Plantain 2,000 mg [Discontinued] by Nature's Answer

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Burns. It is unclear if topical great plantain is beneficial for burns. Details: A very small clinical study in hospitalized adults with bilateral second degree burns shows that applying great plantain extract 10% ointment to burns on one side of the body is similarly effective to applying silver sulfadiazine 1% ointment daily to burns on the other side of the body in relation to healing time, pain intensity, and rate of wound infections (110088). Due to its small size, this study may have been inadequately powered to detect a difference between groups.
• Cough. Oral great plantain has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in children 3-6 years of age with acute cough shows that taking a specific syrup (KalobaTUSS, Schwabe Pharma Italia Srl) based on acacia honey with extracts of great plantain, elecampane, mallow, and sandy everlasting, as 5 mL four times daily for 8 days, produces rapid and sustained reductions in both nighttime and daytime cough scores when compared with placebo (105734). It is unclear if these findings are due to great plantain, other ingredients, or the combination.
• Diabetic foot ulcers. It is unclear if topical great plantain is beneficial for diabetic foot ulcers. Details: A small unblinded clinical study in hospitalized adults in Iran with Wagner's stage 1 or 2 diabetic foot ulcers or stage 2 or 3 pressure ulcers based on the National Pressure Injury Advisory Panel system shows that applying great plantain extract 10% gel for 14 days reduces wound size and erythema when compared to treatment with various standard wound dressings. Complete wound healing may also occur more frequently at 2 weeks with topical great plantain extract (110090). Poor study methodology and a lack of sub-analysis by ulcer type limits the reliability of these findings. Another small clinical study in patients with a Wagner's stage 1 or 2 diabetic foot ulcer receiving oral antibiotics shows that applying a topical product containing great plantain and aloe twice daily for 4 weeks reduces ulcer surface area and healing time when compared with antibiotics alone. However, the combination product has no effect on ulcer depth (97323). It is unclear if these findings are due to great plantain, aloe, or the combination.
• Menorrhagia. It is unclear if oral great plantain leaf extract is beneficial in patients with menorrhagia. Details: A small clinical trial in adults with abnormal uterine bleeding shows that taking a syrup containing great plantain leaf 12% extract 3 times a day for the first 5 days of menstruation and repeating over 3 cycles reduces bleeding severity, but not bleeding duration, similarly to mefenamic acid 250 mg taken every 8 hours (104214).
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral great plantain seed is beneficial in patients with NAFLD. Details: One small clinical trial in patients with NAFLD shows that taking great plantain seed 1000 mg twice daily for 12 weeks improves fatty liver grade on ultrasound and reduces levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and triglycerides when compared with placebo (106645).
• Obesity. It is unclear if oral great plantain leaf is beneficial in patients with obesity. Details: One small clinical trial in females with obesity shows that taking powdered great plantain leaf 400 mg daily for 12 weeks does not reduce body weight or body mass index when compared with placebo (106642).
• Oral mucositis. Small clinical studies suggest that oral great plantain extract might reduce the severity of oral mucositis, but rinsing with great plantain solution does not seem to be superior to sodium bicarbonate or chlorhexidine for improving healing time. Details: A small clinical study in adults undergoing radiation therapy for head and neck cancer shows that taking a syrup containing great plantain extract 7.5 mL three times daily for 7 weeks reduces the severity of oral mucositis when compared with placebo. Patients taking great plantain syrup also reported lower pain scores as measured on a visual analogue scale when compared with those taking placebo (104213). However, a small clinical trial in cancer patients with oral mucositis shows that there is no difference in the healing time of lesions for patients rinsing with either sodium bicarbonate 5%, great plantain 5%, or chlorhexidine 0.12% solutions. All three solutions were used as a rinse for 2 minutes every 6 hours for up to 2 weeks (98209).
• Pressure ulcers. It is unclear if topical great plantain is beneficial in patients with pressure ulcers. Details: One small clinical trial in patients with pressure ulcers being treated with topical phenytoin cream shows that application of great plantain 10% cream 12 hours after application of phenytoin daily for 2 weeks improves healing rate when compared with phenytoin and placebo (106643). Another small, unblinded clinical study in hospitalized adults in Iran with stage 2 or 3 pressure ulcers based on the National Pressure Injury Advisory Panel system or Wagner's stage 1 or 2 diabetic foot ulcers shows that applying great plantain extract 10% gel for 14 days reduces wound size and erythema when compared to a treatment with various standard wound dressings. Complete wound healing may also occur more frequently at 2 weeks with topical great plantain extract (110090). Poor study methodology and a lack of sub-analysis by ulcer type limits the reliability of these findings.
• Ulcerative colitis. It is unclear if oral great plantain seed is beneficial in patients with ulcerative colitis. Details: One small clinical trial in patients with ulcerative colitis shows that taking roasted great plantain seed 1200 mg three times daily for 8 weeks reduces abdominal tenderness, gastroesophageal reflux, and gastric pain when compared with placebo (106644). More evidence is needed to rate great plantain for these uses.

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POSSIBLY SAFE ...when great plantain seed is used orally, short-term. Great plantain seed has been used with apparent safety at doses up to 3600 mg daily for up to 8 weeks and 2000 mg daily for up to 12 weeks (106644,106645). ...when used topically, short-term. Topical great plantain 10% has been used with apparent safety for up to 2 weeks (106643,110088,110090). There is insufficient reliable information available about the safety of great plantain leaf or leaf extract when used orally.

PREGNANCY: LIKELY UNSAFE
when used orally because it can increase uterine tone (4).

LACTATION:
Insufficient reliable information available; avoid using.

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WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, consuming large amounts of great plantain leaves, which contain vitamin K, might decrease the clinical effects of warfarin.  Details Great plantain leaves contain relatively high concentrations of vitamin K (19,97741), which might interfere with the activity of warfarin.

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General ...Orally and topically, great plantain seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Topically: Contact dermatitis in sensitive individuals.

Dermatologic ...Topically, application can cause allergic contact dermatitis in some individuals (4).

Gastrointestinal ...Theoretically, great plantain may have laxative effects when used orally in excessive amounts (4).

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