Individuals with allergy to peanuts, tree nuts, sesame, fish, or shellfish are needed for a phase 2 clinical trial of the Chinese herbal formula FAHF-2. As of April 2011, the Mount Sinai School of Medicine in New York, New York and the University of Arkansas in Little Rock, Arkansas are recruiting participants age 12 to 45 years.
Dr. Julie Wang and collaborators at Mount Sinai School of Medicine reported successful results for the phase 1 trial that evaluated safety and tolerability. FAHF-2 stands for food allergy herbal formula 2, and consists of nine herbs chosen from the traditional formulations of Wu Mei Wan and Ling-Zhi, which have a long history of use in China. Wang's group was the first to obtain United States Food and Drug Administration approval to investigate a botanical product to treat food allergy.
The only adverse event in the phase 1 trial was minor gastrointestinal discomfort. However, symptoms were reported equally by patients in the placebo group and in the active botanical group, so the formula appears to be very well tolerated. Participants took up to 6.6 grams (12 tablets) three times a day for seven days.
Preclinical studies indicate that FAHF-2 is effective in preventing anaphylactic reactions in mice with peanut allergy. Dr. Ying Song and collaborators reported that the mechanism is based on inhibition of mast cells and basophils.
An estimated 6 percent of children and 4 percent of adults in the United States are affected by food allergies, according to Wang. These allergies can be life-threatening, and are now the leading cause of anaphylactic reactions treated in hospital emergency rooms. Strict avoidance of the allergenic food is the primary treatment, but this does not always work because allergens can be found as ingredients in unexpected foods. Patients must carry rescue medication and live with fear of consuming something dangerous at any time. An effective therapy could greatly improve their quality of life.
To participate in the FAHF-2 trial, ask your doctor or check the Clinical Trials website at http://clinicaltrials.gov.