Coltsfoot & Wormwood 450 mg by TerraVita

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

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Biliary disorders. Although there has been interest in using oral wormwood for biliary disorders, there is insufficient reliable information about the clinical effects of wormwood for this purpose.
• Crohn disease. Small clinical studies suggest that oral wormwood may modestly improve symptoms in patients with Crohn disease. Details: Preliminary clinical research in patients with Crohn disease shows that taking a specific product (SedaCrohn, Noor Herbals, LLC) containing powdered wormwood 750 mg 2-3 times daily for 6-10 weeks improves quality of life and mood, increases symptom remission, and reduces corticosteroid requirements when compared with placebo (86545,93468). Clinical remission occurred in 8 out of 10 patients taking wormwood, compared with only 2 out of 10 patients taking placebo (93468).
• Depression. Although there has been interest in using oral wormwood for depression, there is insufficient reliable information about the clinical effects of wormwood for this purpose.
• Dyspepsia. Although there has been interest in using oral wormwood for dyspepsia, there is insufficient reliable information about the clinical effects of wormwood for this purpose.
• Gastritis. Although there has been interest in using oral wormwood for gastritis, there is insufficient reliable information about the clinical effects of wormwood for this purpose.
• IgA nephropathy. It is unclear if oral wormwood is beneficial in patients with IgA nephropathy. Details: Preliminary clinical research in patients with IgA nephropathy shows that taking powdered wormwood (Seda-Leukin, Noor Herbals LLC) 600 mg three times daily for 6 months along with standard treatment reduces proteinuria when compared with baseline. The urinary protein:creatinine ratio decreased from 2340 mg/gram to 315 mg/gram over 6 months. Furthermore, systolic and diastolic blood pressures decreased by 10% and 14%, respectively (93469). The validity of these findings is limited by the lack of a comparator group.
• Insect bite. Although there has been interest in using topical wormwood for insect bites, there is insufficient reliable information about the clinical effects of wormwood for this purpose.
• Osteoarthritis. It is unclear if topical wormwood is beneficial in patients with knee osteoarthritis. Details: Preliminary clinical research in patients with knee osteoarthritis shows that applying an ointment or liniment containing wormwood extract 3% to the knee three times daily for 4 weeks might improve pain, although any pain improvement was not maintained 2 weeks after discontinuation. Topical wormwood appears to be less effective than topical piroxicam gel, which improves pain, stiffness, and physical function when compared with baseline, with benefits maintained 2 weeks after discontinuation (95925). More evidence is needed to rate wormwood for these uses.

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LIKELY UNSAFE ...when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally. Repeated exposure to low concentrations of hepatotoxic PAs can cause severe veno-occlusive disease. Hepatotoxic PAs might also be carcinogenic and mutagenic (12841,12842). Dietary supplement products sold in the US are not required to include the amount of PAs they may contain; therefore, all preparations used orally containing coltsfoot should be considered potentially unsafe (3484). Tell patients not to use coltsfoot preparations that are not certified and labeled as hepatotoxic PA-free.

PREGNANCY: LIKELY UNSAFE
when products containing hepatotoxic pyrrolizidine alkaloid (PA) constituents are used orally. Coltsfoot preparations containing hepatotoxic pyrrolizidine alkaloid (PA) constituents might be teratogenic and hepatotoxic (575,12841,12842). There is one case report of fatal hepatic veno-occlusive disease in a neonate associated with regular maternal consumption during pregnancy of an herb tea containing several pyrrolizidine alkaloid herbs, including coltsfoot (575). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during pregnancy; avoid using.

LACTATION: LIKELY UNSAFE
when used orally. Hepatotoxic pyrrolizidine alkaloid (PA) constituents in coltsfoot are excreted in milk (12841,12842). There is insufficient reliable information available about the safety of using coltsfoot products certified and labeled as hepatotoxic PA-free during lactation; avoid using.

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LIKELY SAFE ...when used orally in the amounts commonly found in foods. Wormwood extracts are included in bitters, vermouth, absinthe, and other food or drink products (12814,15007). Wormwood products that are thujone-free have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912); however, products containing thujone might not be safe. Wormwood is described in the pharmacopoeia of various European countries. After being banned for a period of time, it is now allowed in European Union countries; however, beverages must not contain thujone in concentrations greater than 35 mg/kg (12814,15007,86551).

POSSIBLY SAFE ...when wormwood products not containing thujone are used orally in medicinal amounts, short-term (93468,93469). A specific product

POSSIBLY UNSAFE ...when wormwood products containing thujone are used orally. Thujone is a neurotoxin that is present in wormwood oil (12617). Seizures, rhabdomyolysis, and acute kidney failure can occur when as little as 10 mL of wormwood oil is ingested (662,12817).

PREGNANCY:
LIKELY UNSAFE . .when used orally in amounts greater than those found in foods (662,12817). Some wormwood products contain thujone, a neurotoxin. Theoretically, thujone also has potential uterine and menstrual stimulant effects (12617). There is insufficient reliable information available about the safety of wormwood when used topically during pregnancy.

LACTATION:
Insufficient reliable information available; avoid using.

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ANTICONVULSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking wormwood might interfere with the effects of anticonvulsant drugs.  Details Thujone, a constituent of wormwood, has convulsant effects (12816).

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General ...Orally, the major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These alkaloids can cause liver and lung injury (12841,12842). Chronic exposure to other plants containing hepatotoxic PA constituents has been associated with hepatic veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842). Deep vein thrombosis (DVT) and pulmonary embolus (PE) thought to be associated with coltsfoot have been reported (18242). Coltsfoot products containing PAs should be avoided. There is currently a limited amount of information available about the adverse effects of PA-free coltsfoot.

Cardiovascular ...Orally, a single case report associates coltsfoot and its PA content with deep vein thrombosis (DVT) and pulmonary embolus (PE). A 27-year-old man with no history of coagulation disorders developed a DVT and several PE after consuming unknown quantities of coltsfoot and several other herbs. However, he also had other risk factors for thrombosis, including smoking and recent bed rest (18242).

Hepatic ...Orally, coltsfoot might cause liver damage. Coltsfoot contains hepatotoxic pyrrolizidine alkaloids (PAs) (12841,12842). Chronic exposure to other plants containing hepatotoxic PAs is associated with veno-occlusive disease (4021). Sub-acute veno-occlusive disease can cause vague symptoms, including colicky pains, vomiting, diarrhea, and ascites within several days; persistent liver enlargement occurs within a few weeks (4021,12842).

Pulmonary/Respiratory ...Orally, coltsfoot might cause lung damage. The major concern with coltsfoot use is its pyrrolizidine alkaloid (PA) content. These constituents can cause lung damage with pulmonary-arterial hypertension (12841,12842).

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General ...Wormwood contains thujone, a neurotoxin. When products containing thujone are used orally in medicinal amounts, wormwood may be unsafe.
Most Common Adverse Effects:
Orally: The oil from wormwood leaves can cause diffuse muscle aches, nausea, and vomiting.
Serious Adverse Effects (Rare):
Orally: The oil from wormwood leaves can cause acute kidney toxicity, rhabdomyolysis, and seizures.

Dermatologic ...Topically, a single case report describes a sensitivity or first degree chemical burn reaction, with facial pain and erythema, after a 50-year-old adult applied a homemade poultice containing wormwood to the face for an unreported length of time (93466).

Gastrointestinal ...Orally, the oil from wormwood leaves can cause nausea and vomiting (662). Use of a home-prepared wormwood extract has been associated with vomiting and severe diarrhea in an infant (93467).

Hematologic ...Orally, use of a home-prepared wormwood extract has been associated with severe metabolic acidosis in an infant (93467).

Immunologic ...Theoretically, wormwood might cause an allergic reaction in people sensitive to the Asteraceae/Compositae family (12815). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Musculoskeletal ...Orally, the oil from wormwood leaves can cause diffuse muscle aches and rhabdomyolysis (662).

Neurologic/CNS ...Orally, the oil from wormwood leaves can cause seizures (662).

Renal ...Orally, the oil from wormwood leaves can cause acute kidney toxicity and acute kidney failure (662).

Other ...Chronic ingestion of absinthe, an alcoholic beverage that contains wormwood extract, has been linked to absinthism. Absinthism was first described in the 1800s when absinthe was at its peak levels of consumption. It has been characterized by addiction, gastrointestinal adverse effects, insomnia, auditory and visual hallucinations, tremors, paralysis, epilepsy, and brain damage. There is also increased risk of psychiatric disease and suicide (662,12814,15008). Increasing thujone concentrations of absinthe increases anxiety and decreases attention in healthy individuals (86541). A case of bradyarrhythmias associated with absinthe intoxication has also been reported (86543). However, there is speculation that some of the symptoms of absinthism originally described might be attributed to adulteration with metals or toxic plants such as calamus and tansy, rather than the ingredients usually used in absinthe drinks (15007). Some researchers also suggest that absinthism is not a unique condition and is indistinguishable from alcohol use disorder. In fact, some evidence suggests that the thujone concentrations in the absinthe formulations from the 1800s were too low to cause significant thujone-related toxicities (15008,15009).

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