A novel treatment for food allergy developed using Traditional Chinese Medicine, food allergy herbal formula-2 (FAHF-2), is under investigation in a Phase II clinical trial. Adherence to treatment was assessed.
Subjects aged 12-45 years were randomized to receive active FAHF-2 or placebo, 10 tablets three times a day for 6 months (30 tablets daily). Subjects kept medication diaries and brought study medications to study visits. They were contacted every 2 weeks and study visits were conducted every 2 months. Data collected included number of tablets ingested (per diary), number returned, and number of days between study visits. Adherence was calculated based on number of tablets taken in relation to expected number taken during the study time frame. Adherence was defined by medication completion > 80%.
Sixty eight subjects were enrolled into the study, median age was 16 years old (range 12-44 years), 61.7% male, and 86.7% Caucasian, 4.4% African American, 5.8% Asian, and 2.9% other. Of the 9 subjects who withdrew from the study, three were due to difficulties with medication compliance. Of the 59 subjects who completed 6 months of therapy, 16 (27%) were non-adherent for 1/3 of the study period, 8 (13.6%) were non-adherent for 2/3 of the study and 2 (3%) were non-adherent for the entire study. Twenty-six (44%) of the subjects were non-adherent to either part or all of the 6 month study.
Almost half of study participants had difficulties with medication adherence in this 6 month study, suggesting that the intervention may be too demanding.