Oral administration of milk from cows immunized with human intestinal bacteria leads to significant improvements of symptoms and signs in patients with oral submucous fibrosis

Background: Previous studies have shown that the local and systemic upregul ation of fibrogenic cytokines and downregulation of antifibrotic cytokine a re central to the pathogenesis of oral submucous fibrosis (OSF). The milk f rom cows immunized with human intestinal bacteria (immune milk) contains an antiinflammatory component that may suppress the inflammatory reaction and modulate cytokine production. Therefore, it was decided to test whether im mune milk may have some beneficial effects on controlling the symptoms and signs in OSF patients. Methods: In this preliminary study, 26 OSF patients who received immune mil k treatment (45 g of immune milk powder twice a day) for 3 months and oral habit intervention were included in the experimental group. Another 20 OSF patients who received only oral habit intervention served as the control gr oup. Results: We found that the interincisor distance was significantly improved (greater than or equal to 3 mm of the baseline measurement) in 18 of the 2 6 (69.2%) OSF patients in the experimental group at exit. However, in the c ontrol group none of the OSF patients had an increase in interincisor dista nce greater than 2 mm. In addition, disappearance or significant improvemen t of symptoms at exit was observed in 80% (16/20) of the patients with into lerance to spicy foods (P <0.001) and 72.2% (13/18) of the patients with xe rostomia (P <0.005) in the experimental group, compared with 17.6% (3/17) o f the patients with improvement of intolerance to spicy foods and 15.4% (2/ 13) of the patients with improvement of xerostomia in the control group. Pa rtial regression of concomitant oral leukoplakia or erythroplakia (judged f rom the size reduction of the lesions) at exit was noted in 71.4% (5/7) of the patients in the experimental group (P <0.05), compared with none (0/5) of the patients with improvement in the control group. Conclusion: We conclude that oral administration of immune milk leads to si gnificant improvements of symptoms and signs in OSF patients.