Berberry Root Powder by Bixa Botanical

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Burns. Although there has been interest in using topical tree turmeric for burns, there is insufficient reliable information about the clinical effects of tree turmeric for this purpose.
• Diabetes. Oral tree turmeric has only been evaluated in combination with other ingredients for the management of type 1 and type 2 diabetes; its effect when used alone is unclear. Details: Clinical research in patients with type 2 diabetes shows that taking a specific combination product (Berberol, PharmExtracta) containing tree turmeric extract 1176 mg and milk thistle extract 210 mg improves some measures of diabetes control. A clinical study in patients with type 2 diabetes, obesity, and metabolic syndrome shows that taking this specific product daily for 12 months reduces glycated hemoglobin (HbA1c) by approximately 18% when compared to baseline. This reduction was significant when compared with the 5% reduction in the placebo group. Fasting blood glucose and insulin resistance were also improved, with a reduction in fasting blood glucose of approximately 25% for patients in the treatment group, compared to 10% in the placebo group (97624). Several other small clinical studies in adults with poorly controlled type 2 diabetes shows that taking this same product for 12 months improves HbA1c, fasting blood glucose, and insulin resistance when compared to baseline (96140,96141). A treatment duration of 3 months does not appear to be effective for improving fasting blood glucose levels in these patients; however, it does seem to improve HbA1c when compared with baseline (96141). This product has also been evaluated in patients with type 1 diabetes. A clinical study in patients with type 1 diabetes shows that taking this product with meals for 6 months reduces the amount of insulin needed to achieve adequate glycemic control by 14.5% and lowers fasting blood glucose levels by 10% when compared with placebo (96142).
• Hypercholesterolemia. Oral tree turmeric has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of four mostly low-quality clinical studies in hypercholesterolemic adults shows that taking a specific combination product (Berberol, PharmExtracta) containing tree turmeric extract 588 mg and milk thistle extract 105 mg twice daily for 3 months, along with diet and exercise, reduces levels of low-density lipoprotein (LDL) cholesterol by an average of 33 mg/dL when compared with diet and exercise alone (101158). These studies lasted for no more than 12 months and some studies allowed for inclusion of patients who required a reduction in statin dose due to adverse effects (95019,96140,101158). Taking this product does not appear to significantly lower triglyceride levels or increase high-density lipoprotein (HDL) cholesterol levels in most of these patients (95019,96140,101158). It is unclear if any effects are due to tree turmeric, milk thistle, or the combination. Other clinical research in adults with hypercholesterolemia shows that a similar product (Berberol K, PharmExtracta) containing tree turmeric extract of berberine 500 mg, milk thistle extract 105 mg, and monacolin K and KA 10 mg, taken once daily for 3 months along with diet and exercise, reduces levels of LDL cholesterol by about 28% when compared with diet and exercise alone (97625). It is possible that any benefit of this product is due to the monacolin content. Further, since this product is standardized to monacolin content, it is considered by the US Food and Drug Administration to be a new drug rather than a dietary supplement.
• Menorrhagia. Although there has been interest in using oral tree turmeric for menorrhagia, there is insufficient reliable information about the clinical effects of tree turmeric for this purpose.
• Trachoma. Although there has been interest in using oral tree turmeric for trachoma, there is insufficient reliable information about the clinical effects of tree turmeric for this purpose.
• Wound healing. Although there has been interest in using topical tree turmeric for wound healing, there is insufficient reliable information about the clinical effects of tree turmeric for this purpose. More evidence is needed to rate tree turmeric for these uses.

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LIKELY SAFE ...when a specific product (Berberol, PharmExtracta) containing tree turmeric extract 588 mg and milk thistle extract 105 mg is used. This product has been safely used twice daily for up to 12 months (95019,96140,96141,96142,101158). There is insufficient reliable information available about the safety of other forms of tree turmeric when used orally or topically in medicinal amounts.

CHILDREN: LIKELY UNSAFE
when used orally in newborns. The berberine constituent of tree turmeric can cause kernicterus in newborns, particularly preterm neonates with hyperbilirubinemia (2589). There is insufficient reliable information available about the safety of tree turmeric in older children.

PREGNANCY: LIKELY UNSAFE
when used orally. The berberine constituent of tree turmeric is thought to cross the placenta and may cause harm to the fetus. Kernicterus has developed in newborn infants exposed to berberine (2589).

LACTATION: LIKELY UNSAFE
when used orally. The berberine constituent of tree turmeric and other harmful constituents can be transferred to the infant through breast milk (2589).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, tree turmeric might have additive effects when used with anticoagulant and antiplatelet drugs and increase the risk of bleeding.  Details In vitro and animal research suggest that berberine, a constituent of tree turmeric, can inhibit platelet aggregation (33660,33694).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, tree turmeric, taken alone or in combination with milk thistle, might increase the risk of hypoglycemia in patients taking antidiabetes drugs.  Details Clinical research shows that taking a product containing tree turmeric and milk thistle extracts can lower blood glucose levels, glycated hemoglobin (HbA1c), and insulin resistance in patients with type 2 diabetes, including those on antidiabetic agents (95019,96140,96141). Additionally, clinical research suggests that berberine, a constituent of tree turmeric, can lower blood glucose levels (20579,34247,34265,34282).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking tree turmeric along with antihypertensive drugs might have additive effects and increase the risk of hypotension.  Details Animal research suggests that berberine, a constituent of tree turmeric, can have hypotensive effects (33692,34308). Also, a meta-analysis of clinical research suggests that taking berberine in combination with amlodipine (Norvasc) can lower systolic and diastolic blood pressure when compared with taking amlodipine alone (91956).

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of tree turmeric along with CNS depressants might increase the risk of additive therapeutic and adverse effects.  Details Animal research suggests that berberine, a constituent of tree turmeric, can have sedative effects (13519,33650,33664,33692).

CYCLOSPORINE (Neoral, Sandimmune) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Likely •  Level of Evidence = A Berberine, a constituent of tree turmeric, can reduce metabolism of cyclosporine and increase serum levels.  Details Some clinical evidence suggests that berberine inhibits cytochrome P450 3A4 (CYP3A4), which metabolizes cyclosporine (13524,21112,34239).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, tree turmeric might increase the levels and clinical effects of drugs metabolized by CYP2C9.  Details Preliminary clinical evidence suggests that berberine, a constituent of tree turmeric, can inhibit CYP2C9 (34279).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, tree turmeric might increase the levels and clinical effects of drugs metabolized by CYP2D6.  Details In vitro research and preliminary clinical evidence suggest that berberine, a constituent of tree turmeric, can inhibit CYP2D6 (21117,34279,34297).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = A Theoretically, tree turmeric might increase the levels and clinical effects of drugs that are substrates of CYP3A4.  Details In vitro research and preliminary clinical evidence suggest that berberine, a constituent of tree turmeric, moderately inhibits CYP3A4 (13524,21114,34279,34297).

DEXTROMETHORPHAN (Robitussin DM, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, tree turmeric might increase levels of dextromethorphan and potentially increase the risk of adverse effects including drowsiness, confusion, and irritability.  Details Preliminary clinical research suggests that berberine, a constituent of tree turmeric, can inhibit cytochrome P450 2D6 (CYP2D6) activity and reduce the metabolism of dextromethorphan (34279).

MIDAZOLAM (Versed) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, tree turmeric might increase levels of midazolam and potentially increase the risk of adverse effects including sedation and respiratory depression.  Details Preliminary clinical evidence suggests that berberine, a constituent of tree turmeric, can inhibit cytochrome P450 3A4 (CYP3A4) activity and reduce metabolism of midazolam (34279).

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, tree turmeric might increase the sedative effects of pentobarbital.  Details Animal research suggests that berberine, a constituent of tree turmeric, can prolong pentobarbital-induced sleeping time (13519).

TACROLIMUS (Prograf) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Likely •  Level of Evidence = D Berberine, a constituent of tree turmeric, can inhibit metabolism of tacrolimus and increase plasma levels.  Details Some clinical evidence suggests that berberine inhibits cytochrome P450 3A4 (CYP3A4), which metabolizes tacrolimus (13524,21114,34279,34297,91954). In a 16-year-old patient with idiopathic nephrotic syndrome who was being treated with prednisone 40 mg/m2 and tacrolimus 6.5 mg twice daily, concomitant use of berberine, a constituent of tree turmeric, 200 mg three times daily increased plasma levels of tacrolimus from 8 to 22 ng/mL and increased serum creatinine levels from 0.7 to 1.2 mg/dL. Following a reduction of tacrolimus dosing to 3 mg daily, the blood concentration of tacrolimus decreased to 12 ng/mL and the serum concentration of creatinine decreased to 0.9 mg/dL (91954).

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General ...Orally and topically, no adverse effects have been reported with the use of tree turmeric alone. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Gastrointestinal symptoms, especially nausea, with the use of a specific product containing tree turmeric and milk thistle (Berberol, PharmExtracta).

Gastrointestinal ...Orally, the most common adverse effects of a specific product (Berberol, PharmExtracta) containing tree turmeric and milk thistle extracts include gastrointestinal symptoms, especially nausea (95019,96140,96141,96142).

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