Phase 1 study of a food allergy herbal formula

A new paper has been published describing the progress of safety and tolerability trials of the herbal product, food allergy herbal formula 2 (FAHF-2), in human subjects with food allergy. Previous studies of FAHF-2 in a murine model of peanut-induced anaphylaxis have shown it has a protective effect against peanut allergy.

In the initial part of the Phase 1 study conducted by researchers at the Mount Sinai School of Medicine, 19 food allergic participants received 1 of 3 doses of FAHF-2 or placebo: 2.2 g (4 tablets), 3.3 g (6 tablets), or 6.6 g (12 tablets) 3 times a day for 7 days. Four active and two placebo patients were treated at each dose level. Participants in a 12 to 45 year old age group were selected on the basis of having peanut, tree nut, fish and shellfish allergies as these are deemed to be the most severe and chronic food allergies.

Two patients (one in the FAHF-2 group and one in the placebo group) reported mild gastrointestinal symptoms. One patient withdrew from the study because of an allergic reaction that was not thought to be related to the study medication.

After comparison of results from clinical tests and examinations between the groups of participants, FAHF-2 appeared to be safe and well tolerated in patients with food allergy. Following this early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a 6 month long-term, open-label extension safety trial. The subjects will be randomized to two FAHF-2 dose groups.

Among the components of the herbal formula are Chinese plum, Sichuan pepper, coptis rhizome, philodendron bark, dried ginger rhizome, cinnamon twig, ginseng root, Chinese Angelica root, and the potent wooden mushroom.

Reference: Wang et al. 2010 Annals of Allergy Asthma and Immunology. Vol 105(1) pp. 75-84.e1