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Role of OM-85 BV in the prevention of recurrent acute tonsillitis: a retrospective study and literature review

The Egyptian Journal of Otolaryngology volume 40, Article number: 78 (2024) Cite this article

Abstract

Background

This study aims to assess the effectiveness of OM-85 BV in treating recurrent acute tonsillitis in children and adults during the first year after treatment, as well as to identify response predictors.

Results

The study included 92 patients, and there was a significant decrease in the number of acute tonsillitis cases after OM-85 BV treatment (p < 0.001). Exposure to tobacco smoke predicts non-response or partial response to treatment (OR 5.24, p = 0.005, 95% CI 1.646–16.671/OR 4.57, p = 0.014, 95% CI 1.362–15.339).

Conclusions

The study concludes that OM-85 BV is effective in preventing new episodes of tonsillitis in patients with a history of recurrent acute tonsillitis. Patients exposed to tobacco smoke tend to have a poorer response to treatment.

Background

Acute tonsillitis is a common ENT infection, with a prevalence of 11 to 12.3%, and is more frequent in children than in adults [1,2,3]. Diagnosis is clinical, and odynophagia is mandatory, in association with at least one of the following signs/symptoms [4]: fever (> 38.3 °C), cervical adenopathy, tonsillar exudate, and/or a positive RADT (rapid antigen diagnostic test) for group A beta-hemolytic Streptococcus.

Acute tonsillitis is associated with significant morbidity and absenteeism from school and work. The objective of treating tonsillitis is to alleviate symptoms; prevent local complications such as peritonsillar and retropharyngeal abscesses and systemic complications such as sepsis and rheumatic fever; and reduce absenteeism from school and work. For the initial treatment, a short-spectrum antibiotic like penicillin is used. In cases of recurrence, tonsillectomy may be necessary [5,6,7]. The accepted indications for tonsillectomy in children are as follows [4]: at least seven documented episodes in the previous year, or at least five episodes in each of the previous 2 years, or at least three such episodes in each of the previous 3 years.

In adulthood, the indications for this surgical procedure are not widely agreed upon. The decision to operate must consider the potential risks [8].

Patients with recurrent acute tonsillitis may consider bacterial lysates as a therapeutic option. Bacterial lysates are produced through the chemical or mechanical lysis of specific bacterial cultures. This process has the potential to activate loco-regional non-specific innate and adaptive immune responses, such as polyclonal production of immunoglobulins [9,10,11,12]. Therefore, they can be useful in patients with recurrent infections, regardless of whether the cause is viral or bacterial.

OM-85 BV is a product resulting from the alkaline lysis of 21 strains of pathogenic microorganisms found in the respiratory tract, including Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, and Moraxella catarrhalis. The recommended dosage is one capsule every morning for the first 10 days of each month, for 3 months. A second cycle of administration may be given 6 months after the initial dose. Studies, including a meta-analysis, have demonstrated that OM-85 BV provides greater benefits for pre-school children and children with a history of lower respiratory tract infections [13,14,15,16].

The objective of this study is to evaluate the effectiveness of OM-85 BV treatment in children and adults with recurrent acute tonsillitis during the first year after treatment and to determine predictors of treatment response.

Methods

Study population and data collection

This is a retrospective observational study conducted between January 2018 and December 2022, which includes patients diagnosed with recurrent acute tonsillitis and evaluated at Pedro Hispano Hospital. The diagnosis of acute tonsillitis was established based on the current definition in the Guidelines of the American Society of Otolaryngology and Head and Neck Surgery [4]. The study’s exclusion criteria were limited to individuals who were under 6 months of age, had experienced fewer than three episodes of acute tonsillitis in the past year, or had incorrectly used the OM-85 BV.

For each patient, we conducted a retrospective analysis of their clinical files, recording variables such as age, gender, history of atopy (cutaneous and/or respiratory), exposure to tobacco smoke, number of tonsillitis episodes in the year before and after taking OM-85 BV, and surgical treatment (adenotonsillectomy/tonsillectomy). The clinical records were maintained by various doctors in the department, including specialists and interns. Recurrent acute tonsillitis is defined as experiencing three or more episodes of acute tonsillitis within the last year [17]. All patients were treated with OM-85 BV.

The effectiveness of OM-85 BV was evaluated 1 year after treatment. The clinical response was categorized as total if the number of tonsillitis episodes per year decreased by more than 50%, partial if the reduction was 50% or less, and null if there was no change or an increase. Broncho-Vaxom® 7 mg is recommended for adults (≥ 18 years), while Broncho-Vaxom® Infant 3.5 mg is recommended for children (< 18 years and ≥ 6 months). The recommended dosage is one capsule per day for 10 days during 3 consecutive months.

Statistical analysis

The statistical analysis was conducted using SPSS software (version 28.0, IBM Corporation, Chicago, IL). Descriptive analysis was used to characterize the sample, presenting categorical variables as frequencies and percentages and continuous variables as means and standard deviations or medians and interquartile ranges. Normality was assessed using the Shapiro–Wilk test or by analyzing the asymmetry and flatness values. The study analyzed the temporal variation of variables using statistical tests. Categorical variables were compared using the chi-square test and continuous variables using either Student’s t-test or the Mann–Whitney test. Logistic regression was used to predict the response to treatment, with independent variables selected based on the bivariate analysis (p < 0.05). The significance level was set at p < 0.05.

Results

A final sample of 92 patients was obtained out of the initial 101 patients selected due to incomplete clinical information.

Descriptive analysis

The sample consisted of 92 patients, with a median age of 5 years and a mean age of 8.8 years (range, 1–35 years; SD, 8.57 years). Of the patients, 50 were female (54.3%) and 42 were male (45.7%). A total of 25 patients (27.2%) had been exposed to tobacco smoke (active or passive smoking). A descriptive analysis of the sample is shown in Table 1.

Table 1 Clinical and demographic characteristics of the patients included in the study
Full size table

Prior to taking OM-85 BV, the average number of cases of acute tonsillitis per year was 5.3 ± 2.3, with a minimum of 3 and a maximum of 12. After 1 year of treatment, the average number of acute tonsillitis cases decreased to 2.95 ± 2.5, with a minimum of 0 and a maximum of 9.

Of the 92 patients, 22 (23.9%) did not respond to treatment with OM-85 BV (null response), 19 (20.7%) showed a partial response, and 51 (55.4%) showed a complete response. Furthermore, 47 (51.1%) required surgical intervention due to experiencing more than 3 cases of tonsillitis per year.

Data analysis

Following the administration of OM-85 BV, there was a statistically significant reduction (p < 0.001) in the average number of tonsillitis cases per year, as determined by the paired samples t-test (Table 2).

Table 2 Average number of tonsillitis cases analyzed
Full size table

Association between response and clinical-demographic variables

There were statistically significant differences observed between tobacco smoke exposure and the type of response (p = 0.005). Patients exposed to tobacco smoke tended to have a null response (adjusted residual = 2.2), while patients not exposed to tobacco smoke tended to have a total response (adjusted residual = 3.2).

There were no statistically significant differences in age, gender, history of atopy, or previous number of tonsillitis prior to taking OM-85 BV (Table 3).

Table 3 Analysis of the association between the variables studied and the type of response
Full size table

Logistic regression

Multivariate analysis was performed using logistic regression to predict the type of response (null/partial/total) 1 year after taking OM-85 BV, with the variables selected in the bivariate analysis (p < 0.05) as independent variables. A total response was considered as the reference category in the dependent variable. The exposure to tobacco smoke remained as an independent predictor for the type of response (Table 4). The risk of a person exposed to tobacco smoke having a null response is 5.24 times higher than the risk of having a complete response (p = 0.005). Similarly, the risk of a person exposed to tobacco smoke having a partial response are 4.57 times higher than the risk of having a complete response (p = 0.014).

Table 4 Logistic regression for the response type
Full size table

Discussion

The study results indicate that OM-85 BV is effective in reducing the number of acute tonsillitis cases in children and adults with a history of recurrent acute tonsillitis.

Similar studies on its effect on recurrent acute tonsillitis, especially in pediatric age, are consistent with the obtained results [17, 18]. Studies have also shown that OM-85 BV is effective in preventing lower respiratory tract infections in children for at least 6 months, with a reduction of up to 35–40%, regardless of the cause [18,19,20,21]. However, the effectiveness of this immunomodulator in other respiratory infections, such as acute rhinosinusitis, is more controversial [9, 13, 22,23,24,25].

Although our study included both children and adults, it is important to note that the majority of the sample (81.5%) consisted of children. This may be due to the higher incidence of recurrent acute tonsillitis in pediatric patients compared to adults [1,2,3], which could explain the sample asymmetry. It is crucial to consider this information when interpreting the results.

In the present study, no statistically significant association was found between response type and age (pediatric/adult); however, the p value was marginally significant. The total response rate was higher in the pediatric age group (adjusted residual = 2.4) compared to the adult age group (adjusted residual = -2.4) (p = 0.054). As there are no known studies evaluating the effectiveness of this immunomodulator in adults, the findings cannot be refuted.

A recent study [13] conducted on pediatric patients found that age and the number of previous acute tonsillitis episodes were significant predictors of treatment response. Specifically, younger age and a higher number of previous episodes were associated with a better treatment response. However, in the present study, these factors were not found to be associated with a better response. Neither of the other factors showed any association with treatment response. The study found that exposure to tobacco smoke was the only predictor of treatment response type, with increased risk of null or partial response compared to complete response.

The study has some limitations. It is retrospective and not an RCT (randomized controlled trial), which would provide stronger evidence to confirm the efficacy of OM-85 BV. Also, there was no control group (patients not taking OM-85 BV) to compare responses. Additionally, the study did not evaluate the number of antibiotics used by each patient before and after taking OM-85 BV. Prolonged or excessive antibiotic therapy, especially in the period following the use of OM-85 BV, may overestimate its role in preventing new episodes of acute tonsillitis.

Conclusion

OM-85 BV is an immunomodulatory therapy that has been shown to be effective in preventing new episodes of tonsillitis in patients with a history of recurrent acute tonsillitis. Patients who are exposed to tobacco smoke tend to have a poorer response to treatment. Additional research is necessary to confirm the effectiveness of this treatment in preventing acute tonsillitis and other ear, nose, and throat infections.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Kaplan EL, Top FH Jr, Dudding BA, Wannamaker LW (1971) Diagnosis of streptococcal pharyngitis: differentiation of active infection from the carrier state in the symptomatic child. J Infect Dis 123(5):490–501

    Article  CAS  PubMed  Google Scholar 

  2. Komaroff AL, Pass TM, Aronson MD, Ervin CT, Cretin S, Winickoff RN et al (1986) The prediction of streptococcal pharyngitis in adults. J Gen Intern Med 1(1):1–7

    Article  CAS  PubMed  Google Scholar 

  3. Schroeder BM (2003) Diagnosis and management of group A streptococcal pharyngitis. Am Fam Physician. 67(4):880–884

    PubMed  Google Scholar 

  4. Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA et al (2019) Clinical practice guideline: tonsillectomy in children (update). Otolaryngol Head Neck Surg. 160(1_suppl):S1–S42

    PubMed  Google Scholar 

  5. Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ et al (2011) Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg 144(1 Suppl):S1-30

    PubMed  Google Scholar 

  6. Windfuhr JP, Toepfner N, Steffen G, Waldfahrer F, Berner R (2016) Clinical practice guideline: tonsillitis I. Diagnostics and nonsurgical management. Eur Arch Otorhinolaryngol. 273(4):973–87

    Article  PubMed  PubMed Central  Google Scholar 

  7. Management of sore throat and indications for tonsillectomy: a National Clinical Guideline. [Internet] Edinburgh, Scotland: Scottish Intercollegiate Guidelines Network SIGN; April 2010 [cited 2023 Mar 8]. 44 p. Available from: http://resource.nlm.nih.gov/101609287.

  8. Georgalas CC, Tolley NS, Narula A (2009) Tonsillitis. BMJ Clin Evid 2009:0503

    PubMed  PubMed Central  Google Scholar 

  9. Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB (2018) Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol 18(3):198–209

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Rozy A, Chorostowska-Wynimko J (2008) Bacterial immunostimulants—mechanism of action and clinical application in respiratory diseases. Pneumonol Alergol Pol 76(5):353–359

    PubMed  Google Scholar 

  11. Kearney SC, Dziekiewicz M, Feleszko W (2015) Immunoregulatory and immunostimulatory responses of bacterial lysates in respiratory infections and asthma. Ann Allergy Asthma Immunol 114(5):364–369

    Article  CAS  PubMed  Google Scholar 

  12. Manolova V, Flace A, Jeandet P, Bessier WC, Pasquali C (2017) Biomarkers induced by the immunomodulatory bacterial extract OM-85: unique roles for Peyer’s patches and intestinal epithelial cells. J Clin Cell Immunol 8(2):494

    Article  Google Scholar 

  13. Schaad UB (2010) OM-85 BV, an immunostimulant in pediatric recurrent respiratory tract infections: a systematic review. World J Pediatr 6(1):5–12

    Article  CAS  PubMed  Google Scholar 

  14. Del-Rio-Navarro BE, Espinosa Rosales F, Flenady V, Sienra-Monge JJL (2012) Cochrane review: immunostimulants for preventing respiratory tract infection in children. Evidence-Based Child Health: A Cochrane Review Journal 7(2):629–717

    Article  Google Scholar 

  15. Berber A, Del-Rio-Navarro B (2001) Compilation and meta-analysis of randomized placebocontrolled clinical trials on the prevention of respiratory tract infections in children using immunostimulants. J Investig Allergol Clin Immunol 11(4):235–246

    CAS  PubMed  Google Scholar 

  16. Paupe J (1991) Immunotherapy with an oral bacterial extract (OM-85 BV) for upper respiratory infections. Respiration 58(3–4):150–154

    Article  CAS  PubMed  Google Scholar 

  17. Bitar MA, Saade R (2013) The role of OM-85 BV (Broncho-Vaxom) in preventing recurrent acute tonsillitis in children. Int J Pediatr Otorhinolaryngol 77(5):670–673

    Article  PubMed  Google Scholar 

  18. Jara-Perez JV, Berber A (2000) Primary prevention of acute respiratory tract infections in children using a bacterial immunostimulant: a double-masked, placebo-controlled clinical trial. Clin Ther 22(6):748–759

    Article  CAS  PubMed  Google Scholar 

  19. Lu Y, Li Y, Xu L, Xia M, Cao L (2015) Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 95(3–4):139–144

    Article  CAS  PubMed  Google Scholar 

  20. Razi CH, Harmancı K, Abacı A, Ozdemir O, Hızlı S, Renda R et al (2010) The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 126(4):763–769

    Article  CAS  PubMed  Google Scholar 

  21. Chen ZG, Ji JZ, Li M, Chen YF, Chen FH, Chen H (2007) Immunoregulants improves the prognosis of infants with wheezing. Nan Fang Yi Ke Da Xue Xue Bao 27(10):1612–1613

    CAS  PubMed  Google Scholar 

  22. Esposito S, Bianchini S, Bosis S, Tagliabue C, Coro I, Argentiero A et al (2019) A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections. J Transl Med 17(1):284

    Article  PubMed  PubMed Central  Google Scholar 

  23. Souza FC, Mocellin M, Ongaratto R, Leitão LAA, Friedrich FO, Silveira VD et al (2020) OM-85 BV for primary prevention of recurrent airway infections: a pilot randomized, double-blind, placebo-controlled study. Einstein (Sao Paulo). 18:eAO5262

    Article  PubMed  PubMed Central  Google Scholar 

  24. Esposito S, Bianchini S, Polinori I, Principi N (2019) Impact of OM-85 given during two consecutive years to children with a history of recurrent respiratory tract infections: a retrospective study. Int J Environ Res Public Health 16(6):1065

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Sly PD, Galbraith S, Islam Z, Holt B, Troy N, Holt PG (2019) Primary prevention of severe lower respiratory illnesses in at-risk infants using the immunomodulator OM-85. J Allergy Clin Immunol 144(3):870-872.e11

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Otolaryngology, Hospital Pedro Hispano, Porto, Portugal

    Pedro Marques Gomes, Diogo Cunha Cabral, Joana Barreto, Ana Isabel Gonçalves, Delfim Duarte & Paula Azevedo

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  1. Pedro Marques Gomes
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  2. Diogo Cunha Cabral
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  3. Joana Barreto
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  4. Ana Isabel Gonçalves
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  5. Delfim Duarte
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Contributions

PMG: contributions to the conception and design of the work; the acquisition, analysis and interpretation of data; drafted the work; revised it; and approved the submitted version. DCC, JB, AIG, DD, and PA: drafted the work, revised it, and approved the submitted version.

Corresponding author

Correspondence to Pedro Marques Gomes.

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Ethics approval and consent to participate

This study was approved by the Ethics Committee of Hospital Pedro Hispano in December 2022. Written consent was provided by all participants (or their parents or legal guardians in the case of children under 16).

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The authors declare that they have no competing interests.

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Gomes, P.M., Cabral, D.C., Barreto, J. et al. Role of OM-85 BV in the prevention of recurrent acute tonsillitis: a retrospective study and literature review. Egypt J Otolaryngol 40, 78 (2024). https://doi.org/10.1186/s43163-024-00646-w

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