Plantago
Identity and Botanical Classification
Plantago is a large genus of flowering plants in the family Plantaginaceae. It is a perennial medicinal plant genus with about 265 species distributed all over the world. The Plantago genus originated in Eurasia and then radiated and speciated to the rest of the world, and thus has been widely used in Europe, Asia, and later in the Americas.
Three species dominate both the scientific literature and commercial applications:
- Plantago major L. (Broadleaf plantain / Greater plantain) — also known as broadleaf plantain or greater plantain, is a member of the Plantaginaceae family, which is now widely dispersed throughout the world, though native to much of Europe as well as northern and central Asia. The name Plantago major originates from the Latin planta, meaning "sole of the foot," a reference to the broad size of the leaves.
- Plantago ovata Forssk. (Blond psyllium / Isabgol / Ispaghula) — known by many common names including blond plantain, desert Indianwheat, blond psyllium, and isabghol, is native to the Mediterranean region and naturalized in central, eastern, and south Asia and North America. It is also called Isabgol, meaning "horse ear" in Indian, which describes the shape of the seed.
- Plantago lanceolata L. (Ribwort plantain / Narrowleaf plantain) — an international species distributed in European countries from Iceland south and east to Spain and in Asia's northern and central parts.
A fourth species of note is Plantago asiatica. Plantago asiatica (Chinese Plantain) is a key herb in Traditional Chinese Medicine (TCM) used for its diuretic, detoxifying, and lung-moistening properties.
Common Names and Synonyms
P. major is widely known as "broadleaf plantain," "greater plantain," and "common plantain." The Indians named it "White man's footprint" because it was found everywhere the Europeans had been; this is reflected in the genus name Plantago, from Latin planta, meaning "sole of the foot." In Scandinavia this plant is mostly known for its wound healing properties; the common Norwegian and Swedish name for P. major is groblad, meaning "healing leaves."
P. ovata carries numerous vernacular names across traditions: in English it is called Blond Psyllium, Isabgol, or Desert Indianwheat; in Sanskrit, Ashvagola or Snigdhajira; in Hindi, Isabgol or Isabgul; and in several other South Asian languages it carries equivalent regional names.
Morphology and Source Plant
P. major consists of a short stem, broad leaves, roots, flowers, fruits, and seeds. It has broad leaves which are usually about 15–30 cm in diameter, of oval shape, 4–9 cm wide and 5–20 cm long. There are about five to nine prominent veins on the leaves. The flowers are greenish-brown in colour with purple stamens and are small in size. The plant has small oval-shaped seeds with a slightly unpleasant bitter taste.
P. ovata (psyllium or desert Indian wheat) is a small annual herb cultivated worldwide due to its medicinal importance. It grows well in cool and dry weather with irregular rainfall and is a short-lived plant staying alive for approximately 130 days. Currently, psyllium is extensively cultivated in India and Pakistan. India provides about 85% of the psyllium available in the world market, and the United States is the world's largest importer of psyllium husk.
Common Forms and Preparations
The genus is used in several distinct forms depending on the species and application:
- Psyllium husk (from P. ovata): from the seed coat of psyllium (P. ovata), a mucilage is obtained by mechanical milling and grinding of the outer layer of the seed. Mucilage describes a group of clear, colourless, gelling agents derived from plants. Psyllium mucilage has a long history as a nutritional supplement due to being considered a good source of soluble and insoluble fiber, reported as a medicinally active gel-forming natural polysaccharide.
- Whole seeds: Seeds or seed coats (husks) from the family Plantaginaceae have been used in medicine for centuries. Preparations from Plantago ovata are specifically referred to as ispaghula, whereas psyllium is the name used generically for preparations from any of the Plantago family including Plantago psyllium.
- Leaf preparations (P. major, P. lanceolata): Plantago major has been prescribed in various forms in traditional Persian medicine such as roasted seeds, decoction, syrup, liniment, gargle, rectal enema, vaginal suppository, and eye and nasal drops for different illnesses.
- Standardized leaf extracts (P. lanceolata): P. lanceolata is currently used in tea and syrup form to treat mouth, throat, and upper respiratory tract conditions, and as a topical application for skin diseases. Many products such as teas and syrups containing this herb have appeared on the market, primarily in Europe, and P. lanceolata is listed as a safe herb in the pharmacopoeias of several countries.
Traditional and Historical Use
Ancient and Classical Antiquity
The Plantago genus has been significant to human culture for thousands of years. Historically, Plantago pollen grains have been used in anthropological studies as evidence of human settlements, with human use dating back to the early Neolithic period. Plantago species are referenced in ancient texts such as De Materia Medica for their wound healing properties and were recommended by Pliny the Elder for the treatment of diseases. The Greek physician Dioscorides (c. 40–90 CE) described the uses of the plant; the use of P. major for wound healing dates back to the first century, as described by Dioscorides in De Materia Medica.
Medieval Europe
Henrik Harpestreng (died 1244) from Denmark wrote in Liber Herbarum that P. major could heal everything that was torn apart. Mixed with honey it was recommended on wounds. Boiled with butter and eaten, it could heal any organ in the human body.
In Bernard of Gordon's Lilium medicinae, various species of Plantago were used for different ailments such as wounds, skin infections, general oral diseases, abscesses in the gums, burns, nail infections, nosebleeds, digestive complaints, diarrhea, liver problems, ruptured cornea, respiratory conditions, vomiting of blood, kidney stones, and blood in the urine. Plantago species also appear in Anglo-Saxon charms and Shakespearean works.
Traditional Persian Medicine
Medicinal properties of Plantago major were recorded in credible pharmacopeias and textbooks of traditional Persian medicine (TPM) belonging to the 10th–18th century AD, such as "The Canon of Medicine" and "Makhzan-Al-Advia." Some of its traditional properties in this system, including wound healing, antipyretic, antitussive, anti-infective, anti-hemorrhagic, anti-inflammatory, diuretic, laxative, astringent, and hemostatic activity, have been confirmed in recent research.
Indian Ayurveda
P. ovata (psyllium) is a native plant of India. The hydrophilic mucilloid, water-soluble fiber derived from psyllium husk and seed had been used since ancient times as a vital curative agent for constipation, mainly as a part of the traditional Indian Ayurvedic medicine. Psyllium is also popularly used in the traditional Indian medicine system (Ayurveda) for the prevention of skin irritations, hemorrhoids, constipation, and diarrhea.
Chinese and Asian Medicine
In Asia, Plantago occupies an important place in Chinese and Persian medicinal traditions for its healing properties. Plantago asiatica is commonly used in Asian folk medicine based on its reported antipyretic, antitussive, diuretic, and wound healing properties. In Traditional Chinese Medicine, it is known for its diuretic, detoxifying, and lung-moistening properties.
European Herbal Tradition (P. lanceolata)
Plantago lanceolata (Ribwort Plantain) has been used in European herbalism for its anti-inflammatory and demulcent properties, particularly for coughs and skin irritations. The consumption of P. lanceolata juice with wine or honey is thought to relieve gout, and its crushed leaves mixed with salt have been used to treat arthritis. This species also has a long history as a forage plant in pastures in the United Kingdom and throughout Europe since the 1700s.
Americas
P. major was brought to the Americas by Europeans during the colonial period. Some Mexican tribes mix Plantago fastigiata seeds with water to form a gelatinous mass which is used as a remedy for stomach ache. Though not the most popular botanical for this indication, P. major is among the plants used in the treatment of cutaneous leishmanial ulcers in Bahia, Brazil, where Leishmania braziliensis is endemic.
Key Chemical Constituents and Active Compounds
Overview
Several bioactive compounds have been isolated and characterized from nearly all parts of the plant, including flavonoids, alkaloids, terpenoids, phenolic acid derivatives, iridoid glycosides, fatty acids, polysaccharides, and vitamins. Among these, polysaccharides are the most abundant component, and their multiple functions have been widely studied and reported.
Polysaccharides and Mucilage
The major substance of psyllium is a mucilage that takes the form of a gel, originating from the husk of the Plantago ovata seed. The ground skin of psyllium seeds consists of a blend of polysaccharides containing pentoses, uronic acids, and hexoses. This mixture has been utilized as a non-fermented fiber supplement that forms a viscous, soluble gel. It is a gel-forming mucilage known for its laxative effect due to its high-water holding capacity, which is approximately 80 times its own weight. Ground psyllium seed husks are indigestible, providing a source of soluble dietary fiber which may be fermented into butyric acid — a short-chain fatty acid — by butyrate-producing bacteria.
Iridoid Glycosides
Several iridoid glycosides are isolated from the leaves of P. lanceolata. Aucubin and catalpol are the main iridoid glycosides present; asperuloside, globularin, gardoside, geniposidic acid, mayoroside, melittoside, and desacetylasperuloside acid methyl ester are also present in its leaf. The chemical analysis of the leaves of P. major has revealed the presence of aucubin, a glycoside which has been reported in several studies to be a powerful anti-toxin. Baicalein and aucubin are the two most biologically active components of P. major, and both have been shown to have antioxidant, anti-inflammatory, and anticancer properties.
Flavonoids
Plantago major from Egypt was used to isolate the flavonoids luteolin 7-glucoside, hispidulin 7-glucuronide, luteolin 7-diglucoside, apigenin 7-glucoside, nepetin 7-glucoside, and luteolin 6-hydroxy 4′-methoxy 7-galactoside. Anti-inflammatory activity of P. major is contributed by flavonoids such as baicalein and hispidulin and iridoid glycosides such as aucubin.
Terpenoids and Phenolic Acids
The triterpenoids oleanolic acid, ursolic acid, 18β-glycyrrhetinic acid, and sitosterol were isolated from the leaf wax of P. major. Ursolic acid inhibits cyclooxygenase-2 (COX-2; IC50 130 μM) and cyclooxygenase-1 (IC50 295 μM) catalyzed prostaglandin biosynthesis in vitro, while the structural isomer oleanolic acid is less active. Ursolic acid, oleanolic acid, and α-linolenic acid are three Plantago major components that have shown inhibitory effects on COX-2–catalyzed prostaglandin production.
Other effective ingredients in P. major include baicalein, ascorbic acid, apigenin, benzoic acid, chlorogenic acid, citric acid, ferulic acid, oleanolic acid, salicylic acid, and ursolic acid.
Alkaloids
The alkaloids indicain and plantagonin of Plantago major have also been isolated.
Caffeic Acid Derivatives
P. major contains biologically active compounds such as polysaccharides, lipids, caffeic acid derivatives, flavonoids, iridoid glycosides, and terpenoids. Polyphenols, especially plantamajoside (a caffeic acid derivative), are considered among the main significant compounds for wound healing.
Fatty Acids
The unsaturated fatty acids 18:3ω3 (alpha-linolenic acid) and 18:2ω6 (linoleic acid) and the saturated fatty acid palmitic acid are most abundant in the leaves of P. major. Arachidic acid was isolated from P. major seeds only and not from any other Plantago species investigated.
Established Mechanisms of Action
- Bulk-forming / osmotic laxation: The capacity of psyllium mucilage to absorb water makes it an effective stool softener and eases constipation.
- Bile acid sequestration (cholesterol lowering): The mechanism by which psyllium lowers cholesterol involves psyllium binding bile acids in the intestinal lumen, sequestering these cholesterol-derived compounds, and reducing their reabsorption in the distal ileum.
- Anti-inflammatory (COX and lipoxygenase inhibition): The mechanisms of the anti-inflammatory effects of Plantago also include inhibition of histamine release from mast cells, inhibition of elastase, and inhibition of complement activity. Ursolic acid and oleanolic acid isolated from the hexane extract of P. major showed a significant cyclooxygenase-2 (COX-2) inhibitor effect.
- Immunomodulation: Methanol extracts of P. major seeds demonstrated high inhibition of TNF-α, IL-1β, IL-6, and IFN-γ production in experimental macrophage models.
- Microbiome modulation and short-chain fatty acid (SCFA) production: Clinical studies indicate that Plantago polysaccharides regulate the growth of Bifidobacterium in the stool in a baseline microbiota-dependent manner. Consumption of psyllium husk also results in a significant increase in Faecalibacterium spp., Lachnospira, and Phascolarctobacterium, microorganisms associated with the production of short-chain fatty acids.
- Antimicrobial activity: The aglycone of aucubin, aucubigenin, has antimicrobial activity against bacteria and moulds.
Scientific Evidence by Area of Use
1. Gastrointestinal Health: Constipation
Among the best-documented therapeutic actions related to the prevention and treatment of gastrointestinal disorders are the beneficial effects of Plantago ovata husk in the course of constipation, diarrhea, irritable bowel syndrome, and ulcerative colitis.
Evidence strength: Strong (multiple RCTs and systematic reviews). A 2022 updated systematic review and meta-analysis of fiber supplementation for chronic constipation (published in the American Journal of Clinical Nutrition) found that psyllium increased stool frequency and improved stool consistency. Psyllium often performs as well as, or better than, many other fibers, particularly for people with hard, dry stools, and clinical guidelines commonly include psyllium among first-line treatments for chronic constipation, alongside lifestyle measures.
2. Gastrointestinal Health: Irritable Bowel Syndrome (IBS)
Clinical evidence confirms that psyllium extracted from P. ovata can reduce painful symptoms and normalize stool consistency in patients with IBS in both diarrheal and constipated forms. Bijkerk et al. conducted a study in a group of 275 patients diagnosed with IBS evaluating the effect of psyllium husk and bran consumption on the clinical course of the disease, randomly assigning eligible patients to 3 groups. Psyllium hydrophilic mucilloid (ispaghula husk) is considered moderately effective in treating IBS.
A 2018 systematic review in Alimentary Pharmacology & Therapeutics confirmed that psyllium improves stool consistency in patients with both constipation-predominant and diarrhea-predominant conditions.
3. Cardiovascular: LDL Cholesterol Reduction
Evidence strength: Strong; FDA-authorized health claim. In 1998, in response to a health claim petition, the FDA concluded that soluble fiber of psyllium seed husk, similar to beta-glucan soluble fiber from whole oats, may reduce the risk of coronary heart disease (CHD) by lowering blood cholesterol levels. In 1998, FDA amended 21 CFR 101.81 by adding psyllium seed husk as an eligible source of soluble fiber for this health claim.
The daily dietary intake level of soluble fiber from psyllium seed husk that has been associated with reduced risk of coronary heart disease, per FDA regulations, is 7 grams or more per day.
A systematic review and dose-response meta-analysis of randomized controlled trials found a significant decrease in LDL-C and total cholesterol levels with psyllium supplementation, a nonsignificant decrease in triglycerides, and a nonsignificant increase in HDL-C. Notable heterogeneity was observed in the lipid profiles. Subgroup analysis revealed variability in the effects of psyllium on LDL-C and cholesterol levels. The significance of cholesterol and LDL-C reduction varied with dose — with notable effects observed for doses greater than 10 g per day.
A separate meta-analysis of randomized trials published in the American Journal of Clinical Nutrition (Jovanovski 2018) found that psyllium significantly lowered LDL cholesterol, non-HDL cholesterol, and apolipoprotein B.
4. Glycemic Control and Type 2 Diabetes
Evidence strength: Moderate (multiple RCTs; effect size varies by baseline glycemic status). Systematic reviews focusing on glycemic outcomes find that psyllium can improve fasting blood glucose, long-term blood sugar markers, and measures of insulin sensitivity in people with impaired glucose metabolism.
The FDA has also permitted a qualified health claim that psyllium husk may reduce the risk of type 2 diabetes, though with the qualifier that "there is very little scientific evidence for this claim."
Psyllium supplementation can reduce glycemic levels, relieve constipation symptoms, and increase high-density lipoprotein cholesterol in patients with chronic constipation and type II diabetes. A randomized trial specifically in people with type 2 diabetes and chronic constipation found that psyllium relieved constipation while modestly improving glycemia and lipids.
5. Blood Pressure and Cardiometabolic Markers
Evidence strength: Preliminary to moderate. Research suggests improvements in cardiometabolic indicators including blood pressure and markers of low-grade inflammation, supporting psyllium's role as a complementary tool for heart health. Evidence of therapeutic efficacy for psyllium has been shown in numerous clinical studies for regulation of bowel movements, lowering cholesterol, improving glycemic control, reducing energy intake/weight loss, and lowering blood pressure due to weight loss.
6. Ulcerative Colitis and Inflammatory Bowel Disease
Evidence strength: Weak to preliminary; inconsistent clinical results. Plantago ovata and Plantago psyllium are among notable plants that have been utilized in studies of ulcerative colitis. However, due to methodological flaws, heterogeneity in the definition of diagnostic criteria, and the absence of placebo control and blinded measurement of subjective conclusions, the majority of trials associating herbal medicines with conventional therapies have not provided significant evidence to support the use of herbal medicines in this context.
The results of studies indicate that consumption of Plantago ovata husk may reduce the risk of developing colorectal cancer, though this remains an area of ongoing investigation.
7. Respiratory Tract: Cough and Upper Airway Inflammation
Evidence strength: Weak (limited controlled human trials; strong traditional and regulatory basis). The EMA (European Medicines Agency) confirmed the traditional use of Plantago lanceolata against the common cold and cough in a Community Herbal Monograph. The EMA's HMPC monograph classifies its use for: relief of irritation of the mucous membranes of the mouth and throat and the associated dry, irritating cough. The ESCOP monograph indicates internal use for catarrh of the airways and external use for intermittent inflammatory changes of the mucous membranes of the mouth and throat. The German Commission E monograph also lists internal use for catarrh of the airways and inflammatory changes of the mucous membranes of the mouth and throat, and external use for inflammation of the skin.
As controlled clinical trials with extracts from Plantago lanceolata leaf have not been performed, the EMA assessment report notes that the data do not support efficacy as a well-established use. Plantain (P. lanceolata) is used for the therapy of infections of the upper respiratory airways. While only few clinical data are available, results of experimental research confirm anti-inflammatory, spasmolytic, and immunostimulatory actions. A positive benefit-risk ratio allows the recommendation of plantain in moderate chronic irritative cough.
A double-blind randomized clinical trial in human patients with acute bronchitis evaluated P. major syrup directly: this study aimed to evaluate the effect of Plantago major syrup (PMS) on cough severity in acute bronchitis. Patients (20–75 years old) referred to the clinic of infectious diseases with a complaint of cough and a Bronchitis Severity Scale (BSS) score ≥5 entered the study. Patients randomly received PMS or placebo 30 ml/day for 10 days and were visited before treatment and on days 5 and 10 after treatment. P. major leaves (containing tannin and mucilage) have been found to be effective in controlling the inflammation of the upper respiratory tract.
In vitro, Plantago lanceolata extract and a P. lanceolata-based dry cough syrup resulted in a significant reduction in LTA+PGN-induced increased production of TNFα, IL-6, PGE2, as well as COX-2 and phospho-p65 protein levels. The extract and syrup also reduced bradykinin-mediated inflammatory responses and increased intracellular Ca2+ in bronchial epithelial cells, suggesting potential benefits in interfering with cough responses in the lungs.
8. Wound Healing and Skin Applications
Evidence strength: Preliminary in humans; mechanistically supported in vitro and animal studies. P. major leaves have been used as a wound healing remedy for centuries in almost all parts of the world and in the treatment of a number of diseases apart from wound healing — including diseases related to the skin, respiratory organs, digestive organs, reproduction, the circulation, cancer, pain relief, and infection.
A range of biological activities has been found from plant extracts including wound healing activity, anti-inflammatory, analgesic, antioxidant, weak antibiotic, immunomodulating, and antiulcerogenic activity. In an animal study, water extract of Plantago major was found to be a suitable substitute for silver sulfadiazine, especially when applied in 50% concentration in wound burn healing.
Other dermatologic uses in traditional medicine include eczema, cuts, hemorrhoids, ulcerations, and wounds.
9. Anti-Inflammatory and Analgesic Effects
Evidence strength: Preliminary (primarily in vitro and animal studies). The in vivo anti-inflammatory activity of P. major has been well described in the scientific literature. Luteolin (one of the flavonoids) has the ability to suppress leukocyte migration and inhibit mast cell degranulation, which can be considered as anti-urticaria treatment strategies. Ursolic acid and oleanolic acid also have hepatoprotective, tumor promotion inhibiting activity, and an anti-hyperlipidemic effect.
10. Antimicrobial and Antiviral Activity
Evidence strength: Preliminary (in vitro data only; no human clinical trials identified). Studies have shown that P. major and P. lanceolata have antibiotic activity against some Gram-negative and Gram-positive bacteria, as well as fungi. It has also been documented that psyllium ingestion exhibits antioxidant, immunomodulatory, antiproliferative, anticancer, and antiviral effects in experimental models.
Body Systems Associated
- Gastrointestinal system: Constipation relief, IBS symptom management, diarrhea regulation, colon microbiome modulation, possible ulcerative colitis support
- Cardiovascular system: LDL cholesterol and total cholesterol reduction, possible blood pressure support
- Metabolic/Endocrine system: Glycemic control, insulin sensitivity improvement in type 2 diabetes
- Respiratory system: Cough suppression, throat and airway mucous membrane soothing (P. lanceolata, P. major)
- Integumentary system (skin/wound healing): Topical wound healing, anti-inflammatory skin applications
- Immune system: Immunomodulation, cytokine regulation
Dosage Forms and Reported Dosages
Psyllium Husk (P. ovata) — Oral
- For coronary heart disease health claim: 7 g or more per day of soluble fiber from psyllium seed husk is the daily dietary intake level associated with reduced risk of coronary heart disease per FDA regulations. This corresponds to approximately 10.2 grams of husk, or at least 1.7 g of soluble fiber per serving, assuming four servings per day.
- For cholesterol reduction in clinical trials: Multiple trials in people with raised cholesterol show that psyllium modestly lowers total and LDL cholesterol when taken regularly, especially at doses of 7–10 g of soluble fiber per day in the context of a heart-supportive diet.
- For constipation in clinical practice: For constipation, 5–10 g/day is reported as effective for most people in the literature reviewed.
- For IBS (Bijkerk et al. study): A study in 275 patients diagnosed with IBS evaluated the effect of psyllium husk consumption on the clinical course of the disease.
- Augmented low-calorie meal study: Up to a 7% reduction in LDL cholesterol was reported in patients in certain trials; in another study, an augmented low-calorie meal with 10.2 g psyllium stimulated cholesterol reduction.
Plantago major Syrup — Oral
- Acute bronchitis clinical trial: Plantago major syrup was given at 30 ml/day for 10 days in a double-blind randomized clinical trial for acute bronchitis, with patients visited before treatment and on days 5 and 10 after treatment.
Plantago lanceolata — Oral (European Traditional Use)
- P. lanceolata extract may be prepared according to the HMPC community herbal monograph as a dry ethanol extract (drug extract ratio 3–5:1), and has also been formulated as a dry cough syrup containing 30 mg/mL of the dry extract.
Safety Considerations and Drug Interactions
General Gastrointestinal Side Effects
The main side effects of psyllium husk reported in studies include abdominal cramps, respiratory tract infections, heartburn, constipation, gas, bloating, frequent nighttime urination, diarrhea, increased flatulence, fullness, more frequent defecation, mild gastrointestinal complications, and stomach pains.
Esophageal and Gastrointestinal Obstruction
Esophageal obstruction — difficulty swallowing or chest pain — may indicate that the fiber is blocking the esophagus, usually from taking psyllium in dry form without adequate fluid. Not taking enough fluid could lead to choking or obstruction of the esophagus or bowel.
Allergy and Anaphylaxis
Psyllium allergy is rare but documented, particularly among healthcare workers who handle psyllium-containing products frequently (occupational sensitization). Symptoms include nasal symptoms, asthma-like respiratory symptoms, and in rare cases, anaphylaxis. Individuals with known grass or plantain allergies may have cross-reactivity.
Psyllium husk can cause allergic reactions in some people, as noted by the FDA. Increasing the purity of the husk by mechanical sieving can reduce the allergy-causing substances; the FDA proposed specifications for purity of no less than 95%.
Drug Interactions (Psyllium)
Psyllium is generally safe but can slow the absorption rate of medications taken at the same time due to its gel-forming properties. This is clinically relevant for levothyroxine, metformin, lithium, digoxin, and warfarin, among others.
- Digoxin: Fiber can decrease how much digoxin the body absorbs, which might decrease the effects of digoxin. MedlinePlus advises not to take digoxin within 3 hours of taking psyllium.
- Warfarin: Medications like warfarin may have altered absorption when combined with psyllium; closer monitoring of blood clotting may be necessary if both are used.
- Lithium: Fiber can decrease how much lithium the body absorbs, which might decrease the effects of lithium.
- Levothyroxine (thyroid medications): Levothyroxine and other thyroid drugs require consistent absorption to be effective, and psyllium can reduce how much of these medications the body absorbs, potentially lowering their effectiveness in managing thyroid conditions.
- General guidance: The standard recommendation is to separate psyllium from any medication by at least two hours.
Contraindications
Absolute contraindications for psyllium include intestinal obstruction, severe swallowing difficulties, known psyllium allergy, and acute fecal impaction, which all require complete avoidance.
Safety of Plantago lanceolata
The pharmacovigilance data for P. lanceolata leaf identified no well-documented cases with a proved causality to new risks. However, publications containing safety findings regarding allergy to P. lanceolata pollen were identified in the scientific and medical literature. The EMA assessment report states that the oral use (for certain preparations) in children under 6 years of age is not recommended due to the lack of adequate data, and oral and oromucosal use in children under 12 years of age is not recommended for certain preparations.
Safety of Plantago major in Clinical Use
In the reviewed clinical trials for acute bronchitis using P. major preparations, Carnevali et al. reported no adverse events occurred after four and eight days of treatment. Naderi et al. also demonstrated that patients in the follow-up period (after 10 days) reported no specific adverse effects.
Regulatory and Pharmacopeial Status
Plantago lanceolata leaf (Plantaginis lanceolatae folium) has quality defined in the European Pharmacopoeia, and carries monographs from the EMA/HMPC, ESCOP, and German Commission E for use in respiratory indications. Quality is defined in the European Pharmacopoeia (Ph. Eur.), and the HMPC monograph classifies it as a traditional-use medicine for relief of irritation of the mucous membranes of the mouth and throat and the associated dry, irritating cough.
P. ovata husk is the only natural source of fiber that provides as many as 5 major health benefits identified by the Food and Drug Administration.
References
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