

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, horny goat weed might increase the effects and side effects of CYP1A2 substrates.  Details In vitro, horny goat weed leaf extract inhibits CYP1A2 (97267). This effect has not been reported in humans.

CYTOCHROME P450 2B6 (CYP2B6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, horny goat weed might increase the effects and side effects of CYP2B6 substrates.  Details In vitro, horny goat weed leaf extract inhibits CYP2B6 (97267). This effect has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, horny goat weed might increase the effects and side effects of CYP3A4 substrates.  Details In vitro, horny goat weed extract inhibits CYP3A4 and suppresses CYP3A4 mRNA expression (112708). This effect has not been reported in humans.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of horny goat weed with estrogens might increase their therapeutic and adverse effects.  Details In vitro evidence suggests that horny goat weed has estrogenic activity. In clinical research, horny goat weed has been shown to increase blood levels of estrogen in some females (16061,16063,16060,55452).

(Read more about HORNY GOAT WEED)

(Read more about MACA)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, oats may have additive effects with antidiabetic agents and might increase the risk of hypoglycemia.  Details Consuming oats can decrease blood glucose in patients with diabetes (4980,4982,6266,103345). In those who require insulin, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Concomitant use of oats and insulin might increase the risk of hypoglycemia.  Details In patients with insulin-dependent type 2 diabetes, taking oats 100 grams daily for 2 days reduces the insulin dose required to achieve metabolic control (103336).

(Read more about OATS)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Taking tribulus with antidiabetes drugs might increase the risk of hypoglycemia.  Details Clinical research shows that Tribulus can lower blood glucose levels in adults with type 2 diabetes who are taking antidiabetes medications (97327).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking tribulus with antihypertensive drugs might increase the risk of hypotension.  Details Animal research shows that tribulus can lower blood pressure by inhibiting angiotensin-converting enzyme (ACE) (12673). Tribulus has also demonstrated hypotensive effects in pre-hypertensive adults (105245).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, tribulus might increase the levels and clinical effects of lithium.  Details Tribulus is thought to have diuretic properties (12681). Due to these potential diuretic effects, tribulus might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.

(Read more about TRIBULUS)

General ...Orally, deer velvet powder or extract seems to be well tolerated, short-term. However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about DEER VELVET)

General ...Orally, horny goat weed seems to be well tolerated when used short-term.
Most Common Adverse Effects:
Orally: Dizziness, dry mouth, nosebleed, thirst, and vomiting.
Serious Adverse Effects (Rare):
Orally: Respiratory arrest.

Cardiovascular ...A 66-year-old male with a history of cardiovascular disease developed tachyarrhythmia after taking horny goat weed for 2 weeks (13006). It is not clear if this product contained only horny goat weed or a combination of ingredients; therefore, assigning causality is not possible.

Gastrointestinal ...Orally, long-term use of horny goat weed has been associated with reports of vomiting, dry mouth, thirst, and nosebleed (10346).

Hepatic ...A case of hepatotoxicity characterized by abdominal pain, nausea, vomiting, and fever has been reported in a 40-year-old male patient with hepatitis C, after a month of taking one tablet daily of a combination product containing horny goat weed and multiple other ingredients (Enzyte, Vianda). Symptoms improved following cessation of the product, but it is not clear if they were due to horny goat weed, another ingredients, or hepatitis C (91590). An observational study over 24 years found 26 cases of drug-induced hepatoxicity associated with horny goat weed (112707).

Musculoskeletal ...Orally, large doses of horny goat weed may cause exaggeration of tendon reflexes to the point of spasm (10346).

Neurologic/CNS ...Orally, long-term use of horny goat weed has been associated with reports of dizziness (10346).

Psychiatric ...There is a case report of hypomania in a 66-year-old male who took horny goat weed for 2 weeks (13006). It is not clear if this product contained only horny goat weed or a combination of ingredients; therefore, assigning causality is not possible.

Pulmonary/Respiratory ...Orally, large doses of horny goat weed may cause respiratory arrest (10346).

(Read more about HORNY GOAT WEED)

General ...Orally, no adverse effects have been reported with the medicinal use of maca. However, a thorough evaluation of safety outcomes has not been conducted.

Gastrointestinal ...Consumption of fresh, uncooked maca may cause stomach pain (40231).

(Read more about MACA)

General ...Orally, oats are well tolerated.
Most Common Adverse Effects:
Orally: Abdominal distension, bloating, flatulence, and unpleasant taste.
Topically: Burning, contact dermatitis, itching, and redness.

Dermatologic ...Topically, oat-containing preparations can cause contact dermatitis (12515). Redness, burning, and itchiness have also been reported (103340).

Gastrointestinal ...When consumed orally, oats provide fiber. Increasing fiber in the diet can cause flatulence, bloating, abdominal distention, and unpleasant taste. To minimize side effects, doses should be slowly titrated to the desired level. These adverse effects usually subside with continued use (12514).
In patients who have difficulty chewing food, or those with conditions that decrease small bowel motility, oat bran may cause bezoars (concretions) and intestinal obstruction. Oats and oat bran are unlikely to cause obstruction without other causative factors (4979,4985).

(Read more about OATS)

General ...Orally, tribulus seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Cases of liver and kidney injury, seizures, and chronic painful erection with impaired sexual function have been reported. Pneumothorax and bronchial polyp after consuming the spine-covered tribulus fruit have been reported.

Gastrointestinal ...Orally, tribulus can cause abdominal pain, cramping, nausea, vomiting, diarrhea, and constipation (92022,92027). However, in one study, the rates of these gastrointestinal complaints were similar for patients taking tribulus and those receiving placebo (92022).

Genitourinary ...In one case report, a patient taking two tribulus tablets (unknown dose) daily for 15 days presented to the local emergency department with a painful erection lasting 72 hours. The priapism was resolved with medical management; however, post-episode sexual function was impaired (92023).

Hepatic ...In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of tribulus water (92069).

Neurologic/CNS ...Orally, tribulus has been reported to cause general excitation and insomnia. These symptoms were reversed upon discontinuation of the drug or decreasing the dose (78867). In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of tribulus water (92069).

Pulmonary/Respiratory ...In one case report, a patient developed a bilateral pneumothorax after consuming the spine-covered fruit of tribulus (818). In another case report, a patient developed a polyp in the lobar bronchus of the right interior lobe due to the presence of a tribulus fruit spine (78852).

Renal ...In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of the tribulus water (92069). In another case report, a healthy male taking one tribulus tablet (unknown dose) daily for a few months for bodybuilding purposes developed hyperbilirubinemia followed by acute kidney failure 2-3 weeks later. The patient was managed with intravenous fluids and a low-salt, low-protein diet (92025).

Other ...In one case report, gynecomastia was observed in a male weightlifter taking an herbal combination product containing tribulus. However, it is not clear if this adverse effect can be attributed to tribulus alone (78859).

(Read more about TRIBULUS)