Active ingredient: Extract from Chaste tree fruits

Indication:Menstrual disorders

Botany

Family: Verbenaceae(vervain plants)

Synonyms: Monk‘s pepperMönchspfefferAbrahamsstrauchChaste tree

Origin: Mediterranean area, Central Asia, Isle Krim. Preferably also on brooksides and riversides.

Vitex agnus castus L.

Botany

Medicinal drug: Chaste tree fruits (Agni casti fructus), consisting of the ripe, dried fruits.

Brief profile

Chaste tree is a shrub up to 4 m high.

The leaves are crossed-opposite, long-stemmed.

Separated finger-shaped with up to 7 lanceolate

feathered small leaves.

The mauve, ear-like inflorescences build

reddish-black, peppercorn-sized drupes.

Time of prosperity: June to September.

Ingredients

bicyclic diterpenes (aucubin, agnoside)

lipophile flavonoids (casticin)

essential oil

fatty oil

Effects

inhibition of the prolactin secretion and thus, reduction of increased prolactin levels

point of action at the hypophyseal portal system

dopaminergic effect

inhibition of lactation (experiments in animals)

Release and inhibition of hormones in hormonal circuit of regulation

Quelle: PZ Nr. 10, 144 Jahrg. 1999

feed-back stimulating influence inhibiting influence

Hypo-thalamus

prolactin-release-inhibiting-hormone = dopamine

gonadotropin-releasing-hormone (GnRH)

adenohypophysis prolactin

ovaryestradiol progesterone

luteinizing hormone (LH)follicle-stimulating hormone (FSH)

Fields of application

Traditional

- in the antique for women‘s diseases, especially fertility disorders

Gynaecology

- for all symptoms of corpus luteum insufficiency and estrogen-progesterone-imbalance

1. Premenstrual syndrome (PMS)

Fields of application

symptoms:

psychic: nervousness, irritability, mood swings, depressive states, lack of concentration, insomnia.

somatic: migraine-like headache, feeling of tension in the breasts, swellings, edema, lower abdominal cramps, nausea, feeling of fullness, bloating, constipation, tiredness.

2. Menstrual irregularities

Fields of application

irregularities of the menstrual rhythm polymenorrhea/oligomenorrhea: too frequently / too rarely

irregularities of the menstrual intensityhypomenorrhea/hypermenorrhea: too weak / too strong

irregularities of the duration of the menstruationmenorrhagia/brachymenorrhea: too long / shortened

secondary amenorrhea (absence of menstruation over a period of 6 months, after prior normal course)

3. Mastodynia

Fields of application

premenstrual, mostly painful breast tension, complaints are mostly limited to the second half of the cycle

4. Fertility disorders

Clinical efficacy

Rational phytotherapy with Vitex agnus castus

Menstrual irregularities

Increased prolactin levels, existing before start of the therapy, could be reduced during the treatment with Vitex agnus castus.

Roeder D, (1994): Therapy of menstrual cycle disturbancesVitex agnus-castus. Zeitschrift für Phytotherapie 15, 155-159

Clinical efficacy

Rational phytotherapy with Vitex agnus castus

Premenstrual syndrome

The most frequent and most important symptoms such as headache, breast tension, nervousness, lack of concentration, emotional changes and depressions showed a clear improvement.

Berger D, Schaffner W, Schrader E, Meier B, Brattstrom A, (2000): Efficacy of Vitex agnus castus L. extract Ze 440 in patients with premenstrual syndrome (PMS). Arch Gynecol Obstet. Nov; 264 (3): 150-153

Loch EG, Selle H, Boblitz N, (2000): Treatment of premenstrual syndrome with a phytopharmaceutical formulation containing Vitex agnus castus. J Womens Health Gend Based Med. 9 (3): 315-320

Clinical efficacy

Rational phytotherapy with Vitex agnus castus

Premenstrual syndrome

Placebo-controlled, randomised double-blind study

The treatment of PMS with monk‘s pepper is effective:

Significant reduction of irritability, mood swings, aggressiveness, headache and breast tensions.

Schellenberg R, et al., (2001): Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomized, placebo controlled study. BMJ 322: 134-137

Clinical efficacy

Rational phytotherapy with Vitex agnus castus

Mastodynia

Halaska M, Beles P, Gorkow C, Sieder C, (1999): Treatment of cyclical mastalgia with a solution containing a Vitex agnus castus extract: results of a placebo-controlled double-blind study. Breast. 8 (4): 175-181

Placebo-controlled, randomised double-blind study

Reduction of the inconvenient feeling of tension and swelling in the breast before menstruation

Clinical efficacy

Rational phytotherapy with Vitex agnus castus

Fertility disorders

Milewicz A, Gejdel E, Sworen H, Sienkiewicz K, Jedrzejak J, Teucher T, Schmitz H, (1993): [Vitex agnus castus extract in the treatment of luteal phase defects due to latent hyperprolactinemia. Results of a randomized placebo-controlled double-blind study] Arzneimittelforschung 43 (7): 752-756

Placebo-controlled, randomised double-blind study

Duration of the luteal phases increased clearly

Release of prolactin decreased significantly

Cefanorm® - Advantages at a glance

normalises cycle disorders in a natural and gentle way

stimulates corpus luteum

reduces prolactin level

does not contain any hormones

Basic information

Fields of applicationIrregularities of the menstrual cycle, sensations of tension and swelling in the breasts (mastodynia), monthly recurring complaints before the onset of the menstruation (premenstrual symptoms).

CompositionActive ingredient:1 capsule contains: Dry extract from Chaste tree fruits (7 - 13 : 1) 4 mg.Extraction solvent: Ethanol 60% (m/m).

Excipients:Glucose syrup, lactose monohydrate, talc, maize starch, magnesium stearate, colloidal anhydrous silica, gelatin, sodium laurilsulfate (dodecylsulfate), purified water, titanium dioxide E 171.

Contra-indicationsCefanorm® must not be taken in when suffering from hypersensitivity to Chaste tree fruits (Monk’s pepper) or to one of the excipients of the medicament, hypophyseal tumours, mammary carcinoma. Use during pregnancy and lactation: Due to not sufficient investigations Cefanorm® must not be taken in during pregnancy and lactation.

Interactions with other substancesInteractions are not known. There are references - based on experiments in animals - to a dopaminergic effect of the drug; thus an alternating weakening of the effect could be possible in case of administration of dopamine-receptor-antagonists.

WarningNone known.

DosageIntake of 1 capsule daily (corresponding to 40 mg drug).

Basic information

Kind and duration of applicationCefanorm® capsules should preferably always be taken in at the same time of day. The preparation should be taken in over 3 menstrual cycles.

Side effectsAfter intake of Cefanorm® there are rarely itching rashes (urticarial exanthema).In the leaflet, the patient is instructed to stop the intake and immediately consulta physician in case of signs of hypersensitivity reactions.

Commercial formCapsules: 30 pcs.

Basic information

Monograph

Chaste Tree fruit, Agni casti fructus

Official Monograph of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (German Federal Institute for Drugs and Medical Devices)Commission E (Phytotherapy), BAnz.-No. 226 dated December 02, 1992

Name of DrugAgni castus fructus; chaste tree fruit, vitex fruit.

Composition of DrugChaste tree fruit composed of the ripe, dried fruits of Vitex agnus castus L. [Fam.Verbenaceae], as well as their preparations in effective dosage.

Pharmacological Properties, Pharmacokinetics, ToxicologyThere is evidence that aqueous-alcoholic extracts of chaste tree fruit inhibit secretion of prolactin in vitro. In human pharmacology there are no data about the lowering of prolactin levels. There is no knowledge regarding pharmacokinetics. Systematic studies about toxicology are unknown.

Monograph

Clinical data

1. UsesIrregularities of the menstrual cycle. Premenstrual complaints. Mastodynia.Note: In case of feeling of tension and swelling of the breasts and at disturbances of menstruation, a physician should be consulted for diagnosis.

2. ContraindicationsNone known.

3. Side EffectsOccasional occurrence of itching, urticarial exanthemas.

4. Special Cautions for UseNone known.

5. Use During Pregnancy and LactationNo application during pregnancy. In animal experiments an influence on the nursing performance was observed.

Monograph6. Interactions with Other DrugsInteractions are unknown. In animal experiments there is evidence of a dopaminergic effect of the drug; therefore, a reciprocal weakening of the effect can occur in case of ingestion of dopamine-receptor antagonists.

7. DosageUnless otherwise prescribed: Daily dosage:aqueous-alcoholic extracts corresponding to 30 - 40 mg of the drug.

8. Mode of AdministrationAqueous-alcoholic extracts (50 – 70 percent v/v) from the crushed fruits taken as liquid or dry extract.

9. OverdosageNone known.

10. Special warningsNone known.

11. Effects on Operators of Vehicles and MachinesNone known.

Differentiation in the area of dysmenorrhoea – PMS (Cefadian® / Cefanorm®)

Cefadian®

• girls / young women, 14- 25 (up to an age of 30)• no children• dysmenorrhoea• (increased prostaglandin)

• most intensive on 1st day of menstruation

• colic-like lower abdominal pain

Cefanorm®

• grown-up women over 25• does often have children• PMS• (imbalance estrogen/progesterone)

• complaints during the last 10 days of the cycle

• lower abdominal pain + mastodynia

general accompanying symptoms such as nausea, backache, headache, mental depressive moods