Berberine with InSea2 by XYMOGEN

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dental plaque. It is unclear if oral Ascophyllum nodosum is beneficial in patients with dental plaque. Details: A small crossover study in adults with moderate to heavy calculus formation shows that taking a specific brand of Ascophyllum nodosum capsules (ProDen PlaqueOff, SDC Swedencar eAB) 500 mg daily for 6 months reduces the buildup of supragingival calculus by 52% when compared with placebo. The buildup of plaque was reduced by 19% in males, but was not reduced in females, when compared with placebo (94996).
• Gastroesophageal reflux disease (GERD). Although there has been interest in using oral Ascophyllum nodosum for GERD, there is insufficient reliable information about the clinical effects of Ascophyllum nodosum for this purpose.
• Gingivitis. It is unclear if oral Ascophyllum nodosum is beneficial in patients with dental plaque. Details: A small crossover study in adults with moderate to heavy calculus formation shows that taking a specific brand of Ascophyllum nodosum capsules (ProDen PlaqueOff, SDC Swedencar eAB) 500 mg daily for 6 months does not reduce gingivitis when compared with placebo (94996).
• Impaired glucose tolerance (prediabetes). Oral Ascophyllum nodosum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with prediabetes that are overweight or obese shows that taking a specific product (InSea2, InnoVactiv Inc.) containing 500 mg of Ascophyllum nodosum and Fucus vesiculosus extracts daily for 12 weeks reduces postprandial blood glucose but does not improve fasting blood glucose, glycated hemoglobin (HbA1c), body weight, lipids, or blood pressure when compared with placebo (110560).
• Inflammatory bowel disease (IBD). Although there has been interest in using oral Ascophyllum nodosum for IBD, there is insufficient reliable information about the clinical effects of Ascophyllum nodosum for this purpose.
• Iodine deficiency. It is unclear if oral Ascophyllum nodosum is beneficial in patients with iodine deficiency. Details: Ascophyllum nodosum contains iodine, and there is interest in its use for patients with iodine deficiency. A small clinical study in females with iodine insufficiency shows that taking a specific brand of Ascophyllum nodosum capsules (Napiers Hebridean Seagreens (NaHS), Seagreens Ltd) 500 mg daily for 14 days increases urinary iodine excretion by almost three-fold and increases thyroid stimulating hormone levels by 36% when compared with baseline (94997). The validity of these findings is limited by the lack of a control group.
• Metabolic syndrome. Oral Ascophyllum nodosum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in adults with one or more components of metabolic syndrome has found that taking a specific combination product (Gdue, Aesculapius) containing extracts of Ascophyllum nodosum and Fucus vesiculosus in a 95:5 ratio along with chromium picolinate two to three times daily with meals for around 6 months is associated with reductions in body weight by 7.3 kg, waist circumference by 7.5 cm, fasting blood glucose by 16 mg/dL, glycated hemoglobin (HbA1c) by 0.55%, systolic blood pressure by 7 mmHg, diastolic blood pressure by 4 mmHg, low-density lipoprotein (LDL) cholesterol by 18 mg/dL, and 10-year cardiovascular risk scores by 1.8% when compared to baseline (110559). It is unclear if these effects are due to Ascophyllum nodosum, Fucus vesiculosus, or the combination. Further, the validity of these findings is limited by a lack of control group.
• Obesity. Oral Ascophyllum nodosum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with prediabetes that are overweight or obese shows that taking a specific product (InSea2, InnoVactiv Inc.) containing 500 mg of Ascophyllum nodosum and Fucus vesiculosus extracts daily for 12 weeks does not reduce body weight, body mass index (BMI), body fat, lipids, blood pressure, or measures of glycemic control when compared with placebo (110560).
• Peptic ulcers. Although there has been interest in using oral Ascophyllum nodosum for peptic ulcers, there is insufficient reliable information about the clinical effects of Ascophyllum nodosum for this purpose. More evidence is needed to rate Ascophyllum nodosum for these uses.

(Read more about ASCOPHYLLUM NODOSUM)

POSSIBLY EFFECTIVE

• Canker sores. Some evidence shows that berberine gel applied to canker sores may reduce pain and the size of the sores, but it has not been compared to conventional treatments. Details: Some clinical research shows that applying a gel containing berberine 5 mg/gram four times daily for 5 days can reduce pain by 26% and ulcer size by 30% when compared with placebo in patients with minor recurrent canker sores. Erythema and exudation also appear to be improved (91955).
• Diabetes. Berberine seems to moderately reduce blood glucose in people with type 2 diabetes; it may provide additional benefit when given with conventional medications. Details: Some clinical research shows that taking berberine 500 mg 2-3 times daily for 2-4 months can reduce glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) in subjects with type 2 diabetes when compared with placebo, and may be similarly effective to metformin 500 mg 2-3 times daily or rosiglitazone 4 mg daily (20579,34247,34265,110099). Large meta-analyses show that taking berberine, 0.9-3 grams in 2-3 divided doses daily for 1-11 months, in combination with lifestyle interventions, can reduce FPG by 10-16 mg/dL, PPG by 27-34 mg/dL, and HbA1c by 0.4% to 0.7% when compared with lifestyle interventions alone. Also, taking berberine in combination with oral hypoglycemic drugs appears to lower FPG by 12-19 mg/dL, PPG by 18-24 mg/dL, and HbA1c by 0.6% to 0.9% when compared with hypoglycemic drugs alone (91956,110097). Berberine has also been evaluated in combination with other ingredients. A small clinical study in patients with type 2 diabetes shows that taking berberine 500 mg with Bifidobacterium adolescentis 100 million colony-forming units (CFU) twice daily for 16 weeks reduces FPG by 10 mg/dL, PPG by 28 mg/dL, and HbA1c by 0.22% when compared with placebo (110099). Another clinical study in patients with type 2 diabetes shows that taking berberine 600 mg twice daily with a multi-strain probiotic supplement, containing more than 50 billion CFU, once daily for 12 weeks reduces postprandial cholesterol by 15 mg/dL and postprandial low-density lipoprotein (LDL) cholesterol by 9 mg/dL when compared with placebo. Postprandial triglyceride levels were also improved, while postprandial levels of high-density lipoprotein (HDL) cholesterol were not affected (110100).
• Helicobacter pylori. Oral berberine, when taken with amoxicillin and a proton pump inhibitor (PPI) with or without clarithromycin, might be as effective as bismuth-containing quadruple therapy (BQT), vonoprazan quadruple therapy, and PPI-based triple therapy for eradication of Helicobacter pylori. Details: Most studies evaluate berberine in combination with an antibiotic and acid blocker for the treatment of H. pylori infection. Open-label clinical studies in patients with treatment-naïve H. pylori infection shows that taking berberine 300-500 mg with amoxicillin 1 gram and an acid reducer such as esomeprazole 20 mg, rabeprazole 10 mg, or vonoprazan 20 mg, with or without clarithromycin 500 mg, 2-3 times daily for 14 days is non-inferior to BQT, vonoprazan quadruple therapy (vonoprazan, amoxicillin, clarithromycin, bismuth), and rabeprazole quadruple therapy (rabeprazole, amoxicillin, clarithromycin, bismuth) for H. pylori eradication and clinical symptom improvement. Eradication rates were around 70% to 91% and 69% to 90% in the berberine- and bismuth-containing groups, respectively. BQT is a guideline-recommended treatment regimen for H. pylori eradication (97234,111697). Also, berberine triple therapy appears to be better tolerated when compared with BQT. Quadruple therapy consisted of amoxicillin, rabeprazole, clarithromycin, and bismuth tartrate (110107). A smaller clinical study in patients with H. pylori-associated duodenal ulcers shows that taking berberine 300 mg three times daily for 6 weeks is more effective for eradicating H. pylori than taking ranitidine 150 mg twice daily, but is less effective for promoting ulcer healing (34319).
• Hyperlipidemia. Clinical research shows that taking berberine orally, alone or in combination with other ingredients, reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, and increases high-density lipoprotein (HDL) cholesterol. Details: Meta-analyses of clinical research in people with hyperlipidemia show that berberine can reduce total cholesterol by 21-32 mg/dL, triglycerides by up to 34 mg/dL, LDL cholesterol by 18-26 mg/dL, and apolipoprotein B by 0.25 g/L, as well as increase HDL cholesterol by 2-3 mg/dL, when compared with placebo or lifestyle interventions (20579,34228,111363,111700). Meta-analyses also show that berberine alone is similarly effective to statins at lowering lipid levels (100983,111362). Administration of berberine in combination with lipid-lowering drugs such as statins lowers total cholesterol by 10-15 mg/dL, LDL cholesterol by up to 9 mg/dL, and triglycerides by up to 30 mg/dL when compared with lipid-lowering drugs alone (91953,91956,99921,100983,111362). The dosage of berberine used most often in these studies was 500 mg twice daily, or 200-500 mg three times daily for 3-24 months. However, one meta-analysis suggests that berberine's effects on lipid levels may be transient, with significant improvements in total cholesterol, LDL cholesterol, and HDL cholesterol lacking in studies lasting 3 or more months (111362). Berberine has also been studied in combination with other supplements. Taking a combination product containing berberine 500 mg, policosanol 10 mg, and red yeast rice 200 mg daily for up to 12 months reduces total and LDL cholesterol levels when compared with placebo or ezetimibe 10 mg (34262,34283,34301). Taking another combination product (Armolipid Plus, Rottapharm S.p.A.) containing berberine, red yeast rice, policosanol, folic acid, coenzyme Q10, and astaxanthin daily for up to 12 months reduces total cholesterol by 10% to 13% and LDL cholesterol by 14% to 21%, and increases HDL cholesterol by 4% to 5% when compared with baseline or placebo. These effects are comparable to those seen with pravastatin 10 mg daily (89438,92142). It is unclear if the benefits of this combination product are due to berberine, other ingredients, or the combination. It is possible that the majority of the therapeutic effect is due to an ingredient in red yeast rice (monacolin K) that is identical to lovastatin.
• Hypertension. Berberine may have added benefits for reducing blood pressure when used in combination with amlodipine. Details: A meta-analysis shows that taking berberine 0.9 grams daily in combination with amlodipine for 2 months reduces systolic blood pressure by 5 mmHg and diastolic blood pressure by 2 mmHg when compared with amlodipine alone (91956).
• Polycystic ovary syndrome (PCOS). Berberine may improve some metabolic characteristics in women with PCOS and insulin resistance. It may also increase live births, although the data are conflicting. Details: Clinical research in patients with PCOS and insulin resistance shows that taking berberine 500-550 mg 2-3 times daily for 3 to 6 months reduces fasting plasma glucose, markers of insulin resistance, total cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, testosterone levels, body mass index, waist-to-hip ratio, acne severity, and markers of inflammation when compared with placebo or baseline. Berberine also seems to increase high-density lipoprotein (HDL) cholesterol and sex hormone binding globulin (SHBG) levels (34282,91952,111364). Lipid parameters also improved when compared with metformin, as did waist-to-hip ratio, body mass index, and SHBG levels in some, but not all, studies (34282,91952). The effect of berberine on pregnancy and birth rates in women with PCOS is unclear. One clinical study shows that taking berberine 500 mg three times daily for three months prior to controlled ovarian stimulation increases the number of clinical pregnancies and live births by almost two-fold when compared with placebo. These effects are comparable to taking metformin 500 mg three times daily for 3 months (91952). However, other clinical research shows that taking a combination of berberine 1.5 grams daily and letrozole for ovarian stimulation does not increase live birth rates when compared with letrozole alone (97235).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Antipsychotic-induced metabolic side effects. It is unclear if oral berberine is beneficial in patients with antipsychotic-induced metabolic side effects. Details: A small clinical study in patients with schizophrenia who developed metabolic syndrome associated with antipsychotic therapy shows that taking berberine 300 mg twice daily for 12 weeks reduces body weight by 1.1 kg, body mass index (BMI) by 0.4 kg/m2, total cholesterol by 22 mg/dL, low-density lipoprotein (LDL) cholesterol by 20 mg/dL, and glycated hemoglobin (HbA1c) by 0.09% when compared with placebo (110103).
• Atrial fibrillation. Limited research suggests that oral berberine might prevent atrial fibrillation shortly after coronary artery bypass graft (CABG) surgery. Details: A small clinical study in Chinese patients who underwent CABG surgery shows that taking berberine 400 mg three times daily for 7 days reduces the risk of postoperative atrial fibrillation by 50% when compared with placebo (110106).
• Biliary disorders. It is unclear if oral berberine is beneficial in patients with biliary disorders. Details: A small clinical study in patients with primary sclerosing cholangitis shows that taking berberine ursodeoxycholate, an ionic salt formulation of berberine and ursodeoxycholic acid, 500-1000 mg twice daily for 6 weeks reduces levels of alkaline phosphatase (ALP), a marker of cholestasis and bile duct injury, when compared with placebo. ALP levels decreased by at least 50% in 7% and 17% of patients taking 500 mg and 1000 mg, respectively, compared with 0% of patients taking placebo (110105).
• Burns. Topical berberine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that topical treatment of second degree burns with an ointment containing berberine, beta-sitosterol, sesame oil, and other ingredients, applied every 4 hours for 20 days, is similar to conventional treatment with silver sulfadiazine cream (13526). It is unclear if this benefit is due to berberine, other ingredients, or the combination.
• Cardiovascular disease (CVD). It is unclear if berberine is beneficial in patients with CVD. Details: A meta-analysis of several small clinical studies in patients with atherosclerosis, ischemic stroke, or coronary heart disease shows that taking berberine alone does not improve lipid levels or markers of atherosclerosis but does reduce markers of inflammation when compared with routine therapy or statins. Additionally, the pooled analysis suggests that berberine reduces stroke severity, as measured by the NIH Stroke Scale, in patients with ischemic stroke (111362). This meta-analysis also shows that, when taken with a statin, berberine improves lipid levels, stroke severity, markers of atherosclerosis, and inflammatory markers when compared with statin therapy alone or routine treatment (111362). The validity of these findings is limited by the overall low-quality of the included studies, with unclear blinding and randomization; significant heterogeneity and differences in patient populations, berberine doses, and treatment durations studied; and concerns related to publication bias.
• Cholera. Although taking a single dose of berberine may be modestly beneficial for reducing stool volume, using berberine daily with tetracycline does not seem to provide added benefit. Details: Some preliminary clinical research shows that a single dose of berberine sulfate 400 mg decreases 24-hour stool volume by a small amount in subjects with cholera when compared with placebo (262). However, taking berberine 200-400 mg daily along with tetracycline 500 mg four times daily does not seem to further enhance the effects of tetracycline in treating cholera-induced diarrhea (34305,34306).
• Colorectal adenoma. Berberine may help prevent adenoma recurrence after polypectomy. Details: Preliminary clinical research in Chinese patients with colorectal adenomas who had undergone complete polypectomy shows that taking berberine 0.3 grams twice daily for 2 years reduces the risk of adenoma recurrence by 22% when compared with placebo (103197). A meta-analysis of this trial and two other small clinical studies in Chinese patients with a history of colorectal adenomas shows that taking berberine 0.1 grams three times daily for 18 months or 0.3 grams twice daily for 2 years reduces the risk of adenoma recurrence by 31% and 25% at years 1 and 2, respectively, when compared with placebo (110101). All available research has been conducted in China; it is unclear whether these results can be applied to other geographic locations.
• Congestive heart failure (CHF). Berberine may provide additional benefit to patients with CHF who are taking conventional medications. Details: Preliminary clinical research in patients with CHF secondary to ischemic or idiopathic dilated cardiomyopathy shows that adding berberine 1.2-2 grams daily for 8 weeks to conventional medications can reduce the frequency and complexity of premature ventricular contractions (PVCs) and reduce mortality when compared with placebo (13520).
• Coronary heart disease (CHD). Oral berberine has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in statin-intolerant patients with coronary heart disease treated with a percutaneous intervention (PCI) shows that taking a specific combination product (Armolipid Plus, Rottapharm S.p.A.) containing berberine 500 mg, red yeast rice 200 mg, policosanol 10 mg, folic acid 0.2 mg, coenzyme Q10 2 mg, and astaxanthin 0.5 mg daily for 3 months reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, and increases high-density lipoprotein (HDL) cholesterol to a greater extent than ezetimibe 10 mg daily. Combining this specific product with either ezetimibe or a low-dose statin produces additional improvements in all lipid parameters after 3-12 months of treatment when compared with any of the agents alone (97232,97233). It is unclear if the benefits of this combination product are due to berberine, other ingredients, or the combination. Because red yeast rice contains a compound identical to lovastatin (monacolin K), it is likely that the cholesterol-lowering potential of this combination is mainly attributable to the red yeast rice constituent.
• Diarrhea. Limited data suggest that berberine may be helpful for diarrhea caused by bacteria. Details: Some preliminary clinical research shows that a single dose of berberine sulfate 400 mg decreases 24-hour stool volume in subjects with Escherichia coli-induced diarrhea when compared with placebo (262).
• Glaucoma. It is unclear if berberine is beneficial for glaucoma when used as an eye drop. Details: Preliminary clinical research shows that using eye drops containing berberine 2.5 mg and tetrahydrozoline 2.5 mg for 3 days does not reduce intraocular pressure in patients with open angle glaucoma when compared with eye drops containing tetrahydrozoline alone (34304).
• Hepatitis B. It is unclear if berberine is beneficial for improving liver function in people with hepatitis B. Details: Preliminary clinical research shows that taking berberine 1 gram daily for 2 months decreases blood glucose, triglycerides, and markers of liver damage, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT), in subjects with type 2 diabetes and hepatitis B when compared with control (34265).
• Hepatitis C. It is unclear if berberine is beneficial for improving liver function in people with this form of hepatitis. Details: Preliminary clinical research shows that taking berberine 1 gram daily for 2 months decreases blood glucose, triglycerides, and markers of liver damage, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT), in subjects with type 2 diabetes and hepatitis C when compared with control (34265).
• Impaired glucose tolerance (prediabetes). Small studies suggest that oral berberine may be beneficial in adults with prediabetes. Details: A very small clinical study in adults with overweight and prediabetes shows that taking berberine aqueous root extract (HIMABERB, Pharma Base S.A.) 500 mg 3 times daily for 12 weeks reduces fasting blood glucose by 15 mg/dL, glycated hemoglobin (HbA1c) by 0.7%, and 2-hour oral glucose tolerance test by 28 mg/dL and improves fasting insulin levels and measures of insulin resistance when compared with placebo (111699). The validity of these effects is limited by a very small sample size. Another small clinical study in adults with prediabetes shows that taking berberine phospholipids (Berbevis, Indena, SpA, Italy) 550 mg twice daily for 8 weeks reduces fasting blood glucose by 4 mg/dL and improves insulin levels when compared with placebo (111700).
• Irritable bowel syndrome (IBS). One small clinical study suggests that oral berberine may be beneficial in people with diarrhea-predominant IBS. Details: Preliminary clinical research shows that taking berberine 400 mg twice daily for 8 weeks in patients with diarrhea-predominant IBS reduces the frequency of diarrhea, abdominal pain, and defecation urgency when compared with placebo. Berberine may also improve overall symptom scores and IBS quality of life (97236).
• Menopausal symptoms. Oral berberine 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 of berberine plus soy isoflavones can reduce vasomotor symptoms in menopausal women when compared with taking calcium plus vitamin D (34287). It is not clear if this effect is due to berberine, soy isoflavones, or the combination.
• Metabolic syndrome. Berberine may reduce some of the signs and symptoms of metabolic syndrome, but the evidence is weak. Details: Preliminary clinical research in adults with metabolic syndrome shows that taking berberine hydrochloride 500 mg three times daily before meals for 3 months reduces body mass index (BMI) by 0.6 kg/m2, systolic blood pressure (SBP) by 8 mmHg, triglycerides by 18 mg/dL, and serum glucose levels by 2 mg/dL, and can also improve insulin sensitivity, when compared with baseline (91957). The validity of these findings is limited by the lack of a control group. Other preliminary clinical research shows that taking a combination product (Armolipid Plus, Rottapharm S.p.A.) containing berberine 500 mg, red yeast rice 200 mg, policosanol 10 mg, folic acid 0.2 mg, coenzyme Q10 2 mg, and astaxanthin 0.5 mg daily for 18 weeks improves SBP, left ventricular mass, and flow-mediated dilation in patients with metabolic syndrome when compared with control (34289). It is not clear if this effect is due to berberine, the other ingredients, or the combination.
• Nonalcoholic fatty liver disease (NAFLD). Oral berberine may improve some measures of liver function and blood lipids in people with NAFLD. Details: Preliminary clinical research shows that taking berberine 600 mg twice daily for 12 weeks reduces blood lipids and markers of liver damage, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT), when compared to baseline in patients with NAFLD and type 2 diabetes (34286). Other preliminary clinical research shows that taking berberine 500 mg three times daily for 16 weeks reduces hepatic fat content by 21% when compared with lifestyle modification. Berberine also seems to reduce hepatic fat content, AST, and ALT similarly to pioglitazone 15 mg daily, while reducing body weight, body mass index, and total cholesterol more than pioglitazone (97237).
• Obesity. It is unclear if oral berberine is beneficial in patients with obesity. Details: A meta-analysis of 12 small clinical studies, most in patients with various metabolic conditions, shows that taking berberine 300-1500 mg daily for up to 24 months reduces body weight by around 2 kg, body mass index (BMI) by 0.5 kg/m2, and waist circumference by about 1 cm when compared with a control group (104508). However, most of the studies are small, of varying quality, with significant heterogeneity, and likely inadequately powered to detect significant changes. Additionally, none of the studies required patients to have overweight or obesity for inclusion.
• Radiation-induced diarrhea. One small study suggests that oral berberine may reduce diarrhea associated with radiation-induced intestinal damage. Details: Preliminary clinical research shows that taking berberine 300 mg three times daily for 2 weeks can reduce the frequency and severity of radiation-induced intestinal damage and diarrhea in patients receiving abdominal or pelvic radiation therapy when compared with placebo (34263).
• Radiation fibrosis. It is unclear if oral berberine is beneficial for reducing radiation-induced lung damage. Details: Preliminary clinical research shows that taking berberine 20 mg/kg once daily for 6 weeks during radiation therapy reduces the incidence of radiation-induced lung injury and improves lung function in patients treated for NSCLC when compared with placebo (34253).
• Stroke. It is unclear if oral berberine is beneficial in adults with acute ischemic stroke. Details: A meta-analysis of several small clinical studies in adults with acute ischemic stroke shows that taking berberine 0.3-1.0 grams daily for up to 6 months in addition to conventional therapy reduces stroke severity, as measured by the NIH Stroke Scale, improves markers of atherosclerosis and inflammation, and reduces triglycerides and low-density lipoprotein cholesterol when compared with routine therapy as control (111698). The validity of these findings is limited by the overall low quality of the included studies, with unclear blinding and randomization. Other limitations include significant heterogeneity in patient populations, berberine doses, and treatment durations studied.
• Thrombocytopenia. It is unclear if oral berberine is beneficial for improving platelet counts in people with this condition. Details: Preliminary clinical research shows that taking berberine bisulfate 5 mg three times daily before meals for 15 days, either alone or with prednisolone, can increase platelet count in patients with primary or secondary thrombocytopenia when compared with baseline (34317).
• Trachoma. It is unclear if berberine is beneficial for trachoma when administered as eye drops. Details: Preliminary clinical research shows that berberine ophthalmic solution might be useful for treating trachoma, a common cause of blindness in developing countries. Solutions of 0.2% berberine have been applied three times daily for 3-12 weeks, or solutions of 0.5% three times daily for 1-3 weeks (13523,34303,34310,34313).
• Ulcerative colitis. It is unclear of oral berberine is beneficial for improving symptoms of this condition. Details: Preliminary clinical research in a small number of patients with ulcerative colitis taking mesalamine shows that taking berberine 300 mg three times daily for 3 months does not improve clinical symptoms or markers of inflammation when compared with placebo (103194). However, this study primarily focused on safety outcomes and was inadequately powered to detect differences in efficacy.
• Ventricular arrhythmias. Limited research suggests that oral berberine might lower the frequency of premature ventricular contractions (PVCs). Details: Data from a meta-analysis of 10 small clinical trials, all conducted in China, shows that taking oral berberine, 0.3-0.6 grams 3 or 4 times daily for 7-30 days has a similar efficacy rate to antiarrhythmic drugs, and a lower incidence of adverse effects, in the management of PVCs. A combination of berberine and antiarrhythmic drugs has a higher efficacy rate and similar adverse effect rate, when compared with antiarrhythmic drugs alone (112947). The quality of this evidence is low. More evidence is needed to rate berberine for these uses.

(Read more about BERBERINE)

LIKELY EFFECTIVE

• Chromium deficiency. Oral or parenteral chromium is effective for the treatment and prevention of chromium deficiency. Details: Taking chromium orally is effective for preventing and treating symptoms of chromium deficiency, including hyperglycemia, glycosuria, sudden weight loss, peripheral neuropathy, and confusion (7135).

POSSIBLY EFFECTIVE

• Diabetes. Oral chromium seems to be modestly beneficial for improving glycemic control in diabetes, especially when used in doses greater than 200 mcg daily and in patients with poorly controlled diabetes. It is unclear if chromium helps to prevent the development of diabetes. Details: Epidemiological research has found that lower toenail chromium levels are associated with an increased risk of diabetes and cardiovascular disease (11908). In 2005, the US Food and Drug Administration (FDA) allowed a qualified health claim stating that chromium picolinate may reduce the risk of type 2 diabetes. However, the FDA has determined that any relationship between chromium picolinate and type 2 diabetes is highly uncertain and is based on limited scientific evidence (102362). Research on the use of chromium for the TREATMENT of type 2 diabetes is conflicting but seems to show modest benefit in some patients. Many small clinical studies show that taking chromium orally decreases fasting blood glucose, postprandial glucose, insulin, and glycated hemoglobin (HbA1C) levels, and increases insulin sensitivity (6867,7137,12390,15169,14440,42628,42638,95097,103745). However, other small clinical studies show that chromium is no better than placebo for improving glycemic indices in patients with diabetes (7060,14325,42679,42707,90059,103746,103749). Some of these studies may not have been adequately powered and some had a high risk of bias. Furthermore, these studies had high heterogeneity related to study population and size, chromium supplementation duration, formulation, and dose, and accepted standards of diabetes care. Multiple meta-analyses pooling results of these small clinical trials also show mixed results (90055,90063,95098,105026,110610). The most recent and comprehensive meta-analyses show that chromium picolinate lowers HbA1C by about 0.6%; while it is unclear if chromium yeast, chromium dinicocysteinate, or chromium with biotin or other natural ingredients are beneficial. Chromium seems to be most beneficial in doses of greater than 200 mcg taken for 12 weeks or longer, and in patients with poorly controlled diabetes with a baseline HbA1C of 8% or greater (90063,105026). There is also speculation that chromium might primarily benefit patients with low chromium levels; however, there has not been an analysis specifically evaluating this population (6867,7058,13725,14325,95098). Some research suggests that chromium might also modestly improve lipid levels in patients with type 2 diabetes (1934,6867,95098). A meta-analysis of randomized clinical trials including patients with type 2 diabetes shows that taking chromium 42-1000 mcg orally daily for 5-26 weeks decreases triglyceride levels by 7 mg/dL and increases high-density lipoprotein cholesterol levels by 2 mg/dL when compared with control. Taking chromium did not affect low-density lipoprotein cholesterol levels. However, the validity of these results is limited by high heterogeneity (110605). In addition, some meta-analyses have failed to demonstrate any effects of chromium on lipid levels (110610). A meta-analysis of randomized clinical trials including patients with type 2 diabetes shows that taking chromium 200-1000 mcg orally daily for 8-25 weeks lowers diastolic blood pressure by 2 mmHg, but not systolic blood pressure or body mass index, when compared with placebo (110607). Preliminary clinical research shows that chromium picolinate might improve metabolic parameters in patients with other forms of diabetes as well. This includes those with type 1 diabetes (1935), diabetes secondary to corticosteroid use (5039,42829), and gestational diabetes (42817).

POSSIBLY INEFFECTIVE

• Hypertension. Meta-analyses of small clinical trials suggest that oral chromium does not lower blood pressure by a clinically meaningful amount. Details: A meta-analysis of randomized clinical trials in adults with different metabolic disorders shows that taking chromium 42-1000 mcg orally daily for 12-24 weeks does not lower systolic or diastolic blood pressure when compared with placebo (110609). A meta-analysis of randomized clinical trials in adults with different chronic disorders shows that taking chromium 42-1000 mcg orally daily for 4-25 weeks lowers systolic and diastolic blood pressure by 3 mmHg and 1 mmHg, respectively, when compared with placebo. However, the validity of this meta-analysis is limited by high heterogeneity (110604). Another meta-analysis of randomized clinical trials including patients with type 2 diabetes shows that taking chromium 200-1000 mcg orally daily for 8-25 weeks lowers diastolic blood pressure by 2 mmHg, but not systolic blood pressure, when compared with placebo (110607). In addition, the validity of these results is limited by inclusion of patients with and without hypertension at baseline (110604,110607,110609).
• Impaired glucose tolerance (Prediabetes). Oral chromium does not seem to improve glycemic indices in patients with prediabetes. Details: Some clinical research shows that adults with impaired glucose tolerance do not have improved glycemic parameters or insulin sensitivity after taking chromium picolinate 500-1000 mcg daily for up to 6 months when compared with placebo (13053,42670). Likewise, a small clinical study in elderly patients with impaired glucose tolerance shows that chromium supplements do not improve glucose tolerance or triglyceride or cholesterol levels when compared with placebo (13722). Finally, a preliminary clinical study in overweight or obese adults with prediabetes shows that taking two capsules of a combination product containing chromium, cinnamon, and carnosine (Glycabiane, PiLeJe) daily for 4 months decreases fasting plasma glucose by approximately 4 mg/dL when compared with placebo, but does not improve fasting plasma insulin, measures of insulin sensitivity or resistance, or glycated hemoglobin (HbA1C) (94234). The small effect on fasting plasma glucose is clinically insignificant and may be due to the other ingredients in this product.
• Schizophrenia. Oral chromium does not seem to improve psychological measures in patients with schizophrenia. Details: Clinical research in patients with schizophrenia shows that taking chromium polynicotinate 400 mcg daily for 3 months does not affect weight or mental status when compared with placebo (42613).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Antiretroviral-induced insulin resistance. It is unclear if oral chromium is beneficial for preventing antiretroviral-induced insulin resistance. Details: Preliminary clinical research in HIV patients treated with highly active antiretroviral therapy (HAART) shows that taking chromium nicotinate 200 mcg or chromium picolinate 1000 mcg daily for 8-16 weeks may help decrease insulin resistance and increase glucose disposal when compared to baseline (42630,42662). The validity of this finding is limited by the lack of a control group.
• Athletic performance. It is unclear if chromium enhances athletic performance, although some research suggests that it may improve body composition when used in conjunction with exercise. Details: One large clinical study shows taking chromium 400 mcg daily, in conjunction with resistance training, can increase weight loss, body fat loss, and lean body mass when compared with placebo and resistance training (6868). However, other, very small clinical studies show that adding chromium picolinate or chromium chloride 177-400 mcg daily to a weight-training program does not improve body composition when compared with weight-training alone (6860,6861,6862,42747). These studies may not have been adequately powered to detect a difference in outcomes.
• Atypical depression. It is unclear if oral chromium is beneficial in patients with atypical depression. Details: Preliminary clinical research in patients with atypical depression shows that taking chromium picolinate 400 mcg daily for 2 weeks followed by 600 mcg daily for an additional 6 weeks improves response and remission rates when compared with placebo (10309). However, other clinical research shows that taking elemental chromium 400 mcg in the form of chromium picolinate daily for 2 weeks followed by 600 mcg daily for an additional 6 weeks does not improve most symptoms of atypical depression, although appetite and sexual drive may improve, when compared with placebo (42600).
• Beta blocker-induced dyslipidemia. It is unclear if oral chromium is beneficial in patients with dyslipidemia due to beta-blocker use. Details: One small clinical study in patients who take beta-blockers shows that taking glucose tolerance factor (GTF)-chromium 600 mcg daily for 2 months increases high-density lipoprotein (HDL) cholesterol levels by 16%, but does not affect other lipid parameters, when compared with placebo (5040).
• Binge eating disorder. It is unclear if oral chromium is beneficial in patients with binge eating disorder. Details: One small clinical study in overweight adults with binge eating disorder shows that taking chromium picolinate 600 or 1000 mcg by mouth daily for 6 months does not affect binge eating frequency, body weight, or depressive symptoms when compared with placebo (90057).
• Bipolar disorder. It is unclear if oral chromium is beneficial in patients with treatment-resistant bipolar disorder. Details: Preliminary clinical research in patients with treatment-resistant, rapid-cycling bipolar disorder shows that taking chromium chloride (Hypo-A Chrom, Hypo-A GmbH) 600-800 mcg daily for up to 2 years can decrease the frequency of affective episodes by approximately three episodes annually when compared to baseline (42618). The validity of this finding is limited by the lack of a control group.
• Cognitive impairment. It is unclear if oral chromium prevents cognitive impairment. Details: Some clinical research shows that taking chromium picolinate standardized to contain elemental chromium 1000 mcg daily for 12 weeks does not improve memory or depression in elderly patients with mild cognitive impairment when compared with placebo. However, results from neuroimaging scans suggest that chromium increases the activity of certain regions of the brain during memory tasks when compared with placebo (42666).
• Hyperlipidemia. Small clinical studies suggest that oral chromium may modestly reduce lipid levels in patients with hyperlipidemia. Details: One small clinical study in patients with atherosclerotic disease shows that taking chromium 250 mcg as chromium chloride daily for 7-16 months decreases triglycerides and increases high-density lipoprotein (HDL) cholesterol, but not other lipid parameters, when compared with placebo (7060). Other small clinical studies in adults with hyperlipidemia show that taking chromium picolinate 200 mcg daily for 6 weeks, chromium polynicotinate 200 mcg twice daily, or brewer's yeast containing 48 mcg elemental chromium daily for 6-8 weeks decrease total and low-density lipoprotein (LDL) cholesterol when compared to baseline (37178,42585,42710). The validity of this finding is limited by the lack of comparison with a control group. A meta-analysis of small heterogeneous clinical studies in patients mostly without hyperlipidemia shows that taking chromium orally does not affect lipid levels when compared with placebo (105029). A meta-analysis of randomized clinical trials including patients with type 2 diabetes shows that taking chromium 42-1000 mcg orally daily for 5-26 weeks modestly improves triglyceride and HDL cholesterol levels, but not LDL cholesterol levels, when compared with control. However, the validity of these results is limited by high heterogeneity and inclusion of patients with and without hyperlipidemia (110605). In addition, some meta-analyses have failed to demonstrate any effects of chromium on lipid levels in adults with diabetes (110610). Limited research has tested high-dose chromium in children. One small clinical study in children with hypercholesterolemia shows that taking chromium polynicotinate 400-600 mcg with glucomannan 1000-1500 mg twice daily for 8 weeks reduces total and LDL cholesterol when compared to baseline (90061). It is unclear if this effect is due to chromium, glucomannan, or the combination. Finally, chromium does not seem to reduce lipid levels in people without hyperlipidemia.
• Hypoglycemia. It is unclear if oral chromium helps to reverse or prevent hypoglycemia. Details: One very small clinical study in patients with reactive hypoglycemia shows that taking chromium chloride 200 mcg daily for 3 months increases blood glucose levels and improves insulin binding and hypoglycemic symptoms following an oral glucose load (6859). Another small clinical study in patients with symptomatic hypoglycemia shows that taking chromium yeast (Biochrome, Pharma-Nord) 125 mcg daily for 3 months improves symptoms, including chilliness, trembling, and disorientation, when compared with baseline (42711). The validity of this finding is limited by the lack of a control group.
• Metabolic syndrome. It is unclear if oral chromium is beneficial in patients with metabolic syndrome. Details: One small clinical study in patients with metabolic syndrome shows that taking a particular chromium picolinate product (Chromax, Nutrition 21) 500 mcg twice daily for 16 weeks does not affect weight, waist circumference, insulin sensitivity, glycated hemoglobin (HbA1C), or lipid levels when compared with placebo (42654).
• Myocardial infarction (MI). It is unclear if oral chromium helps to prevent MI. Details: Epidemiological research has found that low toenail chromium concentrations are associated with an increased risk of MI (13728). However, toenail chromium concentrations might not be a reliable predictor of body stores of chromium. There is also no reliable research showing that chromium supplements can prevent MI.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral chromium slows NAFLD progression. Details: One small clinical study in patients with NAFLD shows that taking chromium picolinate 200 mcg two times daily after meals for 12 weeks does not affect liver enzyme levels or body weight when compared with placebo (105027).
• Obesity. Although some research suggests that oral chromium may increase weight loss, this increase in weight loss is not likely to be considered clinically relevant. Details: Meta-analyses of clinical studies in overweight or obese adults show that taking chromium picolinate 200-1000 mcg daily for 12-16 weeks might result in a cumulative weight loss of about 0.5-1 kg when compared with placebo (90062,90065). However, this small reduction in weight is unlikely to be considered clinically significant. Furthermore, certain small clinical studies in healthy, overweight or obese adults and children show that taking oral chromium 200-1000 mcg daily for 6-24 weeks does not reduce weight when compared with control (6860,13727,17224,42680). Some of these studies may not have been adequately powered to detect a smaller effect. A meta-analysis of randomized clinical trials including patients with type 2 diabetes shows that taking chromium 200-1000 mcg orally daily for 8-25 weeks does not lower body mass index when compared with placebo. However, the validity of these results is limited by inclusion of patients with and without obesity at baseline (110607).
• Polycystic ovary syndrome (PCOS). It is unclear if oral chromium improves symptoms of PCOS. Details: One small clinical study in patients with PCOS shows that taking chromium picolinate 1000 mcg daily for 6 months along with diet and exercise counseling decreases body mass index and improves rates of ovulation and regular menstruation when compared with placebo (95094). Also, some clinical research shows that taking chromium picolinate (21st Century HealthCare, Inc. or Nature Made) 200 mcg daily orally for 8 weeks increases insulin sensitivity when compared with placebo (95095,98687). However, other preliminary clinical research shows that taking chromium picolinate 200 mcg daily for 4 months does not affect insulin sensitivity or improve ovulation rates (42603). Although chromium picolinate at doses of less than 1000 mcg might have very small effects on fasting glucose, these doses do not seem to have clinically beneficial effects on fasting glucose, pregnancy rate, or testosterone levels (95094,95095,98687). A lower dose of chromium has also been studied in combination with carnitine. One small clinical study in overweight adults with PCOS shows that taking chromium picolinate 200 mcg daily with carnitine 1000 mg daily for 12 weeks modestly reduces fasting blood glucose, insulin resistance, and body weight, and slightly increases insulin sensitivity, when compared with placebo (103747). However, it is unclear if this benefit is clinically significant. Additionally, it is unclear if these effects are due to chromium, carnitine, or the combination. Carnitine has demonstrated clinical benefit when used alone in PCOS.
• Turner syndrome. It is unclear if oral chromium is beneficial in patients with this condition. Details: A small clinical study shows that taking brewer's yeast 30 grams containing chromium 50 mcg daily for 8 weeks might improve abnormalities in glucose and lipid metabolism when compared with baseline in patients with Turner syndrome, a genetic disorder that has a high incidence of diabetes (13729). The validity of this finding is limited by the lack of a comparator group. More evidence is needed to rate chromium for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Although there has been interest in using topical Fucus vesiculosus for aging skin, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Cardiovascular disease (CVD). Although there has been interest in using oral Fucus vesiculosus for CVD, including atherosclerosis and hypertension, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Constipation. Although there has been interest in using oral Fucus vesiculosus for constipation, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Diarrhea. Although there has been interest in using oral Fucus vesiculosus for diarrhea, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Dyspepsia. Although there has been interest in using oral Fucus vesiculosus for dyspepsia, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Hypercholesterolemia. It is unclear if oral Fucus vesiculosus is beneficial in hypercholesterolemia. Details: A small clinical study in patients with obesity or overweight and low-density lipoprotein (LDL) cholesterol levels exceeding 77 mg/dL shows that taking a polyphenol-rich extract of Fucus vesiculosus (Maritech Synergy, Marinova) 2000 mg, providing 560 mg of polyphenols, daily for 12 weeks increases levels of high-density lipoprotein (HDL) cholesterol by 10%, compared with 2% in those receiving placebo. No differences were observed for total cholesterol, LDL cholesterol, or triglycerides (106723).
• Hypothyroidism. Although there has been interest in using oral Fucus vesiculosus for hypothyroidism, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Impaired glucose tolerance (prediabetes). Oral Fucus vesiculosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with prediabetes and dysglycemia shows that taking a specific product (Gdue, Aesculapius), containing extracts of Fucus vesiculosus and Ascophyllum nodosum in a 5:95 ratio along with chromium picolinate three times daily for 6 months reduces fasting and postprandial blood glucose, glycated hemoglobin (HbA1c), insulin, and insulin resistance when compared with placebo (100847). It is unclear if these effects are due to Fucus vesiculosus, other ingredients, or the combination. Another small clinical study in adults with prediabetes and also overweight or obese shows that taking a specific product (InSea2, InnoVactiv Inc.) containing 500 mg of Fucus vesiculosus and Ascophyllum nodosum extracts daily for 12 weeks reduces postprandial blood glucose but does not improve fasting blood glucose, HbA1c, body weight, lipids, or blood pressure when compared with placebo (110560).
• Iodine deficiency. Although there has been interest in using oral Fucus vesiculosus for iodine deficiency and goiter, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose.
• Metabolic syndrome. Oral Fucus vesiculosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in adults with one or more components of metabolic syndrome has found that taking a specific combination product (Gdue, Aesculapius) containing extracts of Fucus vesiculosus and Ascophyllum nodosum in a 5:95 ratio along with chromium picolinate two to three times daily with meals for around 6 months is associated with reductions in body weight by 7.3 kg, waist circumference by 7.5 cm, fasting blood glucose by 16 mg/dL, glycated hemoglobin (HbA1c) by 0.55%, systolic blood pressure by 7 mmHg, diastolic blood pressure by 4 mmHg, low-density lipoprotein (LDL) cholesterol by 18 mg/dL, and 10-year cardiovascular risk scores by 1.8% when compared to baseline (110559). It is unclear if these effects are due to Fucus vesiculosus, other ingredients, or the combination. Further, the validity of these findings is limited by a lack of control group.
• Obesity. Oral Fucus vesiculosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in moderately overweight females shows that seaweeds such as Fucus vesiculosus, taken in combination with lecithin and vitamins for up to 2 years, do not result in sustained weight loss when compared to baseline (13663). Another small clinical study in adults with prediabetes and also overweight or obese shows that taking a specific product (InSea2, InnoVactiv Inc.) containing 500 mg of Fucus vesiculosus and Ascophyllum nodosum extracts daily for 12 weeks does not reduce body weight, body mass index (BMI), body fat, lipids, blood pressure, or measures of glycemic control when compared with placebo (110560).
• Wound healing. Although there has been interest in using topical Fucus vesiculosus for wound healing, there is insufficient reliable information about the clinical effects of Fucus vesiculosus for this purpose. More evidence is needed to rate Fucus vesiculosus for these uses.

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POSSIBLY SAFE ...when used orally, short-term. Ascophyllum nodosum dried powder has been used with apparent safety at a dose of up to 500 mg daily for up to 6 months (94996,94997,103900). However, marine products such as Ascophyllum nodosum are known to accumulate heavy metals such as arsenic (94997,94999). Some supplement products are prospectively analyzed to confirm a lack of contaminants and that heavy metal levels are below threshold (94997).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those found in food.

(Read more about ASCOPHYLLUM NODOSUM)

POSSIBLY SAFE ...when used orally and appropriately. Berberine has been used safely in doses up to 1.5 grams daily for 6 months (262,13520,20579) (34317,34228,34247,34253,34262,34263,34265,34267,34277,34282), (34283,34286,34287,34289,34293,34301,34305,34306,34319,34325)(99920,99921,103194) or up to 1 gram daily for 24 months (99921,103197). ...when used topically. Berberine ointment has been applied with apparent safety for up to 20 days (13526).

CHILDREN: LIKELY UNSAFE
when used orally in newborns. Berberine can cause kernicterus, particularly in preterm neonates with hyperbilirubinemia (2589). It is unclear if berberine is safe 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). Also, berberine may stimulate uterine contractions (91951).

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

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LIKELY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Chromium has been safely used in doses up to 1000 mcg daily for up to 6 months (1934,5039,5040,6858,6859,6860,6861,6862,6867,6868)(7135,7137,10309,13053,14325,14440,17224,90057,90061)(90063,94234,95095,95096,95097,98687); however, most of these studies have used chromium doses in a range of 150-600 mcg. The Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, long-term. Chromium has been safely used in a small number of studies at doses of 200-1000 mcg daily for up to 2 years (7060,7135,42618,42628,42666,110605,110607,110609). However, the Food and Drug Administration (FDA) and Institute of Medicine (IOM) evaluations of the safety of chromium suggest that it is safe when used in doses of 200 mcg daily for up to 6 months (13241,13242).

CHILDREN: LIKELY SAFE
when used orally and appropriately in amounts not exceeding the daily adequate intake (AI) levels by age: 0-6 months, 0. 2 mcg; 7-12 months, 5.5 mcg; 1-3 years, 11 mcg; 4-8 years, 15 mcg; males 9-13 years, 25 mcg; males 14-18 years, 35 mcg; females 9-13 years, 21 mcg; females 14-18 years, 24 mcg (7135). POSSIBLY SAFE...when used orally and appropriately in amounts exceeding AI levels. Chromium 400 mcg daily has been used safely for up to 6 weeks (42680).

PREGNANCY: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels. The AI for pregnancy is 28 mcg daily for those 14-18 years of age and 30 mcg daily for those 19-50 years of age (7135).

PREGNANCY: POSSIBLY SAFE
when used orally in amounts exceeding the adequate intake (AI) levels. There is some evidence that patients with gestational diabetes can safely use chromium in doses of 4-8 mcg/kg (1953); however, patients should not take chromium supplements during pregnancy without medical supervision.

LACTATION: LIKELY SAFE
when used orally and appropriately in amounts not exceeding adequate intake (AI) levels. The AI for lactation is 44 mcg daily for those 14-18 years of age and 45 mcg daily for those 19-50 years of age (7135). Chromium supplements do not seem to increase normal chromium concentration in human breast milk (1937). There is insufficient reliable information available about the safety of chromium when used in higher amounts while breast-feeding.

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POSSIBLY SAFE ...when applied topically to the skin. A gel containing 1% Fucus vesiculosus extract, applied to the skin twice daily, has been used in clinical research with apparent safety for up to 5 weeks (12799).

POSSIBLY UNSAFE ...when used orally due to its iodine content and possible heavy metal content. Fucus vesiculosus contains up to 0.05% iodine or 226 mcg/gram dry weight (12789,74217). Ingesting more than 150 mcg of iodine daily can cause hyperthyroidism or exacerbate existing hyperthyroidism (12788). Fucus vesiculosus can also contain heavy metals, including cadmium, arsenic, and lead, and can cause heavy metal nephropathy (12789,12800,74213).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when used orally because it may contain iodine and heavy metals (12789,74213,74217); avoid using.

(Read more about FUCUS VESICULOSUS)

AMIODARONE (Cordarone) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, combining Ascophyllum nodosum with amiodarone might cause excessively high iodine levels.  Details Ascophyllum nodosum contains iodine (94997,95000,95102), although the bioavailability of iodine from Ascophyllum nodosum is lower than that of potassium iodide (94997). Amiodarone contains 37.3% iodine and can increase iodine levels. Concomitant use might increase the risk of having excessive iodine levels and adversely affecting thyroid function (7135,17574). Monitor thyroid function.

ANTITHYROID DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, Ascophyllum nodosum might alter the effects of antithyroid drugs.  Details Ascophyllum nodosum contains iodine (94997,95000,95102), although the bioavailability of iodine from Ascophyllum nodosum is lower than that of potassium iodide (94997). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking Ascophyllum nodosum while using antithyroid drugs could alter the effects of the antithyroid drugs (17574).

THYROID HORMONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, Ascophyllum nodosum might alter the effects of thyroid hormone.  Details Ascophyllum nodosum contains iodine (94997,95000,95102), although the bioavailability of iodine from Ascophyllum nodosum is lower than that of potassium iodide (94997). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking Ascophyllum nodosum while using thyroid hormone could alter the effects of thyroid hormone (17574).

(Read more about ASCOPHYLLUM NODOSUM)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, berberine might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.  Details In vitro and in vivo research suggest that berberine can inhibit platelet aggregation (33660,33694). Theoretically, berberine might have additive effects when used with anticoagulant and antiplatelet drugs and increase the risk of bleeding.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, berberine may increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Clinical research shows that berberine may lower blood glucose levels (20579,34247,34265,34282,111363). Theoretically, berberine might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, berberine might have additive effects with antihypertensive drugs.  Details Animal research suggests that berberine can have hypotensive effects (33692,34308). Also, a clinical study suggests that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956).

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, berberine might increase the sedative effects of CNS depressants.  Details Animal research suggests that berberine may have sedative effects (13519,33650,33664,33692). Theoretically, use of berberine along with CNS depressants might produce additive therapeutic and adverse effects.

CYCLOSPORINE (Neoral, Sandimmune) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = A Berberine can increase serum levels of cyclosporine.  Details Berberine can reduce metabolism and increase serum levels of cyclosporine. Berberine might inhibit cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524,21112,34239).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, berberine might increase serum levels of drugs metabolized by CYP2C9.  Details Preliminary clinical research shows that berberine can inhibit CYP2C9 (34279). Theoretically, taking berberine with drugs metabolized by CYP2C9 might increase drug levels and increase the risk of adverse effects.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, berberine might increase serum levels of drugs metabolized by CYP2D6.  Details In vitro research and preliminary clinical evidence show that berberine can inhibit CYP2D6 (21117,34279,34297). Theoretically, use of berberine with drugs metabolized by CYP2D6 might increase drug levels and increase the risk of adverse effects.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, berberine might increase serum levels of drugs metabolized by CYP3A4.  Details In vitro research and preliminary clinical research show that berberine moderately inhibits CYP3A4 (13524,21114,34279,34297). Theoretically, use of berberine with drugs metabolized by CYP3A4 might increase drug levels and increase the risk of adverse effects.

DEXTROMETHORPHAN (Robitussin DM, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, berberine may increase serum levels of dextromethorphan.  Details Preliminary clinical research shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279). This may increase the effects and side effects of dextromethorphan.

LOSARTAN (Cozaar) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Berberine might reduce the therapeutic effects of losartan by decreasing its conversion to its active form.  Details Preliminary clinical research suggests that berberine can inhibit cytochrome P450 2C9 (CYP2C9) activity and reduce metabolism of losartan (34279).

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, berberine might increase the therapeutic and adverse effects of metformin.  Details In vitro and animal studies show that berberine can increase the systemic exposure and half-life of metformin, potentially increasing metformin's effects and side effects. This interaction seems to be most apparent when berberine is administered 2 hours prior to metformin. Taking berberine and metformin at the same time does not appear to increase systemic exposure to metformin (103195).

MIDAZOLAM (Versed) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Berberine can reduce metabolism of midazolam, which might increase the risk of severe adverse effects.  Details Preliminary clinical research shows that berberine can inhibit cytochrome P450 3A4 (CYP3A4) activity and reduce metabolism of midazolam (34279).

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Berberine might increase the sedative effect of pentobarbital.  Details Evidence from animal research shows that berberine can prolong pentobarbital-induced sleeping time (13519). Theoretically, combining berberine and pentobarbital might increase the sedative effects of pentobarbital.

TACROLIMUS (Prograf) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Berberine has been associated with increased blood levels of tacrolimus.  Details In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with tacrolimus 6.5 mg twice daily, intake of berberine 200 mg three times daily increased the blood concentration of tacrolimus from 8 to 22 ng/mL. Following a reduction of the tacrolimus dose to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).

(Read more about BERBERINE)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, chromium may have additive effects with antidiabetic agents and increase the risk of hypoglycemia.  Details Some research shows that taking chromium might lower blood glucose levels, especially in patients with poorly controlled type 2 diabetes (7137,14440,15169,94234,95097,95098,98687).

ASPIRIN Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Possible •  Level of Evidence = D Theoretically, aspirin might increase chromium absorption.  Details Animal research suggests that aspirin may increase chromium absorption and chromium levels in the blood (21055).

INSULIN Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, concomitant use of chromium and insulin might increase the risk of hypoglycemia.  Details In clinical research, chromium has been shown to increase insulin sensitivity (1952,14440,95095),

LEVOTHYROXINE (Synthroid, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Chromium might bind levothyroxine in the intestinal tract and decrease levothyroxine absorption.  Details Clinical research in healthy volunteers shows that taking chromium picolinate 1000 mcg with levothyroxine 1 mg decreases serum levels of levothyroxine by 17% when compared to taking levothyroxine alone (16012). Advise patients to take levothyroxine at least 30 minutes before or 3-4 hours after taking chromium.

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D NSAIDs might increase chromium levels in the body.  Details Drugs that are prostaglandin inhibitors, such as NSAIDs, seem to increase chromium absorption and retention (7135).

(Read more about CHROMIUM)

AMIODARONE (Cordarone) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, combining Fucus vesiculosus with amiodarone might cause excessively high iodine levels.  Details Fucus vesiculosus contains high concentrations of iodine (7135). Amiodarone contains 37.3% iodine and can increase iodine levels. Concomitant use might increase the risk of having excessive iodine levels and adversely affecting thyroid function (7135,17574). Monitor thyroid function.

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking Fucus vesiculosus with antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.  Details In vitro evidence suggests that a constituent of Fucus vesiculosus, known as fucoidan, has anticoagulant effects (12797,74149,74183,74240). However, in clinical research, fucoidan does not seem to have significant anticoagulant activity when taken orally, possibly due to poor absorption (74183).

ANTITHYROID DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, Fucus vesiculosus might alter the effects of antithyroid drugs.  Details Fucus vesiculosus contains high concentrations of iodine (7135). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking Fucus vesiculosus while using antithyroid drugs could alter the effects of the antithyroid drugs (2138,17574).

CYTOCHROME P450 2C8 (CYP2C8) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Fucus vesiculosus with CYP2C8 substrates might increase the risk for adverse effects.  Details In vitro research shows that fucoidan, a constituent of Fucus vesiculosus, inhibits CYP2C8 (97791). This interaction has not been reported in humans.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Fucus vesiculosus with CYP2C9 substrates might increase the risk for adverse effects.  Details In vitro research shows that fucoidan, a constituent of Fucus vesiculosus, inhibits CYP2C9 (97791). This interaction has not been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Fucus vesiculosus with CYP2D6 substrates might alter the effects of these substrates.  Details In vitro research shows that fucoidan, a constituent of Fucus vesiculosus, both inhibits and induces CYP2D6 (97791). This interaction has not been reported in humans.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Fucus vesiculosus with CYP3A4 substrates might increase the risk for adverse effects.  Details In vitro research shows that fucoidan, a constituent of Fucus vesiculosus, inhibits CYP3A4 (97791). This interaction has not been reported in humans.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Concomitant use of Fucus vesiculosus and lithium has resulted in hyperthyroidism.  Details There is a case of hyperthyroidism occurring in a patient taking Fucus vesiculosus and lithium (74217). Monitor thyroid hormones closely in patients taking lithium and Fucus vesiculosus concomitantly.

THYROID HORMONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, Fucus vesiculosus might alter the effects of thyroid hormone.  Details Fucus vesiculosus contains high concentrations of iodine (7135). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking Fucus vesiculosus while using thyroid hormone could alter the effects of thyroid hormone.

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General ...Orally, Ascophyllum nodosum seems to be generally well-tolerated.

Endocrine ...Orally, taking Ascophyllum nodosum powder 500 mg daily for 14 days has been reported to cause elevated levels of thyroid stimulating hormone (TSH) in 2 of 22 women in a clinical trial. The powder contained 356 mcg iodine per 500 mg. Levels of free thyroxine (T4) were unaffected (94997).

Gastrointestinal ...Orally, Ascophyllum nodosum has been reported to cause stomach discomfort in one clinical trial (94996).

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General ...Orally, berberine is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain and distension, constipation, diarrhea, flatulence, nausea, vomiting.
Intravenously: Facial flushing, painful swelling at the injection site.
Serious Adverse Events (Rare):
Intravenously: Ventricular tachycardia consistent with torsades de pointes.

Cardiovascular ...In four of 12 patients with refractory congestive heart failure, intravenous infusion of berberine at a rate of 0. 2 mg/kg per minute caused ventricular tachycardia consistent with torsades de pointes (33642).

Dermatologic ...When administered intravenously, berberine can cause painful swelling at the injection site or facial flushing (34330). In three of 12 people injected subcutaneously with berberine, permanent hyperpigmentation at the injection site occurred (33698).
Orally, berberine may cause rash, but this event appears to be rare (34285,110106).

Endocrine ...Orally, berberine may cause hypoglycemia (111363).

Gastrointestinal ...Orally, berberine may cause diarrhea, constipation, flatulence, nausea, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953,99920,99921,103194,103197)(110106,111363,111699).

Hepatic ...Orally, berberine may occasionally cause an increase in transaminases (99921,103194). However, meta-analyses have found no significant effect of berberine on alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (104508,111363).

Musculoskeletal ...Reports of mild muscle pain and muscle weakness have been reported following the use of a combination product containing berberine, policosanol, red yeast rice, folic acid, coenzyme Q10, and astaxanthin (34283). It is unclear if these effects are due to berberine or other constituents.

Neurologic/CNS ...Orally, berberine may cause headache (33648,99921).

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General ...Orally, chromium is generally well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal irritation, headaches, insomnia, irritability, mood changes.
Serious Adverse Effects (Rare):
Orally: Rare cases of kidney and liver damage, rhabdomyolysis, and thrombocytopenia have been reported.

Dermatologic ...Orally, chromium-containing supplements may cause acute generalized exanthematous pustulosis (42561), skin rashes (42679), and urticaria (17224). Also, chromium picolinate or chromium chloride may cause systemic contact dermatitis when taken orally, especially in patients with contact allergy to chromium (6624,90058). In one clinical study, a patient taking chromium nicotinate 50 mcg daily reported itchy palms that improved after the intervention was discontinued. It is unclear of this effect was due to the chromium or another factor (95096).
Topically, hexavalent chromium, which can be present in some cement, leather products, or contaminated soil, may cause allergic contact dermatitis (42645,42789,90060,90064,110606).
A case of lichen planus has been reported for a patient following long-term occupational exposure to chromium (42688).

Endocrine ...Orally, cases of hypoglycemia have been reported for patients taking chromium picolinate 200-1000 mcg daily alone or 200-300 mcg two or three times weekly in combination with insulin (42672,42783). Chromium picolinate has also been associated with weight gain in young females who do not exercise and in those following a weight-lifting program (1938).

Gastrointestinal ...Orally, chromium in the form of chromium picolinate, chromium polynicotinate, chromium-containing brewer's yeast, or chromium-containing milk powder may cause nausea, vomiting, diarrhea, decreased appetite, constipation, flatulence, or gastrointestinal upset (14325,42594,42607,42622,42643,42679).
Long-term exposure to heavy metals, including chromium, has been associated with increased risk of gallbladder disease and cancer (42682,42704).

Genitourinary ...Orally, chromium polynicotinate has been associated with disrupted menstrual cycles in patients taking the supplement to prevent weight gain during smoking cessation (42643).

Hematologic ...Anemia, hemolysis, and thrombocytopenia were reported in a 33 year-old female taking chromium picolinate 1200-2400 mcg daily for 4-5 months (554). The patient received supportive care, blood product transfusions, and hemodialysis and was stabilized and discharged a few days later. Lab values were normal at a one-year follow-up.

Hepatic ...Liver damage has been reported for a 33-year-old female taking chromium picolinate 1200 mcg daily for 4-5 months (554). Also, acute hepatitis has been reported in a patient taking chromium polynicotinate 200 mcg daily for 5 months (9141). Symptoms resolved when the product was discontinued. Two cases of hepatotoxicity have been reported in patients who took a specific combination product (Hydroxycut), which also contained chromium polynicotinate in addition to several herbs (13037).

Musculoskeletal ...Acute rhabdomyolysis has been reported for a previously healthy 24-year-old female who ingested chromium picolinate 1200 mcg over a 48-hour time period (42786). Also, chromium polynicotinate has been associated with leg pain and paresthesia in patients taking the supplement to prevent weight gain during smoking cessation (42643).

Neurologic/CNS ...Orally, chromium picolinate may cause headache, paresthesia, insomnia, dizziness, and vertigo (6860,10309,14325,42594). Vague cognitive symptoms, slowed thought processes, and difficulty driving occurred on three separate occasions in a healthy 35-year-old male after oral intake of chromium picolinate 200-400 mcg (42751). Transient increases in dreaming have been reported in three patients with dysthymia treated with chromium picolinate in combination with sertraline (2659). A specific combination product (Hydroxycut) containing chromium, caffeine, and ephedra has been associated with seizures (10307). But the most likely causative agent in this case is ephedra.

Psychiatric ...Orally, chromium picolinate has been associated with irritability and mood changes in patients taking the supplement to lose weight, while chromium polynicotinate has been associated with agitation and mood changes in patients taking the supplement to prevent weight gain during smoking cessation (6860,42643).

Renal ...Orally, chromium picolinate has been associated with at least one report of chronic interstitial nephritis and two reports of acute tubular necrosis (554,1951,14312). Laboratory evidence suggests that chromium does not cause kidney tissue damage even after long-term, high-dose exposure (7135); however, patient- or product-specific factors could potentially increase the risk of chromium-related kidney damage. More evidence is needed to determine what role, if any, chromium has in potentially causing kidney damage.
Intravenously, chromium is associated with decreased glomerular filtration rate (GFR) in children who receive long-term chromium-containing total parenteral nutrition - TPN (11787). Topically, burns caused by chromic acid, a hexavalent form of chromium, have been associated with acute chromium poisoning with acute renal failure (42699). Early excision of affected skin and dialysis are performed to prevent systemic toxicity.

Other ...Another form of chromium, called hexavalent chromium, is unsafe. This type of chromium is a by-product of some manufacturing processes. Chronic exposure can cause liver, kidney, or cardiac failure, pulmonary complications, anemia, and hemolysis (9141,11786,42572,42573,42699). Occupational inhalation of hexavalent chromium can cause ulceration of the nasal mucosa and perforation of the nasal septum, and has been associated with pneumoconiosis, allergic asthma, cough, shortness of breath, wheezing, and increased susceptibility to respiratory tract cancer and even stomach and germ cell cancers (42572,42573,42601,42610,42636,42667,42648,42601,42788,90056,90066). Although rare, cases of interstitial pneumonia associated with chromium inhalation have been reported. Symptoms resolved with corticosteroid treatment (42614).

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General ...When used orally, Fucus vesiculosus may be unsafe due to its iodine content. Topically, Fucus vesiculosus appears to be well tolerated.
Most Common Adverse Effects:
Orally: Goiter, hyperthyroidism, hypothyroidism.
Serious Adverse Effects (Rare):
Orally: Thyroid cancer.

Cardiovascular ...In one report, a young adult with obesity developed palpitations and syncope after taking an oral weight loss supplement containing a combination of Fucus vesiculosus, dandelion, and boldo for 3 weeks. The patient was found to have a prolonged QT interval on ECG and frequent episodes of sustained polymorphic ventricular tachycardia (14321). It is not clear whether Fucus vesiculosus, another ingredient, or the combination of ingredients is responsible for this adverse effect. The product was not analyzed to determine the presence of any potential toxic contaminants.

Endocrine ...Orally, Fucus vesiculosus can cause or exacerbate hyperthyroidism due to its high iodine content (12789,13061,74217). One case of hyperthyroidism has been reported for a 60-year-old patient taking lithium for bipolar disorder and a combination product containing Fucus vesiculosus 0.125 grams, cascara 0.170 grams, and Frangula 0.222 grams per tablet for laxative purposes. The patient had been taking one tablet of the combination laxative product daily for several years. Following discontinuation of the supplement, thyroid levels normalized (74217). Similar cases of hyperthyroidism have been reported for patients taking other seaweed-containing herbal supplements (Dream Shape; Ever Youth). Analyses of these supplements shows that these products contain triiodothyronine 1 mcg and thyroxine 3-4 mcg. In addition to seaweed, Dream Shape also contains hydrangea vine, maltose, chrysanthemum, Chinese matrimony vine, and sucrose, while Ever Youth contains radish, lotus leaf, chrysanthemum, hawthorn, senna tea, and Chinese matrimony vine (13061).
Orally, prolonged use of Fucus vesiculosus has been associated with hypothyroidism (13664). The iodine in Fucus vesiculosus can cause idiosyncratic reactions.
According to the Institute of Medicine Food and Nutrition Board, prolonged, high dietary intake of iodine is associated with goiter and an increased risk of thyroid cancer (7135).

Genitourinary ...A case of hemorrhagic cystitis characterized by dysuria and polyuria has been reported in a young adult who took a specific product (Slim-Kombu, Balestra and Mech) containing Fucus vesiculosus and 19 other herbal extracts orally for weight loss. Upon discontinuation, symptoms improved (46959). It is unclear if this effect was due to Fucus vesiculosus or other ingredients in the supplement.

Renal ...A case of hemorrhagic cystitis characterized by dysuria and polyuria has been reported in a young adult who took a specific product (Slim-Kombu, Balestra and Mech) containing Fucus vesiculosus and 19 other herbal extracts orally for weight loss. Upon discontinuation, symptoms improved (46959). It is unclear if this effect was due to Fucus vesiculosus or other ingredients in the supplement. Nephrotoxicity has been associated with oral intake of Fucus vesiculosus that was contaminated with arsenic (12800).

(Read more about FUCUS VESICULOSUS)