Three tablets contain: Shen Min : He Shou Wu (Fo Ti) root powder 12:1 standardized extract: Chrysophanics and Resveratrol complex 1,775 mg • Bioperine brand Black Pepper extract (piper nigrum) 3.0 mg. Other Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Pharmaceutical Glaze.
Brand name products often contain multiple ingredients. To read detailed information about each ingredient, click on the link for the individual ingredient shown above.
Below is general information about the effectiveness of the known ingredients contained in the product Shen Min. 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
Below is general information about the safety of the known ingredients contained in the product Shen Min. 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 orally in amounts commonly found in foods. Black pepper has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when black pepper oil is applied topically. Black pepper oil is nonirritating to the skin and is generally well tolerated (11). ...when black pepper oil is inhaled through the nose or as a vapor through the mouth, short-term. Black pepper oil as a vapor or as an olfactory stimulant has been used with apparent safety in clinical studies for up to 3 days and 30 days, respectively (29159,29160,29161,90502). There is insufficient reliable information available about the safety of black pepper when used orally in medicinal amounts.
CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods (11).
CHILDREN: POSSIBLY UNSAFE
when used orally in large amounts.
Fatal cases of pepper aspiration have been reported in some patients (5619,5620). There is insufficient reliable information available about the safety of topical pepper oil when used in children.
PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods (11).
PREGNANCY: LIKELY UNSAFE
when used orally in large amounts.
Black pepper might have abortifacient effects (11,19); contraindicated. There is insufficient reliable information available about the safety of topical pepper when used during pregnancy.
LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (11).
There is insufficient reliable information available about the safety of black pepper when used in medicinal amounts during breast-feeding.
POSSIBLY UNSAFE ...when used orally. Fo-ti has been linked to several cases of liver damage (7626,7627,14327,14347,14482,16459,17192,50711,50727,50729) (92892,92895,112231).
CHILDREN: POSSIBLY UNSAFE
when used orally.
Fo-ti has been linked to several cases of liver damage in adults and at least one case in a 5-year-old child (14339,92895).
PREGNANCY: POSSIBLY UNSAFE
when used orally.
Fo-ti contains anthraquinone constituents, which can exert a stimulant laxative effect. Bulk-forming or emollient laxatives are preferred in pregnancy (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during pregnancy.
LACTATION: POSSIBLY UNSAFE
when used orally.
Anthraquinone constituents can cross into breast milk and might cause loose stools in some breast-fed infants (272). Fo-ti has also been linked to several cases of liver damage (7626,7627,14327). There is insufficient reliable information available about the safety of fo-ti when used topically during lactation.
LIKELY SAFE ...when used in amounts found in foods (2030).
POSSIBLY SAFE ...when taken orally in doses of up to 1500 mg daily for up to 3 months (71066,71097,91328,91331,95825,95833,98910,100695,105183,109163,109167). Higher doses of 2000-3000 mg daily have been well tolerated when taken for 2-6 months, but are more likely to cause gastrointestinal side effects (91327,98908). ...when used topically for up to 30 days (71064). ...when used as an intranasal spray for up to 4 weeks (97339).
CHILDREN: LIKELY SAFE
when used in amounts found in foods.
CHILDREN: POSSIBLY SAFE
when used as an intranasal spray for up to 2 months in children 4 years of age and older (91332).
There is insufficient reliable information available about the safety of resveratrol when used by mouth in larger amounts as medicine.
PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts found in foods (2030).
Resveratrol is found in grape skins, grape juice, wine, and other food sources. However, wine should not be used as a source of resveratrol during pregnancy and lactation.
Below is general information about the interactions of the known ingredients contained in the product Shen Min. 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, black pepper might increase the effects and side effects of amoxicillin.
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Animal research shows that taking piperine, a constituent of black pepper, with amoxicillin increases plasma levels of amoxicillin (29269). This has not been reported in humans.
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Theoretically, black pepper might increase the risk of bleeding when taken with antiplatelet or anticoagulant drugs.
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In vitro research shows that piperine, a constituent of black pepper, seems to inhibit platelet aggregation (29206). This has not been reported in humans.
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Theoretically, black pepper might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Animal research shows that piperine, a constituent of black pepper, can reduce blood glucose levels (29225). Monitor blood glucose levels closely. Dose adjustments might be necessary.
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Theoretically, black pepper might increase blood levels of atorvastatin.
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Animal research shows that taking piperine, a constituent of black pepper, 35 mg/kg can increase the maximum serum concentration of atorvastatin three-fold (104188). This has not been reported in humans.
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Theoretically, black pepper might increase blood levels of carbamazepine, potentially increasing the effects and side effects of carbamazepine.
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One clinical study in patients taking carbamazepine 300 mg or 500 mg twice daily shows that taking a single 20 mg dose of purified piperine, a constituent of black pepper, increases carbamazepine levels. Piperine may increase carbamazepine absorption by increasing blood flow to the GI tract, increasing the surface area of the small intestine, or inhibiting cytochrome P450 3A4 (CYP3A4) in the gut wall. Absorption was significantly increased by 7-10 mcg/mL/hour. The time to eliminate carbamazepine was also increased by 4-8 hours. Although carbamazepine levels were increased, this did not appear to increase side effects (16833). In vitro research also shows that piperine can increase carbamazepine levels by 11% in a time-dependent manner (103819).
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Theoretically, black pepper might increase the effects and side effects of cyclosporine.
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In vitro research shows that piperine, a constituent of black pepper, increases the bioavailability of cyclosporine (29282). This has not been reported in humans.
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Theoretically, black pepper might increase levels of drugs metabolized by CYP1A1.
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In vitro research suggests that piperine, a constituent of black pepper, inhibits CYP1A1 (29213). This has not been reported in humans.
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Theoretically, black pepper might increase levels of drugs metabolized by CYP2B1.
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In vitro research suggests that piperine, a constituent of black pepper, inhibits CYP2B1 (29332). This has not been reported in humans.
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Theoretically, black pepper might increase levels of drugs metabolized by CYP2D6.
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Theoretically, black pepper might increase levels of drugs metabolized by CYP3A4.
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Theoretically, black pepper might increase blood levels of lithium due to its diuretic effects. The dose of lithium might need to be reduced.
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Black pepper is thought to have diuretic properties (11).
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Black pepper might increase blood levels of nevirapine.
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Clinical research shows that piperine, a constituent of black pepper, increases the plasma concentration of nevirapine. However, no adverse effects were observed in this study (29209).
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Theoretically, black pepper might increase levels of P-glycoprotein substrates.
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Theoretically, black pepper might increase the sedative effects of pentobarbital.
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Animal research shows that piperine, a constituent of black pepper, increases pentobarbital-induced sleeping time (29214).
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Black pepper might increase blood levels of phenytoin.
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Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption, slow elimination, and increase levels of phenytoin (537,14442). Taking a single dose of black pepper 1 gram along with phenytoin seems to double the serum concentration of phenytoin (14375). Consuming a soup with black pepper providing piperine 44 mg/200 mL of soup along with phenytoin also seems to increase phenytoin levels when compared with consuming the same soup without black pepper (14442).
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Black pepper might increase blood levels of propranolol.
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Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption and slow elimination of propranolol (538).
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Black pepper might increase blood levels of rifampin.
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Black pepper might increase blood levels of theophylline.
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Clinical research shows that piperine, a constituent of black pepper, seems to increase absorption and slow elimination of theophylline (538).
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Theoretically, fo-ti might increase the risk of hypoglycemia when taken with antidiabetes drugs.
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Theoretically, taking large amounts of fo-ti might interfere with contraceptive drugs due to competition for estrogen receptors.
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of drugs metabolized by CYP1A2.
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In vitro research suggests that fo-ti might inhibit CYP1A2 (12479,112351). Additionally, in vitro research suggests that the degree of CYP1A2 inhibition depends on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, in an animal study, an aqueous extract of fo-ti inhibited CYP1A2 while an alcoholic extract of fo-ti induced CYP1A2 (92898). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2B6.
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Animal research suggests that fo-ti might inhibit CYP2B6 (92898). One in vitro study suggests that the degree of CYP2B6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C19.
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Animal and in vitro research suggests that fo-ti may inhibit CYP2C19 (12479,92898,112351). An in vitro study suggests that the degree of CYP2C19 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP2C8.
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In vitro research suggests that fo-ti might inhibit CYP2C8 (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2C9.
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Theoretically, fo-ti may increase the levels and clinical effects of drugs metabolized by CYP2D6.
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Animal research suggests that fo-ti might inhibit CYP2D6 (92898). Additionally, an in vitro study suggests that the degree of CYP2D6 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this interaction has not been reported in humans.
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Theoretically, fo-ti might increase the levels and clinical effects of drugs metabolized by CYP3A4.
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In vitro research suggests that fo-ti might inhibit CYP3A4 (12479,112351). One in vitro study suggests that the degree of CYP3A4 inhibition may depend on the type of fo-ti extract (i.e., the raw plant leads to greater inhibition than extensively processed extracts) (112351). However, this evidence conflicts with animal research suggesting that fo-ti does not inhibit CYP3A4 (92898). This interaction has not been reported in humans.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia and cardiotoxicity when taken with digoxin.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of hypokalemia when taken with diuretic drugs.
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Theoretically, taking large amounts of fo-ti might interfere with hormone replacement therapy through competition for estrogen receptors.
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Theoretically, fo-ti might increase the risk of liver damage when taken with hepatotoxic drugs.
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Theoretically, fo-ti, particularly raw fo-ti root, might increase the risk of fluid and electrolyte depletion when taken with stimulant laxatives.
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Theoretically, fo-ti might increase or decrease the levels and clinical effects of sulindac.
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Animal research suggests that the type of fo-ti extract might affect the levels of sulindac differently; the raw plant may increase levels, but processed parts may decrease levels (112351). Induction or inhibition of CYP1A2 by fo-ti has not been reported in humans.
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Theoretically, fo-ti might increase the effects and adverse effects of warfarin.
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Fo-ti may have stimulant laxative effects and cause diarrhea, especially when the raw or unprocessed fo-ti root is used (5,12,16459,50733,99855). Diarrhea can increase the effects of warfarin, increase international normalized ratio (INR), and increase the risk of bleeding. Also, fo-ti has been linked to cases of acute liver failure which can decrease clotting factor production and increase the effects of warfarin. In one case, a patient who had been stable on warfarin presented with acute hepatitis and an INR elevated to 14.98. The patient had been taking fo-ti for 90 days prior to admission. Discontinuation of warfarin and fo-ti lead to a decrease in the INR and full recovery (17192).
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Resveratrol may have antiplatelet effects and may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs.
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Theoretically, resveratrol might increase levels of drugs metabolized by CYP1A1.
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Theoretically, resveratrol might increase levels of drugs metabolized by CYP1A2.
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In vitro research shows that resveratrol can inhibit CYP1A2 enzymes (21733). However, this interaction has not been reported in humans.
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Theoretically, resveratrol might increase levels of drugs metabolized by CYP1B1.
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In vitro research shows that resveratrol can inhibit CYP1B1 enzymes (70834). However, this interaction has not been reported in humans.
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Theoretically, resveratrol might increase levels of drugs metabolized by CYP2C19.
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In vitro research shows that resveratrol can inhibit CYP2C19 enzymes (70896). However, this interaction has not been reported in humans.
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Resveratrol might increase levels of drugs metabolized by CYP2E1.
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In vitro research suggests that resveratrol inhibits CYP2E1 isoenzyme (7864,70896). Also, a pharmacokinetic study shows that taking resveratrol 500 mg daily for 10 days prior to taking a single dose of chlorzoxazone 250 mg increases the maximum concentration of chlorzoxazone by about 54%, the area under the curve of chlorzoxazone by about 72%, and the half-life of chlorzoxazone by about 35% (95824). Chlorzoxazone is used as a probe drug for CYP2E1.
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Theoretically, resveratrol might increase levels of drugs metabolized by CYP3A4.
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Below is general information about the adverse effects of the known ingredients contained in the product Shen Min. 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, black pepper seems to be well tolerated when used in the amounts found in food or when taken as a medicine as a single dose.
Topically and as aromatherapy, black pepper oil seems to be well tolerated.
Most Common Adverse Effects:
Orally: Burning aftertaste, dyspepsia, and reduced taste perception.
Inhalation: Cough.
Serious Adverse Effects (Rare):
Orally: Allergic reaction in sensitive individuals.
Gastrointestinal ...Orally, black pepper can cause a burning aftertaste (5619) and dyspepsia (38061). Single and repeated application of piperine, the active constituent in black pepper, to the tongue and oral cavity can decrease taste perception (29267). By intragastric route, black pepper 1.5 grams has been reported to cause gastrointestinal microbleeds (29164). It is not clear if such an effect would occur with oral administration.
Immunologic ...In one case report, a 17-month-old male developed hives, red eyes, facial swelling, and a severe cough following consumption of a sauce containing multiple ingredients. Allergen skin tests were positive to both black pepper and cayenne, which were found in the sauce (93947).
Ocular/Otic ...Topically, ground black pepper can cause redness of the eyes and swelling of the eyelids (5619).
Pulmonary/Respiratory ...When inhaled through the nose as an olfactory stimulant, black pepper oil has been reported to cause cough in one clinical trial (29162).
General
...Orally, fo-ti may be unsafe.
Most Common Adverse Effects:
Orally: Abdominal pain, diarrhea, nausea, and vomiting with use of unprocessed fo-ti.
Serious Adverse Effects (Rare):
Orally: Hepatotoxicity with processed or unprocessed fo-ti.
Dermatologic ...Orally, one case of a fine maculopapular rash was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if the rash was due to fo-ti or other ingredients in the herbal product.
Gastrointestinal ...Orally, unprocessed fo-ti may cause diarrhea, abdominal pain, nausea, and vomiting (12,50733).
Hematologic ...Orally, one case of mild eosinophilia was reported in a patient taking the herbal product known as Shen-Min, which contains fo-ti. Symptoms resolved within three weeks after discontinuing the product (14482). It is unclear if this reaction was due to fo-ti or other ingredients in the herbal product. A case of agranulocytosis was reported in a 65-year-old female taking fo-ti 30 grams/day for 17 days. The patient recovered gradually following a 15-day hospitalization, which included treatment with intravenous steroids and granulocyte colony-stimulating factor (112231).
Hepatic
...Orally, cases of liver damage due to both processed and unprocessed fo-ti have been well documented in the medical literature.
(7626,7627,14327,14339,14347,14482,16459,17192,50711,50726)(50727,50729,92892,92895,112231).
In a systematic review, around 450 cases of hepatitis associated with fo-ti were identified. These cases occurred in patients 5-78 years of age. Liver damage occurred at a wide range of doses, formulations, and durations of intake. The type of liver injury ranged from hepatocellular, to cholestatic, or mixed. Outcomes ranged from full recovery to cirrhosis, liver transplantation, and/or death. The evidence suggests that when the daily fo-ti dose is less than 12 grams, the median time to occurrence of liver damage is 60 days. When the daily fo-ti dose is more than 12 grams, the median time to liver damage is 30 days (92895). Presenting signs and symptoms may include jaundice, abdominal pain, nausea, fatigue, loss of appetite, dark urine, myalgias, and elevations in liver function tests (LFTs), ferritin, transferrin, prothrombin time, and INR (17192,92892). Other manifestations may include fever, skin rash, thrombocytopenia, pancytopenia, and arthralgias. Symptoms and increased LFTs usually seem to resolve within a month after discontinuing fo-ti (7626,7627,14339,14347,14482,16459). In one case series, liver enzymes began to normalize 48 hours after discontinuation of fo-ti and treatment with S-adenosylmethionine, compound glycyrrhizin injection, polyene phosphatidylcholine, and reduced glutathione. All patients were eventually discharged home in stable condition (92892). Rechallenge with fo-ti should not be attempted. A patient who had recovered from hepatitis associated with fo-ti use presented with myalgias and markedly elevated LFTs after a single dose of the herb (17192).
It is thought that this idiosyncratic reaction leading to liver damage is at least partially related to genetic polymorphisms. Cytochrome P450 1A2 (CYP1A2) is the predominant enzyme involved in biotransformation of emodin, a constituent of fo-ti thought to play a role in liver damage. In one genetic study, the frequency of CYP1A2*1C mutation in fo-ti induced drug-induced liver injury patients was 46.5%, which is significantly higher than the 27.9% frequency of liver injury reported in healthy patients without the mutation. Patients with a CYP1A2*1C mutation may have decreased activity of the CYP1A2 enzyme, which could inhibit the metabolism of fo-ti, causing an accumulation of toxic substances (92897).
General
...In foods, resveratrol is well tolerated.
When used orally in higher doses, as well as topically or intranasally, resveratrol seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal discomfort, and loose stools.
Dermatologic
...Orally, there is one case of a pruritic skin rash that occurred in a clinical trial.
The rash resolved two weeks after stopping resveratrol (109163).
Topically, a case of allergic contact dermatitis has been reported after applying a facial cream (Resveratrol BE, Skinceuticals) containing aqueous resveratrol 1% in combination with Baikal skullcap root extract 0.5%. Patch testing identified a positive reaction to both ingredients (110024).
Gastrointestinal ...Orally, mild gastrointestinal discomfort with increased diarrhea or loose stools has been reported, especially when resveratrol is taken in doses of 2. 5-5 grams daily (71042,71052,91327,95830,109163,109164,109167).
Hematologic ...In one clinical study, a patient developed severe febrile leukopenia and thrombocytopenia after taking oral resveratrol 500 mg three times daily for 10 days. Upon re-exposure to resveratrol, febrile leukopenia recurred (109163).
Musculoskeletal ...Orally, resveratrol has been associated with muscle cramps in patients on peritoneal dialysis. The causality of this adverse effect has not been established (95830).
Neurologic/CNS ...Orally, resveratrol has been associated with headache, fatigue, and memory loss in patients on peritoneal dialysis. The causality of these adverse effects has not been established (95830).