Black Cohosh • Blue Cohosh • Blue vervain • Scullcap • Lobelia . Other Ingredients: Distilled Water, 20% Alcohol.
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Below is general information about the effectiveness of the known ingredients contained in the product Hearing Restore. 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
There is insufficient reliable information available about the effectiveness of blue cohosh.
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 Hearing Restore. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when used orally and appropriately. Black cohosh has been safely used in some studies lasting up to a year (15036,15158,17091,19553,35908); however, most studies have lasted only up to 6 months (141,4614,4620,7054,9437,9494,13143,13184,14330,14423)(14424,15037,15889,15893,35824,35852,35853,35858,35865,35897)(35902,35904,35946,35964,95525,103269). There is concern that black cohosh might cause liver damage in some patients. Several case reports link black cohosh to liver failure or autoimmune hepatitis (4383,10692,11906,12006,13144,14469,15160,16721,16722,16723)(16724,16725,16726,16727,35857,107906). However, the evidence that black cohosh causes liver damage is not conclusive (17085). Until more is known, monitor liver function in patients who take black cohosh.
PREGNANCY: POSSIBLY UNSAFE
when used orally in pregnant patients who are not at term.
Black cohosh might have hormonal effects and menstrual and uterine stimulant effects (15035). Theoretically, this might increase the risk of miscarriage; avoid using during pregnancy. There is insufficient reliable information available about the safety of black cohosh when used to induce labor.
LACTATION: POSSIBLY UNSAFE
when used orally.
Black cohosh might have hormonal effects. Theoretically, maternal intake of black cohosh might adversely affect a nursing child (15035). Until more is known, nursing patients should avoid taking black cohosh.
LIKELY UNSAFE ...when used orally (4,12). Poisonings have occurred after ingestion of blue cohosh leaf or seeds (4).
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally.
Blue cohosh is a uterine stimulant and can induce labor (12047). Several blue cohosh constituents, such as anagyrine and N-methylcytisine, are potentially teratogenic and might cause congenital malformations in newborns (1122,7110,36718,94534). Use of blue cohosh near term can cause life-threatening toxicity in the infant (1207,9492,9493,12047,36725), as well as severe toxicity in the mother (36720). Many midwives still use blue cohosh to facilitate delivery. This dangerous practice should be avoided (1122,1207).
LIKELY UNSAFE ...when used orally (3,11). Lobelia leaf can be toxic in doses of 600-1000 mg; 4000 mg of the leaf may be fatal (18). There is insufficient reliable information available about the safety of lobelia when used topically.
PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally due to its emetic effects (4,12).
There is insufficient reliable information available about the safety of lobelia when used topically during pregnancy and lactation.
There is insufficient reliable information available about the safety of skullcap.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Verbena has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912). There is insufficient reliable information available about the safety of verbena when used orally or topically in medicinal amounts.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of verbena in medicinal amounts during pregnancy and lactation; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Hearing Restore. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Taking black cohosh with atorvastatin might increase the risk for elevated liver function tests.
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In one case report, a patient taking atorvastatin (Lipitor) developed significantly elevated liver function enzymes after starting black cohosh 100 mg four times daily. Liver enzymes returned to normal when black cohosh was discontinued (16725). It is unclear whether the elevated liver enzymes were due to black cohosh itself or an interaction between atorvastatin and black cohosh.
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Theoretically, black cohosh may reduce the clinical effects of cisplatin.
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Animal research suggests that black cohosh might decrease the cytotoxic effect of cisplatin on breast cancer cells (13101).
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Some research suggests that black cohosh might inhibit CYP2D6, but there is conflicting evidence.
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Some clinical research suggests that black cohosh might modestly inhibit CYP2D6 and increase levels of drugs metabolized by this enzyme (13536). However, contradictory clinical research shows a specific black cohosh product (Remifemin, Enzymatic Therapy) 40 mg twice daily does not significantly inhibit metabolism of a CYP2D6 substrate in healthy study volunteers (16848). Until more is known, use black cohosh cautiously in patients taking drugs metabolized by CYP2D6.
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Theoretically, black cohosh may alter the effects of estrogen therapy.
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Theoretically, taking black cohosh with hepatotoxic drugs may increase the risk of liver damage.
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Black cohosh may inhibit one form of OATP, OATP2B1, which could reduce the bioavailability and clinical effects of OATP2B1 substrates.
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In vitro research shows that black cohosh modestly inhibits OATP2B1 (35450). OATPs are expressed in the small intestine and liver and are responsible for the uptake of drugs and other compounds into the body. Inhibition of OATP may reduce the bioavailability of oral drugs that are substrates of OATP.
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There is some concern that blue cohosh might increase blood glucose levels (6002,36724). Theoretically, it might decrease the effectiveness of medicines used for diabetes. Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), chlorpropamide (Diabinese), glipizide (Glucotrol), tolbutamide (Orinase), and others.
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Constituents in blue cohosh might increase blood pressure by causing coronary vasoconstriction (6002). Theoretically, concomitant use might decrease the effectiveness of drugs used for angina and high blood pressure; use with caution. Some antihypertensive drugs include captopril (Capoten), enalapril (Vasotec), losartan (Cozaar), valsartan (Diovan), diltiazem (Cardizem), Amlodipine (Norvasc), hydrochlorothiazide (HydroDiuril), furosemide (Lasix), and many others.
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Blue cohosh can increase the effects of nicotine (6002).
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Lobelia is thought to have diuretic properties. Theoretically, due to these potential diuretic effects, lobelia might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.
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Theoretically, skullcap can have additive effects when used with other CNS depressants.
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In vitro research suggests that beta-myrcene, a terpene constituents of verbena, can significantly inhibit cytochrome P450 2B1 (CYP2B1) enzyme activity (82024). Theoretically, verbena might increase levels of drugs metabolized by this enzyme. However, this interaction has not been reported in humans.
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Some substrates of CYP2B1 include cyclophosphamide, ifosfamide, barbiturates, bromobenzene, and others.
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Below is general information about the adverse effects of the known ingredients contained in the product Hearing Restore. 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 cohosh is generally well tolerated when used in typical doses.
Most Common Adverse Effects:
Orally: Breast tenderness, dizziness, gastrointestinal upset, headache, irritability, rash, tiredness.
Serious Adverse Effects (Rare):
Orally: Endometrial hyperplasia and hepatotoxicity, although data are conflicting for both.
Cardiovascular
...A single case of reversible bradycardia has been reported for a 59-year-old female who took one tablet of a specific black cohosh product (Remifemin, Schaper & Brümmer) daily for 2 weeks.
The adverse event was considered probably related to black cohosh use, although the exact mechanism by which black cohosh exerted this effect was unclear (35920).
There has been concern that, if black cohosh has estrogen-like effects, it could also potentially cause estrogen-like side effects including increased risk for thromboembolism and cardiovascular disease. These outcomes have not been specifically assessed in long-term trials; however, some research shows that a specific black cohosh extract (CimiPure, PureWorld) does not significantly affect surrogate markers for thromboembolism and cardiovascular risk such as fibrinogen, cholesterol, triglycerides, glucose, or insulin levels compared to placebo (16850).
Dermatologic ...Black cohosh has been associated with skin irritation and rashes (7054,10987,14330,15889,35853). A case report describes a patient who developed cutaneous pseudolymphoma 6 months after starting a specific black cohosh extract (Remifemin). Symptoms resolved within 12 weeks of discontinuing black cohosh (15890).
Gastrointestinal ...Orally, black cohosh can commonly cause gastrointestinal upset (4383,4615,4616,10988,13184,35824,35853,35965,103269,111714). Constipation and indigestion have also been reported (7054,35852).
Genitourinary
...Orally, black cohosh, including the specific black cohosh product Remifemin, may cause vaginal bleeding and breast tenderness in some postmenopausal patients (15889,35824).
However, the frequency of these events seems to be less than that of tibolone, a prescription hormone medication used to treat symptoms of menopause (15889,35904).
Due to the potential estrogen-like effects, there is concern that black cohosh might increase the risk of endometrial hyperplasia. However, a specific black cohosh extract CR BNO 1055 (Klimadynon/Menofem, Bionorica AG) does not appear to cause endometrial hyperplasia. Clinical research in postmenopausal adults shows that taking 40 mg daily of this extract for 12 weeks does not significantly increase superficial cells when compared with placebo, and causes significantly fewer superficial cells when compared with conjugated estrogens (Premarin) (14330). Additional clinical research shows that taking 40 mg daily of this extract for a year does not increase the risk of endometrial hyperplasia or endometrial thickening in postmenopausal adults (15036). Another specific combination product containing black cohosh extract plus St. John's wort (Gynoplus, Jin-Yang Pharm) also does not significantly increase superficial cells compared to placebo after 12 weeks of treatment (15893). Some patients taking tamoxifen plus black cohosh have experienced endometrial hyperplasia and vaginal bleeding. However, these effects are more likely due to tamoxifen than black cohosh (7054).
Hepatic
...There is concern that black cohosh might cause liver disease, hepatotoxicity, or hepatitis.
Adverse effects on the liver have not been documented in clinical studies. However, multiple case reports of liver toxicity, hepatitis, and abnormal liver function have been described in females taking black cohosh products alone or in combination with other herbs or drugs. In some cases, patients developed liver failure and required immediate liver transplantation (4383,10692,11909,12006,13144,14469,15160,16721,16722,16723) (16724,16727,35883,35888,35890,35895,89465,101592,107906). In one case, a female developed autoimmune hepatitis after 3 weeks of taking black cohosh. Symptoms resolved 2 weeks after discontinuing black cohosh (11906). In at least three cases, females have developed elevated liver enzymes and symptoms of hepatotoxicity after taking black cohosh products. Symptoms resolved and liver enzymes normalized within a week of discontinuing black cohosh (16725,16726). Analysis of two liver biopsies suggests that hepatotoxicity associated with black cohosh use results from the accumulation of 4HNE protein adducts in the cytoplasm of liver cells, which promotes the migration of lymphocytes to the affected area and induces an autoimmune response leading to troxis necrosis (89469).
However, many of these cases are poorly documented. Causality is possible based on some reports; however, other reports do not indicate that black cohosh is the probable cause of the events (15891,15892,16722,16723,16727,89465). Hepatitis can occur with no identifiable cause, raising the possibility that black cohosh and hepatitis might have been coincidental in some cases. Also, plant misidentification can occur, resulting in accidental substitution of a hepatotoxic plant (11910). Therefore, some experts argue that these cases do not provide conclusive evidence that black cohosh is responsible for liver disease (17085,35882,111634). Nonetheless, some countries require cautionary labeling on black cohosh products suggesting a risk of liver toxicity. The United States Pharmacopeia also recommends cautionary labeling on black cohosh products (16722). Until more is known about this potential risk, consider monitoring liver function in patients who take black cohosh.
Musculoskeletal
...One patient treated with black cohosh in a clinical trial discontinued treatment due to edema and arthralgia (35897).
Black cohosh has been linked to asthenia and muscle damage in one case. A 54-year-old female experienced asthenia with elevated creatinine phosphokinase (CPK) and lactate dehydrogenase (LDH) levels while taking black cohosh. The patient had taken a specific black cohosh extract (Remifemin) for 1 year, discontinued it for 2 months, restarted it, and then experienced symptoms 2 months later. Symptoms began to resolve 10 days after discontinuing black cohosh (14299).
Neurologic/CNS
...Orally, black cohosh may cause headache, dizziness, or tiredness (35852,35886).
There is one case report of seizures in a female who used black cohosh, evening primrose oil, and chasteberry (10988).
Also, there has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.
In another case report, orobuccolingual dyskinesia, including tongue-biting, eating difficulties, and speech problems, was reported in a 46-year-old female who took two tablets containing black cohosh 20 mg and Panax ginseng 50 mg daily for 15 months. The patient's condition improved after stopping treatment with the herbs and taking clonazepam 2 mg daily with baclofen 40 mg daily (89735).
Ocular/Otic ...There is some concern that black cohosh might increase the risk of retinal vein thrombosis due to its estrogenic activity. In one case, a patient with protein S deficiency and systemic lupus erythematosus (SLE) experienced retinal vein thrombosis 3 days after taking a combination product containing black cohosh 250 mg, red clover 250 mg, dong quai 100 mg, and wild yam 276 mg (13155). It is unclear if this event was due to black cohosh, other ingredients, the combination, or another factor.
Oncologic ...There is some concern that black cohosh may affect hormone-sensitive cancers, such as some types of breast or uterine cancer, due to its potential estrogenic effects. However, evidence from a cohort study suggests that regular use of black cohosh is not associated with the risk of breast or endometrial cancer (17412,111634).
Psychiatric ...A 36-year-old female with a 15-year history of depression developed mania with psychotic and mixed features after taking a black cohosh extract 40 mg daily. The patient gradually recovered after stopping black cohosh and receiving treatment with antipsychotics (104517).
Pulmonary/Respiratory ...There has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.
Renal ...There has been a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black cohosh and blue cohosh at 42 weeks gestation to induce labor (1122,9492,9493). However, this adverse effect may have been attributable to blue cohosh.
Other ...While rare, weight gain has been reported in some patients taking black cohosh. However, in most cases the causality could not be established. A review of the literature, including published case reports, spontaneous reports to adverse event databases, and clinical trials, suggests that black cohosh does not cause weight gain (107907).
General
...Orally, blue cohosh can cause significant adverse effects including mucous membrane irritation, stomach upset including diarrhea and cramping, chest pain (angina), hypertension, and hyperglycemia (6002).
Neonatal acute myocardial infarction (MI), congestive heart failure (CHF), and shock has occurred following maternal use of a blue cohosh combination product one month before delivery (566,3383,94534). There is also a case report of severe complications, including seizures, renal failure, and respiratory distress, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94534). In another case, a mother was advised to drink a blue cohosh tea to induce labor. The infant experienced a seizure during delivery, and 2 days later it was discovered that the infant was experiencing an evolving ischemic stroke (12047,94534). In another case, nicotinic toxicity characterized by tachycardia, sweating, abdominal pain, vomiting, and muscle twitching and weakness was reported for a woman taking blue cohosh to induce abortion (36720,94534).
Due to these life-threatening side effects pregnant women should be advised not to ingest any blue cohosh product during pregnancy.
Cardiovascular ...Orally, blue cohosh can cause tachycardia, hypertension, and chest pain (angina) (36720,36724,94934). Neonatal acute myocardial infarction (MI), congestive heart failure (CHF), myocardial toxicity, and shock has occurred following maternal use of a blue cohosh combination product one month before delivery (566,3383,12047,36722,36725).
Gastrointestinal ...Orally, blue cohosh can cause mucous membrane irritation, stomach upset including diarrhea and cramping, nausea, vomiting, and abdominal pain (36720).
Musculoskeletal ...Orally, blue cohosh can cause muscle weakness and involuntary muscle contractions (36720).
Neurologic/CNS ...In one case, a mother was advised to drink a blue cohosh tea to induce labor. The infant experienced a seizure during delivery and 2 days later it was discovered that the infant was experiencing an evolving ischemic stroke (12047,94534). There is also another case report of severe complications, including seizures, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94934).
Renal ...There is a case report of severe complications, including renal failure, in an infant whose mother was given an unknown dose of black and blue cohosh at 42 weeks gestation to induce labor (1122,9492,94934).
General ...Orally, lobelia can cause nausea, vomiting, diarrhea, coughing, dizziness, tremors, and throat irritation. These adverse effects have been reported with doses as low as 50 mg (4,16414). Lobelia leaf can cause toxicity when taken in doses of 600 mg or higher. Symptoms of lobelia toxicity include sweating, tachycardia, convulsions, hypothermia, hypotension, coma, and death (4,11).
Cardiovascular ...Orally, high doses of lobelia leaf can cause toxicity. Symptoms of lobelia toxicity include tachycardia, hypotension, and death (4,11).
Gastrointestinal ...Orally, lobelia can cause nausea, vomiting, diarrhea, and throat irritation (4,16414).
Neurologic/CNS ...Orally, lobelia can cause dizziness and tremors. High doses of lobelia leaf can cause toxicity. Symptoms of lobelia toxicity include convulsions, coma, and death (4,11).
Pulmonary/Respiratory ...Orally, lobelia can cause coughing and throat irritation (4,16414).
Other ...Orally, high doses of lobelia leaf can cause toxicity resulting in death. Toxicity has been reported to occur at doses as low as 600 mg, with doses of 4000 mg or more considered to be fatal (4,11).
General
...There is currently a limited amount of information available on the adverse effects of skullcap.
Most Common Adverse Effects:
Orally: Cognitive impairment, digestive disturbances, sedation.
Gastrointestinal ...Orally, mild digestive disturbances were reported in around 9% of patients taking skullcap 350 mg three times daily for 2 weeks (91690).
Hepatic ...There are four reports of hepatotoxicity associated with products thought to contain skullcap. However, it is uncertain whether the products actually contained skullcap. It is thought that the products might have been contaminated with an adulterant such as germander (515), which is known to cause liver damage.
Neurologic/CNS ...A single skullcap extract dose of 100 mg does not seem to have adverse CNS effects. However, a higher dose of 200 mg might cause sedation and cognitive impairment (12216). One patient taking skullcap 350 mg three times daily for 2 weeks reported vivid dreams (91690). It is unclear if this event was associated with skullcap.
General
...Orally, verbena is well tolerated when used orally in amounts commonly found in foods (4912).
When used in medicinal amounts and in combination with other herbs, adverse effects have included gastrointestinal adverse effects and allergic skin reactions (374,379).
Topically, verbena can cause contact dermatitis (13431).
Gastrointestinal ...Orally, verbena in combination with other herbs can cause gastrointestinal adverse effects (374,379).
Immunologic ...Orally, verbena in combination with other herbs can cause allergic skin reactions (374,379). Topically, verbena can cause contact dermatitis (13431).
