Oral Immunotherapy of Chronic Bronchitis: a Double-Blind Placebo-Controlled Multicentre Study

Abstract

104 patients with chronic bronchitis were treated under randomized double-blind conditions with either Broncho-Vaxom® (BV) or a placebo over a period of 6 consecutive months. The beneficial effect of BV was manifested by a statistically significant reduction in the duration of acute episodes and of fever (p < 0.001) with respect to the placebo group. The consumption of antibiotics dropped significantly in the BV group (p < 0.05) but not in the placebo group. The serum IgA levels increased in the BV group and the difference with the placebo group was statistically significant (p < 0.05) from the 3rd month onwards. In the patients with bronchitic exacerbations during the trial, T-lymphocyte counts increased steadily under BV therapy until 3 months after the exacerbation (p < 0.05), but not under the placebo. BV was generally well tolerated with the exception of 1 patient who reported nausea and upper abdominal pain. In their assessment of the overall therapeutic effect, the physician judged BV to be significantly superior (p < 0.001) to the placebo as regards both the curative and prophylactic efficacy

The immunostimulant OM-85 BV prevents wheezing attacks in preschool children

“…[26][27][28][29][30][31][32][33] OM-85 BV also enhances antimicrobial defenses by eliciting IL-12-dependent synthesis of IFN-g by CD4 1 T cells. 34 Huber et al 35 (3)(4) 5.5 (4)(5)(6)(7)(8) Values are shown as means 6 SDs and medians (25th-75th percentiles).…”

May We Strengthen the Human Natural Defenses with Bacterial Lysates?

“…41 Another RCT involving 104 patients affected by chronic bronchitis, comparing bacterial lysates (OM-85BV) to placebo over a period of 6 month showed a significant reduction of the duration and symptoms of acute episodes in the treatment group, with a concomitant sparing-effect on the use of antibiotics, an increase in serum IgA levels and in T-lymphocyte counts. 42 In a recent Italian study, 140 patients with a medical history of recurrent URTIs were randomly assigned to 3 groups: the first group received, by sublingual administration, a PMBL (Ismigen) obtained by mechanical lysis of 48 billion bacteria commonly responsible for upper respiratory tract infections; the second one received an oral immunoregulating lysate obtained by chemical lysis of 36 billion bacteria (CLBL); the third one, as control group, did not receive any immunostimulating treatment. The number of URTIs, was significantly lower in the PMBL group with respect to the other groups (P Ͻ 0.05).…”

Oral Immunization with Bacterial Lysate against Infection with Streptococcus pneumoniae in Mice

“…A signifi cant reduction in acute episodes with fever and con sumption of antibiotics was described in several stud ies on oral immunization with bacterial lysates in pa tients susceptible to respiratory infection [9][10][11]. These results suggest that it is possible to immunize against respiratory pathogens, circumventing the ad verse reactions often accompanying parenteral im munization.…”