Tea Tree Oil Cream by Herbal Authority

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alzheimer disease. Although there is interest in using oral or intravenous chelation therapy products for Alzheimer disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Angina. It is unclear if oral or intravenous chelation therapy products are beneficial for angina. Details: A small clinical trial (Program to Assess Alternative Treatment Strategies to Achieve Cardiac Health; PATCH) in patients with angina shows that 500-mL infusions of a multicomponent disodium ethylenediamine tetraacetic acid (EDTA) chelation solution (Endrate) does not improve exercise capacity or time to ischemia when compared with a placebo containing all components other than EDTA. The dose of EDTA was 40 mg/kg (maximum 3 grams per dose) and was provided over a period of 3 hours. Infusions took place twice weekly for 15 weeks and then monthly for 3 months. Each infusion also provided magnesium sulfate 750 mg, ascorbic acid 5 grams, and sodium bicarbonate 5 grams. All patients also took an oral multivitamin/multimineral product (108104). This study may have been underpowered to detect differences between groups. There is currently no information suggesting that the oral use of chelation therapy products is beneficial.
• Arsenic poisoning. Although there is interest in using topical chelation therapy products for arsenic poisoning, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Atherosclerosis. Although there is interest in using oral chelation therapy products for atherosclerosis, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Attention deficit-hyperactivity disorder (ADHD). Although there is interest in using oral chelation therapy products for ADHD, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Atopic disease. Although there is interest in using oral chelation therapy products for atopic disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Autism spectrum disorder. It is unclear if oral or topical chelation therapy products are beneficial for autism spectrum disorder. Details: Various chelation therapy products have been investigated in clinical research. One preliminary clinical trial in children aged 3-8 years with autism spectrum disorder shows that taking dimercaptosuccinic acid (DMSA) 10 mg/kg three times daily as chelation therapy does not improve sociability, communication with speech or language, or general stereotypical behaviors when compared with placebo. The DMSA was taken for 3 days and then repeated up to 6 times, with 11 days off between treatment periods. Prior to the initiation of this phase of the study, all children received at least one 3-day round of chelation therapy to ensure the excretion of high amounts of heavy metals; however, heavy metal excretion was not compared between groups . Also, half of the children received topical glutathione for 7 days (21057,108099,108109). Other preliminary clinical research in children aged 3-9 years with autism spectrum disorder shows that taking a single dose of DMSA 10 mg/kg increases urinary excretion of cadmium, mercury, and lead. Taking DMSA monthly for 6 months improves overall behavior when compared with baseline. However, only specific behaviors, such as relating to people, imitation, and communication, were improved; other behaviors, including emotional, visual, auditory, or intellectual responses, were not improved (108110). The validity of these findings is limited by the lack of a comparator group. Small clinical studies have also evaluated other chelation therapy products in children with autism spectrum disorder. These include rectal thiamine tetrahydrofurfuryl disulfide (108111) and oral, intravenous, rectal, or topical 2,3-dimercaptopropane-1-sulfonate (DMPS) (108098). However, there is insufficient reliable information available regarding their effects.
• Cancer. Although there is interest in using oral chelation therapy products for cancer, there is insufficient reliable information about the clinical effects of chelation therapy products for this use.
• Cardiovascular disease (CVD). It is unclear if oral or intravenous chelation therapy products are beneficial for CVD. Details: One large clinical study (the Trial to Assess Chelation Therapy; TACT) in adults with stable coronary disease following a recent myocardial infarction (MI) shows that receiving 500-mL infusions of a multicomponent disodium ethylenediamine tetraacetic acid (EDTA) chelation solution, with or without oral high-dose vitamins, reduces the composite risk of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization by about 18% over 5 years. However, there was no effect of EDTA on the risk of these individual endpoints. A sub-group analysis shows that the risk of this composite outcome is reduced by up to 41% in patients who also have diabetes, with no reduction in patients without diabetes (94983,94985). Also, receiving just the multicomponent disodium EDTA chelation solution without oral high-dose vitamins does not reduce the risk of this composite outcome when compared with placebo, even in the subgroup of patients with diabetes (94986). Each infusion provided EDTA 3 grams over a period of at least 3 hours in combination with ascorbic acid 7 grams, magnesium chloride 2 grams, potassium chloride 2 mEq, sodium bicarbonate 840 mg, pantothenic acid 250 mg, thiamine 100 mg, pyridoxine 100 mg, procaine hydrochloride 100 mg, and heparin 2500 units (94983,94985,94986). Significant limitations of the trial, including missing data and possible unblinding, limit the reliability of these findings (95697).
• Hypertension. Although there is interest in using oral chelation therapy products for hypertension, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Influenza. Although there is interest in using oral chelation therapy products for influenza, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose.
• Lead toxicity. Although there is interest in using topical chelation therapy products for lead toxicity, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Mercury toxicity. Although there is interest in topical chelation therapy products for mercury toxicity, there is insufficient reliable information about the clinical effects of topical chelation therapy products for this condition.
• Osteoporosis. Although there is interest in using oral chelation therapy products for osteoporosis, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Parkinson disease. Although there is interest in using oral chelation therapy products for Parkinson disease, there is insufficient reliable information about the clinical effects of chelation therapy products for this condition.
• Peripheral arterial disease (PAD). It is unclear if oral or intravenous chelation therapy products are beneficial for PAD. Details: Individual preliminary clinical trials included in a systematic review have shown that intravenous disodium ethylenediamine tetraacetic acid (EDTA) has no beneficial effect on blood flow, walking distance, pain-free walking distance, blood lipid levels, or well-being in patients with PAD (5752,5753,5754,108103). Most studies have used EDTA 3 grams twice weekly, usually in combination with vitamins and minerals, over a period of up to 10 weeks (5753,108103). In addition, there is no information suggesting that the oral use of EDTA is beneficial.
• Uterine fibroids. Although there is interest in using oral chelation therapy products for uterine fibroids, there is insufficient reliable information about the clinical effects of chelation therapy products for this purpose. More evidence is needed to rate chelation therapy products for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Chemotherapy-related infection. It is unclear if oral fermented wheat germ extract is effective for the prevention of febrile neutropenia in children receiving chemotherapy. Details: A small, open-label clinical study in children undergoing chemotherapy shows that a specific fermented wheat germ extract (Avemar) 6 grams/m2 dissolved in water and taken by mouth twice daily along with standard chemotherapy for an average of 10-11 chemotherapy cycles (approximately 29 months) reduces the frequency of febrile neutropenia when compared with chemotherapy alone. Thirty episodes of febrile neutropenia were reported for children receiving fermented wheat germ extract, compared to 46 episodes reported for children receiving chemotherapy alone (27702).
• Colorectal cancer. It is unclear if oral fermented wheat germ extract is beneficial in patients with colorectal cancer. Details: Small non-randomized, open-label clinical studies in patients with colorectal cancer show that taking a specific fermented wheat germ extract (Avemar) 9 grams once or twice daily for at least 6 months in addition to chemotherapy reduces colon cancer progression, the frequency of new metastases, and the risk of mortality when compared with chemotherapy alone (27703,27704). The validity of these findings is limited by a lack of randomization and blinding.
• Melanoma. It is unclear if oral fermented wheat germ extract is beneficial in patients with melanoma. Details: A small clinical study in patients with melanoma shows that a specific fermented wheat germ extract (Avemar) 8.5 grams mixed in a drink and taken once daily in addition to dacarbazine (DTIC)-based chemotherapy for 12 months increases overall survival after 7 years of follow-up by around 22 months and progression-free survival by around 26 months when compared with dacarbazine (DTIC)-based chemotherapy alone (27707).
• Prostate cancer. It is unclear if oral fermented wheat germ extract is beneficial in patients with prostate cancer. Details: A small clinical study in patients with castration-resistant prostate cancer shows that a specific fermented wheat germ extract (Avemar) 8.5 grams mixed in a drink and taken once or twice daily in addition to a gonadotropin releasing hormone analog for at least 4 months increases the doubling time for prostate specific antigen levels in most patients, but does not seem to improve quality of life, when compared to baseline (109632). The validity of these findings is limited by a lack of control group.
• Rheumatoid arthritis (RA). It is unclear if oral fermented wheat germ extract is beneficial in patients with RA. Details: A small, uncontrolled clinical study in females with RA shows that taking a specific fermented wheat germ extract (Avemar) 8.5 grams by mouth in a drink twice daily in addition to disease-modifying anti-rheumatic drug (DMARD) and steroid therapies for 12 months reduces morning stiffness and the dose of steroid drug needed when compared to baseline (27706). The validity of these findings is limited by a lack of control group.
• Systemic lupus erythematosus (SLE). Although there has been interest in using oral fermented wheat germ extract for SLE, there is insufficient reliable information about the clinical effects of fermented wheat germ extract for this purpose. More evidence is needed to rate fermented wheat germ extract for these uses.

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POSSIBLY EFFECTIVE

• Acne. Some clinical research shows that topical tea tree oil seems to improve symptoms of acne in adults and adolescents. Details: Some preliminary clinical research shows that applying a tea tree oil 5% gel is as effective as benzoyl peroxide 5% (Oxy-5, Benzac AC, and others) and more effective than placebo for treating acne. Tea tree oil might work more slowly than benzoyl peroxide, but it seems to be less irritating to facial skin (8573). Other clinical research shows that applying a tea tree oil 5% gel for 20 minutes twice daily for 45 days decreases acne lesions 3.6-fold, acne severity 5.7-fold, and comedone numbers, pustules, and papules when compared with placebo in patients with mild to moderate acne (19176). Another small clinical study in patients with mild to moderate acne shows that applying a topical tea tree oil nanoemulsion with adapalene gel 0.1% once daily for 12 weeks reduces acne lesions and improves acne severity scores when compared with adapelene gel alone. However, the tea tree oil product was associated with an increased occurrence of mild adverse effects (109945). Conversely, a small clinical trial shows that applying tea tree oil 5% cream twice daily for 8 weeks reduces inflammatory acne lesions by 38%, compared with a 65% reduction in patients using a product based on Lactobacillus-fermented Chamaecyparis obtuse 5% cream. Additionally, the time of onset was slower with tea tree oil (91447).
• Onychomycosis. Some clinical research suggests that topical pure tea tree oil seems to be beneficial for onychomycosis. It is unclear if the diluted oil is beneficial. Details: Topical application of pure tea tree oil twice daily for 6 months can produce a mycological cure in about 18% of patients with toenail infections. It can also improve nail appearance and symptoms in about 56% of patients after three months and 60% of patients after 6 months of treatment. It seems to be comparable to twice daily application of clotrimazole 1% solution (1538). However, preliminary clinical research shows that lower concentrations of tea tree oil do not seem to be as effective. For example, there is some evidence that a tea tree oil 5% cream applied three times daily for 2 months has no beneficial effect (7032).
• Tinea pedis. Some clinical research suggests that topical tea tree oil 25% or 50% seems to be beneficial for tinea pedis, although it does not seem to work as well as standard treatments. Details: Topical application of tea tree oil 25% or 50% solution twice daily appears to produce both clinical improvement and a mycological cure in 48% to 50% of patients after 4 weeks of treatment, compared with 13% of those using placebo (10033). However, tea tree oil 25% or 50% concentrations don't appear to be as effective for mycological cure as clotrimazole or terbinafine (13713). Also, although topical application of a tea tree oil 10% cream seems comparable to tolnaftate 1% cream for relieving symptoms of tinea pedis, including scaling, inflammation, itching, and burning, the tea tree oil cream appears no more effective than placebo in producing a mycological cure (4031).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angular cheilitis. Although there is interest in using topical tea tree oil for angular cheilitis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Bacterial vaginosis. Although there is interest in using intravaginal tea tree oil for bacterial vaginosis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Blepharitis. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with seborrheic blepharitis shows that using a specific topical swab (TTO Thermal Swab, Jeomed Medicine and Health Production Company) containing tea tree oil and chamomile twice daily for 8 weeks improves blepharitis symptom scores, such as burning, itching, and dry eyes, when compared with using baby shampoo. Symptom improvements were maintained 4 weeks after treatment discontinuation (109944).
• Contact dermatitis. Preliminary clinical research suggests that topical tea tree oil is beneficial for nickel-induced contact dermatitis. Details: Preliminary clinical research shows that undiluted or diluted tea tree oil for 3-5 days may reduce the area and redness of acute contact dermatitis reactions in people with nickel hypersensitivity (16337,19191). Other preliminary clinical research in individuals with nickel allergy shows that applying 60-120 mcL of tea tree oil 20% or 50% (Australian bodycare tea tree oil, Maxmedica AB) once, immediately prior to nickel exposure, reduces nickel-induced contact dermatitis by 41% when compared with no treatment (19191).
• Dandruff. It is unclear if topical tea tree oil is beneficial for dandruff in adults and adolescents. Details: Preliminary clinical research shows that a tea tree oil 5% shampoo, used for three minutes daily prior to rinsing for 4 weeks, reduces the total area and severity of scalp lesions, as well as the severity of dandruff, itchiness, and greasiness, by 23% to 28% in patients aged 14 years and older. However, it does not improve scalp scaliness (19178).
• Dental plaque. It is unclear if brushing or rinsing with tea tree oil is beneficial for dental plaque; the available evidence is conflicting. Details: Preliminary clinical research shows that brushing with a tea tree oil 2.5% gel twice daily for 8 weeks reduces papillary bleeding, but does not improve gingival health or plaque, in patients with plaque-induced gingivitis (19179). Other preliminary clinical research also shows that using tea tree oil mouthwash does not reduce plaque formation following a professional tooth cleaning (19180). However, a small preliminary clinical trial shows that using a mouthwash made from 3-4 drops of pure tea tree oil in water 2-3 times daily after brushing for 14 days is as effective as using a mouthwash containing chlorhexidine 0.12% twice daily for reducing plaque (105241). Some preliminary clinical research has also evaluated tea tree oil in combination with other ingredients. A combination of tea tree oil 1.5% and xylitol 10% (Tebodont) for 3 months reduces plaque formation on tooth surfaces when compared with pretreatment (19181). Other research shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil 0.2% to 0.3% each, for 30 seconds twice daily for 21 days, reduces plaque formation by 64% when compared to baseline (91446). It is not clear if the effects in these studies are due to tea tree oil, other ingredients, or the combinations.
• Dry eye. It is unclear if topical tea tree oil is beneficial for improving symptoms of dry eye due to cataract surgery or meibomian gland dysfunction. Details: Clinical research in patients with dry eye due to cataract surgery also using artificial tears and topical steroid drops shows that eyelid scrubbing with eye shampoo containing an undisclosed amount of tea tree oil for one month improves symptoms of dry eye, such as sensitivity, pain, and blurred vision, and reduces demodex counts, when compared with using shampoo without tea tree oil. There was no benefit of the tea tree oil on visual acuity (101998). Clinical research in patients with meibomian gland dysfunction shows that applying a tea tree oil 1% shampoo around the eye once daily for 3 months improves gland function scores and dry eye symptom scores when compared with Johnson's baby shampoo (109943).
• Furuncles (boils). Although there is interest in using topical tea tree oil for boils, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Gingivitis. It is unclear if brushing or rinsing with tea tree oil is beneficial for gingivitis; the available evidence is conflicting. Details: A small preliminary clinical trial shows that using a mouthwash comprised of 3-4 drops of pure tea tree oil in water 2-3 times daily after brushing for 14 days is as effective as using a mouthwash containing chlorhexidine 0.12% twice daily for reducing plaque and bleeding and improving gum health (105241). Other preliminary clinical research in patients with severe gingivitis shows that brushing with a tea tree oil 2.5% gel twice daily for 8 weeks reduces papillary bleeding when compared with baseline. However, the gel does not appear to improve plaque or the severity of plaque-induced gingivitis (19179). Combination products containing tea tree oil have also been investigated. Preliminary clinical research shows that rinsing with a specific product containing a combination of tea tree oil 1.5% and xylitol 10% (Tebodont) for 3 months reduces gum inflammation by 26% to 32% when compared with pretreatment (19181). Also, clinical research shows that rinsing with 10 mL of a solution containing tea tree oil, clove, and holy basil 0.2% to 0.3% each, for 30 seconds twice daily for 21 days, reduces gum inflammation by 76% when compared to baseline (91446). It is not clear if the effects in these studies are due to tea tree oil, other ingredients, or the combinations.
• Halitosis. It is unclear if tea tree oil mouth rinses are beneficial for halitosis. Details: Preliminary clinical research in adults with halitosis shows that using a specific tea tree oil mouth rinse (100% Organic Tea Tree Oil, Dessert Essence) 10 mL twice daily for 7 days moderately improves halitosis severity scores and reduces salivary levels of Solobacterium moorei when compared with placebo. The improvements were similar to using chlorhexidine gluconate 0.2% mouth rinse (109941). Tea tree oil has also been studied as a combination treatment. One small clinical study suggests that applying an essential oil solution containing tea tree, peppermint, and lemon oils 0.125% as part of a single three-minute oral cleaning reduces the level of bad breath in patients from an intensive care unit when compared with baseline or benzydamine hydrochloride. 15 mL of the solution was applied to cotton sponges used to clean the teeth, tongue, and oral cavity (19177).
• Hemorrhoids. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in children with hemorrhoids shows that application of a specific gel (Proctoial, BSD Pharma) containing tea tree oil, hyaluronic acid, and methylsulfonylmethane (MSM) daily for 14 days decreases symptoms of hemorrhoids, such as anal pain, defecation pain, irritation, inflammation, visible bleeding, and itching, when compared with placebo (19318).
• Herpes labialis (cold sores). It is unclear if topical tea tree oil is beneficial for herpes labialis. Details: One small clinical study in adults with cold sores shows that applying a tea tree oil 6% gel five times daily does not improve the rate of cold sore resolution when compared with a placebo gel (2035). However, this study may have been inadequately powered to detect a difference between groups.
• Hirsutism. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild idiopathic hirsutism shows that using a spray containing lavender and tea tree oils twice daily for 3 months on specific hirsutism-affected areas decreases hair diameter by 8% to 9% and total hirsutism score by 11% when compared with baseline. The spray provides lavender oil 48 mcg and tea tree oil 2 mcg per square cm of skin. These improvements were not observed in a placebo group (91448).
• Insect bite. Although there is interest in using topical tea tree oil for insect bites, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Lice. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: There is preliminary evidence that tea tree oil repels lice and reduces blood feeding (19187). When used in combination with lavender oil, tea tree oil has ovicidal effects on head lice and reduces the number of live lice. A pediculicide containing tea tree oil 10% weight per volume and lavender oil 1% weight per volume (NeutraLice Natural Lotion, Key Pharmaceuticals Pty Ltd) has been applied to the hair for 10 minutes, either as a single application or three times over 2 weeks, in children aged 4-12 years (19188,19189). It is unclear if any effects are due to tea tree oil, lavender, or the combination.
• Methicillin-resistant Staphylococcus aureus (MRSA). It is unclear if topical tea tree oil is beneficial for the prevention of MRSA colonization or the treatment of MRSA infection. Details: Preliminary clinical research shows that tea tree oil is not effective for preventing MRSA colonization. Using tea tree oil 5% body wash (Novabac 5% skin wash, Novasel Australia Pty Ltd.) is no more effective than a standard wash (Johnson's baby softwash, Johnson & Johnson) for preventing MRSA colonization in critically ill patients (91441). There is contradictory evidence on the effects of tea tree oil for the treatment of MRSA infection. In patients with MRSA-colonized wounds, use of a 3% water-miscible solution of tea tree oil during the wound cleansing routine for each dressing change does not improve MRSA clearance (19190). Also, in patients with MRSA colonization, tea tree oil given in various preparations along with standard treatment for 5 days does not appear to increase overall MRSA clearance when compared with standard treatment alone. These various preparations, which contain tea tree oil 5% or 10%, include a cream applied to the nostrils three times daily, a body wash used at least once daily, or a cream applied to lesions, ulcers, wounds, and axillae or groin areas once daily. Although these various preparations do not improve overall clearance, it seems that using a tea tree cream and body wash may be more effective for eradicating MRSA from specific sites such as wounds and superficial skin infections when compared with standard treatments alone (19163). Also, preliminary clinical research suggests that using tea tree oil 4% nasal ointment plus tea tree oil 5% body wash increases MRSA clearance when compared with a triclosan body wash and mupirocin 2% nasal ointment (19158,19159). Larger, high-quality studies are needed to confirm these results.
• Ocular demodicosis. It is unclear if topical tea tree oil is beneficial for ocular demodicosis; available evidence is conflicting. Details: Small clinical studies suggest that tea tree oil can eradicate Demodex infestation in the eyelids and reduce associated symptoms such as corneal and conjunctival inflammation, ocular irritation, and vision loss. In adults, treatments have included weekly scrubs of the eyelid using tea tree oil 50% and daily scrubs of the eyelid with tea tree shampoo, as well as eyelid massages with tea tree ointment 5% to 10%, for up to 12 weeks (19182,19183,19184,19185,91445,105243). In children aged 2.5-11 years, weekly scrubs of the eyelid using tea tree oil 50% and daily eyelid massages with tea tree oil 5% ointment for 4-6 weeks has been used (19184). However, conflicting evidence exists. One meta-analysis of two randomized controlled trials shows that although patients using tea tree oil for 4-6 weeks were 68% more likely to have an eradication of mites, while another meta-analysis of three randomized controlled trials shows that the use of tea tree oil products does not reduce the number of Demodex mites or reported symptoms. Also, a single study shows that receiving intense pulsed light over 12 weeks is more effective than tea tree oil. The certainty of evidence for these endpoints is very low and the majority of available research has an unclear or high risk of bias (105243).
• Oropharyngeal candidiasis. It is unclear if rinsing the mouth with tea tree oil is beneficial for the prevention of oropharyngeal candidiasis in various populations. Details: One very small clinical study in adults with HIV/AIDS who are refractory to fluconazole shows that swishing and expelling tea tree oil solution 15 mL four times daily for 2-4 weeks seems to improve oral candidiasis when compared to baseline (4445). Another small clinical study in adults with terminal cancer shows that using tea tree oil, as part of an essential oil mixture containing geranium, peppermint, and lavender twice daily for one week improves subjective measures of oral comfort and objective measures of oral health status and reduces Candida albicans count when compared with saline solution (19192). However, in patients with dentures, adding 1 mL of tea tree oil to a standard 5 mL dose of Coe-Comfort tissue conditioner treatment for 12 days does not reduce inflammation or Candida albicans growth when compared with Coe-Comfort alone (19193).
• Otitis externa. Although there is interest in using tea tree oil in the ear for otitis externa, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Otitis media. Although there is interest in using tea tree oil in the ear for otitis media, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Pharyngitis. Although there is interest in gargling with tea tree oil for pharyngitis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Rosacea. Topical tea tree oil has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with mild to moderate rosacea shows that applying permethrin 2.5% gel containing an undisclosed amount of tea tree oil to the affected area for one hour twice daily for 12 weeks reduces demodex mite counts by about 13% more than placebo. Furthermore, symptoms such as papules, burning, and redness were improved by moderate amounts when compared with placebo (101999). The effect of tea tree oil alone is unknown.
• Scabies. Although there is interest in using topical tea tree oil for scabies, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Seborrheic dermatitis. Although there is interest in using topical tea tree oil for seborrheic dermatitis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Tinea corporis. Although there is interest in using topical tea tree oil for tinea corporis, there is insufficient reliable information about the clinical effects of tea tree oil for this condition.
• Toothache. Although there is interest in rinsing the mouth with tea tree oil for toothache, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Vaginal candidiasis. Although there is interest in using intravaginal tea tree oil for vaginal candidiasis, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose.
• Water warts. It is unclear if topical tea tree oil is beneficial for water warts in children. Details: Preliminary clinical research in children with a mean age of 6.3 years with water warts shows that a 4 mcL drop of an oil containing iodine plus Australian tea tree oil 75%, standardized to 40.1% terpinene-4-ol, applied twice daily for up to 30 days, increases lesion resolution when compared with tea tree oil or iodine alone (19194).
• Wound healing. Although there is interest in topical tea tree oil for wound healing, there is insufficient reliable information about the clinical effects of tea tree oil for this purpose. More evidence is needed to rate tea tree oil for these uses.

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POSSIBLY UNSAFE ...when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107). Also, infusion of the disodium form of EDTA over less than 3 hours can cause severe, life-threatening adverse effects including hypocalcemia and death (5737).

CHILDREN: POSSIBLY UNSAFE
when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107).

PREGNANCY AND LACTATION: POSSIBLY UNSAFE
when unregulated chelation therapy products are used orally or parentally or when prescription chelation therapy products are used for unproven indications and/or in unapproved doses or routes of administration. The American College of Medical Toxicology and The American Academy of Clinical Toxicology recommend against the unapproved use of chelation therapy products (108106). Chelation therapy products can have teratogenic effects and result in severe side effects including dehydration, hypocalcemia, kidney failure, neurodevelopmental toxicity, and death (107700,108095,108096,108105,108106,108107).

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POSSIBLY SAFE ...when used orally and appropriately. A specific fermented wheat germ extract (Avemar) has been used safely in clinical research at doses of 8.5-9 grams once or twice daily for up to 12 months (27703,27704,27706,27708,109632). There is insufficient reliable information available regarding the safety of fermented wheat germ extract when applied topically.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately. A specific fermented wheat germ extract (Avemar) has been used safely in clinical research at a dose of 6 grams/m2 twice daily for approximately 29 months (27702).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used topically and appropriately for up to 12 weeks (1538,4028,4031,4445,7032,8573,19157,19158,19159,19163)(19318,109944,109945).

LIKELY UNSAFE ...when used orally. Tea tree oil has been reported to cause significant toxicity when used orally (4028,10011,19166,19168,19170,109947).

CHILDREN: POSSIBLY SAFE
when used topically and appropriately. Tea tree oil 5% preparations have been used with apparent safety in children (8573).

CHILDREN: LIKELY UNSAFE
when used orally. Ingestion of tea tree oil can be toxic (4030,10010,10013,11799).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used topically and appropriately (512).

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally. Ingestion of tea tree oil can be toxic (515).

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DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Concomitant use of ethylenediamine tetraacetic acid (EDTA) and potassium-depleting diuretics might increase the risk for hypokalemia.  Details EDTA can decrease serum potassium levels and increase excretion of potassium (15).

INSULIN Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = B Ethylenediamine tetraacetic acid (EDTA) can decrease the activity of insulin and increase the risk for hypoglycemia.  Details Concomitant use of disodium EDTA with insulin can cause severe decreases in blood glucose concentrations (5737,5771). Additionally, EDTA chelates zinc in insulin products (15) and might interfere with the onset and duration of activity of various insulin preparations.

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, disodium ethylenediamine tetraacetic acid (EDTA) can decrease the anticoagulant effects of warfarin.  Details Disodium EDTA has been reported to decrease international normalized ratio (INR) in a patient taking warfarin (4611).

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IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, fermented wheat germ extract might decrease the effects of immunosuppressants.  Details Animal research suggests that fermented wheat germ extract can stimulate immune function (27709,27712,27713,27714,27727).

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General ...The use of chelation therapy products for unproven indications, or in unapproved doses or routes of administration, is generally considered to be unsafe.
Most Common Adverse Effects:
Orally: Gastrointestinal upset, nausea.
Intravenous: Abdominal cramps, anorexia, burning and pain at infusion site, diarrhea, headache, nausea, vomiting.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, Stevens-Johnson syndrome.
Intravenous: Allergic reactions, arrhythmias, convulsions, death, heart failure, hypercalcemia, hypocalcemia, insulin shock, kidney failure, paresthesia, respiratory arrest, tetany, thrombophlebitis.

Cardiovascular ...Intravenously, chelation therapy products such as 2,3-dimercaptopropane-1-sulfonate (DMPS) or ethylenediamene tetraacetic acid (EDTA) have been associated with hypotension and irregular heartbeat (5737,5771,5772,108105,108106). Intravenously, EDTA can also cause thrombophlebitis (108099,108103). Disodium EDTA, when given as a rapid infusion or highly concentrated solution, can cause hypocalcemia, severe cardiac arrhythmias, respiratory arrest, and death (15,108102).
There are at least three case reports of intravenous chelation therapy-related hypocalcemia resulting in cardiac arrest. Two cases involved the use of disodium EDTA in children and one involved the unapproved use of an unknown type of EDTA over a 10- to 15-minute infusion in an adult (107700,108095,108096,108097,108105). At least in part because of these cases, disodium EDTA is no longer FDA-approved (108105). In a large clinical trial in patients with a previous myocardial infarction, the rate of hypocalcemia was 6.2% in patients given disodium EDTA, compared with 3.5% of those given placebo; however, disodium EDTA did not increase the risk of heart failure or death (94985).

Dermatologic ...There is a case report of Stevens-Johnson syndrome after two weeks of oral 2,3-dimercaptopropane-1-sulfonate (DMPS) chelation therapy in a child with chronic mercury exposure. Symptoms included a widespread eruption of red, itchy macules which gradually improved after discontinuation of DMPS therapy (108112). Rash has also been reported in patients given intravenous DMPS or oral dimercaptosuccinic acid (DMSA) (108099).
Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause exfoliative dermatitis (15,108103) and a burning sensation and pain at the site of infusion (5744,108103).

Endocrine ...Intravenously, calcium disodium ethylenediamene tetraacetic acid (EDTA) can cause zinc deficiency (5771,5772) and hypercalcemia (5771,5772). Disodium EDTA can occasionally reduce magnesium and potassium serum concentrations (5771,5772), and rarely cause insulin shock (5737).
Disodium EDTA, when given as a rapid infusion or highly concentrated solution, can cause hypocalcemia, leading to tetany, convulsions, cardiac arrhythmias, cardiac failure, respiratory arrest, and death. This has occasionally occurred when the disodium form of EDTA was used in error, instead of the calcium disodium form (15,94984,94985,107700,108095,108096,108097,108099,108105).

Gastrointestinal ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause abdominal cramps, anorexia, nausea, vomiting, and diarrhea (15). EDTA can also sometimes cause thirst (15).
When given orally or intravenously, 2,3-dimercaptopropane-1-sulfonate (DMPS) has caused nausea and dysgeusia.
Orally, dimercaptosuccinic acid (DMSA) has caused gastrointestinal upset and diminished appetite (108099).

Hematologic ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes cause anemia (15), prolonged prothrombin time (5737) and transient bone marrow suppression (5737,5772).

Hepatic ...Intravenously, the calcium disodium form of ethylenediamene tetraacetic acid (EDTA) can cause mild elevations of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and decreased alkaline phosphatase (ALP) levels (15,108102).
Orally, dimercaptosuccinic acid (DMSA) has been associated with mild elevations in liver transaminase levels (108105).

Immunologic ...Intravenously, disodium ethylenediamene tetraacetic acid (EDTA) can rarely cause histamine-like reactions (5737). There are rare reports of allergic reactions to EDTA given as a nasal provocation, topically, intradermally, and subcutaneously (94992). In one case report, a 57-year-old male presented with pruritus on the hands and feet, as well as urticaria and swelling of the face, following subcutaneous injection with a local anesthetic containing EDTA. Allergy to other ingredients in the anesthetic was ruled out, and intradermal and subcutaneous testing with calcium disodium EDTA confirmed the allergic response. The patient also reacted to radio-contrast medium containing EDTA (94992).
Topically, application of EDTA in cosmetics, shampoos, and other products has rarely been reported to cause contact dermatitis (94992).
Orally, dimercaptosuccinic acid (DMSA) has been associated with allergic reactions (108105).

Musculoskeletal ...Intravenously, disodium ethylenediamene tetraacetic acid (EDTA) can occasionally cause muscle cramps, back pains, muscle weakness, and myalgias (15). In a large clinical trial in patients with a previous myocardial infarction, the rate of hypocalcemia was 6.2% in patients given disodium EDTA, compared with 3.5% of those given placebo; however, only one patient had associated muscle cramping leading to a hospital visit (94985).

Neurologic/CNS ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can commonly cause headache and faintness (15,108103). EDTA can also sometimes cause fever, chills, fatigue, and malaise (15,108099). Disodium EDTA can occasionally cause tremors, tingling, and paresthesias (15).
Orally, dimercaptosuccinic acid (DMSA) was associated with lethargy in one child in a clinical trial. Other possible adverse effects associated with DMSA included sleep problems (108099).

Pulmonary/Respiratory ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes increase sneezing and nasal congestion (15). Inhalation of disodium EDTA contained in nebulizer solutions has been reported to cause dose-related bronchoconstriction (5765).

Renal ...Intravenously, ethylenediamene tetraacetic acid (EDTA) can sometimes cause urinary urgency and frequency (5772). However, the most serious adverse effect of EDTA is kidney toxicity (5772,108095,108099,108102) for doses greater than 3 grams daily (15). In a clinical trial in patients with angina, intravenous disodium EDTA has resulted in an elevation of serum creatinine (108104). EDTA can cause nocturia, hyperuricemia, polyuria, dysuria, oliguria, proteinuria, glycosuria, hematuria. and distal tubule and glomeruli changes (15). EDTA can also cause acute renal tubular necrosis, renal insufficiency, and renal failure (5772).

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General ...Orally, fermented wheat germ extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, nausea.

Gastrointestinal ...Orally, fermented wheat germ extract may cause diarrhea, nausea, flatulence, satiation, soft stools, and constipation. In one clinical study, diarrhea and nausea with or without vomiting were reported in 6% and 3% of patients, respectively (27703).

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General ...Orally, tea tree oil can cause significant toxicity and should not be used. Topically, tea tree oil is generally well tolerated.
Most Common Adverse Effects:
Topically: Allergic reactions, burning, dryness, irritation, pruritus, redness, and stinging.

Dermatologic ...Ingestion of as little as 2. 5 mL of tea tree oil can cause petechial body rash. It can take up to a week for symptoms to resolve (10011).
Topically, tea tree oil is usually well tolerated. However, it can cause local irritation and inflammation in some patients. Treatment with topical corticosteroids may be needed in some cases (10033,13713,19176,91442,91443,109946,109947). Severe allergic contact dermatitis has also been reported (109948). Tea tree oil can cause skin dryness, and less frequently pruritus, stinging, burning, and redness in patients with acne (8573,91447,109947). It may also cause mild oral mucosal burning (4445).

Endocrine ...In one case, a prepubertal male who used a hair styling gel and shampoo product containing both tea tree oil and lavender oil developed gynecomastia. The gynecomastia resolved when the products were discontinued. It is possible that this effect was due to lavender oil, which has been associated with other cases of gynecomastia in prepubertal males (15254).

Gastrointestinal ...Orally, tea tree oil can cause eucalyptus-like odor on the breath. In young children, ingestion of 10 mL or less of tea tree oil can cause this effect (4030,10010,11799).

Hematologic ...Orally, as little as 2. 5 mL of tea tree oil can cause neutrophil leukocytosis. It can take up to a week for symptoms to resolve (10011).

Immunologic ...Orally, tea tree oil can cause or worsen systemic contact dermatitis (4028,19168). Topically, tea tree oil is usually well tolerated. However, it can cause allergic contact eczema and allergic contact dermatitis in some children and adults. Corticosteroids may be needed in some cases (658,4027,4028,4029,10015,10029,10030,10031,10032)(91443,105242,105244).
In young children, ingestion of 10 mL or less of tea tree oil can cause significant ataxia, drowsiness, disorientation, and coma (4030,10010,11799).

Neurologic/CNS ...Orally, tea tree oil can cause ataxia and CNS depression (109947).

Ocular/Otic ...There is some concern that topical use of tea tree oil in the middle ear for treatment of ear infections might cause ototoxicity. There is preliminary evidence from animal research that preparations of pure tea tree oil can cause ototoxicity and impaired hearing. However, so far there are no reports of ototoxicity in humans. Until more is known, tell patients to avoid pure or highly concentrated tea tree oil preparations. Concentrations of 2% seem less likely to have this effect (7025).

Pulmonary/Respiratory ...Orally, tea tree oil can cause dyspnea and pneumonitis (109947).

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