OBJECTIVES:Patients with chronic constipation due to food hypersensitivity (FH) had an elevated anal sphincter resting pressure. No studies have investigated a possible role of FH in anal fi ssures (AFs). We aimed to evaluate (1) the effectiveness of diet in curing AFs and to evaluate (2) the clinical effects of a double-blind placebo-controlled (DBPC) challenge, using cow ' s milk protein or wheat.
METHODS:One hundred and sixty-one patients with AFs were randomized to receive a " true-elimination diet " or a " sham-elimination diet " for 8 weeks; both groups also received topical nifedipine and lidocaine. Sixty patients who were cured with the " true-elimination diet " underwent DBPC challenge in which cow ' s milk and wheat were used.
RESULTS:At the end of the study, 69 % of the " true-diet group " and 45 % of the " sham-diet group " showed complete healing of AFs ( P < 0.0002). Thirteen of the 60 patients had AF recurrence during the 2-week cow ' s milk DBPC challenge and 7 patients had AF recurrence on wheat challenge. At the end of the challenge, anal sphincter resting pressure signifi cantly increased in the patients who showed AF reappearance ( P < 0.0001), compared with the baseline values. The patients who reacted to the challenges had a signifi cantly higher number of eosinophils in the lamina propria and intraepithelial lymphocytes than those who did not react to the challenges.CONCLUSIONS: An oligo-antigenic diet combined with medical treatment improved the rate of chronic AF healing. In more than 20 % of the patients receiving medical and dietary treatment, AFs recurred on DBPC food challenge .