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Fumaria (Fumaria)

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Authorisation details
Latin name of the genus: Fumaria
Latin name of herbal substance: Fumariae herba
Botanical name of plant: Fumaria officinalis L.,
English common name of herbal substance: Fumitory
Status: P: Draft published
Date added to the inventory: 11/03/2010
Date added to priority list: 11/03/2010
Outcome of European Assessment:
Additional Information:



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    • Product Characteristics - Assessment Report
    Table of contents
    Assessment report on Fumaria officinalis L., herba
    EMA/HMPC/576232/2010
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    1. Introduction
    1.1. Description of the herbal substance(s), herbal preparation(s) or
    combinations thereof
    Herbal substance(s)
    Fumariae herba, common fumitory herb, consists of the dried, above-ground parts of Fumaria
    officinalis L. (fam. Fumariaceae ), gathered during the flowering season, as well as their preparations
    in effective dosages (Blumenthal 1998).
    Fumitory is an annual plant of somewhat variable characteristics, often resembling a bush but also
    growing as a low trailing shrub. It has a gray, pointed leaves that at a distance give the plant a wispy
    appearance of smoke (hence the common name). The pink-purple flower blooms in spring. The plant is
    a widely dispersed and can be found in gardens, slopes and in wastelands.
    According to the European Pharmacopoeia (6.2. 2008), t he whole or fragmented dried aerial parts of
    Fumaria officinalis are harvested in full bloom. They contain a minimum of 0.40% of total alkaloids,
    expressed as protopine (C 20 H 19 NO 5 =353.4).
    Fumitory comprises of the dried or fresh flowering plant Fumaria officinalis ( Papaveraceae ) and is used
    in herbal medicine. It is an ingredient of preparations used mainly for gastrointestinal and biliary-tract
    disorders (Ph. Eur. 6.2. 2008; Martindale 1996).
    Erdrauchkraut; Fumaria; Fumariae herba; Fumeterre; Zemědýmová nat’; Ziele dymnicy; Дымовая
    Трава; Дымянка Лекарственная
    According to Goetz et al. (2009), British Herbal Pharmacopoeia (1976), British Herbal Compendium
    (1992) and Paris & Moyse (1981) chemical constituents are:
    - Alkaloids (0.3-1% calculated as protopine (0.13%) even though several different types of alkaloids
    have been isolated and structurally elucidated derivatives
    Protopines, the quantitatively predominant type, as protopine (fumarine) and cryptopine
    Protoberberines: aurotensine, stylopine, N-methylsinactine and others
    Spirobenzylisoquinolines: fumaritine, fumaricine anf fumariline and others
    Benzophenanthridines such as sanguinarine and corydamine (traces)
    Indenobenzazepines: fumaritrididine and fumaritrine (Preininger 1975; Forgacs et al. 1982, 1986;
    Wawrzynowicz et al. 1968; Hermansson & Sandberg 1973; Mardirossian et al. 1983)
    Fumaricine
    Protopine
    Assessment report on Fumaria officinalis L., herba
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    - Flavonoids: principally glucosides of quercetin such as isoquercitrin, rutin, quercetin-3,7-diglucoside-
    3-arabinoglucoside (Torck et al. 1971; Massa et al. 1971)
    - Acids: chlorogenic and caffeic acids, also fumaric acid, caffeoylmalic acid and other aliphatic acids
    (Massa et al. 1971; Boegge et al. 1995; Hahn & Nahrstedt 1985)
    - Other constituents: bitter principles, mucilage, resin and potassium salts (Barnes et al. 2002)
    Herbal preparation(s)
    a) Comminuted herbal substance
    b) Powdered herbal substance
    c) Dry extract (DER 3.5-5:1), extraction solvent water
    d) Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V
    e) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 45% V/V
    f) Juice of fresh plant
    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.
    This monograph refers only to Fumariae herba.
    1.2. Information about products on the market in the Member States
    Regulatory status overview
    Member State Regulatory Status
    Comments
    Austria
    MA
    TRAD
    Other TRAD
    Other Specify: Dry water extract, DER
    5:1, since 1978
    Belgium
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Bulgaria
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Cyprus
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Czech Republic
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Denmark
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Estonia
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Finland
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    France
    MA
    TRAD
    Other TRAD
    Other Specify: 1) Powdered aerial parts
    2), 3) Dried water
    extract (DER: 3.5-4.5:1)
    Since: 1) 1982, 2) 1963,
    3) 1987
    Germany
    MA
    TRAD
    Other TRAD
    Other Specify: Only two herbal teas
    Greece
    MA
    TRAD
    Other TRAD
    Other Specify: No products on the
    market
    Assessment report on Fumaria officinalis L., herba
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    Member State Regulatory Status
    Comments
    Hungary
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Iceland
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Ireland
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Italy
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Latvia
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Liechtenstein
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Lithuania
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Luxemburg
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Malta
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    The Netherlands
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Norway
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Poland
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Portugal
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Romania
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Slovak Republic
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    Slovenia
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    Spain
    MA
    TRAD
    Other TRAD
    Other Specify: 1) Powdered herbal
    substance as herbal tea
    2) Powdered herbal
    substance for oral use in
    capsules
    Since: 1) 1985, 2) 1993
    Sweden
    MA
    TRAD
    Other TRAD
    Other Specify: No products registered
    United Kingdom
    MA
    TRAD
    Other TRAD
    Other Specify: Not known
    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’
    This regulatory overview is not legally binding and does not necessarily reflect the legal status of the
    products in the MSs concerned.
    Assessment report on Fumaria officinalis L., herba
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    Analytically
    Member State
    Regulatory Status
    Member state
    Products, indications
    Austria
    WEU
    Preparations
    1) Dry extract, extraction solvent water, DER not specified, not less than 1.5%
    alkaloids calc. as protopine.
    1 film-coated tablet contains 250 mg extract
    2) Dry extract, extraction solvent water, DER 5:1, not less than 2.5 mg
    alkaloids calc. as protopine per film coated tablet.
    1 film-coated tablet contains 250 mg extract
    3) Combination 275.1 mg dry extract, extraction solvent water, DER 4-6:1, not
    less than 1.5% alkaloids calc. as protopine. 83.1 mg dry extract of Silybi
    marianae fructus (no more details) Combination
    Since
    1) 1992
    2) 1978
    3) 1988
    Pharmaceutical form
    1), 2) Film coated tablet
    3) Hard capsules
    Posology for oral use in adults
    1), 2) 3 times daily 1-2 tablets
    3) 3 times daily 2 tablets
    Indications
    1. Dyskinesia of the biliary duct; pain in case of cholelithiasis when surgery is
    not possible; pain in case of cholecystitis and cholangitis;
    postcholecystecomia syndrome; posthepatic syndrome with cholestasis.
    2. Pain in the biliary system in case of dyskinesia of the biliary duct,
    complaints after cholecystectomia, cholelithiasis when surgery is not
    possible.
    3. Supportive treatment of dyskinesias of the biliary duct (also after
    cholecystectomia) in cases of an impairment of the liver.
    Belgium
    Not known
    Bulgaria
    Not known
    Cyprus
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Czech Republic
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Denmark
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Estonia
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Finland
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    France
    TU
    Preparations
    Assessment report on Fumaria officinalis L., herba
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    Member State
    Regulatory Status
    1) Powdered aerial parts
    2) Dried extract (DER: 3.5-4.5:1), solvent water
    3) Dried extract (DER: 3.5-4.5:1), solvent water
    Since
    1) 1982
    2) 1963
    3) 1987
    Pharmaceutical form
    1), 3) Hard capsules
    2) Coated tablet
    Posology for oral use in adults
    1) 3-5 times daily (containing 220 mg powder each), (1100 mg maximum
    daily)
    2) 4 times daily 250 mg of extract /tablet (1000 mg daily)
    3) 2 times daily 200 mg of extract /capsule
    Indications
    1) Traditionally used to promote urinary and digestive elimination functions.
    Traditionally used as a choleretic and cholagogoue.
    2), 3) Traditionally used to promote urinary and digestive elimination functions.
    Germany
    Only two herbal teas
    Greece
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Hungary
    Not known
    Iceland
    Not known
    Ireland
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Italy
    Not known
    Latvia
    Not known
    Lithuania
    Not known
    Luxembourg
    Not known
    Malta
    Not known
    Netherlands
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Norway
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Poland
    Not known
    Portugal
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Romania
    Not known
    Slovakia
    Not known
    Slovenia
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    Spain
    Preparations
    1) Powdered herbal substance for oral use as herbal tea or
    2) Powdered herbal substance for oral use in capsules (160 mg) up to three
    times daily
    Assessment report on Fumaria officinalis L., herba
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    Member State
    Regulatory Status
    Since
    1) 1985
    2) 1993
    Posology for oral use in adults
    1) 2g/250 ml divided in 2-3 times daily, 2-6 g/day
    2) 6-8 capsules daily, 960-1280 mg/day
    Indications
    1) Traditionally used digestive complaints, difficult digestions.
    2) Dyspeptic symptoms; THMP to facilitate difficult digestions; spastic
    discomfort in the gastrointestinal tract (gall bladder).
    Sweden
    No authorized herbal medicinal products containing Fumariae herba as a single
    drug preparation are on the market
    United Kingdom
    Not known
    1.3. Search and assessment methodology
    Search terms: Fumaria officinalis L., Fumariae herba, fumitory, fumitory alkaloids
    Databases: Pubmed, Medline, HealLink, Scopus
    Libraries: University of Athens, Lab. Of Pharmacognosy of the University of Athens
    2. Historical data on medicinal use
    2.1. Information on period of medicinal use in the Community
    The name of fumitory is said to be derived either from the fact that its whitish, blue-green colour gives
    it the appearance of smoke rising from the ground, or according to Pliny and Olivier de Serres (XIV
    century) because the juice of the plant brings on such a flow of tears that the sight becomes dim as
    with smoke (Delaveau 1980), and hence its reputed use in affections of the eye. The leaves have no
    odour but a bitter and salty taste.
    Fumitory has been known since antiquity and was described in herbals from the Middle-Ages. It was a
    predominantly the Mediterranean genus that was once used medicinally.
    Traditionally the plant has been used as digestive and diuretic.
    Fumaria extracts may be useful in the management of disorders of hepatobiliary tract, spastic
    discomfort in the area of the gallbladder bile ducts as well as gastrointestinal tract.
    Unproven uses: in folk medicine, the herb has been used for skin diseases, constipation, cystitis,
    arteriosclerosis, rheumatism, arthritis, as a blood purifier, for hypoglycaemia and infections (PDR
    2007).
    Traditional preparation involved expressing the juice and evaporating, while the plant has also been
    used to treat chronic eczema, cutaneous eruptions and other dermatological conditions (The Review of
    Natural Products 2005). The use as an eye lotion in conjunctivitis has been reported (British Herbal
    Pharmacopoeia 1976).
    Physicians and writers from Dioscorides to modern times value its depurative properties. The herbal
    drug has been monographed in old official pharmacopoeias (e.g. Codex Medicamentarius Gallicus
    Pharmacopée Française 1908; British Herbal Pharmacopoeia 1976; Madaus 1979; Les Cahiers de
    l’Agence 2008; Wichtl 1998; HagerROM 2006; Blumenthal 1998; The British Herbal Pharmacopoeia
    1976; British Herbal Compendium 1992). It was also included in the Pharmacopée Française of 1908
    for its diuretic and depurative properties.
    Assessment report on Fumaria officinalis L., herba
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    Fumitory was officially recognized in 1986 by the French Health authorities (Bulletins Officiels N° 86/20
    bis and N° 90/22 bis, Direction de la Pharmacie et du Médicament) as an herbal remedy traditionally
    used in renal and digestive elimination functions and to help digestion. Moreover, fumitory is on the
    United Kingdom General Sales List (GSL) and is approved by the German Commission E Monograph
    (Blumenthal 1998). It has been used as a traditional remedy for a long time without safety problems,
    in Europe and worldwide, for more than 30 years.
    The flowers are used to make a yellow dye for wool.
    Fumitory is listed by the Council of Europe as a natural source of food flavouring (category N3). This
    category indicates that fumitory can be added to foodstuffs in the traditionally accepted manner,
    although there is insufficient information available for an adequate assessment of potential toxicity
    (Barnes et al. 2002).
    Type of tradition: European.
    Fumitory (shatara) has been used in Afghanistan for the treatment of asthma (Delaveau 1980), while
    in India fumitory is widely used against dyspeptic disorders (Fiegel 1971).
    2.2. Information on traditional/current indications and specified
    substances/preparations
    Herbal preparations
    According to the overview of the European marketm, the herbal preparations a), b) and c) fulfil the
    criteria of the thirty years at least in Europe. The herbal preparations d), e) and f) were found in many
    literature references, also for at least 30 years (British Herbal Pharmacopoeia 1976).
    For Fumariae herba, a period of at least 30 years in medicinal use, as requested by Directive 2004/24
    EC for qualification as a traditional herbal medicinal product, is easily fulfilled. The evidence on
    traditional medicinal use is supported by a large number of publications providing consistent
    information.
    a) Comminuted herbal substance
    b) Powdered herbal substance (in France since 1982)
    c) Dry extract (DER 3.5-5:1), extraction solvent water (in France since 1963 and in Austria since 1978)
    From the literature (British Herbal Pharmacopoeia 1976; Van Hellemont 1986; British Herbal
    Compendium 1992; Barnes et al. 2002; PDR 2007; Goetz et al. 2009)
    d) Liquid extract (1:1), extraction solvent ethanol 25% V/V
    e) Tincture (1:5), ethanol 45% V/V
    f) Juice of fresh plant
    Herbal preparations in solid or liquid dosage forms for oral use or Comminuted herbal substance as
    herbal tea for oral use.
    Indications
    Traditional herbal medicinal product used to promote urinary and digestive elimination functions
    (France).
    Traditional herbal medicinal product for the symptomatic relief of digestive disorders such as dyspepsia
    and flatulence (Spain).
    Assessment report on Fumaria officinalis L., herba
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    Dyskinesia of the biliary duct, pain in case of cholelithiasis when surgery is not possible, pain in case of
    cholecystitis and cholangitis, postcholecystecomia syndrome and posthepatic syndrome with
    cholestasis (Austria).
    Pain in the biliary system in case of dyskinesia of the biliary duct, complaints after cholecystectomia,
    cholelithiasis when surgery is not possible (Austria).
    Supportive treatment of dyskinesias of the biliary duct (also after cholecystectomia) in cases of an
    impairment of the liver (Austria).
    The indication by MLWP-HMPC: Traditional herbal medicinal product used to increase bile flow for the
    relief of symptoms of indigestion (such as sensation of fullness, flatulence and slow digestion).
    2.3. Specified strength/posology/route of administration/duration of use
    for relevant preparations and indications
    Posology
    Adults and elderly
    a) Comminuted herbal substance
    2-4 g/day (2 g/250 ml), 2-3 times daily
    To be taken 30 min before meals
    b) Powdered herbal substance
    Single dose of 220 mg, up to 1100 mg of herbal substance daily
    c) Dry extract (DER 3.5-4.5:1), extraction solvent water
    Single dose of 250 mg of extract, up to 1000 mg daily
    d) Liquid extract (1:1, solvent alcohol 25% V/V)
    2-4 ml (30-50 drops) before meals
    e) Tincture (1:5 alcohol 45% V/V)
    Daily dose 1-4 ml before meals
    f) Juice of fresh plant
    Daily dose 3.5-4 g
    Duration of use
    Up to 2-3 weeks.
    3. Non-Clinical Data
    3.1. Overview of available pharmacological data regarding the herbal
    substance(s), herbal preparation(s) and relevant constituents thereof
    In vitro and animal studies
    The herb has been used as amphocholeretic (Boucard & Laubenheimer 1966; Fiegel 1971; British
    Herbal Compendium 1992), mild antispasmodic on smooth muscle, mild diuretic and laxative (Reynier
    et al. 1977).
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    Amphocholeretic activity
    The amphocholeretic activity of fumitory has been demonstrated in animals, showing that it has no
    effect on normal choleresis but modified bile flow which was artificially increased or decreased
    (Boucard & Laubenheimer 1966; Reynier et al. 1977), slowing down artificially increased flow and
    increasing reduced flow.
    Fumitory extract inhibited the formation of gall bladder calculi in animals (Lagrange & Aurousseau
    1973).
    Antispasmodic activity
    Antispasmodic activity on smooth muscle has been reported by Reynier et al. (1977). Extracts inhibited
    formation of gallbladder calculi in animals (Lagrange & Aurousseau 1973).
    Antibacterial activity
    Bactericidal activity against the Gram-positive organisms Bacillus anthracis and Staphylococcus has
    been reported (Preininger 1975).
    Antiallergic and choleretic activity
    In in vivo (rats) studies, preparations of the herb had no effect on normal choloresis but modified bile
    flow that had been artificially increased or decreased (Boucard & Laubenheimer 1966).
    Plantago major together with Fumaria officinalis ethanolic extracts appeared to be of interest because
    of their antiallergic and choleretic properties in a study in the Tunisian population (Denden et al. 2010).
    Bioactivities of secondary metabolites from Fumaria
    The alkaloid protopine has a contractile action on Oddi’s sphincter in animals (Van Hellemont 1986).
    One preparation of the total alkaloids of Fumaria officinalis L. (no further information) has shown
    arrhythmic activity (Gorbunov et al. 1977).
    The major alkaloid protopine has antihistaminic, hypotensive, bradycardic and sedative activities in
    small doses in animals (Goetz et al. 2009), whereas larger doses cause excitation and convulsions
    (Preininger 1975).
    All these observations of such bioactivities help to account for some of the existing clinical effects.
    3.2. Overview of available pharmacokinetic data regarding the herbal
    substance(s), herbal preparation(s) and relevant constituents thereof
    No data on Fumaria extracts have been found or reported, while there is only the following reference
    on protopine alkaloids purified from Fumaria extracts.
    The alkaloid protopine, the major secondary metabolite was extracted from Fumaria officinalis and
    purified by column chromatography. Urine samples were collected from horses and a human volunteer
    that had been administered either F. officinalis or protopine free base. Plant and urine samples were
    acetylated and analysed by GC-MS after solid-phase extraction (SPE). The urinary metabolites of
    protopine were identified as 4,6,7,13-tetrahydro-9,10-dihydroxy-5-methyl-benzo[e]-l,3-benzodioxolo
    [4,5-1][2] benzazecin-12(5H)-one, 4,6,7,13-tetrahydro-10-hydroxy-9-methoxy-5-methyl- benzo[e]-
    1,3-benzodioxolo[4,5-1][2] benzazecin-12(5H)-one and 4,6,7,13-tetrahydro-9-hydroxy-10-methoxy-
    5-methyl-benzo[e]-1,3-benzodioxolo[4, 5-l][2] benzazecin-12(5H)-one, chelianthifoline,
    isochelianthifoline and 2-O-desmethylchelianthifoline. The metabolic formation of the
    Assessment report on Fumaria officinalis L., herba
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    tetrahydroprotoberberines by closure of the bridge across N5 and C13 is rate limited and protopine-like
    metabolites accumulate only when the route is overloaded. Metabolism was qualitatively similar in the
    horse and human ( Wynne et al. 2004 ).
    3.3. Overview of available toxicological data regarding the herbal
    substance(s)/herbal preparation(s) and constituents thereof
    The main constituents of fumitory include:
    - alkaloids, principally protopines, protoberberines, spirobenzylisoquinolines, benzophenanthridines and
    indenobenzazepines types;
    - flavonoids, principally glycosides of quercetin;
    - acids: chlorogenic and caffeic acids, fumaric acid and other aliphatic acids.
    Single-dose and repeated-dose toxicity studies
    No data available.
    Genotoxicity studies
    No genotoxicity studies have been carried out on fumitory according to available scientific literature.
    Carcinogenicity studies
    No carcinogenicity studies have been carried out on fumitory according to available scientific literature.
    Reproduction and developmental toxicity studies
    No reproductive and developmental toxicity studies have been carried out on fumitory according to
    available scientific literature.
    The safety of fumitory during pregnancy and lactation has not been established. In accordance with
    general medical practice, the herbal medicinal products (herbal teas or finished products) should not
    be used during pregnancy and lactation without medical advice.
    3.4. Overall conclusions on non-clinical data
    Fumitory was officially recognized in 1986 by the French Health authorities (Bulletins Officiels N° 86/20
    bis and N° 90/22 bis, Direction de la Pharmacie et du Médicament) as an herbal remedy traditionally
    used in renal and digestive elimination functions and to help digestion. Moreover, fumitory is on the
    United Kingdom General Sales List (GSL) and is approved by the German Commission E Monograph. It
    has been used as a traditional remedy for a long time without safety problems, in Europe and
    worldwide, for more than 30 years.
    The published data that refers to the indications and preparations is limited, but on the basis of
    existing data the pharmacological activities (choleretic amphocholeretic, mild antispasmodic on smooth
    muscle, mild diuretic and laxative antispasmodic activity on smooth muscle (Reynier et al. 1977 ;
    Lagrange & Aurousseau 1973; Boucard & Laubenheimer 1966; Fiegel 1971; British Herbal
    Compendium 1992) support the traditional use of Fumaria officinalis and preparations thereof in the
    proposed indication:
    Traditional herbal medicinal product used to increase bile flow for the relief of symptoms of indigestion
    (such as sensation of fullness, flatulence and slow digestion).
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    The efficacy of traditional herbal medicinal products is only plausible but not proven by clinical data.
    Nevertheless, the safety must be guaranteed.
    The lack of genotoxicity, carcinogenicity as well as reproductive and developmental toxicity studies do
    not allow the establishment of a Community List Entry.
    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
    No data available.
    4.1.2. Overview of pharmacokinetic data regarding the herbal
    substance(s)/preparation(s) including data on relevant constituents
    No data available.
    4.2. Clinical Efficacy
    4.2.1. Dose response studies
    No data available.
    4.2.2. Clinical studies (case studies and clinical trials)
    There is a lack of clinical research assessing the effects of fumitory; therefore, rigorous randomised
    controlled clinical trials are required.
    The following data on clinical studies has been found in the literature:
    Clinical trials
    In a clinical study involving 105 patients with biliary disorders (hepatopathy, chololethiasis, post-
    operation cholocystectomy syndrome) favourable results were claimed (British Herbal Compendium
    1992; Fiegel 1971). Doses of 2 tablets containing sprayed water extract (3-6:1) in tablets of 250 mg
    each, in a proposed dose of 2 tablets 3 times per day were used for a period of 2-6 months. No
    detailed response has been given but an excellent tolerability was reported.
    In another clinical trial by Müscher (1971) an amphocholeretic herbal medicinal product (Fumitory herb
    water extract 4-6:1, in tablets containing 250 mg of sprayed water extract) was used for one year in a
    group of 178 patients with biliary disorders. Ninety six treated patients (20-70 years old) were
    suffering from biliary disorders (especially dyskinesia), taking doses of 3 tablets per day (two before
    the meals and the 3 rd before sleep). The safety and tolerability was proven and for 64 patients the
    results were characterised as successful, especially against the symptoms of fullness and flatulence.
    Another 43 patients (40-70 years old) with diagnosed chololithiasis and post-operation syndrome were
    treated with 2 tablets containing 250 mg, 3 times daily for a period of 3 weeks, showing for 36 among
    them successful results, good tolerability and safety. In total, 125 patients among the 176 treated
    claimed favourable results. In all cases the tablets were taken before meals and the safety and
    tolerability were proven.
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    Roux (1977): In that clinical study 31 patients (16 men and 15 women, 25-78 years old) with biliary
    syndrome (either dyskinesia or low digestion and digestive complains (diarrhoea) have shown very
    positive amphocholeretic effects. The treatment lasted 15-30 days (depending on the problem) with
    doses of 2 dragees containing 250 mg of a water extract of fumitory (no further data given).
    The clinical experience with a Fumaria officinalis nebulisate (water extract of 4-6:1) as an
    amphocholinergic agent used in 64 patients suffering from biliary disorders (dyskinesia, hepatopathy
    Heully et al. (1969): The effect of a water extract of Fumitory herba has been studied in a group of 20
    persons vis-a-vis the choleretic result in a dose containing 500 mg of direct infusion in duodenal. The
    results appeared very variable and not comparable. The tolerability to the extract was very good.
    Bourjat (1974 ): A clinical study has been carried out on the effect of trials of treatment with a water
    extract sprayed in tablets (nebulizate) of Fumaria officinalis against Xerostomia due to radiotherapy,
    Fablet et al. (1968): The therapeutic activity of the extract of Fumaria officinalis against the
    hepatobiliary syndrome and the depending migraines has been studied in a group of 101 patients (82
    women and 19 men of 16-79 years old).
    Double blind placebo clinical trial
    One double blind placebo clinical trial was performed in a group of 30 patients (20 women, 10 men of
    26-57 years old) with different biliary disorders (dyskinesia, cholocystitis, hepatopathy, chololithiasis,
    post-operation cholocystectomy syndrome ) taking doses of 3 tablets of ‘Fumaria-Nebulisat’ (water
    extract 4-6:1) 250 mg per day (two before the meals and the 3 rd before sleep) for 28 days. The safety
    and tolerability was proven, and for all 30 patients the results were described as successful, especially
    against the symptoms of fullness and flatulence (Kopp 1979).
    Open studies
    Kopp (1979): The Choleretic activity of an herbal medicinal product containing an extract of fumitory
    was studied in an open study in 18 patients for 10 days with favourable results. No data on the exact
    preparation or the posology are provided.
    Zacharewicz et al. (1979): In an open study 45 patients (30 women and 15 men 28-59 years old)
    among them 27 with biliary dyskinesia problems (20 hypertonic, 7 hypotonic), were treated with 3
    tablets containing 250 mg of extract per day (water extract not further specified), for 16 days. In some
    cases the daily doses reached 2000 mg. No adverse effects were reported, while 80% of the
    participants of the open study improved their daily life and their symptoms were clearly reduced.
    However, the methodological limitations of these studies do not allow attributing the reported effects
    to the administration of fumitory (Barnes et al. 2002).
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    Irritable bowel syndrome
    Neither fumitory nor Javanese turmeric was effective in a study in patients with irritable bowel
    syndrome (Brinkhaus et al. 2005).
    The aim of this study was to determine the efficacy of two herbal remedies used in the treatment of
    IBS. In a randomized, double-blind, placebo-controlled trial, IBS patients were randomly assigned to
    one of three treatment groups: 1) Curcuma xanthorriza 60 mg daily (curcuma group) (n=24), 2)
    Fumaria officinalis 1500 mg daily (fumitory group) (n=24) and 3) placebo (n=58). The study treatment
    was applied three times a day for 18 weeks. The main outcome parameters were changes in global
    patient ratings of IBS-related pain and distension on a visual analogue scale (0-50 mm) between
    baseline and at the end of treatment. Additional outcome parameters included global assessments of
    changes in IBS symptoms and psychosocial stress caused by IBS.
    A total of 106 patients (mean age 48±12 years, 63% F) were included in the intention-to-treat group.
    IBS-related pain decreased by -0.9 ± 11.5 (mm±SD) in the fumitory group, -0.3±9.9 in the placebo
    group and increased by 2.0±9.5 in the curcuma group (p=0.81). IBS-related distension decreased by -
    1.4±12.5 in the curcuma group, -2.1±9.2 in the placebo group and increased by 0.3±9.3 in the
    fumitory group (p=0.48). Additionally, the global assessment of changes in IBS symptoms and
    psychological stress due to IBS did not differ significantly among the three treatment groups.
    Neither fumitory nor curcuma showed any therapeutic benefit over placebo in patients with IBS.
    Therefore, the use of these herbs for the treatment of IBS cannot be recommended.
    4.2.3. Clinical studies in special populations (e.g. elderly and children)
    None reported.
    4.3. Overall conclusions on clinical pharmacology and efficacy
    Eight existing clinical studies in 617 patients (British Herbal Compendium 1992; Fiegel 1971; Müscher
    1971; Roux 1977; Zawodsky 1974; Hunold 1975; Bourjat 1974 ; Salembier 1967; Fablet et al. 1968)
    as well as one existing double blind placebo trial (30 patients) (Kopp 1979) and two open studies in 63
    patients (Kopp 1979; Zacharewicz et al. 1979) fully support the traditional use with intended choleretic
    and digestive effects of fumitory. However, there is a lack of rigorous clinical research assessing the
    effects of preparations of fumitory.
    It is obvious, that according the published in vitro and in vivo studies as well as the existing clinical
    trials an antispasmodic effect on the upper digestive tract is sufficiently documented.
    5. Clinical Safety/Pharmacovigilance
    5.1. Overview of toxicological/safety data from clinical trials in humans
    Eight existing clinical studies in 617 patients (British Herbal Compendium 1992; Fiegel 1971; Müscher
    1971; Roux 1977; Zawodsky 1974; Hunold 1975; Bourjat 1974 ; Salembier 1967; Fablet et al. 1968)
    as well as one existing double blind placebo trial (30 patients) (Kopp 1979) and two open studies in 63
    patients (Kopp 1979; Zacharewicz et al. 1979) fully support the traditional use with intended choleretic
    and digestive effects of fumitory. A very good tolerability was proven and no adverse effects have been
    reported, showing enough safety data for the proposed traditional use of fumitory.
    5.2. Patient exposure
    No data available.
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    5.3. Adverse events and serious adverse events and deaths
    Raised intraocular pressure and oedema have been reported as possible effects (Anderson & Phillipson
    1986).
    One case of an acute hepatitis probably induced by product containing Fumaria and Vitis vinifera has
    been recently reported by Bonnet et al. (2007).
    5.4. Laboratory findings
    No data available.
    5.5. Safety in special populations and situations
    Special patient population
    In the absence of data, Fumaria is intended only for adults.
    Use in pregnancy and lactation
    In the absence of data and in accordance with general medical practice, it is recommended not to use
    the herbal medicinal products containing fumitory during pregnancy and lactation.
    Overdose
    No cases of overdose have been reported in the scientific literature.
    Drug abuse
    No data available.
    Effects on ability to drive or operate machinery or impairment of mental ability
    No data available.
    5.6. Overall conclusions on clinical safety
    In the absence of data in special patient populations, Fumaria is intended only for adults.
    In the absence of data and in accordance with general medical practice, it is recommended not to use
    the herbal medicinal products containing fumitory during pregnancy and lactation.
    Seven hundred and ten patients were treated with water extracts of fumitory (mainly 1 500 mg daily)
    for a period from 10 days to 21 weeks with variable results, but showing very good tolerability ( British
    Herbal Compendium 1992; Fiegel 1971; Müscher 1971; Roux 1977; Zawodsky 1974; Hunold 1975;
    Bourjat 1974 ; Salembier 1967; Fablet et al. 1968; Kopp 1979; Zacharewicz et al. 1979). The results
    fully support the traditional use of fumitory for its choleretic and digestive effects.
    There is only one published report suggesting that a raised intraocular pressure and oedema have
    been reported as possible effects (Anderson & Phillipson 1986) during the use of an herbal medicinal
    product containing fumitory. No further data are available. Also one case of an acute hepatitis probably
    induced by Fumaria and Vitis vinifera products has been recently reported by Bonnet et al. (2007).
    A good tolerability in all clinical trials was proven and no adverse effects have been reported, showing
    enough safety data for the proposed traditional use of fumitory.
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    As there is no available data on genotoxicity, carcinogenity and reproducibility on fumitory extracts,
    the establishment of a Community List Entry is not possible for safety reasons.
    6. Overall conclusions
    The positive effects of fumitory aerial parts on digestive and hepatobiliary problems have long been
    recognised empirically. The use is made plausible by pharmacological data. There is a lack of controlled
    clinical studies, using herbal preparations, containing the herbal substance of Fumariae herba.
    In conclusion, Fumariae herba and its preparations can be regarded as traditional herbal medicinal
    products in the indications:
    Traditional herbal medicinal product used to increase bile flow for the relief of symptoms of indigestion
    (such as sensation of fullness, flatulence and slow digestion).
    In the absence of data in special patient populations, Fumaria is intended only for adults.
    In the absence of data and in accordance with general medical practice, it is recommended not to use
    the herbal medicinal products containing fumitory during pregnancy and lactation.
    Seven hundred and ten patients have been treated with water extracts of fumitory (mainly 1 500 mg
    daily) from 10 days up to 21 weeks with very good tolerability.
    No adverse effects have been reported in the above referred clinical studies except one report
    suggesting that a raised intraocular pressure and oedema (Anderson & Phillipson 1986). Also one case
    of an acute hepatitis probably induced by Fumaria and Vitis vinifera plant therapy products has been
    recently reported by Bonnet et al. (2007).
    As there is no available data on genotoxicity, carcinogenity and reproducibility on fumitory extracts,
    the establishment of a Community List Entry is not possible for safety reasons.
    Annex
    List of references
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    Source: European Medicines Agency


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