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 less than 0.001) with respect to the placebo group. The consumption of antibiotics dropped significantly in the BV group (p less than 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 less than 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 less than 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 less than 0.001) to the placebo as regards both the curative and prophylactic efficacy.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 104 participants or records.
Read the paper
Related studies
- Impact of antibiotics on the human microbiome and consequences for host health
- Antibiotics in the clinical pipeline in October 2019
- The incidence of collagen-associated adverse events in pediatric population with the use of fluoroquinolones: a nationwide cohort study in Taiwan
- Research Communications of the 32nd ECVIM-CA Online Congress
- Singlet-Oxygen Therapy. Scientific And Methodological Materials
- Artificial Intelligence in Pharmacovigilance
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.