The Fat Transporter by The Vitamin Shoppe

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Each tablet contains: Vitamin B6 (as pyridoxine HCl) 10 mg • Choline (as choline bitartrate) 333 mg • Inositol 333 mg • L-Methionine 167 mg • Taurine 167 mg • Betaine HCl (from sugar beets) 50 mg • Barberry root (berberis vulgaris) 33 mg. Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Hydroxypropylmethyl Cellulose, Acacia, Magnesium Stearate, Polyethylene Glycol.

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Effectiveness view details

Below is general information about the effectiveness of the known ingredients contained in the product The Fat Transporter. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETAINE HYDROCHLORIDE (Betaine HCl)

INSUFFICIENT RELIABLE EVIDENCE to RATE

Allergic rhinitis (hay fever). Although there has been interest in using oral betaine hydrochloride for allergic rhinitis, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Asthma. Although there has been interest in using oral betaine hydrochloride for asthma, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Atherosclerosis. Although there has been interest in using oral betaine hydrochloride for atherosclerosis, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Diarrhea. Although there has been interest in using oral betaine hydrochloride for diarrhea, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Dyspepsia. Although there has been interest in using oral betaine hydrochloride for indigestion caused by hypochlorhydria, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Food allergies. Although there has been interest in using oral betaine hydrochloride for food allergies, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Gallbladder disease. Although there has been interest in using oral betaine hydrochloride for gallbladder disease, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Hyperhomocysteinemia. Although there has been interest in using oral betaine hydrochloride for hyperhomocysteinemia, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Hypothyroidism. Although there has been interest in using oral betaine hydrochloride for hypothyroidism, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose.
Rheumatoid arthritis (RA). Although there has been interest in using oral betaine hydrochloride for RA, there is insufficient reliable information about the clinical use of betaine hydrochloride for this purpose. More evidence is needed to rate betaine hydrochloride for these uses.

CHOLINE

POSSIBLY INEFFECTIVE

Athletic performance. Taking oral choline before exercise does not improve athletic performance. Details: Clinical research in trained athletes shows that taking oral choline 2.43 grams as a single dose does not delay fatigue during endurance sports when compared with placebo (5164). Other clinical research in untrained adults shows that taking oral choline 8.425 grams or 50 mg/kg once prior to participating in exhaustive, load-carrying exercise does not improve dexterity, upper or lower body strength, grip strength, or run time-to-exhaustion following exercise when compared with placebo (42229,42237).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Age-related cognitive decline. It is unclear if oral choline is beneficial in patients with age-related cognitive decline. Details: Small clinical studies in adults with memory loss shows that taking choline 2 grams four times daily orally for 21 days does not improve memory when compared with placebo (5170). Observational research in adults over 60 years of age has found that intake of choline 187-399.5 mg daily is associated with a 33% to 42% reduced odds of low cognitive function when compared with intake of less than 187 mg daily. Intake of more than 399.5 mg daily was not associated with low cognitive function when compared with less than 187 mg daily (109100).
Allergic rhinitis (hay fever). It is unclear if oral choline is beneficial in patients with allergic rhinitis. Details: Preliminary clinical research shows that taking oral choline, as tricholine citrate, 500 mg three times daily for 8 weeks is less effective than intranasal budesonide 200 mcg twice daily for reducing symptoms of allergic rhinitis (42252).
Alzheimer disease. Although there has been interest in using oral choline for Alzheimer disease, there is insufficient reliable information about the clinical effects of choline for this purpose.
Asthma. Small clinical studies suggest that oral choline may modestly improve symptoms in patients with asthma. Details: Preliminary clinical research shows that taking choline 500-1000 mg orally three times daily for 3-4 months decreases the severity of symptoms, the number of symptomatic days, and the need to use bronchodilators in patients with asthma when compared with placebo (5165,5166). Preliminary data also shows that choline 3 grams daily might be more effective than 1.5 grams daily (5165).
Autism spectrum disorder. Oral choline has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination of donepezil 2.5-5 mg daily and choline bitartrate 350 mg daily for 12 weeks improves receptive language skills, but no other outcomes, for up to 6 months after treatment when compared with placebo in children aged 5-10 years with autism spectrum disorder. Also, adolescents aged 11-16 years experienced no benefits, and some experienced an increase in behavioral symptoms, such as irritability (103571). It is unclear if this effect is due to choline, donepezil, or the combination.
Breast Cancer. It is unclear if dietary intake of choline reduces the risk of breast cancer. Details: A meta-analysis of 6 low to moderate-quality observational studies suggests that neither high nor low dietary intake of choline is associated with breast cancer risk. This finding is largely influenced by inclusion of the European Prospective Investigation into Cancer and nutrition (EPIC) cohort study, which analyzed data from over 300,000 subjects. However, subanalysis of 3 case-control studies suggests that high dietary intake of choline may be associated with a decreased risk of breast cancer when compared with low choline intake (111416). The interpretation of these findings is limited by the heterogeneity of the included studies, self-reported data, and a small number of studies.
Bronchitis. Although there has been interest in using oral and inhaled choline for bronchitis, there is insufficient reliable information about the clinical effects of choline for this purpose.
Cancer. It is unclear if dietary choline intake reduces the risk for cancer. Details: A meta-analysis of 11 low-quality population studies has found that high dietary intake of choline is associated with an 18% lower risk of cancer when compared with low choline intake. High dietary intake of both choline and betaine was associated with a 40% lower risk of cancer (97390).
Cardiovascular disease (CVD). It is unclear if dietary choline intake reduces the risk of CVD or improves outcomes in patients with CVD. Details: A meta-analysis of population research has found that high intake of dietary choline is not associated with a lower risk of coronary artery disease, stroke, or mortality when compared with a diet low in choline (97388). A more recent population study has found that energy-adjusted total choline intake is not associated with the incidence of CVD over ten years. However, the highest intake of free choline is associated with a 34% reduced risk of CVD when compared with the lowest intake (109104).
Cerebellar ataxia. It is unclear if oral choline is beneficial in patients with cerebellar ataxia. Details: Despite some anecdotal reports suggesting that taking choline improves motor function, preliminary clinical research shows that taking choline 4-5 grams orally daily for 4 days to 6 weeks does not reduce cerebellar ataxia (5161,5173,23679).
Cognitive function. It is unclear if oral choline is beneficial for improving cognitive function in healthy adults. Details: Preliminary clinical research shows that taking a single dose of choline 50 mg/kg orally prior to participating in an exhaustive, load-carrying task does not improve reaction time, reasoning, memory, or serial addition and subtraction ability following the task when compared with placebo (42237). Also, preliminary clinical research in patients requiring long-term total parenteral nutrition (TPN) shows that adding choline chloride 2 grams daily to TPN for 24 weeks might improve delayed visual memory, but does not improve other measures of cognitive performance, when compared with TPN alone (42232).
Cirrhosis. Although there has been interest in using oral choline for cirrhosis, there is insufficient reliable information about the clinical effects of choline for this purpose.
Complex partial seizures. Although there has been interest in using oral choline for complex partial seizures, there is insufficient reliable information about the clinical effects of choline for this purpose.
Dementia. Although there has been interest in using oral choline for dementia, there is insufficient reliable information about the clinical effects of choline for this purpose.
Depression. It is unclear if oral choline is beneficial for the treatment or prevention of depression. Details: Observational research has found that dietary choline intake of at least 198 mg daily is associated with a 32% to 43% decreased risk of depressive symptoms when compared with intakes of less than 198 mg daily (109106). It is unclear if choline supplementation is beneficial for depression.
Diabetes. It is unclear if oral choline is beneficial for the treatment or prevention of type 2 diabetes; the available research is conflicting. Details: Preliminary clinical research shows that taking oral choline bitartrate 1000 mg daily for 2 months does not affect coagulation parameters or levels of triglycerides, low-density lipoprotein (LDL) cholesterol, or high-density lipoprotein (HDL) cholesterol in patients with type 2 diabetes (103569). Choline has also been evaluated for the prevention of type 2 diabetes. In Finnish males, observational research has found that dietary intake of total choline at levels of more than 482 mg daily, especially as phosphatidylcholine, is associated with a 25% lower risk of developing type 2 diabetes over the following 19.3 years when compared with intakes of less than 382 mg daily (103567). However, in males and females in the US, additional observational research has found no association between dietary choline and risk of type 2 diabetes over a mean of 9 years (103570). In addition, a sub-analysis found that the highest intakes of choline (a median of 487 mg daily) were associated with a 54% higher risk of type 2 diabetes among females, but not males, when compared with the lowest intakes (a median of 175 mg daily) (103570). Population research in patients with diabetes has found that an intake of dietary choline in amounts of at least 279 mg daily is associated with a 2.1-fold increased odds of diabetic retinopathy in females, but not males, when compared with an intake less than 206 mg daily (109102). It is unclear if choline itself is responsible for the increased odds of diabetic retinopathy in this population.
Fetal alcohol spectrum disorders (FASD). It is unclear if oral choline improves cognition in children with fetal alcohol spectrum disorders (FASD). Details: Clinical research in children aged 2.5-5 years with FASD shows that taking oral choline bitartrate, providing choline 500 mg, daily for 9 months does not improve global cognitive development or hippocampal-dependent memory when compared with placebo. However, a subgroup analysis of only children aged 2.5-4 years suggests that choline may improve hippocampal-dependent memory (92112). Follow-up of this study at 7 years shows that choline improves motor speed and suggests a trend towards improved color naming, which are components of executive functioning testing, when compared with placebo (111745). The validity of these findings is limited by the high rate of patient discontinuation which limits statistical power. A small clinical trial in children 5-10 years old with FASD shows that taking oral glycerophosphocholine, providing choline 625 mg, daily for 6 weeks does not improve cognitive function, executive function, attention, or hyperactivity when compared with placebo (97389).
Hepatitis. Although there has been interest in using oral choline for hepatitis, there is insufficient reliable information about the clinical effects of choline for this purpose.
Huntington disease. Although there has been interest in using oral choline for Huntington disease, there is insufficient reliable information about the clinical effects of choline for this purpose.
Hypertension. It is unclear if oral choline is beneficial for the prevention or treatment of hypertension. Details: Population research has found that every 100-mg increase in daily dietary choline intake is associated with a 15% decreased risk of developing hypertension over the next 4.6 to 9.1 years (109098). However, it is unclear if any benefits are specifically related to dietary choline or whether choline supplementation is beneficial.
Infant development. It is unclear if oral choline intake during pregnancy is beneficial for infant development; the available research is conflicting. Details: Two observational studies have found that higher intake of choline during the second and third trimesters of pregnancy is associated with improvement in offspring cognitive development and visual memory at the age of 18 months and 7 years, respectively, when compared with lower choline intake (94654,94657). One of these studies found that each 1 mcmol/L increase in maternal blood levels of choline at 16 weeks' gestation was associated with a 2.23-point increase in cognitive skill score based on the Bayley Scales of Infant Development (BSID-III) at 18 months of age (94657). Also, some observational research has found that higher plasma levels of choline during pregnancy are associated with higher processing speed and decreased social withdrawal at 4 years of age in the offspring (109101). In contrast, 3 observational studies have found that higher intake of choline during pregnancy, as well as higher maternal and cord blood levels of choline, are not associated with improved offspring intelligence at 5 years of age or cognitive performance at 3 or 7 years of age (94654,94655,94656). However, many of these observational studies, including those with positive findings, included populations with a mean intake of choline that was below the recommended adequate intake of 450 mg daily (94654,94656). It's possible that higher intake of choline is needed to observe a benefit; however, research on the effects of choline supplementation is limited. One small clinical trial shows that taking choline 930 mg daily during the third trimester modestly improves sustained attention in the child at 7 years of age when compared with taking 480 mg daily (109105).
Metabolic syndrome. It is unclear if oral choline is beneficial in patients with metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that taking oral choline 400 mg daily for 4 weeks does not decrease body weight, blood pressure, plasma glucose levels, or low-density lipoprotein (LDL) cholesterol levels, or increase high-density lipoprotein (HDL) cholesterol levels, when compared with baseline (105731).
Neural tube birth defects. It is unclear if oral choline intake is beneficial for preventing neural tube defects. Details: Population research has found that females who have a high dietary choline intake around the time of conception have a lower risk of having offspring with a neural tube defect when compared to those with lower intake (13134).
Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral choline is beneficial in patients with nonalcoholic fatty liver disease (NAFLD). Details: A cross-sectional analysis of results from observational and clinical research shows that low dietary intake of choline is associated with increased fibrosis in postmenopausal adults with NAFLD, but not in children, males, or premenopausal adults with NAFLD. Dietary choline intake was not associated with steatosis severity in any patient subgroup (92109).
Schizophrenia. Although there has been interest in using oral choline for schizophrenia, there is insufficient reliable information about the clinical effects of choline for this purpose.
Tourette syndrome. Although there has been interest in using oral choline for Tourette syndrome, there is insufficient reliable information about the clinical effects of choline for this purpose.
TPN-associated hepatic steatosis. It is unclear if intravenous choline is beneficial in patients with TPN-associated hepatic steatosis. Details: In patients receiving long-term total parenteral nutrition (TPN), plasma levels of choline can decrease. Small, low-quality clinical studies show that administering intravenous choline 1-4 grams daily for 24 weeks improves some markers of TPN-associated hepatic steatosis when compared with baseline or placebo (5174,42235). More evidence is needed to rate choline for these uses.

(Read more about CHOLINE)

EUROPEAN BARBERRY (Barberry)

INSUFFICIENT RELIABLE EVIDENCE to RATE

Acne. It is unclear if oral European barberry fruit is beneficial for acne. Details: Preliminary clinical research in adolescents 12-17 years of age with moderate or severe acne shows that taking European barberry aqueous extract 200 mg three times daily for 4 weeks reduces acne severity and decreases the number of acne lesions when compared with placebo (94824).
Bacterial vaginosis. It is unclear if topical European barberry is beneficial for bacterial vaginosis. Details: A small clinical study in adults with bacterial vaginosis shows that applying 5 grams of a cream containing European barberry 5% with metronidazole 0.75% vaginally nightly for 7 days modestly reduces infection recurrence rate over the following three weeks when compared with metronidazole cream alone (94826).
Breast cancer. Although there is interest in using oral European barberry for breast cancer prevention, there is insufficient reliable information about the clinical effects of European barberry for this condition.
Dental plaque. It is unclear if brushing the teeth with a gel containing European barberry is beneficial for dental plaque. Details: Preliminary clinical research in males 11-12 years of age shows that brushing with a European barberry extract gel containing berberine 1%, three times daily for 3 weeks reduces plaque index when compared with placebo. This effect was similar to that seen with a commercial antiplaque toothpaste (Colgate) (33695).
Diabetes. It is unclear if oral European barberry is beneficial for diabetes. Details: A small clinical study in adults with type 2 diabetes shows that taking European barberry juice 200 mL daily for 8 weeks, in conjunction with standard treatment, reduces fasting blood glucose levels by 7.5%, compared with an increase of 20% in those receiving standard treatment alone. Patients taking European barberry also had improvements in body weight, systolic and diastolic blood pressure, and total cholesterol when compared with standard treatment alone (98575).
Gingivitis. It is unclear if brushing the teeth with a gel containing European barberry is beneficial for gingivitis. Details: Preliminary clinical research in males 11-12 years of age shows that brushing with a European barberry extract gel containing berberine 1%, three times daily for 3 weeks, reduces gingival inflammation when compared with placebo. This effect was similar to that seen with a commercial antiplaque toothpaste (Colgate) (33695).
Hyperlipidemia. It is unclear if oral European barberry is beneficial for hyperlipidemia. Details: Meta-analyses of five small clinical trials shows that taking European barberry decreases total cholesterol by 24 mg/dL, low-density lipoprotein (LDL) cholesterol by 14 mg/dL, and triglycerides by 29 mg/dL, without significantly affecting high-density lipoprotein (HDL) cholesterol, when compared with a control intervention (102055,105756). However, because the studies included in these analyses enrolled patients with diabetes, metabolic syndrome, or nonalcoholic fatty liver disease (NAFLD), the effects of European barberry on lipid levels in patients with hyperlipidemia are unclear.
Opioid withdrawal. It is unclear if oral European barberry is beneficial for opioid withdrawal. Details: Clinical research in patients using methadone during opioid withdrawal shows that taking European barberry root extract 500 mg twice daily for 4 weeks reduces overall symptoms of withdrawal by a large amount, but does not improve depression, anxiety, stress, or sleep quality, when compared with placebo (108156). More evidence is needed to rate European barberry for these uses.

(Read more about EUROPEAN BARBERRY)

INOSITOL

POSSIBLY EFFECTIVE

Metabolic syndrome. Oral inositol seems to modestly improve lipid parameters, blood pressure, and insulin resistance in patients with metabolic syndrome. Details: Some clinical research in postmenopausal adults with metabolic syndrome following a low-calorie diet shows that taking myo-inositol 2 grams twice daily for one year reduces total cholesterol by 29 mg/dL, triglycerides by 64 mg/dL, systolic and diastolic blood pressure by 9 mmHg and 6 mmHg, respectively, increases high-density lipoprotein (HDL) cholesterol by 6 mg/dL, and improves insulin resistance when compared with placebo. It did not reduce body mass index or waist circumference in these patients (91554). A meta-analysis of clinical studies in a mixed population shows similar effects on blood pressure, especially among postmenopausal adults with metabolic syndrome, at durations exceeding 8 weeks, and at doses of at least 4 grams (108820). Inositol has also been evaluated in combination with other ingredients to treat metabolic syndrome. A clinical study in postmenopausal adults with metabolic syndrome and at risk for breast cancer shows that taking a combination of inositol and alpha-lipoic acid daily for 6 months, in combination with a low-calorie diet, reduces insulin resistance (HOMA-IR) by at least 20% when compared with a low-calorie diet alone. Also, taking inositol and alpha-lipoic acid seems to increase HDL cholesterol by about 6% and reduce triglycerides by 5% when compared to baseline (91543). Another small clinical study in adults with metabolic syndrome shows that taking a specific combination product containing D-chiro-inositol 40 mg, Ceylon cinnamon 250 mg, glucomannan 1000 mg, and inulin 200 mg orally daily for 4 months modestly improves total cholesterol levels and body weight, but not serum glycated hemoglobin, low-density lipoprotein levels, high-density lipoprotein levels, or triglyceride levels when compared with no intervention (114552).
Polycystic ovary syndrome (PCOS). Oral inositol, often in combination with folic acid, seems to improve some glycemic, lipid, metabolic, hormonal, and reproductive parameters in patients with PCOS. However, research is conflicting. Details: Oral inositol, most frequently in the forms of myo-inositol or D-chiro-inositol, has been evaluated for efficacy in a wide range of outcomes associated with PCOS including reproductive and pregnancy outcomes, metabolic parameters, and anthropomorphic measures. Often, inositol is taken in combination with folic acid or metformin. Inositol has been investigated for its effect on metabolic parameters that are often altered in PCOS. A meta-analysis of 9 studies in patients with PCOS shows that taking myo-inositol or D-chiro-inositol with or without folic acid marginally decreases body mass index (BMI) by about 0.5 kg/m2 when compared with placebo (111670). Inositol has also been evaluated for its effect on glucose metabolism in adults with PCOS. Meta-analyses of about 10 studies show that taking myo-inositol or D-chiro-inositol with or without folic acid reduces fasting plasma glucose by 1-4 mg/dL (98944,111670). However, evidence is conflicting on the effect of inositol on insulin levels and measures of insulin resistance (98944,111670). Additionally, most studies show that inositol does not improve measures of glucose metabolism more than metformin. The effect of inositol on lipid profiles has also been studied. A meta-analysis of 2 clinical studies and other small clinical studies show that taking inositol as D-chiro-inositol with or without folic acid modestly reduces total cholesterol and triglycerides when compared with control (2028,98944,91552). Some studies have also investigated the effect of inositol on hormone levels. Meta-analyses show that inositol modulates androgen levels as shown by reduced total and free testosterone, androstenedione, and increased sex-hormone binding globulin when compared with placebo. (2028,91552,98944,111670). The validity of these effects is limited by high heterogeneity in terms of inclusion and exclusion criteria, dose, and treatment duration within the included studies. Myo-inositol has also been compared with metformin in some clinical research, with some evidence of benefit (95085,95086). Meta-analyses of small clinical studies show that taking myo-inositol 2-4 grams daily, with or without folic acid, for 12-24 weeks does not improve fasting blood glucose, fasting insulin, insulin resistance (HOMA-IR), BMI, waist-hip circumference, or androgen levels when compared with metformin 1.5-2.5 grams daily (100705,108823,111670,111670). However, inositol seems to have a lower risk of adverse effects than metformin. These analyses are limited due to the small size, methodological issues, and high heterogeneity of the included studies. In combination with metformin, small clinical studies show that taking metformin, myo-inositol 550 mg, and D-chiro-inositol 150 mg twice daily is associated with improved lipid parameters and postprandial insulin levels when compared with metformin alone (108822). Meta-analyses and clinical studies have investigated the effect of inositol on ovulation, reproduction, and pregnancy outcomes. Some research suggests that inositol increases ovulation rate, promotes cycle normalization, and improves ovarian function in patients with PCOS (2028,91552,98944,111670). A small clinical study shows that taking myo-inositol 4 grams and folic acid 400 mcg (Inofolic, Lo.Li.Pharma) daily for three spontaneous cycles induces ovulation in about 62% of individuals with anovulatory PCOS and insulin resistance. Adding clomiphene citrate with myo-inositol induces ovulation in about 72% of the patients who remain anovulatory after treatment with myo-inositol alone (91547). Another clinical study shows that taking a combination of inositol 2 grams, folic acid 200 mcg, and N-acetyl cysteine 600 mg (Ovaric HP, Just Pharma) twice daily for 12 months improves ovulation rates in PCOS patients with oligomenorrhea, regardless of insulin sensitivity at baseline (91553). Despite evidence that inositol improves ovulation rates, it does not appear to impact pregnancy rates (111670). Some research has also investigated the effects of taking both isomers of inositol concomitantly. Taking myo-inositol 550 mg plus D-chiro-inositol 13.8 mg (Inofolic Combi, Lo.Li.Pharma) twice daily, beginning 12 weeks before ovarian hyperstimulation and continuing throughout pregnancy, improves oocyte quality when compared to treatment with D-chiro-inositol alone. The combination appears to increase fertilization rate in patients aged 35 years or younger, but not those older than 35 years (91544). Other clinical research shows that taking myo-inositol 550 mg and D-chiro-inositol 150 mg twice daily for 12 weeks improves pregnancy rates and live birth rates by an additional 10% and 11%, respectively, when compared with myo-inositol 550 mg plus D-chiro-inositol 13.8 mg. The higher-dose combination also resulted in a 15% lower rate of ovarian hyperstimulation syndrome when compared with those taking the lower dose of D-chiro-inositol (102317). Lastly, other research shows that taking myo-inositol and D-chiro-inositol together may improve metabolic parameters faster than taking myo-inositol alone (91550). Research has also evaluated the effects of inositol on other pertinent clinical outcomes in PCOS. Several small clinical studies show that taking the combination of myo-inositol and D-chiro-inositol, alone or in combination with metformin, improves menstrual cycle irregularity when compared with metformin alone, but not as much as a taking a combined hormonal contraceptive (108822,108824). The validity of these findings is limited by the unblinded nature of the studies. Also, a small clinical study shows that taking metformin with myo-inositol 550 mg and D-chiro-inositol 150 mg twice daily is associated with improved acne, but not hirsutism, at 6 months, when compared with metformin alone (108822). The validity of these findings is limited by the unblinded nature of the study. More research is needed to clarify the effect of inositol on anthropometric, metabolic, and endocrine outcomes in patients with PCOS.
Preterm labor. Oral inositol in combination with folic acid seems to prevent preterm labor in individuals at risk for gestational diabetes. Details: A meta-analysis of five clinical trials in individuals at risk for gestational diabetes shows that taking myo-inositol plus folic acid daily, beginning during the first trimester and continuing throughout pregnancy, decreases the risk of preterm delivery by 64% when compared with folic acid alone. Patients in all but one study included in this analysis took myo-inositol 2 grams plus folic acid 200 mcg twice daily, while patients in the other study took myo-inositol 1100 mg plus D-chiro-inositol 27.6 mg and folic acid 400 mcg daily (100706). It's unclear if these results are generalizable to individuals with a low risk for gestational diabetes.

POSSIBLY INEFFECTIVE

Acute respiratory distress syndrome (ARDS). Oral or intravenous inositol does not seem to prevent ARDS in preterm infants and may be associated with worsened outcomes. Details: Historically, small clinical trials in infants with or at risk for ARDS have suggested that myo-inositol, given parenterally and enterally for 5-10 days, might improve survival and reduce the risk of death and serious complications (2191,2192,91546). However, a large, high-quality clinical study in infants born at less than 28 weeks' gestation at risk for ARDS shows that myo-inositol 40 mg/kg given intravenously and then enterally every 12 hours for up to 70 days does not reduce the risk of death or retinopathy of prematurity (ROP). In fact, the rate of death or type 1 ROP increased by 7% in the myo-inositol group when compared to the control group, and a higher incidence of adverse events in the myo-inositol group, including poor perfusion, hypotension, and infections, led to early trial discontinuation (98946). Long-term follow-up until 24 months corrected age confirms that the initial increase in mortality rate in the myo-inositol group remained stable; however, there was no difference in a composite outcome of death or survival with moderate or severe neurodevelopmental impairment, as well as no difference in the risk of ROP, between the treatment and control groups (108819). The most recent meta-analysis, which incorporates this large clinical study, concludes that inositol supplementation does not reduce the risk of death in infants at risk for ARDS (102319).
Anxiety. Oral inositol does not seem to be beneficial for patients with anxiety. Details: A meta-analysis of four clinical trials shows that taking inositol orally does not improve anxiety severity in patients with anxiety disorders, including obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder, when compared with placebo (91549).
Depression. Oral inositol does not seem to be beneficial for patients with depression. Details: Guidelines from the World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce state that inositol in doses up to 12 grams daily is not currently recommended as monotherapy or adjunctive use for major depressive disorder due to a lack of evidence for efficacy (110318). Additionally, a meta-analysis of seven clinical trials shows that inositol does not significantly improve symptoms of depression in patients with bipolar depression, major depressive disorder, or premenstrual dysphoric disorder (PMDD) (91549). While limited research shows that patients receiving inositol for 4 weeks may improve, patients initially responding to inositol seem to relapse rapidly upon discontinuation of treatment (2026,2185). Additionally, taking inositol with a selective serotonin reuptake inhibitor (SSRI) doesn't appear to improve the effectiveness of SSRI therapy or improve depression in SSRI treatment failures (2025,10851).
Diabetic neuropathy. Oral inositol does not seem to be beneficial for patients with diabetic neuropathy. Details: Most preliminary clinical research shows that taking inositol orally doesn't improve the symptoms of diabetic neuropathy (2193,2194,2195).
Retinopathy of prematurity. Oral or intravenous inositol does not seem to prevent retinopathy of prematurity (ROP) in preterm infants. Details: A meta-analysis of six clinical trials shows that myo-inositol, given parenterally and/or enterally, does not seem to reduce the risk of ROP when compared with placebo in preterm infants (100704). A large, high-quality clinical study included in this meta-analysis shows that myo-inositol 40 mg/kg given intravenously and then enterally every 12 hours for up to 70 days does not reduce the risk of death or ROP in infants born at less than 28 weeks' gestation. In fact, the rate of death or type 1 ROP increased by 7% in the myo-inositol group when compared with placebo and a higher incidence of adverse events in the myo-inositol group, including poor perfusion, hypotension, and infections, led to early trial discontinuation (98946). Long-term follow-up until 24 months corrected age confirms that the initial increase in mortality rate in the myo-inositol group remained stable; however, there was no difference in a composite outcome of death or survival with moderate or severe neurodevelopmental impairment, as well as no difference in the risk of ROP, between the treatment and control groups (108819).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Age-related testosterone deficiency. It is unclear if oral D-chiro-inositol is beneficial in patients with age-related testosterone deficiency. Details: A very small clinical study in males aged 65-75 years with low-normal morning testosterone levels and signs and symptoms of androgen deficiency shows that taking D-chiro-inositol 600 mg twice daily for 30 days improves sexual function and physical strength when compared with baseline (108821). The validity of these findings is limited by the lack of a comparator group.
Bipolar disorder. It is unclear if oral inositol is beneficial in patients with bipolar disorder. Details: Evidence is conflicting on whether inositol helps treat bipolar disorder in children. One very small preliminary study in children aged 5-12 years with bipolar disorder not on concomitant mood-stabilizing medications shows that taking inositol 80 mg/kg (maximum 2 grams) daily for 12 weeks reduces manic symptoms when compared to baseline. Additionally, taking a combination of inositol 80 mg/kg and high eicosapentaenoic acid omega-3 fatty acid capsules (EPA; Nordic Naturals) 1650-3000 mg daily for 12 weeks reduces manic and depressive symptoms when compared to baseline (95092). However, another more recent study with the same intervention and protocol shows that the combination of inositol and high eicosapentaenoic acid omega-3 fatty acid reduces symptoms of depression, but does not improve manic symptoms, when compared with either ingredient taken alone (111676).
Chemotherapy-induced leukopenia. Oral inositol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults undergoing breast cancer surgery and adjuvant chemotherapy shows that taking inositol orally 390 mg twice daily and applying IP-6 gel 4% twice daily to the surgical site, starting 2 weeks before adjuvant chemotherapy and stopping 2 weeks after the last cycle, attenuates reductions in white and red blood cell counts when compared with no intervention. Using inositol and IP-6 also improves breast and arm symptom scores and some quality of life scores; however, these improvements were not consistent over time.
Diabetes. It is unclear if oral inositol is beneficial for the treatment of type 1 diabetes or the prevention of gestational diabetes. Details: Preliminary clinical research in patients with type 1 diabetes and a body mass index of at least 25 kg/m2 shows that taking a specific combination product containing D-chiro-inositol and folic acid (Chirofol 500, LJ Pharma) daily for 6 months, along with insulin therapy, decreases glycated hemoglobin (HbA1c) by approximately 0.5% when compared to taking folic acid alone with insulin therapy. However, there was no difference between groups with respect to insulin resistance or body mass index (95088). Most research shows that taking inositol during pregnancy prevents gestational diabetes. However, most studies conducted to date are of low quality and it is unclear if the results are generalizable. Meta-analyses of 4-7 clinical studies in pregnant adults, some with overweight and obesity, shows that taking myo-inositol 200-4000 mg daily may reduce the risk of gestational diabetes and gestational hypertension, improve 1- and 2-hour glucose tolerance test results, and reduce insulin requirements. Inositol may also be associated with improved infant outcomes such as increased gestational age at birth and reduced preterm delivery but does not seem to influence birth weight, NICU admission rate, neonatal hypoglycemia, the incidence of shoulder dystocia, macrosomia or cesarian delivery when compared with control (111664,111667,111671,111677,114560). The validity of these effects is limited by significant heterogeneity within the included studies, concerns about blinding, and overall low-quality evidence. Most clinical research shows that taking myo-inositol 2 grams plus folic acid 200 mcg twice daily (usually as Inofolic, Lo.Li. Pharma International), beginning during the first trimester and continuing throughout pregnancy, decreases the incidence of gestational diabetes by 57% to 92% when compared with folic acid alone in patients at risk for gestational diabetes. Myo-inositol seems to be more effective than D-chiro-inositol (91545,91548,95083,95084,100706,103750,104688). Subgroup analysis suggests that supplementation with lower doses of inositol, mimicking natural inositol occurring in the body, may not be effective at preventing gestational diabetes (114560). However, this analysis may have been inadequately powered to detect a difference between groups, and it is further limited by heterogenous methods between trials, including duration, population, and product. Other evidence is conflicting about whether inositol prevents gestational diabetes. One clinical study shows that taking a combination of myo-inositol 1.1 grams, D-chiro-inositol 27.6 mg, and folic acid 400 mcg (Inofolic Combi, Lo.Li. Pharma International) daily during pregnancy does not decrease the incidence of gestational diabetes when compared with folic acid alone in patients with a family history of diabetes (95082,103750). In patients eventually diagnosed with gestational diabetes, one small clinical study shows that taking myo-inositol 2 grams reduces the number of patients requiring insulin by at least 50% (104688), although another small clinical study shows that adding D-chiro-inositol, myo-inositol, or both to folic acid does not affect insulin resistance when compared with placebo (98945).
Dyslipidemia. Although there has been interest in using oral inositol for hypercholesterolemia and hypertriglyceridemia, there is insufficient reliable information about the clinical effects of inositol for these conditions.
Erectile dysfunction (ED). Oral inositol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Another very small study in males with overweight or obesity, mild ED, and normal to low androgen levels shows that taking a combination product containing myo-inositol 4000 mg, alpha-lipoic acid, folic acid, and apple (Sinopol Forte) improves measures of erectile dysfunction when compared with baseline (111674). The validity of these effects is limited by the small sample size and the lack of a comparator group, and it is unclear if these effects are due to inositol, other ingredients, or the combination.
Hypertension. Although there has been interest in using oral inositol for hypertension, there is insufficient reliable information about the clinical effects of inositol for this condition.
Hypothyroidism. Inositol has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of clinical and observational research in adults with hypothyroidism, subclinical hypothyroidism, and other thyroid disorders shows that taking a combination of inositol 600-1200 mg and selenium 83-166 mg orally daily for 6-12 months modestly improves thyroid stimulating hormone (TSH) levels and thyroxine levels when compared with control (114562). Clinical research in females aged 18 to 50 years with or at risk for subclinical hypothyroidism in Slovakia shows that taking myo-inositol 600 mg and selenium 83 mcg daily for 6 months reduces patient-reported hypothyroid symptoms including fatigue, menstrual cycle irregularity, and intolerance to heat or cold (110591). The interpretation of this result is limited by the lack of a control group. In addition, it is unclear if the effects in these studies are due to myo-inositol, selenium, or the combination.
Infertility. It is unclear if oral inositol is beneficial in patients undergoing intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF). Details: Several small studies in patients undergoing ICSI show that taking a specific combination product containing myo-inositol 4 grams and folic acid 400 mcg (Inofolic, Lo.Li. Pharma International S.r.l) daily, starting 1-3 months before ICSI and continuing until ovulation, improves fertilization rate, but does not improve implantation or pregnancy rates, when compared with taking folic acid alone (103752,108825). However, another moderate-sized clinical study in adults with infertility undergoing ICSI and IVF shows that taking the same combination of myo-inositol 4000 mg and folic acid 400 mcg daily for 2 months starting on the third day of the cycle improves mean number of oocytes, meiosis II oocytes, 2 pronuclear embryos, and clinical pregnancy and live birth rates when compared with taking folic acid alone (111672). The effects of inositol on fertility have been studied in patients with specific comorbidities. A case-control study in long-term survivors of lymphoma suggests that taking myo-inositol 400 mg and D-chiro-inositol 45 mg (Ovofert Fast, CRL Pharma) three times daily for 12 months is associated with reductions in follicle stimulating hormone (FSH), luteinizing hormone (LH), dyspareunia, and dysmenorrhea and a modest increase in antral follicle count of the right ovary when compared with control (111673). The validity of these effects is limited by a lack of blinding. Inositol has also been evaluated in females with polycystic ovary syndrome (PCOS). A meta-analysis of clinical studies in adults with PCOS undergoing IVF or ICSI shows that inositol does not improve pregnancy rates when compared to no treatment. However, inositol may increase clinical pregnancy rates when compared with metformin (111675). Inositol has also been evaluated in combination with other ingredients. A large clinical study in females planning to conceive shows that taking a combination product containing myo-inositol 4 grams, vitamin D, riboflavin, vitamin B6, vitamin B12, zinc, and probiotics does not improve time-to-conception, clinical pregnancy rates, or live birth rates when compared with a standard micronutrient supplement. However, the supplement shortens time-to-conception in adults with overweight to durations equivalent to patients who are not overweight, but lengthens time to conception in adults with obesity when compared with placebo (111665). It is unclear whether these effects are due to inositol, other ingredients, or the combination.
Insomnia. It is unclear if oral inositol is beneficial for improving sleep during pregnancy. Details: Clinical research shows that taking myo-inositol 2 grams plus folic acid 200 mcg (Inofolic, Lo.Li. Pharma International) before bed for 10 weeks, starting at 14 weeks gestation, improves overall measures of sleep quality by a small amount when compared with folic acid alone. However, this improvement was not maintained until 37-38 weeks' gestation. Also, the study was not limited to patients with poor sleep quality during pregnancy, but to any healthy pregnant individual (104687).
Lithium-induced side effects. It is unclear if oral inositol is beneficial for reducing lithium-induced side effects. Details: A small clinical study suggests that taking inositol 6 grams daily for 10 weeks may improve psoriasis associated with lithium therapy when compared with baseline (11972). However, taking inositol orally does not seem to improve other lithium-induced adverse effects, such as tremor, thirst, and changes in thyroid and adrenal function (2027).
Lung cancer. It is unclear if oral inositol is beneficial for slowing the rate of bronchial dysplasia. Details: Preliminary clinical research in smokers with bronchial dysplasia considered at high risk for lung cancer shows that taking myo-inositol (Tsuno Food Industries Co., Ltd.) 9 grams orally once daily for 2 weeks then twice daily for 6 months, does not increase the rate of complete or partial response when compared with placebo (95090).
Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral inositol is beneficial for NAFLD. Details: A small clinical study in adults with NAFLD and obesity shows that taking myo-inositol powder 4 grams daily for 8 weeks does not improve liver health markers, such as liver function test levels or liver steatosis, but does improve some components of lipid profiles, glycemic indices, and anthropometric measures when compared to baseline (111304) However, this study may have been inadequately powered to detect differences in some of the outcomes.
Obesity. It is unclear if oral inositol is beneficial in patients with overweight or obesity. Details: A meta-analysis of 15 clinical studies in adults shows that taking inositol 600-4450 mg daily for 6-48 weeks decreases body mass index (BMI) by about 0.4 kg/m2. Subgroup analysis suggests that myo-inositol may be beneficial at a dosage less than 1000 mg for less than 12 weeks, especially in patients with polycystic ovary syndrome (PCOS) and overweight or obesity, with higher baseline BMI, and above 40 years of age (111666). However, the validity of this finding is limited by significant heterogeneity in the included studies.
Obsessive-compulsive disorder (OCD). It is unclear if oral inositol is beneficial in patients with OCD. Details: One preliminary clinical study in adults with OCD shows that taking inositol 18 grams daily for 6 weeks improves Yale-Brown Obsessive Compulsive Scale scores when compared with placebo (2186). However, taking inositol does not seem to improve the severity or type of OCD symptoms in patients already taking a selective serotonin reuptake inhibitor (91556). Both of these studies were small, and treatment was administered for only 6 weeks.
Panic disorder. Oral inositol seems to improve symptoms of panic disorder. Details: A very small clinical study shows that taking inositol 12 grams daily reduces the severity and rate of panic attacks and the severity of agoraphobia over 4 weeks of treatment when compared with placebo (2184). Another very small clinical study shows that taking inositol 18 grams daily for one month may be as effective as fluvoxamine 150 mg daily for treatment of panic disorder (10387). However, the one-month duration may not have provided adequate time to see the full effects of fluvoxamine.
Post-traumatic stress disorder (PTSD). It is unclear if oral inositol is beneficial in patients with PTSD. Details: Preliminary clinical research shows that taking inositol 12 grams daily for 4 weeks does not improve distress when compared with placebo in patients with PTSD (91557).
Pregnancy-induced hypertension. It is unclear if oral inositol is beneficial for preventing hypertension during pregnancy. Details: In patients with a body mass index (BMI) between 25-29.9 kg/m2, preliminary clinical research shows that taking myo-inositol 2 grams plus folic acid 200 mcg (Inofolic, Lo.Li. Pharma International) twice daily, beginning during the first trimester and continuing throughout pregnancy, decreases the incidence of pregnancy-induced hypertension by 66% when compared with folic acid alone (104688).
Psoriasis. It is unclear if oral or topical inositol is beneficial for improving symptoms of psoriasis. Details: One small clinical study shows that taking inositol 6 grams daily for 10 weeks does not improve symptoms of psoriasis in a small group of patients when compared to baseline. However, taking this dose of inositol has a moderate effect on overall symptoms in patients with psoriasis related to lithium use (11972). Preliminary clinical research also shows that topical use of D-chiro-inositol is unlikely to be beneficial for reducing overall symptoms of psoriasis. Topical application of inositol 0.25% or 1% for 6 weeks improves overall symptoms when compared with baseline. However, the inositol-containing creams were no more effective than the control cream (104686). Inositol has also been evaluated in combination with other ingredients. A small prospective observational study in adults with mild plaque psoriasis suggests that applying amino-inositol and urea 40% cream (Inosit U40, Biogena) 1-2 times daily for 4 weeks is associated with reductions in the severity and extent of psoriasis symptoms and improvements in quality of life measures when compared to baseline (111668). The validity of these effects is limited by a small sample size, a lack of a comparator group, insufficient blinding, and the observational study design.
Trichotillomania. It is unclear if oral inositol is beneficial for reducing hair pulling. Details: Preliminary clinical research shows that taking inositol in doses ranging from 6-18 grams daily over a period of 10 weeks is no more effective than placebo in reducing subjective or clinician-documented symptoms of hair pulling in patients with trichotillomania (95089). More evidence is needed to rate inositol for these uses.

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METHIONINE (L-Methionine)

POSSIBLY EFFECTIVE

Neural tube birth defects. High dietary intake of methionine during pregnancy seems to reduce the risk of neural tube birth defects. Details: Population research has found that higher dietary intake of methionine during pregnancy is associated with a reduced risk of neural tube defects when compared with lower dietary intake (63117,63135).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Acetaminophen poisoning. It is unclear if oral methionine is beneficial in patients with acute acetaminophen poisoning. Details: Observational research has found that taking methionine 2.5 grams every 4 hours for a total of four doses, starting within 10 hours of acetaminophen overdose, may have similar efficacy to acetylcysteine for preventing liver damage and death (2413).
Allergic rhinitis (hay fever). Although there has been interest in using oral methionine for seasonal allergies, there is insufficient reliable information about the clinical effects of methionine for this purpose.
Asthma. Although there has been interest in using oral methionine for asthma, there is insufficient reliable information about the clinical effects of methionine for this purpose.
Breast cancer. It is unclear if high dietary intake of methionine reduces the risk of breast cancer. Details: A meta-analysis of observational studies suggests that higher dietary intake of methionine is associated with a 6% lower risk of breast cancer, especially for postmenopausal adults, when compared with lower intake. Increasing dietary intake of methionine by 1 gram daily may be associated with a 4% reduction in the risk of breast cancer. These results appear to be more prominent in postmenopausal adults when compared with premenopausal adults; however, this could have been by chance due to the small number of studies that assessed premenopausal adults (94093). A more recent meta-analysis, including 4 additional observational studies, suggests that there is no significant association between methionine intake and breast cancer risk. This finding is largely influenced by inclusion of the European Prospective Investigation into Cancer and nutrition (EPIC) cohort study, which analyzed data from over 300,000 subjects and found no relationship between methionine intake and breast cancer risk (111416).
Cisplatin-associated ototoxicity. It is unclear if oral D-methionine prevents cisplatin-associated ototoxicity. Details: A small clinical study in adults with cancer receiving cisplatin shows that taking D-methionine 100 mg/kg one hour prior to chemotherapy for up to 5 cycles prevents shifts in the hearing threshold at all four tested frequencies, compared with shifts occurring at three of the four tested frequencies in those receiving placebo (108039). The validity of these findings is limited by the lack of statistical comparison between groups.
Colorectal cancer. It is unclear if high dietary intake of methionine reduces the risk of colorectal cancer. Details: A meta-analysis of observational research has found that higher dietary intake of methionine is associated with an 11% lower risk of colorectal cancer, a 23% lower risk of colon cancer, and a 12% lower risk of rectal cancer, when compared with lower intake of methionine. Increasing dietary intake of methionine by 1 gram daily is associated with a 11% reduction in the risk of colorectal cancer. Subgroup analyses have shown a significant inverse relationship between risk of colorectal cancer and dietary methionine intake in patients followed for at least 13.3 years, in Western populations, and in males (94094). There is some evidence that high dietary intake of methionine and folate might have a synergistic effect in decreasing the risk of colon cancer, especially in those with a family history of colon cancer and in those who consume large amounts of alcohol (9325,9326).
Genital herpes. Oral L-methionine has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: A small clinical study in patients with genital warts caused by herpes simplex virus (HSV) shows that taking acyclovir 200 mg five times daily for 5 days followed by 4 capsules of a combination product providing a total daily dose of L-methionine 200 mg, coenzyme Q10 50 mg, vitamin E 50 mg, and selenium 50 mcg for 90 days increases the rate of skin reepithelization by approximately 2 days and decreases the incidence of relapse when compared with acyclovir alone. Patients receiving combination therapy had a relapse rate of 13%, compared with a rate of 43% with acyclovir alone (94091).
Herpes zoster (shingles). Oral L-methionine has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: A small clinical study in patients with herpes zoster shows that taking acyclovir 800 mg five times daily for 10 days followed by 4 capsules of a combination product providing a total daily dose of L-methionine 200 mg, coenzyme Q10 50 mg, vitamin E 50 mg, and selenium 50 mcg for 90 days increases the rate of skin reepithelization by approximately 2 days, decreases the incidence of relapse, and decreases postherpetic neuralgia pain when compared with acyclovir alone. Patients receiving combination therapy had a relapse rate of 7%, compared with a rate of 44% with acyclovir alone (94091).
Human papillomavirus (HPV). It is unclear if oral methionine is beneficial for the treatment of HPV lesions or for reducing the incidence of relapse. Details: A clinical study in patients aged 14 years or older with cutaneous warts caused by HPV shows that receiving conventional therapy in combination with one capsule of a product containing methionine, echinacea, inulin, taurine, vitamin A, vitamin C, coenzyme Q10, vitamin B3, zinc gluconate, and probiotics (Immuno Skin Plus tablets, Morgan Pharma S.r.l) daily for 20 days each month for 4 months reduces the number of warts at 6 months by about 5, with complete remission achieved in 86% of patients. The group receiving conventional therapy alone had a reduction in the number of warts by about 3, with complete remission achieved in 55% of patients. Conventional therapy consisted of either liquid nitrogen cryotherapy or topical therapy with salicylic acid 15% and lactic acid 15%. These findings are limited by the fact that patients in the combination therapy group had more warts at baseline when compared with those receiving conventional therapy alone (94092). Another small clinical study in patients with skin warts caused by HPV shows that cryotherapy followed by taking 4 capsules of a product containing a total dose of L-methionine 200 mg, coenzyme Q10 50 mg, vitamin E 50 mg, and selenium 50 mcg daily for 180 days increases the rate of complete recovery and decreases the incidence of relapse when compared with cryotherapy followed by placebo. At 180 days, 56% of patients in the active group experienced complete recovery, compared with 44% in the placebo group, and 30% of patients in the active group experienced a relapse, compared with 41% in the placebo group (94091). It is unclear if these effects are due to methionine, other ingredients, or the combination.
Menopausal symptoms. It is unclear if oral L-methionine is beneficial for reducing hot flashes. Details: Preliminary clinical research in postmenopausal adults experiencing at least 5 hot flashes daily for the prior two months shows that taking L-methionine 1 gram twice daily for 12 weeks, then 2 grams twice daily for 8 weeks, does not improve hot flashes when compared with placebo (94090).
Pancreatitis. Oral methionine has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: A meta-analysis of eight randomized and nonrandomized clinical studies in patients with chronic or recurrent acute pancreatitis shows that taking a combination of methionine, selenium, vitamin E, vitamin C, and beta-carotene reduces pain when compared with placebo. However, when the two nonrandomized studies were excluded, the significant reduction in pain was lost. Daily doses of individual components studied included methionine 1.6-2.88 grams, selenium 300-600 mcg, vitamin E 188-280 mg, vitamin C 540-720 mg, and beta-carotene 12-54 mg. The study durations ranged from 10 weeks to 12 months (94095). The validity of these findings is limited by the heterogeneity of the included studies.
Parkinson disease. Although there has been interest in using oral methionine for Parkinson disease, there is insufficient reliable information about the clinical effects of methionine for this purpose.
Urinary tract infections (UTI). Oral methionine has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: A low-quality observational study in patients with symptomatic UTI and culture-confirmed bacteriuria during pregnancy has found that taking a specific combination of methionine 800 mg, Hibiscus sabdariffa extract 200 mg, and Boswellia serrata 200 mg (Acidif Plus, Biohealth S.r.l) daily for one week increases the rate of negative urine cultures to 70% and symptom resolution to 63%, compared with 43% and 46%, respectively, in patients who increased fluid intake but did not take the combination product (97263). The validity of these findings is limited by the fact that the study groups were not comparable at baseline.
Wound healing. Although there has been interest in using oral methionine for wound healing, there is insufficient reliable information about the clinical effects of methionine for this purpose. More evidence is needed to rate methionine for these uses.

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TAURINE

POSSIBLY EFFECTIVE

Congestive heart failure (CHF). Oral taurine may improve left ventricular function, heart failure-related symptoms, and exercise capacity in patients with CHF. Details: Taking taurine 2-6 grams in two or three divided doses daily for 6-8 weeks seems to improve left ventricular function (5248,5271,8221) and symptoms of heart failure (5271,5306,8221) when compared with placebo or coenzyme Q10 in patients with New York Heart Association (NYHA) functional class II to IV. Also, taking taurine 500 mg three times daily for 2 weeks seems to improve exercise capacity when compared with placebo in patients with heart failure (77176). Some patients with severe heart failure rapidly improve from NYHA class IV to II after 4-8 weeks of treatment. Improvement seems to continue for as long as taurine treatment is continued, up to one year (5306,8217,8218,8221).
Hepatitis. Oral taurine may improve liver function in patients with acute or chronic hepatitis. Details: Several small clinical trials show that taking taurine 1.5-4 grams daily for up to 3 months improves liver function in patients with acute and chronic hepatitis when compared with placebo (10454,77114,77147).

POSSIBLY INEFFECTIVE

Obesity. Oral taurine does not appear to improve body weight in adults who are obese or overweight. Details: A meta-analysis of 12 small clinical trials shows that taurine supplementation does not reduce body weight or body mass index (BMI) when compared with placebo. The studies included in this analysis evaluated taurine doses of 0.5-6 grams daily for 15 days to 6 months. Most of the patient populations evaluated in the included studies had liver or metabolic disorders; three studies specifically evaluated overweight or obese adults (104166). Additionally, a more recent clinical trial in a small group of females with obesity shows that taking taurine 1 gram three times daily along with a calorie-restricted diet for 8 weeks does not reduce body weight, BMI, or waist circumference when compared with calorie restriction alone (104167). In contrast, a very small study in adults with type 2 diabetes on antidiabetes medication shows that taking taurine 500 mg twice daily for 8 weeks reduces body mass, BMI, and body fat percentage when compared with control (112271). The validity of these effects is limited by the small sample size.

INSUFFICIENT RELIABLE EVIDENCE to RATE

Academic performance. It is unclear if oral taurine is beneficial to improve academic performance. Details: A very small clinical study in college entrance examinees over age 19 shows that taking a jelly containing taurine 3 grams daily for 14 days does not improve academic achievement when compared with baseline or placebo (110579). Due to its small size, this study may have been inadequately powered to detect a difference between groups.
Age-related macular degeneration (AMD). Although there has been interest in using oral taurine for AMD, there is insufficient reliable information about the clinical effects of taurine for this purpose.
Androgenic alopecia. Oral taurine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study in adults with androgenic alopecia or telogen effluvium shows that taking a combination product containing taurine, cysteine, methionine, iron, selenium, and hydrolyzed collagen (GFM Oral, Cantabria Labs) along with conventional therapy, consisting primarily of finasteride or minoxidil, daily for 12 weeks improves hair loss when compared with conventional therapy alone (111636). It is unclear if this effect is due to taurine, other ingredients, or the combination.
Athletic performance. Research on the use of taurine for improving endurance or power output is limited and conflicting; however, it may improve performance by a small amount in some athletes. Details: Research is conflicting on the effects of taurine on athletic performance. Several clinical studies in trained and untrained athletes show that taking taurine 1-6 grams as a single dose before endurance exercise, or 3 grams daily for 8 weeks after endurance exercise, does not improve endurance or aerobic capacity when compared with placebo (77159,77203,95613,98334). However, a meta-analysis of 7 small clinical trials shows that taking taurine 1-6 grams daily for up to 2 weeks slightly improves endurance when compared with control. Also, preliminary studies in male cyclists, recreationally active males, Olympic-level athletes, and female athletes habituated to caffeine show that taking taurine 50 mg/kg or 1-6 grams one time 1.5-2 hours prior to a cycling test increases the time to exhaustion and peak, mean, and minimum power output but does not improve perceived exertion, fatigue index, heart rate, or anaerobic capacity when compared with placebo (101475,103211,112265,112269). The reasons for these discrepancies are unclear; the meta-analysis did not identify a dose or duration-related benefit. One small clinical trial shows that taking taurine 40 mg/kg improves muscle power in caffeine-deprived athletes who regularly use caffeine, but actually seems to worsen muscle power in athletes who do not regularly use caffeine (98335). Overall, it is not clear which population is most likely to benefit from taurine use (98337,98338). Study results are mixed when taurine has been evaluated in combination with other ingredients. One small study shows that taking a specific product containing taurine and caffeine (AdvoCare Spark) does not improve sprint performance in college athletes when compared with placebo (77195). However, other small studies of cyclists and boxers suggest that taking taurine in combination with a variety of other ingredients including B vitamins, caffeine, and glucuronolactone (Red Bull Energy Drink) or ginseng, kudzu, and soybean, may improve measures such as endurance, power, balance, or agility (37815,57945,110577,112269). It is unclear if the benefits seen in these studies are due to taurine, other ingredients, or the combinations.
Attention deficit-hyperactivity disorder (ADHD). Although there has been interest in using oral taurine for ADHD, there is insufficient reliable information about the clinical effects of taurine for this purpose.
Autism spectrum disorder. Although there has been interest in using oral taurine for autism spectrum disorder, there is insufficient reliable information about the clinical effects of taurine for this purpose.
Chemotherapy-induced nausea and vomiting (CINV). It is unclear if oral taurine is beneficial in patients with CINV. Details: One small clinical trial in patients with acute lymphoblastic leukemia receiving 6 months of chemotherapy shows that taking taurine (pure powder, Aviforme) 1000 mg twice daily, starting 6 hours after receiving chemotherapeutic agents, significantly improves CINV in 87.5% of patients. Other symptoms, such as reduced appetite and smell and taste impairment, are also improved in some patients (91512).
Chemotherapy-induced nephrotoxicity. It is unclear if oral taurine is beneficial for preventing or treating chemotherapy-induced nephrotoxicity. Details: One small clinical trial in patients with acute lymphoblastic leukemia receiving 6 months of chemotherapy shows that taking taurine (pure powder, Aviforme) 1000 mg twice daily reduces plasma creatinine, urea, bilirubin, and liver enzymes after 4 months when compared with placebo. This suggests a protective effect against chemotherapy-induced nephrotoxicity and hepatotoxicity. A reduction in overall fatigue is also observed (95616).
Cirrhosis. It is unclear if oral taurine is beneficial in patients with cirrhosis. Details: One small, uncontrolled clinical study in patients with cirrhosis shows that taking taurine 1 gram three times daily for 4 weeks reduces the severity and frequency of muscle cramps when compared to baseline (104165). Another small clinical trial in patients with cirrhosis shows that taking taurine 6 grams daily for 4 weeks reduces portal hypertension by 12%, compared with a 2% increase in the placebo group (98336). However, it is unclear if this is associated with a reduced risk for complications such as variceal bleeding and ascites.
Cognitive function. It is unclear if oral taurine is beneficial for improving cognitive function; however, taking an energy drink (Red Bull Energy Drink) containing taurine and other ingredients may modestly improve some measures of cognitive function. Details: Levels of taurine decrease with age, but supplementation does not seem to have neuroprotective effects or cognitive benefits in the elderly (101471,110574,110578). In one small crossover study, taurine alone did not reduce errors in sleep-deprived individuals when compared with placebo (38154). However, taurine taken as part of an energy drink formulation containing taurine, caffeine, glucuronolactone, and B vitamins (Red Bull Energy Drink) improves focused and sustained attention, wakefulness, verbal reasoning, driving ability and quality, and reaction speed when compared with placebo (9899,38117,77088,77202). Preliminary clinical research in young adults also shows that consuming the Red Bull Energy Drink might improve attention and verbal reasoning, but does not seem to improve memory, when compared with placebo (9899,77088).
Cystic fibrosis. Oral taurine may reduce steatorrhea in children with cystic fibrosis, but it does not seem to improve other measures of nutritional status. Details: Some small clinical studies in children with cystic fibrosis show that taking taurine 30-40 mg/kg daily for 7 days to 6 months might be useful as adjunctive therapy to reduce steatorrhea when compared with baseline or placebo (10455,77227,77231). However, it does not seem to improve growth, lung function, muscle protein breakdown, or other symptoms of cystic fibrosis (77224,77228). Also, adding taurine 500-1500 mg daily to treatment with ursodeoxycholic acid for up to one year does not improve liver function tests, fat absorption, or nutritional status in patients with cystic fibrosis and associated liver disease when compared with ursodeoxycholic acid alone (77246,77256).
Delirium. It is unclear if oral taurine prevents delirium in patients in the intensive care unit. Details: A large clinical study of hospitalized adults in Iran who underwent liver transplantation shows that taking a specific taurine powder product (100% Taurine Amino Acid, MyProtein) 2 grams daily for 30 days post-transplant reduces the risk of delirium by 73% when compared with placebo. These results also suggest that for every four patients treated with taurine over placebo, one additional case of delirium is prevented. Patients who took taurine also had less time on the ventilator and shorter intensive care and hospital stays (110575). However, it is unclear if these effects are due to taurine or other factors since ventilator time and intensive care length of stay are risk factors for delirium.
Diabetes. It is unclear if oral taurine is beneficial in patients with diabetes. Details: Plasma levels of taurine are reported to be lower in patients with diabetes than in healthy controls (101473). However, clinical research evaluating taurine for glycemic control is mixed (77074,103212). One small clinical trial in patients with type 2 diabetes shows that taking taurine 1 gram three times daily for 8 weeks reduces blood glucose, insulin resistance, total cholesterol, and low-density lipoprotein (LDL) cholesterol when compared with placebo (103212). Although there was no improvement in glycated hemoglobin (HbA1c), the study was not long enough to detect a meaningful reduction in HbA1c. Other preliminary clinical research shows that taking taurine 1-1.5 grams twice daily for 2-4 months does not affect fasting blood glucose, HbA1c, or insulin but may improve measures of insulin resistance in patients with type 2 diabetes when compared with placebo (77074,112271). However, taking taurine while following an exercise program 3 times weekly does appear to reduce fasting blood sugar and HbA1c when compared with exercise plus placebo (112271). The reasons for these discrepant findings are unclear; however, all the included studies were small and potentially inadequately powered to detect a difference in outcomes.
Epilepsy. Although there has been interest in using oral taurine for epilepsy, there is insufficient reliable information about the clinical effects of taurine for this condition.
Exercise-induced muscle soreness. Small clinical studies suggest that oral taurine may modestly improve exercise-induced muscle soreness. Details: One small clinical trial in healthy, untrained adults shows that taking taurine 2 grams in combination with branched chain amino acids (BCAAs) three times daily for 2 weeks reduces subjective muscle soreness by 37% when compared with placebo (77212). Another small clinical trial in young, untrained males shows that taking taurine (Taisho Pharmaceutical Co., LTD.) 2 grams three times daily after meals before exercise, and continuing for three days after exercise, reduces delayed onset muscle soreness (DOMS), but not creatine kinase levels, when compared with placebo (91513).
Fatigue. It is unclear if oral taurine is beneficial for improving fatigue. Details: One small clinical trial shows that taurine seems to reduce fatigue when taken alone, but increases fatigue when taken in combination with caffeine (77202). However, an observational study in young adults has found that subjective scores for physical and mental fatigue do not seem to correlate with dietary taurine intake (101472). One small clinical trial shows that drinking 500 mL of an energy drink providing taurine 1 gram plus other ingredients including caffeine and B vitamins decreases measures of driving-related fatigue in a driving simulation when compared with placebo (91075).
Helicobacter pylori. It is unclear if oral taurine can aid in the eradication of helicobacter pylori (H. pylori). Details: One clinical trial shows that taking taurine 500 mg twice daily in combination with conventional treatment for 6 weeks increases H. pylori eradication and shortens duodenal ulcer scarring time in patients with confirmed H. pylori infection when compared with conventional treatment alone (77145).
Hyperlipidemia. It is unclear if oral taurine is beneficial for lowering lipid levels. Details: A meta-analysis of 12 small clinical trials in adults with various liver or metabolic disorders, but without a specific diagnosis of hyperlipidemia, shows that taurine supplementation reduces total cholesterol by 11 mg/dL and triglycerides by 13 mg/dL, but does not seem to improve low-density lipoprotein (LDL) cholesterol or high-density lipoprotein (HDL) cholesterol levels, when compared with placebo. The studies included in this analysis evaluated doses of 0.5-6 grams daily for 15 days to 6 months (104166). The benefits of taurine in adults with hyperlipidemia are unclear. The effect of taurine has also been investigated in combination with exercise. A very small study in adults with type 2 diabetes on antidiabetes medication shows that taking taurine 500 mg twice daily while participating in an exercise program 3 times weekly for 8 weeks reduces triglycerides, total cholesterol, and LDL cholesterol and increases HDL cholesterol when compared with exercise plus placebo (112271).
Hypertension. Oral taurine may modestly reduce blood pressure in patients with hypertension; however, the long-term antihypertensive effects of taurine are unclear. Details: One clinical study in patients with elevated blood pressure or stage 1 hypertension shows that taking taurine 1.6 grams daily for 12 weeks reduces systolic blood pressure (SBP) by 5 mmHg and diastolic blood pressure (DBP) by 3 mmHg when compared with placebo. The benefit is seen after 8 weeks of continued supplementation (95614). A small clinical trial in patients with stage 2 hypertension (previously classified as borderline hypertension) shows that taking taurine 6 grams daily for 7 days reduces both SBP and DBP when compared to baseline (77229). The long-term effects of taurine on blood pressure are unclear. A meta-analysis of 12 small clinical trials in adults with various liver or metabolic disorders, but without a specific hypertension diagnosis, shows that taurine supplementation reduces SBP by 5 mmHg and DBP by 3 mmHg when compared with placebo. The studies included in this analysis evaluated doses of 0.5-6 grams daily for 15 days to 6 months (104166). Taurine is commonly found in energy drinks, and its effect on blood pressure when used in combination with other ingredients in the form of an energy drink has been evaluated. A small observational study in young adults suggests that drinking a specific combination product containing taurine 100 mg, caffeine, and group B vitamins (Redbull Energy Drink) reduces heart rate but does not change SBP or DBP when compared to baseline (112266). However, another small observational study in young healthy adults suggests that drinking a specific combination product containing taurine 2000 mg, caffeine, ginseng, glucuronolactone, inositol, guarana, L-carnitine, and B vitamins (Monster Energy Drink) increases both SBP and DBP by about 16 mmHg and raises heart rate by 17 beats per minute 15 minutes after consumption when compared to baseline. However, 90 minutes after consumption only DBP and heart rate remain elevated (112268). In both studies, the validity of the effects is limited by a lack of a comparator group. Additionally, it is unclear if the effects are due to taurine, other ingredients, or the combination.
Infant development. Higher maternal intake of taurine from the diet may be linked to increased newborn length and weight; however, feeding taurine-containing formula to newborns does not appear to improve infant development. Details: One observational study has found a positive correlation between maternal dietary taurine intake and newborn length. In pregnant patients with high taurine intake (>120 mg/day), neonatal birth weight and length were significantly higher when compared with groups with lower taurine intake (101474). However, clinical research shows that administering infant formula containing taurine 45 mg/L for up to 12 weeks does not affect weight, length, head circumference, or behavior in preterm and full-term infants when compared with formula without taurine (77119,77216,77218,77239,77260).
Iron deficiency anemia. It is unclear if oral taurine is beneficial in patients with iron deficiency anemia. Details: One small clinical trial in females with iron deficiency anemia shows that taking taurine 1000 mg plus ferrous sulfate 325 mg daily for 20 weeks improves hemoglobin concentrations, red blood cell counts, and serum ferritin levels when compared with ferrous sulfate plus placebo (77070).
Muscular dystrophy. It is unclear if oral taurine is beneficial in patients with muscular dystrophy. Details: One very small crossover trial in patients with muscular dystrophy shows that taking taurine 100-150 mg/kg for 6 months improves the ability to relax muscles after voluntary use when compared with placebo (77235).
Physical performance. It is unclear if oral taurine improves physical performance in older adults. Details: A small study in elderly females living in a care facility shows that taking taurine powder 1.5 grams daily for 14 weeks in addition to standardized exercise training may modestly improve some measures of physical fitness (i.e. agility, endurance) when compared to baseline. These measures were not improved in patients who took taurine but did not participate in exercise training or who participated in exercise training but did not take taurine (110574). The validity of these findings is limited by lack of randomization, blinding, and statistical comparison between groups.
Postoperative recovery. It is unclear if oral taurine is beneficial for improving postoperative recovery. Details: One small clinical trial in patients recovering from surgery after a hip fracture shows that taking taurine 6 grams daily for 7 days after surgery does not improve morbidity and mortality outcomes after 1 year when compared with placebo (95615).
Psychosis. It is unclear if oral taurine is beneficial in patients with psychosis. Details: One small clinical trial in adults up to 25 years of age with first-episode psychosis shows that taking taurine 4 grams daily for 12 weeks in combination with prescribed antipsychotics reduces positive psychotic symptoms, but not negative or cognitive symptoms, when compared with placebo (95612).
Sleep deprivation. Oral taurine 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 taurine, caffeine, glucuronolactone, and B vitamins (Red Bull Energy Drink) reduces lane drifting and sleepiness and improves driving quality and reaction time during a car-driving simulator exercise in sleep-deprived individuals when compared with placebo (38117,77066). Other preliminary clinical research in sleep-deprived surgical trainees shows that taking taurine 2 grams in addition to caffeine 150 mg improves reaction time during performance of simulated laparoscopic surgery when compared with placebo, although error-making is not reduced (38154).
Tourette syndrome. Oral taurine may improve tic severity in children with Tourette syndrome who are taking tiapride at a dose of 300 mg or less. Taurine may not be effective in children taking higher doses of tiapride. Details: One clinical trial in children 6-16 years of age with Tourette syndrome or other tic disorders shows that taking taurine along with tiapride reduces the severity of tics when compared with tiapride alone. For every 6 children taking taurine, one additional child saw a 60% or greater reduction in tic severity as measured on the Yale Global Tic Severity Scale when compared with placebo. However, taurine did not improve tic severity in children taking tiapride at a dose greater than 300 mg daily (103210). Taurine was taken in age-dependent doses of 2.4 grams daily in those 6-8 years, 3.6 grams daily in those 9-13 years, and 4.8 grams daily in those 14-16 years.
Traumatic brain injury (TBI). It is unclear if oral taurine is beneficial in patients with a TBI. Details: A small clinical study of adults in Iran receiving treatment in the intensive care unit (ICU) following TBI shows that adding a specific taurine powder product (Nutricost) 30 mg/kg/day up to 3 grams daily to enteral nutrition for 14 days may modestly improve disease severity scores, but does not reduce days on the ventilator, ICU length of stay, or mortality at 30 days when compared with usual enteral nutrition (110573). Due to its small size, this study may have been underpowered to detect differences between groups. More evidence is needed to rate taurine for these uses.

(Read more about TAURINE)

VITAMIN B6

EFFECTIVE

Pyridoxine-dependent epilepsy. Intravenous vitamin B6 is effective for controlling pyridoxine-dependent seizures. Details: Pyridoxine-dependent seizures are a rare type of refractory seizures in neonates that do not respond to anticonvulsant drugs. These seizures are typically controlled within minutes of intravenous administration of pyridoxine, a form of vitamin B6. Pyridoxine-dependent seizures can be due to genetic (autosomal recessive) pyridoxine dependency, or more commonly, a result of the use of high-dose pyridoxine during pregnancy (8197,8198).
Sideroblastic anemia. Oral vitamin B6 is effective for treating hereditary sideroblastic anemia. Details: Taking vitamin B6 (pyridoxine) orally is effective for treating hereditary sideroblastic anemia (15,9518). Taking the active form of vitamin B6 (pyridoxal-5'-phosphate) also seems to be effective in cases in which the patient does not respond to pyridoxine (93049).
Vitamin B6 deficiency. Oral vitamin B6 is effective for preventing and treating vitamin B6 deficiency. Details: Taking oral vitamin B6 can prevent and treat vitamin B6 deficiency (15).

LIKELY EFFECTIVE

Hyperhomocysteinemia. Taking vitamin B6 orally, alone or in combination with folic acid, is effective for reducing hyperhomocysteinemia. Details: Vitamin B6 (pyridoxine) seems to lower homocysteine concentrations when folic acid and vitamin B12 are at physiologic levels or when given with folic acid and vitamin B12 supplements (9451,83042,107136). A combination of vitamin B6 100 mg and folic acid 0.5 mg daily seems to lower homocysteine levels by about 35% and is recommended for people with postprandial hyperhomocysteinemia (1489,9406). Other research shows that taking pyridoxine 50-200 mg daily reduces postprandial homocysteine levels by 32% to 35% (9406,10350). Pyridoxine also seems to reduce homocysteine levels in patients with kidney failure, kidney transplant patients (1489,6884,9414,9415), or patients who receive general anesthesia with nitrous oxide (9481). However, some research in healthy adults suggests that adding pyridoxine to folic acid might not provide any additional benefit over folic acid alone (9400,9405,9409,50145). Hyperhomocysteinemia is considered by some to be an independent risk factor for atherosclerosis, recurrent thromboembolism, deep vein thrombosis, myocardial infarction, and ischemic stroke (1899,3323,9402,9405,9408,9409). However, elevated homocysteine levels may be a marker, as opposed to a cause, of vascular disease (11387,11388). A 5 µmol/L increase in plasma homocysteine increases the risk of cerebrovascular disease by 50% and the odds of coronary heart disease by 60% and 80% in males and females, respectively (9407,9411). However, it is not clear if reducing homocysteine levels results in reduced cardiovascular morbidity and mortality (1489,6883,6884,9308,9400,9405,9409). Folic acid, vitamin B6, and vitamin B12 supplementation can reduce total homocysteine from 13.4 to 11 µmol/L. However, this reduction does not seem to help with secondary prevention of death or myocardial infarction, and some research even suggests an increase in cardiovascular disease (CVD) risk (11387,13482,50423,83050,97619). There is also debate about whether supplementation with homocysteine-lowering B vitamins can reduce the risk of stroke. A number of large clinical studies and meta-analyses show that supplementation with folic acid, vitamin B6, and vitamin B12, alone or in combination, does not reduce the risk of stroke in patients with CVD or impaired renal function (11387,13482,50423,83050,96150). However, a more recent meta-analysis shows that B vitamin supplementation modestly reduces the relative risk of stroke by 10% when compared with placebo in patients at risk for or with a history of CVD (97619). Also, a meta-analysis in patients with a history of stroke shows that B vitamin supplementation modestly reduces the relative risk of stroke recurrence by 13% and the risk of vascular death by 11% when compared with placebo (107136).

POSSIBLY EFFECTIVE

Antipsychotic-induced hyperprolactinemia. It is unclear if oral vitamin B6 is beneficial for patients with antipsychotic-induced hyperprolactinemia. Details: Clinical research in male patients with hyperprolactinemia who are on a consistent antipsychotic dose shows that taking vitamin B6 300 mg twice daily for 16 weeks reduces serum prolactin levels by 68%, compared with 37% in patients taking aripiprazole 5 mg twice daily. Also, 67% of patients taking vitamin B6 had prolactin levels less than 40 mcg/mL versus 2% of those taking aripiprazole (107128).
Kidney stones (nephrolithiasis). Oral vitamin B6 seems to decrease urinary oxalate levels and decrease the risk of kidney stone formation in some patients. Details: There is some evidence that taking vitamin B6 (pyridoxine) orally, alone or in combination with magnesium, can decrease urinary oxalate levels in people with type I primary hyperoxaluria, a hereditary disorder (1201,6437,6438,6439,6440,8548,8549,8550). Additionally, a small clinical study in this population suggests that intravenous pyridoxine hydrochloride can reduce urinary oxalate by 25.5% when compared to baseline (90796). In patients with idiopathic hyperoxaluria, taking a combination of pyridoxine 25mg and magnesium oxide 400 mg for 3 months decreases urinary oxalate by approximately 16%, with 68% of patients experiencing a reduction. However, supplementation is less effective than following a low-oxalate diet, which reduces urinary oxalate in 91% of patients by an average of 31% (107127). There is also preliminary evidence that higher pyridoxine intake in females with no history of kidney stones is associated with decreased risk of kidney stone formation (6441), but this association has not been found in males (6442).
Pregnancy-induced nausea and vomiting. Oral vitamin B6 may reduce nausea and vomiting in some pregnant patients and is sometimes used in combination with doxylamine. Details: While some conflicting evidence exists, most small clinical studies suggest that oral vitamin B6 is effective for improving nausea and vomiting associated with pregnancy when compared with baseline or placebo. However, vitamin B6 may not be as effective as ginger (110459). Two small clinical studies show that taking vitamin B6 (pyridoxine) 25 mg every 8 hours for 3-4 days decreases pregnancy-induced nausea severity and vomiting incidence when compared with placebo (6168,16306). A larger clinical trial shows that taking lower doses of vitamin B6, 10 mg every 8 hours over 5 days, improves pregnancy-induced nausea, but not vomiting, when compared with placebo (6167). A small clinical study in patients with mild to moderate nausea and vomiting shows that taking a higher dose of 40 mg twice daily for 4 days is more effective than placebo, but no better than ginger 500 mg twice daily (99404). The American College of Obstetrics and Gynecology (ACOG) considers vitamin B6 at a dose of 10-25 mg 3 to 4 times daily a first-line treatment for pregnancy-induced nausea and vomiting due to its benign safety profile (111601). However, it is not effective for all patients, such as those with hyperemesis gravidarum, a severe form of pregnancy-induced nausea and vomiting. Adding vitamin B6 20 mg three times daily for 2 weeks to intravenous rehydration, metoclopramide, and thiamine seems to be no more effective than placebo for reducing vomiting in hyperemesis gravidarum (99405). Vitamin B6 is also sometimes used in combination with doxylamine. In fact, a combination of vitamin B6 plus doxylamine (Diclegis or Bonjesta, Duchesnay Inc., and various generics) has been approved by the US Food and Drug Administration (FDA) as a prescription product111601). ACOG recommends vitamin B6 in combination with doxylamine as another first-line treatment option (111601). However, the clinical trial used to obtain FDA approval has some methodological problems, and the significance of the results has been questioned. The improvement in symptom scores seen with Diclegis was less than one point on a 13-point scale, which is unlikely to be clinically significant (97998). Also, some clinical research shows that taking pyridoxine 25 mg and doxylamine 12.5 mg is less effective than ondansetron 4 mg when taken every 8 hours for 5 days. Only 41% of the patients using pyridoxine and doxylamine had a clinically significant reduction in nausea, compared to 92% of patients using ondansetron (90797). The combination of vitamin B6 and doxylamine is also studied with acupuncture. A large clinical study in patients with moderate to severe pregnancy-induced nausea and vomiting conducted in China shows that taking vitamin B6-doxylamine (Diclegis, Duchesnay, Inc) 20 to 40 mg each at bedtime for 14 days in combination with daily acupuncture modestly improves patient-reported nausea and vomiting scores when compared with either intervention alone (111820). However, it is unclear whether this improvement is clinically significant.
Premenstrual syndrome (PMS). Oral vitamin B6 seems to reduce PMS symptoms. Details: There is some evidence that taking vitamin B6 (pyridoxine) orally can improve symptoms of PMS such as breast pain or tenderness (mastalgia) and depression in some patients. Pyridoxine in doses of at least 50 mg daily, plus magnesium oxide 200 mg daily, seems to relieve PMS-related anxiety and other symptoms (8555,39007,82962). Although some clinicians advocate doses of pyridoxine 200-500 mg daily for PMS, doses of 50-100 mg daily seem to work just as well. There is no apparent dose-response curve for PMS, so the lowest effective dose should be used. Higher doses might increase the risk of side effects (3093).

POSSIBLY INEFFECTIVE

Age-related cognitive decline. Oral vitamin B6 does not seem to slow age-related cognitive decline. Details: One clinical trial in elderly people with memory complaints shows that taking a combination of B vitamins, including folic acid 0.8 mg, vitamin B12 0.5 mg, and vitamin B6 (form not specified) 20 mg daily for 24 months reduces cerebral atrophy in the gray matter regions associated with Alzheimer disease by up to seven-fold when compared with placebo. However, this protection does not occur in patients with the lowest average blood levels of homocysteine (90374). Furthermore, other clinical research shows that taking vitamin B6 (pyridoxine) 3-75 mg daily in combination with folic acid and vitamin B12 does not improve cognitive function in elderly adults (14392,50225,50510).
Alzheimer disease. Oral vitamin B6 does not seem to improve cognitive function in patients with Alzheimer disease when used in combination with other B vitamins. Also, oral vitamin B6 does not seem to reduce the risk of developing this condition. Details: Clinical research in patients with probable Alzheimer disease taking routine medications shows that taking vitamin B6 25 mg with folic acid 5 mg and vitamin B12 1 mg daily for 18 months does not have a beneficial effect on cognitive function or the severity of disease when compared with placebo. In this study, all patients were consuming a folate-fortified diet (50319). Also, population research in elderly adults has found that a high intake of vitamin B6 from dietary or supplemental sources is not associated with a decreased risk of Alzheimer disease when compared to lower vitamin B6 intake (13165,15270).
Carpal tunnel syndrome. Oral vitamin B6 does not seem to reduce symptoms of carpal tunnel syndrome. Details: Most research shows that people with carpal tunnel syndrome are not generally deficient in vitamin B6 and do not benefit from taking vitamin B6 supplements (8203,8937,9448,9450,9478,9482). Although early studies by a single group of researchers, as well as anecdotal reports, suggest that taking vitamin B6 may relieve carpal tunnel symptoms, more reliable research has not supported these findings (8202,9445,9447,9449,9483,15955,83086). Vitamin B6 has also been evaluated in combination with other ingredients. A moderate-sized clinical study in adults with mild to moderate carpal tunnel syndrome shows that taking a combination product containing vitamin B6, alpha-lipoic acid, acetyl-L-carnitine, phosphatidylserine, turmeric, and vitamins C, E, B1, B2, and B12 twice daily for 60 days reduces symptom severity and pain but does not improve measures of hand and wrist function when compared with a control (111702). The dose of vitamin B6 was not provided. The validity of this study is limited by the lack of blinding and placebo. Additionally, it is unclear if the effects are due to vitamin B6, other ingredients, or the combination.
Cataracts. Oral vitamin B6 does not seem to slow cataract development. Details: Clinical research in females with existing cardiovascular disease (CVD) or at increased risk of CVD shows that taking a combination of folic acid 2.5 mg, vitamin B6 (form not specified) 50 mg, and vitamin B12 1 mg daily for an average of 7.3 years does not reduce the risk of cataracts when compared with placebo. Furthermore, the risk of cataract extraction was increased by 28% (96149).
Chemotherapy-induced acral erythema. While some conflicting evidence exists, most research suggests that oral or topical vitamin B6 does not seem to prevent or reduce the severity of acral erythema induced by chemotherapy. Details: A meta-analysis of 10 clinical trials and 4 observational studies shows that taking vitamin B6 60-500 mg daily for up to 8 chemotherapy cycles does not prevent chemotherapy-induced acral erythema or reduce the incidence of severe cases when compared with control. Most studies used capecitabine chemotherapy alone or in combination, and one study used pegylated liposomal doxorubicin; however, no subgroup analysis was conducted to differentiate chemotherapy regimens. Results did not seem to vary based on study location, study design, or vitamin B6 dose (104930). However, a more recent preliminary clinical study in patients receiving doxorubicin for multiple myeloma shows that taking vitamin B6 100 mg on the first day of chemotherapy then twice daily for 7 days with each cycle reduces the risk of developing acral erythema by 72%, but does not improve the severity of acral erythema, when compared with no vitamin B6 supplementation (110458). Also, one small, low-quality clinical study suggests that taking vitamin B6 400 mg daily reduces the risk of moderate or severe chemotherapy-induced acral erythema when compared with vitamin B6 200 mg daily; however, the higher dose also seems to be associated with worsened tumor response and increased treatment failure (97620). Topical vitamin B6 has also failed to show benefit. A small clinical study in patients with acral erythema from capecitabine or pegylated liposomal doxorubicin shows that applying vitamin B6 1% cream to affected areas three times daily for 6 weeks does not improve symptoms when compared with placebo (104929).
Colorectal adenoma. Oral vitamin B6 does not seem to reduce the risk of developing colorectal adenomas. Details: Clinical research shows that taking a combination of B vitamins, including folic acid 2.5 mg, vitamin B6 (pyridoxine) 50 mg, and vitamin B12 1 mg, daily for up to 9.2 years does not reduce the risk of colorectal adenoma in females at high risk of cardiovascular disease when compared with placebo (90389).
Eclampsia. Oral or intramuscular vitamin B6 does not seem to reduce the risk of eclampsia. Details: Meta-analyses of limited clinical research in pregnant patients show that taking vitamin B6 (pyridoxine), either as 25 mg daily or a single dose of 100 mg orally or intramuscularly, does not reduce the risk of eclampsia when compared with control (83046,96166).
Osteoporosis. Oral vitamin B6 does not seem to reduce the risk of osteoporotic fractures. Details: Clinical research in patients with cerebrovascular disease shows that taking a combination of B vitamins, including folic acid 2 mg, vitamin B6 (form not specified) 25 mg, and vitamin B12 500 mcg daily for up to 10.5 years does not prevent osteoporotic fractures when compared with placebo (90377). Furthermore, a secondary analysis of two large studies in patients with cardiovascular disease has found that taking vitamin B6 (pyridoxine) 40 mg daily in addition to folic acid and vitamin B12 for 1-3 years is associated with a 42% increased risk of hip fracture over an 11-year period when compared with only folic acid and vitamin B12 (96163). This finding is limited because these studies were not designed to assess the effects of vitamin B6 on fracture risk and the analyses were not adjusted for baseline bone health or fall risk.
Pre-eclampsia. Oral or intramuscular vitamin B6 does not seem to reduce the risk of pre-eclampsia. Details: Meta-analyses of limited clinical research in pregnant patients show that taking vitamin B6 (pyridoxine), either as 25 mg daily or a single dose of 100 mg orally or intramuscularly, does not reduce the risk of pre-eclampsia when compared with placebo (83046,96166).
Preterm labor. Oral or intramuscular vitamin B6 does not seem to reduce the risk of preterm labor. Details: Meta-analyses of limited clinical research in pregnant patients shows that taking vitamin B6 (pyridoxine), either as 25 mg daily or a single dose of 100 mg orally or intramuscularly, does not reduce the risk of preterm labor when compared with placebo (83046,96166).

INSUFFICIENT RELIABLE EVIDENCE to RATE

Acne. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults and children with inflammatory acne shows that taking 1-4 tablets of a specific product (NicAzel, Elorac Inc.) containing vitamin B6 (pyridoxine), nicotinamide, azelaic acid, zinc, copper, and folic acid for 8 weeks reduces inflammatory lesions and improves appearance in 88% and 81% of patients, respectively, when compared to baseline (90800). The validity of these findings is limited by the lack of a comparator group.
Age-related macular degeneration (AMD). Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large-scale clinical study shows that taking vitamin B6 (pyridoxine) 50 mg, vitamin B12 1000 mcg, and folic acid 2.5 mg daily reduces the risk for AMD in females over 40 years of age with a history of cardiovascular disease (CVD) or with risk factors for CVD. Those who took this combination for an average of 7.3 years had a 34% reduced risk of developing AMD and a 41% reduced risk of visually significant AMD when compared with placebo (14620). It is unclear if this effect is due to vitamin B6, other ingredients, or the combination.
Angioplasty. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some evidence suggests that vitamin B6 (pyridoxine) 10 mg, folic acid 1 mg, and vitamin B12 400 mcg daily can decrease the rate of restenosis in patients treated with balloon angioplasty (8009,9412). However, this combination does not seem to be as effective for reducing restenosis in patients after coronary stenting (8009). An intravenous loading dose of folic acid, vitamin B6 (pyridoxine), and vitamin B12 followed by oral administration of folic acid 1.2 mcg, vitamin B6 (pyridoxine) 48 mg, and vitamin B12 60 mcg daily after bare metal coronary stenting also does not seem to reduce restenosis and might actually increase restenosis (12150,12151). Due to the lack of evidence of benefit and potential for harm, this combination of vitamins should not be recommended for patients receiving coronary stents (12151). It is unclear if any effects are due to vitamin B6, other ingredients, or the combination.
Antipsychotic-induced metabolic side effects. It is unclear if oral vitamin B6, as an adjunct to progesterone, is beneficial in patients with antipsychotic-induced amenorrhea. Details: A small clinical study in females with antipsychotic-induced amenorrhea shows that taking vitamin B6 80 mg three times daily for 1 month plus intramuscular progesterone daily for 5 days increases levels of estradiol and follicle stimulating hormone, reduces prolactin levels, and increases the rate of clinical efficacy, defined as the normalization of menstruation and improvement in endocrine indicators, by 14% when compared with progesterone alone (110457).
Anxiety. It is unclear if oral vitamin B6 is beneficial in patients with anxiety. Details: Clinical research in college students shows that taking vitamin B6 100 mg daily for one month does not reduce anxiety scores when compared with placebo (110453). However, because a diagnosis of anxiety was not a requirement for study participation, it is unclear if these findings can be generalized to patients diagnosed with anxiety.
Asthma. It is unclear if oral vitamin B6 is beneficial in patients with asthma. Details: Preliminary clinical studies show that taking vitamin B6 (pyridoxine) 200-300 mg daily may improve symptoms of asthma in some patients, but not others, when compared with placebo (7064,7065). Studies have yielded conflicting results, with some research suggesting that it may only be beneficial in children with severe asthma (7065). Additionally, some research suggests that theophylline may lower vitamin B6 levels, although it is unclear if vitamin B6 supplementation is beneficial (4522,7066,9503).
Atherosclerosis. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with intermediate risk for coronary heart disease shows that taking a specific supplement (Kyolic, Total Heart Health, Formula 108, Wakunga) containing vitamin B6 12.5 mg, aged garlic extract 250 mg, vitamin B12 100 mcg, folic acid 300 mcg, and L-arginine 100 mg daily for 12 months reduces coronary artery calcium progression when compared with placebo (88385). It is unclear if this effect is due to vitamin B6, other ingredients, or the combination.
Atopic dermatitis (eczema). It is unclear if oral vitamin B6 is beneficial in patients with eczema. Details: A small clinical study in children with eczema shows that taking vitamin B6 (pyridoxine hydrochloride) 50 mg daily for 4 weeks does not reduce symptoms such as redness and itchiness when compared with placebo (83090).
Attention deficit-hyperactivity disorder (ADHD). It is unclear if oral vitamin B6 is beneficial for ADHD. Details: A small crossover study in children with ADHD shows that taking vitamin B6 600 mg, niacinamide and ascorbic acid 3 grams, and calcium pantothenate 1.2 grams daily for 6 weeks does not improve behavior scores when compared with placebo (9957).
Autism spectrum disorder. Although there is interest in using oral vitamin B6 for autism, there is insufficient reliable information about the clinical effects of vitamin B6 for this condition.
Bipolar disorder. It is unclear if oral vitamin B6 is beneficial in patients with bipolar disorder. Details: A small clinical trial in patients with type 1 bipolar disorder who are taking lithium and experiencing an acute episode of mania shows that taking vitamin B6 80 mg daily for 8 weeks does not improve cognitive function or the severity of mania when compared with placebo. Cognitive function was reduced in patients taking vitamin B6; any effect on sleep was unclear (107132).
Cancer. It is unclear if oral vitamin B6 reduces overall cancer risk. Details: Population research has found that higher dietary intake of vitamin B6 is associated with a 22% reduced risk of cancer, including esophageal, pancreatic, gastric, colorectal, and breast cancer. However, when dietary and supplemental vitamin B6 intake is considered, the inverse association between vitamin B6 and cancer risk is weaker and limited to fewer tumor sites. Furthermore, a meta-analysis of 9 clinical studies shows that taking vitamin B6 3-100 mg orally daily for 2-7.3 years, in combination with vitamin B12 and folate, does not reduce the risk of cancer in patients with cardiovascular disease or kidney failure (96164).
Cardiovascular disease (CVD). Oral vitamin B6, taken along with other B vitamins, does not seem to improve secondary prevention of death or myocardial infarction in patients with CVD. However, it might slightly lower the risk of stroke. Details: Overall evidence from clinical research and meta-analyses shows that taking vitamin B6 in combination with folic acid and/or vitamin B12 does not seem to help with secondary prevention of death or myocardial infarction in patients with or at risk for CVD (11387,13482,34540,50423,83050,90379,97619). In fact, some research suggests that long-term supplementation with vitamin B6, folic acid, and vitamin B12 for secondary prevention increases the risk of CVD by 20% despite lowering homocysteine levels by 30% (13482). However, some research shows that taking vitamin B6 in combination with other B vitamins modestly reduces the risk of stroke, although results are conflicting (11387,13482,50423,83050,96150,96165,97619,107136). Additionally, it is unclear which specific combination of B vitamins is optimal for reducing stroke risk and which patients are most likely to benefit. In 2001, prior to the publication of the highest quality research on this topic, the US Food and Drug Administration (FDA) approved a qualified health claim stating that, as part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6, and vitamin B12 may reduce the risk of vascular disease (102368).
Cognitive function. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study in healthy adults aged 40-65 years shows that taking a supplement containing vitamin B6, ginkgo leaf, bacopa, and other B vitamins twice daily for 12 weeks does not improve memory or attention when compared with placebo (111334).
Colorectal cancer. It is unclear if oral vitamin B6 reduces the risk of colorectal cancer. Details: A meta-analysis of observational studies suggests that the highest dietary intake of vitamin B6 is associated with a 20% reduced risk of colorectal cancer when compared with the lowest dietary intake. However, this association was not shown in subgroup analyses of studies conducted in Australia, Europe, or North America (111600). The validity of this analysis is limited by the heterogeneity of the included studies.
Dental caries. There is limited evidence on the oral use of vitamin B6 for dental decay during pregnancy. Details: Meta-analyses of limited clinical research show that taking vitamin B6 (pyridoxine), 25 mg daily or a single dose of 100 mg orally or intramuscularly, may reduce the risk of dental decay during pregnancy when compared with placebo (83046,96166).
Depression. It is unclear if oral vitamin B6 reduces the risk of developing depression or improves symptoms of depression. Details: Clinical research in healthy college students shows that taking vitamin B6 100 mg daily for one month does not reduce depression scores when compared with placebo (1104453). However, because a diagnosis of depression was not a requirement for study participation, it is unclear if these findings can be generalized to patients diagnosed with depression. Whether vitamin B6 reduces the risk of developing depression is also unclear. A meta-analysis of population research has found that the highest dietary intake of vitamin B6 is associated with a 19% lower risk of depression when compared with the lowest intake. However, sub-analyses suggest that this association is only relevant in females and not males (107133). In one individual population study in community dwelling older adults included in the analysis, the consumption of at least 1.71 mg of vitamin B6 daily from food was associated with a 43% reduction in the likelihood of becoming depressed when compared with the consumption of 1.33 mg or less daily in females. However, there was no association between vitamin B6 levels and risk of depression in males, and the finding in females was no longer significant when adjusted for total energy intake, since foods rich in vitamin B6 are energy-dense (96168). Another observational longitudinal study in healthy adults starting oral contraceptives containing ethinyl estradiol and levonorgestrel has found that taking vitamin B6 25 mg daily for 6-12 months is associated with a 40% lower risk of depression when compared with no supplementation (90789). Most available studies are cross-sectional in nature, making any conclusions related to causation difficult.
Diabetes. It is unclear if oral vitamin B6 is beneficial in patients with type 2 diabetes or gestational diabetes. Details: Observational research in Chinese adults with type 2 diabetes has found that dietary intake of vitamin B6 in the highest quartile is associated with 53% lower odds of developing cardiovascular disease, defined as a non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina, when compared with vitamin B6 intake in the lowest quartile (110452). Small clinical studies in patients with gestational diabetes and vitamin B6 deficiency shows that taking vitamin B6 (pyridoxine) 100 mg daily for 2 weeks improves glucose tolerance and blood glucose levels when compared with baseline (82967,83088). However, there is concern that these findings were confounded by dietary alterations. This benefit was not observed in a subsequent small case series in patients with gestational diabetes (22380).
Diabetic neuropathy. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research suggests that taking a combination of B vitamins, including folic acid (L-methylfolate), vitamin B12 (methylcobalamin), and vitamin B6 (pyridoxal-5'-phosphate) for 24 weeks does not improve neural dysfunction based on vibration perception when compared with placebo in patients with diabetic neuropathy. However, taking this combination appears to modestly improve neuropathy symptoms and quality of life related to mental functioning when compared with placebo (90375).
Dysmenorrhea. It is unclear if oral vitamin B6 is beneficial in patients with dysmenorrhea. Details: Preliminary clinical research shows that taking vitamin B6 (form not specified) 200 mg daily reduces pain associated with dysmenorrhea when compared with placebo. However, taking vitamin B6 in combination with magnesium does not reduce pain when compared with placebo (77388).
Fibromyalgia. It is unclear if oral vitamin B6 is beneficial in patients with fibromyalgia. Details: A small clinical study in patients with fibromyalgia shows that taking vitamin B6 80 mg daily for 8 weeks does not improve pain, disease severity, anxiety, depression, or quality of life when compared with placebo (110454).
Gastroenteritis-associated nausea and vomiting. It is unclear if oral vitamin B6 is beneficial in children with gastroenteritis. Details: A small clinical study in children aged 6 months to 12 years with acute viral gastroenteritis shows that taking vitamin B6 (form not specified) does not improve symptoms of dehydration or the frequency of vomiting when compared with placebo (90793).
Helicobacter pylori. It is unclear if oral vitamin B6 is beneficial for Helicobacter pylori. Details: A large clinical study in adults with Helicobacter pylori infection shows that taking vitamin B6 20 mg twice daily for 2 weeks alongside conventional quadruple therapy does not improve eradication rates when compared with a control group not receiving vitamin B6 (113551). Conventional therapy consisted of a proton pump inhibitor, bismuth, minocycline, and metronidazole. The validity of this study is limited by the lack of placebo and inadequate blinding.
Hypertension. It is unclear if oral vitamin B6 reduces blood pressure. Details: One small clinical study in patients with essential hypertension shows that taking vitamin B6 (pyridoxine hydrochloride) 5 mg/kg daily for 4 weeks can reduce systolic and diastolic blood pressure when compared with baseline (83091). The validity of this finding is limited by the lack of a control group.
Hypertriglyceridemia. It is unclear if oral vitamin B6 reduces triglyceride levels. Details: Preliminary clinical research shows that vitamin B6 (form not specified) 50 mg daily for 12 weeks does not reduce triglyceride levels in people with hypertriglyceridemia when compared with placebo. However, vitamin B6 appears to decrease total cholesterol and high-density lipoprotein (HDL) cholesterol by approximately 9% in these patients (59028).
Infertility. Although there is interest in using oral vitamin B6 for infertility, there is insufficient reliable information about the clinical effects of vitamin B6 for this condition.
Insomnia. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in healthy adults with self-reported sleep difficulty shows that taking a specific product (LZ Complex3, Sanofi Consumer Healthcare Pty Ltd.) containing vitamin B6, zizyphus extract, hops extract, hydrolyzed milk protein (Lactium), and magnesium oxide nightly, 30 minutes before bed, for 2 weeks does not improve sleep quality, daytime functioning, or physical fatigue when compared with placebo. However, due to the large improvement seen in both the treatment and placebo groups, the effectiveness of this product is unclear (95971).
Isoniazid-induced neuropathy. It is unclear if oral vitamin B6 prevents the development of neuropathy in patients taking isoniazid. Details: Preliminary clinical research in patients taking isoniazid for tuberculosis shows that taking vitamin B6 (pyridoxine) 6 mg daily reduces the development of neuropathy when compared with control (83068).
Lactation. It is unclear if oral vitamin B6 helps to suppress postpartum lactation. Details: A meta-analysis of two small clinical trials shows that taking vitamin B6 (pyridoxine) 400-600 mg daily for 6-7 days postpartum does not suppress lactation when compared with no treatment (83047).
Levetiracetam-induced side effects. While some conflicting evidence exists, several small, low-quality studies suggest that oral vitamin B6 (pyridoxine) may reduce some neuropsychiatric adverse effects related to the use of levetiracetam. Details: In an analysis of case reports, retrospective studies, and a single low-quality prospective study, improvement in levetiracetam-associated neuropsychiatric symptoms occurred in approximately 73% of patients taking pyridoxine (107137). A more recent preliminary clinical trial in children ages 1-17 years shows that taking pyridoxine 10 or 15 mg/kg daily as needed based on symptoms improves behavioral side effects associated with levetiracetam by a small amount when compared with low-dose pyridoxine 0.5 mg/kg daily used as placebo (107124). Also, observational research in children ages 9 months to 14 years has found that taking vitamin B6 is associated with improved behavior and a 44% lower risk of levetiracetam discontinuation when compared with no vitamin B6 supplementation (110455). Some observational research in adults with levetiracetam-associated irritability has found that taking vitamin B6 is associated with an improvement in irritability in 45% of patients when compared to baseline (107129). However, a small clinical trial in adults with epilepsy shows that taking pyridoxine 40 mg daily for 3 weeks does not improve levetiracetam-related psychiatric adverse effects when compared with placebo (110456). This study may have been underpowered to detect differences between groups. Pyridoxine doses used in the studies above have ranged from 50-400 mg daily in children and 40-600 mg daily in adults (107124,107129,107137,110456).
Lung cancer. It is unclear if dietary or oral vitamin B6 reduces lung cancer risk. Details: Epidemiological research has found that higher serum levels of vitamin B6 in male smokers is associated with a lower risk of lung cancer (9454). Also, people with blood levels of vitamin B6 in the top quartile have a modestly lower risk of lung cancer when compared with those whose levels are in the lowest quartile. The association is stronger for males and for people who have smoked (97999). However, other epidemiological research found that increased dietary intake of vitamin B6 is not associated with a reduced risk of lung cancer (96164).
Menopausal symptoms. Although there is interest in using oral vitamin B6 for menopausal symptoms, there is insufficient reliable information about the clinical effects of vitamin B6 for this condition.
Motion sickness. Although there is interest in using oral vitamin B6 for motion sickness, there is insufficient reliable information about the clinical effects of vitamin B6 for this condition.
Nausea and vomiting. It is unclear if oral vitamin B6 is beneficial for nausea and vomiting in patients taking oral contraceptives or antibiotics for Helicobacter pylori. Details: A large clinical study in adults with Helicobacter pylori infection shows that taking vitamin B6 20 mg twice daily for 2 weeks alongside conventional quadruple therapy reduces the incidence and severity of gastrointestinal adverse effects when compared with a control group not receiving vitamin B6 (113551). Conventional therapy consisted of a proton pump inhibitor, bismuth, minocycline, and metronidazole. The validity of this study is limited by the lack of placebo and inadequate blinding. An observational longitudinal study in healthy females taking oral contraceptives containing ethinyl estradiol and levonorgestrel has found that taking vitamin B6 25 mg daily for 6-12 months is associated with a 43% reduced risk of nausea when compared with no supplementation (90789).
Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral vitamin B6 for patients with NAFLD. Details: A small clinical trial in patients with NAFLD shows that taking vitamin B6 (pyridoxine) 30 mg three times daily for 12 weeks does not reduce levels of liver transaminases or plasma lipids when compared with baseline. However, hepatic fat accumulation was modestly reduced (107130). The validity of this study is limited by the lack of a comparator group.
Obesity. It is unclear if oral vitamin B6 in beneficial in overweight or obese individuals. Details: A small clinical trial in females with a body mass index (BMI) of at least 25 kg/m² shows that taking vitamin B6 as pyridoxine 80 mg daily for 8 weeks reduces fat mass and improves insulin resistance and triglyceride levels by a small amount when compared with placebo. Although some other anthropometric and metabolic indices were improved when compared with baseline, there was no effect of pyridoxine on body weight, visceral adiposity, or other endpoints when compared with placebo (107131).
Overall mortality. It is unclear if oral vitamin B6 reduces the risk of overall mortality. Details: Observational research in US adults has found that dietary intake of vitamin B6 in the highest quintile is associated with a 12% to 21% lower risk of all-cause mortality and a 31% to 44% lower risk of cardiovascular mortality when compared with the lowest quintile of dietary vitamin B6 intake (110451).
Pancreatic cancer. It is unclear if oral vitamin B6 reduces the risk of pancreatic cancer. Details: Observational research has found that higher dietary intake of vitamin B6 is associated with a 37% lower risk of developing pancreatic cancer when compared with lower intake (104927).
Postpartum depression. It is unclear if oral vitamin B6 is beneficial in patients with postpartum depression. Details: Preliminary clinical research in individuals considered at increased risk for postpartum depression, but without clinical depression, shows that taking vitamin B6 80 mg daily from the 28th week of pregnancy until birth, and then 40 mg daily for one month, reduces symptoms of depression 1.5 months after birth when compared with baseline (measured during the third trimester) and when compared with placebo. However, it is unclear if any of the patients included in the study developed postpartum depression, as there were no changes in overall symptoms in patients taking placebo (107126).
Proton pump inhibitor-induced gastrointestinal (GI) symptoms. It is unclear if oral vitamin B6 is beneficial for proton pump inhibitor-induced GI symptoms. Details: A large clinical study in adults with Helicobacter pylori infection shows that taking vitamin B6 20 mg twice daily for 2 weeks alongside conventional quadruple therapy reduces the incidence and severity of gastrointestinal adverse effects when compared with a control group not receiving vitamin B6 (113551). Conventional therapy consisted of a proton pump inhibitor, bismuth, minocycline, and metronidazole. The validity of this study is limited by the lack of placebo and inadequate blinding.
Restless legs syndrome (RLS). It is unclear if oral vitamin B6 is beneficial in patients with RLS. Details: A small clinical study in adults with RLS who are beginning treatment with pramipexole shows that also taking vitamin B6 40 mg daily for 2 months moderately improves RLS scores and sleep quality scores when compared with pramipexole and placebo (110052).
Schizophrenia. It is unclear if oral vitamin B6 is beneficial for patients with treatment-resistant schizophrenia. Details: Clinical research in male patients with treatment-resistant schizophrenia who are on a consistent antipsychotic dose shows that adding vitamin B6 300 mg twice daily for 16 weeks modestly improves psychotic symptoms and some measures of cognitive performance when compared with adding aripiprazole 5 mg twice daily (107128). More research is needed to determine if these benefits are clinically relevant.
Seizures. It is unclear if oral vitamin B6 is beneficial for preventing seizures in patients with glycosylphosphatidylinositol (GPI) deficiency. Details: Observational case series in a small number of children and young adults with GPI deficiency has found that taking vitamin B6 20-30 mg/kg daily for 3-12 months is associated with some reduction in seizure frequency in 9 of 13 patients. However, no patient reached seizure freedom (107125,107135). In one case series, treatment for 12 months was associated with modest developmental improvements in almost all patients (107135). The study patient populations were slightly different in terms of age and underlying genetic causes for GPI deficiency.
Sickle cell disease. Oral vitamin B6 has only been evaluated in combination with other B vitamins; its effect when used alone is unclear. Details: Preliminary clinical research in adults with sickle cell disease shows that taking vitamin B6 4.2-6 mg, vitamin B12 4.2-6 mcg, and folic acid 700 mcg daily might lower homocysteine levels. However, it is unknown if this will reduce the risk of endothelial damage in these patients (9324).
Stroke. It is unclear if oral vitamin B6, either alone or with other B vitamins, is beneficial for stroke prevention. Details: There is some debate about whether supplementation with homocysteine-lowering B vitamins, including vitamin B6, can reduce the risk of stroke. A number of clinical studies and meta-analyses show that supplementation with folic acid, vitamin B6, and vitamin B12, alone or in combination, does not reduce the risk of stroke in patients with cardiovascular disease (CVD) or impaired kidney function (11387,13482,50423,83050,96150). However, a more recent meta-analysis of 10 clinical trials, including over 44,000 patients at risk for or with a history of CVD, shows that B vitamin supplementation reduces the relative risk of stroke by 10% when compared with placebo (97619). This meta-analysis differed from some of the earlier analyses due to the inclusion of several additional clinical trials. Also, another meta-analysis of three clinical trials including 9900 patients with a history of stroke shows that B vitamin supplementation reduces the relative risk of stroke recurrence by 13% when compared with placebo, although this finding was determined to have a low level of certainty. Based on two clinical trials, there was also a 17% reduced risk of vascular death and an 11% reduction in the combined risk of stroke, myocardial infarction, and vascular death (107136). In 2001, prior to the publication of the highest quality research on this topic, the US Food and Drug Administration (FDA) allowed a qualified health claim stating that, as part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6, and vitamin B12 may reduce the risk of vascular disease (102368). Unfortunately, even after the publication of higher quality research, it is still unclear which specific combination of B vitamins is optimal and which patients are most likely to benefit. One network meta-analysis shows that a combination of folic acid and vitamin B6 lowers the risk of stroke more effectively than B vitamin mixtures that include vitamin B12 (96165). However, this analysis is limited because it didn't account for dosing. Exposure to low, but not high amounts, of vitamin B12 (cyanocobalamin) seems to reduce stroke risk (96150).
Tardive dyskinesia. It is unclear if oral vitamin B6 prevents tardive dyskinesia in patients taking neuroleptic drugs. Details: A small clinical study in patients taking neuroleptic drugs for schizophrenia shows that taking vitamin B6 (form not specified) 400 mg daily seems to improve Parkinsonian, dystonic, and dyskinetic symptoms when compared with placebo (8558).
Tourette syndrome. Oral vitamin B6 has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, nonblinded clinical study in children aged 4-17 years with untreated Tourette syndrome or with chronic tic disorder and associated symptoms of anxiety shows that taking a liquid nutritional supplement providing vitamin B6 2.8 mg and L-theanine 200 mg daily for 2 months improves scores on the Yale Global Tic Severity Scale, but does not reduce anxiety, when compared with patients receiving psychoeducation (108555). This study may have been inadequately powered to detect a difference between groups.
Vincristine-induced neuropathy. Oral vitamin B6 has only been evaluated in combination with pyridostigmine; its effect when used alone is unclear. Details: A small clinical study in children ages 11 months to 13 years with neuropathy due to vincristine treatment for acute lymphoblastic leukemia, shows that taking vitamin B6 150 mg/m2 and pyridostigmine 3 mg/kg twice daily for 3 months is associated with reduced severity of sensory and motor neuropathy when compared with baseline (104928). The validity of this finding is limited by the lack of a control group. More evidence is needed to rate vitamin B6 for these uses.

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Safety view details

Below is general information about the safety of the known ingredients contained in the product The Fat Transporter. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETAINE HYDROCHLORIDE (Betaine HCl)

POSSIBLY SAFE ...when taken orally as a single dose of up to 1500 mg (93328,93329). There is insufficient reliable information available about the safety of betaine hydrochloride when used in multiple doses.

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

CHOLINE

LIKELY SAFE ...when used orally and appropriately. Choline is safe in adults when taken in doses below the tolerable upper intake level (UL) of 3.5 grams daily (3094) ...when used intravenously and appropriately. Intravenous choline 1-4 grams daily for up to 24 weeks has been used with apparent safety (5173,5174).

POSSIBLY UNSAFE ...when used orally in doses above the tolerable upper intake level (UL) of 3. 5 grams daily. Higher doses can increase the risk of adverse effects (3094).

CHILDREN: LIKELY SAFE
when used orally and appropriately (3094). Choline is safe in children when taken in doses below the tolerable upper intake level (UL), which is 1 gram daily for children 1-8 years of age, 2 grams daily for children 9-13 years of age, and 3 grams daily for children 14-18 years of age (3094).

CHILDREN: POSSIBLY UNSAFE
when used orally in doses above the UL. High doses can increase the risk of adverse effects (3094).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately. Choline is safe when taken in doses below the tolerable upper intake level (UL), which is 3 grams daily during pregnancy and lactation in those up to 18 years of age and 3.5 grams daily for those 19 years and older (3094,92114). There is insufficient reliable information available about the safety of choline used in higher doses during pregnancy and lactation.

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EUROPEAN BARBERRY (Barberry)

LIKELY SAFE ...when the fruit is consumed orally in food amounts (13527). There is insufficient reliable information available about the safety of European barberry when used orally in medicinal amounts or when used topically.

CHILDREN: LIKELY UNSAFE
when used orally in newborns. The berberine constituent of European barberry can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589). There is insufficient reliable information available about the safety of European barberry when used orally in older children.

PREGNANCY: LIKELY UNSAFE
when used orally. Berberine is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to berberine (2589).

LACTATION: LIKELY UNSAFE
when used orally. Berberine and other harmful constituents can be transferred to the infant through breast milk (2589).

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INOSITOL

POSSIBLY SAFE ...when used orally and appropriately, short-term. Inositol has been used with apparent safety in doses up to 18 grams daily for up to 6 weeks or 6 grams daily for 10 weeks (2184,2185,2187,95089). Myo-inositol 4 grams daily has also been used with apparent safety for 6 months (95085). There is insufficient reliable information available about the safety of inositol when used topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. Inositol 80 mg/kg (maximum 2 grams) has been taken daily for up to 12 weeks in children aged 5-12 years (95092). ...when used enterally or intravenously and appropriately in premature infants for treating acute respiratory distress syndrome for up to 10 days (2191,2192,91546,91551).

CHILDREN: POSSIBLY UNSAFE
when used enterally or intravenously for extended durations in premature infants. A large clinical study in infants born at less than 28 weeks' gestation found that myo-inositol 40 mg/kg, given intravenously and then enterally every 12 hours for up to 10 weeks, was associated with a small increased risk of death (98946). Long-term follow-up until 24 months corrected age confirms that the initial increase in mortality rate in the myo-inositol group remained stable; however, there was no difference in a composite outcome of death or survival with moderate or severe neurodevelopmental impairment, as well as no difference in the risk of retinopathy of prematurity, between those who received myo-inositol or control (108819).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately, short-term. Myo-inositol has been used with apparent safety in amounts up to 4000 mg daily during pregnancy (91548,95082,104688).

LACTATION:
Insufficient reliable information available; avoid using. Breast milk is rich in endogenous inositol (2138); however, the effects of exogenously administered inositol are not known.

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METHIONINE (L-Methionine)

LIKELY SAFE ...when used orally in amounts commonly found in food (94500).

POSSIBLY SAFE ...when used orally or intravenously and appropriately in medicinal amounts under the supervision of a healthcare professional (2410,2411,2413).

POSSIBLY UNSAFE ...when used orally or intravenously in excessive doses. Doses larger than 100 mg/kg should be avoided to prevent severe and potentially lethal cerebral effects (9339).

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods (94500).

CHILDREN: POSSIBLY SAFE
when used intravenously and appropriately (9338).

CHILDREN: POSSIBLY UNSAFE
when used intravenously in infants receiving parenteral nutrition. In infants, blood methionine concentration can increase due to lower enzyme activity and inability to metabolize methionine. High levels of methionine can cause liver toxicity (9338).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in food (94500). There is insufficient reliable information available about the safety of methionine in medical doses during pregnancy and lactation; avoid using.

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TAURINE

LIKELY SAFE ...when used in amounts found in foods. Typical daily intakes for adults range from 40-400 mg (101471).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Taurine 2-4 grams daily in two or three divided doses has been used safely in studies lasting up to 3 months (5248,5271,8217,8221,10454,77147,95612,98337,104165,104167). Higher doses of taurine 6 grams daily have been used safely in studies lasting up to 4 weeks (98336,98337). A risk assessment of orally administered taurine has identified an Observed Safe Level (OSL) of up to 3 grams daily for healthy adults (31996).

CHILDREN: LIKELY SAFE
when used in amounts found in foods.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in medicinal amounts. Taurine 2.4-4.8 grams daily in three divided doses has been safely used in children 6-16 years of age for up to 12 weeks (103210).

PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts found in foods. There is insufficient reliable information available about the safety of taurine when used in medicinal amounts during pregnancy and lactation; avoid using.

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VITAMIN B6

LIKELY SAFE ...when used orally and appropriately in doses that do not exceed the tolerable upper intake level (UL) of 100 mg daily in the form of pyridoxine for adults (15,6243). ...when used parenterally and appropriately. Injectable vitamin B6 (pyridoxine) is an FDA-approved prescription product (15).

POSSIBLY SAFE ...when used orally and appropriately in doses of 101-200 mg daily (6243,8558).

POSSIBLY UNSAFE ...when used orally in doses at or above 500 mg daily. High doses, especially those exceeding 1000 mg daily or total doses of 1000 grams or more, pose the most risk. However, neuropathy can occur with lower daily or total doses (6243,8195). ...when used intramuscularly in high doses and frequency due to potential for rhabdomyolysis (90795).

CHILDREN: LIKELY SAFE
when used orally and appropriately in doses that do not exceed the tolerable upper intake level (UL) of vitamin B6 in the form of pyridoxine 30 mg daily for children aged 1-3 years, 40 mg daily for 4-8 years, 60 mg daily for 9-13 years, and 80 mg daily for 14-18 years (6243).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in amounts exceeding the recommended dietary allowance (5049,8579,107124,107125,107135).

CHILDREN: POSSIBLY UNSAFE
when used orally in excessive doses, long-term (6243).

PREGNANCY: LIKELY SAFE
when used orally and appropriately. A special sustained-release product providing vitamin B6 (pyridoxine) 75 mg daily is FDA-approved for use in pregnancy. Vitamin B6 (pyridoxine) is also considered a first-line treatment for nausea and vomiting in pregnancy by the American College of Obstetrics and Gynecology (111601). However, it should not be used long-term or without medical supervision and close monitoring. The tolerable upper intake level (UL) refers to vitamin B6 in the form of pyridoxine and is 80 mg daily for those aged 14-18 years and 100 mg daily for 19 years and older (6243).

PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive doses. There is some concern that high-dose maternal vitamin B6 (pyridoxine) can cause neonatal seizures (4609,6397,8197).

LACTATION: LIKELY SAFE
when used orally in doses not exceeding the tolerable upper intake level (UL) of vitamin B6 in the form of pyridoxine 80 mg daily for those aged 14-18 years and 100 mg daily for those 19 years and older. The recommended dietary allowance (RDA) in lactating women is 2 mg daily (6243). There is insufficient reliable information available about the safety of vitamin B6 when used in higher doses in breast-feeding women.

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Interactions with Drugs view details

Below is general information about the interactions of the known ingredients contained in the product The Fat Transporter. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETAINE HYDROCHLORIDE (Betaine HCl)

ANTACIDS

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Betaine hydrochloride increases stomach acidity and could decrease the effects of antacids.

Details

In human research, betaine hydrochloride increases stomach acidity (93328,93329). Antacids are taken to decrease stomach acidity. Theoretically, taking betaine hydrochloride along with antacids might decrease the effects of the antacids.

H2-BLOCKERS

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Betaine hydrochloride increases stomach acidity and could decrease the effects of H2-blockers.

Details

In human research, betaine hydrochloride increases stomach acidity (93328,93329). H2-blockers are used to decrease stomach acidity. Theoretically, taking betaine hydrochloride along with H2-blockers might decrease the effects of H2-blockers.

PROTON PUMP INHIBITORS (PPIs)

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Betaine hydrochloride increases stomach acidity and could decrease the effects of PPIs.

Details

In human research, betaine hydrochloride increases stomach acidity (93328,93329). PPIs are used to decrease stomach acidity. Theoretically, taking betaine hydrochloride along with PPIs might decrease the effects of PPIs

CHOLINE

ATROPINE

Interaction Rating = Minor Be watchful with this combination.

Severity = Mild • Occurrence = Possible • Level of Evidence = D

Theoretically, choline might decrease the effects of atropine in the brain.

Details

Animal research shows that administering choline one hour before administering atropine can attenuate atropine-induced decreases in brain levels of acetylcholine (42240). Theoretically, concomitant use of choline and atropine may decrease the effects of atropine.

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EUROPEAN BARBERRY (Barberry)

ANTICHOLINERGIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, taking European barberry with anticholinergic drugs might cause additive effects.

Details

In vitro evidence suggests that European barberry might have anticholinergic properties (13527).

ANTICOAGULANT/ANTIPLATELET DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, European barberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.

Details

In vitro and animal evidence suggest that berberine, a constituent of European barberry, might inhibit platelet aggregation (33591,33660,33661,33694). Theoretically, European barberry might have a similar effect.

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, taking European barberry with antidiabetes drugs might increase the risk of hypoglycemia.

Details

Preliminary clinical evidence suggests that European barberry juice reduces fasting glucose levels in patients with type 2 diabetes who are also taking antidiabetes drugs (98575). Additionally, some animal studies show that berberine, a constituent of European barberry, has antiglycemic potential (33622,33667). Monitor blood glucose levels closely.

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, taking European barberry with antihypertensive drugs might increase the risk of hypotension.

Details

Animal and human research suggests that European barberry extracts can have hypotensive effects (13528,33604,98575).

CHOLINERGIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, taking European barberry with cholinergic drugs might decrease the effects of cholinergic drugs.

Details

In vitro evidence suggests that European barberry might have anticholinergic properties (13527).

CNS DEPRESSANTS

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, concomitant use with drugs that have sedative properties may cause additive effects.

Details

Animal research suggests that berberine, a constituent of European barberry, might have sedative effects (33650,33692). Theoretically, European barberry might have a similar effect.

CYCLOSPORINE (Neoral, Sandimmune)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

Theoretically, concomitant use with cyclosporine may cause additive effects.

Details

Berberine, a constituent of European barberry, can reduce the metabolism and increase serum levels of cyclosporine. This effect is attributed to the ability of berberine to inhibit cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524). Theoretically, European barberry might have a similar effect.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = D

Theoretically, European barberry might increase the levels and clinical effects of CYP3A4 substrates.

Details

There is very preliminary evidence suggesting that berberine, a constituent of European barberry, might inhibit the CYP3A4 enzyme (13524). Theoretically, European barberry might have a similar effect.

(Read more about EUROPEAN BARBERRY)

INOSITOL

ANTIDIABETES DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = A

Theoretically, taking inositol with antidiabetes drugs might increase the risk of hypoglycemia.

Details

Clinical research shows that inositol lowers blood glucose levels and glycated hemoglobin (HbA1c) levels in patients with diabetes (95083,95084,95088).

(Read more about INOSITOL)

METHIONINE (L-Methionine)

None known.

(Read more about METHIONINE)

TAURINE

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taurine might increase the risk of hypotension when taken with antihypertensive drugs.

Details

Some clinical evidence suggests that taurine can reduce both systolic and diastolic blood pressure (77229,95614,104166).

LITHIUM

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taurine might reduce excretion and increase plasma levels of lithium.

Details

Taurine is thought to have diuretic properties (3647), which might reduce the excretion of lithium.

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VITAMIN B6

AMIODARONE (Cordarone)

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, vitamin B6 might increase the photosensitivity caused by amiodarone.

Details

Despite initial case reports suggesting that pyridoxine may have a protective effect against amiodarone-induced photosensitivity, preliminary clinical research suggests that pyridoxine may actually exacerbate this adverse effect (8892,8893).

ANTIHYPERTENSIVE DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Possible • Level of Evidence = B

Theoretically, vitamin B6 may have additive effects when used with antihypertensive drugs.

Details

Research in hypertensive rats shows that vitamin B6 can decrease systolic blood pressure (30859,82959,83093). Similarly, clinical research in patients with hypertension shows that taking high doses of vitamin B6 may reduce systolic and diastolic blood pressure, possibly by reducing plasma levels of epinephrine and norepinephrine (83091).

LEVODOPA

Interaction Rating = Minor Be watchful with this combination.

Severity = Moderate • Occurrence = Unlikely • Level of Evidence = D

Vitamin B6 may increase the metabolism of levodopa when taken alone, but not when taken in conjunction with carbidopa.

Details

Vitamin B6 (pyridoxine) enhances the metabolism of levodopa, reducing its clinical effects. However, this interaction does not occur when carbidopa is used concurrently with levodopa (Sinemet). Therefore, it is not likely to be a problem in most people (3046).

PHENOBARBITAL (Luminal)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

High doses of vitamin B6 may reduce the levels and clinical effects of phenobarbital.

Details

Preliminary clinical evidence suggests that vitamin B6 200 mg daily can reduce plasma levels of phenobarbital, possibly by increasing metabolism. It is not known whether lower doses have any effect. Advise people taking phenobarbital to avoid high doses of vitamin B6 (3046,10801).

PHENYTOIN (Dilantin)

Interaction Rating = Moderate Be cautious with this combination.

Severity = High • Occurrence = Possible • Level of Evidence = D

High doses of vitamin B6 may reduce the levels and clinical effects of phenytoin.

Details

Preliminary clinical evidence suggests that vitamin B6 200 mg daily can reduce plasma levels of phenytoin, possibly by increasing metabolism. It is not known whether lower doses have any effect. Advise people taking phenytoin to avoid high doses of vitamin B6 (3046,10801).

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Adverse Effects view details

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Below is general information about the adverse effects of the known ingredients contained in the product The Fat Transporter. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BETAINE HYDROCHLORIDE (Betaine HCl)

General ...Orally, betaine hydrochloride is generally well tolerated when taken as a single dose.

Gastrointestinal ...Theoretically, the hydrochloric acid produced from betaine hydrochloride might irritate gastric or duodenal ulcers or impede ulcer healing. It might also cause heartburn.

CHOLINE

General ...Orally, choline is well tolerated when used appropriately. Adverse effects have been reported with doses exceeding the tolerable upper intake level (UL) of 3.5 grams daily.
Most Common Adverse Effects:
Orally: Fishy body odor. At high doses of at least 9 grams daily, choline has been reported to cause diarrhea, nausea, salivation, sweating, and vomiting.

Cardiovascular ...Orally, doses of choline greater than 7. 5 grams daily may cause low blood pressure (94648).

Gastrointestinal ...Orally, large doses of choline can cause nausea, vomiting, salivation, and anorexia (42275,91231). Gastrointestinal discomfort has reportedly occurred with doses of 9 grams daily, while gastroenteritis has reportedly occurred with doses of 32 grams daily (42291,42310). Doses of lecithin 100 grams standardized to 3.5% choline have reportedly caused diarrhea and fecal incontinence (42312).

Genitourinary ...Orally, large doses of choline greater than 9 grams daily have been reported to cause urinary incontinence (42291).

Neurologic/CNS ...Orally, high intake of choline may cause sweating due to peripheral cholinergic effects (42275).

Oncologic ...In one population study, consuming large amounts of choline was associated with an increased risk of colorectal cancer in females, even after adjusting for red meat intake (14845). However, more research is needed to confirm this finding.

Psychiatric ...Orally, large doses of choline (9 grams daily) have been associated with onset of depression in patients taking neuroleptics. Further research is needed to clarify this finding (42270).

Other ...Orally, choline intake may cause a fishy body odor due to intestinal metabolism of choline to trimethylamine (42285,42275,42310,92111,92112).

(Read more about CHOLINE)

EUROPEAN BARBERRY (Barberry)

General ...European barberry is generally well tolerated when consumed in amounts commonly found in food. A thorough evaluation of safety outcomes has not been conducted for the use of larger, medicinal amounts. Topically, European barberry seems to be well tolerated.

Hepatic ...Orally, a case of hepatitis-associated aplastic anemia is reported in an adult male after consuming European barberry 15 drops and nannari root 15 drops twice a day for 2 weeks. The patient presented with lethargy, loss of appetite, and jaundice that progressed to high-grade fevers, chills, rigors, severe pancytopenia, and abnormal liver function tests. Liver biopsy was suggestive of drug-induced liver injury. The patient was hospitalized for multiple infections and symptomatic thrombocytopenia. Despite receiving supportive care, blood transfusions, and corticosteroids, the patient died 7 weeks after diagnosis (110021). The exact reason for this adverse effect is not clear.

(Read more about EUROPEAN BARBERRY)

INOSITOL

General ...Orally and intravenously, inositol seems to be well tolerated. Topically, no adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gas, and nausea.

Gastrointestinal ...Orally, inositol may cause nausea, diarrhea, gas, and gastrointestinal discomfort (10387,11972,91547,91549,95089,95090,95092).

Immunologic ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of cold and allergy symptoms in children in clinical research (95092).

Musculoskeletal ...Orally, inositol in combination with omega-3 fatty acids has been associated with reports of tics and other musculoskeletal side effects in children in clinical research (95092).

Neurologic/CNS ...Orally, inositol may cause dizziness, tiredness, insomnia, agitation, and headache (10387,11972,95089,95092). In combination with omega-3 fatty acids, inositol has been associated with reports of feelings of thirst in children in clinical research (95092).

Psychiatric ...In one case report, a 36-year-old male with adequately controlled bipolar disorder was hospitalized with symptoms of mania after consuming several cans of an energy drink containing inositol, caffeine, taurine, and other ingredients (Red Bull Energy Drink) over a period of 4 days (14302). It is not known if this is related to inositol, caffeine, taurine, a different ingredient, or a combination of the ingredients.

(Read more about INOSITOL)

METHIONINE (L-Methionine)

General ...Orally, methionine is well tolerated when used in amounts commonly found in foods. Intravenously, methionine is generally well tolerated.
Most Common Adverse Effects:
All ROAs: Dizziness, drowsiness, hypotension, irritability, and vomiting. Methionine may also cause headache, increased homocysteine levels, increased urinary calcium excretion, and leukocytosis.
Serious Adverse Effects (Rare):
All ROAs: Cerebral edema, hepatic encephalopathy. In infants, intravenous methionine has been linked to liver toxicity.

Cardiovascular ...Orally or intravenously, methionine can cause hypotension (9339,9340). High-dose methionine (75-100 mg/kg daily) may increase plasma concentrations of homocysteine, which is a risk factor for vascular disease (63112,63114,63115). However, a study of patients with type 2 diabetes and a history of cardiovascular disease (CVD) showed that methionine loading did not increase homocysteine concentrations, and that a cause-effect relationship between increased intake of methionine and endothelial dysfunction has not been clearly established (63110).

Gastrointestinal ...Orally or intravenously, methionine can cause vomiting (9339,9340).

Genitourinary ...Orally or intravenously, methionine may increase urinary calcium excretion (9340,63112,94095).

Hematologic ...Orally or intravenously, methionine may cause leukocytosis when used at a dose of 8-13. 9 grams daily for 4-5 days (9340).

Hepatic ...A single dose of 8 grams of methionine has reportedly caused hepatic encephalopathy in patients with cirrhosis (9340). Long-term use of methionine-containing parenteral nutrition solution has been linked to liver toxicity in infants (9338).

Neurologic/CNS ...Orally or intravenously, methionine can cause dizziness, drowsiness, headache, and irritability (9339,9340,94095).
A case of cerebral edema ultimately leading to death has been reported in a patient receiving methionine 100 mg/kg orally. The post-load plasma concentrations of methionine were substantially higher in this patient than those previously reported in humans receiving this usual oral loading dose, leading the authors to postulate that an overdose of methionine may have been administered erroneously. This can occur when plasma methionine levels rise above 3000 mcmol/L (9339). Another case of progressive cerebral edema associated with high methionine levels and betaine (N,N,N-trimethylglycine) therapy in a patient with cystathionine beta-synthase (CBS) deficiency has been reported (63119). The authors stated that the cerebral edema was most likely precipitated by the betaine therapy, but that the exact mechanism is uncertain.

Oncologic ...Although one case-control study of incident, histologically-confirmed gastric cancer has indicated that a diet rich in methionine, salt, and nitrite is associated with an increased risk of gastric cancer (2409), a large observational study that adjusted for multiple factors, including sodium intake, has found no association between high dietary intake of methionine and gastric cancer (108041).

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TAURINE

General ...Orally, taurine is generally well-tolerated when used in typical doses for up to one year.
Most Common Adverse Effects:
Orally: Constipation, diarrhea, and dyspepsia.
Serious Adverse Effects (Rare):
Orally: Hypersensitivity reactions in sensitive individuals. Case reports raise concerns for serious cardiovascular adverse effects, but these reports have involved energy drinks containing taurine and other ingredients. It is unclear if these adverse effects are due to taurine, other ingredients, or the combination.

Cardiovascular ...Changes in heart rate and increased blood pressure have been reported following the co-administration of taurine and caffeine, although the effects of taurine alone are unclear (77088). In healthy individuals, consumption of energy drinks containing taurine increased platelet aggregation and decreased endothelial function (77151,112268,112741). A case of cardiac arrest following strenuous exercise and an excessive intake of energy drinks containing caffeine and taurine has been reported (77136). In another case report, a 28-year-old male without cardiovascular risk factors presented to the hospital with radiating chest pain, shortness of breath, and diaphoresis after excessive intake of an energy drink containing taurine, caffeine, sugar, and glucuronolactone. Electrocardiogram findings confirmed myocardial infarction, and subsequent catheterization confirmed thrombotic occlusion (112741).

Endocrine ...Orally, taurine has been reported to cause hypoglycemia (77153).

Gastrointestinal ...Orally, constipation has been reported following the administration of taurine (77231). Dyspepsia has also been reported after oral taurine use (104165).

Hematologic ...In clinical research, taurine reduced platelet aggregation (77245). A case of massive intravascular hemolysis, presenting with confusion, dark urine, dyspnea, emesis, and fever, has been reported following the administration of a naturopathic vitamin infusion containing taurine, free amino acids, magnesium, and a vitamin B and D complex (77177). However, the effects of taurine alone are unclear.

Immunologic ...A case report describes a hypersensitivity reaction in a female patient with a history of allergies to sulfonamides, sulfites, and various foods, after ingestion of taurine and other sulfur-containing supplements. The amount of taurine in the products ranged from 50-500 mg per dose. The allergic reaction recurred upon rechallenge with taurine 250-300 mg (91514).

Neurologic/CNS ...In a case study, encephalopathy occurred in a body-builder who took approximately 14 grams of taurine in combination with insulin and anabolic steroids. It is not known if this was due to the taurine or the other drugs taken (15536).
Cases of seizures following the consumption of energy drinks containing taurine have been reported (77105,77196). In clinical research, taurine has been reported to cause drowsiness and ataxia in epileptic children (77241).

Psychiatric ...In a case report, a 36-year-old male with adequately controlled bipolar disorder was hospitalized with symptoms of mania after consuming several cans of an energy drink containing taurine, caffeine, glucuronolactone, B vitamins, and other ingredients (Red Bull Energy Drink) over a period of four days (14302). It is unknown if this effect was related to taurine.

Pulmonary/Respiratory ...In human research, an exacerbation of pulmonary symptoms of cystic fibrosis has been associated with taurine supplementation, although this could also be caused by progression of the disease (77231).

Renal ...A case of acute kidney failure has been reported following the concomitant intake of 1 liter of vodka and 3 liters of an energy drink providing taurine 4. 6 grams, caffeine 780 mg, and alcohol 380 grams (77185).

(Read more about TAURINE)

VITAMIN B6

General ...Orally or by injection, vitamin B6 is well tolerated in doses less than 100 mg daily.
Most Common Adverse Effects:
Orally or by injection: Abdominal pain, allergic reactions, headache, heartburn, loss of appetite, nausea, somnolence, vomiting.
Serious Adverse Effects (Rare):
Orally or by injection: Sensory neuropathy (high doses).

Dermatologic ...Orally, vitamin B6 (pyridoxine) has been linked to reports of skin and other allergic reactions and photosensitivity (8195,9479,90375). High-dose vitamin B6 (80 mg daily as pyridoxine) and vitamin B12 (20 mcg daily) have been associated with cases of rosacea fulminans characterized by intense erythema with nodules, papules, and pustules. Symptoms may persist for up to 4 months after the supplement is stopped, and may require treatment with systemic corticosteroids and topical therapy (10998).

Gastrointestinal ...Orally or by injection, vitamin B6 (pyridoxine) can cause nausea, vomiting, heartburn, abdominal pain, mild diarrhea, and loss of appetite (8195,9479,16306,83064,83103,107124,107127,107135). In a clinical trial, one patient experienced infectious gastroenteritis that was deemed possibly related to taking vitamin B6 (pyridoxine) orally up to 20 mg/kg daily (90796). One small case-control study has raised concern that long-term dietary vitamin B6 intake in amounts ranging from 3.56-6.59 mg daily can increase the risk of ulcerative colitis (3350).

Hematologic ...Orally or by injection, vitamin B6 (pyridoxine) can cause decreased serum folic acid concentrations (8195,9479). One case of persistent bleeding of unknown origin has been reported in a clinical trial for a patient who used vitamin B6 (pyridoxine) 100 mg twice daily on days 16 to 35 of the menstrual cycle (83103). It is unclear if this effect was due to vitamin B6 intake.

Musculoskeletal ...Orally or by injection, vitamin B6 (pyridoxine) can cause breast soreness or enlargement (8195).

Neurologic/CNS ...Orally or by injection, vitamin B6 (pyridoxine) can cause headache, paresthesia, and somnolence (8195,9479,16306). Vitamin B6 (pyridoxine) can also cause sensory neuropathy, which is related to daily dose and duration of intake. Doses exceeding 1000 mg daily or total doses of 1000 grams or more pose the most risk, although neuropathy can occur with lower daily or total doses as well (8195). The mechanism of the neurotoxicity is unknown, but is thought to occur when the liver's capacity to phosphorylate pyridoxine via the active coenzyme pyridoxal phosphate is exceeded (8204). Some researchers recommend taking vitamin B6 as pyridoxal phosphate to avoid pyridoxine neuropathy, but its safety is unknown (8204). Vitamin B6 (pyridoxine) neuropathy is characterized by numbness and impairment of the sense of position and vibration of the distal limbs, and a gradual progressive sensory ataxia (8196,10439). The syndrome is usually reversible with discontinuation of pyridoxine at the first appearance of neurologic symptoms. Residual symptoms have been reported in patients taking more than 2 grams daily for extended periods (8195,8196). Daily doses of 100 mg or less are unlikely to cause these problems (3094).

Oncologic ...In females, population research has found that a median intake of vitamin B6 1. 63 mg daily is associated with a 3.6-fold increased risk of rectal cancer when compared with a median intake of 1.05 mg daily (83024). A post-hoc subgroup analysis of results from clinical research in adults with a history of recent stroke or ischemic attack suggests that taking folic acid, vitamin B12, and vitamin B6 does not increase cancer risk overall, although it was associated with an increased risk of cancer in patients who also had diabetes (90378). Also, in patients with nasopharyngeal carcinoma, population research has found that consuming at least 8.6 mg daily of supplemental vitamin B6 during treatment was associated with a lower overall survival rate over 5 years, as well as a reduced progression-free survival, when compared with non-users and those with intakes of up to 8.6 mg daily (107134).

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