Plantain [Discontinued] by Herb Pharm

There is insufficient reliable information available about the effectiveness of Asian water plantain.

(Read more about ASIAN WATER PLANTAIN)

EFFECTIVE

• Constipation. Consuming oral soluble fibers, such as black psyllium, is effective for short-term treatment of constipation. Details: The U.S. Food and Drug Administration (FDA) considers black psyllium to be generally recognized as safe and effective (GRASE) as an over-the-counter (OTC) laxative for short-term treatment of constipation (272,93218). After oral administration, the laxative effect of black psyllium occurs within 12-72 hours. Continued use for 2-3 days is necessary for maximum laxative benefit (93214).

LIKELY EFFECTIVE

• Coronary heart disease (CHD). Consuming products that contain soluble fiber, such as black psyllium, may reduce the risk of CHD when used as part of a diet low in saturated fat and cholesterol. Details: In 1998, the U.S. Food and Drug Administration (FDA) authorized a health claim stating that the addition of soluble fiber, such as that from black psyllium, to a diet low in saturated fat and cholesterol might reduce the risk of CHD. The daily dietary intake of psyllium husk must be 7 grams or more (93216).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Although there has been interest in using oral black psyllium for cancer, there is insufficient reliable information about the clinical effects of black psyllium for this purpose.
• Diabetes. It is unclear if black psyllium is beneficial for the prevention or treatment of diabetes. Details: Preliminary clinical research in adults with type 2 diabetes shows that taking black psyllium 15 grams orally daily for 10 days reduces fasting blood glucose by 28 mg/dL when compared with baseline (19156). The US Food and Drug Administration (FDA) has allowed a qualified health claim stating that psyllium husk may reduce the risk of type 2 diabetes. However, the FDA has concluded that there is very little scientific evidence supporting this claim (102827).
• Diarrhea. Although there has been interest in using oral black psyllium for diarrhea, there is insufficient reliable information about the clinical effects of black psyllium for this purpose.
• Hypertension. It is unclear if oral black psyllium is beneficial in patients with hypertension. Details: A meta-analysis of 11 randomized clinical trials in normotensive or hypertensive adults shows that using psyllium 3.7-15 grams daily for 1-6 months reduces systolic blood pressure by an average of 2 mmHg when compared with placebo. Subgroup analyses suggest that psyllium is more effective at reducing systolic blood pressure when taken for at least 8 weeks and in those with higher baseline blood pressure. Taking psyllium did not appear to affect diastolic blood pressure; however, some analyses suggest that taking psyllium may reduce diastolic blood pressure in certain subgroups, such as those with higher baseline blood pressure (102826). It is not clear if any reduction in blood pressure achieved with psyllium would be considered clinically significant. Additionally, it is not clear whether these studies used black psyllium or blond psyllium supplements.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral black psyllium is beneficial in patients with NAFLD. Details: Preliminary clinical research in overweight adults newly diagnosed with NAFLD shows that taking black psyllium 10 grams orally daily, in divided doses before lunch and dinner for 12 weeks, decreases body weight by about 2 kg and body mass index (BMI) by about 0.7 kg/m2 when compared with baseline. However, the changes in weight and BMI from baseline were similar to those in a control group receiving only standard care. This study may have been inadequately powered to detect a difference between groups (93215).
• Obesity. It is unclear if oral black psyllium can improve weight loss in overweight or obese adults. Details: A meta-analysis of 22 trials using psyllium 1.7-21 grams daily for 2-36 weeks in overweight or obese adults shows that taking psyllium does not have a significant effect on body weight, body mass index, or waist circumference. However, the validity of this study is limited by several sources of heterogeneity (102825). Additionally, it is not clear whether these studies used black psyllium or blond psyllium supplements. More evidence is needed to rate black psyllium for these uses.

(Read more about BLACK PSYLLIUM)

There is insufficient reliable information available about the effectiveness of buckhorn plantain.

(Read more about BUCKHORN PLANTAIN)

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.

(Read more about GREAT PLANTAIN)

There is insufficient reliable information available about the safety of Asian water plantain.

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

(Read more about ASIAN WATER PLANTAIN)

LIKELY SAFE ...when used orally with appropriate fluid intake, short-term (12,272). Black psyllium has been used with apparent safety in doses of 15-30 grams daily for up to 6 months (19156,10091,93215,102826). The U.S. Food and Drug Administration (FDA) requires over-the-counter medicines that contain dry or incompletely hydrated psyllium to carry a warning that they should be taken with at a least a full glass of liquid to reduce the risk of choking. This labeling also applies to foods containing psyllium that are marketed with a claim of reducing the risk of coronary heart disease (93217,93218).

LIKELY UNSAFE ...when black psyllium is used orally without adequate fluid intake due to the risk for choking and gastrointestinal obstruction (2,18,93218). ...when granular dosage forms containing black psyllium are used as over-the-counter (OTC) laxatives. The U.S. Food and Drug Administration (FDA) states that these granular dosage forms are not generally recognized as safe and effective (GRASE) as OTC laxatives due to an increased risk of choking and gastrointestinal obstruction (93219).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally with appropriate fluid intake (272).

(Read more about BLACK PSYLLIUM)

POSSIBLY SAFE ...when used orally and appropriately (2). ...when used topically (2).

PREGNANCY: LIKELY UNSAFE
when used orally or topically. Some evidence suggests buckhorn plantain affects muscle tone of the uterus (4275).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about BUCKHORN PLANTAIN)

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.

(Read more about GREAT PLANTAIN)

(Read more about ASIAN WATER PLANTAIN)

CARBAMAZEPINE (Tegretol) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, black psyllium might reduce the effects of carbamazepine and increase the risk for convulsions.  Details Theoretically, black psyllium might reduce carbamazepine absorption. A preliminary study using blond psyllium reported decreased carbamazepine bioavailability due to binding of the drug to psyllium, as well as reduction of available fluid in the gut for dissolution of the drug (539). This interaction may also occur with black psyllium.

DIGOXIN (Lanoxin) Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = B Theoretically, taking black psyllium at the same time as digoxin might reduce digoxin absorption and decrease digoxin levels.  Details Psyllium might bind digoxin in the gut (12). However, some clinical evidence suggests that psyllium does not impact digoxin absorption (10098).

ETHINYL ESTRADIOL Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking black psyllium at the same time as ethinyl estradiol might alter levels of estradiol.  Details Concurrent use of blond psyllium with ethinyl estradiol results in a slight increase in the extent of ethinyl estradiol absorption and a slower rate of absorption. This is unlikely to be clinically significant (12421).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking black psyllium at the same time as lithium might reduce lithium absorption.  Details The fiber in black psyllium might reduce lithium absorption and plasma levels. Some case reports describe a reduction in plasma lithium levels with concomitant administration of blond psyllium. This was reversed when psyllium was stopped (540,92194). This interaction may also occur with black psyllium.

METFORMIN (Glucophage) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, black psyllium might increase the therapeutic and adverse effects of metformin.  Details Animal research shows that concurrent consumption of blond psyllium with metformin slows and increases the absorption of metformin (99433). This interaction may also occur with black psyllium. To avoid changes in absorption, take psyllium 30-60 minutes after metformin.

OLANZAPINE (Zyprexa) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking black psyllium at the same time as olanzapine might reduce olanzapine absorption.  Details The fiber in black psyllium might decrease the absorption of olanzapine. A single case report describes a reduction in the effectiveness of olanzapine when it was concomitantly administered with an unspecified type of psyllium 3 grams orally twice daily. This effect was reversed when psyllium was stopped (106858).

ORAL DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, psyllium might increase, decrease, or have no effect on the absorption of oral drugs.  Details Psyllium seems to have variable effects on drug absorption. To avoid changes in absorption, take psyllium 30-60 minutes after oral medications. Animal research shows that blond psyllium delays and increases the absorption of metformin and ethinyl estradiol (12421,99433). Case reports and animal research suggest that blond psyllium might reduce absorption of lithium, digoxin, olanzapine, and carbamazepine (12,18,272,93214,106858). Finally, some pharmacokinetic studies show that psyllium does not affect the absorption of levothyroxine or warfarin (12420,103940). Although many of these studies evaluated blond psyllium, the fiber content in black psyllium may have similar effects.

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(Read more about BUCKHORN PLANTAIN)

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.

(Read more about GREAT PLANTAIN)

General ...There is limited information available about the potential adverse effects of Asian water plantain. Orally, it has been used as a part of Traditional Chinese Medicine (TCM) with apparent safety; there have been no reported adverse effects in most patients. However, one case of hepatotoxicity and nephrotoxicity has been reported with the use of a combination TCM product containing Asian water plantain (99434).

Hepatic ...One case report of drug-induced systemic toxicity, including hepatotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He presented with gum bleed and petechiae, and his admission lab values indicated fulminant liver failure. His condition progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).

Renal ...One case report of drug-induced systemic toxicity, including nephrotoxicity, has occurred in a 59-year-old man with chronic hepatitis B who had taken six doses of a combination product containing Asian water plantain 3 weeks prior to admission. He initially presented with hepatic failure, which progressed to include renal failure and eventual death after 4 weeks. It is not clear if Asian water plantain, the other ingredients, or the combination caused this toxicity. However, the authors identified Asian water plantain as the likely causative ingredient based on animal research (99434).

(Read more about ASIAN WATER PLANTAIN)

General ...Orally, black psyllium is generally well tolerated when taken with adequate fluids.
Most Common Adverse Effects:
Orally: Bloating, flatulence.
Serious Adverse Effects (Rare):
Orally: Bowel obstruction, esophageal obstruction.

Gastrointestinal ...Black psyllium can cause flatulence and bloating. These effects are generally transient and can be reduced by increasing the daily dose gradually (93214). Taking black psyllium with too little fluid can lead to esophageal or intestinal obstruction (18,93217,93218).

Immunologic ...Several psyllium species have been associated with sensitization and allergic reactions, especially in people exposed to airborne psyllium dust, such as nurses preparing doses of psyllium powder, and workers in psyllium processing plants (93214). Symptoms of occupational exposure include rhinitis, conjunctivitis, wheezing, asthma, and urticarial rashes (18,93214). Severe anaphylactic reactions have been reported in individuals with occupational exposure who then ingest psyllium products (2329,8079,9246).

(Read more about BLACK PSYLLIUM)

General ...Orally, topically, or by inhalation, buckhorn plantain can cause allergic reactions (3901,98010).

Dermatologic ...There are case reports of phototoxic reactions on sun-exposed skin after oral ingestion of buckhorn plantain, or skin contact with the plant. An erythematous, burning rash develops, with vesicles and bullae, followed by necrotic crusting (98010).

Immunologic ...Buckhorn plantain can cause allergic reactions after oral ingestion, skin contact, or inhalation of pollen (3901,98010).

(Read more about BUCKHORN PLANTAIN)

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).

(Read more about GREAT PLANTAIN)