TABLE OF CONTENTS
I.
REGULATORY STATUS OVERVIEW .......................................................................................... 3
II.
ASSESSMENT REPORT ............................................................................................................... 5
II.1
Introduction ..................................................................................................................................... 6
II.2
Historical data on medicinal use .................................................................................................... 8
II.2.3 Specified strength/posology/route of administration/duration of use for relevant preparations
II.3
Non-Clinical Data ............................................................................................................................ 9
II.4
Clinical Data .................................................................................................................................. 10
II.5
Clinical Safety/Pharmacovigilance .............................................................................................. 12
II.6
Overall Conclusions ...................................................................................................................... 12
III.
ANNEXES...................................................................................................................................... 13
III.1
Public Statement on
Euphrasia officinalis
L. and
Euphrasia rostkoviana
Hayne, herba
,
...... 13
III.2
Literature References.................................................................................................................... 13
©
EMEA 2010
2/13
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’
Member State
Regulatory Status
Comments
Austria
MA
TRAD
Other TRAD
Other Specify: Only homeopathic
products
Belgium
MA
TRAD
Other TRAD
Other Specify: Homeopathic
products* and non
registered eye drops.
A simplified
registration procedure
is allowed.
Bulgaria
MA
TRAD X Other TRAD
Other Specify: Only in homoeopathic
products
Cyprus
MA
TRAD
Other TRAD
Other Specify: No information
Czech Republic
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Denmark
MA
TRAD
Other TRAD
Other Specify: No aurhorized or
registrered
preparations
Estonia
MA
TRAD
Other TRAD
Other Specify: Food supplements
Finland
MA
TRAD
Other TRAD
Other Specify: No information
France
MA
TRAD
Other TRAD
Other Specify: No information
Germany
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Greece
MA
TRAD
Other TRAD
Other Specify: No information
Hungary
MA
TRAD
Other TRAD
Other Specify: No information
Iceland
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Ireland
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Italy
MA
TRAD
Other TRAD
Other Specify:
No authorized or
registered
preparations
Latvia
MA
TRAD
Other TRAD
Other Specify: No information
1
This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in
the MSs concerned.
©
EMEA 2010
3/13
Member State
Regulatory Status
Comments
Liechtenstein
MA
TRAD
Other TRAD
Other Specify: No information
Lithuania
MA
TRAD
Other TRAD
Other Specify:
Multicompound
homeopathic products
Luxemburg
MA
TRAD
Other TRAD
Other Specify: No information
Malta
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
The Netherlands
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Norway
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Poland
MA
TRAD
Other TRAD
Other Specify: No information
Portugal
MA
TRAD
Other TRAD
Other Specify:
No authorized or
registered
preparations
Romania
MA
TRAD
Other TRAD
Other Specify: No information
Slovak Republic
MA
TRAD
Other TRAD
Other Specify:
No authorized or
registered
preparations
Slovenia
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
Spain
MA
TRAD X Other TRAD
Other Specify: Only combined
preparations used as
an eye wash
Sweden
MA
TRAD
Other TRAD
Other Specify:
No authorized or
registered
preparations
United Kingdom
MA
TRAD
Other TRAD
Other Specify: No authorized or
registered
preparations
*The following preparations could be identified in Belgium (they can be considered as homeopathic
preparations without a tradition of at least 30 years):
- Optilan eye drops: 0.045g mother tincture per 100 mL.
- Optilan monodoses: 0.05g mother tincture per 100 mL.
- Oculoheel: D5 :
solvent = aqua purificata.
- Euphrasia stillidoses Unda D2: solvent = aqua purificata
©
EMEA 2010
4/13
II.
ASSESSMENT REPORT
BASED ON ARTICLE 16D(1), ARTICLE 16F AND ARTICLE 16H OF DIRECTIVE 2001/83/EC AS
AMENDED
(TRADITIONAL USE)
Herbal substance(s) (binomial scientific name of
the plant, including plant part)
Euphrasia officinalis
L., and
Euphrasia
rostkoviana
Hayne, herba
Herbal preparation(s)
Comminuted herbal substance
Infusion (3% w/v; water)
Tincture (ratio of herbal substance to extraction
solvent 1:5; extraction solvent 45% v/v ethanol)
Pharmaceutical forms
Herbal preparation in liquid or semi-solid dosage
forms for ocular or nasal use.
Rapporteurs
Gert Laekeman
Assessor(s)
Maite Houdart, Pieter Vervisch
©
EMEA 2010
5/13
II.1
I
NTRODUCTION
This assessment report reviews the scientific data available for
Euphrasia officinalis
(L.) and
Euphrasia rostkoviana
Hayne, herba. The classification of the genus
Euprasia
differs greatly
in the literature and is to some extent contradictory. Some authors consider
Euphrasia
officinalis
the same as
Euphrasia rostkoviana
whereas others consider it as
E. rostkoviana
as
E. stricta
Wolff. (Heimans et al. 1983). However, other sources make a distinction between
both species.
Euphrasia
or eyebright belongs to the botanical family of the
Scrophulariaceae
.
The herbal substance is mainly used in liquid form for external ocular application (i.e.
conjunctivitis, blepharitis, styes,…). Secondly, the dried herb is used as an infusion for
internal administration in case of common cold and eye problems. Thirdly,
Euphrasia
can be
applied as an nasal ointment against a runny nose. There is only poor clinical evidence as the
data available are scarce. Eyebright is listed by the Council of Europe as a natural source of
food flavouring (category N3).
The following databases were assessed:
•
PubMed, until February 2009;
•
The Cochrane Library, December 2008;
•
OvidMedline, December 2008;
•
Embase, December 2008;
Search terms: Euphrasia, Eyebright, Euphrasia AND officinalis.
Apart from these sources standard books on phytotherapy were reviewed (see literature
references).
II.1.1
Description of the herbal substance(s), herbal preparation(s) or combinations thereof
Herbal substance
The herbal substance described in the Hagers Handbuch der pharmazeutischen Praxis as the
dried total herb of
Euphrasia officinalis
harvested before flowering and dried out under
sunlight in a well-ventilated area (Blascheck et al. 1998). In the Deutsche Arzneimittel Codex
(Anonymus 2003) ‘Augentrostkraut’ is described as:
… aus den zur Blütezeit gesammelten,
getrockneten, ganzen oder geschnittenen oberirdischen Teilen verschiedener Euphrasia-
Arten, besonders der Gruppen E. stricta D. Wolff ex F. J. Lehm., E. rostkoviana Hayne (E.
officinalis L. p. p.) (Scrophulariaceae), deren Bastarde oder Mischungen davon ...
According to the information in the DAC, the plant is collected in the flowering status.
The species used are confirmed.
Therefore, for the sake of the establishment of a Community herbal monograph, in the herbal
substance definition, flowers are also included in the herb.
Euphrasia
herba is also known under the synonyms:
English: Eyebright
German: Augentrost
French: Euphraise, Casse-Lunettes
Dutch: Ogentroost
2
Euphrasia officinalis is considered as an ambiguous name (De Langhe et al. Flora van België, het Groothertogdom
Luxembrug, Noord-Frankrijk en de aangrenzende gebieden. Patrimonium van de Nationale Plantentuin van
België)
©
EMEA 2010
6/13
Danish: Øjentrøst
Spanish: Ojo brillante
Lituanian: Akišveité
Norvegian: Augetrøst
Polish: Świetlik
Swedish: Ögontröstsläktet
Other species
Euphrasia stricta
Host. is a well known European species (2 to 40 cm high), of which the
aeral parts are harvested during flowering.
Euphrasia stricta
can be differentiated from
Euphrasia officinalis
by the presence of curved hairs on the tops of the leaves (Schulze &
Diepenbrock, 1944).
•
Constituents (Blazics 2008)
−
Flavonoids: 0.38%: apigenin, luteolin, kaempferol, rhamnetin, quercetin.
−
Polyphenols: 1.47%.
−
Phenolic acids: caffeic acid and its ester derivatives, chlorogenic acids and
coumaric acids.
−
Hydroxycinnamic derivatives: 1.97%
−
Tannins: 0.56%
−
Iridoids: aucubin 0.05%
H
O
H
OGlc
Figure 1: aucubine
From a phytopharmacological point of view
Euphrasia
has different effects: adstringent (due
to the tannins) and anti-inflammatory (due to the iridoids).
Chudnicka et al (2005) showed that eyebright contains acidic phosphatases and naphtol-AS-
BI-phosphohydrolase.
Herbal preparation(s):
•
Comminuted herbal substance
•
Infusion (2-3% w/v; water) (Delfosse et al, 1998; Weiss et al, 1999; Van Hellemont,
1985; Wichtl, 1994)
•
Tincture (1:5 in 45% alcohol) (Barnes et al, 2007)
Combinations of herbal substance(s) and/or herbal preparation(s)
(Delfosse et al, 1998)
•
Infusion: 50% Camomille flower and 50% eyebright herb. Five soupspoons dried herb in
0.25 l freshly boiled water.
©
EMEA 2010
7/13
•
Infusion: 60% eyebright herb, 20% melilot herb and 20% plantain herb. One soupspoon
dried herb in a cup of freshly boiled water. After fifteen minutes the infusion is passed
through a filtering tissue and applied as an ocular compress.
•
Tincture: 50% eyebright tincture, 35% passionflower tincture and 15% belladonna
tincture. Twenty drops in 15 ml of water can be taken orally up to four times a day.
II.2
H
ISTORICAL DATA ON MEDICINAL USE
II.2.1
Information on period of medicinal use in the Community
Euphrasia
is used in a European tradition since the fourteenth century. It was supposed to
cure ‘all evils of the eye’. Paracelsus also recognised the structure of an eye in the plant.
Many literature of different European countries from the late eighteenth and early nineteenth
century refer to eyebright “as a solution for all the eye problems”.
Euphrasia
is mentioned
in standard works such as
The British flora medica
(Barton and Castle, 1837),
Reine
Arzneimittellehre
(Hahnemann, 1826),
Flora parisiensis
(Bulliard, 1779),
Flora veneta
(Naccari, 1827),
Flora Scotica
(Lightfoot, 1777) and
Afbeeldingen der artsenygewassen met
derselver nederduitsche en latynse beschryvingen
(Oskamp, 1796).
The use of
Herba Euphrasiae
in case of inflammations of the eye is confirmed by more
recent sources. Indications for homoepathic use are common cold, headache, cough and also
eye ailments (Anonymus 1953).
II.2.2
Information on traditional/current indications and specified substances/preparations
•
Traditional herbal medicinal product for symptomatic treatment and prevention of
conjunctivitis of any etiology (allergic, irritative, infectious). (Barnes et al, 2007; Blascheck,
1998; Delfosse, 1998; Van Hellemont, 1985; Weiss, 1999; Wichtl, 1994)
•
Traditional herbal medicinal product for symptomatic treatment of minor ocular diseases;
for example blepharitis, eye fatigue, purulent ocular inflammation and styes. (Barnes et al,
2007; Blascheck, 1998; Delfosse, 1998; Van Hellemont, 1985; Weiss, 1999; Wichtl, 1994)
•
Traditional herbal medicinal product for symptomatic treatment of cold. (Delfosse, 1998)
II.2.3
Specified strength/posology/route of administration/duration of use for relevant
preparations and indications
•
Liquid preparations used for conjunctivitis and minor ocular affections.
Application:
oral and external use.
Posology:
Eye drops (D
3
; a thousandfold dilution of
Euphrasia
M.T.): one drop 3 times daily.
(Stoss et al, 2000)
Eye rinse, ocular compress: tea is prepared by pouring freshly boiled water over two to
three grams of the dried substance (2-3%). After five to ten minutes, the tea is passed
through a filtering tissue and applied several times a day. (Wichtl et al, 1994)
Oral use: an infusion of one teaspoon dried herb in 0.5 l freshly boiled water. (Weiss et al,
1999)
©
EMEA 2010
8/13
•
Liquid preparations in case of common cold.
Application:
oral use.
Posology:
Tincture (1:5 in 45% alcohol): 50 drops 3 to 5 times a day. (Delfosse et al, 1998; Barnes
et al, 2007; Van Hellemont, 1985)
•
Nasal ointment for a runny nose (Van Hellemont, 1985)
Application:
external use.
Posology:
R/ Euphrasia tincture 5 g
Lanoline 5 g
Vaseline 15 g
Bergamot essence 2 drops
1 application 3 times a day in each nostril.
II.3
N
ON
-C
LINICAL
D
ATA
II.3.1
Overview of available pharmacological data regarding the herbal substance(s), herbal
preparation(s) and relevant constituents thereof
Porchezhian et al (2000) tested the anti-hyperglycemic effects of
Euphrasia officinalis
on
wistar albino rats. Hyperglycemia was induced by an intraperitoneal injection of alloxan
monohydrate. 100 grams of air-dried leaves from
Euphrasia officinalis
growing in Nilgiri
district (India) were extracted with hot distilled water and dried using a vacuum rotating
evaporator. The obtained extract was used in the experiment (600 mg extract per kg
bodyweight).
In the first part of the experiment, there were three groups of rats (fasted overnight): control
group (distilled water), test group (600 mg
Euphrasia
extract per kg, p.o.) and a reference
group (phenformin, 600 mg/kg, p.o.). The control group received only the vehicle in which
alloxan was dissolved, the other two groups received alloxan.
The administration of alloxan showed a rise in the blood glucose levels as compared to the
control group. Three to six hours after oral administration of the aqueous extract of
Euphrasia
to diabetic rats, the blood glucose level had significantly dropped (P<0.01), while the control
group showed no significant reduction of the blood glucose level.
©
EMEA 2010
9/13
In the second part of the experiment, the effect of
Euphrasia
on normoglycemic rats was
tested. Again there were three groups of rats (fasted overnight): control group (distilled
water, test group (600 mg
Euphrasia
extract per kg, p.o.) and a reference group (phenformin,
600 mg/kg, p.o.). There was no alloxan administered.
Treatment with the extract showed no significant decrease in blood glucose levels in
normoglycemic rats (P<0.01).
II.3.2
Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
preparation(s) and relevant constituents thereof
No data available.
II.3.3
Overview of available toxicological data regarding the herbal substance(s)/herbal
preparation(s) and constituents thereof
Porchezhian et al (2000) investigated the acute toxicity of aqueous eyebright extract on wistar
albino rats. 100 grams of air-dried leaves from
Euphrasia officinalis
growing in Nilgiri
district (India) were extracted with hot distilled water and dried using a vacuum rotating
evaporator (DER = 4:1). The obtained extract was used in the experiment (600 mg extract
per kg bodyweight). Graded doses ranging from 0.1 to 6 g/kg were orally administered to
groups of six rats and observed for 72 h. There were no symptoms of toxicity seen.
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
II.3.4
Overall conclusions on non-clinical data
In general there is a discrepancy between the traditional use and the non-clinical data, as
these data are not related to ocular use. Safety data on ocular use are not available either.
II.4
C
LINICAL
D
ATA
II.4.1
Clinical Pharmacology
No data available.
©
EMEA 2010
10/13
II.4.1.1
Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s)
including data on relevant constituents
No data available.
II.4.1.2
Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s)
including data on relevant constituents
No data available.
II.4.2
Clinical Efficacy
II.4.2.1
Dose response studies
No data available.
II.4.2.2
Clinical studies (case studies and clinical trials)
Stoss et al (2000) performed an open prospective cohort trial of
Euphrasia
single-dose eye
drops (WALA Heilmittel GmbH, Eckwälden/Bad Boll, Deutschland) in conjunctivitis.
Eighty patients were enrolled. The eye drops contained 10 g
Euphrasia
33c D3 and 10 g
Rosae
aetheroleum D7.
The recommended dose was one drop 1-3 (up to 5) times a day during fourteen days.
As efficacy parameters the variables “reddening”, “swelling”, “secretion”, “burning of the
conjunctiva” and “foreign body sensation” were investigated as therapeutic outcomes.
Undesirable effects were also observed and documented.
In 81% of the patients, there was complete recovery. Only one case showed a slight
worsening of the symptoms. The tolerability of the medication was very good.
No undesirable serious adverse events occurred due to the medication during the entire
prospective cohort trial.
II.4.2.3
Clinical studies in special populations (e.g. elderly and children)
Stoffel et al (2007) performed a pilot project to investigate the effect of local application of
Euphrasia
eye drops (in Switzerland ‘Euphrasia Augentropfen’: exact composition not given)
on antibiotic consumption by 44 neonates. They selected neonates with redness and
lacrymation of the eyes. Before the treatment, they performed a culture of the eyefluid.
There were 2 groups: in the control group (20 neonates) the eyes of the neonates were
washed every six hours with NaCl 0.9% and in the test group (24 neonates) the eyes were
washed every six hours with NaCl 0.9% and additionally one drop of
Euphrasia
was
administered. If the doctors considered the treatment after 48 hours as “successfull”, it was
not changed. If they considered the treatment as “not successfull”, the treatment changed to
Neosporin-Augentrophen
®
. The criteria for this decision was a worsening of the symptoms
or a positive culture. Seven neonates of the test group and 3 of the control group had to
change to Neosporin-Augentrophen
®
. Cultures of 11 neonates were positive for
Staphylococcus aureus,
but there was no need to change the treatment because the symptoms
had ameliorated.
The authors concluded that there was no difference between the control group and the test
group and so immediate antibiotic treatment is not always necessary. There were no side
effects reported.
©
EMEA 2010
11/13
II.4.3
Overall conclusions on clinical pharmacology and efficacy
The two published studies are of limited value. The open design of the first one is not reliable
to confirm whether the therapeutic effect is due to the preparation or to spontaneous healing.
The second study with the neonates is not conclusive due to the limited number of patients
and divergent outcomes. No adverse effects were reported, but this finding is also not
conclusive because of the small-scale of the trials. As a consequence of these results, only a
traditional use could be considered.
II.5
C
LINICAL
S
AFETY
/P
HARMACOVIGILANCE
II.5.1
Overview of toxicological/safety data from clinical trials in humans
In the study performed by Stoss et al (2000) no serious adverse events were reported.
II.5.2
Patient exposure
No data available.
II.5.3
Adverse events and serious adverse events and deaths
No data available.
II.5.4
Laboratory findings
No data available.
II.5.5
Safety in special populations and situations
No data available.
II.5.6
Overall conclusions on clinical safety
The clinical studies reported above involved 124 patients. The number is too few to draw any
conclusions on clinical safety. As up to now no authorized or registered medicinal
preparations are on the market in Europe, no periodic safety update reporting has been
established.
II.6
O
VERALL
C
ONCLUSIONS
Traditional herbal preparations from
Euphrasiae herba
are mainly liquid water extracts
which are
ex tempore
made as infusions for application as an ocular impregnated dressing for
symptomatic treatment of minor irritation of the eye”. A nasal ointment containing an
irritation in common cold has also been described.
No adequate data are however available for these preparations concerning their safe use and
the plausibility of their pharmacological effects.
3
Specifications of the tincture not available.
©
EMEA 2010
12/13
STRUCTURAL RISK – BENEFIT ANALYSIS
Quality
A monograph on
Euphrasia rostkoviana
does not yet exist in the actual European
Pharmacopoeia. There is no major concern about adulteration with related species as
Euphrasia stricta
can be differentiated from
Euphrasia officinalis
by the presence of curved
hairs on the tops of the leaves.
Safety
There are no concerns about serious adverse events or drug-drug interactions with
Euphrasia
preparations. Also from non-clinical experiments, no toxic effects were reported. However, in
order to avoid deterioration of ocular conditions, medical supervision is necessary when the
symptoms do not improve within 2 days. There is only one study with a limited amount of
paediatric patients, not resulting in serious adverse events.
Efficacy
From the presence of secondary metabolites, an adstringent and anti-inflammatory activity
can be hypothesized for Euphrasia preparations. On one hand ocular use of Euphrasia is
based upon a long-standing tradition. On the other hand, there is no clinical proof for such an
indication. An ointment made with Euphrasia tincture has been documented as a traditional
herbal medicinal product for the relief of local nasal irritation in common cold.
Conclusion
Based on the above-mentioned concerns, no Community herbal monograph on
Euphrasia
officinalis
L. and
Euphrasia rostkoviana
Hayne, herba can be established.
III.
ANNEXES
III.1
P
UBLIC
S
TATEMENT ON
E
UPHRASIA OFFICINALIS
L.
AND
E
UPHRASIA ROSTKOVIANA
H
AYNE
,
HERBA
III.2
L
ITERATURE
R
EFERENCES
©
EMEA 2010
13/13
Source: European Medicines Agency
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