[Reduction of acute recurrence in patients with chronic recurrent hypertrophic sinusitis by treatment with a bacterial immunostimulant (Enterococcus faecalis Bacteriae of human origin].

A double-blind, placebo-controlled multicenter study in 157 patients with chronic recurrent sinusitis investigated the occurrence of acute relapses during treatment of patients with a bacterial immunostimulant (3 x 30 drops/day), comprised of cells and autolysate of human Enterococcus faecalis bacteria (Symbioflor 1, n = 78) in comparison to placebo (n = 79). The study included a treatment period of 6 months and a follow-up period of 8 months. Under verum the occurrence of relapses (50 incidents) was about half (56%) the number observed under placebo (90 incidents). In the Kaplan-Meier test the verum preparation emerged as significantly superior (p = 0.045, log rank test) compared to placebo. This superiority of verum was found during the treatment period with 17 vs. 33 relapses (p = 0.019) as well as during the follow-up observation with 33 vs. 57 relapses (p = 0.013). The time interval to the first relapse was clearly longer under verum (513 days) than under placebo (311 days). The relative risk for a relapse under the test preparation compared to placebo was 49.0% during the treatment and 55.8% during the follow-up period. Severity of the acute relapses was comparable in both groups. However, antibiotic therapy was only required in 2 patients treated with verum compared to 6 patients in the placebo group. Both preparations were well tolerated and serious side effects did not occur in either group. No changes in laboratory tests--hematology and clinical chemistry--were observed. Potential immunomodifying effects of the test preparation in view of the significant reduction in relapses were discussed.

RCT Entities:   Population Interventions Outcomes