With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age. GLA itself is not always elevated; however, DGLA can be highly elevated by GLA supplementation. Contraindications have not been identified. We comply with the HONcode standard for trustworthy health information -. The efficacy and safety of comfrey. Borage may also lower the seizure threshold and should not be used with drugs that can lower the seizure threshold, such as tricyclic antidepressants and phenothiazines. It was also shown to reduce transepidermal water loss, suggesting an improvement in the stratum corneum barrier.60 A review of the literature found varying results with the use of borage for atopic dermatitis, with a total of 12 studies of topical or oral borage oil identified. Wang YP, Yan J, Fu PP, Chou MW. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. Human liver microsomal reduction of pyrrolizidine alkaloid N-oxides to form the corresponding carcinogenic parent alkaloid. Borage seed oil 1 to 3 g/day has been given in clinical trials (1 g/day has been used in children, and up to 3 g/day has been used in adults). Stewart MJ, Steenkamp V. Pyrrolizidine poisoning: a neglected area in human toxicology. Available for Android and iOS devices. Changes in these mediators of inflammation could possibly have an effect on a variety of diseases and conditions; some animal model experiments have been reported. No animal data exist regarding the use of borage for psychiatric disorders. Internal use of whole borage leaf is not recommended. WHO working group. Toxicol Lett 2005;155:411-20. The fresh plant has a salty flavor and a cucumber-like odor.1, Borage leaves have been used as a potherb and in European herbal medicine since the Middle Ages, and were mentioned by Pliny (AD 61), Dioscorides (AD 40), and Galen (AD 129). Investigations in humans have followed a similar pattern. The unsaturated, potentially toxic alkaloids lycopsamine and amabiline are found in borage leaves, stems, and roots in relatively low concentrations.10 The seeds and flowers contain the saturated pyrrolizidine alkaloid thesinine, along with traces of amabiline, supinine, and other alkaloids. This document describes chemical, toxicological, pharmacological and pharmacokinetic properties of unsaturated pyrrolizidine alkaloids (PAs). Improvement was found in arthritis symptoms for both groups, with the cohort receiving 12 months of GLA supplementation improving throughout both phases.49 No adverse effects were detected in any of these regimens. Scientific Name(s): Borago officinalis L.Common Name(s): Bee fodder, Bee-bread, Borage, Burrage, Common bugloss, Cool tankard, Ox's tongue, Star flower. Wang YP, Yan J, Fu PP, Chou MW. PPRL 2010 Outline Plants Toxin Metabolism Poisoning Susceptibility Clinical signs Lesions Diagnosis Current Research April 2009. Some butterbur products contain chemicals called pyrrolizidine alkaloids (PAs). Last updated on Mar 23, 2020. The stem and leaves are covered with coarse, prickly hairs, and the flowers are large, star-shaped, and bright blue with contrasting black anthers. In patients with rheumatoid arthritis (RA) taking borage, belching and soft stools occurred. Pyrrolizidine alkaloids are produced by plants as a defense mechanism against insect herbivores. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. Only butterbur products that have been processed to remove PAs and are labeled or certified as PA-free should be considered for use. Because borage seeds contain small amounts of unsaturated pyrrolizidine alkaloids, including amabiline, a hepatotoxin, the German Federal Ministry of Health recommends no more than 10 mcg of unsaturated pyrrolizidine alkaloid consumption each day. Pharmazie 1995;50:83-98. Avoid use due to documented adverse effects (pyrrolizidine alkaloids). turmeric, echinacea, saw palmetto, milk thistle, Ginkgo Biloba. Treatment with borage oil was found to exert anti-inflammatory activity as measured by chemically induced inflammation; it was also found to increase skin hydration and reduce transepidermal water loss.63 A small, open experiment in healthy elderly individuals reported improved cutaneous barrier function after 2 months of borage oil supplementation.59. alkaloids, which include senecionine, seneciphvlline, jacoline, jaCOflifle, jacohine, and jacozine, are potential/v carcinogenic, Pnutagenic. PAs can damage the liver, lungs, and blood circulation, and possibly cause cancer. Keywords: Herbal medicinal products, pyrrolizidine alkaloids, European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. 1. Pyrrolizidine alkaloids (PAs), sometimes referred to as necine bases, are a group of naturally occurring alkaloids based on the structure of pyrrolizidine. 2. However, when the groups were combined, reductions in total and low-density lipoprotein (LDL) cholesterol and triglyceride levels, an increase in HDL cholesterol levels, and improvement in the atherogenic index were noted.50, A Cochrane review of trials from 1966 to 2000 suggests some benefit from GLA in RA, despite the relative poor quality of the individual studies. Public Health Nutr 2000;3:501-8. Rats demonstrated increases in plasma GLA and DGLA,33 but lung microvascular permeability after endotoxin was not improved.34 Pulmonary eicosanoids were altered in endotoxic rats,35 but bacterial killing by macrophages was not changed.36 In pigs, pulmonary surfactant function was not altered despite changes in PUFA composition of the surfactant.37 GLA supplementation in aged rats provided protection against ventricular fibrillation.38 Thus, the link between dietary modulation of PUFA and functional changes remains tenuous in many cases. This document describes chemical, toxicological, pharmacological and pharmacokinetic properties of unsaturated pyrrolizidine alkaloids (PAs). Oral doses of 2,000 to 4,000 mg/day (GLA 400 to 1,000 mg) in adults and 1,000 to 2,000 mg/day (GLA 240 to 480 mg) in children with atopic dermatitis have been studied. The efficacy and safety of comfrey. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. A 2 g dose of dried herb brewed in 1 cup of boiling water taken 3 times daily has been suggested. Jia Ning, Lu Chen, Marije Strikwold, Jochem Louisse, Sebastiaan Wesseling, Ivonne M. C. M. Rietjens, Use of an in vitro–in silico testing strategy to predict inter-species and inter-ethnic human differences in liver toxicity of the pyrrolizidine alkaloids lasiocarpine and riddelliine, Archives of Toxicology, 10.1007/s00204-019-02397-7, (2019). Stickel F, Seitz HK. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. Pyrrolizidine alkaloids. Ithomiine butterflies use pyrrolizidine alkaloids (PAs) as precursors for male pheromones, such as dihydropyrrolizines or lactones. Borage has been used in European herbal medicine since the Middle Ages, alone and in combination with fish oil for the treatment of rheumatoid arthritis, atopic eczema, and osteoporosis, although clinical evidence to support these uses is limited. A case report describes the development of temporal lobe and gelastic seizures ultimately progressing to status epilepticus in a healthy 41-year-old woman who consumed borage oil 1,500 to 3,000 mg/day for 1 week. Exposure to pyrrolizidine alkaloids in food, in particular for frequent and high consumers of tea and herbal infusions, is a possible long-term concern for human health due to their potential carcinogenicity, say EFSA’s experts. Supplement 2: Pyrrolizidine alkaloids Over 200 PAs have been identified to … Antioxidant activity of borage has been attributed to rosmarinic acid found in the plant leaves.13, The 18-carbon fatty acid linoleic acid is considered essential in human nutrition because it must be obtained from the diet. Pyrrolizidine Alkaloids in Comfrey & Liver Damage Comfrey has been found to contain pyrrolizidine alkaloids that damage the liver and has been implicated in causing cancer of the liver. This information relates to an herbal, vitamin, mineral or other dietary supplement. Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids (2020). This information should not be used to decide whether or not to take this product. View abstract. Borage is an annual plant that grows to about 0.6 m in height. Ther Drug Monit 2001;23:698-708. Another source recommends no more than 1 mcg/day of unsaturated pyrrolizidine alkaloids. Human liver microsomal reduction of pyrrolizidine alkaloid N-oxides to form the corresponding carcinogenic parent alkaloid. The content of gamma-linolenic acid (GLA) is between 20% and 26% of the oil. Pyrrolizidine alkaloids are the leading plant toxins associated with disease in humans and animals. Ther Drug Monit 2001;23:698-708. Author information: (1)Institut für Lebensmittelchemie, Technische Universität Braunschweig, Schleinitzstrasse 20, 38106 Braunschweig, Germany. In contrast to most other ithomiine genera, none of these compounds have ever been detected in Oleria species. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. A pyrrolizidine alkaloid doronine a molecular constituents of Emilia sonchifolia is an herbal alternative to known drugs in the prophylaxis of inflammation. Pharmazie 1995;50:83-98. Roulet M, Laurini R, Rivier L, Calame A. Hepatic veno-occlusive … Meta-analyses could not be conducted on these studies because results were reported in different ways; however, assessments support previous reports of the lack of a significant effect of borage oil on global eczema symptoms. Pyrrolizidine alkaloid containing plants are the most widespread and expensive poisonous plant problem that affects plants, insects, animals and humans. A 24-week randomized, double-blind, placebo-controlled trial of borage seed oil (GLA 1.4 g/day) in 37 individuals with RA found clinically important reduction in symptoms compared with a cotton seed oil placebo.48 A trial in 56 participants using a higher dose (GLA 2.8 g/day) included a 6-month, double-blind phase and a second 6-month, single-blind trial. This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. Committee on Herbal Medicinal Products (HMPC), EMA/HMPC/893108/2011 Rev. 4 Public statement on the use of herbal medicinal products1 5 containing toxic, unsaturated pyrrolizidine alkaloids (PAs) 6 including recommendations regarding contamination of 7 herbal medicinal products with pyrrolizidine alkaloids 8 Draft Draft discussed by Working Party on Community monographs and Community list (MLWP) November 2011 Safety evaluation of certain food additives and contaminants: prepared by the eightieth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Human liver microsomal reduction of pyrrolizidine alkaloid N-oxides to form the corresponding carcinogenic parent alkaloid. Risk assessment on the use of herbal medicinal products containing pyrrolizidine alkaloids. A 2 g dose of dried herb brewed in 1 cup of boiling water taken 3 times daily has been suggested… (‎1988)‎. World Health Assembly » ... Safety evaluation of certain food additives and contaminants: supplement 2: pyrrolizidine alkaloids, prepared by the eightieth meeting of the Joint FAO/WHO Expert Committee on Food Additives (‎‎JECFA) WHO Food additives series;71-S2. View abstract. Among the pyrrolizidine-alkaloid-containing plants used by humans are Petasites japonicus Maxim (a kind of coltsfoot), which is used as a food and herbal remedy in Japan, and Symphytum officinale L. (comfrey), which is widely used as a medicinal herb, salad ingredient, or ‘tea.’ Both of these plants have been shown to be carcinogenic when fed to rats. It is native to the Mediterranean region but has been widely naturalized in other areas. Toxic pyrrolizidine alkaloids in herbal medicines commonly used in Ghana. It sets out recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs. Upon ingestion, metabolic activation in liver converts the parent compounds into highly reactive electrophiles capable of reacting with cellular macromolecules forming adducts which may initiate acute or chronic toxicity. No animal data exist regarding the use of borage for RA. Additionally, borage has been reported as the likely cause of several cases of methemoglobinemia in infants in Europe. Toxic reactions to some of those medicinal herbs have been reported following long-term ingestion, usually after many months. Atopic eczema/dermatitis syndrome has been recommended by an international task force to encompass all forms of eczema, including atopic dermatitis.94, In a study of 26 children ages 2 to 7 years, daily use of undershirts coated with borage oil (GLA 69.3 mg per 100 g of cotton) for 1 month slightly improved or improved erythema (61.6%), itch (65.3%), and dryness (57.7%). Two edible plants in Southeast Asia, Gynura bicolor and G.divaricata, are not only known to be nutritive but also useful as medicinal herbs.Previous phytochemical investigation of Gynura species showed the presence of hepatotoxic pyrrolizidine alkaloids (PAs), indicating the toxic risk of using these two plants. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It is converted by the enzyme delta-6-desaturase to GLA, which is thought to be rate-limiting in the pathway. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. EFSA was asked by the European Commission to deliver a scientific opinion on the risks for human health related to the presence of pyrrolizidine alkaloids (PAs) in honey, tea, herbal infusions and food supplements and to identify the PAs of relevance in the aforementioned food … You should talk with your health care provider for complete information about the risks and benefits of using this product. Author information: (1)ACA-pharma Concept GmbH, Deutscher Platz 5, 04103, Leipzig, Germany; Rudolf-Boehm-Institute of Pharmacology and Toxicology and PGS Toxikologie und Umweltschutz, University of Leipzig, Leipzig, Germany. In an 18-month, randomized, double-blind study, 146 patients with RA received either 3.5 g of omega-3 fatty acids, GLA 1.8 g/day, or combination therapy. However, in planned subgroup analysis, male participants fed the long-chain PUFA and borage oil–enriched formula scored higher on growth and neurodevelopment indicators.72, No clinical effect could be demonstrated in a randomized, controlled trial of dietary supplementation versus placebo in asthma patients, despite measurable biochemical differences.5, In an in vitro study, borage was found to exert amoebicidal activity against Entamoeba histolytica.73 In another study, borage oil was found to exert bactericidal effects against Helicobacter pylori within 60 minutes of application.74, Borage oil was found to exert hepatoprotective effects in rats with alcoholic steatohepatitis. They are found frequently in plants in the Boraginaceae, Asteraceae, Orchidaceae and Fabaceae families; less frequently in the Convolvulaceae This is only a brief summary of general information about this product. Specifically, rats receiving the oil experienced an improvement in liver morphology, a reduction in triglyceride concentrations, and normalization of serum marker enzyme activities.75, One study found that GLA from borage significantly reduced the overall severity of alcoholic hangover, as well as headache, laziness, and fatigue, compared with placebo (P < 0.01).76, Borage oil has been used experimentally to deliver tamoxifen transcutaneously, with the aim of delivering tamoxifen and GLA through intact breast skin.77, Borage seed oil 1 to 3 g/day has been given in clinical trials (1 g/day has been used in children and up to 3 g/day has been used in adults).44, 53, 78 The content of GLA is 20% and 26% of the oil.48, 49, A 2 g dose of dried herb brewed in 1 cup of boiling water taken 3 times daily has been suggested.79, Oral doses of 2,000 to 4,000 mg/day (GLA 400 to 1,000 mg) in adults and 1,000 to 2,000 mg/day (GLA 240 to 480 mg) in children with atopic dermatitis have been studied.61, Avoid use due to documented adverse effects (pyrrolizidine alkaloids). It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Butterbur has been reported to have a variety of synergistic and antagonistic effects. Avoid use.11, 80, 81, 82, 83, Because borage contains low concentrations of unsaturated pyrrolizidine alkaloids, which have been associated with hepatotoxic effects, it should not be used with hepatotoxic drugs, such as anabolic steroids, phenothiazine, or ketoconazole. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Because borage contains low concentrations of unsaturated pyrrolizidine alkaloids, which have been associated with hepatotoxic effects, it should not be used with hepatotoxic drugs such as anabolic steroids, phenothiazine, or ketoconazole. View abstract. Of these studies, 5 found an effect, 5 found borage oil to be ineffective, and 2 found borage oil to be effective in some patients.61, In healthy female volunteers, a combination of GLA 150 mg in borage oil, catechin 47 mg, and vitamin E 2 mg mixed in a dairy matrix containing probiotics given twice daily was found to improve skin barrier function as early as 16 weeks, with the largest effects after 18 weeks.62 In another study, 45 healthy women were randomized to receive flaxseed 2.2 g/day, borage oil with tocopherol 10 mg/day, or placebo containing 2.2 g/day of medium-chain fatty acids for 12 weeks. Pharmazie 1995;50:83-98. April 2009. pyrrolizidine alkaloids (PAs) in selected food items, to estimate the dietary exposure to PAs of the Hong Kong adult population and to assess the associated health risks. Stickel F, Seitz HK. EMA is in the process of making appropriate changes to this website. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. There was a trend toward reduction of morning stiffness, joint tenderness, and pain. Letsyo E(1), Jerz G(1), Winterhalter P(1), Beuerle T(2). The effects were greater at the higher of the 2 doses.45 In another study of healthy humans, administration of borage oil containing GLA 1.5 g/day for 3 weeks was found to decrease leukotriene synthesis as compared with baseline. View abstract. View abstract. Borage leaves and flowers were added to wine and lemon juice to make the popular English beverages claret cup and cool tankard. Toxicol Lett 2005;155:411-20. Borage seed oil 1 to 3 g/day has been given in clinical trials (1 g/day has been used in children, and up to 3 g/day has been used in adults). Pyrrolizidine alkaloids World Health Organization, Geneva, 2020. Boneset Uses, Benefits & Dosage - Drugs.com Herbal Database Total alkaloid content of the plant is estimated at less than 0.001%, while mature seeds yield about 0.03% crude alkaloids.11, 12 More sensitive trace analyses are required to measure the safety of borage seed oils. The seed yields a fixed oil with a high content (20% to 26%) of GLA, about twice the content of evening primrose oil, another commercial source.3 The triacylglycerol structure of borage oil has been compared with evening primrose oil and other GLA sources, with GLA attached at position sn-3 in evening primrose oil but at position sn-2 in borage seed oil.4, 5 This difference explains the apparently poorer bioavailability of GLA from borage seed oil compared with evening primrose oil.6 Results of numerous methods for analysis of GLA and other polyunsaturated fatty acids (PUFA) from borage seed oil and leaves have been published.4, 7, 8, 9, Because of the occurrence of toxic pyrrolizidine alkaloids in other members of the Boraginaceae family, borage leaves, seeds, and seed oil have been carefully investigated for their alkaloid content. The hepatotoxic pyrrolizidine alka-loids present in local tansy ragwort (Se-neclo jacobaea L.) have been demon- People use alkanna for wound healing, burns, diarrhea, and stomach ulcers, but there is no good scientific evidence to support these uses. Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids. Because borage seeds contain small amounts of unsaturated pyrrolizidine alkaloids, including amabiline, a hepatotoxin, the German Federal Ministry of Health recommends no more than 10 mcg of unsaturated pyrrolizidine alkaloid consumption each day.10, 11, 12, 90, 91, 92 Another source recommends no more than 1 mcg/day of unsaturated pyrrolizidine alkaloid.79 Internal use of whole borage leaf is not recommended. Stewart MJ, Steenkamp V. Pyrrolizidine poisoning: a neglected area in human toxicology. The pyrrolizidine alkaloid content of seeds is often very high (up to 5% dry weight) and the effects can be acute or cumulative. They are found worldwide in a very large number of plants. Borage oil should be used cautiously in patients with epilepsy. Borage oil should also be used cautiously with any medication that may increase the risk of bleeding. By weeks 4 and 6, treatment with borage lowered obsessive, compulsive, and anxiety symptoms.68, 69, The Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults (2009) states that there is insufficient evidence for a recommendation of use.93, In a study of rats, short-term (ie, 4 days) enteral feeding with a GLA and eicosapentaenoic acid (EPA) diet was found to form less inflammatory eicosanoids by alveolar macrophages.36, Compared with controls, a multicenter trial of fish oil and borage seed oil added to enteral feeding mixtures in patients with acute respiratory distress syndrome resulted in improvement in outcomes, with reduced major organ failures, shorter intensive care unit stays, and less ventilator support required.64 On the basis of this trial, Canadian practice guidelines for nutritional support in mechanically ventilated, critically ill patients, made the recommendation that the use of products with fish oils, borage oils, and antioxidants be considered in patients with adult respiratory distress syndrome.65, In a study of 19 pediatric burn patients with acute respiratory distress syndrome, treatment with a specialized enteral product containing EPA, GLA, and antioxidants was found to improve oxygenation and pulmonary compliance compared with baseline after an average of 10.8 ± 0.9 days.66, 67. 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