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The second part of the study, published recently, has shown equally promising results. Of 18 patients enrolled, 14 completed the study. The patients received 3.3g (six tablets) of FAHF-2 three times a day for six months. Vital signs, physical examination results, laboratory data, pulmonary function test results and electrocardiographic data were acquired at the start and at two-month intervals. The test results showed no significant drug-associated harmful effects.
As before, there were clear signs that FAHF-2 was effective. The study team reports: “There was a significant reduction in basophil CD63 expression in response to ex vivo stimulation at month 6. There was also a trend toward a reduction in eosinophil and basophil numbers after treatment.” These are signs that the medicine could be effective in treating food allergy.
The conclusion is that FAHF-2 is safe and well tolerated and has inhibitory effects on basophil numbers. A controlled phase two study is now under way.
The first part of the study was published in Annals of Allergy, Asthma, & Immunology. To read the abstract, click here.
The second part has been published in the Journal of Allergy and Clinical Immunology. To read the abstract, click here.
To see other research findings, click here
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February 2012: Researchers in New York headed by Dr. Xiu-Min Li have high hopes that a Chinese herbal product known as Food Allergy Herbal Formula 2 (FAHF-2) could eventually be used to treat people with food allergy. There have been promising results with peanut-allergic mice and more recently, two studies set up to look at safety issues have shown the product to be safe and well tolerated in people with food allergy.
Nineteen people with food allergy took part in the first part of the study, which was randomized, double-blinded and placebo-controlled. This means that neither the patients nor the medical team knew who was receiving the remedy and who was receiving a placebo.
Two patients (one in the FAHF-2 group and one in the placebo group) reported mild gastro-intestinal symptoms. One patient withdrew from the study because of an allergic reaction but the study team believes that was unlikely to be related to the herbal remedy.
No significant differences were found in vital signs, physical examination results, laboratory data, pulmonary function test results and electrocardiogram data obtained before and after treatment visits. Blood tests showed clear signs that FAHF-2 was having an effect in the group that underwent the treatment. Significantly decreased interleukin (IL) 5 levels were found in the active treatment group after seven days – a sign of reduced allergy.
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