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Barberry

Scientific Name(s): Berberis aristata Sims., Berberis vulgaris L., Mahonia aquifolium (Pursh) Nutt.
Common Name(s): Barberry, Berberis, Holly barberry, Jaundice berry, Oregon barberry, Oregon grape, Oregon grapeholly, Pepperidge bush, Sour-spine, Sowberry, Trailing mahonia, Woodsour

Clinical Overview

See also: Amitiza

Use

Clinical applications may include use in treating diabetes and dyslipidemia, although clinical trials are limited and are often of poor quality. Other activity includes antimicrobial, antioxidant, and anti-inflammatory effects. No clinical trials exist to support uses related to effects on the cardiovascular and central nervous systems or treating cancer.

Dosing

Daily doses of 2 g of the berries and 1.5 to 3 g daily of dry bark have been used; however, there are limited clinical studies to substantiate barberry's varied uses.

Contraindications

Caution is warranted in the presence of cardiac arrhythmia. Use in children has not been validated.

Pregnancy/Lactation

Avoid use. There are documented adverse effects, including uterine stimulant effects.

Interactions

Case reports are lacking; however, barberry exhibits anti-cytochrome P450 3A4 (CYP3A4) activity similar to that of grapefruit. Caution is warranted with coadministration of potentially toxic medicines such as cyclosporine.

Adverse Reactions

GI symptoms (eg, nausea, vomiting, diarrhea), dizziness, and fainting have been reported. Effects on the cardiovascular system (eg, hypotension, decreased heart rate) and decreased respiration may occur with high dosages. The German Commission E reports that lower doses of berberine are well tolerated. Hypersensitivity has been documented.

Toxicology

Symptoms of poisoning are characterized by lethargy, stupor and daze, vomiting and diarrhea, and nephritis. A median lethal dose (LD50) for berberine was noted as 27.5 mg/kg in humans. Berberine showed mutagenicity in yeast cells and Ames test, while a phototoxic reaction between berberine alkaloid and ultraviolet A (UVA) light has been described.

Botany

Some 500 species of barberry are recognized, and plants within the genus Berberis and Mahonia have similar chemical composition. Barberry grows wild throughout Europe but has been naturalized to many regions of the eastern US. M. aquifolium is an evergreen shrub native to the northwestern US and Canada. Barberry grows to more than 3 m with branched, spiny, holly-like leaves and is widely planted as an ornamental. Its yellow flowers bloom from May to June and develop into red to blue/black oblong berries.1, 2, 3, 4

History

Barberry has a long history of use, dating back to the Middle Ages in Europe. Salishan tribe native elders of the Pacific Northwest used M. aquifolium to treat acne, and Native Americans utilized Mahonia berries to treat scurvy. The species B. aristata has been used in traditional Chinese and Nepalese medicine and in the Ayurvedic medical system for many years. The sundried fruits are eaten for antipyretic and diuretic effects in Turkey. A decoction of the plant has been used to treat GI ailments and coughs. The alkaloid berberine was included as an astringent in eye drops, but its use has become rare. The edible fruits have been used to prepare jams, jellies, and juices. The use of the plant in traditional medicine has been limited by the bitter taste of the bark and root. However, multiple medicinal uses for barberry have been listed and include treatments in cancer, cholera, and hypertension.2, 3, 5

Chemistry

Plant parts include the stem, root, fruit, flowers, and leaves. Alkaloids, tannins, phenolic compounds, sterols, and triterpenes have all been described. The isoquinoline alkaloids are of primary interest and include berberine, berbamine, and oxycanthine, among numerous others. Variation in content exists among the different species. Methods for identification and quantification have been established and berberine fingerprinting has been described.2, 4, 6, 7, 8

Uses and Pharmacology

Anti-inflammatory

Animal data

Alkaloids isolated from M. aquifolium exhibited anti-inflammatory and antiproliferative activity.2, 3

Clinical data

Limited clinical studies have evaluated the efficacy of topical M. aquifolium in psoriasis. Efficacy was greater than with placebo but not as effective as with standard therapy; exacerbations have been described. Further studies are required. 9

Antimicrobial effects

Because of the association of Helicobacter pylori with gastritis, peptic ulcer, and gastric cancer, in vitro experimentation was conducted in H. pylori-infected gastric epithelial cells with 24 medicinal plants indigenous to Pakistan to evaluate their effect on secretion of interleukin (IL)-8 and generation of reactive oxygen species (ROS) in order to assess anti-inflammatory and cytoprotective effects. Although no significant direct cytotoxic effects on the gastric cells or bactericidal effects on H. pylori were found, root extract of barberry was observed to have mild and moderate inhibitory activity on IL-8 at 50 and 100 mcg/mL, respectively, and the most significant suppression on ROS generation in H. pylori-infected gastric cells of extracts tested.9

Animal data

Antimicrobial effects have been described for Berberis spp. and berberine.2, 10, 11 In mice, a topical 20% root bark extract application was effective against cutaneous leishmaniasis,12 while chickens with severe diarrhea fed B. vulgaris root bark extract fared better through anticoccidal activity.13

Clinical data

Older, limited clinical studies evaluated berberine for treating diarrhea caused by Eschericia coli and cholera, and against microbes such as giardia and trichomonas.14, 15

Cancer

Animal data

Induction of apoptosis and cell cycle arrest, signalling, and tumor promotion have been shown in vitro by B. vulgaris and B. aristata extracts, and berberine and berbamine constituents.7, 10, 16, 17

Clinical data

Research reveals no clinical data regarding the use of barberry for cancer. Berberine alone has been evaluated as an adjunct to prevent adverse effects of radiation.18

Cardiovascular effects

Animal data

Experiments have shown berberine to exhibit effects on the cardiovascular system, although the mechanisms remain poorly understood. Positive inotropic and negative chronotropic effects, as well as vasodilatory, antiarrhythmic, and hypotensive effects, have been described.7, 19, 20

Clinical data

Research reveals no clinical data regarding the use of Berberis or Mahonia spp. for cardiovascular conditions. Caution is warranted in the presence of cardiac arrhythmia.

CNS/Dementia

Animal data

Anti-acetylcholinesterase activity has occurred for berberine and extracts of B. vulgaris in animal studies and in vitro experiments.10, 21, 22, 23, 24 In mice, neuroprotective effects have been demonstrated whereby berberine inhibited apoptosis in hippocampal tissue and prevented dopaminergic neuronal damage on histology. Improvements in short-term memory and enhanced motor balance and coordination were observed in a mouse model of Parkinson disease.24 An anticonvulsant effect was demonstrated in mice.21

Clinical data

Research reveals no clinical data regarding the use of Berberis or Mahonia spp. for CNS-related conditions.

Diabetes

Animal data

Studies in rodents both normotensive and with induced diabetes have consistently demonstrated improved glycemic control with administration of berberine and Berberis extracts. Inhibition of alpha-glucosidase activity has been demonstrated; however, the precise mechanism of action remains unclear.10, 25, 26, 27, 28

Clinical data

Berberine exerted a hypoglycemic action in a small trial of patients with type 2 diabetes.29 In women with metabolic-associated polycystic ovary syndrome, berberine taken over 3 months decreased fasting blood glucose levels.30 Findings from a larger, multicenter clinical trial evaluating this effect have not been concluded.31 Small clinical trials examining the effect of consumption of the fruit in type 2 diabetes showed improvements in the lipid profile and glycemic control.28, 32 Data from trials in which Berberis extracts were used in combination with other plant extracts cannot be attributed to a single plant.33, 34, 35

Dyslipidemia

Animal data

Studies in rodents have shown positive effects of berberine on the lipid profile.10, 36

Clinical data

Berberine alone improved the lipid profile in dyslipidemia in several clinical trials among participants with differing conditions, including familial hypercholesterolemia, obesity, and diabetes.37, 38, 39 Barberry taken over 6 weeks improved the lipid profile and influenced C-reactive protein in a randomized clinical study in 106 patients with metabolic syndrome; effect on blood pressure or other cardiovascular outcomes was not reported.40 Small clinical trials have been conducted examining the effect of barberry consumption in type 2 diabetes and demonstrated improvements in the lipid profile and glycemic control.28, 32 In 124 euglycemic, dyslipidemic patients intolerant to high doses of statins, administration of half the statin dose plus twice daily dosing of a B. aristata 588 mg/S. marianum 105 mg combination product significantly reduced fasting plasma glucose, insulin, insulin index and stabilized lipid levels compared to baseline and placebo in a 6-month double-blind, randomized, placebo-controlled trial. Lipid levels increased significantly during the study period in the placebo group. The intervention (a patented nutraceutical in Italy containing B. aristata extract standardized to 85% berberine plus S. marianum extract titrated to more than 60% flavanolignans) was well tolerated.53

Other uses

Limited studies in rodents and when using homeopathic doses suggest B. vulgaris extracts possess activity against calcium oxalate deposition.41, 42 B. aristata improved benign prostatic hyperplasia in rats possibly by inhibition of androgen and anti-inflammatory effects.22, 43 A small clinical trial reported positive effects for B. vulgaris fruit extract in treating acne. The study was conducted for only 4 weeks, with results from a longer trial required.44 The American Academy of Dermatology/American Academy of Dermatology Association guidelines of care for the management of acne vulgaris (2016) states that oral barberry has been reported to have value in the treatment of acne (limited; moderate).55

Antioxidant effects have been documented.45, 46 Effects on the GI tract have been described in rodent studies. Protection against inflammatory-related damage and motility effects have been reported, suggesting therapeutic uses for inflammatory bowel conditions.47, 48

Further effects for berberine alone have been described in studies using Goldenseal (see Goldenseal monograph).

Dosing

Barberry berries and root bark have been used as a source of berberine. Daily doses of 2 g of the berries and 1.5 to 3 g daily of dry bark have been used3; however, there are limited clinical studies to substantiate barberry's varied uses.2, 49 Berberine and related alkaloids are poorly absorbed when taken orally; in vitro and animal studies must be interpreted with care. Use in children has not been validated.

Pregnancy / Lactation

Avoid use. There are documented adverse effects, including uterine stimulant effects.3, 49, 50

Interactions

Case reports are lacking; however, Berberis exhibits anti-CYP3A4 activity similar to that of grapefruit. Caution is warranted with coadministration of potentially toxic medicines such as cyclosporine.19, 51 Berberine may also induce P-glycoprotein.56

Adverse Reactions

GI symptoms (eg, nausea, vomiting, diarrhea), dizziness, and fainting have been reported. Effects on the cardiovascular system (eg, hypotension, decreased heart rate) and decreased respiration may occur with high dosages.2, 3 Hypersensitivity has been documented.9 The German Commission E reports that doses of berberine 500 mg are well tolerated.49

Toxicology

Symptoms of poisoning are characterized by lethargy, stupor and daze, vomiting and diarrhea, and nephritis.49 An LD50 for berberine was noted as 27.5 mg/kg in humans.8

Berberine showed mutagenicity in yeast cells and Ames test.3 A phototoxic reaction between berberine alkaloids and UVA light has been described.52

References

1. Berberis vulgaris L. USDA, NRCS. 2014. The PLANTS database (http://plants.usda.gov, 2014). National Plant Data Team, Greensboro, NC 27401-4901 USA. Accessed September 25, 2014.
2. Khan IA, Abourashed EA. Leung’s Encyclopedia of Common Natural Ingredients Used in Food, Drugs, and Cosmetics. 3rd ed. Hoboken, NJ: Wiley; 2009.
3. Duke JA. Handbook of Medicinal Herbs. 2nd ed. Boca Raton, FL: CRC Press; 2002.
4. Mokhber-Dezfuli N, Saeidnia S, Gohari AR, Kurepaz-Mahmoodabadi M. Phytochemistry and pharmacology of Berberis species. Pharmacogn Rev. 2014;8(15):8-15.24600191
5. Isikli ND, Yilmaz I. Some physical properties of sun-dried Berberis fruit (Berberis crataegina). J Food Sci Technol. 2014;51(1):104-110.24426054
6. Zovko Koncić M, Kremer D, Karlović K, Kosalec I. Evaluation of antioxidant activities and phenolic content of Berberis vulgaris L. and Berberis croatica Horvat. Food Chem Toxicol. 2010;48(8-9):2176-2180.20488218
7. Potdar D, Hirwani RR, Dhulap S. Phyto-chemical and pharmacological applications of Berberis aristata. Fitoterapia. 2012;83(5):817-830.22808523
8. Duke J. Dr. Duke's phytochemical and ethnobotanical databases. Agricultural Research Service website. http://www.ars-grin.gov/duke. Updated June 13, 1996. Accessed September 25, 2014.
9. Deng S, May BH, Zhang AL, Lu C, Xue CC. Plant extracts for the topical management of psoriasis: a systematic review and meta-analysis. Br J Dermatol. 2013;169(4):769-782.23909714
10. Abd El-Wahab AE, Ghareeb DA, Sarhan EE, Abu-Serie MM, El Demellawy MA. In vitro biological assessment of Berberis vulgaris and its active constituent, berberine: antioxidants, anti-acetylcholinesterase, anti-diabetic and anticancer effects. BMC Complement Altern Med. 2013;13:218.24007270
11. Rouhani S, Salehi N, Kamalinejad M, Zayeri F. Efficacy of Berberis vulgaris aqueous extract on viability of Echinococcus granulosus protoscolices. J Invest Surg. 2013;26(6):347-351.23978263
12. Salehabadi A, Karamian M, Farzad MH, Namaei MH. Effect of root bark extract of Berberis vulgaris L. on Leishmania major on BALB/c mice. Parasitol Res. 2014;113(3):953-957.
13. Malik TA, Kamili AN, Chishti MZ, Tanveer S, Ahad S, Johri RK. In vivo anticoccidial activity of berberine [18, 5,6-dihydro-9,10-dimethoxybenzo(g)-1,3-benzodioxolo(5,6-a) quinolizinium]—an isoquinoline alkaloid present in the root bark of Berberis lycium. Phytomedicine. 2014;21(5):663-669.24411651
14. Rabbani GH, Butler T, Knight J, Sanyal SC, Alam K. Randomized controlled trial of berberine sulfate therapy for diarrhea due to enterotoxigenic Escherichia coli and Vibrio cholerae. J Infect Dis. 1987;155(5):979-984.3549923
15. Kin-Maung U, Myo-Khin, Nyunt-Nyunt-Wai, Aye-Kyaw, Tin-U. Clinical trial of berberine in acute watery diarrhoea. Br Med J (Clin Res Ed). 1985;291(6509):1601-1605.
16. Ho YT, Yang JS, Lu CC, et al. Berberine inhibits human tongue squamous carcinoma cancer tumor growth in a murine xenograft model. Phytomedicine. 2009;16(9):887-890.19303753
17. Yang F, Nam S, Brown CE, et al. A novel berbamine derivative inhibits cell viability and induces apoptosis in cancer stem-like cells of human glioblastoma, via up-regulation of miRNA-4284 and JNK/AP-1 signaling. PLoS One. 2014;9(4):e94443.24732116
18. Li GH, Wang DL, Hu YD, et al. Berberine inhibits acute radiation intestinal syndrome in human with abdomen radiotherapy. Med Oncol. 2010;27(3):919-925.19757213
19. Brenyo A, Aktas MK. Review of complementary and alternative medical treatment of arrhythmias. Am J Cardiol. 2014;113(5):897-903.24528618
20. Lau CW, Yao XQ, Chen ZY, Ko WH, Huang Y. Cardiovascular actions of berberine. Cardiovasc Drug Rev. 2001;19(3):234-244.11607041
21. Bonesi M, Loizzo MR, Conforti F, et al. Berberis aetnensis and B. libanotica: a comparative study on the chemical composition, inhibitory effect on key enzymes linked to Alzheimer's disease and antioxidant activity. J Pharm Pharmacol. 2013;65(12):1726-1735.24236982
22. Bhutada P, Mundhada Y, Bansod K, Dixit P, Umathe S, Mundhada D. Anticonvulsant activity of berberine, an isoquinoline alkaloid in mice. Epilepsy Behav. 2010;18(3):207-210.20638957
23. Simões Pires EN, Frozza RL, Hoppe JB, Menezes Bde M, Salbego CG. Berberine was neuroprotective against an in vitro model of brain ischemia: survival and apoptosis pathways involved. Brain Res. 2014;1557:26-33.24560603
24. Kim M, Cho KH, Shin MS, et al. Berberine prevents nigrostriatal dopaminergic neuronal loss and suppresses hippocampal apoptosis in mice with Parkinson's disease. Int J Mol Med. 2014;33(4):870-878.24535622
25. Moazezi Z, Qujeq D. Berberis fruit extract and biochemical parameters in patients with type II diabetes. Jundishapur J Nat Pharm Prod. 2014;9(2):e13490.24872938
26. El-Sayed MM, Ghareeb DA, Talat HA, Sarhan EM. High fat diet induced insulin resistance and elevated retinol binding protein 4 in female rats; treatment and protection with Berberis vulgaris extract and vitamin A. Pak J Pharm Sci. 2013;26(6):1189-1195.24191325
27. Ashraf H, Heidari R, Nejati V, Ilkhanipoor M. Effects of aqueous extract of Berberis integerrima root on some physiological parameters in streptozotocin-induced diabetic rats. Iran J Pharm Res. 2013;12(2):425-434.24250618
28. Meliani N, Dib Mel A, Allali H, Tabti B. Hypoglycaemic effect of Berberis vulgaris L. in normal and streptozotocin-induced diabetic rats. Asian Pac J Trop Biomed. 2011;1(6):468-471.23569815
29. Yin J, Xing H, Ye J. Efficacy of berberine in patients with type 2 diabetes mellitus. Metabolism. 2008;57(5):712-717.18442638
30. Wei W, Zhao H, Wang A, et al. A clinical study on the short-term effect of berberine in comparison to metformin on the metabolic characteristics of women with polycystic ovary syndrome. Eur J Endocrinol. 2012;166(1):99-105.22019891
31. Li Y, Ma H, Zhang Y, et al. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial. Trials. 2013;14:226.23866924
32. Shidfar F, Ebrahimi SS, Hosseini S, Heydari I, Shidfar S, Hajhassani G. The effects of Berberis vulgaris fruit extract on serum lipoproteins, apoB, apoA-I, homocysteine, glycemic control and total antioxidant capacity in type 2 diabetic patients. Iran J Pharm Res. 2012;11(2):643-652.24250489
33. Di Pierro F, Villanova N, Agostini F, Marzocchi R, Soverini V, Marchesini G. Pilot study on the additive effects of berberine and oral type 2 diabetes agents for patients with suboptimal glycemic control. Diabetes Metab Syndr Obes. 2012;5:213-217.22924000
34. Di Pierro F, Putignano P, Villanova N, Montesi L, Moscatiello S, Marchesini G. Preliminary study about the possible glycemic clinical advantage in using a fixed combination of Berberis aristata and Silybum marianum standardized extracts versus only Berberis aristata in patients with type 2 diabetes. Clin Pharmacol. 2013;5:167-174.24277991
35. Derosa G, Bonaventura A, Bianchi L, et al. Berberis aristata/Silybum marianum fixed combination on lipid profile and insulin secretion in dyslipidemic patients. Expert Opin Biol Ther. 2013;13(11):1495-1506.23971720
36. Zhou Y, Cao S, Wang Y, et al. Berberine metabolites could induce low density lipoprotein receptor up-regulation to exert lipid-lowering effects in human hepatoma cells. Fitoterapia. 2014;92:230-237.24321576
37. Pisciotta L, Bellocchio A, Bertolini S. Nutraceutical pill containing berberine versus ezetimibe on plasma lipid pattern in hypercholesterolemic subjects and its additive effect in patients with familial hypercholesterolemia on stable cholesterol-lowering treatment. Lipids Health Dis. 2012;11:123.22998978
38. Hu Y, Ehli EA, Kittelsrud J, et al. Lipid-lowering effect of berberine in human subjects and rats. Phytomedicine. 2012;19(10):861-867.22739410
39. Cianci A, Cicero AF, Colacurci N, Matarazzo MG, De Leo V. Activity of isoflavones and berberine on vasomotor symptoms and lipid profile in menopausal women. Gynecol Endocrinol. 2012;28(9):699-702.22313171
40. Zilaee M, Kermany T, Tavalaee S, Salehi M, Ghayour-Mobarhan M, Ferns GA. Barberry treatment reduces serum anti-heat shock protein 27 and 60 antibody titres and high-sensitivity C-reactive protein in patients with metabolic syndrome: a double-blind, randomized placebo-controlled trial. Phytother Res. 2014;28(8):1211-1215.24536039
41. Jyothilakshmi V, Thellamudhu G, Kumar A, Khurana A, Nayak D, Kalaiselvi P. Preliminary investigation on ultra high diluted B. vulgaris in experimental urolithiasis. Homeopathy. 2013;102(3):172-178.23870376
42. Bashir S, Gilani AH, Siddiqui AA, et al. Berberis vulgaris root bark extract prevents hyperoxaluria induced urolithiasis in rats. Phytother Res. 2010;24(8):1250-1255.20564494
43. Dumbre RK, Kamble MB, Patil VR. Inhibitory effects by ayurvedic plants on prostate enlargement induced in rats. Pharmacognosy Res. 2014;6(2):127-132.24761116
44. Fouladi RF. Aqueous extract of dried fruit of Berberis vulgaris L. in acne vulgaris, a clinical trial. J Diet Suppl. 2012;9(4):253-261.23038982
45. Qujeq D, Kamei S. In vitro antioxidant effects of barberry fruit extracts. Int J Mol Cell Med. 2012;1(3):168-172.24551773
46. Sahin K, Orhan C, Tuzcu M, et al. Berberis vulgaris root extract alleviates the adverse effects of heat stress via modulating hepatic nuclear transcription factors in quails. Br J Nutr. 2013;110(4):609-616.23312115
47. Minaiyan M, Ghannadi A, Mahzouni P, Jaffari-Shirazi E. Comparative study of Berberis vulgaris fruit extract and berberine chloride effects on acetic acid-induced colitis in rats. Iran J Pharm Res. 2011;10(1):97-104.24363687
48. Chen DP, Xiong YJ, Lv BC, et al. Effects of berberine on rat jejunal motility. J Pharm Pharmacol. 2013;65(5):734-744.23600391
49. Blumenthal M, Goldberg A, Brinckmann J, eds. Herbal Medicine: Expanded Commission E Monographs. Newton, MA: Integrative Medicine Communications; 2000.
50. Ernst E. Herbal medicinal products during pregnancy: are they safe? BJOG. 2002;109(3):227-235.11950176
51. Chatuphonprasert W, Nemoto N, Sakuma T, Jarukamjorn K. Modulations of cytochrome P450 expression in diabetic mice by berberine. Chem Biol Interact. 2012;196(1-2):23-29.22342832
52. Inbaraj JJ, Kukielczak BM, Bilski P, Sandvik SL, Chignell CF. Photochemistry and photocytotoxicity of alkaloids from goldenseal (Hydrastis canadensis L.) 1. Berberine. Chem Res Toxicol. 2001;14(11):1529-1534.117129110
53. Derosa G, Romano D, D’Angelo A, Maffioli P. Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high doses. Atherosclerosis. 2015;239(1):87-92.25577665
54. Zaidi SF, Muhammad JS, Shahryar S, et al. Anti-inflammatory and cytoprotective effects of selected Pakistani medicinal plants in Helicobacter pylori-infected gastric epithelial cells. J Ethnopharmacol. 2012;141(1):403-410.22433535
55. Zaenglein AL, Pathy AL, Schlosser BJ, at al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33.26897386
56. Dietie A, Hume AL. Berberine may be a promising botanical for glycemic control. Pharmacy Today. 2017;23(7):21.

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This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

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