Global advances in integrative medicine and health最新文献

{"title":"The Feasibility of Investigating Acupuncture in Patients With COVID-19 Related Olfactory Dysfunction.","authors":"Michael F Armstrong, Thomas J O'Byrne, Jason J Calva, Molly J Mallory, Sara E Bublitz, Alexander Do, Carlos D Pinheiro Neto, Garret W Choby, Erin K O'Brien, Brent A Bauer, Janalee K Stokken","doi":"10.1177/27536130251343834","DOIUrl":"https://doi.org/10.1177/27536130251343834","url":null,"abstract":"<p><strong>Background: </strong>Olfactory dysfunction (OD) is a common symptom in patients with coronavirus disease 2019 (COVID-19) with limited treatment options.</p><p><strong>Objective: </strong>This pilot study aimed to investigate an acupuncture protocol in patients with COVID-19 related OD.</p><p><strong>Methods: </strong>Thirty patients were randomized into 2 groups. The standard group was treated with budesonide nasal irrigation and olfactory training. The acupuncture group received ten sessions of acupuncture therapy in addition to the standard group treatment. Olfaction was assessed using the University of Pennsylvania Smell Identification Test, 10-point visual analog scale, and Sino-Nasal Outcome Test at baseline and after 3 months of treatment. Differences between study arms were compared using Fisher's exact and Wilcoxon rank sum tests.</p><p><strong>Results: </strong>Eighteen of the 30 (60%) enrolled patients completed the study, including 11 (73%) in the standard and 7 (47%) in the acupuncture group. Reasons for participant drop-out included cost of travel and time constraints. There were no acupuncture complications.</p><p><strong>Conclusions: </strong>Acupuncture as an adjunct therapy for COVID-19 related OD is well tolerated. Subsequent studies with larger sample sizes are needed to assess the effect of acupuncture on OD.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251343834"},"PeriodicalIF":0.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12078969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recruitment and Retention for an Acupuncture Trial in an Underrepresented 65 and Older Population With Chronic Low Back Pain.","authors":"Ray Y Teets, Arya Nielsen, Donna Mah, Matthew Beyrouty, Marsha J Handel, Morgan Justice, Hyowoun Jyung, Carolyn M Eng, Lynn L DeBar","doi":"10.1177/27536130251340921","DOIUrl":"https://doi.org/10.1177/27536130251340921","url":null,"abstract":"<p><strong>Background: </strong>The consequences of health disparities in underrepresented populations persist with increased disease burden and reduced access to care. Even with inclusion mandates, underserved populations are poorly represented across trials. This article describes recruitment and retention efforts of an underrepresented population in a large NIH-funded trial.</p><p><strong>Methods: </strong>The BackInAction (BIA) study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial testing the effectiveness of acupuncture needling for reducing back pain-related disability among 800 older adults (≥65 years) with chronic low back pain. The Institute for Family Health (IFH), an FQHC in New York City, one of four BIA sites, provides primary care to largely underrepresented patients. The IFH recruitment goal was 123 participants. PCPs were oriented to trial referral, clinical research coordinators worked as navigators, and electronic health records (EHR) mechanisms were adapted to allow seamless communication between trial acupuncturists and the research team.</p><p><strong>Results: </strong>IFH met its goal of 123 trial participants with sociodemographic (22.8% ≥ 75 yrs of age, 72.4% female, 59.4% reported having at least some college education, 62.6% reported an annual household income of less than $25 000) and ethnic/racial diversity (39.0% Hispanic, 35.6% Black, 22.0% White non-Hispanic, 26.8% Spanish-speaking). IFH study withdrawal rate was 12.2% with 18.7% missingness in follow-up data rates at the trial's 6-month primary endpoint.</p><p><strong>Conclusion: </strong>The IFH site team successfully recruited and retained diverse participants through trusted connections with the study population, building on experience with acupuncture research, engaging PCPs, study team members, primary care clinical sites and EHR communication options.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251340921"},"PeriodicalIF":0.0,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12064889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144013675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Construct Validity and Reliability of the 'Lifestyle (PAHO) in the Adult Population' Questionnaire.","authors":"Mayra Alejandra Barajas Lizarazo, César Andrés Gómez Acosta, Katty Dayana Escobar Velásquez","doi":"10.1177/27536130251340403","DOIUrl":"https://doi.org/10.1177/27536130251340403","url":null,"abstract":"<p><p>Having validated instruments for the evaluation of lifestyles becomes a necessity for professional practice in terms of promoting the adoption of health-promoting behaviors in various aspects of daily life, such as social interactions, nutrition, physical activity, oral health, environmental health, mobility, and psychoactive substance use.</p><p><strong>Objective: </strong>To evaluate the construct validity and reliability of the 'Lifestyle Questionnaire in the Colombian Population\" over 18 years of age from the northeastern of Colombia.</p><p><strong>Methodology: </strong>A psychometric study was conducted with the participation of 551 adults using the instrument proposed by the Pan American Health Organization (PAHO). A confirmatory analysis using the structural equation modeling (SEM) technique was carried out, in addition to an internal consistency analysis.</p><p><strong>Results: </strong>The confirmatory factor analysis reports the same structure, with adequate goodness-of-fit indicators (X²/df = 2.10, CFI = .88, TLI = .87, RSMEA = .05, SRMR = .04). The reliability estimation of the test and its dimensions, with internal consistency coefficients Cronbach's α and McDonald's ω, reported optimal levels in the total test (ω = .93).</p><p><strong>Conclusions: </strong>The instrument developed by PAHO showed adequate construct validity and reliability indicators for evaluating lifestyles in northeastern Colombian people over 18 years old.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251340403"},"PeriodicalIF":0.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025246","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Depression, Anxiety of Death, and Fear of Death in Family Caregivers of People With Prader-Willi Syndrome: A Mixed Study.","authors":"Monserrat Abigail Mora-Lagunes Recinos, María Luisa Escamilla Gutiérrez, Luis Israel Ledesma Amaya, Itzel Moreno Vite, Rebeca María Elena Guzmán Saldaña, Claudia Rubio Moreno","doi":"10.1177/27536130251319793","DOIUrl":"https://doi.org/10.1177/27536130251319793","url":null,"abstract":"<p><strong>Background: </strong>Family caregivers of individuals with Prader-Willi syndrome face significant challenges that affect their social, economic, personal, and emotional well-being. The mental health of these caregivers remains largely unexplored, particularly regarding their own premature death.</p><p><strong>Objective: </strong>This study seeks to explicate how caregivers manage their responsibility of providing continuous specialized care for individuals with Prader-Willi syndrome. A mixed research approach was used to uncover depression, death anxiety, and anticipated fear of own death among caregivers of patients with SPW who access a foundation in the state of Hidalgo, Mexico.</p><p><strong>Method: </strong>A mixed-methods approach was employed, using a sequential explanatory design. The quantitative sample included 15 volunteer participants between 35 and 66 years old, belonging to a foundation in Hidalgo, Mexico. Research instruments had an internal consistency of r = >0.70. Qualitative data was gathered through a focus group, using interpretive description to explore caregivers' emotional experiences.</p><p><strong>Results: </strong>Statistical analyses, including Gamma and Kendall Tau tests, revealed significant correlations (<i>P</i> = 0.01) between caregivers' anticipated fear of death and the levels of death anxiety and depression. The qualitative findings yielded 3 principal themes: uncertainty about future self-sufficiency, fear of the future if they pass away, and the crucial role of community support.</p><p><strong>Discussion and conclusion: </strong>This methodological mixed study reveals a correlation between anxiety about the future, fear of death, and the emotional need for support. Continual emotional support and counselling are crucial for caregivers responsible for PWS patients' care.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251319793"},"PeriodicalIF":0.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12035207/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144044133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Equity Through Black Feminist Healing: A Narrative Review on the Contributions of Black Womxn to Integrative Medicine.","authors":"Eushavia V Bogan, Elondra D Harr","doi":"10.1177/27536130251332568","DOIUrl":"https://doi.org/10.1177/27536130251332568","url":null,"abstract":"<p><strong>Background: </strong>Black women and Black femme-identifying individuals (referred to as womxn) have developed alternative health practices that support their well-being when navigating oppressive systems. Within the U.S. healthcare system, Black womxn are disproportionally impacted by inequities and discriminatory practices, leading to higher incidences of chronic conditions, limited healthcare access, and higher mortality rates. Integrative medicine has not yet adequately examined or incorporated healing modalities practiced by Black womxn and therefore has not investigated its potential to foster more inclusive care.</p><p><strong>Objectives: </strong>This critical narrative review aims to explore the contributions of Black womxn to integrative medicine, identify components of Black feminist healing modalities, and discuss future directions for integrating these practices into integrative medicine.</p><p><strong>Methods: </strong>A critical review was conducted using databases including PubMed, JSTOR, Taylor & Francis Online, and Sage to gather academic and praxis-focused sources. Books and films related to Black womxn healing practices were also examined. Sources were selected based on their focus on non-Western, alternative, and complementary therapies developed and practiced by Black womxn in the United States.</p><p><strong>Results: </strong>We identified three key categories of Black feminist healing modalities: (1) Communal Care and Communication, which includes practices like storytelling, gossip, and community gathering to foster resilience; (2) Art as a Form of Cultural Strengthening, which emphasizes the use of creative expression for healing and resistance; and (3) Spirituality. These modalities provide tools for Black womxn to resist systemic oppression and promote well-being.</p><p><strong>Conclusion: </strong>Black feminist healing modalities are crucial for creating inclusive models of care that address the specific health needs of marginalized communities. Incorporating these modalities into healthcare can contribute to health equity by offering culturally relevant and holistic approaches to health for Black womxn and other historically minoritized groups. Future research should focus on developing evidence-based practices for integrating these modalities into clinical settings.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251332568"},"PeriodicalIF":0.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12032434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Wholeness and Interconnection as the Foundation for a New Epistemology of Health.","authors":"Scarlet Soriano","doi":"10.1177/27536130251328636","DOIUrl":"10.1177/27536130251328636","url":null,"abstract":"<p><p><b>Background:</b> A confluence of factors is ushering forward growing opportunities for global-level reconsideration and expansion of foundational concepts of health. This process draws on dynamic and evolving contributions from Traditional, Complementary, and Integrative Medicine (TCIM) systems, Indigenous Knowledge systems, and existing biomedical models to center wholeness and balanced interconnection within individuals and between people and the planet as elements of an emergent collective redefinition of health. <b>Purpose & Conclusions:</b> This article threads US-based and global efforts in this emergence by showcasing the National Academy of Medicine Report, Achieving Whole Health: A New Approach for Veterans and the Nation, alongside an overview of several significant recent contributions to the global integration of TCIM into national health systems by the World Health Organization (WHO), briefly also highlighting examples of the range of country and state-wide integration. The opening of the first WHO Global Traditional Medicine Centre in India, the first Traditional Medicine Global Summit held in 2023, and the Summit's official meeting report: The Gujarat Declaration, are briefly explored as structures and experiences supporting enhanced collaboration and technical exchange as nations work to implement more expansive wholeness-based health concepts into national health systems. A discussion of the societal-level changes needed to implement such epistemic change is briefly explored, with emphasis on the need for equitable, cross-sectoral collaboration and visionary leadership in the development of new financial models to sustainably translate these emergent concepts of health into new healthcare delivery structures that center whole health and planetary health as part of the common good.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251328636"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11963721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143775220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Hidden Complexity of Virtual Mindfulness-Based Group Medical Visits: Comfort, Challenge, and the Influence of Social Determinants of Health.","authors":"Jessica L Barnhill, Gabriela Castro, Christine Lathren, Elondra Harr, Isabel Roth, Jose E Baez, Ruth Rodriguez, Suzanne Lawrence, Paula Gardiner, Carol M Greco, Holly N Thomas, Susan A Gaylord, Graham Dore, Anita Bengert, Natalia E Morone","doi":"10.1177/27536130251326938","DOIUrl":"10.1177/27536130251326938","url":null,"abstract":"<p><strong>Background: </strong>Chronic low back pain is globally prevalent and associated with significant impairment in quality of life. Furthermore, people from historically marginalized communities are less likely to receive treatment, contributing to health inequities. Group mindfulness-based interventions improve pain and function, and virtual delivery has been demonstrated to be feasible. Little is known about how participants experience the virtual delivery of mindfulness-based interventions, especially participants from historically marginalized communities.</p><p><strong>Objective: </strong>This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain.</p><p><strong>Methods: </strong>Participants were recruited from the intervention arm of OPTIMUM, a study of virtual medical group visits using an adapted Mindfulness-Based Stress Reduction program for chronic low back pain. Semi-structured exit interviews were examined, and reflexive thematic analysis was used to compose key themes.</p><p><strong>Results: </strong>Interviews from 59 participants (mean 56 years, 69.5% women; 45.8% Black or African American) were examined. Two major themes were derived from analysis. The first theme was 'effects of the external environment,' ie, the physical location from which the participant engaged with the session. The subthemes were comfort, social demands in the home setting, and sharing personal spaces. The second theme was 'navigating the virtual platform.' Subthemes were ease, struggle, and levels of support.</p><p><strong>Conclusion: </strong>Patient experiences varied substantially during the virtual mindfulness-based group medical visit intervention and this variation was influenced by social determinants of health. The key themes bring attention to the effects of the external environment and the technology itself on participation for people from historically marginalized communities. Basic tenets of mindfulness, such as <i>present state awareness</i> and <i>equanimit</i>y, can provide a structure within which to navigate virtual participation amid home environments. Future studies are needed to explore differences in virtual and in-person mindfulness programs and to adapt virtual mindfulness programs.</p><p><strong>Clinicaltrialsgov id number: </strong>NCT04129450.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251326938"},"PeriodicalIF":0.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11951895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Outcomes Improve in a Pragmatic Implementation Pilot Study of Mindful Awareness in Body-Oriented Therapy (MABT) for Chronic Pain.","authors":"Cynthia J Price, Dana Dharmakaya Colgan, Erin Abu-Rish Blakeney, Jacquelyn S Pennings, Claudia Davidson, Kathryn A Hansen","doi":"10.1177/27536130251331029","DOIUrl":"10.1177/27536130251331029","url":null,"abstract":"<p><strong>Objectives: </strong>Non-pharmacologic approaches are now considered best practice for the treatment of chronic pain. The purpose of this pilot study was to evaluate patient responses to a newly integrated clinic service called Mindful Awareness in Body-oriented Therapy (MABT) at a chronic pain clinic. MABT is designed to develop interoceptive sensibility for improved well-being and emotion regulation.</p><p><strong>Methods: </strong>A one-group repeated measures design was used to examine MABT referral and delivery follow-through feasibility and change on health outcomes among chronic pain patients. Upon referral, participants were scheduled for the MABT program involving eight individual sessions with one of the clinic massage therapists trained in MABT. Measures were administered at baseline, post-intervention (3 months) and at 6 month follow-up). Outcome measures assessed physical and mental health distress, interoceptive awareness, and emotional well-being. Analyses included descriptive statistics and repeated measures ANOVA.</p><p><strong>Results: </strong>Seventy patients were referred and 41 received at least one MABT session. Thirty patients (73%) completed the MABT intervention. Statistically and/or clinically significant improvements were identified for most subscales of the PROMIS-29 (the primary outcome), including Physical Function, Fatigue, Anxiety, Sleep Disturbance, Social Roles, and Pain Interference. Improvements in interoceptive sensibility and emotion regulation difficulties also demonstrated statistically significant and large effects.</p><p><strong>Discussion: </strong>This pilot study demonstrates the feasibility of MABT referral and delivery follow-through when delivered in a real-life context. Significant improvements with large effects on outcomes in response to the MABT intervention program offers a promising non-pharmacological approach for chronic pain patients.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251331029"},"PeriodicalIF":0.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11938458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143722914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Moral Distress as a Critical Driver of Burnout in Medicine.","authors":"Amy Locke, Tanya L Rodgers, Margaret L Dobson","doi":"10.1177/27536130251325462","DOIUrl":"10.1177/27536130251325462","url":null,"abstract":"<p><p>There are many known drivers of burnout and distress among physicians and other healthcare providers. Current conversations have not fully characterized the significant impact of workload increases alongside staffing shortages as drivers of moral distress and subsequent burnout. Together these factors pose a significant systemic threat to the workforce, and a personal threat to the individuals within it. Physicians are at high risk for moral distress because of work ethic and culture. The drive to do the right thing for the patient limits an ability to set boundaries around work. Moral distress is experienced when the needs of patients can't be met; this drives us to work even harder. Culturally, there has been limited opportunity to acknowledge this distress, so we haven't been able to deal with it outright. Financial pressures continue pressure health systems to drive productivity. Additional patient encounters drive more after visit work that requires time and attention. Simultaneously, the remaining physicians are further stretched as people burnout and leave. There are few groups of workers more mission-driven than primary care physicians. We are committed to doing the right thing for patients and our teams. If we can acknowledge and talk about moral distress as an indicator that we need to change the way we do things, we can use it as a tool to optimize patient care. The physician voice may help us move beyond the learned helplessness and shift to engagement in solutions. We propose three solutions: 1) acknowledge the presence of routinized stress injury that occurs in healthcare 2) leverage data on physician wellbeing to understand how to optimize care, and 3) foster connection and community. Fundamentally, when our healthcare workers feel seen, heard, and valued, they are healthier themselves, and better able to support the missions of the medical system.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251325462"},"PeriodicalIF":0.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11915272/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective, Interventional, Randomized, Double-Blinded, Placebo-Controlled, Monocentric Clinical Study to Evaluate the Efficacy and Safety of <i>Alkalihalobacillus clausii</i> 088AE in Resolution of Acute Allergic Rhinitis Symptoms.","authors":"Abhijit Rathi, Rajeshree A Khaire, V L Rathi","doi":"10.1177/27536130251321821","DOIUrl":"https://doi.org/10.1177/27536130251321821","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Allergic rhinitis (AR) is a common inflammatory disease of the upper respiratory tract mainly triggered by allergens such as dust mites, pollen, spores, and viral or bacterial infections. AR is primarily associated with symptoms such as nasal itching, sneezing, rhinorrhea, nasal congestion, and watery, itchy, or red eyes. AR significantly affects an individual's quality of life. Probiotics have been proven effective in the clinical management of AR through immunomodulation. However, studies on the use of &lt;i&gt;Alkalihalobacillus clausii&lt;/i&gt; to alleviate the symptoms of AR have rarely been reported.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to explore the clinical efficacy, safety, and possible underlying mechanism of &lt;i&gt;Alkalihalobacillus clausii&lt;/i&gt; 088AE in alleviating the associated symptoms of acute AR in patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A prospective, interventional, randomized, double-blinded, placebo-controlled, monocentric clinical study was conducted on patients with acute AR (N = 40) randomized into two groups, test (N = 20) and placebo (N = 20). Patients in the test arm received a probiotic strain, &lt;i&gt;A. clausii&lt;/i&gt; 088AE, whereas patients in the placebo arm received Maltodextrin. The primary endpoints (efficacy) were total 4 nasal symptoms scores (T4NSS), total 2 ocular symptoms scores (T2OSS), cough scores, and immunological parameters (T-helper 1 (Th1), Th2, Th17, and T-regulatory (Treg) cells, Interleukin (IL)-4, IL10, IL17, IL22, interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α) and -beta (TNF-β), and forkhead box P3 (FOXP3)) evaluated from baseline to end of treatment (EOT). The secondary endpoints (safety) assessed were vital physical signs, hematology, and biochemical parameters, along with an assessment of adverse or serious adverse events (AEs and SAEs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;&lt;i&gt;A. clausii&lt;/i&gt; 088AE supplementation significantly reduced the T4NSS (rhinorrhoea, nasal stuffiness, nasal itching, and sneezing; &lt;i&gt;P&lt;/i&gt; &lt; 0.001), T2OSS (itching and watery eyes; &lt;i&gt;P&lt;/i&gt; &lt; 0.001), and cough scores (&lt;i&gt;P&lt;/i&gt; &lt; 0.01) by the EOT compared to baseline. The placebo group reported a significant increase in all the above symptom scores at the EOT from their baseline values (&lt;i&gt;P&lt;/i&gt; &lt; 0.001). The intergroup analysis between &lt;i&gt;A. clausii&lt;/i&gt; 088AE and placebo indicated a significant change in T4NSS, T2OSS, and cough score (&lt;i&gt;P&lt;/i&gt; &lt; 0.001). Further, the immunological parameters were improved (non-significant, &lt;i&gt;P&lt;/i&gt;-value ≥ 0.05) with the probiotic supplementation. No adverse events (AEs) or serious adverse events (SAEs) leading to termination of study participation were reported with the use of &lt;i&gt;A. clausii&lt;/i&gt; 088AE in the study. No clinically significant vital signs and physical examinations were reported as AEs or SAEs by the investigator.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;&lt;i&gt;A. clausii&lt;/i&gt; 088AE supplementation improved the clinical symptoms in patients with AR.","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"14 ","pages":"27536130251321821"},"PeriodicalIF":0.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}