Ingredients | Amount Per 2 Capsules |
---|---|
Proprietary Blend
|
860 mg |
(Articum lappa )
(root)
|
|
(Opuntia streptacantha )
(leaf)
|
|
(Eleutherococcus senticosus )
(root)
|
|
(Armoracia rusticana )
(root)
|
|
(Hydrastis canadensis )
(Root and Rhizome)
|
Capsule (Form: Gelatin, Water)
Below is general information about the effectiveness of the known ingredients contained in the product PBS. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product PBS. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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.
LIKELY SAFE ...when used orally and appropriately, short-term. Eleuthero root extract 300-2000 mg has been used safely in clinical trials lasting up to 3 months (730,1427,2574,7522,11099,15586,91509). There is insufficient reliable information available about the safety of eleuthero when used long-term.
CHILDREN: POSSIBLY SAFE
when used orally in adolescents aged 12-17 years, short-term.
Eleuthero 750 mg three times daily was used for 6 weeks with apparent safety in one clinical trial (75028). There is insufficient reliable information available about the safety of eleuthero in children or adolescents when used long-term.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
POSSIBLY SAFE ...when used orally and appropriately as a single dose (260,261). There is insufficient reliable information available about the safety of goldenseal when used as more than a single dose.
CHILDREN: LIKELY UNSAFE
when used orally in newborns.
The berberine constituent of goldenseal can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589).
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 goldenseal (2589).
LACTATION:
LIKELY UNSAFE when used orally.
Berberine and other harmful constituents can be transferred to the infant through breast milk (2589). Use during lactation can cause kernicterus in the newborn and several resulting fatalities have been reported (2589).
LIKELY SAFE ...when the root is used orally in amounts commonly found in foods. Horseradish has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (2,4,6,12,18). Horseradish has been used with apparent safety at a dose of 480 mg daily for 12 weeks (96309). ...when topical preparations containing no more than 2% mustard oil, a constituent of horseradish, are used (2).
CHILDREN: LIKELY UNSAFE
when used orally in children less than 4 years of age because it can cause gastrointestinal problems (2,12,19).
PREGNANCY AND:
CHILDREN: LIKELY SAFE
when the root is used orally in amounts commonly found in foods.
Horseradish has Generally Recognized as Safe (GRAS) status in the US (4912).
CHILDREN: LIKELY UNSAFE
when the tincture is used regularly and in large amounts, as it is considered an abortifacient (19).
LACTATION: LIKELY SAFE
when the root is used orally in amounts commonly found in foods.
Horseradish has Generally Recognized as Safe (GRAS) status in the US (4912).
LACTATION: LIKELY UNSAFE
when used orally in large amounts.
The mustard oils produced by glucosinolates from horseradish are considered toxins that can be excreted through breast milk (33031).
LIKELY SAFE ...when prickly pear cactus fruit and pads are used orally as a food (5969).
POSSIBLY SAFE ...when prickly pear cactus fruit and pads are used orally and appropriately in supplemental amounts, short-term. Prickly pear cactus fruit pulp 250 grams twice daily has been used with apparent safety for up to 2 weeks (12086) and prickly pear cactus pads 3-15 grams daily have been used with apparent safety for up to 2 years (92146). Extracts of prickly pear fruit skin 400 mg daily or prickly pear pads 960 mg daily have been used with apparent safety for 12-16 weeks (92146,105903).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product PBS. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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. |
Theoretically, eleuthero may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
Details
|
Theoretically, eleuthero might have additive effects when used with antidiabetes drugs.
Details
Animal research suggests that certain constituents of eleuthero have hypoglycemic activity in both healthy and diabetic animals (7591,73535,74932,74956,74988,74990). A small study in adults with type 2 diabetes also shows that taking eleuthero for 3 months can lower blood glucose levels (91509). However, one very small study in healthy individuals shows that taking powdered eleuthero 3 grams, 40 minutes prior to a 75-gram oral glucose tolerance test, significantly increases postprandial blood glucose levels when compared with placebo (12536). These contradictory findings might be due to patient-specific variability and variability in active ingredient ratios.
|
Theoretically, eleuthero might increase levels of drugs metabolized by CYP1A2.
Details
In vitro and animal research suggest that standardized extracts of eleuthero inhibit CYP1A2 (7532). This effect has not been reported in humans.
|
Theoretically, eleuthero might increase levels of drugs metabolized by CYP2C9.
Details
In vitro and animal research suggest that standardized extracts of eleuthero might inhibit CYP2C9 (7532). This effect has not been reported in humans.
|
Theoretically, eleuthero might increase levels of drugs metabolized by CYP2D6.
Details
|
Theoretically, eleuthero might increase levels of drugs metabolized by CYP3A4.
Details
|
Eleuthero might increase serum digoxin levels and increase the risk of side effects.
Details
In one case report, a 74-year-old male who was stabilized on digoxin presented with an elevated serum digoxin level after starting an eleuthero supplement, without symptoms of toxicity. After stopping the supplement, serum digoxin levels returned to normal (543). It is not clear whether this was due to a pharmacokinetic interaction or to interference with the digoxin assay (15585). Although the product was found to be free of digoxin and digitoxin (543), it was not tested for other contaminants (797).
|
Theoretically, eleuthero might interfere with immunosuppressive drugs because of its immunostimulant activity.
Details
|
Theoretically, eleuthero might decrease levels of drugs metabolized by OATP.
Details
In vitro research suggests that eleuthero inhibits OATP2B1, which might reduce the bioavailability of oral drugs that are substrates of OATP2B1 (35450). Due to the weak inhibitory effect identified in this study, this interaction is not likely to be clinically significant.
|
Theoretically, eleuthero might increase levels of P-glycoprotein substrates.
Details
|
Theoretically, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.
Details
|
Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.
Details
|
Theoretically, goldenseal might increase the risk of hypotension when taken with antihypertensive drugs.
Details
Goldenseal contains berberine. Animal research shows that berberine can have hypotensive effects (33692,34308). Also, an analysis of clinical research shows that taking berberine in combination with amlodipine can lower systolic and diastolic blood pressure when compared with amlodipine alone (91956). However, this effect has not been reported with goldenseal.
|
Theoretically, goldenseal might increase the sedative effects of CNS depressants.
Details
|
Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2C9.
Details
In vitro research shows that goldenseal root extract can modestly inhibit CYP2C9. This effect may be due to its alkaloid constituents, hydrastine and berberine (21117). However, this effect has not been reported in humans.
|
Goldenseal might increase serum levels of drugs metabolized by CYP2D6.
Details
|
Theoretically, goldenseal might increase serum levels of drugs metabolized by CYP2E1.
Details
In vitro research shows that goldenseal root extract can inhibit the activity of CYP2E1 (94140). However, this effect has not been reported in humans.
|
Goldenseal might increase serum levels of drugs metabolized by CYP3A4.
Details
Most clinical and in vitro research shows that goldenseal inhibits CYP3A4 enzyme activity and increases serum levels of CYP3A4 substrates, such as midazolam (6450,13536,21117,91740,111725). However, in one small clinical study, goldenseal did not affect the levels of indinavir, a CYP3A4 substrate, in healthy volunteers (10690,93578). This is likely due to the fact that indinavir has a high oral bioavailability, making it an inadequate probe for CYP3A4 interactions (13536,91740) and/or that it is primarily metabolized by hepatic CYP3A, while goldenseal has more potential to inhibit intestinal CYP3A enzyme activity (111725). Both goldenseal extract and its isolated constituents berberine and hydrastine inhibit CYP3A, with hydrastine possibly having more inhibitory potential than berberine (111725).
|
Theoretically, goldenseal might increase serum levels of dextromethorphan.
Details
Goldenseal contains berberine. A small clinical study shows that berberine can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).
|
Goldenseal might increase serum levels of digoxin, although this effect is unlikely to be clinically significant.
Details
Clinical research shows that goldenseal modestly increases digoxin peak levels by about 14% in healthy volunteers. However, goldenseal does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal does not cause a clinically significant interaction with digoxin. Digoxin is a P-glycoprotein substrate. Some evidence suggests that goldenseal constituents might affect P-glycoprotein; however, it is unclear whether these constituents inhibit or induce P-glycoprotein.
|
Theoretically, goldenseal might decrease the conversion of losartan to its active form.
Details
Goldenseal contains berberine. A small clinical study shows that berberine inhibits cytochrome P450 2C9 (CYP2C9) activity and reduces the metabolism of losartan (34279). However, this effect has not been reported with goldenseal.
|
Theoretically, goldenseal might reduce blood levels of metformin.
Details
In vitro research shows that goldenseal extract decreases the bioavailability of metformin, likely by interfering with transport, intestinal permeability, or other processes involved in metformin absorption. It is unclear which, if any, of metformin's transporters are inhibited by goldenseal. Goldenseal does not appear to alter the clearance or half-life of metformin (105764).
|
Theoretically, goldenseal might reduce the therapeutic effects of oseltamivir by decreasing its conversion to its active form.
Details
In vitro evidence suggests that goldenseal reduces the formation of the active compound from the prodrug oseltamivir (105765). The mechanism of action and clinical relevance is unclear.
|
Theoretically, goldenseal might increase or decrease serum levels of P-glycoprotein (P-gp) substrates.
Details
There is conflicting evidence about the effect of goldenseal on P-gp. In vitro research suggests that berberine, a constituent of goldenseal, modestly inhibits P-gp efflux. Other evidence suggests that berberine induces P-gp. In healthy volunteers, goldenseal modestly increases peak levels of the P-gp substrate digoxin by about 14%. However, it does not seem to affect other pharmacokinetic parameters such as area under the curve (AUC) (15132). This suggests that goldenseal is not a potent inhibitor of P-gp-mediated drug efflux. Until more is known, goldenseal should be used cautiously with P-gp substrates.
|
Theoretically, goldenseal might increase the sedative effects of pentobarbital.
Details
Animal research shows that berberine, a constituent of goldenseal, can prolong pentobarbital-induced sleeping time (13519). However, this effect has not been reported with goldenseal.
|
Theoretically, goldenseal might increase serum levels of tacrolimus.
Details
Goldenseal contains berberine. 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 tacrolimus dosing to 3 mg daily, blood levels of tacrolimus decreased to 12 ng/mL (91954).
|
Theoretically, horseradish might interfere with the effects of thyroid hormone.
Details
Horseradish and other members of the cabbage and mustard family are associated with depressed thyroid function (4).
|
Combining prickly pear cactus with antidiabetes drugs might increase the risk of hypoglycemia.
Details
Case reports show that combining prickly pear cactus with antidiabetes drugs such as chlorpropamide, glyburide, glipizide, and metformin can increase the risk of hypoglycemia in patients with type 2 diabetes (5968,14806,17226,65319,92146). Advise patients to monitor glucose levels closely. Dose adjustments may be necessary.
|
Below is general information about the adverse effects of the known ingredients contained in the product PBS. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
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.
General
...Orally, eleuthero root is generally well tolerated when used short-term.
Most Common Adverse Effects:
Orally: Diarrhea, dyspepsia, gastrointestinal upset, headache, nausea, and urticaria.
Cardiovascular ...Orally, increased blood pressure has been reported in children with hypotension taking eleuthero in one clinical study (74980). Eleuthero has been reported to cause tachycardia, hypertension, and pericardial pain in patients with rheumatic heart disease or atherosclerosis. It is unclear if these effects were caused by eleuthero, or by the cardioglycoside-containing herb, silk vine (Periploca sepium), which is a common adulterant found in eleuthero products (12,797,6500).
Dermatologic ...Orally, eleuthero has been reported to cause rash in some clinical studies (75013,75028).
Gastrointestinal ...Orally, eleuthero has been reported to cause dyspepsia, nausea, diarrhea, and gastrointestinal upset in some patients (74938,75028,91510).
Genitourinary ...Orally, mastalgia and uterine bleeding were reported in 7. 3% of females taking eleuthero 2 grams daily in one clinical study (6500,11099). These adverse effects seem to be more likely with higher doses.
Neurologic/CNS
...Orally, headaches have been reported in 9.
8% of people taking eleuthero in one clinical study (11099).
In one case report, a 53-year-old female developed spontaneous subarachnoid hemorrhage associated with the use of an herbal supplement containing red clover, dong quai, and eleuthero (70419). It is unclear if this event was related to the use of eleuthero, the other ingredients, the combination, or another cause entirely.
Psychiatric ...Orally, nervousness has been reported in 7. 3% of people taking eleuthero in one clinical study (11099). Eleuthero has also been reported to cause slight anxiety, irritability, and melancholy in some patients (6500,11099). These adverse effects seem to be more likely to occur with higher doses.
General
...There is limited reliable information available about the safety of goldenseal when used in more than a single dose.
Berberine, a constituent of goldenseal, is generally well tolerated when used orally.
Most Common Adverse Effects:
Orally: Berberine, a constituent of goldenseal, can cause abdominal distension, abdominal pain, bitter taste, constipation, diarrhea, flatulence, headache, nausea, and vomiting.
Dermatologic ...Orally, berberine, a constituent of goldenseal, may cause rash. However, this appears to be rare (34285). A case of photosensitivity characterized by pruritic, erythematous rash on sun-exposed skin has been reported in a 32-year-old female taking a combination product containing goldenseal, ginseng, bee pollen, and other ingredients. The rash resolved following discontinuation of the supplement and treatment with corticosteroids (33954). It is not clear if this adverse effect is due to goldenseal, other ingredients, or the combination.
Endocrine ...A case of severe, reversible hypernatremia has been reported in an 11-year-old female with new-onset type 1 diabetes and diabetic ketoacidosis who took a goldenseal supplement (52592).
Gastrointestinal ...Orally, berberine, a constituent of goldenseal, may cause diarrhea, constipation, flatulence, vomiting, abdominal pain, abdominal distention, and bitter taste (33648,33689,34245,34247,34285,91953). Theoretically, these effects may occur in patients taking goldenseal. However, this hasn't been reported in clinical research or case reports.
Neurologic/CNS ...Orally, berberine, a constituent of goldenseal, may cause headache when taken in a dose of 5 mg/kg daily (33648). Theoretically, this may occur with goldenseal, but this hasn't been reported in clinical research or case reports.
General
...Orally, horseradish is generally well tolerated when consumed in amounts commonly used with foods.
But consuming large amounts of horseradish can cause various adverse effects.
Most Common Adverse Effects:
Orally: When consumed in large amounts, bloody vomiting, diarrhea, gastrointestinal upset.
Topically: Fresh horseradish can cause irritation or allergic reaction.
Serious Adverse Effects (Rare):
Orally: Transient vasovagal syncope.
Dermatologic ...Topically, skin contact with fresh horseradish can cause irritation (4,19) or allergic reaction (4).
Endocrine ...Orally, horseradish and other members of the cabbage and mustard family are associated with depressed thyroid function (4).
Gastrointestinal ...Orally, consuming large amounts of horseradish can cause gastrointestinal upset, bloody vomiting and diarrhea (2,6), and irritation of mucous membranes (2,4).
Genitourinary ...Orally, consuming large amounts of horseradish can cause irritation of the urinary tract (19).
Neurologic/CNS ...Orally, consuming large amounts of horseradish can cause vasovagal syncope in rare cases. At least two cases of vasovagal syncope associated with horseradish consumption have been reported. In one case, a 56-year-old male experienced a sharp burning sensation in his stomach followed by tachycardia, weakness, and excessive perspiration after consuming an oyster topped with an olive-sized dollop of fresh horseradish. He experienced vasovagal syncope within 5 minutes of horseradish ingestion but regained consciousness moments later, with few residual symptoms and no medical intervention required. Researchers theorize that the vapors from horseradish can irritate the gastric or respiratory tract mucosa triggering the vaso-vagal response. Horseradish-induced vasovagal syncope has also been referred to as Seder syncope due to the tradition of consuming bitter herbs, including horseradish, during the Jewish Passover holiday dinner. To reduce the potential for this reaction, researchers suggest that freshly prepared horseradish rest before consumption, allowing some of the active vapor ingredient, thought to be isothiocyanate, to evaporate before ingestion (111724).
General
...Orally, prickly pear cactus is generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal fullness, dyspepsia, mild diarrhea, nausea.
Dermatologic ...Orally, prickly pear cactus has been linked to rare cases of urticaria and pruritus. In a clinical study of 41 patients taking prickly pear cactus pad ethanolic extract, three patients experienced pruritus and one patient experienced urticaria (105903).
Gastrointestinal ...Orally, prickly pear cactus may cause mild diarrhea, dyspepsia, nausea, increased stool volume and frequency, and abdominal fullness (7028,65266,105903). Cases of low colonic obstruction and rectal phytobezoars resulting in rectal perforation have been reported for patients who ingested prickly pear cactus fruit seeds (65260,65266). However, these events are extremely rare and attributed to the ingestion of a large number of fruits. Because dried prickly pear cactus swells into a mass much larger than its original size, it may potentially cause dangerous blockages of the esophagus or intestines. Similar products have been associated with serious or even fatal blockages, but cases of such blockages from prickly pear cactus are lacking in the scientific literature.
Neurologic/CNS ...Orally, prickly pear cactus has been linked to rare cases of headache, insomnia, and dizziness (65266,105903). In a clinical study of 41 patients taking prickly pear cactus pad ethanolic extract, two patients experienced headache, one patient experienced dizziness, and one patient experienced insomnia (105903).