Achillea – Yarrow (Millefolii herba)
|Latin name of the genus:||Achillea|
|Latin name of herbal substance:||Millefolii herba|
|Botanical name of plant:||Achillea millefolium l.|
|English common name of herbal substance:||Yarrow|
Latin name of the genus: Achillea
Latin name of herbal substance: Millefolii herba
Botanical name of plant: Achillea millefolium L.
English common name of herbal substance: Yarrow
- 1. Introduction
- 2. Historical data on medicinal use
- 3. Non-Clinical Data
- 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
- 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
- 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof
- 3.4. Overall conclusions on non-clinical data
- 4. Clinical Data
- 4.1. Clinical Pharmacology
- 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
- 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
- 4.2. Clinical Efficacy
- 4.2.1. Dose response studies
- 4.2.2. Clinical studies (case studies and clinical trials)
- 4.2.3. Clinical studies in special populations (e.g. elderly and children)
- 4.3. Overall conclusions on clinical pharmacology and efficacy
- 5. Clinical Safety/Pharmacovigilance
- 6. Overall conclusions
1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof
Herbal substance(s) Definition:
The whole or cut dried flowering tops of yarrow, Achillea millefolium.
This definition can be found in:
European Pharmacopoeia 7th ed. (2010) Yarrow,
Extra Pharmacopoeia Martindale XXV. Edition (Todd 1976),
Herbal Medicines (Newal et al. 1996), (Barnes et al. 2007),
WHO Monographs (Volume 4, 2009),
ESCOP Monographs (Supplement 2009).
Fresh or dried aerial (above ground) part collected during the flowering season of Achillea millefolium.
This definition can be found in:
Pharmacopoeia Hungarica Editio VI. Tomus III, 1967,
Hagers Handbuch der Pharmazeutischen Praxis (Kern 1969),
German Commission E Monograph 1990,
British Herbal Pharmacopoeia 1996 (dried aerial parts),
British Herbal Compendium (dried aerial parts) (Volume 1, Bradley 1992),
WHO Monographs (Volume 4, 2009),
ESCOP Monographs (Supplement 2009).
Assessor’s comment: The MLWP decided to use the definition of the European Pharmacopoeia monograph for Yarrow.
Communited herbal substance as infusion for tea preparation (Augustin et al. 1948, Todd 1967, BHP 1974, Rácz et al. 1984, German Commission E monograph 1990, Blumenthal et al. 1998, Wren 1988, Bisset 1994, Newal et al. 1996, Hänsel et al. 1992, Bradley 1992)
Expressed juice (1:1) from fresh herb (Blumenthal et al. 1998, Hänsel et al. 1992)
Liquid extract (1:1), extraction solvent: ethanol 25% (V/V) (Wren 1988, Bradley 1992, Newal et al. 1996, BHP 1974)
Tincture (1:5) extraction solvent: ethanol 45% (V/V) (Bradley 1992, Newal et al. 1996, BHP 1974)
Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable.
Millefolii herba is a frequent component of combinations mainly for mild
Achillea millefolium L. s.l. is a cytogenetically, morphologically, and chemically polymorphic aggregate. The genus Achillea consists of about 140 perennial herbs native in the Northern hemisphere.
Principal components of the herbal substance
According to the literature the pharmacological effects are mainly due to the essential oil, proazulenes and other sesquiterpene lactones, phenolic compounds such as dicaffeoylquinic acids and flavonoids. However, according to the two below mentioned articles these components can be found in very different quantities in the various plant materials.
Benedek et al. (2007 (a)) developed a
In their study Benedek et al. (2008) revealed that the quality of 40 commercial drug samples was very heterogenous and only 50% of the samples met the standards of the European Pharmacopoeia.
1.2. Information about products on the market in the Member States
Regulatory status overview
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in the MSs concerned.
Table I. Products on the market as provided by the Member states.
1.3. Search and assessment methodology
The assessment report of Millefolii herba is based on the following literature resources:
Monographs: ESCOP Monographs (Supplement 2009), WHO Monographs on Selected Medicinal Plants (Volume 4 2009), Hagers Handbuch (Hansel et al. 1992), Expanded Commission E Monograph (Blumenthal et al. 2000).
Articles and references retrieved from data bases (Pubmed, Toxnet) or internet sources (e.g. Google) until the end of 2009. The term Achillea millefolium was searched.
Articles and data that were found to be relevant for assessment are included in the list of references.
2. Historical data on medicinal use
2.1. Information on period of medicinal use in the Community
According to Blumenthal et al. (2000), yarrow has been used as medicine by many cultures for hundreds of years (Budavari 1996; Zeylstra 1997). Its English common name is a corruption of the
European National pharmacopoeial monographs:
Hungarian Pharmacopoeia 6th Edition Volume III (1967),
Extra Pharmacopoeia Martindale
British Herbal Pharmacopoeia (BHP) 1974, 1996,
Polish Herbal Compendium (1978),
German Pharmacopoeia (1997),
Austrian, Czech, French, Romanian Pharmacopoeias (mentioned by Newal et al. 1996). Other monographs:
Hungarian Herbal Drugs (Augustin et al. 1948),
German Commission E monograph (1990),
Hagers Handbuch (Kern et al. 1969, Hansel et al. 1992),
Potter’s New Cyclopaedia of Botanical Drugs and Preparations (Wren 1988).
2.2. Information on traditional/current indications and specified substances/preparations
Evidence regarding the indication/traditional use
In Belgium (cited in Bradley 1992):
Circulaire No. 367 of July 1991: Traditionally used topically as soothing antipruriginous application for dermatological affection.
In France (cited in Bradley 1992):
Bulletin Officiel No.90/22 bis: Achillée millefeuille, sommité fleurie.
Taken orally: traditionally used in symptomatic treatment digestive disorders such as epigastric distension; sluggishness of digestion; belching; flatulence as adjuvant treatment for painful component of spasmodic colitis.
Traditionally used topically as soothing and antipruriginous application for dermatological ailments, as protective treatment for cracks, grazes, chaps and against insect bites.
As aromatic, somatic, adstringent, choleretic, in problems of menstruation, in bleeding haemorrhoids, varicose veins, as diuretic in hypertension, diaphoretic, liver problems, emmenagogue, abortifacient, in pertussis, lung tuberculosis, haematoma, as an infusion or expressed juice from fresh herb for spring- cure. Externally it is used for healing wounds and ulcers similarly as chamomile (Kern et al. 1969).
Internally: loss of appetite; dyspeptic complaints such as mild, spasmodic disturbances in the gastrointestinal region. In hip baths: painful,
Gastrointestinal complaints (inflammation, diarrhoea, flatulence, cramps), as bitter aromatic for loss of appetite, and for stimulation of bile secretion. Externally: inflammation of the skin and mucous membranes, for healing wounds. In folk medicine, the drug is often employed as haemostyptic, e.g. for bleeding from haemorrhoids, and in problems of menstruation and to treat perspiration (baths) (Bisset 1994, Hänsel et al. 1992).
The use of Millefolii herba in case of dysmenorrhoea is mentioned already in the Madaus handbook (1938) until now, in recent editions of handbooks on phytotherapy (e.g. Fintelmann and Weiss 2002). In this reference also the use of the infusion (1 spoon of comminuted herbal substance per cup, several times a day) is mentioned.
In Romania (Rácz et al. 1984):
It is used for the inflammation of the mucous membrane of the stomach,
In the United Kingdom:
Diaphoretic, stimulant, and haemostatic (Todd 1967).
Indications: feverish conditions, common cold; digestive complaints. Other uses: loss of appetite, hypertension, menstrual irregularities. It is used topically for
Millefolii herba belongs to the bitter substances, because it stimulates the digestive system and metabolism. In folk medicine, it has been used in female diseases, especially in the climacteric period; the drug is often employed as a haemostyptic in bleedings from the intestine, uterus, lung or nose (Augustin et al. 1948).
The proposed indications for the monograph:
Indications based on products on the markets for more than 30 years:
Traditional herbal medicinal product used for temporary loss of appetite (indication 1)).
Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro- intestinal complaints including bloating, and flatulence (indication 2)).
Traditional herbal medicinal product for treatment of small superficial wound.(indication 4)) Indications based on literature:
For symptomatic treatment of minor spasm associated with menstrual periods (indication 3)).
Assessor’s comment: During the consultation period indication 3 in the form of hip baths was recommended by an interested party based on the reference of Weiss RF 1982. The working party questioned the plausibility of this indication. Spasmolytic,
Evidence regarding specified substances/preparations
In the literature:
Comminuted herbal substance as infusion for tea preparation (Kern et al. 1969, Hansel et al. 1992, BHP 1974, 1983, Augustin et al. 1948, Rácz et al. 1984, German Commission E monograph 1990, Wren 1988, Bisset 1994, Newal et al. 1996, Bradley 1992, Bisset 1994, Newal et al. 1996)
Liquid extract (DER: 1:1), extraction solvent: ethanol 25% (V/V) (BHP 1974, Wren 1988, Bradley 1992, Newal et al. 1996)
Tincture (ratio of herbal substance to extraction solvent: 1:5), extraction solvent: ethanol 45% (V/V) (BHP 1974, Bradley 1992, Newal et al. 1996)
Products on the market for more than thirty years:
Comminuted herbal substance
Expressed juice from fresh herb (DER
Expressed juice from fresh herb (DER
Tincture (ratio of herbal substance to extraction solvent: 1:5), extraction solvent ethanol 31.5% (V/V).
Assessor’s comment: The two expressed juices are combined in the monograph:
Expressed juice from fresh herb (DER
2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications
Indication 1) and 2):
Comminuted herbal substance as infusion for tea preparation
Three times daily:
Daily dose: 4.5 g of yarrow herb (German Commission E monograph 1990, Bisset 1994).
Wording of the package insert, from the German Standard Licence:
Hot water (ca. 150 ml) is poured over two teaspoonfuls
Single dose: 1.5 g (Kern 1969).
Herbal tea: 3.5 g of herbal substance as infusion in ½ glass of boiling water
Expressed juice from fresh herb
Assessor’s comment: The two expressed juices are combined in the monograph:
Expressed juice (DER:
Liquid extract (DER: 1:1), extraction solvent: ethanol 25% (V/V):
Tincture (ratio of herbal substance to extraction solvent: 1:5), extraction solvent: ethanol 45% (V/V):
Tincture (ratio of herbal substance to extraction solvent: 1:5), extraction solvent: ethanol 31.5% (V/V) 4 times daily 4.3 ml (=4.2 g) (products on the market for more than 30 years).
One spoon of comminuted herbal substance per cup, as infusion, several times a day (Madaus 1938, Fintelmann and Weiss 2002).
Herbal substance as herbal tea (infusion) 3.5 g of herbal substance in ½ glass of boiling water
The posology in the monograph
Adolescents, adults and elderly.
Indications 1) and 2):
d)Tincture extraction solvent ethanol 45% (V/V)
e)Tincture extraction solvent ethanol 31.5% (V/V) 4.3 ml (=4.2 g) four times daily.
For the indication “loss of appetite” the liquid preparations are to be taken 30 minutes before meals.
Comminuted herbal substance for infusion preparation for cutaneous use: 3.5 g of the comminuted herbal substance in 250 ml water
The use in children under 12 years of age is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Assessor’s comment: The use of the comminuted herbal substance by adolescents was accepted taking into consideration that Millefoii flos liquid extract has been used traditionally by adolescents for more than 30 years. There are no safety concerns since a herbal tea preparation contains assumingly a similar or rather lower amount of ingredients compared to a liquid extract prepared with liquor vine: ethanol 96% (V/V) 91:9 (m/m). The cutaneous use for adolescents can also be considered as safe.
Duration of use
Indications 1) and 2):
If the symptoms persist more than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Indications 3 and 4):
If the symptoms persist more than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
Method of administration
Indications 1), 2) and 3):
Cutaneous use: to be applied to the affected area in a form of impregnated dressing.
3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
In vitro studies
An extract of yarrow herb, prepared as 0.2 mg/ml of a lyophilized cold water extract, produced 41±2% inhibition of platelet activating factor
The same extract (0.2 mg/ml) showed 21±2% activity in a test for inhibition of the biosynthesis of prostaglandins from
As various proteases, for instance human neutrophil elastase (HNE) and matrix metalloproteinases
An inhibitory effect of the water soluble fraction of a
Infusions of pulverized flower heads of various Achillea (Asteraceae) species protected human erythrocytes and leucocytes against hydrogen
The in vitro antioxidant activities of the essential oil and methanol extracts of Achillea millefolium subsp. millefolium Afan. were investigated by Candan et al.
The above mentioned
The mechanism of
The antiproliferative activities of
A lyophilized decoction (approx. 5:1) from yarrow (Achillea millefolium L.) was evaluated for anti- hepatoma activity (cytotoxicity) on five human liver cancer cell lines; at 2mg/ml the average inhibition of proliferation was 55% on
Dry methanolic and
Antispasmodic activity on isolated rabbit intestine has been documented for
The spasmolytic activity of a flavonoid fraction of a commercial sample of yarrow (Achillea millefolium L. s.l), its main flavonoids as well as quercetin and two flavonoid metabolites were investigated on isolated
In isolated rabbit jejunum preparations, a
Benedek et al. (2006) investigated the choleretic effect in the isolated perfused rat liver (IPRL) of a fraction from a 20% methanolic extract of the aerial part of yarrow enriched in dicaffeoylquinic acids (48%) and
A lipophilic extract of aerial parts of Achillea millefolium (hexane: ether: methanol=1:1:1 solvent, DER approx. 11:1) has been tested for antimicrobial activity in a disk diffusion assay against five bacteria (Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Salmonella enteritidis) and two fungi (Aspergillus niger and Candida albicans). The extract possessed a broad spectrum of antimicrobial activity against all tested strains (Stojanovic et al. 2005).
A 95% methanolic extract of powered aerial parts of yarrow (Achillea millefolium L.) inhibited 15 different strains of the
The in vitro antimicrobial activities of the essential oil and of the methanol extracts of Achillea millefolium subsp. millefolium Afan. (Asteraceae) were investigated. The oil showed antimicrobial activity against Streptococcus pneumoniae, Clostridium perfringens, Candida albicans, Mycobacterium smegmatis, Acinetobacter woffii and Candida krusei while
A 5% m/V hot water infusion of yarrow (Achillea millefolium) significantly shortened recalcification time (a test of blood coagulation) in human plasma to 43% of that of the reference substance, 0.9% sodium chloride (p<0.001). The flowering herb had the highest hamostypic activity, whereas pressed juice significantly prolonged blood coagulation (p<0.05 to p<0.001) (Sellerberg and Glasl 2000).
In vivo studies
In this study, the efficacy of herbal extracts of Thymus vulgaris (thyme) and Achillea millefolium (yarrow), propolis hydroalcoholic extract and systemic glucantime against cutaneous leishmaniasis in Balb/c mice were evaluated. A total of 45 mice were randomised into five groups each including nine mice. They were treated with pure ethanol 70 degrees, systemic glucantime, Achillea millefolium hydroalcoholic extract, Thymus vulgaris hydroalcoholic extract and propolis hydroalcoholic extract for six weeks. The statistical tests including student
The aim of the study of Noureddini and Rasta was to assess the analgesic effects of aqueous extract (AE) of Achillea millefolium L. in the rat’s formalin test. Oral administration of different doses of AE (80, 160 and 320 mg/kg) induced a
An aqueous extract of the dry flower heads of Achillea millefolium has been found to possess anti- inflammatory activity as measured by the
Gastro protective effects:
Seven days after induction of chronic gastric lesions in rats by acetic acid a hot (70ºC) water extract (yield 36%, approximately DER: 2.8:1) from the aerial part of yarrow (Achillea millefolium L.), was administered orally at 100 or 300 mg/kg/day for 7 days. Compared to controls, a significant and dose- dependent healing effect was observed (p<0.05, ED50 = 32.4 mg/kg). However, the same treatment started 1 day after injection of acetic acid did not prevent the formation of gastric ulcers. Oral pre- treatment of rats with the extract one hour before induction of acute gastric lesions by ethanol had a
A dry extract of aerial parts of yarrow (5.5:1, 70% methanol) administered
The antihepatotoxic activity of dry extracts of yarrow (Achillea millefolium L.), of varying polarity (following extraction with chloroform, methanol or water) was evaluated in rats treated with carbon tetrachloride or paracetamol as toxicants. Liver function was assessed by determining the levels of serum glutamic oxalacetate transaminase (ALAT) and serum glutamic pyruvic transaminase (ASAT), increases indicating necrosis of the liver. Intraperitoneal administration of the extract at 50 mg/kg reduced ALAT/ASAT levels by
The effects of Achillea millefolium total extract on the electrocardiogram, cardiac enzymes and serum electrolytes in 12 clinically healthy sheep were investigated. The treatment group was administered intravenously a total extract of Achillea millefolium (no details on DER and extraction solvent are available) at a dose of 20 mg/kg. The control group received normal saline.
3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof
No pharmacokinetic data are available.
3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof
Single dose toxicity
Yarrow dry extracts of varying polarity (following extraction with chloroform, methanol or water) were
After intraperitoneal treatment of mice with an extract (70%
According to a safety assessment of its use in cosmetics, the oral and subcutaneous LD50 values of yarrow, Achillea millefolium L. extract (2% flowers in propylene glycol and water) in mice were both 1g/kg (Anonymous 2001).
Repeated dose toxicity
Female and male Wistar rats were treated daily with a hot water extract (yield 36%, approximately DER: 2.8:1) from the aerial part of yarrow (Achillea millefolium L.) in doses of
No adequate genotoxicity studies have been performed with Millefolii herba.
A herbal tea from Achillea millefolium provided some, albeit inconclusive evidence of genotoxicity in the wing Somatic Mutation and Recombination Test (SMART). Quercetin and rutin, two flavonols present in beverages of plant origin, exhibited weak genotoxic activity in somatic cells of Drosophila. The standard herbal teas (infusions) were prepared by adding 20 g dry tea to 100 ml boiling tap water and allowing it to draw for 10 min (Graf et al. 1994).
The genotoxicity evaluation of the essential oil of Achillea millefolium was performed at concentrations of 0.13 microL/mL, 0.19 microL/mL and 0.25 microL/mL with a heterozygous diploid strain of Aspergillus nidulans, named A757//UT448, with green conidia. A statistically significant increase of mitotic recombinants due to either the induction of mitotic
In the present study, the action of an infusion prepared from the leaves of Achillea millefolium L. (Am) was assessed in vitro on chromosomal aberration formation in a human lymphocyte system alone or in combination with the alkylating agent mitomycin C (MMC) and the DNA repair inhibitor
Because yarrow has traditionally been used as an abortifacient, emmenagogue, contraceptive, and for stimulating uterine contractions, it is
of ethanolic solution of a commercial yarrow leaf extract on either gestation days (GD)
Another study (Dalsenter et al. 2004) evaluated the toxicity of the exposure to the aqueous extract from leaves of Achillea millefolium L. on reproductive endpoints in Wistar rats. Adult male rats were treated daily with yarrow extract (0.3, 0.6 and 1.2 g/kg/day) during 90 days by oral gavage. Endpoints including reproductive organ weights, sperm and spermatid numbers as well as sperm morphology were evaluated. No clinical signs of toxicity were detected over the treatment period, and body weight gain was similar in all groups. A significant increase in the percentage of abnormal sperm in the group treated with the highest dose of yarrow extract was detected with no other important changes in the other reproductive endpoints studied in the male rats. Furthermore, a
The effect of
Sensitisation potential was assessed in groups of guinea pigs (Hausen et al. 1991) in a modified Freund’s complete adjuvant method, by 0.1% and 1% crude ethylether extract of the whole yarrow plant, and by 0.1% and 1% crude ethylether extract of the flowers. The sensitisation potential of the sesquiterpene lactone
3.4. Overall conclusions on
The above mentioned pharmacological studies made the proposed indications plausible.
The indication of temporary loss of appetite is based on the bitter component(s) of the herbal substance. A limit for the bitter value of up to 5000 is included in the German Pharmacopoeia 1997.
The beneficial effect on mild, spasmodic
herbal substance. These activities are connected to the sesquiterpenes, phenolic (such as dicaffeoylquinic acids) and flavonoid content of yarrow.
The antispasmodic and analgesic properties of the plant may support its effectiveness in the indication of symptomatic treatment of minor spasms associated with menstrual periods.
The studies on antimicrobial and antiphlogistic activity may make the wound healing effect plausible.
Adequate tests on reproductive toxicity genotoxicity and carcinogenicity have not been performed. Three experimental studies on embryotoxicity and reproductive toxicity demonstrate relatively marginal effects. Guinea pig sensitisation tests indicated some sensitisation potential for yarrow extracts and one sesquiterpene lactone component.
4. Clinical Data
4.1. Clinical Pharmacology
4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents
4.2. Clinical Efficacy
4.2.1. Dose response studies
4.2.2. Clinical studies (case studies and clinical trials)
There was no clinical study performed with yarrow herb as a single component.
Only studies with combination products can be found.
The aim of a randomised, placebo controlled trial was to test the efficacy of a
The response to the study medication was significant in objective and subjective parameters. Patients maintained partial remission until the end of
A herbal preparation containing 110 mg feverfew (Chrysanthemum parthenium), 90 mg American aspen (Populus tremuloides) and 60 mg milfoil (A. millefolium,yarrow) was tested for its efficacy in the treatment of mild to moderate osteoarthritis.
4.2.3. Clinical studies in special populations (e.g. elderly and children)
4.3. Overall conclusions on clinical pharmacology and efficacy
As there are no clinical studies thus
Taking into consideration the
5. Clinical Safety/Pharmacovigilance
5.1. Overview of toxicological/safety data from clinical trials in humans
Yarrow, Achillea millefolium L., is one of the most common species of the Compositae family. Cases of allergic contact dermatitis have been described since 1899. Although 10 sesquiterpene lactones (SL) and 3 polyines have previously been identified, the responsible allergens in yarrow have not been established. A reinvestigation of short ether extracts of yarrow revealed the presence of five unsaturated hitherto unknown guaianolides of peroxide character. The main SL, identified as a strong sensitiser in guinea pig sensitisation experiments, was named
A Compositae plant mixture consisting of short ether extracts of arnica, German chamomile, feverfew, tansy, and yarrow has been included in the standard series for several years (1985 to 1990) to study the frequency of allergic reactions to Compositae (Asteraceae) species. One hundred and eighteen out of 3,851 tested individuals gave a positive response (3.1%). Further tests with the single species of the mixture and some additionally tested extracts of chrysanthemums and laurel oil (bay leaf; Lauraceae) revealed a high percentage of reactions to feverfew (70.1%) and lower responses to chrysanthemums (63.6%), tansy (60.8%), chamomile (56.5%), arnica (51.8%), yarrow (51.8%), and the
face eczema (including airborne contact dermatitis) might be diagnosed more frequently (Hausen 1996 – abstract).
5.2. Patient exposure
5.3. Adverse events and serious adverse events and deaths
None known (German Commission Monograph 1990, Blumenthal et al. 1998, 2000).
In case of allergies to Asteraceae, itching and inflammatory changes in the skin with formation of vesicles (yarrow dermatitis) may occur, in which case the treatment must be stopped immediately (Bisset NG. 1994).
Rarely allergic reactions with rash, formation of vesicles and pruritus can occur after internal or external use. Cases of contact dermatitis (“meadow dermatitis”) and cross reaction with other Compositae can occur (Hänsel et al. 1992).
Allergic reactions to yarrow (e.g. dermatitis) have been documented, and positive patch tests have been produced in individuals sensitised to other plants. An instance of yarrow tea causing a generalised eruption in a sensitised individual was reported in 1929 (Barnes et al. 2007).
Several cases of contact allergy have been reported (ESCOP Supplement 2009).
Numerous reports of allergic contact dermatitis have been published. Direct contact with the crude drug or its preparations may cause hypersensitivity reactions of the skin or mucosa, such as rash, formation of vesicles and pruritus in sensitive individuals (WHO 2009).
Compositae dermatitis occurred in a
Five months after her first contact with dried flowers of yarrow a
In a clinical testing with 20 subjects, product formulations containing 2% of extracts of the crude drug in propylene glycol and water were generally not irritating. In provocative testing, patients reacted to a Compositae mixture that contained the crude drug, as well as to the crude drug alone. In clinical testing, a formulation containing 0.1% yarrow extract (propylene glycol and water) was not a
sensitiser in a maximization test and alcoholic extracts of aerial parts of A. millefolium did not produce a phototoxic response (Anonymous 2001).
Proposed wording in the monograph:
Hypersensitivity reactions of the skin have been reported. The frequency is not known.
5.4. Laboratory findings
No data are available.
5.5. Safety in special populations and situations
Contra indications (hypersensitivity and allergic potential to be both covered)
Allergy to yarrow and other Compositaes (Blumenthal et al. 1998, 2000, Bradley 1992, Hänsel et al. 1992, Newal et al. 1996).
Warnings and precautions for use
The use in children under 12 years of age is not recommended due to lack of adequate data.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.
For tinctures, extracts containing ethanol the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the label and package leaflet of medicinal products for human use’, must be included.
None documented. However, the potential for preparations of yarrow to interact with other medicines administered concurrently, particularly those with similar or opposing effects, should be considered. There is limited evidence from preclinical studies that achilleine, a constituent of yarrow, has anticoagulant activity, although the clinical relevance of this, if any, is not clear (Barnes et al. 2007).
Assessor’s comment: Because the above mentioned
Use in pregnancy and lactation
Yarrow should not be taken during pregnancy. It is reputed to be an abortifacient and to affect the menstrual cycle, and the volatile oil contains trace amounts (0.3%) of the abortifacient principle thujone. Excessive use should be avoided during lactation (Newal et al. 1996, 2007).
The standard sentences are suggested in the monograph:
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No case of overdose has been reported.
Effects on ability to drive or operate machinery or impairment of mental ability
No studies on the effect on the ability to drive and use machines have been performed.
5.6. Overall conclusions on clinical safety
The medicinal use of yarrow preparation can be considered safe. Only the reported hypersensitivity reactions may present a risk therefore for safe use the sentence of “Hypersensitivity to the active substance and to other plants of the Asteraceae (Compositae) family” was included in the Contraindication section of the Community monograph.
The known toxic principle thujone has been documented as a minor component of yarrow oil, but the concentrations are too low to present a risk to human health.
Dry methanolic and
Since there are insufficient data, the use during pregnancy and lactation is not recommended.
6. Overall conclusions
Yarrow herb has been in medicinal use for a period of at least 30 years as requested by Directive 2004/24/EC, thus the requirement for the qualification as a traditional herbal medicinal product is fulfilled
The pharmacological studies on the
As there are insufficient data, the use during pregnancy and lactation is not recommended.
Due to inadequate data on genotoxicity the inclusion of Millefolii herba in the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products cannot be recommended.