Published December 5, 1984; Replaced April 15, 1994.
List of German Commission E Monographs (Phytotherapy)
Hippocastani semen, horse chestnut seed.
A dry extract manufactured from horse chestnut seeds, Aesculus hippocastanum L. [Fam. Hippocastanaceae], adjusted to a content of 16 - 20 percent triterpene glycosides (calculated as anhydrous aescin).
As found in different animal experiments, the principal ingredient in horse chestnut seed extract is the triterpene glycoside mixture, aescin (escin), which has an anti-exudative and vascular-tightening effect.
There are indications that horse chestnut seed extract reduces the activity of lysosomal enzymes that is increased in chronic pathological conditions of the veins, so that the breakdown of glycoacalyx (mucopolysaccharides) in the region of the capillary walls is inhibited. The filtration of low-molecular proteins, electrolytes and water into the interstitium is inhibited through a reduction of vascular permeability.
Using placebo as reference, a significant reduction of transcapillary filtration has been demonstrated in pharmacological studies involving human subjects, and a significant improvement shown in the symptoms of chronic venous insufficiency (sensation of tiredness, heaviness and tension, pruritus, pain and swelling in the legs) in various randomized double-blind studies and/or cross-over studies.
Pilot studies are available on the toxicology of horse chestnut seed extract. The oral LD50 of the extract is 990 mg per kg body weight in the mouse, 2150 mg per kg body weight in the rat, 1530 mg per kg body weight in the rabbit, and 130 mg per kg body weight in the dog. In the rat, the "no effect" dose is between 9 and 30 mg per kg body weight after intravenous administration of horse chestnut seed extract over a period of 8 weeks. Chronic administration above 80 mg per kg body weight over a period of 34 weeks produced gastric irritation in dogs. In rats, no toxic changes were observed throughout the same period up to an oral dose of 400 mg per kg body weight.
Clinical Data 1. Indications Treatment of complaints found in pathological conditions of the veins of the legs (chronic venous insufficiency), for example, pains and a sensation of heaviness in the legs, nocturnal systremma (cramps in the calves), pruritis and swelling of the legs.
Note: Other non-invasive treatment measures prescribed by a physician, such as leg compresses, wearing of supportive elastic stockings, or cold water applications, must be observed under all circumstances.
Pruritis, nausea, and gastric complaints may occur in isolated cases after oral intake.
No restriction known.
100 mg aescin (escin) corresponding to 250 - 312.5 mg extract 2 times per day in delayed release form. 8. Overdosage None known.