Whether Immunostimulants Are Effective in Susceptible Children Suffering From Recurrent Respiratory Tract Infections: A Modeling Analysis Based on Literature Aggregate Data

Zhang, Weilong; Huang, Jihan; Liu, Hongxia; Xiao, Wen; Zheng, Qingshan; Li, Lujin

doi:10.1002/jcph.1969

Cited by 7 publications

(6 citation statements)

References 33 publications

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“…Most recently, Zhang and colleagues 25 published a systematic review assessing whether immunostimulants are effective in susceptible children suffering from recurrent RTI, using a modeling analysis based on literature aggregate data by constructing a quantitative pharmacodynamic model. The factors potentially affecting the slope of the cumulative number of RTIs were explored by covariate modeling.…”

Section: Resultsmentioning

confidence: 99%

“…Finally, Zhang et al 25 constructed a quantitatively pharmacodynamic regression model using aggregated data from literature and found that the OM-85 BV could reduce the incidence of RTIs by 0.21 times per month; that is, ~1.26 fewer RTIs every half-year. Among these seven systematic review on RTIs, only one review 22 had "high confidence" (i.e., ≤1 non-critical weakness, providing an accurate and comprehensive summary of the results of the available studies that address the question of interest), and six [19][20][21][23][24][25] "critical low confidence" (i.e., >1 critical flaw and should not be relied on to provide an accurate and comprehensive summary of existing studies).…”

Section: Discussionmentioning

confidence: 99%

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A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis

Castro‐Rodriguez,

Turi,

Forno

2024

Pediatric Allergy Immunology

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Acute respiratory tract infections (RTIs) are one of the most common causes of pediatric consultations/hospitalizations and a major trigger for asthma exacerbations. Some consensus statements have recommended the use of immunostimulants to boost natural defenses against severe or repeated infections. One of the most common immunostimulants is OM‐85; while several randomized clinical trials (RCTs) have evaluated its efficacy in preventing acute RTIs and wheezing/asthma exacerbations, results have been conflicting. Similarly, various systematic reviews with meta‐analyses (SRMs) on OM‐85 have used different strategies, populations, and outcomes; moreover, SRM conclusions are limited when the original studies are highly heterogeneous or have a low quality, hindering the generalizability of the findings. Here we summarize the evidence on the effect of OM‐85 to prevent acute RTIs, wheezing/asthma episodes, or loss of asthma control in children, by including and critically evaluating all SRMs published to date. We searched for SRMs on OM‐85 in three publication databases and found nine SRMs (seven for RTI, and two for wheezing/asthma). Among those, one had a high confidence evaluation of quality (AMSTAR‐2 tool) and found a reduction in the total number of acute RTIs among the OM‐85 group. Overall, no strong recommendations can be derived from the existing literature, mainly due to the high heterogeneity among included RCTs and SRMs. Further, large, high‐quality RCTs are needed to confirm the true efficacy of OM‐85 for the prevention of acute RTIs, asthma development, and asthma exacerbations.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis

Castro‐Rodriguez,

Turi,

Forno

2024

Pediatric Allergy Immunology

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“…Orally administered OM-85, absorbed through the gastrointestinal tract, is an effective stimulant that activates the innate and adaptive arms of the immune system, and leads to functional immune responses against the invading pathogens. Since the 1950s, OM-85 has been widely used for the prevention of recurrent respiratory tract infections in several European and Asian countries ( 47 - 49 ). Respiratory tract infection is a major predisposing factor that contributes to asthma exacerbations.…”

Section: Discussionmentioning

confidence: 99%

Bacterial lysate add-on therapy in adult and childhood asthma: a systematic review and meta-analysis

Yao,

Qin,

Song

et al. 2023

J Thorac Dis

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Background It has been proposed that bacterial lysates may serve as a suitable immunomodulatory oral medication to improve and control asthma symptoms. However, the difference in its efficacy in adults and children remains unclear. Methods Randomized controlled trials (RCTs) evaluating OM-85 add-on therapy in asthma patients up to December 2021 were searched using PubMed, Scopus, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang database, and WP (WeiPu) database. Risk of bias was evaluated using the Cochrane risk of bias assessment tool. Results A total of 36 studies were included. The results showed that OM-85 add-on treatment provided a 24% improvement in asthma symptom control [relative rates (RR) =1.24, 95% confidence intervals (CI): 1.19–1.30], and also significantly improved lung function, increased numbers of T-lymphocytes and the subtypes, and elevated levels of interferon-γ (IFN-γ), interleukin-10 (IL-10), and IL-12. Levels of serum immunoglobulin E (IgE), eosinophil cationic protein (ECP) and pro-inflammatory cytokines (including IL-4 and IL-5) were suppressed in the OM-85 add-on treatment group. Moreover, OM-85 add-on treatment showed more prominent effects in asthmatic children than in asthmatic adults. Conclusions OM-85 add-on therapy showed important clinical benefits for patients with asthma, especially asthmatic children. Further studies focusing on the immunomodulatory function of OM-85 in personalized asthma treatment are warranted.

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“…The perspective of “new-age” immunotherapy, such as checkpoint inhibition triggering the immunopathology events or cytokine therapies modulating inflammation development, has been raised to reduce the burden of infectious diseases threatened by antibiotic resistance ( 46 ). The recent meta-analysis has shown that the immunostimulants, OM-85 BV and pidotimod, which have been widely used and suggested by pediatricians in the prevention and treatment of RRTi in susceptible children, can reduce the incidence of respiratory tract infections by 0.21 and 0.19 per month, respectively ( 47 ); however, long-term use of the said drugs is challenging for children and their families. Actually, probiotics do have great potential as the “new-age” immunotherapy, as several in vitro / in vivo studies have summarized the strain-specific immunomodulatory effects and the stimulation of interferon (IFN) pathways to antagonize viral respiratory infections due to that microbiome has co-evolved with the eukaryotic genome of its host ( 26 , 48 ).…”

Section: Discussionmentioning

confidence: 99%

Oropharyngeal Probiotic ENT-K12 as an Effective Dietary Intervention for Children With Recurrent Respiratory Tract Infections During Cold Season

et al. 2022

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Recurrent respiratory tract infections (RRTi) cause a high burden of disease and lead to negative impact on quality of life, frequent school/work absenteeism, and doctor visits, which remain a great challenge to pediatricians because RRTi can increase the risk of various complications including antibiotic overuse and resistance, which is one of the biggest threats to global health, and there is no confirmed effective treatment. In this study, we aimed to assess the clinical efficacy and safety of oropharyngeal probiotic ENT-K12 as a dietary intervention or a complementary treatment along with standard medical treatment during acute respiratory infections among children with RRTi during cold season. The results of this study show that when comparing to practicing of standard medical treatment only, the complementary intake of oropharyngeal probiotic ENT-K12 can effectively reduce episodes of both acute and RRTi in school children, shorten the course of respiratory symptoms onset, reduce the use of antibiotics and antiviral drugs, and reduce the absence days from both children's school and parents' work. Using oropharyngeal probiotics as a complementary dietary intervention to stabilize oropharyngeal microflora, specifically inhibiting respiratory pathogens and enhancing host immunity, could possibly be a promising approach to reduce RRTi burden and combating antibiotic resistance in long term, more clinical studies will be needed to further confirm the clinical practicing guide to ensure its clinical benefit.MethodsA total of 100 susceptible children with RRTi aged 3–10 years, living in Wuhan, China, were selected. They were randomized to the probiotic group and control group at the beginning of the trial during the cold season. Fifty children in the probiotic group took oropharyngeal probiotic ENT-K12 for 30 days, along with standard medical treatment when there was an onset of respiratory symptoms and medical treatment was needed, and fifty children in the control group did not take oropharyngeal probiotics but only had standard medical treatment when there was an onset of respiratory symptoms and medical treatment was needed. Patients were followed up for 30 days during the cold season. The primary objective of this study is to assess the complementary dietary interventional efficacy of oropharyngeal probiotic ENT-K12 on episodes of respiratory tract infections during the cold season, and the secondary objective is to assess the interventional efficacy of oropharyngeal probiotic on days of respiratory symptoms onset, using antiviral drugs, antibiotics, and antipyretics, days of children absent from school, and days of parents absent from work, as well as to confirm tolerability and safety judged by adverse event reporting.ResultsThere were 47 children, 22 male and 25 female children, with an average age of 5.71 years (SD = 1.99) in the probiotic group finishing the study, and 50 children, 32 male and 18 female children, in the control group with an average age of 6.12 years (SD = 1.98) finishing the study. During the 30-day period of oropharyngeal probiotic intake, children in the probiotic group totally had 7 episodes of upper respiratory tract infections, while children in the control group totally had 17 episodes of upper respiratory tract infections, indicating that the incidence of upper respiratory tract infection in the probiotic group (14.89%) was significantly lower than that in the control group (34.00%) during the intervention period. The days of using antibiotics and antiviral drugs in the probiotic group were significantly lower than that in the control group, and the course of respiratory symptoms onset was shorter and more moderate in the probiotic group than that in the control group; in addition, compared with the control group, both the days of children absent from school and parents' absence from work in the probiotic group were significantly lower. Children treated with oropharyngeal probiotic ENT-K12 had excellent tolerability with no side effects reported, hence confirmed safety of applying oropharyngeal probiotic ENT-K12 as a prophylactic use or an effective dietary intervention along with standard medication during respiratory infections onset.ConclusionIntake of oropharyngeal probiotic ENT-K12 as a dietary intervention can effectively reduce episodes of upper respiratory tract infections in school children with RRTi during high peak season, reduce the days of using antibiotics and antiviral drugs, and reduce children's sick leave days, parents' absence days from work, and shorten the course of respiratory infections; the safety of oropharyngeal probiotic ENT-K12 has been confirmed with no side effects reported, excellent tolerability, and easy acceptance. Notably, this study opens up a new research idea in the field of microbe promoting human health by supplying direct proof to support its efficiency and safety.

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Whether Immunostimulants Are Effective in Susceptible Children Suffering From Recurrent Respiratory Tract Infections: A Modeling Analysis Based on Literature Aggregate Data

Cited by 7 publications

References 33 publications

A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis

A critical analysis of the effect of OM‐85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta‐analysis

Bacterial lysate add-on therapy in adult and childhood asthma: a systematic review and meta-analysis

Oropharyngeal Probiotic ENT-K12 as an Effective Dietary Intervention for Children With Recurrent Respiratory Tract Infections During Cold Season

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