Irish Sea Moss Complex 2,250 mg by Nature's Truth

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.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there is interest in using topical burdock for acne, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Aging skin. It is unclear if topical burdock is beneficial for reducing wrinkles. Details: A very small study in females aged 39-65 years shows that applying an emulsion containing burdock fruit extract 1.2% to the face twice daily for 4 weeks slightly reduces skin wrinkles around the eyes when compared with placebo (37420).
• Atopic dermatitis (eczema). Although there is interest in using topical burdock for eczema, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Breast cancer. Oral burdock root has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Population research in breast cancer patients has found that using a specific product containing burdock root, sheep sorrel, slippery elm bark, and Indian rhubarb (Essiac, Resperin Canada Limited) is not associated with improved quality of life when compared with no intervention (37419).
• Common cold. Although there is interest in using oral burdock for symptoms of the common cold, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diabetes. Although there is interest in using oral burdock for diabetes, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Diverticulitis. It is unclear if oral burdock is beneficial in patients with diverticulitis. Details: A small open-label clinical study in patients with colonic diverticulitis shows that taking burdock tea (Ajikan, Co., Ltd.) providing 1.5 grams three times daily for a median of 26 months is associated with an acute diverticulitis recurrence rate of 11%, compared with 32% of those not taking burdock tea. Furthermore, the recurrence-free duration was increased by about 14 months. However, taking burdock tea for a median of 16 months does not prevent colonic diverticular bleeding recurrence (102696).
• Dry skin. Although there is interest in using topical burdock for dry skin, there is insufficient reliable information about the clinical effects of burdock for this purpose.
• Gout. Although there is interest in using oral burdock for gout, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Hepatitis. Although there is interest in using oral burdock for hepatitis, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Metabolic syndrome. It is unclear if oral burdock is beneficial in patients with metabolic syndrome. Details: A very small clinical study in patients with metabolic syndrome shows that drinking burdock extract 100 mL three times daily after meals for 16 weeks does not reduce body weight, abdominal fat, blood pressure, lipid levels, or glucose when compared with baseline or control (105667).
• Obesity. Although there is interest in using oral burdock for obesity, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Urinary tract infections (UTIs). Although there is interest in using oral burdock for UTI, there is insufficient reliable information about the clinical effects of burdock for this condition.
• Vaginitis. Topical burdock has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Observational research in adults and children with vaginitis has found that applying a specific solution containing burdock, chamomile, and aloe (Zelesse, ITF Research Pharma S.L.U., Alcobendas) to the vaginal area once or twice daily for 5-20 days is associated with moderate improvements in symptoms such as pruritus, erythema, and discharge when compared with baseline (102695,102697). The validity of this finding is limited by its observational nature and the lack of a control group. More evidence is needed to rate burdock for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Fatigue. It is unclear if oral sea moss is beneficial for increasing energy. Details: A small observational study in a heterogenous population of patients with various subjective symptoms at baseline has evaluated the effects of overwintered and stressed sea moss versus non-overwintered or stressed sea moss. This study found that the overwintered and stressed sea moss powder, taken as 500 mg three times daily for 3 weeks, is associated with improvements in exhaustion and fatigue in about 36% of patients and improvements in strength and energy in 84% of patients. The non-overwintered or stressed sea moss powder, taken in the same dose, is associated with improvements of about 18% and 27%, respectively (109121). This study is limited by the subjective nature of the reported symptoms and the lack of an appropriate comparator group.
• Iodine deficiency. Although there is interest in using oral sea moss as a source of iodine, there is insufficient reliable information about the clinical effects of sea moss for this use.
• Muscle strength. Although there is interest in using oral sea moss for muscle support in athletes, there is insufficient reliable information about the clinical effects of sea moss for this use.
• Pain (chronic). It is unclear if oral sea moss is beneficial for pain reduction. Details: A small observational study in a heterogenous population of patients with various subjective symptoms at baseline has evaluated the effects of overwintered and stressed sea moss versus non-overwintered or stressed sea moss. This study found that the overwintered and stressed sea moss powder, taken as 500 mg three times daily for 3 weeks, is associated with a reduction in pain in 10% of patients, compared with 0% of patients taking non-overwintered or stressed sea moss powder (109121). This study is limited by the subjective nature of the reported symptoms and the lack of an appropriate comparator group.
• Quality of life. It is unclear if oral sea moss is beneficial for improving quality of life. Details: A small observational study in a heterogenous population of patients with various subjective symptoms at baseline has evaluated the effects of overwintered and stressed sea moss versus non-overwintered and stressed sea moss. This study found that the overwintered or stressed sea moss powder, as 500 mg three times daily for 3 weeks, is associated with an improvement in mood in 26% of patients, compared with only 3% of those taking non-overwintered or stressed sea moss powder (109121). This study is limited by the subjective nature of the reported symptoms and the lack of an appropriate comparator group. More evidence is needed to rate sea moss 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)

LIKELY SAFE ...when used in amounts commonly found in foods (12659,12660). Burdock root is commonly eaten as a vegetable (37422,92153,92154)

POSSIBLY SAFE ...when used topically, short-term. An emulsion containing burdock fruit extract 1.2% has been safely applied to the face twice daily for 4 weeks (37420). There is insufficient reliable information available about the safety of burdock when used orally in supplemental doses.

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

(Read more about BURDOCK)

LIKELY SAFE ...when sea moss is used orally in the amounts found in foods (109120). There is insufficient reliable information available about the safety of sea moss when used in medicinal amounts. However, sea moss contains iodine in a concentration of approximately 4-7 mcg per gram. Total daily intake of iodine above the tolerable upper intake level (UL) of 1100 mcg should be avoided (109117).

PREGNANCY AND LACTATION: LIKELY SAFE
when used in food amounts (109120). There is insufficient reliable information available about the safety of using larger amounts; avoid using.

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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).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking burdock with anticoagulant or antiplatelet drugs might increase the risk of bleeding.  Details In vitro research shows that lignans from burdock reduce rabbit platelet aggregation by inhibiting platelet activating factor (12619). This interaction has not been reported in humans.

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AMIODARONE (Cordarone) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining sea moss with amiodarone might cause excessively high iodine levels.  Details Amiodarone contains 37.3% iodine and can increase iodine levels. Concomitant use with sea moss, which contains approximately 4-7 mcg of iodine per gram, might increase the risk of adverse effects from iodine, including altered thyroid function (109117).

ANTITHYROID DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, sea moss might alter the effects of antithyroid drugs.  Details Sea moss contains approximately 4-7 mcg of iodine per gram (109117). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking sea moss could theoretically alter the effects of antithyroid drugs.

THYROID HORMONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Due to its iodine content, sea moss might alter the effects of thyroid hormone.  Details Sea moss contains approximately 4-7 mcg of iodine per gram (109117). Iodine in high doses has been reported to cause both hyperthyroidism and hypothyroidism, depending on the individual's past medical history. Taking sea moss could theoretically alter the effects of thyroid hormone.

(Read more about SEA MOSS)

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, burdock is well tolerated when consumed as a food. Although a thorough evaluation of safety outcomes is lacking, there has been long-standing historical use of burdock with few noted adverse effects.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions, including contact dermatitis and anaphylaxis.

Dermatologic ...Contact dermatitis has been reported secondary to burdock, especially after prolonged use of the root oil (37422). There are cases of allergic dermatitis secondary to using burdock plasters. Two males and a 14 year-old female developed erythematous and vesicular, pruritic, and exudative reactions in areas corresponding to the application of burdock root plasters (12667). Reactions occurred up to 7 days after initial use. Patch testing was positive for burdock sensitivity in all three patients and was nonreactive in matched controls.

Hematologic ...In one case report, a 38-year-old female developed immune-mediated thrombocytopenia after consuming a "cleansing" tea containing unknown amounts of burdock and yellow dock. The patient presented with bruising, mild weakness, and fatigue, which started 2-3 days after consuming the tea, and was found to have a platelet count of 5,000 per mcL. Symptoms resolved after platelet transfusion and treatment with oral dexamethasone (108971). It is unclear if these effects were caused by burdock, yellow dock, the combination, or other contributing factors.

Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing burdock and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to burdock, other ingredients, or the combination.

Immunologic ...There is one case of anaphylactic shock secondary to eating boiled burdock. One hour after eating boiled burdock the patient presented with redness over the entire body and dyspnea. He was found to have low blood pressure and was treated with subcutaneous epinephrine 1 mg and intravenous lactated ringer's solution containing hydrocortisone 100 mg and dexamethasone 8 mg. The cause of anaphylactic shock was attributed to allergenicity to burdock based on positive skin prick test results. Previously, the patient had experienced urticaria after eating boiled burdock (12660).

Neurologic/CNS ...Anticholinergic reactions including dry mouth, dizziness, blurred vision, weakness, dilated pupils, inability to urinate, and bradycardia have been reported following the consumption of burdock products (12662,37421,37431,37434,37435). However, these anticholinergic reactions are believed result from contamination of burdock with belladonna alkaloids. Burdock itself does not contain atropine or other constituents that would be responsible for these reactions.

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General ...Orally, sea moss is well tolerated when used appropriately.

Gastrointestinal ...Orally, see moss has been reported to cause constipation and diarrhea in one observational study (109121).

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