A randomized, double-blind, placebo- -controlled study to investigate the use of bacteriophages in patients with chronic rhinosinusitis with nasal polyps.

Abstract

Background A randomized, double-blind placebo-controlled study investigated the use of bacteriophages in the treatment of chronic rhinosinusitis with nasal polyps. Materials and Methods 40 adult patients with сhronic rhinosinusitis with nasal polyps were examined. All patients underwent functional endoscopic sinus surgery. After the surgery, 20 patients got the intranasal gel with a bacteriophages mixture (Otofag, Micromir, Russia) twice a day for ten weeks, and 20 patients got a placebo. Results On the 10th day, IL-1β secretion diminished (63 mg/ml versus 440 mg/ml in control). There was a decrease in the total number of microorganisms and Enterobacteriaceae (5.7 x 106 CFU/ml versus 1.2 x 109 CFU/ml in control), and the absence of Streptococci (versus 2.1 x 109 CFU/ml in control) on the 30th day of the treatment in the group with the bacteriophages. On the 10th day, a decrease in the activity of secretory IL-1β and IL-8 strongly and very strongly correlated with a total number of microorganisms (r = 0.7; r = 0.9 respectively), as well as secretory IL-8 with Enterobacteriaceae (r = 0.72) and Staphylococci (r = 0.65) in the active group treated with the bacteriophages. On the 30th day, the decrease in serum IL-1β significantly correlated with the total number of microorganisms (r = 0.80) and enterobacteria (r = 0.90) in the active group. Conclusions The administration of bacteriophages restored the balance of microorganisms in the nasal cavity and decreased the inflammatory response in chronic rhinosinusitis with nasal polyps. These changes, such as an inflammation dampening, could theoretically reduce the recurrent growth of polyp tissue in the future.