Active ingredient: Extract from Cimicifuga rootstock

Indication:Climacteric disorders

Hormonal changes during climacteric period

LH

, FS

H

LH

, FS

H

EstrogensProgesterone

EstrogensProgesterone

Source: F. Borrelli et al. / Life Sciences 73 (2003) 1215-1229

Hormonal changes during climacteric period

Estrogens

LH, FSH

Climacteric .

Premenopause Menopause Postmenopause

Black cohosh - a gentle and natural alternative to hormone substitution

A study of the Women‘s Health Initiative (WHI) with 16,609 women was abandoned prematurely due to a bad benefit/risk proportion!

The end for the classical hormone therapy?

Source: JAMA 2002, 288 (3) : 321 - 333

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%

The end for the classical hormone therapy?

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 rootstockwith attached roots is used for production of the extract.

Brief profile - Black cohosh

The enduring plant can reach a height of up to 2 m.

The upright stems have big, multiple-feathered leaves with deep-sawed small leaves.

The small white blossoms build long narrow clusters.

The originating fruits are ovoid capsules which contain numerous flat seeds.

The rootstock which is used for extraction of the drug is dense and branched.

triterpene glycosides (actein, cimicifugoside) isoflavonoids essential oil bitter substances resins several fatty acids

Ingredients

The drug basically contains triterpene glycosides of the type cycloartenol, e.g.actein and cimicifugoside.

actein

The estrogen-like ingredients attack in mesolimbic and hypothalamic structures:

Therapeutic principle: Total extract

selective reduction of the LH-secretion

no influence on the FSH- and prolactin level

contains phyto-SERMs (selective estrogen receptor modulators)

without undesired effects on uterus, mamma

reduction of the osteoporosis and arteriosclerosis risk

no undesired effects on the endometrium

estrogen-like effect

LH-suppression (suppression of the hypothalamic LHRH pulse generator)

binding to estrogen receptors (competitively to estradiol)

stabilisation of neurovegetative symptoms (effect on the vasomotor centre, balance vagus - symphaticus)

Therapeutic principle

Hormonal circuit of regulation

Source: ÄP Gynakologie 2000

Therapeutic principle

at normal production of estradiol

in menopause

Endocrine regulation

Therapeutic principle

Fields of application

Ancient medicinal plant of the North American Indians:

use against snake bites

in case of painful menstruation

for easing of the birth process

as fresh pressed juice with honey

as good preparation for cough

for tinnitus and particular diseases, socialised with certain depressions

Traditional

About 1940 introduction of Cimicifuga in the therapy of premenstrual und climacteric disorders.

Fields of application

In menopause

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 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 estrogen-sensitive 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 estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract. Cancer Res. 62 (12): 3448-52

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

Pre-clinic

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 FSH- and 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

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

Therapy studies

Clinical efficacy

Rational phytotherapy with Cimicifugae racemosae rhizoma

Cefakliman® mono - advantages at a glance

Gentle and natural alternative to hormone replacement therapy

Regulation of hormonal disharmonies

Normalisation of psychosomaticand vegetative disorders in menopause

Basic informationFields of applicationFor improvement of psychical and neurovegetative disorders caused by the menopause.

CompositionActive 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-indicationsIf 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 informationInteractions with other medicamentsNone known.

Precautions for use and warningsDuring 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.

DosageUnless otherwise prescribed, adults take 1 capsule twice daily.

Kind and duration of applicationCefakliman® 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.

Side effectsOccasionally gastric disorders. An increase in weight is possible.

Commercial formCapsules: 50 pcs.

Basic information

Monograph

Black Cohosh root, Cimicifugae racemosae rhizomaOfficial 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 DrugCimicifugae racemosae rhizome, black cohosh root.

Composition of DrugPreparations 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.

UsesPremenstrual discomfort, dysmenorrhea or climacteric [menopausal] neurovegetative ailments.

ContraindicationsNone known.

MonographSide EffectsOccasionally, gastric discomfort.

Interactions with Other DrugsNone known.

DosageUnless otherwise prescribed: Daily dosage:Extracts with alcohol 40 – 60 percent (v/v) corresponding to 40 mg of drug.

Mode of AdministrationGalenical preparations for internal use.

Duration of AdministrationNot longer than 6 months.

ActionsEstrogen-like actionLuteinizing hormone suppressionBinding to estrogen receptors