This information relates to an herbal, vitamin, mineral or other dietary supplement. After 2 weeks, activity returned to baseline.46 In a study of 50 formerly obese patients, supplementation with GLA (borage oil 5 g/day) was found to reduce weight regain, particularly when completing at least 50 weeks of treatment.47, In a study of guinea pigs, borage oil given as part of a diet for 2 weeks reversed epidermal hyperproliferation.52, A randomized clinical trial conducted in adults and children favored placebo compared with borage oil for efficacy in atopic eczema.53 Other smaller trials noted a trend toward efficacy, but without reaching clinical importance.54, 55, 56, 57 In a trial designed to estimate the degree of prevention of atopic dermatitis in infants with a familial risk, borage oil supplementation had no effect on dermatitis incidence or serum immunoglobulin E and showed only a trend toward decreased severity of atopic dermatitis.58 In 2013, a Cochrane review identified 8 placebo-controlled randomized clinical trials conducted in adults and children that assessed borage oil for treatment of signs and symptoms of eczema. Borage seed oil protected mice from experimental autoimmune encephalomyelitis, with improved clinical, biochemical, and histological parameters.31 Neovascularization of chemically burned rabbit corneas was favorably modulated by dietary GLA.32 The use of enteral and parenteral feeding formulations supplemented with GLA and fish oil was investigated with rat and pig models of acute endotoxin and burn injuries. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. Roulet M, Laurini R, Rivier L, Calame A. Hepatic veno-occlusive … It sets out recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs. 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 … Toxic pyrrolizidine alkaloids in herbal medicines commonly used in Ghana. Letsyo E(1), Jerz G(1), Winterhalter P(1), Beuerle T(2). Ther Drug Monit 2001;23:698-708. Borage leaves and flowers were added to wine and lemon juice to make the popular English beverages claret cup and cool tankard. 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. They are found frequently in plants in the Boraginaceae, Asteraceae, Orchidaceae and Fabaceae families; less frequently in the Convolvulaceae View abstract. Public Health Nutr 2000;3:501-8. Borage is an annual plant that grows to about 0.6 m in height. Keywords: Herbal medicinal products, pyrrolizidine alkaloids alkaloids, which include senecionine, seneciphvlline, jacoline, jaCOflifle, jacohine, and jacozine, are potential/v carcinogenic, Pnutagenic. Stickel F, Seitz HK. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Borage seed oil increased plasma phospholipid GLA and DGLA levels while augmenting the arterial baroreflex control of vascular resistance in healthy humans, actions that may be useful in the treatment of hypertension.39 Proportions of different phospholipid types were unchanged, but DGLA was increased in platelets when borage seed oil was administered for 42 days.40 Neutrophils from participants whose diets were supplemented with GLA mobilized 3-fold more DGLA after ionophore stimulation compared with controls.41 In older participants, GLA had no effect on natural killer cell activity, while fish oil reduced it by 50%.42 In contrast, T-lymphocyte proliferation was decreased by GLA and fish oil in the same type of population.43 This effect on lymphocytes was reproduced by a second group for GLA in borage seed oil, where increases in plasma GLA and DGLA were observed.44 The release of proinflammatory leukotriene B4 from neutrophils with ionophore stimulation was reduced, while DGLA was elevated in healthy adults. 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. Pyrrolizidine alkaloid containing plants are the most widespread and expensive poisonous plant problem that affects plants, insects, animals and humans. Infusions of the leaves have been used to induce sweating and diuresis.2, The leaves and flowers contain mucilage, tannin, and a small amount of essential oil. 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. Human liver microsomal reduction of pyrrolizidine alkaloid N-oxides to form the corresponding carcinogenic parent alkaloid. Toxicol Lett 2005;155:411-20. 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. WHO working group. 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. Scientific Name(s): Borago officinalis L.Common Name(s): Bee fodder, Bee-bread, Borage, Burrage, Common bugloss, Cool tankard, Ox's tongue, Star flower. 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. Another source recommends no more than 1 mcg/day of unsaturated pyrrolizidine alkaloids. The efficacy and safety of comfrey. 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. 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. Pyrrolizidine alkaloids. 27 November 2020 Toxicol Lett 2005;155:411-20. Pharmazie 1995;50:83-98. Pharmazie 1995;50:83-98. To … Last updated on Mar 23, 2020. GLA is further elaborated to the 20-carbon fatty acid dihomogammalinolenic acid (DGLA), a key metabolite for the synthesis of the anti-inflammatory prostaglandins of the 1-series (eg, PGE1) and 15-(S)-hydroxy-8,11,13-eicosatrienoic acid (15HETrE) by different types of cells.14 Theoretically, supplementation with GLA might bypass the rate-limiting step in biosynthesis, providing more of these anti-inflammatory modulators. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. 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 differences were found among treatment groups except for triglycerides. The efficacy and safety of comfrey. Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids. People use alkanna for wound healing, burns, diarrhea, and stomach ulcers, but there is no good scientific evidence to support these uses. PAs can damage the liver, lungs, and blood circulation, and possibly cause cancer. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. 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). Several double-blind studies have shown that high doses of Petasites hybridus" extract, containing petasin and/or isopetasin, are effective both in preventing and in relieving migraine, with the best results in groups taking the higher dose of the supplement. GLA itself is not always elevated; however, DGLA can be highly elevated by GLA supplementation. 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. Toxicol Lett … Supplement 2: Pyrrolizidine alkaloids 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 converted by the enzyme delta-6-desaturase to GLA, which is thought to be rate-limiting in the pathway. A 2 g dose of dried herb brewed in 1 cup of boiling water taken 3 times daily has been suggested… 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%). It sets out recommendations for the oral and cutaneous use of herbal medicinal products and traditional herbal medicinal products containing PAs. 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). In addition, pathophysiological conditions alter the ability to convert linoleic acid to GLA.14 Commercial sources of GLA include borage seed oil, evening primrose oil, and black currant seed oil, as well as the oil from the fungus Mucor javanicus.4 Cloning of delta-6-desaturase enzymes into plants that do not typically possess them has been proposed as a means to increase dietary GLA.15, Extensive research has demonstrated that dietary supplementation with GLA can alter lipid fatty acid profiles in animal experiments. Public Health Nutr 2000;3:501-8. The content of gamma-linolenic acid (GLA) is between 20% and 26% of the oil. This is only a brief summary of general information about this product. Toxic reactions to some of those medicinal herbs have been reported following long-term ingestion, usually after many months. A pyrrolizidine alkaloid doronine a molecular constituents of Emilia sonchifolia is an herbal alternative to known drugs in the prophylaxis of inflammation. The stem and leaves are covered with coarse, prickly hairs, and the flowers are large, star-shaped, and bright blue with contrasting black anthers. This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. PAs are a group of secondary compounds that are produced by plants all over the world. Select one or more newsletters to continue. Available for Android and iOS devices. Risk assessment on the use of herbal medicinal products containing pyrrolizidine alkaloids. Sufficient evidence was found to warrant further larger trials to provide optimal dosage, information regarding outcome, and duration of therapy.51, A pilot study of fish oil plus borage seed oil in elderly, osteoporotic women found improved bone density in the treatment arm compared with placebo and improvement after crossover to all treatment in both groups.70, An in vivo experiment with borage oil failed to show an effect on insulin action and was associated with adversely affected lipid levels.71, No differences in neurodevelopment were found in a randomized, controlled trial with infants fed supplemented formulas. 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. Pyrrolizidine alkaloids (PAs), sometimes referred to as necine bases, are a group of naturally occurring alkaloids based on the structure of pyrrolizidine. Borage may lower the seizure threshold and should not be used with drugs that can lower the seizure threshold, such as tricyclic antidepressants and phenothiazines.84 Borage oil should also be used cautiously with coadministration of any medication that may increase the risk of bleeding.85, Borage oil should be used cautiously in patients with epilepsy.86 A case report describes the development of temporal lobe and gelastic seizures ultimately progressing to status epilepticus occurring in a healthy 41-year-old woman who consumed borage oil 1,500 to 3,000 mg/day for 1 week.87 Additionally, borage has been reported as the likely cause of several cases of methemoglobinemia in infants in Europe.88 In patients with RA taking borage, belching and soft stools occurred.89. 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. Only butterbur products that have been processed to remove PAs and are labeled or certified as PA-free should be considered for use. April 2009. Allgaier C(1), Franz S(2). 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. and tera (ogenic and rna' pose health hazards to the human consumer. 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. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. Pharmazie 1995;50:83-98. Internal use of whole borage leaf is not recommended. In contrast to most other ithomiine genera, none of these compounds have ever been detected in Oleria species. 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. 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). Wang YP, Yan J, Fu PP, Chou MW. Borage oil should also be used cautiously with any medication that may increase the risk of bleeding. 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). This information should not be used to decide whether or not to take this product. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. 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). Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. Medically reviewed by Drugs.com. Contraindications have not been identified. Stickel F, Seitz HK. Pharmazie 1995;50:83-98. Pyrrolizidine alkaloids are produced by plants as a defense mechanism against insect herbivores. Human liver microsomal reduction of pyrrolizidine alkaloid N-oxides to form the corresponding carcinogenic parent alkaloid. This document describes chemical, toxicological, pharmacological and pharmacokinetic properties of unsaturated pyrrolizidine alkaloids (PAs). There was a trend toward reduction of morning stiffness, joint tenderness, and pain. 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 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. This document describes chemical, toxicological, pharmacological and pharmacokinetic properties of unsaturated pyrrolizidine alkaloids (PAs). Macrophage phospholipids of mice fed borage seed oil showed altered ratios of 20-carbon PUFA.16 DGLA was selectively increased in the same system.17 The particular phospholipid classes altered by GLA supplementation were examined in mice.18 GLA and DGLA in cutaneous phospholipids were markedly increased in guinea pigs after an 8-week feeding experiment, along with the metabolites PGE1 and 15HETrE.19, 20, 21 Borage seed oil and evening primrose oil were equivalent sources of GLA in rats, despite the higher GLA content in borage oil.22 Upon stimulation with zymosan, isolated mouse peritoneal macrophages increased PGE1 synthesis when the mice had been maintained on high-GLA diets.23 Similar changes in hepatocyte PUFA were seen in Atlantic salmon smolts fed diets enriched with borage seed oil.24 Analysis of the interaction of cholesterol metabolism with PUFA metabolism in rats showed that GLA had a smaller hypercholesterolemic effect than alpha-linolenic acid.25 The effects of GLA supplementation in rats administered PUFA differed in immune tissues compared with other tissues.26 Other effects of GLA supplementation in animal models included an increase in Mn-superoxide dismutase in rats,27 decrease in rat liver fatty acid oxidation,28 changes in mouse macrophage–vascular smooth muscle cell interactions, and inhibition of serum cholesterol in aged rats on high-cholesterol diets.29 In a murine model of senile osteoporosis, mice supplemented with GLA-containing diets exhibited improved bone parameters, specifically suggesting a lower osteoclast activity level and, ultimately, a reduction in resorption rate and bone loss.30. The leaves have been used to treat rheumatism, colds, and bronchitis, as well as to increase lactation in women. We comply with the HONcode standard for trustworthy health information -. Pyrrolizidine alkaloids are the leading plant toxins associated with disease in humans and animals. View abstract. More than 660 PAs and PA N-oxides have been identified in over 6,000 plants, and about half of them exhibit hepatotoxicity. Ther Drug Monit 2001;23:698-708. Borage oil should be used cautiously in patients with epilepsy. 1. 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. 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. In a 6-week, randomized, double-blind, parallel study, the effects of Echium amoenum (Boraginaceae) 500 mg compared with placebo were assessed in 44 patients with obsessive-compulsive disorder. View abstract. 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. Additionally, borage has been reported as the likely cause of several cases of methemoglobinemia in infants in Europe. A 2 g dose of dried herb brewed in 1 cup of boiling water taken 3 times daily has been suggested. Pyrrolizidine alkaloids World Health Organization, Geneva, 2020. Wang YP, Yan J, Fu PP, Chou MW. The content of gamma-linolenic acid (GLA) is between 20% and 26% of the oil. Boneset Uses, Benefits & Dosage - Drugs.com Herbal Database Stewart MJ, Steenkamp V. Pyrrolizidine poisoning: a neglected area in human toxicology. This product may be unsafe when used before surgery or other medical procedures. 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. The pyrrolizidine alkaloid content of seeds is often very high (up to 5% dry weight) and the effects can be acute or cumulative. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Pyrrolizidine alkaloids / published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health … View abstract. Roeder E. Medicinal plants in Europe containing pyrrolizidine alkaloids. Pharmazie 1995;50:83-98. The principal medicinal genera in current use are Senecio, Borago, Lithospermum, Heliotropium, and Eupatorium. EMA is in the process of making appropriate changes to this website. European Medicines Agency. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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. Over 200 PAs have been identified to … World Health Organization, International Programme on Chemical Safety & WHO Task Group on Pyrrolizidine Alkaloids. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Pyrrolizidine alkaloids are probably the major alkaloidal food contaminants in terms of wide distribution and the degree of economic and health damage caused. 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. Wang YP, Yan J, Fu PP, Chou MW. They are found worldwide in a very large number of plants. It is native to the Mediterranean region but has been widely naturalized in other areas. 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. General information about this product as safe, effective, or other dietary supplements the... Task Group on pyrrolizidine alkaloids ( PAs ) been used to treat rheumatism, colds, bronchitis..., 38106 Braunschweig, Germany, Ginkgo Biloba Diagnosis current Research April 2009 PA-free should be used cautiously patients... Products that have been identified in over 6,000 plants, insects, animals and humans to have a variety synergistic. Herbs have been processed to remove PAs and PA N-oxides have been as... The Mediterranean region but has been suggested and blood circulation, and possibly cause cancer herbs have been in... 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