Hamamelis Distillate – Hamamelidis folium et cortex aut ramunculus destillatum (Hamamelis virginiana L.)

Latin name of the genus: | Hamamelidis folium et cortex aut ramunculus destillatum |
Latin name of herbal substance: | Hamamelis virginiana l. |
Botanical name of plant: | Herbalref.com |
English common name of herbal substance: | Hamamelis distillate |
Used to: Eye discomfort; Skin disorders & minor wounds;
Latin name of the genus: Hamamelidis folium et cortex aut ramunculus destillatum
Botanical name of plant: Hamamelis virginiana L.
English common name of herbal substance: Hamamelis Distillate

I.REGULATORY STATUS OVERVIEW
MA: Marketing Authorisation;
TRAD: Traditional Use Registration;
Other TRAD: Other national Traditional systems of registration;
Other: If known, it should be specified or otherwise add ‘Not Known’
1This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in the MSs concerned.
1 Not mandatory field
Austria: Ointment containing per 1 g, 50 mg of liquid extract (1:1), extraction solvent ethanol 45% V/V; Aqua Hamamelidis cooling gel.
Belgium: For oral use (herbal tea), authorisation date
For rectal use (suppositories): authorisation date 1965 (combination with lidocaine, triclosan…): indication: hemorrhoids
For cutaneous use (ointments): authorisation date
Czech Republic: there is not registered any herbal medicinal product containing Hamamelis
Denmark: Hamamelis virginiana L., fresh leaf and twig distillate (water steam distillate) (1:1.6); 0.5 g extract (HEL)/100 g ointment
Estonia: No medicinal product containing hamamelidis folium is authorised in. Finland: No herbal medicinal product containing Hamamelis.
Germany:
Hamamelidis folium: WEU (In the market at least since 1976). For adults and adolescents over 12 years old.
1)Liquid extract (1:1), extraction solvent ethanol 45% V/V. Ointment, containing 50 mg of liquid extract per 1 g of ointment. For cutaneous use 1 string of ointment
For treatment of small skin lesions and minor inflammation of the skin. For relief of disorders in the beginning of haemorrhoids disease.
2)Liquid extract (1:1), extraction solvent ethanol 30% m/m. Gel, containing 2.5 g liquid extract per 25 g of gel. For cutaneous use. 1 string of ointment several times daily. For supporting treatment of superficial skin lesions.
3)Liquid extract (1:2), extraction solvent ethanol 60% V/V. Suppositories, containing 400 mg of extract. For rectal use. 1 Suppository two times daily. For relief of disorders as: itching, burning, slight bleeding in haemorrhoids grade I and II.
4)Liquid extract (1:2), extraction solvent ethanol 60% V/V. Ointment, containing 200 mg liquid extract per 1g ointment. For cutaneous use: 1 string of ointment two times daily. For relief of itching, weeping and burning in the beginning of haemorrhoids disease as soon as inflammation (i.e.:
5)Liquid extract (1:2), extraction solvent ethanol 60% V/V. Suppositories, containing 400 mg of extract. For rectal use. 1 suppository two times daily, in case of heavy discomfort temporarily 1 suppository three times a day. For relief of: itching, weeping and burning in the beginning of haemorrhoids disease as soon as inflammation of mucosa in the anal region.
Risks:
The products are in the market as authorised products. No pharmacovigilance actions taken on medicinal products containing the herbal substance.
The Herbal substance (Hamamelidis folium) is only available in combination products. There are 6 authorised products 4
There is also 1 German Standard Marketing Authorisation product. A herbal tea (single ingredient) for the preparation of poultices, for gargling and for rinsing of the
Hamamelidis destillatum: WEU
1), 2) and 4) Ointment, 100 g of ointment containing 6.25 g distillate, for cutaneous and mucosal use. Several times daily, thinly to the affected regions. Minor skin lesions, minor inflammation of skin and mucosa. For relief of disorders in the beginning of haemorrhoids disease.
3)Liquid, 100g (=102 ml) containing 25 g distillate. For cutaneous use: apply several times daily undiluted to the affected regions. For oromucosal use: In case of gums bleeding add 1 measuring spoon (=5 ml) liquid to the mouthwash. Minor skin lesions and inflammation of skin and gums.
5)Cream, 100 g containing 5.35 g destillate. For cutaneous and mucosal use. Apply several times daily at regular intervals thinly to the affected regions. Superficial skin lesions, minor inflammation of skin and mucosa.
Risks:
The products are in the market as authorised products. No pharmacovigilance actions taken on medicinal products containing the herbal substance.
There is also 1 product in combination
Hamamelidis cortex: WEU
1)Ointment, containing 129 mg dry extract per 10 g ointment. Dry extract
2)Suppository, containing 66 mg dry extract. Dry extract
Risks:
The products are in the market as authorised products. No pharmacovigilance actions taken on medicinal products containing the herbal substance.
The Herbal substance (Hamamelidis cortex) is only available in combination products. There are 3 authorised products
There is also 1 German Standard Marketing Authorisation product. A herbal tea (single ingredient) for the preparation of poultices, for gargling and for rinsing of the oropharynx. For supporting treatment in superficial skin lesion at minor inflammation of the skin and mucosa.
Greece: There is not registered any herbal medicinal product containing Hamamelis Hungary: No herbal medicinal product containing Hamamelis.
Ireland: Four products which contain hamamelis distillate of fresh Hamamelis virginiana L. leaves and branches
Italy: Cream, 100 g containing 5.35 g distillate (1:1,6); Distillate of fresh Hamamelis virginiana L. leaves and branches
Latvia: Only combinations.
Spain: Cream, 100 g containing 5.35 g distillate (1:1,6); Distillate of fresh Hamamelis virginiana L. leaves and branches
II.ASSESSMENT REPORT
Hamamelis virginiana L cortex
Hamamelis virginiana L., folium
Hamamelis virginiana L., folium et cortex out ramunculus destillatum
BASED ON ARTICLE 16D(1) AND ARTICLE 16F AND 16H OF DIRECTIVE 2001/83/EC AS
AMENDED
(TRADITIONAL USE)

II.1 INTRODUCTION
The aim of this report is to assess the available information on the herbal substances of Hamamelis virginiana L., bark, leaf and twigs and preparations thereof for the categorisation as products under well- established use or traditional use and the establishment of the corresponding Community herbal monographs.
This report is based on a scientific systematic review of the literature (mainly on efficacy and safety) of Hamamelis virginiana L. and the documentation provided by the European Medicines Agency completed by additional searches in biomedical databases and the available articles from references included in monographs on Hamamelis virginiana L. (Commission E Monographs, 2001; ESCOP, 2003; WHO, 2002), as well as the information provided by Member States.
MEDLINE
This assessment report refers to preparations of Hamamelis virginiana L. as a single ingredient, while studies performed with combinations are not discussed.
II.1.1 Description of the herbal substance (s), herbal preparation(s) or combinations thereof
Hamamelis virginiana L. (synonym: witch hazel) is a plant of the Hamamelidaceae family. It is a deciduous, tall shrub, or small tree, branches highly branched, indigenous to the Atlantic coast of North America, found in damp woods ranging from Nova Scotia to Florida and as far west as Texas. It is cultivated on a small scale in Europe, though the material of commerce is obtained mainly from the eastern USA and Canada (Wichtl and Bisset, 1994).
The flowers, bark and leaves of the common, colourful American witch hazel shrub provided tonics and remedies to Native Americans. Today, natural witch hazel is considered as one of of the few plant products that meet FDA standards for safety and effectiveness. The plants of the genus Hamamelis are unusual because they bear their blossoms and fruits together, at the very same time of the year, usually in autumn or winter. Flowers of Hamamelis virginiana L. are
According to Laux (1993), Hamamelis virginiana L. has the following synomyms: Hamamelis macrophylla Pursh, H. androgyna Walt, H. coryfolia, H. dioica, Trilopus dentate, T. nigra, T. rotundifolia, and T. virginiana.
Hamamelis bushes are very similar in appearance to the hazelnut (Coryllus avellana), which can also lead to confusion during harvesting period. The two plants can be distinguished anatomically and analytically.
Herbal substances 2
“Hamamelidis folium” consists of the dried or fresh leaves of Hamamelis virginiana L. It contains not less than 3% of tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) and calculated with reference to the dried drug. The material complies with the monograph of the European Pharmacopoeia 6.1, [monograph (04/2008:0909)]. Leaves are about 7 to 15 cm long, brittle, dark green or
3According to the ‘Procedure for the preparation of Community monographs for traditional herbal medicinal products’ (EMEA/HMPC/182320/2005 Rev.2) and the ‘Procedure for the preparation of Community monographs for herbal medicinal products with
prominent on the under surface, each ending in a marginal crenation; trichomes stellate, scattered or under surface, numerous on young leaves. Flowers
“Hamamelidis cortex” consists of the dried bark from the stems, branches and twigs of Hamamelis virginiana L. (Fam. Hamamelidaceae), collected in spring. It contains not less than 4.0% of
Stems and fruits are present in small amounts; stems pale
“Hamamelidis ramunculus (twigs)” have structures called buds, leaf scars and bundle scars that can differ for different species. Hamamelis twig is the herbal substance used in the preparation of hamamelis water, or as Witch Hazel as described in USP monograph.
Chemical constituents of herbal substances
The leaf contains
Witch hazel bark contains
Herbal preparations
Herbal preparations are obtained from dried or fresh leaves and/or the dried bark of the trunk and twigs of Hamamelis virginiana L. (Fam. Hamamelidaceae). The following herbal preparations have been proposed by Member States or cited in the literature search:
Dried comminuted herbal substance, for tea preparation (decoction), official in the standard license monographs (Banz, 1998; Braun et al, 1997; DAC, 1986; Wichtl and Bisset, 1994) and German Drug Codex (1986). Herbal tea preparation (decoction)
Powdered herbal substance (a green to
Tincture (1:10; ethanol 60%)
Tincture (bark) (1:10; ethanol 45% V/V) Tincture (leaf or bark) (1:10; ethanol 45% V/V) Tincture (leaf) (1:10; ethanol 55% V/V) Liquid extract (leaf) (1:1; ethanol 30% m/m).
Liquid extract (leaf) (1:1; ethanol 45% V/V). Liquid extract (leaf) (1:1; ethanol 60% V/V). Liquid extract (1:2; ethanol 60% V/V).
Liquid extract (leaf) (1:3), extraction solvent ethanol 62% V/V (Gracza, 1987) Dry extract (cortex)
Hamamelis water (Hamamelis distillate): Aqua hamamelidis. Distilled Witch Hazel; Witch Hazel USP; Liquor Hamamelidis. Several preparations, similar but not equivalent, obtained from different processes and called with different names are referring to hamamelis wate.
Leaves, bark and twigs collected in spring are used for the production of water distillates. Aqua hamamelidis is a clear colourless liquid; the odour is characteristic. Their acidity or alkalinity is neutral or slightly acid to litmus solution. Its weight per ml at 20ºC is 0.976 g to 0.982 g. The residue on evaporation, not more than 0.025% w/v, the residue being dried to constant weight at 105ºC. The alcohol content is from 13 to 15% v/v of ethyl alcohol, determined by the method included in BP Codex.
Preparations:
Distillate of fresh Hamamelis virginiana L. (leaves and branches)
Distillate prepared from dried twigs (1:2; ethanol
Chemical constituents of hamamelis preparations.
Polyphenols
Tannins are a broad class of complex phenolic compounds of molecular weight between 500 and 3000. The biological importance of tannins is attributed to their ability to bind and precipitate mainly proteins but also alkaloids. Tannins have been defined as “phenolic natural products that precipitate proteins from their aqueous solutions”. There are two types of tannins, the hydrolyzable tannins, which, upon acidic, alkaline, or enzymatic hydrolysis produce glucose and phenolic acids; and the condensed tannins (proanthocyanidins), which are
Hydrolizable tannins are polyesters of glucose, and upon hydrolysis, they release the sugar, and either gallic acid, hexahydroxydiphenic acid, or both, the latter acid rapidly lactonizes to ellagic acid (which explains the traditional terminology of ellagitannins). Oligomer hydrolysis also yields compounds with three or four aromatic rings, whose structures vary depending on the nature of the bond between monomers.
Tannins are generally extracted with a water and acetone mixture. The polymeric proanthocyanidins and high molecular weight gallotannins remain in the aqueous phase.
The therapeutic activity of tannins is mainly due to the astringency, and result from their affinity for proteins. Externally, they waterproof the external layers of the skin and mucosas, thus protecting the underlying layers; they also have a vasoconstrictor effect on small superficial vessels. By limiting fluid losses, tannins enhance tissue regeneration in case of superficial burn or wound.
Generally speaking tannins are enzyme inhibitors. They block
Tannins especially the hydrolysable ones inhibit the peroxidation induced by ADP and ascorbic acid in rat hepatic mitochondria. In vitro they are radical scavengers and inhibitors of superoxide ion formation, and some of them inhibit lipoxygenase in rat peritoneal granulocytes. (Bruneton 1999)
The main characteristic constituent of Hamamelis virginiana L. is hamamelitannin, a mixture of the α- and β- forms of (2´,

Hamamelitanin
Proanthocyanidins are also present including: procyanidin dimers such as
Other constituents include
Epicatechin
Polymeric proanthocyanidins were isolated from an
According to Vennat et al (1992), proanthocyanidins, phenolic acids and flavonoids have been identified in leaf extracts. Ollivier et al (1992) studied on the biotransformation of polyphenols in Hamamelis virginiana L. leaves and had shown variations on the qualitative and quantitative determination of gallic acid and ethyl gallate in hamamelis leaves according to the extraction solvent used. In water, only gallic acid was present; both were found in solutions containing
Hydroxycinnamic acids and flavonoids (e. g. myricetin, leucodelphinidin, quercetin, kaempferol, and gallic acid ) are found mainly in the leaves of Hamamelis virginiana L. (Besset et al, 1986).
Phenolic compounds from leaves of Hamamelis virginiana L. were studied by Sagareishvili (1999), where kaempferol, quercetin, trifolin, kaempferol
Several pharmacological activities, including
Volatiles
According to Engel et al, (1998), the composition of the volatile fraction obtained by water distillation from the leaves and bark of Hamamelis virginiana L., and determined in detail by
Reporting the same data, Engel et al (1998) stated “bark of young twigs” but Hartisch (1997) stated “young twigs tips were coarsely milled and then steam distilled”. The volatile fraction (0.009% of the crude drug on the dry weight basis) contained about 160 compounds: aliphatic hydrocarbons (45.4% , of which nonacosane 6.9%, heptacosane 5.4%), sesquiterpenes (20.2% of which α- ylangene 11.1% , trans- nerolidol 2.73%) , monoterpenes (8.3%, of which linalool 2.0%), phenylpropanoids (7.5%, of which trans- anethole 3.3%, eugenol 2.4%), aldehydes (6.1%, of which nonanal 2.7%) and small amounts of many other compounds (British Herbal Compendium, 2006).
Literature data on the content of these components fluctuate between 0.01% and 0.5% referred to the leaf drug and 0.1% for the bark. Safrole was also found at a level of < 0.2% in hamamelis leaf oil.
The study of distilled water of Hamamelis virginiana L. permitted the identification of volatile components and relative changes under the effects of different storage conditions (Messerschmidt, 1971; Martelli et al, 1977, 1978 and 1979). Among identified compounds were phenylacetaldehyde, linalool oxide, guaiacol, and geranylacetone. Storage of the oil with addition of ethanol or storage at
Combinations of herbal substance(s) and/or herbal preparation(s)
Hamamelis preparations aresometimes used in combinations with other herbal substances (herbal preparations), such as Hydrastis canadensis L., Ruscus aculeatus L., or Aesculus hippocastanum L.
This assessment report refers exclusively to the use of hamamelis preparations as single ingredient products.
Vitamin(s)
Not applicable
Mineral(s)
Not applicable
Pharmacopoeias’ references
The European Pharmacopoeia (1997)
There is a monograph on Hamamelidis folium in the European Pharmacopoeia (Hamamelis leaf. Eur. Pharm 6.1, monograph 04/2008:0909). The herbal substance consists of the whole or cut, dried leaf of Hamamelis virginiana L., containing minimum 3% of tannins, expressed as pyrogallol (C6H6O3; Mr 126.1) (dried drug), and has the macroscopic and microscopic characters described under identification tests.
The leaf is green or
The powder is
It may contain no more than 7% of stem pieces and maximum and not more of 2% of other foreign matter, determined on 50 g. Loss on drying, not more than 10.0%, determined on 2.000 g of powdered drug by drying in an oven at 100 °C to 105 °C for 4 h. Total ash, not more than 7.0%. Ash insoluble in hydrochloric acid, not more than 2.0%. Botanical identity must be confirmed by TLC as well as macroscopic and microscopic examinations. Assay: determination of tannins in herbal drugs. Action and use: Astringent.
Real Farmacopea Española , 3ª ed. 3.0 (1997)
Hamamelis, hoja de, monografía 01/2005, 0909. (Ph. Eur. monograph 0909)
British Pharmacopoeia (2007)
Hamamelis leaf. BP, 2007, Vol 1: 1007. (Ph. Eur. monograph 0909). Currently, there is no monograph for Hamamelis water in BP.
British Pharmacopoeia (1932)
Hamamelis leaves. BP, 1932: 201
Extractum Hamamelidis Liquidum. BP, 1932: 170
1000 g of moderately coarse powder hamamelis and alcohol 45% V/V sufficient to produce 1000 ml. Exhaust the hamamelis by percolation with alcohol (45%), and reserve the first 850 ml of the percolate; remove the alcohol from the remainder of the percolate and evaporate the residue to a soft extract. Dissolve this in the reserved portion, and add the sufficient alcohol (45%) to produce the required volume. Set aside for not less than twelve hours; filter. Alcohol content 32 to 40% V/V of ethyl alcohol. Doses: 2 to 4 ml.
German Drug Codex (1986)
Witch hazel is listed in the German Drug Codex, approved in the Commission E monographs, and the tea infusion is officially included in the standard license monographs (Banz 1998; Braun et al, 1997; DAC, 1986; Wichtl and Bisset, 1994). Witch hazel leaf and bark are used in some haemorrhoidal teas and antiphlebitis drugs. Several witch hazel
Hamamelidis folium (Hamamelisblätter, DAC 86). The German Drug Codex requires for witch hazel leaf not less than 5.0% tannins, precipitated with hide powder (DAC, 1986; Wichtl and Bisset, 1994). The German standard license requires that the leaf comply with the quality requirements of the German Drug Codex monograph.
Preparations: Suppositoria Hamamelidis
Herbal tea preparation (decoction):
Liquid extract (1:1) ethanol 45%, 3 times daily,
Pharmacopoeial grade witch hazel bark consists of the dried bark from stems and branches of Hamamelis virginiana L. collected in spring. The bark is required a content of not less than 9.0 % tannins, precipitable with hide powder (DAC, 1986; Wichtl and Bisset, 1994), and not less than 20% ethanol (45%) soluble extractive.
Hamamelidia aqua (Hamamelisrindenwasser); Aqua Hamamelidis corticis (Monographiensammlungen:
Preparations: Unguentum Hamamelidis (Hamamelissalbe, EB6)
The mother tincture (1:10) and liquid dilutions thereof, are also official in the German Homeopathic Pharmacopoeia (GHP), prepared from different plants of plants including the fresh leaves, the fresh bark from roots and branches, as well as the mixture of bark from the branches with tips of the shoots. The GHP also includes a monograph for an ethanolic decoction of the dried bark from stems and branches as pyrogallol (GHP, 1993).
USP 31/ NF 26 (2008)
Witch hazel is the clear, colourless distillate prepared from recently cut and partially dried dormant twigs of Hamamelis virginiana L. It is prepared by macerating a weighted amount of the twigs in water for 24 hours in about twice their weight of water. Then it is distilled until not less than 800 ml and not more of 850 ml of clear, colourless distillate is obtained from each 1,000 g of the twigs taken, which is followed by the addition of 150 ml of alcohol to each 850 ml of distillate, and thorough mixing. It has a tannins limit of 0.03 mg tannic acid per ml, a pH between 3.0 and 5.0, and alcohol content of
Pharmacopoeia Helvetica VII (1987)
Hamamelidis Extractum Liquidum Normatum. Syn. Extractum Hamamelidis folium alcohol content
II.1.2 Information on period of medicinal use in the Community regarding the specified indication
Witch hazel preparations have a long history of traditional use in North America. The bark aqueous infusion was used in aboriginal medicine to treat haemorrhages, inflammations and haemorrhoids (Millspaugh, 1974). Pharmacopoeias and handbooks list the therapeutic uses as an astringent and anti- inflammatory product for the treatment of minor skin injuries, local inflammation of skin and mucous membranes; for bruises and localized inflamed swellings; to treat vascular disorders including hemorrhoids, varicose veins, phlebitis and other conditions associated with poor venous tone or congestion; menorrhagia and metrorrhagia; diarrhea; as a protective against oxidative stress and ultraviolet radiation. Mainly Hamamelidis aqua has been reported in medicinal use for many decades.
The decoction was used in poultices for painful swellings and tumours (Grieve, 1979). The alcoholic fluidextract form became official in the United States Pharmacopoeia in 1882 (Millspaugh, 1974). Native Americans applied poultices of hamamelis leaves and barks as a remedy for haemorrhoids, wounds, insect bites, painful tumours and ulcers (Duke, 1985). Today, the external use of witch hazel is well known for the astringency associated with the tannin content of its leaves and bark. In Europe, tannin rich witch hazel extracts made from the leaf and bark are used.
K. Hering
In folk medicine, the drug is used in menorrhagia and dysmenorrhea as a haemostatic, and there are similar uses in homeopathy. Total extracts, such as hamamelis extracts or distillates from flowering branches freshly collected (“hazeline” witch hazel water), dry extracts of the leaves (“green hamamelin” and bark (“brown hamamelin”) are applied in the form of infusions, ointments, or suppositories, far more often than herbal teas made from the leaves or bark. Therapeutically, they are used for their astringent, antiseptic and haemostatic properties, and especially as venotonic, properties which have been demonstrated in animal experiments (Wichtl, 1994).
An hamamelis ointment containing a distillate of leaves and bark, has been commercially available in Germany since 1878 (Gäble, 1978).
The British Pharmacopoeia of 1932 included a monograph on Extractum Hamamelidis Liquidum. This liquid extract was obtained by percolation of 1000 g of moderately coarse powder hamamelis and alcohol 45%. The final ethanol content was 32 to 40% V/V and the recommended dose: 2 to 4 ml.
The medicinal use of hamamelis has been reported by Gathercoa & Wirth, 1936 (WHO monographs, 2002).
The herbal substance and some herbal preparations of hamamelis have also been mentioned in Hager’s Handbuch (List and Horhammer,
The alcoholic fluid extract (Witch Hazel water distillate (1:2) became official in the United States Pharmacopoeia in 1882 (Millspaugh, 1974). The FDA has approved as an OTC drug “witch hazel water”, made from the steam distillate of the twigs containing about
In USA witch hazel is used in several OTCs in astringent and haemostatic preparations in combination with Aloe.
An alcoholic tincture (1:10 w/v, in 55% ethanol V/V) of the bark, including the root bark, is classified in the Homeopathic Pharmacopoeia of the United States as an OTC Class C drug (HPUS, 1992), as well.
Witch hazel does not have GRAS status. However, it is freely available as dietary supplement in the USA under DSHEA legislation (1994 Dietary Supplement Health and Education Act).
Witch hazel has been defined as an astringent active ingredient in OTC skin protecting medical products, for relief of minor skin irritations due to insect bites, minor cuts, minor scrapes and in OTC anorectal products. These OTC products, in a suitable form for topical administration, are generally recognized as safe and effective. The FDA, however, advises “that based on evidence currently available, there is inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses” (USP 30/ NF 25, 2007).
Hamamelis virginiana L. preparations are used in cosmetics (skin lotions, nourishing creams, pre- and
II.1.2.1 TYPE OF TRADITION, WHERE RELEVANT
American traditional medicinal use: Witch hazel distillate from twigs is official in the United States Pharmacopoeia- National Formulary
European traditional use: Witch hazel leaf is official in European Pharmacopoeia since 1997. ESCOP monographs, 2003.
II.1.2.2 EVIDENCE REGARDING THE INDICATION/TRADITIONAL USE
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, 2007)
Hamamelidis distillate, 10%: “Temporary relief of eye irritation or discomfort due to various causes (smoky atmospheres, sustained visual effort, swimming in the sea or swimming baths, etc)”. Hamamelidis distillate (1:1.6) 5% Ointment: “Temporary relief of haemorrhoids symptoms”
Afssaps Avis aux fabricants… Bulletin officiel nº 86/20 bis (1986); (1990)
Hamamelis virginiana leaf (feuilles d´hamamélis, feuilles du noisetiere la sorcière): Listed in Médicaments à base de plantes.
Nº 7: “Traditionally used in subjective symptoms of chronic insufficiency such as sensation of heavy legs and in haemorrhoids symptoms”.
Nº 16: Traditionally used as a gargle in inflammation of the mouth and throat.
Afssaps monograph : cahiers de l’Agence n° 3(1998)
Hamamelis virginiana leaf (feuilles d´hamamélis, feuilles du noisetierde la sorcière): Listed in Médicaments à base de plantes.
“Traditionally used in subjective symptoms of chronic insufficiency such as sensation of heavy legs and in haemorrhoids symptoms”.
“Traditionally used in the case of eye irritation or discomfort due to various causes (smoky atmospheres, sustained visual effort, swimming in the sea or swimming baths, etc)”.
British Herbal Medicines Association, British Herbal Compendium Vol II (2006)
Hamamelis bark (Hamamelidis Cortex)
Indications: None adequately substantiated by pharmacological or clinical studies. Uses based on experience or tradition.
External: Small wounds, skin injuries and bruises, local inflammation of skin and mucous membranes; haemorrhoids and varicose veins complaints.
Internal: Diarrhoea, mucus colitis, haemorrhoids.
Regulatory status in UK: Medicinal products are accepted for general sale, internal or external use. Permitted by Council of Europe as food flavouring, category N3 (this category indicates that there is insufficient information available for an adequate assessment of potential toxicity).
Hamamelis leaf
Indications: None adequately substantiated by pharmacological or clinical studies. Uses based on experience or tradition
External: Minor skin injuries, local inflammation of skin and mucous membranes, bruises; varicose vein complaints and haemorrhoids.
A hamamelis leaf extract (not defined) appears to be beneficial in the topical treatment of dermatitis atopica.
Internal: Diarrhoea, colitis.
Regulatory status in UK: Medicinal products are accepted for general sale, internal or external use.
Permitted by Council of Europe, as food flavouring, category N3.
Hamamelis water
The BPC 1973 monograph and the USP monograph for witch hazel water are broadly similar. Indications: None adequately substantiated by pharmacological or clinical studies. Uses based on experience or tradition: hamamelis water is used to alleviate minor affections of the skin such irritation, roughness, or soreness. It has also been employed when diluted, as a constituent of eye lotions.
Topical use: Minor sores, inflammation or irritations of the skin such as cuts, grazes, insect bites, dermatitis, slight burns or scalds and sunburn; bruises and sprains, muscle pains; external haemorrhoids, varicose vein complaints; as a mouthwash for inflamed mucosa or bleeding gums; as a nasal plug for nosebleeds; as an eyewash for conjunctivitis and sore or tired eyes.
Regulatory status in UK: Medicinal products are accepted for general sale, internal or external use. Food: Not used in foods. Witch hazel is not on the UK General Sale List.
British Herbal Pharmacopoeia (1983)
Hamamelis leaf indications: Diarrhoea, mucus colitis, haematemesis, haemoptysis, haemorrhoids. Topical bruises, localised inflamed swellings.
British Pharmaceutical Codex (1973)
Witch hazel leaf
Actions and Uses: hamamelis has astringent properties and its preparations are used in the treatment of haemorrhoids. It is used in toilet preparations.
Preparations: Hamamelis dry extract BPC; Hamamelis liquid extract BPC; Hamamelis ointment, BPC; Hamamelis suppositories.
Hamamelis water.
Uses: Hamamelis water is used to alleviate minor affections of the skin such irritation, roughness, or soreness. It has also been employed when diluted, as a constituent of eye lotions.
German Drug Codex (1986)
Witch hazel is listed in the German Drug Codex, approved in the Commission E monographs, and the tea infusion is officially included in the standard license monographs (Banz, 1998; Braun et al, 1997; DAC, 1986; Wichtl and Bisset, 1994). Witch hazel leaf and bark have been used in some haemorrhoidal teas and
Hamamelis herbal medicinal products are traditionally used in the form of herbal tea, as astringent in supportive therapy for acute diarrhoea, as a gargle in inflammation of the mouth and throat, especially when accompanied by inflammation of the gums.
In folk medicine the drug is used in menorrhagia as a haemostatic and in dysmenorrhoea, and there are similar uses in homeopathy. Extracts (of the leaves and bark) and distillates are applied in the form of infusions, ointments, or suppositories, far more often than teas, for their astringent, antiseptic and haemostatic properties, and especially for their ability to increase blood vessel tonus. It is used against haemorrhoids, varicose veins, local inflammation of the mucous membranes with swelling and superficial skin damage, and in body and face lotions (Bisset et al, 1994).

USP 30/ NF 25 (2007)
Witch hazel has been defined as an astringent active ingredient in OTC skin protectant drug products for relief of minor skin irritations due to insect bites, minor cuts, minor scrapes and OTC anorectal products. These OTC products in a suitable form for topical application are generally recognized as safe and effective. The FDA, however, advises “that based on evidence currently available, there is inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses”.
ESCOP Monograph (ESCOP, 2nd ed. 2003)
Hamamelis water Therapeutic indications:
External use: “Treatment of bruises, skin irritations, sunburn, insect bites, external haemorrhoids. Minor inflammatory conditions of the skin and mucosa”.
Hamamelis bark Therapeutic indications:
Internal use: “Inflammations of mucous membranes of the oral cavity”. “Short term symptomatic treatment of diarrhoea”
External use: “Haemorrhoids, minor injuries and local inflammations of the skin”
“Symptomatic treatment of problems related to varicose veins, such as painful and heavy legs”.
Hamamelis leaf Therapeutic indications:
Internal use: “Symptomatic treatment of complaints related to varicose veins, such as painful and heavy legs, and of haemorrhoids”.
External use: “Bruises, sprains and minor injuries of the skin, local inflammations of the skin and mucosa, haemorrhoids, relief of symptoms of neurodermitis atopica and feeling of heavy legs”.
Commission E Monograph (1985, correction 1990)
Witch hazel leaf and bark (Hamamelisblätter und
Witch hazel leaf and bark are covered by positive Commission E monographs and both have the following applications: “Mild damage to the skin (minor skin wounds), local inflammation of the skin and mucous membranes, haemorrhoids and varicose veins.”
WHO Monographs on selected medicinal plants. Volume 2 (World Health Organization, 2002)
Folium et Cortex Hamamelidis.
Medicinal uses supported by clinical data: Topically for minor skin lesions, bruises and sprains, local inflammation of the skin and mucous membranes, haemorrhoids and varicose veins.
Uses described in pharmacopoeias and in traditional systems of medicine: Topically as a haemostat.
Uses described in folk medicine, not supported by experimental or clinical data: Treatment of colitis diarrhoea, dysentery, dysmenorrhoea, eye inflammations, haematuria, kidney pains, neuralgia, nosebleeds and excessive menstruation, and as tonic.
Martindale, The complete drug reference (35th edition, 2007)
Hamamelis, Witch hazel, Amamelide.
Hamamelis has astringent properties. It is used in preparations for the symptomatic relief of haemorrhoids. Hamamelis water is used as a cooling application and has been applied as a haemostatic.
Hamamelis from various parts of the plant is used in herbal or homeopathic preparations for a variety of disorders.
Hamamelis water:
Includes references to different preparations of Witch hazel 50%, with glycerine, water, or aloe barbadensis, as astringent products suitable for external use in case of haemorrhoids.
A product for insect bites/stings which contains Witch hazel distilled 100% and some astringents, is used for the relief of pain and swelling caused by insect bites.
Handbook of
Therapeutic uses: Witch hazel has been used both externally and internally although it is currently recommended only for external use.
Dosage and Administration Guidelines: Witch hazel preparations are applied topically, as needed for the described disorders.
Safety: Oral use may cause stomach irritation and liver damage. Topical use may result in contact dermatitis.
Most commercially available Witch hazel preparations are mixture of alcohol 14% in water with only a trace amount of the volatile water.
Clinical evidence: Little clinical trial data are available. Witch Hazel’s astringent effects are useful for treating minor skin injuries and relieving the itch, irritation, and pain of haemorrhoids and after anal surgery.
Table 1. Summary of Indications (short description)
II.1.2.3 EVIDENCE REGARDING THE SPECIFIED STRENGTH /POSOLOGY
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS, information, 2007)
Hamamelidis distillate 10%, eye drops: Single dose 2 drops/each eye,

British Herbal Medicines Association, British Herbal Compendium Vol II (2006)
Hamamelis bark (Hamamelidis cortex)
External use:
Internal use: Tincture,
Hamamelis leaf
External use, hamamelis ointment BPC 1973 (10% by weight of hamamelis liquid extract BPC 1973 in an ointment base);
Local use for mouthwashes: as a decoction of
Hamamelis suppositories BPC 1973 (200 mg of hamamelis dry extract BPC 1973 in a suitable base) or, more generally, suppositories containing the equivalent of
Internal use, three times daily: dried leaf, 2 g or by infusion; hamamelis liquid extract BPC 1973 (1:1, 45% ethanol),
Hamamelis water
Topical use: undiluted hamamelis water for applications to cuts, grazes, insect stings, other skin complaints and haemorrhoids, as a mouthwash, and in a saturated cotton wool swab as a nasal plug for nosebleeds, or to place over eyelids; for compresses, undiluted or diluted 1:3 with water; in
As an eyewash use diluted hamamelis water, 10 drops to an eyebath
German Drug Codex (1986)
Hamamelis folium (Hamamelisblätter. DAC 86; Wichtl and Bisset, 1994). Preparations: Suppositoria Hamamelidis
Herbal tea preparation (decoction)
Liquid extract (1:1) Ethanol 45%, 3 times daily,
Hamamelidia aqua (Hamamelisrindenwasser); Aqua Hamamelidis corticis (Monographiensammlungen:
Preparations: Unguentum Hamamelidis (Hamamelissalbe, EB.6), according to Pharmacopoeial grade (DAC, 1986; Wichtl and Bisset, 1994)
British Herbal Pharmacopoeia (1983)
Adults and elderly: Dried hamamelis leaf 2 g (or by infusion) three times daily.
Liquid extract 1:1 in 45% alcohol. Dose
Hamamelis water BPC for local application.
ESCOP Monograph (ESCOP, 2nd ed. 2003)
Hamamelis water
For compresses: hamamelis water undiluted or diluted 1:3 with water; in semisolid preparations,
For mucosa: hamamelis water undiluted or diluted with water, several times daily.
Hamamelis bark
Internal use:
Other preparations: the equivalent of
Extracts in
Hamamelis leaf
Internal use:
External use: Extracts in
It has to be noted that the ESCOP Monograph considers only the available data on Hamamelis virginiana L. preparations as a single ingredient.
Commission E Monograph (1998)
Internal use: (mucous membranes): Several times daily, corresponding to
External use: Water steam distillate (witch hazel water) undiluted or diluted 1:3 with water. Extracts in
Decoctions,
For poultices,
WHO Monographs on selected medicinal plants. Volume 2 (World Health Organization, 2002)
External use: steam distillate, undiluted or diluted 1:3 with water to make poultices;
Extracts: in semisolid and liquid preparations corresponding to
Rectal suppositories,
Other preparations, several times daily, corresponding to
Posology in children
Good tolerance and lack of adverse effects have been reported for hamamelis ointment (Hametum) for temporary relief of minor skin injuries such as diaper skin rash, nevertheless such kind of treatment should be monitored by medical supervision to avoid other clinical complications (Candida infections).There are not adequate clinical data on the paediatric use of other hamamelis preparations.
Elderly: Same posology as recommended for adults.
Table 2. Summary of recommended Posologies.
External use:
1.Skin/mucosae (irritation/inflammation). Wounds. Insect bites.
2.Haemorrhoids
3.Heavy legs/varicose veins. Bruises
4.Gargle & mouth & throat
5.Eye irritation/eye lotion
Internal use:
6.Diarrhoea/colitis
7.Haemorrhoids
8.Heavy legs/varicose veins. Bruises
9.Menorrhagia. Dysmenorrhoea
10.Nosebleed
II.1.2.4 EVIDENCE REGARDING THE ROUTE OF ADMINISTRATION
The oromucosal, cutaneous and rectal applications, have been proposed for hamamelis preparations in the recommended traditional indications.
II.1.2.5 EVIDENCE REGARDING THE DURATION OF USE
It is recommended not to take oral preparations for more than 1 month. In case of external application, it might be used for a longer time.
II.1.2.6 OVERALL CONCLUSION ON THE TRADITIONAL MEDICINAL USE
Based on the information obtained from Member States and the literature search, it can be concluded that the following extracts and uses fulfil the criteria for traditional use:
Hamamelis water:
1)Distillate prepared from fresh leaves and bark (1:
2)Distillate prepared from dried twigs (1:2; ethanol
A)Traditional Herbal Medicinal Product for relief of minor skin inflammation and dryness of the skin. Distillates (1, 2) in a strength corresponding to
External use
B) Traditional Herbal Medicinal Product for the temporary relief of discomfort due to dryness of the eye or to exposure to wind and sun. Eye drops: Distillate (2) diluted (1:10), 2 drops each eye, 3 to 6 times a day.
External use
A)Traditional Herbal Medicinal Product for relief of minor skin inflammation and dryness of the skin. Tincture in a strength corresponding to
Dry extract in a strength corresponding to 1.3% in
B)Traditional herbal medicinal product for symptomatic relief of itching and burning associated with hemorrhoids.
Tincture in a strength corresponding to
Suppositories containing 66 mg of dry extract
C)Traditional Herbal Medicinal Product for (mouthwash and gargles) relief of minor inflammation of mucous membranes of the oral cavity.
Hamamelis leaf:
Dried comminuted herbal substance for herbal tea
–Tincture (fresh leaf) (1:10; ethanol 45% v/v)
–Liquid extract (fresh leaf) (1:1; ethanol 45% v/v)
–Liquid extract (dried leaf) (1:1; ethanol 30% m/m)
–Liquid extract (dried leaf) (1:2; ethanol 60% v/v)
A)Traditional herbal medicinal product for relief of minor skin. inflammation and dryness of the skin. Tincture or liquid extracts (1:1) in a strength corresponding to
Liquid extract (1:2; ethanol 60% V/V) in a strength corresponding to 20% as
B)Traditional herbal medicinal product for symptomatic relief of itching and burning associated with hemorrhoids.
Tincture or liquid extracts in a strength corresponding to
Liquid extract (1:2; ethanol 60% V/V) in a strength corresponding to 20% as a
Comminuted herbal substance as decoction:
Suppository containing 400 mg of liquid extract (1:2; ethanol 60% v/v),
C)Traditional Herbal Medicinal Product for (mouthwash and gargles) relief of minor inflammation of mucous membranes of the oral cavity.
Tincture (1:10) in 45% ethanol (diluted (1:3) with water)
II.2.1 Pharmacology
Venotonic activity
Hamamelis has been used as venoconstrictor substance but there are not well performed experimental tests to demonstrate this effect. Balansard et al (1970) described a method derived from the technique of
The venotonic effects of leaf preparations (steam distillate, tincture or alcohol extract) were tested by measuring the blood supply to the rear paw of rabbits (Bernard, 1972).
Neugebauer (1948) studied the similarity of effects between Hamamelis virginiana and Corylus avellana. For monitoring the haemostatic effect determined the bleeding time for the rabbit ear according to the method of Fleisch and Tripod. The preparations studied had an ethereal oil content of 0.015% on average, and manufactured by distillation from fresh leaves previously treated with alcohol and water. Both the distillate and the ethereal oil produced a positive reduction in bleeding time and an acceleration of blood coagulation, as demonstrated by experiments with the
Vasoconstrictor activity
A randomized, placebo controlled study assessed the vasoconstrictive effects of an aqueous propylene glycol extract of hamamelis in 30 volunteers. The hamamelis extract used was a hydroglycolic extract (water/propylenglycol 50:50), obtained from hamamelis leaves. A thermometric method is proposed in this study. The extract produced a significantly reduction in skin temperature as compared with the placebo (Diemunsch and Mathis, 1987).
Astringent activity
Hamamelis leaves and bark contain tannins. Although tannins may be responsible for the astringent and styptic properties, the distilled product contains almost no active tannins. Alcohol provides the astringent effect. When applied to broken skin or mucous membranes, hamamelis products induce protein precipitation that tightens up superficial cell layers and shrinks colloidal structures. This action, in turn, causes capillary vasoconstriction, decreasing vascular permeability and inflammation (Lamont Hume and Strong, 2006).
In vitro experiments
The phenolic constituents of hamamelis, particularly the tannins (e.g. hamamelitannin), aldehydes and oligomeric proanthocyanidins are responsible for its astringent activity. Similar to other astringent drugs, application of hamamelis preparations to the skin and mucosa in low concentrations sealed cell membranes and reduced capillary permeability. Higher concentrations precipitated proteins and thickened colloidal tissue, forming a thin membrane in the wound region, and slightly compressed the skin tissue
beneath it. Alcohol hamamelidis extracts showed strong astringent action, the bark extract is slightly superior to the leaf extract (Laux, 1993, Vennat 1988, Hänsel 1993)
The astringent effect of a tincture (1:3; 62% ethanol) prepared from fresh hamamelis bark was demonstrated with hide powder (Gracza, 1987)
In vivo experiments
The healing effect of hamamelis distillate was compared with hydrogen peroxide on skin damaged by application of dichlorodiethyl sulfide (mustard gas) in various animal models. The distillate was more effective than hydrogen peroxide in reducing the occurrence of pus in the affected skin areas. Furthermore, subsequent treatment of the purulent skin areas with a 20% Hamamelidis ointment reduced the incidence of suppuration as compared with hydrogen peroxide treatment.
Hamamelis extracts and isolated chemical constituents have shown
In vitro experiments
In the
According to Deters et al (2001), polysaccharides and proanthocyanidins from hamamelis bark could influence on human skin keratinocyte proliferation and differentiation of cultured human keratinocytes, and influence on irritated skin. While the polysaccharide fraction, consisting mainly of arabinans and arabinogalactans, did not have effect human keratinocytes, the proanthocyanidins strongly increased the proliferation of the cells, while the differentiation was not influenced significantly. Within a preliminary cumulative in vivo study on
In vivo experiments
A aqueous ethanolic extract of hamamelis bark (ethanol 70%) showed a significant
potential and the inhibition of
Studies by Brown and Dattner (1998), presented witch hazel preparations as useful in the treatment of atopic dermatitis or pruritus (Millikan et al, 2003).
The aqueous ethanolic extracts of Polygonum bistorta L., Guaiacum officinale L. and Hamamelis virginiana L. were screened for their
In vitro Antibacterial activity
An aqueous extract of the leaves of hamamelis inhibited the growth of Escherichia coli (MIC 0.4 mg/ml),
Staphylococcus aureus (MIC 0.4 mg/ml), Bacillus subtilis (MIC 1.1mg/ml) and Enterococcus faecalis
(MIC 3.0mg/ml). Aqueous extracts of the bark inhibited the growth of Escherichia coli, Staphylococcus aureus, Bacillus subtilis and Enterococcus faecalis (MIC for all 10.0 mg/ml) (Brantner et al, 1994, WHO monograph).
The antimicrobial activity of a distillate of Aqua Hamamelidis (USP) (90%) and urea (5%) formulated as a topical dermatological preparation was studied in vitro by the agar diffusion test showed inhibition of Staphylococcus aureus and Candida albicans, among other organisms. Comparison with earlier studies of chlorhexidine digluconate and fuchsine, hamamelis distillate and urea were relatively weak. (Leyden et al, 1979).
Lauk et al (2003), studied the antibacterial activity of some medicinal plant extracts against periodontopathic bacteria, such as: Porphyromonas gingivalis, Prevotella ssp, Fusobacterium nucleatum, Capnocytophaga gingivalis, Veilonella parvula, Eikenella corrodens, Peptoscoccus micros and
Actinomyces odontolyticusamong which the methanol extract of H. virginiana was shown to possess an inhibiting activity (MIC≥2048 mg/L) against all the tested species except for Prevotella sp.
Antiviral activity
Hamamelitannin and proanthocyanidins obtained from a hydroethanolic extract of Hamamelis virginiana L., bark subjected to ultrafiltration exhibited in vitro antiviral activity against Herpes simplex virus type
Radical scavenging effects
The activity of
Hamamelitannin inhibited the production of superoxide anion radicals (IC50 1.38 µmol/l) and hydroxyl radicals (IC50 5.46 µmol/l) in murine dermal fibroblasts, as measured by electron spin resonance spectrometry and showed significant protective activity at minimun concentrations of 50 µM, while the corresponding figure for gallic acid was 100 µM.
values, which represent the concentration giving 50% inhibition of active oxygens generated, was evaluated by ESR
Hamamelitannin exhibits potent
The extracts (leaf and bark) were extracted with ethanol 50%, and the bark extract showed higher activity than the leaf one. The study confirmed through further isolations procedures that the
Witch hazel (Hamamelis virginiana L.) bark extract and hamamelitannin, the major active component of witch hazel bark, were shown to possess a strong ability to scavenge peroxynitrite
Touriño et al (2008) showed that Hammamelis virginiana L. bark is a rich source of tannins. They, by extraction and solvent fractionation, generated fractions rich in
The mixtures were highly active as free radical scavengers. The antiradical efficiency of the fractions was evaluated by the DPPH stable radical method (hydrogen donation and electron transfer) and HNTTM (electron transfer). These fractions were also able to reduce the newly introduced TNPTM radical, meaning that they included some highly reactive components. Witch hazel phenolics protected red blood cells from free radical
The abundance of pyrogallol groups appears to play a major role in the antioxidant/prooxidant effects os hamamelis phenolics (Touriño et al, 2008).
Tumour necrosis
The effect on
The protective effect of hamamelitannin was comparable with that of a related compound epigallocatechin gallate while gallic acid was a weak protective agent (<40% protection). The cytoprotection assay (Habtemariam et al, 1997) has been used to study the effect of protective agents (hamamelitannin, gallate or epigallocathechin gallate) on
mediated cytolysis was: hamamelitannin> epigallocathechin gallate > gallate. These data are in agreement with previous reports which revealed that compounds with catecholic functional moeity could inhibit the

Assessor’s comments
Most of the tests have been performed on pure isolated components of hamamelis such as: hamamelitannin, polyphenols, proanthocyanidins and gallic acid.
Venotonic, astringent, antibacterial, antiviral, antioxidative and scavenging mainly in vitro activities have been reported.
The in vivo
II.2.2 Pharmacokinetics
According to the definition of HMP, the total preparation (e.g: Hamamelidis destillatum) must be regarded as the active substance. This involves a mixture of numerous constituents. The active constituents have not yet been clearly defined and many compounds are only contained in very small concentrations or defy analytical detection due to their chemical structure or their ubiquitous occurrence (polymeric phenols) No single constituent has been defined as therapeutically active marker and consequently, no appropriate pharmacokinetic studies are available.
Witch hazel extracts locally applied in therapeutic amounts do not penetrate into the deeper layers of the skin because of the astringency of their ingredients, and they are therefore not absorbed into the blood circulation (Fachinfo Posterine ® Salbe, 1997)
II.2.3 Toxicology
Hamamelis virginiana L. distillate was one of the substances studied in the Carcinogenesis Bioassay Program by the National Toxicology Program of the National Cancer Institute in 1981; thus relatively reliable data on hamamelis can be found both in original articles and extensive analyses of this program (Haseman et al, 1984, 1987; Woodruff et al, 1985).
Acute and subchronic toxicity
The oral administration of
The i.v. administration of different aqueous solutions of a liquid extract of Hamamelis (unknown declaration)
Genotoxicity
Mortelmans et al (1986) included data of Salmonella mutagenicity results of 270 coded chemicals, encompassing 329 tests performed by three laboratories under contract to the NTP. The Salmonella/ mammalian microsome assay was used to test chemicals in up to five strains TA1535; TA1537; TA98; TA100 in the presence and absence of rat and hamster liver S9. Tests performed after Jan 1983 included the strain TA97 replacing TA1537. Hamamelis water was negative in all tests.
In a study by McGregor et al (1988), eighteen chemicals were tested for their mutagenic potential in the L5178Y tk+/- mouse lymphoma cell forward mutation assay. Cultures were exposed to the chemicals for 4h, and cultured for 2 days before plating in soft agar with or without trifluorothymidine (TFT),
3 μg/ml. The chemicals were tested at least twice. Witch hazel was not identified as a mutagen. [PMID: 3338442, PubMed – indexed for MEDLINE]

Witch hazel was evaluated for the induction of
Carcinogenicity
The results of approximately 86 chronic studies in rodents were published as technical repots by Huff et al (1984, 1985). The studies consist in two years feeding or gavage experiments involving groups of 50 male and female Fischer
Hamamelis water
Antimutagenic activity
In the Ames mutagenicity test, a tincture (1:5) and a methanolic extract (1:5) of hamamelis bark dose dependently inhibited
Reproductive and development toxicity.
There is not information on reproduction toxicity.
II.2.3.1 OVERALL CONCLUSIONS ON TOXICOLOGY
Limited information is available on toxicology of herbal preparations of hamamelis. Details of the preparations used in the studies reported are usually lacking. There are only few studies with Hamamelis virginiana L. distillate, fractions of hamamelis preparations and isolated compounds such as hamamelitannin.
Reliable data from tests on genotoxicity are only available for Hamamelidis aqua preparations, which are devoid of genotoxic activity. Although the definite carcinogenicity NTP study has not been formally reported, it can be provisionally concluded that hamamelis water is not carcinogenic. Nevertheless, according to the studies of hamamelis water preparations, the external application of hamamelis water probably poses a very low or absent genotoxic or carcinogenic risk.
The safe use of hamamelis distillates has been accepted by the MLWP and HMPC, taking into account the data in the AR toxicology section (II.2.3) and all available data for the therapeutic indications for cutaneous use as well as the
II.3 | CLINICAL DATA |
II.3.1 Clinical Pharmacology
II.3.1.1 PHARMACODYNAMICS
Although Hamamelis virginiana L. has long been used in the traditional treatment of skin diseases, there are few controlled clinical studies defining the extent of its
Topical herbal drugs have for centuries been used for treating skin ailments. Although they are currently widely accepted by patients, their scientific esteem among dermatologists in particular is limited. In a review of the efficacy and safety of
In a randomized, placebo controlled study Sorkin (1980) assessed the vasoconstrictive effects of an aqueous propylene glycol extract of hamamelis in 30 healthy volunteers. The extract produced a reduction in skin temperature as compared with the placebo. The
Fluvography involves the measurement of the thermal conductivity of the skin, this being as a factor in linear proportion to skin circulation. Fluvography measurements indicated that in both groups the ointment reduced the thermal conductivity of the skin due to vasoconstriction, suggesting a mild anti- inflammatory activity. These data were confirmed by
The
Erythema 4 to 8 h after the stripping of the horny layer was suppressed by hydrocortisone 1% (P≤ 0.05). Inflammation was also less pronounced following lower dose hamamelis
As expected, the results have demonstrated the
The
The
Eighteen subjects underwent the dithranol (anthralin) irritation test for 3 days. An erythema was produced by application of 1% dithranol for 10 minutes. The product containing hamamelis against the product without hamamelis, and one site untreated. Cutaneous blood flow (Laser Doppler) and skin redness chromameter were determined at baseline and after 3 days.
In both irritation models, hamamelis produced significant reductions in cutaneous blood flow and skin redness compared with the vehicle. In the SLS irritation test, TEWL and stratum corneum water the effects were mainly due to the vehicle that contained both glycerol and urea. Hamamelis USP was ineffective on all measures. Hydrocortisone 1% had similar effect on cutaneous blood flow and had also significant hydrating effect. The vehicle in the formulation is fundamental for having an effective product. (Gloor et al, 2001).
Clinical trials data regarding the efficacy in eczema patients are conflicting (Swoboda et al, 1991; Korting et al, 1995). However it has been possible to demonstrate a beneficial effect of hamamelis preparations in inflammation induced by UV light (Korting et al, 1993,
Vasoconstriction
A randomized, placebo controlled study assessed the vasoconstrictive effects of an aqueous propylene glycol (water/propylenglycol 50:50) extract of hamamelis leaves in 30 volunteers in three arms. A thermometric method is proposed in this study. The extract produced a significant reduction in skin temperature as compared with placebo (Diemunsch & Mathis, 1987).
Antimicrobial activity
The antimicrobial activity of a distillate of Hamamelis (Aqua Hamamelidis), United States Pharmacopoeia (USP) 23, and urea (5%) formulated as a topical dermatological preparation was studied. The study was conducted in 15 healthy volunteers. In vivo, the occlusion and expanded flora tests produced consistent results. The occlusion and expanded flora tests were described by Leyden et al (1979). The occlusion test involved the application of a commercial water impermeable cling film, following the test solution application, having it in place for 24 hours and then the bacteriological test was performed. The expanded flora test involved
The distillate showed significant antimicrobial activity on aerobes. The simple occlusion test showed the same tendency, but results were not significant. Formulations of hamamelis distillate and urea are mainly used for their
Typical symptoms of skin aging are tautness and itching, which may eventually lead to exsiccation eczema. This study investigated the safety and efficacy of hamamelis ointment for skin care and symptom relief in patients with dry aging skin.
An

II.3.1.2 PHARMACOKINETICS
No data available.
II.3.2 Clinical Efficacy3
Eczema
Hamamelis preparations could be proposed in the maintenance therapy for atopic eczema, particularly as follow up to treatment with steroidal
A randomized double blind comparison study assessed the efficacy of ointments containing either a standardized extract of the dried leaves or bufexamac in the treatment of 22 patients with bilateral, moderately or severe endogenous eczema. Patients were treated three times daily for an average of 17 ± 5 days (Treatment duration between 5 to 22 days). Comparison of the patients’ forearms showed that both treatments reduced the severity of symptoms such as desquamation of the skin, redness, itching, infiltration and lichenification, with desquamation showing the highest reduction (55%). No differences were observed in the global assessment of the therapy or the severity of symptoms between treatments (Swoboda et al, 1991).
A randomized,
3 In case of traditional use the longstanding use and experience should be assessed.
Wilkinson’s test. All treatments significantly reduced the incidence of itching, scaling and erythema after 1 week of treatment. Hydrocortisone proved superior to hamamelis distillate. The cream containing hamamelis distillate did not differ from the vehicle. The results showed that the therapeutic outcome using the hamamelis preparation was not better than following the base preparation (Korting et al, 1995).
A case of accidental skin injury caused by leakage of sodium hypochlorite solution from the rubber dam during root canal preparation is reported. The patient developed a skin rash followed by scab formation which required medical treatment with topical Hamamelis virginiana extract for 2 weeks, with full recovery (Ahmet et al, 2004).
The efficacy of two hamamelis ointments (differing only in the ointment base) containing 25 g aqueous distillate/100 g ointment base (equivalent to about 4 g drug), for the treatment of endogenous eczema (neurodermatitis) and toxic degenerative eczema (attrition eczema) was compared in a placebo controlled, double blind study (the placebo was not described) in 80 patients. Symptomatic improvements in itching, redness, burning sensation and desquamation of the skin were observed in 36 patients after 28 days of treatment with endogenous eczema with both hamamelis preparations after treatment for 39 days (Pfister, 1981).
In a pilot study of 37 patients with endogenous eczema a cream containing a hamamelis leaf extract was applied twice daily for two weeks. Following treatment, considerable improvement in symptoms like such as inflammation and itching was noted in 24 patients (Wokalek, 1993)
In a multicenter, prospective paediatric cohort study on the efficacy and tolerability of hamamelis ointment, children of different age groups (27 days to 1 year; 1 to 5 years; 6 to 11 years of age) suffering from superficial skin lesions/ diaper skin rash/ or other local inflammations of skin and mucous membranes were treated in a randomized manner at a ratio of 3:1 with either an hamamelis ointment and dexpanthenol. The recommended individual observation was 7 to 10 days; dosage was based on the recommendations of the treating physician.
309 patients were enrolled into the study (hamamelis ointment: 231; dexpanthenol: 78). Both therapeutic groups showed comparable initial values. The efficacy of both therapeutic treatments could be proven for all three diagnoses with statistically significant and clinically relevant improvement of the total score between the beginning and the end of treatment (p< 0.0001 in each case). Within the three age groups, the total score for the skin diseases investigated improved in both therapeutic treatments without statistically relevant differences between the comparative cohorts. In total, 83.5% of the doctors and 83.1% of the parents considered the efficacy of hamamelis ointment as excellent or good (Dexpanthenol: 83.3% and 80.7%). Tolerability of hamamelis ointment was assessed as excellent or good by 99.1% of the doctors and 98.2% of the parents (Dexpanthenol: 97.4% and 92.3%).
Hamamelis ointment could be considered effective and safe as a temporary treatment for certain skin disorders in children up to 11 years of age in minor skin injuries, diaper dermatitis, or localized inflammation of skin (Wolff et al, 2005). Regarding the safety in this study: 12 out of 309 children experienced adverse events, 1 out of 78 in the dexpanthenol treatment (conjunctivitis) and 11 out of 231 in the hamamelis treatment group (confusion, head lice, cough/allergic reaction, fungal infection/deterioration, otitis, erythema increased, rhinopharyngitis, burning sensation,
Antihemorrhoidal efficacy
Witch hazel extracts, high in tannins and volatile oils, have a long therapeutic tradition and are used primarily for its astringent,
A randomized double blind three limb study, of 21 days duration, compared the efficacy of rectal ointments containing either a hamamelis liquid extract, bismuth subgallate or a local anaesthetic in the treatment of 90 patients with acute stage 1 haemorrhoidal symptoms. The local anesthetic was presented in two control ointments which also contained either policresulen or fluocinolone acetonide. After 21 days of treatment, all four ointments were equally effective in improving: pruritus, bleeding, burning sensation and pain. All three ointments proved highly effective. Both during the course of treatment and at the final examination; no major differences were to be found between the three groups (Knoch 1992; Barnes et al, 2007).
The study of Steinhart (1982) considered
Episiotomy pain
In a randomized clinical trial involving 300 mothers patients undergoing episiotomy, the efficacy of three topical agents (Epifoam, hamamelis water and ice) was investigated to determine their effects on pain, bruising and oedematous swelling. Data were collected in 266 women for immediate postnatal evaluation. The treatment tested were local application of a cream containing hamamelis water BPC 1973; a reference cream containing 1% hydrocortisone and a local anesthetic (Epifoam); and ice packs. All three agents were equally effective at achieving on the first day though
East et al (2007) reviewed in Cochrane database the published and unpublished randomised or quasi randomised trials (RCTs) that compared localised cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth. Seven published RCT were included, comparing local cooling treatment (ice packs, cold gel pads or cold/iced baths) with no treatment, hamamelis water, Pulse electromagnetic energy (PET), a hydrocortisone/pramoxine foam (Epifoam) or warm baths. The RCTs reported on a total of 859 women. Ice packs improved pain relief 24 to 72 hours after birth compared with no treatment. Woman preferred the utility of the gel pads compared with ice packs or no treatment, although no differences in pain relief were detected between the treatments. None of the treatments resulted in differences detected in perineal oedema or bruising. Women reported more pain and used more additional analgesia following the application of ice packs compared with PET. There is only limited evidence to support the effectiveness of local cooling treatments.
II.3.3 CLINICAL SAFETY
The special feature of Hamamelis virginiana L. is that the indications, mode of administration and the parts of the plant therapeutically used in preparations have always been the same. This simplifies the toxicological assessment and provides further evidence that hamamelis is effective and safe. A fact worth mentioning is that Hamamelis virginiana L. has been reported as of no toxicological importance.
II.3.3.1 PATIENT EXPOSURE
No exact data on patient exposure are available. Hamamelis products are widely used as safe ingredients in medicinal products and in cosmetics.
II.3.3.2 ADVERSE EVENTS
Witch hazel preparations are referred in Mayler’s Side Effects of Drugs among the Agents known or believed to have caused immunological contact urticaria. The patch test concentration and vehicle is 10% alcohol distillate and the proposed frequency of sensitization is rare (reference SEDA 19, 162).
No significant adverse effects from the ingestion of witch hazel are expected. It may cause irritation of the stomach in a small number of susceptible individuals and topical application may cause contact allergy in rare cases (Mills and Bone, 2000).
Allergic contact dermatitis may occur in sensitive individuals. The type of contact reactions to witch hazel in the older literature is not clear, as patch test were not performed or not reported. Bruynzeel et al (1992) tested 1032 patients consecutively or randomly chosen, in 6 patch test clinics with a series of 5 popular ointments. The ointments elicited positive reactions in 11 patients among which 4 were found to react to an ointment containing 25% extract of hamamelis.
Grandlund (1994) reported a case of a 31
Conjunctivitis has been reported by Ireland and Spain for eye drops (hamamelis distillate (1.6:1) the frequency is not known.
Contraindications (hypersensitivity and allergic potential to be both covered)
Hypersensitivity to the active substance.
II.3.3.3 SERIOUS EVENTS AND DEATHS
None known.
II.3.3.4 LABORATORY FINDINGS
No data available.
II.3.3.5 SAFETY IN SPECIAL POPULATIONS AND SITUATIONS.
Caution should be exercised with long term oral use due to the presence of tannins. In susceptible patients, irritation of the stomach may occur occasionally. In rare cases,
II.3.3.5.1 Intrinsic (including elderly and children)/extrinsic factors
None known.

II.3.3.5.2
None reported for hamamelis preparations.
Tannins inhibit absorption of minerals and B vitamins.
II.3.3.5.3 Use in pregnancy and lactation
Safety during pregnancy and lactation has not been established definitely. In accordance with general medical practice and in absence of sufficient data, hamamelis preparations for internal use should not be used during pregnancy and lactation without medical advice (ESCOP, 2003).
II.3.3.5.4 Overdose
No case of overdose has been reported.
II.3.3.5.5 Drug abuse
None known.
II.3.3.5.6 Withdrawal and rebound
None known.
II.3.3.5.7 Effects on ability to drive or operate machinery
None known.
II.3.3.6 OVERALL CONCLUSIONS ON SAFE USE
The external application of hamamelis preparations can be regarded as safe, especially at the recommended doses.
Contact allergic dermatitis has been reported only in rare cases.
Some conjunctivitis cases have been reported during the use of eye drops containing hamamelis (dilution of hamamelis distillate (1.6:1)), while the frequency is not known.
In view of the results of the preclinical toxicological studies, clinical trials and several decades of experience of its use in human beings, as well as the degree of satisfaction expressed by the patients, the hamamelis preparations can be classified as safe and well tolerated medicines.
As is the case for many other plant preparations, consistent scientific data supporting the efficacy of hamamelis preparations are still limited. Some controlled clinical trials have been performed, some of them showed positive outcomes but of weak statistical interpretation. The beneficial effect of hamamelis is primarily supported by traditional use.
Diluted preparations of hamamelis distillate virtually with no tannin content,
In relation to the cutaneous use of hamamelis, some randomized, placebo controlled studies have been performed with products containing hamamelis distillate. The results of some of these clinical trials regarding the efficacy in eczema are conflicting

1993). In both of these studies the
The plausibility of the traditional cutaneous use of hamamelis distillate and its preparations (semi solid/ solid preparations) is reinforced upon available
The assessor’s final conclusion is to recommend only the traditional registration procedure for the preparations of hamamelis considered in this AR mainly for cutaneous use (skin and external mucosa), including products containing hamamelis water preparations which are considered as the most extensively studied.
The oral use of hamamelis preparations such as tincture (1:10) (leaf); tincture (1:10 w/v, in 55% ethanol V/V) (bark); Liquid extract (1:1) ethanol 45% v/v (leaf) which has been referred and supported by handbooks and hamamelis monographs ( WHO, Commission E and ESCOP), is not recommended by the assessor , as there are not products in the market which comply with the conditions required for traditional herbal medicinal products.
The following extracts: Dry extract with ethanol 80% V/V (DER
Period of traditional use (art. 16a(1)(d)), as laid down in (art. 16(1)(c)), has elapsed for the preparations included in the monograph. The traditional use outside and inside the European Union has been shown in detail for much more than 30 years.
Recommended indications for hamamelis leaf or bark for cutaneous use: Traditional herbal medicinal product for relief of minor skin, inflammation and dryness of the skin.
Recommended indications for hamamelis leaf or bark preparations for anorectal use:
Traditional herbal medicinal product for symptomatic relief of itching and burning associated with haemorrhoids.
Recommended indications for hamamelis leaf or bark for oromucosal use
Traditional herbal medicinal product used as a mouthwash and gargle for relief of minor inflammation of mucous membranes of the oral cavity conditions of the oral mucosa.
Recommended indications for diluted hamamelis distillate/External use
Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin. Traditional herbal medicinal product for the temporary relief of discomfort due to dryness of the eye or to exposure to wind and sun.
The product is a traditional herbal medicinal product for use in specified indication exclusively based upon

Hamamelis bark (Hamamelidis cortex)
Recommended posology
External use:
For cutaneous use:
Tincture (bark) (1:10; ethanol 45% v/v) in a strength corresponding to
Dry extract
For anorectal use:
Tincture in a strength corresponding to
For rectal use:
Suppositories containing 66 mg of dry extract
For oromucosal use (mouthwash and gargles):
Hamamelis leaf (Hamamelidis folium)
For cutaneous use:
Tincture or liquid extracts (1:1) in a strength corresponding to
Liquid extract (1:2; ethanol 60% v/v) in a strength corresponding to 20% as
For oromucosal use:
Decoctions of
Tincture (1:10) in 45% ethanol (diluted (1:3) with water)
For symptoms associated with hemorrhoids:
Tincture or liquid extracts (1:1) in a strength corresponding to
Liquid extract (1:2; ethanol 60% v/v) in a strength corresponding to 20% as a
Comminuted herbal substance as decoction:
For rectal use:
Suppository containing 400 mg of liquid extract (1:2; ethanol 60% v/v),

Hamamelis distillate (Hamamelidis destillatum)
For cutaneous use: distillates in a strength corresponding to
Eye drops:
Hamamelidis distillate 10% diluted: Single dose 2 drops/each eye,
Route of administration (art. 16a(1)(c))/duration of use
Hamamelis products are mainly recommended for cutaneous application. The average duration of use is two weeks. In case of application on the eye, the duration of use should be limited to 4 days.
Non clinical safety
Limited information is available on toxicology of herbal preparations of hamamelis. Details of the preparations used in the studies reported are usually lacking. There are only few studies with Hamamelis virginiana, destillatum (Hamamelidis Aqua USP), fractions of hamamelis preparations and isolated compounds such as hamamelitannin.
Reliable data from test on genotoxicity are only available for Hamamelidis aqua preparations.
According to the experience acquired during the prolonged use of hamamelis preparations, the external application can be regarded as safe.
Clinical Safety
The external application of hamamelis preparations can be regarded as safe at the recommended doses. Contact allergic dermatitis has been reported only in rare cases.
Conjunctivitis case has been reported for eye drops (dilution of hamamelis distillate (1.6:1)), the frequency is not known.
In view of the results of the preclinical toxicological studies, clinical trials and several decades of experience of its use in human beings, as well as the degree of satisfaction expressed by the patients, the hamamelis preparations can be classified as safe and well tolerated medicines, proved not to be harmful in the specified conditions of use. Their pharmacological effects or efficacy are plausible on basis of longstanding use and experience.
These preparations comply the criteria for traditional herbal medicinal products as established in the Art 16 c(1)(e) of the Directive 2004/24/EC.
The safe use of hamamelis distillates has been accepted by the MLWP and HMPC, taking into account the data of the AR toxicology section (II.2.3) and all available data for the therapeutic indications for cutaneous use as well as the

ANNEXES
II.5 COMMUNITY HERBAL MONOGRAPHS ON HAMAMELIS VIRGINIANA L., CORTEX; HAMAMELIS VIRGINIANA L., FOLIUM;
HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX OUT RAMUNCULUS DESTILLATUM4,5
4According to the “Procedure for the preparation of Community monographs for traditional herbal medicinal products” (EMEA/HMPC/182320/2005 rev.2)
5According to the “Procedure for the preparation of Community monographs for herbal medicinal products with
6According to the “Structure of the Community list of herbal substances, preparations and combinations thereof for
use in traditional herbal medicinal products” (EMEA/HMPC/100824/2005 rev.2)