Monster Plexx by Innovative Laboratories

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. It is unclear if oral 1-androsterone is beneficial for athletic performance. Details: Preliminary clinical research in healthy males undergoing resistance training shows that taking 1-androsterone 330 mg orally daily for 4 weeks moderately improves back squat performance when compared with placebo. Taking a-androsterone also decreased body fat mass by 3 kg and increase lean body mass by 5 kg when compared with placebo (91095). More evidence is needed to rate 1-androsterone for this use.

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There is insufficient evidence about the effectiveness of 4-androsterone.

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LIKELY EFFECTIVE

• Vaginal atrophy. Intravaginal DHEA can reduce pain during intercourse and improve vaginal health in patients with this condition. Details: Clinical research shows that ovules or suppositories containing DHEA 0.25% to 1%, inserted vaginally once daily for 12 weeks, can reverse vaginal thinning, restore vaginal pH, and reduce pain during sexual intercourse by up to 15% when compared with placebo in patients with vaginal atrophy (21320,21429,21430,94576). A specific vaginal insert containing DHEA 0.5% (Intrarosa, Endoceutics Inc.) is an FDA approved drug used for reducing pain during sexual intercourse in patients with vaginal atrophy (94573,94576). Other clinical research shows that applying DHEA 10% cream (Diosynth) to the inner thighs daily for 12 months might improve vaginal atrophy by stimulating maturation of the vaginal epithelium in postmenopausal patients. It might also increase bone mineral density in these patients (4242).

POSSIBLY EFFECTIVE

• Aging skin. Oral and topical DHEA have been evaluated for treating aging skin, with promising results. Details: Some clinical research shows that taking DHEA 50 mg daily for 12 months increases epidermal thickness, sebum production, and skin hydration, and decreases facial skin pigmentation in elderly patients (6446). Other preliminary clinical research shows that applying 1% DHEA daily for 4 months improves the appearance of paper-like skin when compared with placebo in postmenopausal patients. It also improves sebum production, skin wrinkling, and skin appearance when compared with baseline (21428).
• Depression. Oral DHEA 30-500 mg daily for up to 8 weeks seems to improve symptoms of depression and dysthymia in patients with depression. Details: Canadian clinical practice guidelines recommend DHEA as a third-line treatment for depression (95691). Most clinical research shows that taking DHEA 30-500 mg daily for around 6-8 weeks improves symptoms of depression and dysthymia when compared with placebo (3270,3864,3892,4233,21404,21405). Additionally, a pooled analysis of these and 9 other clinical studies shows that DHEA can improve depressive symptoms when compared with placebo, although most of the trials evaluated in the analysis included patients without clinically diagnosed depression (104161). Other preliminary clinical research using lower doses of 5-20 mg daily over 3 weeks shows no improvement in depressive symptoms in psychotic patients (21406).
• Infertility. Oral DHEA appears to improve fertility outcomes, including pregnancy and live birth rates, in females undergoing assisted reproduction. However, it is unclear if oral DHEA can reduce the risk for miscarriage after in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI). Details: Meta-analyses of clinical research show that taking DHEA, typically at a dose of 75 mg daily improves fertility outcomes for females undergoing assisted reproduction (96819,96820,96821,111227). One meta-analysis limited to randomized controlled trials in patients with poor ovarian response (POR) found that taking DHEA prior to IVF or ICSI treatments increases clinical pregnancy rates by 34% and the rate of live births or ongoing pregnancy by 88% when compared with placebo or no treatment (96820,111227,113072). Additionally, meta-analyses, including both randomized controlled trials and observational research, in patients with POR or diminished ovarian reserve (DOR) undergoing IVF or ICSI show that taking DHEA 50-90 mg daily is associated with improved markers of ovarian reserve and increased oocyte yields, fertilized oocytes, top-quality embryos, and transferred embryos when compared with control groups (111227,113072). Some observational research in older females with DOR has also found that taking DHEA 30 mg three times daily for 12 weeks before IVF cycles is associated with a greater number of retrieved oocytes, improved oocyte quality, and increased cumulative pregnancy rates (103185). Inclusion of lower quality research also supports these findings (21413,21414,88493,96819,96821,99923). Additionally, in females with various conditions of compromised fertility, some preliminary clinical research shows that taking DHEA 50-75 mg daily for at least 4 months may aid with natural conception, insemination-induced conception, and IVF pregnancy outcomes (21362). However, not all evidence shows that DHEA supplementation is beneficial for infertility (21415,88726,90304,111226). In one meta-analysis, DHEA supplementation was not linked to improvements in live birth rates (111227) In another meta-analysis, the benefits such as increased clinical pregnancy rates, live birth rates, oocyte yields, and number of embryos transferred dissipated upon subgroup analysis limited to higher quality randomized controlled trials (113072). Furthermore, a large clinical study shows that pretreatment with DHEA in infertile females with POR prior to IVF and embryo transfer does not improve the number of retrieved oocytes and the rates of clinical pregnancy, pregnancy loss, and cumulative live births when compared with placebo (111226). Observational research in older patients with DOR suggests that DHEA supplementation is not linked to improved clinical pregnancy or live birth rates when compared with a control group (103185). Other clinical research in females with primary ovarian insufficiency shows that taking DHEA 75 mg daily for 16 weeks might not improve follicle size when compared with placebo (21364). The effect of DHEA pretreatment on miscarriage rates after IVF or ICSI is not clear. One meta-analysis of randomized clinical research does not support the use of DHEA pretreatment for preventing miscarriage (96820). However, another meta-analysis and lower quality research suggests that DHEA supplementation reduces the risk of miscarriage by up to 50% (21418,96819,113072).

POSSIBLY INEFFECTIVE

• Aging. Oral DHEA, taken for up to 2 years, does not appear to improve bone health, quality of life, or sexual function in older adults. Details: Clinical research shows that DHEA, taken as 75 mg daily in males or 50 mg daily in females, for 2 years does not seem to improve body composition, bone mineral density (BMD), insulin sensitivity, or quality of life in people aged 60 years or older who have low DHEA-S levels (15027). Additionally, a pooled analysis of clinical trials shows that taking DHEA 50-1600 mg daily for up to 2 years does not improve body composition, bone health, sexual function, lipid and glycemic parameters, or quality of life in elderly males (88434).
• Muscle strength. Oral DHEA does not seem to improve muscle strength in adults. Details: While some clinical research shows that adults who take DHEA have increased muscle strength when measured by grip strength, leg press, chest press, and other measures, most clinical evidence shows that DHEA provides no benefit to muscle strength in younger and older adults (1365,10406,17617,21392,21419,21420,21421,47198).
• Physical performance. Oral DHEA does not seem to improve physical performance in elderly patients. Details: Most clinical research and a meta-analysis show that older adults who take DHEA do not have increased physical function or performance as measured by oxygen uptake, duration of exercise, balance, and ability to rise from a chair (17617,21420,21421). However, one clinical study shows that taking DHEA 50 mg daily for 6 months improves lower body strength and function by a small amount when compared with placebo in elderly frail females (21392). More research is needed to determine if DHEA is beneficial in specific populations.

LIKELY INEFFECTIVE

• Cognitive function. Oral DHEA does not improve cognitive function or prevent cognitive decline in most populations. Details: In the majority of clinical research, taking DHEA orally does not seem to improve cognitive function or decrease cognitive decline in healthy people over the age of 50 (3893,11334,14862,21333,21445), in peri- or post-menopausal women (6011,21397,21445), in patients with HIV (47435), or in young healthy adults when given as an acute dose (21399). However, preliminary clinical research shows that taking DHEA 50 mg daily for 4 weeks may improve certain measures of visual spatial performance and memory when compared with placebo in middle aged and elderly females (21396,21398).
• Sjogren syndrome. Oral DHEA does not appear to improve symptoms with this condition. Details: Clinical research shows that taking DHEA 50-200 mg daily for 4-12 months does not benefit symptoms of primary Sjogren syndrome when compared with placebo (21354,21358,21363,21365).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Addison disease. It is unclear if oral DHEA is beneficial in patients with this condition. Details: Some preliminary clinical research shows that taking DHEA up to 50 mg daily for up to 12 months improves symptoms of Addison disease, including reversing the loss of bone mineral density (BMD) and lean mass, but without improving cognitive function (8595,21387). However, taking DHEA 50 mg daily for 12 weeks does not appear to improve cognitive or sexual function, body composition, or BMD, although it may improve mood and fatigue (7614,21330,21356).
• Adrenal insufficiency. It is unclear if oral DHEA is beneficial in patients with primary or secondary adrenal insufficiency. Details: Some clinical research shows that taking low-dose DHEA, 20-50 mg daily, improves feelings of well-being, skin and hair, pubic hair growth, and sexuality in females with adrenal insufficiency or androgen deficiency due to hypopituitarism (3231,8593,17218,21317,21370,21385). However, other clinical research shows that taking low-dose DHEA for 3-12 months has little to no effect on quality of life, body composition, physical performance, cardiac function, depression, anxiety, and sexual arousal in patients with primary or secondary adrenal insufficiency (17218,21351,21357,21360,21386,21388,21389). Also, there is contradictory evidence about the effects of DHEA on plasma lipid levels in patients with adrenal insufficiency (21348,21351).
• Athletic performance. It is unclear if oral DHEA can improve sprint performance. Details: Preliminary clinical research in female recreationally trained athletes shows that taking DHEA 100 mg daily for 4 weeks does not improve sprint performance when compared with placebo (99925).
• Cardiovascular disease (CVD). Observational research has found that low DHEA levels are linked to a greater risk for CVD, but it is unclear if supplementation with oral DHEA is beneficial. Details: A meta-analysis of population research shows that patients with CVD and lower blood levels of DHEA-S have a worse overall prognosis when compared with patients with higher levels. Patients with the lowest levels have a 47% increased risk of future mortality events, including a 58% increased risk of fatal cardiovascular events. There was also a 42% increased risk of nonfatal cardiovascular events (96817). In elderly males, population research also shows that low serum levels of DHEA and DHEA-S are associated with an increased risk of coronary heart disease (CHD) but not cerebrovascular disease (90303).
• Cervical dysplasia. It is unclear if intravaginal DHEA is beneficial in patients with cervical dysplasia. Details: Preliminary clinical research shows that DHEA 150 mg intravaginally for up to 6 months reverses dysplasia in 83% of treated females with low-grade cervical dysplasia when compared to baseline (21426). The validity of these findings is limited by the lack of a comparator group.
• Chronic fatigue syndrome (CFS). It is unclear if oral DHEA is beneficial in patients with CFS. Details: Preliminary clinical research shows that oral DHEA 25-100 mg daily for 6 months improves symptoms of CFS by 8.5% to 26% when compared to baseline (7559). The validity of these findings is limited by the lack of a comparator group.
• Chronic obstructive pulmonary disease (COPD). It is unclear if oral DHEA is beneficial in patients with COPD. Details: A small clinical study shows that taking DHEA 200 mg daily for 3 months increases walking distance and improves lung function in patients with COPD when compared to baseline (21395). The validity of these findings is limited by the lack of a comparator group.
• Cocaine dependence. It is unclear if oral DHEA is beneficial for reducing cocaine cravings. Details: A small clinical study shows that taking DHEA 100 mg daily for 12 weeks, in addition to cognitive-behavioral group counseling, does not reduce cocaine craving when compared with counseling alone in cocaine-dependent participants (21411).
• Crohn disease. It is unclear if oral DHEA is beneficial for inducing Crohn disease remission. Details: A small clinical study shows that taking DHEA 200 mg daily for 8 weeks reduces symptoms in some patients with Crohn disease when compared to baseline. Remission occurred in 6 of 7 Crohn patients (21416). The validity of these findings is limited by the small study size and lack of a comparator group.
• Diabetes. Although there has been interest in using oral DHEA for diabetes, there is insufficient reliable information available about the clinical effects of DHEA for this purpose.
• Erectile dysfunction (ED). It is unclear if oral DHEA is beneficial in patients with ED. Details: Preliminary clinical research shows that taking DHEA orally for 24 weeks improves erectile function, orgasmic function, sexual desire, and overall sexual satisfaction in patients with ED. DHEA seems to be beneficial for idiopathic ED or ED secondary to hypertension, but doesn't seem to provide benefit for ED related to diabetes or neurological disorders (793,8596).
• Exercise-induced muscle damage. It is unclear if oral DHEA is beneficial for reducing muscle damage from exercise. Details: Preliminary clinical research shows that taking DHEA 50 mg twice daily for 5 days improves delayed-onset muscle soreness and reduces post-training blood creatinine kinase levels when compared with placebo in young males completing a 5-day exercise training program (88375).
• Fibromyalgia. It is unclear if oral DHEA is beneficial for improving fibromyalgia symptoms. Details: Preliminary clinical research shows that taking DHEA 50 mg daily for 3 months does not reduce fibromyalgia symptoms when compared with placebo in postmenopausal patients with fibromyalgia (21355).
• HIV/AIDS. Small clinical studies suggest that oral DHEA may improve mental health and quality of life in patients with HIV/AIDS, but DHEA does not seem to improve CD4 counts or body composition. Details: Population research shows that levels of DHEA seem to be lower in patients with more severe HIV/AIDS, suggesting that DHEA could be a marker for disease severity. Some evidence suggests that lower DHEA levels are associated with an increased risk of disease progression and AIDS (8598,14278,14279). Some clinical research shows that taking DHEA 50-500 mg daily for 2-4 months might improve mental health and quality of life when compared with placebo (3864,8598,14277,21390). However, taking DHEA in doses up to 2.25 grams daily does not appear to improve CD4 counts, muscle mass, or bone mass when compared with placebo (3865,14277,21390).
• Menopausal symptoms. Oral DHEA might reduce hot flashes and intravaginal DHEA might improve vaginal atrophy and sexual activity; however, oral DHEA does not seem to improve psychological symptoms associated with menopause. Details: Some research shows that taking DHEA 10-25 mg daily for 12 months improves subjective vasomotor symptoms such as hot flashes, as well as psychological symptoms and sexuality (11464,21417). Also, administering a daily ovule containing DHEA (Vaginorm, Recipharm) 3.5-13 mg intravaginally for 12 weeks appears to reverse vaginal atrophy and improve sexual activity in postmenopausal patients with vaginal atrophy (21442). However, other clinical research shows that taking DHEA 50 mg daily for up to 26 weeks does not improve mood, fatigue, cognition, sexual function, or sense of well-being in post- or peri-menopausal patients when compared with placebo (6011,21361). Additionally, a pooled analysis of clinical research shows that DHEA taken orally does not improve psychological symptoms related to menopause (88492).
• Metabolic syndrome. It is unclear if oral DHEA is beneficial for reducing risk for metabolic syndrome. Details: Preliminary clinical research shows that taking DHEA 50 mg daily for 6 months or 100 mg daily for 3 months decreases weight, abdominal fat, and blood pressure and reduces cholesterol, glucose, and insulin levels when compared with placebo in overweight elderly patients (12215,21350).
• Muscular dystrophy. It is unclear if oral DHEA is beneficial in patients with myotonic dystrophy type I. Details: Taking DHEA 100 or 400 mg daily for 12 weeks might not affect muscle strength in patients with myotonic dystrophy type I when compared with placebo (21334). However, intravenous DHEA-S 200 mg daily for 8 weeks appears to improve daily function, muscle strength, and heart function compared with baseline (21434). The validity of this finding is limited by the lack of a control group.
• Obesity. It is unclear if oral DHEA is beneficial for reducing body weight in patients who are obese or overweight. Details: Preliminary clinical research shows that taking DHEA 40 mg sublingually twice daily for 8 weeks, or 1600 mg by mouth for 28 days, does not affect body weight or body composition when compared with placebo in obese adults (21410,21427). Also, preliminary clinical research shows that taking DHEA 50-100 mg daily for 3-12 months does not affect central adiposity in older individuals when compared with placebo (21349).
• Opioid withdrawal. It is unclear if oral DHEA is beneficial in patients with heroin withdrawal. Details: Preliminary clinical research shows that taking DHEA 100 mg daily as adjunct to standard therapy for 12 months does not improve drug withdrawal symptoms in heroin addicts when compared with standard therapy alone (21412).
• Osteoporosis. It is unclear if oral DHEA is beneficial in patients with osteoporosis; any benefit may depend on individual patient characteristics. Details: There is contradictory evidence about the effectiveness of DHEA 50-100 mg daily for improved bone mineral density (BMD) in older adults with osteoporosis or osteopenia (12563,12564,21392), as well as the effectiveness of DHEA for improved BMD in females with anorexia nervosa (12562,21393). One pooled analysis shows that DHEA does not improve BMD in postmenopausal patients (88492), while another shows that DHEA can increase hip BMD in healthy older females, but not males (103186). The reason for these discrepant findings is unclear, but may relate to different patient populations, durations of therapy, and DHEA doses assessed in the included studies. Additionally, most of the studies included in these analyses were of low quality and inadequate statistical power.
• Parkinson disease. Although there has been interest in using oral DHEA for Parkinson disease, there is insufficient reliable information available about the clinical effects of DHEA for this purpose.
• Partial androgen deficiency. It is unclear if oral DHEA is beneficial for symptom improvement in patients with this condition. Details: Preliminary clinical research shows that taking DHEA 25 mg daily for one year might clinically improve mood, fatigue, and joint pain in older males with partial androgen deficiency when compared to baseline (21331). Other preliminary clinical research shows that taking DHEA 50 mg twice daily for 4 months does not improve erectile or sexual function when compared with placebo in hypoandrogenic males (21424).
• Parturition. Intravenous DHEA before the onset of labor may shorten the time to labor onset and shorten labor duration. Details: Clinical research shows that intravenous DHEA-S 100 mg daily for 3 days, or given twice weekly until the onset of labor starting after 38 weeks of gestation, increases cervical ripening and shortens the time to onset of labor and the duration of labor when compared with a control in nulliparous women (21384,21431). Also, intravenous DHEA 50-200 mg given multiple times until the onset of labor starting after 37 weeks of gestation appears to shorten the time to delivery in primiparous and multiparous women (21432,21433). It is unclear if oral DHEA is beneficial for this purpose.
• Rheumatoid arthritis (RA). It is unclear if oral DHEA is beneficial in patients with RA. Details: Preliminary clinical research shows that taking oral DHEA 200 mg for 16 weeks does not reduce symptoms of RA in elderly patients (21422). However, other clinical research in a small number of premenopausal females with RA shows that taking DHEA 50 mg daily for 12 weeks improves quality of life, but not disease activity, when compared with placebo (104159).
• Schizophrenia. It is unclear if oral DHEA is beneficial in patients with schizophrenia. Details: Some research shows that taking DHEA orally improves both negative and positive symptoms in patients with schizophrenia. It may be more effective in females (9692). However, other clinical research shows no benefit (21423).
• Sexual dysfunction. It is unclear if oral or intravaginal DHEA is beneficial for improving sexual dysfunction in males or females. Details: DHEA may be modestly beneficial in some postmenopausal patients with decreased libido or dyspareunia. Preliminary clinical research shows that taking DHEA 50-100 mg daily, or a single dose of DHEA 300 mg, improves sexual desire when compared to baseline (9906,21443). Additional clinical research shows that use of intravaginal DHEA (Vaginorm, Recipharm) at concentrations of 0.25% to 1% daily for 12 weeks might improve sexual function when compared with placebo (47361). However, a pooled analysis shows that DHEA is not associated with improvements in libido or sexual function (88414,88492). DHEA has also been evaluated in other patient populations. Small clinical studies show that taking DHEA doesn't seem to influence response to sexual stimuli in sexually functional premenopausal women (8594) or improve libido in individuals age 40-70 years (21449). Preliminary clinical research in males with hypoactive sexual desire disorder (HSDD) shows that taking DHEA 50 mg twice daily for 6 weeks does not improve erectile or sexual function when compared with placebo (88414). In adults with midlife-onset or HIV-associated depression, preliminary clinical research shows that taking DHEA 90-500 mg daily for 3-8 weeks may improve sexual function and libido when compared with placebo (3864,21405).
• Systemic lupus erythematosus (SLE). Most small clinical studies suggest that oral DHEA may modestly improve symptoms in patients with SLE, but some conflicting research exists. Details: Some clinical research shows that taking DHEA has little to no effect on disease activity in patients with mild to moderate SLE (21425,21447). However, small clinical studies and a meta-analysis of these studies show that taking DHEA in conjunction with conventional treatment may help improve frequency of flare-ups, muscle ache, oral ulcers, and quality of life, reduce corticosteroid doses needed (2113,2114,2136,6068,6447,12561,12574,21346,21447), and improve bone mineral density (6068,6097,6447,21394).
• Ulcerative colitis. It is unclear if oral DHEA is beneficial for inducing ulcerative colitis remission. Details: A small clinical study shows that taking DHEA 200 mg daily for 8 weeks reduces symptoms of ulcerative colitis when compared to baseline in some patients with ulcerative colitis. Remission occurred in 6 of 13 ulcerative colitis patients (21416). The validity of these findings is limited by the small study size and the lack of a comparator group. More evidence is needed to rate DHEA for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Although there is interest in using oral epiandrosterone for athletic performance, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Erectile dysfunction (ED). Although there is interest in using oral epiandrosterone for ED, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Exercise-induced muscle damage. Although there is interest in using oral epiandrosterone for muscle recovery after exercise, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Muscle strength. Although there is interest in using oral epiandrosterone for increasing muscle strength, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Obesity. Although there is interest in using oral epiandrosterone for weight loss, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Psychological well-being. Although there is interest in using oral epiandrosterone for improving well-being, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose.
• Sexual arousal. Although there is interest in using oral epiandrosterone for increasing sexual arousal, there is insufficient reliable information about the clinical effects of epiandrosterone for this purpose. More evidence is needed to rate epiandrosterone for these uses.

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There is insufficient reliable information available about the effectiveness of laxogenin.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cardiovascular disease (CVD). Although there has been interest in using oral Monterey pine for preventing CVD, there is insufficient reliable information about the clinical effects of Monterey pine for this condition.
• Cognitive function. It is unclear if oral Monterey pine bark extract improves cognition. Details: Preliminary clinical research shows that taking vitamin C 120 mg daily along with a specific product containing Monterey pine bark extract (Enzogenol, ENZO Nutraceuticals) 960 mg daily for 5 weeks improves response speed related to working memory tasks and immediate recognition tasks in middle-aged and elderly males when compared with baseline. Improvements in memory do not appear to occur with vitamin C alone (63620).
• Migraine headache. Although there has been interest in using oral Monterey pine for preventing migraine headache, there is insufficient reliable information about the clinical effects of Monterey pine for this condition.
• Neurological trauma. It is unclear if oral Monterey pine bark extract is beneficial in patients with neurological trauma. Details: A small clinical study in patients 3-12 months post-traumatic brain injury shows that taking a specific Monterey pine bark extract (Enzogenol, ENZO Nutraceuticals) 1000 mg daily for 12 weeks improves cognitive function scores when compared with placebo. However, measures of working memory, episodic memory, anxiety, and depression were not improved (105777). Another small clinical study in college students suffering from chronic concussion symptoms shows that taking a specific Monterey pine bark extract (Enzogenol, ENZO Nutraceuticals) 1000 mg daily for 6 weeks improves mental fatigue when compared with placebo (105779). More evidence is needed to rate Monterey pine for these uses.

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POSSIBLY EFFECTIVE

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

POSSIBLY INEFFECTIVE

• Benign prostatic hyperplasia (BPH). Although individual study results are conflicting, the overall body of evidence suggests that saw palmetto does not offer clinically meaningful improvements in BPH-related symptoms. Details: Research on the use of saw palmetto for improving symptoms of BPH is inconsistent and contradictory. To date, the best available evidence addressing the effectiveness of saw palmetto in patients with BPH comes from two high-quality clinical trials sponsored by the National Institutes of Health (NIH). In one of these trials, saw palmetto 160 mg twice daily for one year was ineffective for reducing moderate to severe symptoms of BPH when compared with placebo (14274). In the other trial, taking saw palmetto 320-960 mg daily for 72 weeks did not significantly improve symptoms when compared with placebo (17684). Additionally, meta-analyses of these trials and many of the small trials described below show that taking saw palmetto does not improve BPH-related signs and symptoms or International Prostate Symptom Scores (IPSS) (89441,102835,112804). While several small, low-quality clinical trials and observational studies in patients with BPH suggest that saw palmetto provides some improvement in urinary symptoms, nocturia, urinary flow, and/or residual urine volume when compared with placebo or baseline (6750,6764,6772,73315,73383,73385,73387,89441,96570,110541), other studies show that saw palmetto has no clinically meaningful effect on BPH-related signs and symptoms, including prostate volume (5093,6752,11314,73343,96409). The validity of several of these studies is limited due to the use of per-protocol analyses and/or a lack of placebo control groups. Beyond this, reasons for these discrepant findings are unclear; however, the mixed results may be due to use of different saw palmetto products, varying study methodologies, different patient populations, and varying symptom scoring tools. Additionally, research shows significant variation in the chemical composition of commercially available saw palmetto extracts (17305,89441). Several clinical trials have compared saw palmetto to 5-alpha reductase inhibitors such as finasteride (Proscar) or dutasteride (Avodart). Some small studies suggest that it may be comparable to these medications for relieving BPH symptoms, but with less effect on prostate size or prostate-specific antigen (PSA) levels (6424,96570). It may also be better tolerated, with a positive effect on sexual dysfunction (6424,6763,18215,89441). Additionally, one observational study in patients with BPH has found that taking saw palmetto 320 mg with tamsulosin 0.4 mg daily for 6 months is associated with similar improvements in IPSS and quality of life scores, but also has a lower risk of reduced libido, when compared with tamsulosin plus dutasteride 5 mg or finasteride 0.5 mg daily (110542). Some research has also compared saw palmetto to alpha-adrenergic blockers. Alpha-adrenergic blockers appear to have a faster onset of symptom relief (2732,6750), and saw palmetto might be less effective than the alpha-adrenergic blocker prazosin (Minipress). Although some studies and a meta-analysis suggest it is similarly effective to tamsulosin (Flomax) after 6-12 months of treatment for improving various symptoms of BPH (6775,6776,11243,89441,96570,104804,107483), another meta-analysis found that alpha-blockers were more effective than saw palmetto for these outcomes (102835). Additionally, tamsulosin appears to be more effective than saw palmetto for reducing prostate volume (104802). However, some research suggests that saw palmetto may be better tolerated than tamsulosin (107483). It is unclear if taking saw palmetto with tamsulosin can improve BPH symptoms. Several low-quality studies and a meta-analysis of two of these studies show no additional benefit over using tamsulosin alone (8901,89443,89448,96410). However, one study suggests that a specific saw palmetto extract (Permixon, Pierre Fabre Medicament) 320 mg daily is associated with a 29% decrease in the IPSS when taken alone, compared with a 37% decrease when taken along with tamsulosin 0.4 mg daily for 6 months. Tamsulosin alone was associated with a 31% decrease (104802). Saw palmetto has also been evaluated in combination with other ingredients. A meta-analysis of 8 clinical studies in adults with lower urinary tract symptoms due to BPH shows that taking saw palmetto in combination with other herbal ingredients does not improve urologic symptoms of BPH when compared with placebo or no intervention (112804). However, small, low-quality studies of various combinations of saw palmetto with other ingredients have demonstrated some benefit for improving symptoms of BPH, and some have shown equivalence to finasteride, tamsulosin, or tadalafil (Cialis). These ingredients include stinging nettle root (PRO 160/120, Dr. Willmar Schwabe Pharmaceuticals) (6763,17307,73330,89441); cernitin, beta-sitosterol, and vitamin E (11241); selenium and lycopene (Profluss, Konpharma) (90354,97255); pygeum, lycopene, Epilobium parviflorum, and pumpkin seed oil (ProstateEZE Max, Caruso's Natural Health) (92164); and quercetin and beta-sitosterol (Difaprost, Difass International) (96784). Additionally, one study suggests that an enriched form of saw palmetto oil containing 3% beta-sitosterol seems to be more effective than standard saw palmetto oil containing 0.3% beta-sitosterol in reducing IPSS scores (104803).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Androgenic alopecia. It is unclear if oral or topical saw palmetto is beneficial in patients with androgenic alopecia. Details: A small clinical study in males and females with androgenic alopecia shows that taking a specific saw palmetto oil (VISPO, Vidya Herbs) 100 mg daily for 16 weeks reduces hair fall and increases hair density but does not improve hair thickness, anagen-telogen ratio, or most subjective measures of hair growth when compared with placebo (112805). Other clinical research shows that taking saw palmetto extract 320 mg daily for 24 months is less effective for improving hair growth in males with androgenic alopecia when compared with finasteride 1 mg daily (89444). Topical saw palmetto has also been investigated for treating androgenic alopecia. Some clinical research shows that saw palmetto lotion, applied twice daily for 50 weeks, improves hair density by 27% in individuals with androgenic alopecia. However, a 13% improvement was observed in the placebo group, and no between-group comparisons were made (73435). Another small clinical study in male and females with mild to moderate androgenic alopecia shows that applying 5 mL of a lotion containing saw palmetto oil 20% (VISPO, Vidya Herbs) to the scalp for 30 minutes daily for 16 weeks reduces hair fall and increases hair density but does not improve hair thickness, anagen-telogen ratio, or subjective measures of hair growth when compared with placebo (112805). Saw palmetto has also been evaluated in combination with other ingredients. A very small clinical study in males with androgenic alopecia shows that taking a combination of saw palmetto extract 200 mg plus beta-sitosterol 50 mg twice daily for 18-24 months improves subjective scores of hair quantity and quality when compared with placebo (15550). Another small clinical study in males with androgenic alopecia receiving platelet-rich plasma every 3 weeks shows that applying 1 mL of topical saw palmetto, redensyl, and biotin daily for 12 weeks modestly improves subjective hair loss scores and photographic assessment of hair growth when compared with 1 mL of topical Procapil daily (112176). However, it is unclear if these effects are due to saw palmetto, other ingredients, or the combination.
• Asthma. Although there has been interest in using oral saw palmetto for asthma, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic bronchitis. Although there has been interest in using oral saw palmetto for chronic bronchitis, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). It is unclear if oral saw palmetto is beneficial in patients with CP/CPPS. Details: Preliminary clinical research shows that oral saw palmetto 325 mg daily for one year does not significantly improve symptoms of CP/CPPS when compared with finasteride 5 mg once daily (11354). However, a clinical trial in patients with moderate to severe CP/CPPS shows that taking saw palmetto 160 mg orally twice daily for 12 weeks improves NIH Chronic Prostatitis Index (NIH-CPSI) score after two weeks of treatment in patients with moderate disease and after 4 weeks of treatment in patients with severe disease when compared with placebo. Independent of severity, 73% of patients taking saw palmetto report a 6-point reduction in NIH-CPSI total score, compared to 33% of patients taking placebo (107482). Saw palmetto extract has also been evaluated in combination with other ingredients. A preliminary clinical study shows that taking a combination of saw palmetto extract 320 mg, selenium 50 mcg, and lycopene oil extract 5 mg daily for 8 weeks improves symptoms and peak flow in patients with CP/CPPS when compared with baseline. However, these effects were not observed or were less significant in patients treated with saw palmetto alone (60442).
• Common cold. Although there has been interest in using oral saw palmetto for the common cold, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Hirsutism. Although there has been interest in using oral and topical saw palmetto for hirsutism, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Non-neurogenic lower urinary tract symptoms (LUTS). It is unclear if oral saw palmetto is beneficial in females with non-neurogenic LUTS. Details: A small clinical study in elderly Japanese females with LUTS shows that taking saw palmetto extract 320 mg daily for 12 weeks reduces daytime urinary frequency and might improve nocturia, but it does not seem to reduce urinary urgency, incontinence, straining, bladder pain, or urethral pain when compared with placebo (110540).
• Prostate cancer. Small preliminary studies suggest that saw palmetto does not reduce prostate cancer risk or symptoms associated with prostate cancer. Details: Population research shows that people who take saw palmetto supplements do not have a lower risk of developing prostate cancer (15217). Preliminary clinical research also shows that taking saw palmetto 960 mg daily before, during, and after radiation treatment for early prostate cancer does not significantly improve lower urinary tract symptoms when compared with placebo (96412).
• Prostatitis. Adding saw palmetto to antibiotic therapy seems to relieve some symptoms of bacterial prostatitis more effectively than antibiotics alone. Details: Preliminary clinical research in patients with bacterial prostatitis shows that taking saw palmetto extract daily for eight weeks, with prulifloxacin 600 mg daily for 15 days, reduces pain and urinary symptoms more than prulifloxacin alone, but the combination does not appear to improve bacterial eradication or sexual dysfunction more than the antibiotic alone (89442). One small clinical study in patients with chronic nonbacterial prostatitis shows that a specific saw palmetto extract (Prostamol Uno, Profluss) 320 mg daily improves symptoms when compared with no treatment (73329). Combinations of saw palmetto with other supplements have also been used with fluoroquinolone antibiotics, typically resulting in symptom improvement when compared with the antibiotic alone. These supplement combinations include saw palmetto, indole-3-carbinol, and epigallocatexin-3-gallate (Indigal Plus) 2 capsules twice daily for 3 months (73355); saw palmetto 160 mg, stinging nettle 120 mg, curcumin 200 mg, and quercetin 100mg (ProstaMEV plus FlogMEV) for 2 weeks (73346); and saw palmetto 320 mg, Bacillus coagulans 200 mg, and arbutin 100 mg (Lactorepens) daily for 30 days (96411).
• Sexual desire. Although there has been interest in using oral saw palmetto for sexual desire, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Sexual dysfunction. Although there has been interest in using oral saw palmetto for sexual dysfunction, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose. More evidence is needed to rate saw palmetto for these uses.

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POSSIBLY UNSAFE ...when used orally. Although the safety of 4-androsterone has not been studied in clinical trials, this prohormone might cause serious anabolic steroid-like side effects including stroke, kidney failure, and liver injury (91094,91095).

PREGNANCY AND LACTATION:
Insufficient information available; avoid use.

(Read more about 4-ANDROSTERONE)

POSSIBLY SAFE ...when used orally and appropriately, short-term. Most studies have been small and lasted from a few weeks to 6 months, with usual doses of 50 mg daily (793,1635,2133,3231,4249,4251,4252,4253,4254,4255,9691)(9692,10986,12215,12564,14277,21416,88726,90304,99925). Some studies have also used oral DHEA with apparent safety for 12-24 months (2113,6446,10406,11464,12561,15027,88492). ...when used intravaginally and appropriately. Intravaginal ovules of DHEA 3.25 mg to 13 mg have been safely used for up to 12 weeks (21320,21429,21430). ...when used topically and appropriately. A DHEA cream 1% to 10% has been safely used for up to 12 months (4242,21428).

POSSIBLY UNSAFE ...when used orally in high doses or long-term. There is concern that long-term use or use of amounts that cause higher than normal physiological DHEA levels might increase the risk of prostate cancer (2111,12565), breast cancer (10370,10401,10403), or other hormone-sensitive cancers (6445). In some cases, 50-100 mg daily can produce slightly higher than normal physiological DHEA levels (4249,4251). There is insufficient reliable information available about the safety of using DHEA intravenously or intramuscularly.

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally. DHEA can cause higher than normal androgen levels (2133,4249,4251,4253), which might adversely affect pregnancy or a nursing infant.

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POSSIBLY UNSAFE ...when used orally. Anabolic androgenic steroids, such as epiandrosterone, can disrupt the body's hormonal balance and cause various adverse effects including reduced fertility, gynecomastia (in males), hair loss, acne, and behavioral changes. Anabolic androgenic steroid use has also been associated with hepatotoxicity and increased risk for heart disease. The US Food and Drug Administration and other regulatory agencies warn that dietary supplements containing anabolic steroids are dangerous (91094).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally. Anabolic androgenic steroids, such as epiandrosterone, can disrupt the body's hormonal balance and cause various adverse effects including reduced fertility, hair loss, acne, and behavioral changes. Anabolic androgenic steroid use has also been associated with hepatotoxicity and increased risk for heart disease. The US Food and Drug Administration and other regulatory agencies warn that dietary supplements containing anabolic steroids are dangerous (91094). Avoid using.

(Read more about EPIANDROSTERONE)

POSSIBLY UNSAFE ...when used orally. Although the safety of purified laxogenin, or its synthetic analogue 5-alpha-hydroxy laxogenin, has not been studied in clinical trials, products labeled as containing either of these ingredients are often contaminated with prohibited compounds. Some products have been shown to contain potentially unsafe ingredients such as arimistane, dehydroepiandrosterone (DHEA), and testosterone phenylpropionate (99191).

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

(Read more about LAXOGENIN)

POSSIBLY SAFE ...when used orally and appropriately, short-term. A specific product containing Monterey pine bark extract (Enzogenol, ENZO Nutraceuticals) has been used with apparent safety at a dose of 1000 mg daily for up to 12 weeks (63614,63618,63620,105777) or 480 mg daily for up to 6 months (105778). There is insufficient reliable information available about the safety of Monterey pine when used topically.

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

(Read more about MONTEREY PINE)

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

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

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

(Read more about SAW PALMETTO)

TESTOSTERONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking 1-androsterone with testosterone might increase the risk for additive adverse effects such as mood disturbances and cardiovascular, kidney, or liver problems.  Details 1-Androsterone is converted to 1-testosterone and other androgens upon ingestion (90399,91095).

(Read more about 1-ANDROSTERONE)

(Read more about 4-ANDROSTERONE)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.  Details Human and laboratory research show that DHEA and DHEA-S can inhibit platelet aggregation (19109,19127).

ANTIDEPRESSANT DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might increase the risk of psychiatric adverse events when used with antidepressants.  Details In a human case report, the use of a selective serotonin reuptake inhibitor (SSRI) with DHEA caused a manic episode (7023). Concern for this interaction may be greater in younger individuals with higher baseline DHEA levels.

AROMATASE INHIBITORS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might interfere with the clinical effects of aromatase inhibitors.  Details DHEA is a potent estrogen agonist, which may antagonize the anti-estrogen activity of aromatase inhibitors (10401).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might increase the levels of drugs metabolized by CYP3A4.  Details Some preliminary evidence shows that DHEA may inhibit CYP3A4 (1389); however, the clinical significance of this potential interaction is not known.

ESTROGENS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might increase the effects and adverse effects of estrogen therapy.  Details DHEA is a precursor to estrogen and androgen and is metabolized into those substances. In clinical research, DHEA supplements increase the levels of these hormones (6012,7614,8593,10986,12651,12564,15027,21321,21323,21324)(21325,21326,21327,21328,21330,21331,21356,21364,21389,21393)(21397,21398,21417,21419,21427,47273,47348,88375,90304). Also, in clinical research, estrogen-progestin oral contraceptives and conjugated estrogens reduce blood levels of DHEA and DHEA-S (21372,21373,21374,21437,21438). The clinical significance of these findings is unclear.

FULVESTRANT (Faslodex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might interfere with the anti-estrogen effects of fulvestrant.  Details DHEA is a potent estrogen agonist (10401). Some research shows that it can overcome the estrogen receptor antagonist action of fulvestrant in estrogen-receptor positive cancer cells (10370).

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might interfere with the anti-estrogen effects of tamoxifen.  Details DHEA is a potent estrogen agonist. Some research shows that it can overcome the estrogen receptor antagonist activity of tamoxifen in estrogen-receptor positive cancer cells (10370,10403).

TESTOSTERONE Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, DHEA might increase the effects and side effects of testosterone therapy.  Details DHEA is a precursor to estrogen and androgen and is metabolized into those substances. In clinical research, DHEA supplements increase the levels of these hormones (6012,7614,8593,10986,12651,12564,15027,21321,21323,21324)(21325,21326,21327,21328,21330,21331,21356,21364,21389,21393)(21397,21398,21417,21419,21427,47273,47348,88375,90304,99924,99925,104162). The clinical significance of these findings is unclear.

TRIAZOLAM (Halcion) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D DHEA can increase blood levels of triazolam.  Details Administration of DHEA 200 mg daily for two weeks was shown to inhibit the cytochrome P450 3A4 (CYP3A4) metabolism of triazolam. This inhibition appears to be due to DHEA-S, rather than DHEA (1389).

TUBERCULOSIS VACCINE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D DHEA might reduce the effectiveness of the tuberculosis vaccine.  Details Animal research shows that high doses of DHEA can reduce the efficacy of the Bacillus Calmette-Guérin (BCG) tuberculosis vaccine (21316).

(Read more about DHEA)

(Read more about EPIANDROSTERONE)

(Read more about LAXOGENIN)

(Read more about MONTEREY PINE)

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

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

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

(Read more about SAW PALMETTO)

General ...There is currently a limited amount of information on the adverse effects of 1-androsterone. A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Dyslipidemia, transaminitis, renal dysfunction.

Cardiovascular ...Significant increases in LDL cholesterol of around 29 mg/dL and significant decreases in HDL cholesterol of around 19 mg/dL have been reported in patients taking 1-androsterone for 4-weeks (91095).

Hepatic ...Significant increases in AST of around 15. 4 IU/L have been reported in patients taking 1-androsterone daily for 4 weeks. Despite the elevation, average AST levels did not go much beyond 40 IU/L, the upper limit of normal for AST (91095).

Renal ...Significant increases in serum creatinine of around 0. 2 mg/dL and significant decreases in GFR of around 16.4 mL/min/1.72m² have been reported in patients taking 1-androsterone for 4 weeks. Serum creatinine remained within normal range despite the elevation, GFR dropped below 89 mL/min/1.72m2, which is suggestive of renal impairment (91095).

(Read more about 1-ANDROSTERONE)

General ...There is insufficient information available about adverse effects associated with 4-androsterone. It is purported that 4-androsterone is metabolized to anabolic compounds. Therefore, in theory, there is concern that it might cause serious anabolic steroid-like side effects including stroke, kidney failure, and liver injury.

(Read more about 4-ANDROSTERONE)

General ...Orally and topically, DHEA seems to be well tolerated when used in typical doses, short-term. However, there is some concern that long-term oral use of DHEA may be linked to a greater risk for cancer.
Most Common Adverse Effects:
Orally: Acne, headache, insomnia, mood changes, and nausea. In females, masculinization symptoms including deepening of the voice, increased size of genitals, irregular menses, oily skin, reduced breast size, and unnatural hair growth. In males, aggression, breast tenderness or enlargement (gynecomastia), urinary urgency, and testicular wasting.
Serious Adverse Effects (Rare):
Orally: Possible increased risk for cardiovascular events and various types of cancer.

Cardiovascular ...Incidences of arrhythmia (21334,47540), chest pain (21332,21333), palpitations (21332,21333,88492), hypertension, and transient ischemic attacks (21353,21354,47300) have been reported. DHEA has also been found to decrease high-density lipoprotein (HDL) levels (21344,21345,21346,21347,21348,21349) and increase triglycerides (21334).

Dermatologic ...Acne has been the most commonly reported adverse effect in human research, particularly in females (2113,2114,4242,7614,7559,12561,12574,21346,21351,21354)(21355,21356,21357,21358,21360,21361,21362,21363,21364,47300)(47355,47409,90304,103185). However, it is generally mild and may be treated by reducing the dose (7559). Incidences of contact dermatitis (47402), acneiform dermatitis (2113), greasy hair and skin (17218,21351,21355,21363,21387,21389,47355), keratosis (47402), skin rash (12574,21361,21363), erythema (21334), scalp itching (17218,21357), and skin spots (21387) have also been reported. Increased hair growth and hirsutism have been noted in several clinical trials, including the development of mild mustache in females (2114,4242,12561,12574,17218,21346,21351,21354,21355,21358) (21361,21362,21363,21370,21387,21389,21415,47300). Increased perspiration and odor have also been reported in human research (17218,21354,21356,21357).

Endocrine ...In postmenopausal patients, high doses of DHEA (1600 mg daily) induced insulin resistance, reportedly due to increased androgen levels that occurred during supplementation (21324).

Gastrointestinal ...Gastrointestinal disturbances such as nausea, diarrhea, and abdominal discomfort have been noted in human research (2111,6098,7559,12574,21348,21358,21386).

Genitourinary ...In older adults, elevated and severe urinary symptoms (as evidenced by scores of more than 20, using the American Urological Association Symptom Index for Benign Prostatic Hyperplasia [International Prostate Symptom Score]) and urinary tract infection were reported (21353). Rare incidences of abnormal menses (2114) and increased discharge (21415) have been reported. DHEA has been associated with hematuria (47300).

Hepatic ...Elevated liver enzymes have been reported following DHEA supplementation (21364,47300). However, an analysis of multiple studies in varied patient populations taking DHEA supplements found no elevations in liver enzymes (107791).

Musculoskeletal ...Incidences of asthenia, arthralgia, and myalgia, including calf cramps, have been reported (12574,21354,21358,21365,47355).

Neurologic/CNS ...In humans, dizziness, fatigue, malaise, sleep disturbances, increased dreaming, night sweats, restlessness, "painful spots," and a crawling scalp sensation have been reported (3865,21354,21363,21389). There is a case of seizure associated with DHEA use in a 30 year-old female with fragile X syndrome and no history of convulsive disorder who used DHEA to try to improve ovarian production (47344).

Ocular/Otic ...In patients with Sjögren syndrome, maculae lesions, ocular pain and dryness, and painful eye exams have been reported (21358,21363,21365).

Oncologic ...Preclinical research suggests that DHEA may increase the risk of cancer, particularly prostate, liver, breast, and pancreatic cancers (2111,10370,10401,10403,12565,21332,21333,21334,47251,47256)(47366,47388,47539). High concentrations of DHEA in postmenopausal patients have been associated with an increased risk of breast cancer (2115,6445).

Psychiatric ...DHEA-induced mania has been reported (5870,6102,7023,21383). Clinical studies have also reported anxiety, nervousness, irritability, emotional change, and depression in patients receiving DHEA (2114,21358,21360,21370).

Pulmonary/Respiratory ...Increased cough and nasal congestion have been noted in human research (3865,11334). A report of acute respiratory failure was made in clinical study evaluating the use of DHEA in patients with myotonic dystrophy (type 1) (21334).

Other ...Perceived increases in weight gain have been reported with use of DHEA (2114,21361).

(Read more about DHEA)

General ...A thorough evaluation of adverse effects has not been conducted. However, epiandrosterone is an anabolic androgenic steroid. This drug class is associated with cardiac, hepatic, and hormonal adverse effects.

(Read more about EPIANDROSTERONE)

General ...There is currently a limited amount of information available about the adverse effects of laxogenin. Products labeled as containing laxogenin or 5-alpha-hydroxy laxogenin might contain contaminants, including prohibited compounds (99191).

(Read more about LAXOGENIN)

General ...Orally, Monterey pine seems to be well tolerated. Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

Dermatologic ...Contact dermatitis from Monterey pine sawdust has been reported (63615).

Immunologic ...Monterey pine pollen may cause seasonal rhinoconjunctivitis (63612).

(Read more about MONTEREY PINE)

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

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

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

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

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

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

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

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

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

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

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

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

(Read more about SAW PALMETTO)