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Published on: December 10, 2013
Polyvalent mechanical bacterial lysate for the prevention of recurrent respiratory infections: a meta-analysis
Mario Cazzola1, Sreedhar Anapurapu, Clive P Page
1Department of Internal Medicine, Unit of Respiratory Clinical Pharmacology, University of Rome Tor Vergata, Rome, Italy. mario.cazzola@uniroma2.it
Background:
Respiratory tract infections are common and remain a major source of morbidity, mortality and economic cost worldwide, despite advances in modern medicine. One treatment approach is to non-specifically increase the immune response or augment innate defense mechanisms through the use of bacterial lysates. Polyvalent Mechanical Bacterial Lysate (PMBL) is a bacterial lysate made from a wide range of pathogenic bacteria, including all of the most commonly occurring pathogens of the upper and lower respiratory tract obtained by mechanical lysis.
Aim:
To test the available evidence that PMBL is able to prevent respiratory tract infections.
Methods:
A number of studies investigating randomized comparisons of PMBL (active) with placebo or no treatment (control) were selected for analysis. The primary outcome measure was the prevention of exacerbations or acute respiratory tract infection. The results were expressed as relative risk (RR) and the number of patients needed to treat for one to benefit (NNTB).
Results:
Data from 2557 patients from 15 randomized clinical trials (RCTs) was investigated. PMBL induced a significant reduction of infections vs placebo (RR -0.513; 95% CI; -0.722 - -0.303; p = 0.00). The NNTB was 1.15. The RR was always in favor of PMBL (in recurrent respiratory infections other than COPD, chronic bronchitis and tuberculosis, RR -0.502; 95% CI -0.824 - -0.181; in children RR -2.204; 95% CI -3.260 - -1.147; in COPD or chronic bronchitis, RR -0.404; 95% CI -0.864-0.057; in tuberculosis, RR -0.502; 95% CI -0.890 - -0.114).
Conclusions:
The results of the present meta-analysis suggest that PBML is effective in both in children and in adults in preventing respiratory tract infections. Our current meta-analysis shows that there is a trend with PBML toward clinically significant results in patients with COPD but it did not quite achieve statistical significance due to the small number of COPD studies.
Insights
Polyvalent Mechanical Bacterial Lysate (PMBL) significantly reduces respiratory tract infections in adults and children. This bacterial lysate therapy offers a promising approach to preventing common infections, with a low number needed to treat.
Area of Science:
- Immunology
- Microbiology
- Pharmacology
Background:
- Respiratory tract infections (RTIs) are a significant global health burden, causing morbidity, mortality, and economic costs.
- Bacterial lysates, like Polyvalent Mechanical Bacterial Lysate (PMBL), are explored to enhance innate immune defenses against RTIs.
- PMBL is derived from common respiratory pathogens using mechanical lysis.
Purpose of the Study:
- To evaluate the efficacy of PMBL in preventing respiratory tract infections.
- To synthesize evidence from randomized controlled trials comparing PMBL to placebo or no treatment.
Main Methods:
- A meta-analysis of randomized clinical trials (RCTs) was conducted.
- The primary outcome was the prevention of acute respiratory tract infections or exacerbations.
- Relative risk (RR) and number needed to treat for one to benefit (NNTB) were calculated.
Main Results:
- Data from 15 RCTs involving 2557 patients showed PMBL significantly reduced infections compared to placebo (RR -0.513).
- The number needed to treat for one to benefit (NNTB) was 1.15, indicating high efficacy.
- Consistent benefits were observed across various patient groups, including children and those with recurrent infections, COPD, or tuberculosis.
Conclusions:
- PMBL demonstrates effectiveness in preventing respiratory tract infections in both children and adults.
- While a trend towards clinical significance was noted in COPD patients, further research with larger sample sizes is needed to achieve statistical significance.
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