Immunotoxicological safety and observational studies of homeopathic preparations from mycelium cultures of Laricifomes officinalis

Fruiting bodies of Laricifomes officinalis (Vill.: Fr.) Kotl. & Pouz. (Polyporaceae) are used in Traditional European Medicine (Fungus laricis, Agaricus albus, German Pharmacopoeia Supplement ErgB 6) as well as in Homeopathy (Laricifomes officinalis, Boletus laricis, German Homeopathic Pharmacopoeia HAB).

Homeopathic preparations from the mycelium of the strain DSM 5211 of this fungus are evaluated in the view of safety.

The biotechnological produced biomass from the mycelium culture is purified from fermentation medium and then mechanically opened through a cell mill. After different purification steps, the water-soluble filtrate undergoes sterile filtration and is freeze-dried. The resulting lyophilisate is named “e volumine cellulae (lyophil, steril.)”, synonym: “e volumine mycelii (lyophil, steril.)”.

Acute toxicity and possible immunotoxic effects after repeated oral or subcutaneous application were tested in various studies with GLP compliance in genetic defined mice and guinea pigs. These studies include general immunotoxicity, mitogenic effects of naive T-cells, proliferation of antigen-stimulated T-cells, delayed type hypersensitivity reactivity (DTH), antigen-specific antibody production, acute systemic anaphylaxis induction, and skin sensitisation studies. The tested preparations for oral use can be regarded as immuno-toxicologically safe in potencies D3, D4 and D5. For the subcutaneous administration, DTH reactions were detected in individual animals (potency D4); however, no systemic effects of immediate hypersensitivity were observed for the therapeutically used potency D5. This data is valid only for the investigated fungus strain as well as for the specific, GMP controlled manufacturing process.

An observational study with oral and parenteral used homeopathic preparations (D4 capsules, D5 drops and D5 injection of the Larifikehl-line) was carried out. This study showed a very good safety profile with no side effects.

The mentioned dosage forms of Larifikehl are authorised in Switzerland for the homeopathic treatment of fever, lung diseases and gastrointestinal inflammations.