Immunotoxicological safety and observational studies of homeopathic preparations from Candida albicans and Candida parapsilosis

The cell biomass of Candida albicans (C.P. Robin) Berkhout DSM 5197 and Candida parapsilosis (Ashford) Langeron et Talice DSM 4884 produced by fermentation is purified from culture medium components 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 (homeopathic starting material) is named e volumine cellulae (evc; synonym: e volumine mycelii) and potentised to dilutions or triturations used for homeopathic medicinal products.

The ointment, suppositories, capsules, drops and injections with declared D3 (3X), D4 (4X) and D5 (5X) potencies from mentioned starting materials (brand names: Albicansan^®, Pleo^® Alb and Pefrakehl^®, Pleo^® Pef) are authorised in Switzerland for the homeopathic treatment of eczema as well as mycotic skin and mucosa disorders.

Acute toxicity and possible immunotoxic effects after repeated oral, rectal, subcutaneous or intradermal/dermal 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, antigen-specific antibody production, acute systemic anaphylaxis induction, and skin sensitisation as well as local tolerance studies in rabbits. Candida albicans evc and Candida parapsilosis evc can be regarded as safe for the potencies used in the homeopathic medicinal products. These data are valid only for the investigated yeast strains and the specific, GMP controlled manufacturing process.

Observational studies with oral, rectal, cutaneous and parenteral applications of Albicansan^® and Pefrakehl^® were carried out. All these studies show a very good safety profile with a low level of side effects and intolerabilities.

Keywords: Candida albicans, Candida parapsilosis, immunotoxicity, observational studies.