Rash Formula Ointment by Dr. Christopher's

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anal fissures. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax for 12 hours reduces pain, bleeding, and itching associated with anal fissures (34100). It is unclear if these effects are due to beeswax, the other ingredients, or the combination.
• Burns. Preliminary clinical research in individuals with second-degree burns shows that applying a dressing containing a mixture of beeswax, olive oil, and alkanna once daily reduces healing time by almost 4 days, decreases pain during dressing changes, and shortens the duration of hospitalization by about 6 days compared to using a dressing containing nitrofurazone and rifamycin, applied once every 2 days (96328). Other preliminary clinical research shows that using a topical product containing beeswax (Medilixir, Medilixir Pty Ltd) for 14 days decreases the severity of itching, lengthens the time until itch recurrence, and decreases the use of anti-itch medications compared to standard aqueous cream (Biotech Pharmaceuticals Pty Ltd) in individuals experiencing post-burn itch (96329). Poor study designs limit the reliability of the findings.
• Diaper rash. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax four times daily for 7 days reduces symptoms of diaper rash by more than 75% (34094). It is unclear if this effect is due to beeswax, the other ingredients, or the combination.
• Hemorrhoids. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax for 12 hours reduces pain, bleeding, and itching associated with hemorrhoids (34100). It is unclear if these effects are due to beeswax, the other ingredients, or the combination.
• Oral mucositis. Preliminary clinical research in children with severe chemotherapy-induced mucositis shows that applying of mixture of honey, olive oil-propolis extract, and beeswax topically three times daily until healing or for a maximum of 10 days, along with standard oral care, reduces recovery time by almost 3 days compared to using benzocaine 7.5% gel. However, the mixture does not appear to reduce recovery time compared to benzocaine in patients with moderate chemotherapy-induced mucositis. Additionally, applying honey alone 0.5 grams/kg (maximum 15 grams), appears to be more efficacious for both moderate and severe mucositis than either the honey mixture or benzocaine gel (55245).
• Radiation dermatitis. A small clinical study in patients undergoing radiotherapy shows that applying a topical ointment containing beeswax, olive oil, calendula oil extract, and St. John's wort oil extract to the treated area nightly during radiotherapy and for two weeks post-radiotherapy, while also applying a topical cream containing aloe vera gel, calendula oil extract, and St. John's wort oil extract to the treated area three to four times daily, reduces the intensity of dermatitis and improves quality of life scores when compared to baseline (105769). The validity of these findings is limited by the lack of a comparator group. Additionally, it is unclear if these findings are due to beeswax, other ingredients, or the combination.
• Tinea corporis. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax three times daily for 4 weeks achieves clinical response in 75% of patients with tinea corporis (34092). It is unclear if this effect is due to beeswax, the other ingredients, or the combination.
• Tinea cruris. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax three times daily for 4 weeks achieves clinical response in 78% of patients with tinea cruris (34092). It is unclear if this effect is due to beeswax, the other ingredients, or the combination.
• Tinea versicolor. Preliminary clinical research shows that topical use of a mixture of honey, olive oil, and beeswax three times daily for 4 weeks achieves clinical response in 86% of patients with tinea versicolor (34092). It is unclear if this effect is due to beeswax, the other ingredients, or the combination. More evidence is needed to rate beeswax for these uses.

(Read more about BEESWAX)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with mild to moderate acne associated with mask wearing shows that topical application of a combination of calendula 4%, licorice root extract 0.3%, and snail secretion filtrate 40% (AI complex) to the face twice daily for 12 weeks modestly reduces inflammatory, but not non-inflammatory or total, acne lesions when compared with placebo. There was no difference in overall treatment success, defined as at least almost clear skin or a large improvement (110322). It is unclear if any benefits are due to calendula, other ingredients, or the combination.
• Bacterial vaginosis. It is unclear if topical calendula is beneficial for improving bacterial vaginosis. Details: A small clinical study in patients with bacterial vaginosis shows that applying 5 grams of vaginal cream containing calendula flower extract before bed for one week improves vaginal burning, odor, painful urination, and painful intercourse when compared to baseline (96649). The validity of these findings is limited by the lack of a comparator group.
• Burns. It is unclear if oral calendula is beneficial for burn healing. Details: A small clinical trial in patients hospitalized for second-degree burns shows that taking calendula 2 grams daily for 2 weeks has a large beneficial effect on wound healing when compared with placebo (110323).
• Chronic obstructive pulmonary disease (COPD). Oral calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in males aged 40-70 years with a history of smoking and stage 2 COPD shows that taking a specific combination of calendula flowers 165 mg, elderberry 165 mg, and heart's ease herb 165 mg (Inflaminat, INAT-Farma), 3 capsules daily for 6 months, modestly improves symptoms, as measured on the breathlessness, cough, and sputum scale (BCSS), and mean forced expiratory volume in 1 second (FEV1) when compared to baseline. However, there was no improvement of COPD exacerbations or other pulmonary function tests (103629). The validity of this finding is limited by the lack of statistical comparison to the placebo group. Furthermore, it is unclear if these effects are due to calendula, the other ingredients, or the combination.
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). Calendula in rectal suppositories has only been evaluated in combination with turmeric extract; its effect when used alone is unclear. Details: A small clinical study in patients with CP/CPPS shows that using a rectal suppository containing turmeric extract 350 mg and calendula extract 80 mg daily for one month improves pain, peak urine flow rate, and erectile function when compared with placebo (96648). It is unclear if these effects are due to calendula, turmeric, or the combination.
• Conjunctivitis. Although there is interest in using topical calendula for conjunctivitis, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Diabetic foot ulcers. It is unclear if topical calendula is beneficial for improving diabetic foot ulcers. Details: Observational research has found that applying a calendula hydroglycolic extract spray in addition to standard care and hygiene is associated with reduced bacterial colonization and improved odor in patients that have had a diabetic ulcer for over 3 months (93548).
• Diaper rash. It is unclear if topical calendula is beneficial for improving diaper rash. Details: One preliminary clinical study in children less than 3 years of age shows that topical application of calendula 1.5% ointment three times daily for 10 days improves diaper rash when compared with aloe gel (19779). However, other preliminary clinical research shows that applying calendula 1.5% cream every 4-6 hours for 3 days improves diaper rash in fewer infants when compared to treatment with bentonite 50% mineral solution (93545,93554).
• Dysmenorrhea. Although there is interest in using oral calendula for dysmenorrhea, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Gingivitis. It is unclear if using a mouth rinse with calendula is beneficial for improving gingivitis. Details: Preliminary clinical research in patients with mild gingivitis and bleeding gums shows that rinsing the mouth with a tincture containing calendula 25% (Dr. Willmar Schwabe Germany Home Pharmacy Pvt. Ltd.) twice daily for 6 months decreases plaque, gingivitis, and bleeding by 10% to 18% when compared to rinsing with water (93551). Other preliminary clinical research in adults with mild to moderate gingivitis and mild plaque shows that rinsing the mouth with a combination mouthwash containing a 5% extract of calendula, rosemary, and ginger for 30 seconds twice daily after food for 2 weeks decreases plaque, gingivitis, and bleeding when compared with a placebo mouthwash. The effects of this combination mouthwash appear to be similar to chlorhexidine 0.2% mouthwash (93555). It is unclear if these effects are due to calendula, other ingredients, or the combination.
• Hemorrhoids. Although there is interest in using topical calendula for hemorrhoids, there is insufficient reliable information about the clinical effects of calendula for this purpose.
• Liver disease. Although there is interest in using oral calendula for liver disease, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Mosquito repellent. It is unclear if topical calendula essential oil helps to repel mosquitos. Details: Preliminary clinical research shows that applying calendula 50% essential oil to the skin does not repel mosquitos as effectively as applying DEET. Mean repellency time was about 2 hours for patients applying calendula, which was shorter than the 6 hour repellency with DEET (93562).
• Oral leukoplakia. It is unclear if topical calendula is beneficial for improving oral leukoplakia. Details: Preliminary clinical research in patients with oral leukoplakia shows that applying a gel containing calendula flower extract 0.2% three times daily for one month reduces lesion size by about 2 cm when compared to baseline (96650). The validity of this finding is limited by the lack of a comparator group.
• Oral mucositis. Calendula as a mouth rinse has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with head and neck cancer receiving chemotherapy and radiotherapy shows that rinsing with 7 mL of a specific product (Faringel, Cadigroup) containing calendula powder extract 2%, propolis, aloe vera, and chamomile three times daily for 6 weeks does not prevent oral mucositis when compared with placebo (95879).
• Otitis media. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children with otitis media shows that applying a specific combination product containing calendula, mullein, garlic, and St. John's wort in olive oil (Otikon Otic Solution, Healthy-On Ltd, Petach-Tikva, Israel), five drops into the affected ear three times daily for 3 days, may reduce ear pain when compared with baseline (39500,39552). It is unclear if this effect is due to calendula, other ingredients, or the combination. Furthermore, due to the lack of an adequate control group, it is unclear whether the pain reduction was due to the resolution of otitis media.
• Peptic ulcers. Although there is interest in using oral calendula for peptic ulcers, there is insufficient reliable information about the clinical effects of calendula for this condition.
• Pressure ulcers. It is unclear if topical calendula is beneficial for improving pressure ulcers. Details: Observational research has found that the application of a specific calendula product (Plenusdermax) twice daily is associated with improved healing in patients with pressure ulcers that have not changed in size for at least 3 months (93549). Preliminary clinical research in hospice patients with symptomatic pressure ulcers and other wounds shows that applying a homeopathic powder (RGN107) containing calendula 0.1% and arnica 0.01% to wounds for 4 weeks is rated by the patients and caregivers to be acceptable for controlling pain, odor, and exudate when compared with baseline (96647). The validity of this finding is limited by the lack of a control group.
• Radiation dermatitis. It is unclear if topical calendula reduces radiation dermatitis symptoms. Details: A meta-analysis of three preliminary clinical trials in patients with breast cancer shows that topical calendula does not affect the development of radiation dermatitis or the incidence of moderate to severe symptoms when compared to control (110325). In addition, a meta-analysis of two studies (39503,93560) shows that topical calendula does not reduce the incidence of treatment interruptions due to severe symptoms of radiation dermatitis (110325). In one of the included studies, a specific calendula petroleum jelly ointment (Pommade au Calendula par Digestion, Boiron Ltd.) used twice daily during radiation therapy was found to reduce acute radiation dermatitis occurrence when compared with topical trolamine (Biafine) (39503). However, it is unclear if the benefit was due to calendula or petroleum jelly. Another clinical study used a specific calendula 10% cream in wool fat and sesame oil (Calendula Weleda, Weleda AG) twice daily during radiation therapy. This product was found to be no better than aqueous petroleum jelly cream (Essex, Schering-Plough) for reducing acute skin reactions and dermatitis symptoms of pain, burning, itching, pulling, and tenderness (93560).
• Vaginal atrophy. Topical calendula has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in menopausal patients with vaginal atrophy shows that use of a specific vaginal gel containing calendula, Lactobacillus sporogenes, isoflavones, and lactic acid (Estromineral Gel, Rottapharm-Madaus) daily for 4 weeks reduces vaginal itching, burning, dryness, and painful intercourse when compared with no topical treatment. Both groups also received oral isoflavones (39534). It is unclear if these effects are due to calendula, other ingredients, or the combination.
• Vaginal candidiasis. One small clinical study suggest that topical calendula is not beneficial for the treatment of vaginal candidiasis. Details: Preliminary clinical research shows that applying 5 grams of calendula 1% cream intravaginally once daily for 7 days effectively treats vaginal candidiasis in 34% fewer patients when compared with using clotrimazole 1% cream (93559).
• Venous leg ulcers. It is unclear if topical calendula is beneficial for improving venous leg ulcers. Details: Preliminary clinical research shows that applying a calendula 7.5% ointment twice daily for 3 weeks to venous leg ulcers accelerates healing when compared with applying saline solution dressing (39509).
• Wound healing. It is unclear if topical calendula is beneficial for improving the healing of small wounds. Details: Two small clinical trials in postpartum patients show that applying calendula ointment (formulation unspecified) to the episiotomy wound every 8 hours for 5-10 days modestly reduces pain, and seems to speed up the resolution of redness, edema, and ecchymosis, when compared with standard care, such as application of betadine solution (93550,105087). Another small clinical study in adults with wounds smaller than 10 cm² on the hands and fingers shows that applying calendula flower extract 2% to the wound twice daily may modestly improve healing and epithelialization time when compared with mineral oil (107806). More evidence is needed to rate calendula for these uses.

(Read more about CALENDULA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angina. Although there has been interest in using oral comfrey for angina, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Back pain. It is unclear if topical comfrey is beneficial in patients with back pain. Details: Clinical research in patients with lower or upper back pain shows that applying a specific ointment (Kytta-Salbe f, Merck Selbstmedikation GmbH) containing comfrey root extract 35% as 4 grams three times daily for 5 days decreases pain approximately 2-fold when compared with placebo (44912). Other clinical research shows that applying a specific cream (Kytta-Balsam f, Merck Selbstmedikation GmbH) containing comfrey root extract 35% and methyl nicotinate 1.2% as 4 grams three times daily for 5 days decreases pain scores by 54% at rest and by 50% during active motion when compared with placebo. These improvements were 24% and 27%, respectively, when compared with methyl nicotinate alone (92570).
• Bronchitis. Although there has been interest in using oral comfrey for bronchitis, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Bruises. It is unclear if topical comfrey is beneficial in patients with bruises. Details: Preliminary clinical research in adults with bruises from therapeutic subcutaneous enoxaparin injections shows that applying comfrey 10% ointment four times daily for 5 days reduces the average bruise size by 77% when compared with placebo. Topical comfrey also improved the bruise color (108668).
• Cancer. Although there has been interest in using oral comfrey for cancer, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Cough. Although there has been interest in using oral comfrey for cough, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Diarrhea. Although there has been interest in using oral comfrey for diarrhea, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Gastritis. Although there has been interest in using oral comfrey for gastritis, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Menorrhagia. Although there has been interest in using oral comfrey for menorrhagia, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Osteoarthritis. It is unclear if topical comfrey is beneficial in patients with osteoarthritis. Details: Preliminary clinical research in patients with knee osteoarthritis shows that applying a specific ointment (Kytta-Salbe f, Merck Selbstmedikation GmbH) containing comfrey root extract 35% three times daily for 3 weeks decreases pain scores 4-fold to 5-fold more than placebo. Applying comfrey root extract ointment also improved functional scores when compared with placebo (44904). Other clinical research in adults with knee osteoarthritis shows that applying a specific cream (4Jointz, Arthritis Relief Plus Ltd) containing comfrey extract 10% to 20%, plus tannic acid, aloe vera gel, eucalyptus oil, and frankincense oil three times daily for 6-12 weeks decreases pain approximately 2-fold more than placebo. The combination product also improved stiffness and physical functioning when compared with placebo (44919,92571).
• Peptic ulcers. Although there has been interest in using oral comfrey for peptic ulcers, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Pharyngitis. Although there has been interest in using oral or topical comfrey for pharyngitis, there is insufficient reliable information about the clinical effects of comfrey for this purpose.
• Sprains. It is unclear if topical comfrey is beneficial in patients with sprains. Details: Preliminary clinical research in adults with acute ankle sprains shows that applying a specific ointment (Kytta-Salbe f, Merck Selbstmedikation GmbH) containing comfrey root extract 35% as 2 grams four times daily for 8 days reduces pain and swelling and improves ankle mobility when compared with placebo (44898). Other research in adults with acute ankle sprains also shows that applying the same ointment reduces pain and tenderness scores to a similar extent as diclofenac gel 1.16% (44902).
• Tuberculosis. Although there has been interest in using oral comfrey for tuberculosis, there is insufficient reliable information about the clinical effects of comfrey for this purpose. More evidence is needed to rate comfrey for these uses.

(Read more about COMFREY)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• ACE inhibitor-induced cough. It is unclear if oral marshmallow root is beneficial in patients with cough due to ACE inhibitors. Details: A small clinical study in patients with ACE inhibitor-induced cough shows that taking marshmallow root 40 mg (20 drops) three times daily for 4 weeks improves cough when compared to baseline (62027). The validity of this finding is limited by the lack of a control group.
• Atopic dermatitis (eczema). It is unclear if topical marshmallow is beneficial in children with eczema. Details: A very small clinical study in children ages 3 months to 12 years with a recent diagnosis of mild to moderate eczema shows that applying a marshmallow 1% ointment twice daily for 1 week and then three times weekly for 3 weeks seems to reduce symptoms, as measured on the SCORing Atopic Dermatitis (SCORAD) scale, when compared with applying hydrocortisone 1% ointment (105437). This finding is limited by the large number of drop-outs due to non-compliance, most of which were in the marshmallow group.
• Breast engorgement. It is unclear if topical marshmallow is beneficial in women with this condition. Details: A small clinical study in breastfeeding women with breast engorgement shows that applying a compress containing 40-50 mL of a solution made from marshmallow leaves and stems 3 times daily for 2 days in conjunction with standard treatment improves patient-reported breast engorgement scores when compared with standard treatment alone. Standard treatment consisted of massage and alternating warm and cold compresses before and after breastfeeding (92845).
• Constipation. Although there is interest in using oral marshmallow for constipation, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Cough. Although there is interest in using oral marshmallow for cough, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Diarrhea. Although there is interest in using oral marshmallow for diarrhea, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Fever. It is unclear if topical marshmallow is beneficial for pediatric fever. Details: A moderate-sized clinical study in children aged 6 months-10 years with fever receiving rectal acetaminophen shows that applying marshmallow extract body wash and lukewarm water reduces the time to defervescence by 8 minutes when compared with lukewarm water alone, but does not improve the change in body temperature, number of acetaminophen doses given, or incidence of fever recurrence (112375). However, the interpretation of these findings is limited to patients without fevers greater than 40 degrees Celsius or history of febrile seizures since these patients were not studied.
• Leishmania lesions. Topical marshmallow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research suggests that the topical application of an herbal extract containing a combination of marshmallow and Althaea rosa to affected areas for 5 days can help promote curing of Leishmania lesions (62020).
• Respiratory tract infections. Although there is interest in using oral marshmallow for respiratory tract infections, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Vaginal candidiasis. It is unclear if vaginal marshmallow is beneficial for vulvovaginal candidiasis. Details: A small clinical study in adults with vulvovaginal candidiasis shows that applying a vaginal cream comprised of marshmallow extract 4% and clotrimazole 1% daily for 7 days improves itching, dyspareunia, and dysuria at 7 days when compared with clotrimazole 1% alone. At 30 days, the marshmallow intervention also results in fewer positive yeast cultures and sustained reduction in itching (112371). However, the validity of these results is limited by significant differences between groups at baseline for dyspareunia and dysuria, and lack of adjustment for multiple comparisons which can increase false positive findings. Additionally, all primary outcomes were patient-reported.
• Venous leg ulcers. Although there is interest in using topical marshmallow for venous leg ulcers, there is insufficient reliable information about the clinical effects of marshmallow for this condition.
• Wounds. Although there is interest in using topical marshmallow for wounds, there is insufficient reliable information about the clinical effects of marshmallow for this condition. More evidence is needed to rate marshmallow for these uses.

(Read more about MARSHMALLOW)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyspepsia. Oral olive leaf extract has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in healthy adults shows that taking a specific combination product containing olive leaf extract 24% and prickly pear cactus 33% (Mucosave, Bionap S.R.L.) 400 mg daily for 8 weeks seems to improve dyspepsia and other gastrointestinal symptoms when compared with placebo (105904). It is unclear if this benefit would occur in patients with clinically diagnosed dyspepsia.
• Exercise-induced respiratory infections. It is unclear if oral olive leaf extract is beneficial for reducing respiratory infections from exercise. Details: A small clinical study in high school athletes shows that taking one tablet of olive leaf extract providing eleuropein 100 mg daily for 2 months during training season does not reduce the incidence of the common cold when compared with placebo. While it may reduce the number of sick days by 28%, a sub-group analysis suggests that this reduction is only evident in female athletes (101860).
• Gastroesophageal reflux disease (GERD). Although there is interest in using oral olive leaf for GERD, there is insufficient reliable information about the clinical effects of olive for this condition.
• Herpes zoster (shingles). Although there is interest in using oral olive leaf for shingles, there is insufficient reliable information about the clinical effects of olive for this condition.
• Influenza. Although there is interest in using oral olive leaf for influenza, there is insufficient reliable information about the clinical effects of olive for this condition.
• Metabolic syndrome. It is unclear if oral olive leaf extract is beneficial for improving body composition and cardiovascular risk factors in patients with metabolic syndrome. Details: A small clinical trial in overweight, middle-aged males at risk for metabolic syndrome shows that taking four capsules of olive leaf extract providing oleuropein 51.1 mg and hydroxytyrosol 9.7 mg daily for 12 weeks improves insulin sensitivity by 15% when compared with placebo. However, body composition, blood pressure, cholesterol levels, and other cardiovascular risk factors were not improved (92245).
• Osteoarthritis. It is unclear if oral olive fruit or leaf extract is beneficial for improving osteoarthritis. Details: Preliminary clinical research shows that taking a freeze-dried aqueous extract of olive fruit 400 mg daily for 8 weeks decreases pain and increases mobility in people with osteoarthritis (14844). Other preliminary clinical research in adults with knee osteoarthritis shows that taking olive leaf extract 50.1 mg daily for 4 weeks improves overall pain measurements by 14%, compared to only 4% in the placebo group. However, many individual measurements of pain are not improved (92252).
• Osteoporosis. It is unclear if oral olive leaf extract is beneficial for osteoporosis. Details: Clinical research shows that taking olive leaf extract (Bonolive, BioActor BV) 250 mg daily for 12 months, along with elemental calcium 400 mg daily, increases osteocalcin levels by about 32% when compared to baseline; this increase was significant when compared to those taking calcium 400 mg plus placebo, who showed a 6% decrease in osteocalcin levels. However, taking olive leaf extract does not significantly increase bone mineral density of the lumbar spine or femur neck when compared with placebo (92247).
• Rheumatoid arthritis (RA). It is unclear if oral olive fruit extract is beneficial for improving RA symptoms. Details: Preliminary clinical research in adults with RA shows that taking an aqueous freeze-dried extract of olive fruit 400 mg daily for 8 weeks does not improve symptoms when compared with control (14844). More evidence is needed to rate the effectiveness of olive for these uses.

(Read more about OLIVE)

There is insufficient reliable information available about the effectiveness of ornamental marigold.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Beeswax has Generally Recognized as Safe (GRAS) status in the US (4912). ...when used orally as a medicinal agent (11)....when used topically (11,55245,96328,96329).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of medicinal amounts of beeswax during pregnancy and lactation.

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LIKELY SAFE ...when the flower preparations are used orally or topically and appropriately (4,19779,36931,39503,93552,93557,96647,105088).

PREGNANCY: LIKELY UNSAFE
when used orally; contraindicated due to spermatocide, antiblastocyst, and abortifacient effects. There is insufficient reliable information available about the safety of calendula when used topically during pregnancy (4).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about CALENDULA)

POSSIBLY SAFE ...when used topically for less than 6 weeks on unbroken skin at a daily dose providing no more than 100 mcg of pyrrolizidine alkaloid (PA) constituents. PAs are absorbed through the skin (11990,44898,44902,92568).

POSSIBLY UNSAFE ...when used for extended durations or in high concentrations on unbroken skin. Topically, hepatotoxic pyrrolizidine alkaloids (PAs) in comfrey can be absorbed in quantities sufficient to cause toxicity with extended use for greater than 6 weeks or in quantities providing more than 100 mcg of PAs (11990,92568). ...when used topically on broken skin. PAs can be absorbed through broken skin. In countries where the PA content of comfrey is not regulated, including Australia and the United States, creams containing comfrey are required to include a warning not to use on broken skin (44950,44951).

LIKELY UNSAFE ...when used orally because of its potential for acute or chronic liver toxicity. Comfrey contains hepatotoxic pyrrolizidine alkaloids (PAs). Chronic ingestion of more than 1 mg daily for 2 weeks or more than 100 mcg daily for longer durations can cause liver disease. PAs may also be carcinogenic (11987,99068). The FDA has recommended removal of oral comfrey products from the market (11988).

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally or topically. In addition to hepatotoxicity and possible carcinogenicity, the pyrrolizidine alkaloids (PAs) in comfrey might be teratogenic. PAs are absorbed through the skin (11987,11988,11990).

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LIKELY SAFE ...when marshmallow root and leaf are used in amounts commonly found in foods. Marshmallow root has Generally Recognized As Safe (GRAS) status for use in foods in the US (4912).

POSSIBLY SAFE ...when marshmallow root and leaf are used orally in medicinal amounts (4,12). ...when used topically (4,62020). There is insufficient reliable information available about the safety of marshmallow flower.

PREGNANCY AND LACTATION:
Insufficient reliable information available.

(Read more about MARSHMALLOW)

LIKELY SAFE ...when olive fruit is used orally and appropriately in amounts commonly found in foods.

POSSIBLY SAFE ...when olive leaf extract is used orally and appropriately. Olive leaf extract providing 51-100 mg oleuropein daily has been used with apparent safety for 6-8 weeks (92245,92247,101860). There is insufficient reliable information available about the safety of olive fruit extract when used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; stick with amounts commonly found in foods.

(Read more about OLIVE)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Tagetes has Generally Recognized as Safe (GRAS) status in the US (4912). There is insufficient reliable information available about the safety of tagetes used in amounts greater than those found in foods.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid amounts greater than those commonly found in foods.

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CNS DEPRESSANTS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, calendula might have additive effects when used with CNS depressants, although this appears to be unlikely.  Details Although some animal research has suggested that a saponoside constituent in calendula may have sedative effects (39545,39547), calendula has been used for over 30 years without reports of sedation in humans (105088).

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CYTOCHROME P450 3A4 (CYP3A4) INDUCERS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, CYP3A4 inducers might increase the risk of adverse effects from the pyrrolizidine alkaloid constituents in comfrey.  Details CYP3A4 enzymes convert pyrrolizidine alkaloids, constituents of comfrey, to toxic metabolites (11990). Some case reports show that enzyme inducers, such as phenobarbital, seem to enhance the toxicity of comfrey (12841,12860).

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, comfrey might have additive adverse effects on the liver when used with hepatotoxic drugs.  Details Due to its pyrrolizidine alkaloid constituents, comfrey can cause hepatotoxic effects, including ascites, cirrhosis, hepatic fibrosis, hepatomegaly, and sinusoidal obstruction syndrome (11988,11990).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, marshmallow flower might have antiplatelet effects.  Details Animal research suggests that marshmallow flower extract has antiplatelet effects (92846). However, the root and leaf of marshmallow, not the flower, are the plant parts most commonly found in dietary supplements. Theoretically, use of marshmallow flower with anticoagulant/antiplatelet drugs can have additive effects, and might increase the risk for bleeding in some patients.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, due to potential diuretic effects, marshmallow might reduce excretion and increase levels of lithium.  Details Marshmallow is thought to have diuretic properties. To avoid lithium toxicity, the dose of lithium might need to be decreased when used with marshmallow.

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, mucilage in marshmallow might impair absorption of oral drugs.  Details Marshmallow contains mucilage which can affect oral drug absorption (1,11,12,19). To avoid changes in absorption, take marshmallow 30-60 minutes after oral medications.

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General ...Orally, beeswax is well tolerated. Allergic reactions to beeswax are possible in some patients (11).
Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (55245,102517).

Dermatologic ...Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (55245,102517). While this reaction is thought to be rare in the general population, one cross-sectional study found that 18% of patients with a history of cheilitis or facial dermatitis experienced positive reactions to beeswax. While most of these patients also had a positive reaction to a propolis patch test, some did not, suggesting that a substance in beeswax itself may be involved in this sensitization (102517).

Immunologic ...Orally, beeswax may cause allergic reactions (11). Topically, beeswax may cause allergic contact dermatitis. In most cases, this reaction is likely caused by the propolis component of beeswax (102517).

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General ...Orally and topically, calendula is generally well tolerated.
Serious Adverse Effects (Rare):
All ROAs: Allergic reactions.

Dermatologic ...Topically, a preparation containing calendula powder 0. 1% resulted in inflammation around the wound to which it was applied (96647). Burning sensation, itching, redness, and scaling were reported rarely in patients applying a combination of calendula, licorice, and snail secretion filtrate to the face. The specific role of calendula is unclear (110322).

Immunologic ...Orally, calendula can cause allergic reactions. Topically, calendula can cause eczematous allergic reactions. Calendula-specific patch testing is recommended prior to usage to determine allergenic potential. Testing is particularly necessary in individuals sensitive to the Asteraceae/Compositae family (10691,11458,96647). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs. A preparation containing calendula powder 0.1% resulted in hives in a patient with a ragweed allergy (96647). Despite the widespread use of calendula and the occurrence of allergies to other family members, there has been only one report of anaphylaxis (11152).

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General ...When used orally, comfrey may be unsafe. Topically, comfrey is generally well tolerated when applied to intact skin.
Most Common Adverse Effects:
Topically: Eczema, erythema, irritation, itching, rash.
Serious Adverse Effects (Rare):
All ROAs: Ascites, cirrhosis, death, hepatic fibrosis, hepatomegaly, pulmonary hypertension, and sinusoidal obstruction syndrome. These adverse effects are likely related to the pyrrolizidine alkaloid constituents of comfrey.

Dermatologic ...Topically, comfrey-containing creams and ointments may cause skin redness, irritation, itching, rash, and eczema (44902,44912,44917,44919,92566,92570,92571).

Hepatic ...The pyrrolizidine alkaloid constituents of comfrey can cause acute sinusoidal obstruction syndrome characterized by sudden abdominal pain, vomiting, ascites, and hepatomegaly. In subacute disease, comfrey can cause ascites, hepatomegaly, abdominal pain, diarrhea, vomiting, and abdominal swelling. Chronic toxicity appears as asthenia and progressive ascites. Hepatic fibrosis and inflammation may resolve, but hepatic failure is common with more severe disease. This may occur as late as 2 years after the initial ingestion. Other signs and symptoms of pyrrolizidine toxicity include bile duct proliferation, fatty changes of the liver, fibrosis, cirrhosis, and vascular lesions (11988). The mortality associated with comfrey toxicity is 50%. However, specific toxic levels seem to vary among individuals (11990).

Pulmonary/Respiratory ...The pyrrolizidine alkaloid constituents of comfrey can damage the lungs, resulting in pulmonary hypertension (11987,11988,11990). A case report involving a 66-year-old female with known arterial hypertension, mild kidney insufficiency, and type 2 diabetes described severe partial respiratory insufficiency and pulmonary hypertension. The patient admitted to using a number of alternative therapies daily, including comfrey (44911).

Other ...Comfrey contains toxic pyrrolizidine alkaloids, which are carcinogenic and mutagenic (12841,12842).

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General ...Orally and topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

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General ...Orally, olive fruit is well tolerated when used in typical food amounts. Olive leaf extract seems to be well tolerated.
Most Common Adverse Effects:
Orally: Headache and stomach discomfort.

Dermatologic ...Orally, one patient in one clinical trial reported bad skin and acne after using olive leaf extract (101860).

Gastrointestinal ...Orally, three patients in one clinical trial reported stomach ache after using olive leaf extract (101860).

Neurologic/CNS ...Orally, three patients in one clinical trial reported headache after using olive leaf extract (101860).

Psychiatric ...In one case report, a 67-year-old female experienced irritability, anger, a lack of control, and feelings of sadness and negativity after consuming a multi-ingredient product containing olive leaf extract 5 grams, horseradish root, and eyebright daily for 38 days. All psychiatric symptoms disappeared within days of stopping the combined product. It is hypothesized that the hydroxytyrosol component of olive leaf extract contributed to these symptoms due to its chemical similarity to dopamine; however, it is not clear if these symptoms were due to the olive leaf extract or to the other ingredients (96245).

Pulmonary/Respiratory ...Olive tree pollen can cause seasonal respiratory allergy (1543).

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General ...Orally, ornamental marigold is well tolerated in amounts found in foods. No adverse effects have been reported when used in amounts greater than those found in foods. A thorough evaluation of safety outcomes has not been conducted. Topically, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis.

Dermatologic ...Topically, ornamental marigold has been reported to cause contact dermatitis (11).

Immunologic ...Ornamental marigold can cause an allergic reaction in individuals sensitive to the Asteraceae/Compositae family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs (11).

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