Transcript Cefakliman mono

Active ingredient:
Extract from Cimicifuga rootstock
Indication:
Climacteric disorders
Hormonal changes during
climacteric period
Source: F. Borrelli et al. / Life
Sciences 73 (2003) 12151229
Estrogens
Progesterone
Estrogens
Progesterone
Hormonal changes during
climacteric period
Climacteric
Premenopause
Menopause
.
Postmenopause
Estrogens
LH, FSH
Black cohosh a gentle and natural alternative to
hormone substitution
The end for the classical hormone therapy?
A study of the Women‘s Health Initiative (WHI) with 16,609
women was abandoned prematurely due to a bad
benefit/risk proportion!
Source: JAMA 2002, 288 (3) : 321 - 333
The end for the classical hormone therapy?
The probands took in daily, for on average 5.2 years, a
combination preparation of conjugated estrogen (0.625
mg) and medroxyprogesterone-acetate (2.5 mg/d)
compared to placebo:
- thromboembolisms + 100%
- cerebral apoplexy + 41%
- risk of breast cancer + 26%
- myocardial infarcts + 29%
- hip fractures (osteoporosis) - 33%
- colon cancer - 37%
Source: JAMA 2002, 288 (3): 321 - 333
Botany
Cimicifuga racemosa (L.) Nuttal
Family:
Ranunculaceae
(crowfoot plants).
Synonyms:
Black snake root, Bugbane, Rattleroot,
Squaw root
Origin:
Eastern and central part of North America,
Canada, Europe, moderate to arctic parts
of Asia.
Botany
Cimicifuga racemosa (L.) Nuttal
Medicinal drug: Black cohosh rootstock,
Cimicifugae rhizoma.
After the fruits have become ripe
in autumn, the rhizome is collected,
dried and cut up.
The fresh or dried rootstock
with attached roots is used for
production of the extract.
Brief profile - Black cohosh
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The enduring plant can reach a height of up to 2 m.
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The upright stems have big, multiple-feathered leaves
with deep-sawed small leaves.
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The small white blossoms build long narrow clusters.
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The originating fruits are ovoid capsules which
contain numerous flat seeds.
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The rootstock which is used for extraction of the drug
is dense and branched.
Ingredients
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triterpene glycosides (actein, cimicifugoside)
isoflavonoids
essential oil
bitter substances
resins
several fatty acids
The drug basically contains
triterpene glycosides of the
type cycloartenol, e.g.
actein and cimicifugoside.
actein
Therapeutic principle: Total extract
The estrogen-like ingredients attack in mesolimbic
and hypothalamic structures:
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selective reduction of the LH-secretion
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no influence on the FSH- and prolactin level
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contains phyto-SERMs
(selective estrogen receptor modulators)
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without undesired effects on uterus, mamma
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reduction of the osteoporosis and arteriosclerosis risk
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no undesired effects on the endometrium
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estrogen-like effect
Therapeutic principle
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LH-suppression (suppression of the hypothalamic
LHRH pulse generator)
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binding to estrogen receptors
(competitively to estradiol)
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stabilisation of neurovegetative symptoms
(effect on the vasomotor centre, balance vagus symphaticus)
Therapeutic principle
Hormonal circuit of regulation
at normal production
of estradiol
in menopause
Source: ÄP Gynakologie 2000
Therapeutic principle
Endocrine regulation
Fields of application
Traditional
Ancient medicinal plant of the North American Indians:
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use against snake bites
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in case of painful menstruation
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for easing of the birth process
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as fresh pressed juice with honey
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as good preparation for cough
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for tinnitus and particular diseases, socialised with
certain depressions
Fields of application
In menopause
About 1940 introduction of Cimicifuga
in the therapy of premenstrual und
climacteric disorders.
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hot flushes and outbreaks of sweat
tiredness and lack of motivation
sleep disorders
weight changes
headache
articular and muscular pain
ventricular tachycardia
sometimes urinary incontinence
weakness of concentration
Fields of application
In menopause
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irritability
anxiety
depressive moods
irregular menstruation
decreasing libido
dry skin and mucosa
pains during the sexual intercourse
falling out of hair, greasy hair
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Pre-clinic
In-vitro study precludes proliferative effect on estrogensensitive mammary carcinoma cells
Bodinet C, Freudenstein J (2002): Influence of Cimicifuga racemosa on the proliferation
of estrogen receptor-positive human breast cancer cells. Breast Cancer Res Treat 76
(1): 1-10
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Pre-clinic
Extract from Cimicifuga does not show any estrogen-like
stimulation of tumour growth in the animal model
Freudenstein J, Dasenbrock C, Nisslein T (2002): Lack of promotion of estrogendependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa
extract. Cancer Res. 62 (12): 3448-52
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Pre-clinic
Extract from Cimicifuga in case of osteoporosis
Nisslein T, Freudenstein J (2003): Effects of an isopropanolic extract of Cimicifuga
racemosa on urinary crosslinks and other parameters of bone quality ovariectomized rat
model of osteoporosis. J Bone Miner Metab 21 (6): 370-6
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Therapy studies
Placebo-controlled study:
Düker E et al. (1991): Effects of extracts from cimicifuga racemosa on gonadotropin
release in menopausal women and ovariectomized rats. Planta Med 57: 420-424
 Extract from Cimicifuga does not influence the FSHand prolactin level
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Therapy studies
Double-blind, randomised study:
Stoll W. (1987): Phytopharmacon influences atrophic vaginal epithelium: double-blind
study Cimicifuga vs. estrogen preparation. Therapeutikon 1: 23-31
 Extract from Cimicifuga can absolutely be
compared with estrogens
Clinical efficacy
Rational phytotherapy with
Cimicifugae racemosae rhizoma
Therapy studies
Three-armed double-blind study:
Wuttke W, Seidlova-Wuttke D, Gorkow C (2003): The Cimicifuga preparation BNO 1055
vs. conjugated estrogens in a double-blind placebo-controlled study: effects on
menopause symptoms and bone markers. Maturitas 44 Suppl 1: 67-77
Osmers R (2004):Efficacy and tolerability of an isopropanolic extract from the rootstock
of the Black cohosh. Abstract on the lecture. Phytopharmaka und Phytotherapie 2004,
Forschung und Praxis, 26.-28. Februar 2004, Berlin
 Extract from Cimicifuga improves psychovegetative
complaints clearly
Cefakliman® mono advantages at a glance
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Gentle and natural alternative to
hormone replacement therapy
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Regulation of hormonal disharmonies
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Normalisation of psychosomatic
and vegetative disorders in menopause
Basic information
Fields of application
For improvement of psychical and neurovegetative disorders
caused by the menopause.
Composition
Active ingredient:
1 capsule contains: Cimicifuga rootstock dry extract (4 : 1) 5 mg.
Excipients:
Lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose,
povidone, gelatin, titanium dioxide (E 171), erythrosine (E 127), indigotine (E 132),
ferric oxide red (E 172), ferric oxide black (E 172).
Contra-indications
If patients, suffering from estrogen-dependent tumours, are/were in medical care,
Cefakliman® mono must not be used as it is not known if Cimicifuga rootstock
extracts support estrogen-dependent tumours or if they do not have any influence.
There has not been sufficient research for the application of this medicine during
pregnancy and lactation. Therefore it should not be used during this period.
Basic information
Interactions with other medicaments
None known.
Precautions for use and warnings
During the treatment liver function tests must be followed up.
The long-term usage of Cimicifuga racemosa preparations can have rare side
effects on the liver. Therefore, if you notice fatigue, anorexia, yellowness of the
skin and eyes, pain of stomach, nausea, vomiting or darkness of urine during the
use of Cefakliman® mono you should stop usage and tell your doctor.
Dosage
Unless otherwise prescribed, adults take 1 capsule twice daily.
Kind and duration of application
Cefakliman® mono capsules are taken with some liquid (e.g. water).
The duration of the treatment is generally not limited, but Cefakliman® mono
should not be taken for more than 3 months without medical advice.
Basic information
Side effects
Occasionally gastric disorders. An increase in weight is possible.
Commercial form
Capsules: 50 pcs.
Monograph
Black Cohosh root, Cimicifugae racemosae rhizoma
Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German
Federal Institute for Drugs and Medical Devices)
Commission E (Phytotherapy), BAnz.-No. 228 dated March 02, 1989
Name of Drug
Cimicifugae racemosae rhizome, black cohosh root.
Composition of Drug
Preparations of black cohosh consist of the fresh or dried rhizome with attached
roots of Cimicifuga racemosa (L.) Nutt. [Fam. Ranunculaceae] in effective dosage.
The drug contains triterpene glycosides.
Uses
Premenstrual discomfort, dysmenorrhea or climacteric [menopausal]
neurovegetative ailments.
Contraindications
None known.
Monograph
Side Effects
Occasionally, gastric discomfort.
Interactions with Other Drugs
None known.
Dosage
Unless otherwise prescribed: Daily dosage:
Extracts with alcohol 40 – 60 percent (v/v) corresponding to 40 mg of drug.
Mode of Administration
Galenical preparations for internal use.
Duration of Administration
Not longer than 6 months.
Actions
Estrogen-like action
Luteinizing hormone suppression
Binding to estrogen receptors