Cold Sore Drops by Strauss Herb Co

POSSIBLY INEFFECTIVE

• Urine drug tests. Drinking water with goldenseal or adding goldenseal tea to urine does not appear to cause a false negative urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, or tetrahydrocannabinol (THC). Details: Goldenseal is often promoted to mask illicit drugs in the urine, but drinking one gallon of water with goldenseal or adding goldenseal tea to urine samples does not seem to cause a false negative immunoassay (EMIT and TDx) for cocaine, amphetamines, barbiturates, benzodiazepines, or opiates. It also does not produce a false negative for Microgenics CEDIA DAU assays for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, or THC (260,261,52599). Although adding goldenseal tea to urine samples at 15 grams per liter may produce a false-negative EMIT reading for the presence of THC, the adulteration is obvious due to a brownish color in the urine (52599). Some people also claim that goldenseal can cause a false positive on a drug screen. However, goldenseal does not seem to cause false positives for the fluorescent polarization immunoassay (FPIA) or thin-layer chromatography (TLC) assays for amphetamines, opiates, cocaine, methadone, or their metabolites (2590).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Although there has been interest in using topical goldenseal for acne, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Allergic rhinitis (hay fever). Although there has been interest in using oral goldenseal for allergic rhinitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Anorexia nervosa. Although there has been interest in using oral goldenseal for anorexia nervosa, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Atopic dermatitis (eczema). Although there has been interest in using topical goldenseal for atopic dermatitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Chronic fatigue syndrome (CFS). Although there has been interest in using oral goldenseal for CFS, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Conjunctivitis. Although there has been interest in using goldenseal as an eye drop for conjunctivitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Dandruff. Although there has been interest in using topical goldenseal for dandruff, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Flatulence. Although there has been interest in using oral goldenseal for flatulence, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Gastritis. Although there has been interest in using oral goldenseal for gastritis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Gingivitis. Although there has been interest in using goldenseal as a mouthwash for gingivitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Hemorrhoids. Although there has been interest in using oral goldenseal for hemorrhoids, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Herpes labialis (cold sores). Although there has been interest in using topical goldenseal for herpes labialis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Menorrhagia. Although there has been interest in using oral goldenseal for menorrhagia, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Otitis media. Although there has been interest in using goldenseal as an ear drop for otitis media, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Peptic ulcers. Although there has been interest in using oral goldenseal for peptic ulcers, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Respiratory tract infections. Although there has been interest in using oral goldenseal for various respiratory tract infections, including influenza, pneumonia, rhinosinusitis, and the common cold, there is insufficient reliable information about the clinical effects of goldenseal for these conditions.
• Tinnitus. Although there has been interest in using goldenseal as an ear drop for tinnitus, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Urinary tract infections (UTIs). Although there has been interest in using oral goldenseal for UTIs, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Uveitis. Although there has been interest in using goldenseal as an eye drop for uveitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Vaginitis. Although there has been interest in using oral goldenseal for vaginitis, there is insufficient reliable information about the clinical effects of goldenseal for this purpose.
• Wound healing. Although there has been interest in using topical goldenseal for wound healing, there is insufficient reliable information about the clinical effects of goldenseal for this purpose. There is insufficient reliable information available about the effectiveness of goldenseal for its other uses.

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LIKELY INEFFECTIVE

• Schistosomiasis. Most research suggests that oral myrrh extract is not effective for treating schistosomiasis. Details: Although one manufacturer-sponsored study shows that taking a specific myrrh extract (Mirazid, Pharco Pharmaceuticals) 600 mg once daily for 6 days cures schistosomiasis in about 90% of patients, multiple clinical studies show that taking this myrrh extract does not treat schistosomiasis in children or adults. In one study, only about 9% of adults and children treated with this myrrh extract at a dose of 600 mg every 3 weeks for 2 doses were cured compared to about 76% of patients treated with praziquantel (95541). A similar lack of benefit was shown in another clinical trial in which children were given a higher dose of 300 mg daily for 3 days or 600 mg daily for 6 days (95542,95545). A systematic review of the available literature concludes that praziquantel continues to be the treatment of choice for schistosomiasis, and that myrrh appears ineffective for parasitological cure (95544).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Back pain. It is unclear if oral myrrh is beneficial in patients with back pain, and topical myrrh has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with chronic low back pain shows that two 15-minute sessions of lumbar massage weekly with 5 mL of myrrh 2% and frankincense 2% essential oils for 3 weeks reduces measures of pain and disability when compared with placebo (111504). An observational study in adults with chronic lower back pain and sciatica suggests that taking a combination of myrrh 200 mg, palmitoylethanolamide 600 mg, and alpha-lipoic acid 800 mg daily for 30 days, along with periradicular infiltrations of oxygen-ozone, is associated with resolution of pain in 17% more patients when compared with periradicular steroid infiltrations at 60 days (111308). However, it is unclear if the effects in these studies are due to myrrh, other ingredients, or the combinations. Additionally, observational research in adults with chronic low back pain of varying intensity has found that taking a specific myrrh extract (MyrliMax, Sundyota Numandis Pharmaceuticals) 100 mg twice daily for 20 days is associated with reductions in pain and the need for rescue analgesics when compared to baseline (111112). The validity of these findings is limited by the lack of a control group.
• Cancer. Although there has been interest in using oral myrrh for cancer, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Canker sores. Although there has been interest in using topical myrrh for canker sores, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Common cold. Although there has been interest in using oral myrrh for the common cold, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Cough. Although there has been interest in using oral myrrh for cough, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Crohn disease. Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: Observational research over a period of 24-28 days in a small group of patients with active inflammatory bowel disease (50% ulcerative colitis and 50% Crohn disease) has found that taking a specific combination product containing myrrh 100 mg, coffee charcoal 50 mg, and chamomile extract 70 mg per tablet (MYRRHINIL-INTEST, Repha GmbH) results in symptom resolution in 16-26 days. The probability of being free of symptoms did not differ between patients using other treatments, the myrrh combination product alone, or a combination of the myrrh product with other treatments. Overall efficacy was rated as good to very good by patients and physicians (104593). The validity of these findings is limited by the observational nature of the study. Also, it is unclear if these findings are due to myrrh, other ingredients, or the combination.
• Dental peri-implantitis. It is unclear if rinsing with myrrh mouthwash solution is effective for the prevention of dental peri-implantitis. Details: A small clinical study in adults undergoing dental implant placement shows that rinsing with myrrh 1% mouthwash solution twice daily for 2 weeks leads to similar rates of postoperative bleeding, pain, redness, and swelling when compared with chlorhexidine 0.12% mouthwash (111114).
• Diarrhea. Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: Observational research over a period of 7-14 days in a group of patients with active diarrhea related to an acute inflammatory disorder has found that taking a specific combination product containing myrrh 100 mg, coffee charcoal 50 mg, and chamomile extract 70 mg per tablet (MYRRHINIL-INTEST, Repha GmbH), alone or in combination with other therapies, improves overall symptoms of diarrhea. The median time to symptom resolution was 4 days. The probability of symptom resolution with use of the myrrh combination product was similar to that observed when other treatments were used. Overall efficacy was rated as good to very good by patients and physicians (104593). The validity of these findings is limited by the observational nature of the study. Also, it is unclear if these findings are due to myrrh, other ingredients, or the combination.
• Fasciolosis. It is unclear if oral myrrh extract is beneficial in patients with fasciolosis. Details: A small clinical study in adults and children with fasciolosis shows that taking a specific myrrh extract (Mirazid, Pharco Pharmaceuticals) 600 mg daily for 6 days leads to a cure rate of about 94% at 3 months. However, the lack of standardized stool sample evaluation and absence of a control group limit the validity of this finding (95543). Furthermore, another small study in adults and children with fasciolosis shows that taking this same product, 600 mg daily for 6 days, leads to a 0% cure rate at both 1 and 2 months (95545).
• Gingivitis. Although there has been interest in using topical myrrh for gingivitis, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Herniated disc. Oral myrrh has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small observational study in adults with acute lumbosacral radiculopathy secondary to lumbar disc herniation suggests that taking a combination supplement containing myrrh 100 mg, alpha-lipoic acid 404 mg, and palmitoylethanolamide (PEA) 306 mg (Tiobec Dol, Uriach Italy Srl) twice daily for 4 weeks, along with steroids and as needed opioids, is associated with reduced pain and disability and improved physical but not mental health as it pertains to quality of life when compared with steroids and as needed opioids alone (111711). However, it is unclear if these effects are due to alpha-lipoic acid, other ingredients, or the combination.
• Intestinal parasite infection. It is unclear if oral myrrh extract is beneficial in children with intestinal parasite infections. Details: A small clinical study in immunocompetent children shows that taking a specific myrrh extract (Mirazid, Pharco Pharmaceuticals) 10 mg/kg daily in combination with paromomycin 500 mg four times daily for 2 weeks improves symptoms such as abdominal pain, diarrhea, nausea, and vomiting when compared with paromomycin or myrrh extract alone. However, no differences in oocyst elimination were observed across groups (95546).
• Irritable bowel syndrome (IBS). Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: Observational research over a period of 24-28 days in a group of patients with IBS has found that taking a specific combination product containing myrrh 100 mg, coffee charcoal 50 mg, and chamomile extract 70 mg per tablet (MYRRHINIL-INTEST, Repha GmbH), alone or in combination with other therapies, improves overall symptoms of diarrhea. The probability of being free of symptoms did not differ between patients using other treatments or when the myrrh combination product was used in combination with other treatments. Overall efficacy was rated as good to very good by patients and physicians (104593). The validity of these findings is limited by the observational nature of the study. Also, it is unclear if these findings are due to myrrh, other ingredients, or the combination.
• Miscarriage. It is unclear if oral myrrh is beneficial in patients with incomplete miscarriage. Details: A small clinical study in adults with incomplete miscarriage (incomplete abortion) shows that taking myrrh 500 mg three times a day for 2 weeks increases the proportion of patients with successful complete abortion, defined as no retained products of conception, to 83%, compared to only 54% of those taking placebo (104840).
• Muscle cramps. Although there has been interest in using oral myrrh for muscle cramps, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Oral mucositis. Although there has been interest in using topical myrrh for oral mucositis, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Pain (acute). It is unclear if oral myrrh extract is beneficial in patients with acute pain. Details: A small clinical study shows that taking a specific, standardized myrrh extract (MyrLiq, Biosfered S.r.l.) 200-400 mg daily for 20 days can improve various types of acute pain, including headache, fever-associated pain, joint or muscle pain, lower back pain, and menstrual cramps, when compared with placebo (98224).
• Pain (chronic). It is unclear if oral myrrh extract is beneficial in patients with chronic pain. Details: A small clinical study shows that taking a specific, standardized myrrh extract (MyrLiq, Biosfered S.r.l.) 200-400 mg daily for 20 days can improve various types of chronic pain, including joint or muscle pain and lower back pain, when compared with placebo (98224).
• Peptic ulcers. Although there has been interest in using oral myrrh for peptic ulcers, there is insufficient reliable information about the clinical effects of myrrh for this purpose.
• Sciatica. Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: Observational research in patients with sciatic pain due to herniated discs has found that taking a combination of myrrh extract 200 mg, alpha-lipoic acid 800 mg, and palmitoylethanolamide 600 mg daily for 20 days along with 3 sessions of oxygen-ozone therapy over 30 days is associated with slight improvements in pain when compared with oxygen-ozone therapy alone (111113). The validity of these findings is limited by the observational nature of the study. Additionally, it is unclear if these findings are due to myrrh, other ingredients, or the combination.
• Tooth extraction. It is unclear if rinsing with myrrh extract solution is beneficial in patients undergoing tooth extraction. Details: A small clinical study in healthy, non-smoking adults shows that using a mouthwash containing myrrh extract 0.5% twice daily for 7 days following simple tooth extraction decreases the socket size in 90% of patients compared with 40% in the control group. Swelling and tenderness also decreased when compared with control (105846).
• Trichomoniasis. It is unclear if oral myrrh extract is beneficial in patients with trichomoniasis. Details: A small clinical study in patients with resistant Trichomonas vaginalis shows that taking a specific myrrh extract (Mirazid, Pharco Pharmaceuticals) 600 mg daily for 6-8 days cures infections in most patients. In this small study, 85% (11/13) of patients who did not respond to combination therapy with metronidazole and tinidazole were cured after receiving this myrrh extract (93652). A lack of control group limits the validity of these findings.
• Ulcerative colitis. Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: A small clinical study in patients with ulcerative colitis shows that taking a specific combination product containing myrrh 100 mg, chamomile extract 70 mg, and coffee charcoal 50 mg per tablet (MYRRHINIL-INTEST, Repha GmbH), four tablets three times daily for 12 months, is non-inferior to mesalamine therapy for maintaining remission (93653). In addition, observational research over a period of 24-28 days in a small group of patients with active inflammatory bowel disease (50% ulcerative colitis and 50% Crohn disease) has found that taking this same product results in symptom resolution in 16-26 days. The probability of being free of symptoms did not differ between patients using other treatments, the myrrh combination product alone, or the myrrh combination product with other treatments. Overall efficacy was rated as good to very good by physicians (104593). It is unclear if these findings are due to myrrh, other ingredients, or the combination.
• Urinary tract infections (UTIs). Oral myrrh has only been evaluated in combination with other ingredients, its effect when used alone is unclear. Details: A small clinical study in patients with at least 2 recurrent UTIs in the past 6 months or more than 3 UTIs in the past year shows that taking a combination of myrrh, hibiscus, and vegetable proteases (Aviur Retard ) for 6 months might reduce the risk of UTI recurrence. A UTI episode was not reported by 49% of females over the 6-month period, with an additional 35% reporting fewer than 2 UTIs (101115). The validity of these findings is limited by the lack of comparator group. Additionally, it unclear if this benefit is due to myrrh, other ingredients, or the combination.
• Wound healing. It is unclear if topical myrrh extract is beneficial for wound healing. Details: Two small clinical studies in patients requiring episiotomy during childbirth shows that using myrrh 1:5 tincture 10 mL or myrrh extract 20 mL, diluted in 5 L of water as a sitz bath, twice daily for 7 days, modestly improves ecchymosis, discharge, and wound healing scores when compared with either placebo, frankincense extract 20 mL, or betadine 10% solution 20 mL (104838,104839). It is unclear if these modest effects are clinically relevant. More evidence is needed to rate myrrh for these uses.

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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).

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LIKELY SAFE ...when consumed in amounts commonly found in food. Myrrh is approved for use in foods as a flavoring agent in the US (11).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Myrrh 400 mg three times daily has been safely used for up to 12 months (93653,104593). Myrrh 500 mg three times daily has been used with apparent safety for 2 weeks (104840). ...when used topically and appropriately (2,4,5,11,18). As a diluted bath, myrrh has been used with apparent safety for up to 7 days (104838,104839).

POSSIBLY UNSAFE ...when used orally in excessive doses. Myrrh may cause kidney irritation and diarrhea when used in doses of 2-4 grams (12).

PREGNANCY: LIKELY UNSAFE
when used orally. Myrrh stimulates uterine tone and blood flow and may have an abortifacient effect (4,12,19,93645). There is insufficient reliable information available about the safety of the topical use of myrrh during pregnancy.

LACTATION:
Insufficient reliable information available; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, goldenseal might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.  Details Goldenseal contains berberine. In vitro and animal research shows that berberine can inhibit platelet aggregation (33660,33694). However, this effect has not been reported in humans.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, goldenseal might increase the risk of hypoglycemia when used with antidiabetes drugs.  Details Goldenseal contains berberine. Clinical research shows that berberine can lower blood glucose levels (20579,34247,34265,34282). However, this effect has not been reported with goldenseal.

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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.

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, goldenseal might increase the sedative effects of CNS depressants.  Details Goldenseal contains berberine. Animal research shows that berberine can have sedative effects (13519,33650,33664,33692). However, this effect has not been reported in humans.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Goldenseal might increase serum levels of drugs metabolized by CYP2D6.  Details Clinical and in vitro research shows that goldenseal can significantly inhibit CYP2D6 enzymes, potentially increasing levels of drugs metabolized by CYP2D6 (13536,16848,35907).

CYTOCHROME P450 2E1 (CYP2E1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B 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).

DEXTROMETHORPHAN (Robitussin DM, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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).

DIGOXIN (Lanoxin) Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = B 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.

LOSARTAN (Cozaar) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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.

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D 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).

OSELTAMIVIR (Tamiflu) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D 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.

P-GLYCOPROTEIN SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = B 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.

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D 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.

TACROLIMUS (Prograf) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D 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).

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, myrrh might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details In vitro and animal research suggests that myrrh has hypoglycemic effects (4,104841).

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, myrrh might decrease the effectiveness of warfarin.  Details In one case, a patient who was previously stable on warfarin had a significant decline in international normalized ratio (INR) following consumption of an aqueous extract of myrrh (14425).

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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.

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General ...Orally, myrrh seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Kidney impairment and heart rate changes at high doses.

Cardiovascular ...Orally, myrrh taken at doses of 2-4 grams may cause heart rate changes in some patients (12,19).

Dermatologic ...Topically, myrrh has been reported to cause dermatitis (6).

Gastrointestinal ...Orally, myrrh may cause diarrhea in some patients when taken at doses of 2-4 grams (12,19).

Genitourinary ...Severe lower abdominal pain has been reported in a pregnant woman drinking myrrh resin dissolved in 500 mL of water twice daily as prescribed by a traditional practitioner. This adverse effect resolved one day after discontinuing myrrh. The investigators suggest that this acute abdominal pain was related to myrrh's activity as a uterine stimulant (93645).

Immunologic ...Orally, myrrh has been reported to cause severe allergic skin reactions, with redness, swelling, and itching, in two case reports of individuals using oral traditional Chinese medicines containing myrrh (101114).

Renal ...Orally, myrrh may cause kidney impairment in some patients when taken at doses of 2-4 grams (12,19).

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