Global advances in integrative medicine and health最新文献

{"title":"Contribution of Ethnomedical Use Data to the Marketing Authorization of Traditional Herbal Medicines in Mali.","authors":"Aboubacar Sangho, Kampadilemba Ouoba, Rasmané Semdé, Rokia Sanogo","doi":"10.1177/27536130241296823","DOIUrl":"10.1177/27536130241296823","url":null,"abstract":"<p><strong>Background: </strong>To improve the supply of health care and health care products, traditional herbal medicines that are safe, effective, and of good quality need marketing authorizations. This study aims to determine the contribution of ethnomedical evidence to the marketing of traditional herbal medicines in Mali.</p><p><strong>Methods: </strong>This was a descriptive cross-sectional study conducted from December 2023 to March 2024 supplemented by a literature review of the legislative and regulatory provisions relating to traditional medicine and the requirements for marketing authorization of traditional herbal medicines in Mali and the West African sub-region.</p><p><strong>Results: </strong>The regulatory framework for marketing authorization is governed by decree no. 04-557/P-RM of 01 December 2004 and interministerial order no. 05-2203/MS-MEP-SG of 20 September 2005 in Mali. These texts set out the specific requirements for the marketing authorization of traditional plant-based medicines, depending on the category. They consider ethnomedical evidence drawn from long experience of traditional use as proof of efficacy and tolerance for category 2 traditional medicines. As a result, marketing authorizations were issued for 15 products derived from traditional medicine and pharmacopeia, 5 of which are included in the National List of Essential Medicines and the National Therapeutic Formulary of Mali.</p><p><strong>Conclusion: </strong>The use of ethnomedical evidence provides a good opportunity to obtain marketing authorization for phytomedicines derived from traditional medicine without having to go through long and costly non-clinical and clinical studies.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241296823"},"PeriodicalIF":0.0,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514143","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":"Ethyl Acetate Extract from Romdoul (<i>Sphaerocoryne affinis</i>) Fruit Induced Apoptosis in Human Promyelocytic Leukemia Cells.","authors":"Nguyen Thi Hoai Nga, Tran Thanh Long, Truong Thi Bich Ngoc, Nguyen Hoang Khoi Nguyen, Dang Thi Phuong Thao, Nguyen Thi My Trinh","doi":"10.1177/27536130241296826","DOIUrl":"10.1177/27536130241296826","url":null,"abstract":"<p><strong>Background: </strong>Romdoul (<i>Sphaerocoryne affinis</i>) is a flowering plant of the Annonaceae family and has been used customarily in folk medicine. The bioactivities of this plant, especially the anti-cancer effect, however, remain surprisingly few.</p><p><strong>Objective: </strong>this study aimed to elucidate the anti-leukemic effect of romdoul fruit extracts and their underlining mechanisms.</p><p><strong>Methods: </strong>The extracts were prepared from fresh fruits and the phytochemical contents were evaluated by biochemical assays and HPLC method. The promising extract was identified via the inhibition of HL60 as well as normal NIH-3T3 cell densities utilizing MTT assay. The underline mechanism of the extract's effect was studied by accessing the treated HL60 cell population overtime (via MTT assay). The morphology of abnormal cells was examined by bright-field microscopic imaging. Hallmarks of apoptosis including nucleus characteristics and caspase 3 activation were analyzed by fluorescence imaging. The underline mechanisms of apoptosis and proliferation inhibition were accessed via RT-qPCR examination of involved genes.</p><p><strong>Results: </strong>Our findings showed that the ethyl acetate extract of romdoul fruit (SA-EA) was found to be an exceptional anti-leukemic candidate (IC₅₀ was as low as 4.11 μg/mL). More interestingly, the treated HL60 cells expressed nuclear fragmentation and caspase 3 activation, indicating the effect could follow an apoptotic mechanism. Importantly, the transcription assessment of apoptotic and proliferative genes suggested that SA-EA might suppress the growth of HL60 cells and induce p21-dependent apoptotic pathway.</p><p><strong>Conclusion: </strong>This study demonstrated one of the first scientific evidence for the anti-cancer activity of <i>Sphaerocoryne affinis</i> fruit-derived extract. Thus, our findings exhibited a novel and promising anti-leukemic candidate for future studies.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241296826"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570513","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":"Making a Case for Whole Person Health.","authors":"Patricia M Herman, Mark H Pitcher, Helene M Langevin","doi":"10.1177/27536130241293642","DOIUrl":"10.1177/27536130241293642","url":null,"abstract":"<p><p><b>Background:</b> Our conventional approach to health care tends to separate patients' health by body system, treating each independently and \"efficiently\"-e.g., minimal time with a provider, reliance on medications, and little investment to support behavioral and lifestyle improvements. Meanwhile, the United States has the most expensive health care in the world, with some of the worse outcomes. Purpose In this paper, we make the case for transforming health care from a disease-centric approach to a \"whole person\" model. <b>Research Design:</b> We provide detailed health and health care utilization assumptions for a hypothetical patient, Mrs. M, over her life from age 40 to 80 years under 2 care scenarios: the continuation of conventional care (Version A) and a whole person care approach (Version B). Analysis We developed a set of health care utilization assumptions for each scenario, applied 2023 U.S. dollar (USD) resource prices, and estimated cumulative total health care costs. The price and the health care utilization assumptions for the conventional care scenario were validated using Medical Expenditures Panel Survey (MEPS) data. <b>Results:</b> At age 80, with conventional care, we find Mrs. M increasingly frail and living in a skilled nursing facility, with total cumulative health care costs of $353,155. With whole person care, we find her active and generally healthy at age 80, with total cumulative health care costs of $52,425. <b>Conclusions:</b> Although based on an \"imagined\" case, the 2 versions of Mrs. M's history illustrate how an investment beginning in early middle age to support a healthy diet, physical activity, and stress management can plausibly lead to improved health and well-being, as well as reduced health care spending.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241293642"},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11489912/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142482352","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":"Implementation of Virtual, Livestream Yoga Classes for Veterans at Home During the COVID-19 Pandemic: A Mixed-Methods Pilot Program Evaluation.","authors":"Catherine Pham, Caitlin Hildebrand, Gary Tarasovsky, Natalie Purcell, Karen Seal, Francesca Nicosia","doi":"10.1177/27536130241268107","DOIUrl":"10.1177/27536130241268107","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic and shut down of in-person complementary and integrative (CIH) wellness services at the San Francisco Veterans' Affairs Healthcare System (SFVAHCS) required implementation of virtual program delivery. In May 2020, VA in-person group yoga classes pivoted to virtual classes for existing attendees. In October 2020, we partnered with SFVAHCS Integrative Health and the VA Office of Rural Health to formalize the TeleYoga Program to expand yoga access to Veterans in SFVAHCS' geographically dispersed area.</p><p><strong>Objective: </strong>This pilot study evaluated Veterans' experiences and self-reported health outcomes after participating in at-home tele-yoga groups during the COVID-19 pandemic.</p><p><strong>Methods: </strong>The RE-AIM framework guided program delivery evaluation. Reach was assessed with medical record data. Adoption was assessed by the number of new facilities providing referrals to tele-yoga. Implementation, satisfaction, and patient-reported outcomes, were evaluated through structured interviews with Likert scale and open-ended responses.</p><p><strong>Results: </strong>We offered 4-6 weekly livestreamed classes between October 2020-September 2021. The program reached 70 Veterans, including 40 new participants, with 1208 total unique encounters. Referrals increased from 2 to 6 SFVAHCS facilities. Fourteen participants completed structured interviews. Over half rated highly the convenience and overall experience of tele-yoga classes and reported improvement with pain, stress management, exercise, and flexibility. Open-ended responses indicated opportunities for social connection, maintaining mental health, cultivating resilience, improving function, and managing pain. Suggestions for improvement focused on technological aspects, including audiovisual quality.</p><p><strong>Conclusions: </strong>During the COVID-19 pandemic, we successfully transitioned and expanded virtual group yoga delivery to Veterans from all geographic locations within SFVAHCS. We attribute this success to existing infrastructure for telehealth and CIH services and a virtual program orientation for new participants. The results of this pilot study suggest in-person group yoga may be successfully implemented virtually, serving as a viable modality that contributes to holistic wellbeing for Veterans.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241268107"},"PeriodicalIF":0.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11489906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142482351","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":"Using Lean Six Sigma Methods to Develop an Efficient and Sustainable Interdisciplinary Team Program for Chronic Pain in a VA: PREVAIL Interdisciplinary Team Track.","authors":"Rena E Courtney, Mary J Schadegg, Natalie Hicks, Melissa Truitt, Rendelle E Bolton, Brian Dezzutti, Francis Cannizzo, Beth D Darnall, Marilyn Radatz, Samantha M Harden","doi":"10.1177/27536130241290798","DOIUrl":"10.1177/27536130241290798","url":null,"abstract":"<p><strong>Background: </strong>Chronic pain is highly prevalent in US military Veterans, and pain interdisciplinary teams (IDTs) are the gold standard in pain care. There is no standard or guidance for how best to develop and implement pain interdisciplinary teams within complex health care systems.</p><p><strong>Objectives: </strong>The purpose of this quality improvement project was to evaluate the effectiveness of the standard 9-step Lean 6 Sigma (LSS) methodology in redesigning a pre-existing VA outpatient pain clinic solely offering interventional pain services into an efficient, sustainable pain IDT program.</p><p><strong>Methods: </strong>The initial evaluation process at a VA Medical Center that primarily serves rural Veterans was redesigned with the a priori goal of developing an efficient, sustainable IDT program that decreased driving days (ie, in-person appointments) required for a comprehensive initial pain evaluation, decreased number of consults required for initial pain evaluations, increased the number of consults to Whole Health services, and increased compliance with policies and standards. Feedback from administrators, clinicians, and Veterans was used to identify inefficiencies then iteratively design, test, and finalize a redesigned service called the PREVAIL Interdisciplinary Team Track (PREVAIL IDT Track). Baseline data was collected for 1 year followed by sustainment data for 14 months. Results were analyzed using descriptive statistics.</p><p><strong>Results: </strong>PREVAIL IDT Track decreased the number of in-person appointments from 5 to 2, decreased consults required for evaluations from 5 to 1, increased the number of unique consults to Whole Health education classes, and made the VA fully compliant with policies and standards. To date, 486 Veterans have participated in the redesigned program, including 167 graduates and 212 current enrollees in this sustained clinical program.</p><p><strong>Conclusion: </strong>The success of PREVAIL IDT Track suggests that LSS may be a promising method for redesigning sustainable pain IDTs in VA that improve efficiency.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241290798"},"PeriodicalIF":0.0,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11526189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559640","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":"Needs and Preferences for Remote-Delivered Mindfulness-Based Cognitive Therapy in Patients After Acute Coronary Syndrome: A Qualitative Study.","authors":"Christina M Luberto, Sydney Crute, Amy Wang, Runnan Li, Gloria Y Yeh, Jeff C Huffman, Christopher M Celano, David Victorson, Bettina B Hoeppner, Elyse R Park","doi":"10.1177/27536130241288213","DOIUrl":"10.1177/27536130241288213","url":null,"abstract":"<p><strong>Background: </strong>Following acute coronary syndrome (ACS), up to 40% of patients report elevated depressive symptoms which is associated with a two-fold increase in mortality risk due to behavioral and biological mechanisms. Mindfulness-Based Cognitive Therapy (MBCT) delivered via synchronous group videoconferencing could help reduce depressive symptoms.</p><p><strong>Objective: </strong>To guide MBCT adaptation for ACS patients for a future clinical trial, this qualitative study aimed to explore ACS patients' (1) symptoms after ACS, (2) needs for behavioral health treatment, (3) perspectives on mindfulness intervention and group videoconference delivery, and (4) willingness to self-collect dried blood spots in a research study.</p><p><strong>Methods: </strong>We compared ACS patients with and without depressive symptoms to highlight particularly relevant treatment topics for patients developing depression following ACS experience. From 2/2019-11/2019, we conducted semi-structured individual telephone interviews with N = 23 patients after ACS (N = 13 with and N = 10 without elevated depressive symptoms; 63.4 (SD = 8.5) years, 87% male, 96% non-Hispanic white, 7.1 (SD = 7.5) years since ACS). In qualitative content analyses, four independent coders coded each interview.</p><p><strong>Results: </strong>Participants with depressive symptoms experienced emotional, physical, social, and health behavior problems, while those without depressive symptoms made positive health behavior changes and struggled with anxiety symptoms. Both groups were interested in a behavioral health treatment for emotional and social support. Most were willing to participate in a mindfulness group via videoconferencing; some preferred in-person, but accessibility and convenience outweighed these cons. Almost all were willing to self-collect dried blood spots and some were already familiar with this technique.</p><p><strong>Conclusion: </strong>ACS patients, especially those with depressive symptoms, need help managing a multitude of quality of life concerns that can be targeted with an adapted MBCT approach. A videoconference-delivered MBCT approach is of interest. Suggestions for adapting MBCT to target the needs of ACS patients are discussed.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241288213"},"PeriodicalIF":0.0,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457197/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395691","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":"Using PROMIS Methodology to Create Self-Report Measures of Mindfulness and Related Concepts.","authors":"David Victorson, Natalia E Morone, Paul A Pilkonis, Benjamin Schalet, Lan Yu, Kathryn L Jackson, Nathan Dodds, Bruriah Horowitz, Kelly Johnston, Christine McFarland, Mary Lou Klem, Christina Sauer, Seung Choi, Judith T Moskowitz, Jason C Ong, Elizabeth L Addington, Maureen D Satyshur, Stephen J Suss, Sarah Daehler, Carol M Greco","doi":"10.1177/27536130241290771","DOIUrl":"10.1177/27536130241290771","url":null,"abstract":"<p><strong>Background: </strong>Mindfulness meditation is ubiquitous in health care, education, and communities at large. Mindfulness-Based Interventions (MBIs) are the focus of hundreds of NIH-funded trials given the myriad health benefits associated with this practice across multiple populations. Notwithstanding, significant gaps exist in how mindfulness concepts are measured using currently available self-report instruments. Due to the number of available mindfulness measurement tools, each measuring different aspects, it is difficult to determine the extent to which individuals develop comparable mindfulness skills and attitudes and which health benefits can be attributed to which gains in mindfulness. The Patient-Reported Outcomes Measurement Information System (Puerto RicoOMIS®) has established a rigorous instrument development methodology to create brief, precise, and clinically relevant outcomes tools.</p><p><strong>Objective: </strong>This is the first of 4 papers representing an NCCIH-funded initiative (R01AT009539), which has applied Puerto RicoOMIS® instrument development methodologies to mindfulness measurement to improve the rigor, relevance, and reproducibility of MBI research results.</p><p><strong>Methods/results: </strong>This introductory paper sets the stage for why improved mindfulness measurement tools are needed and briefly describes the Puerto RicoOMIS® development approach. The second 2 papers highlight results from a national survey, focus groups, and expert interviews to identify and organize relevant mindfulness concepts, domains, and items for eventual item bank creation. The fourth paper reviews the item writing and development process of these new instruments, including results from stakeholder cognitive interviews and a translatability review.</p><p><strong>Conclusion: </strong>Together these papers feature the rigorous development approach, rationale, logic, and significance that supports the development, calibration, and validation of new Puerto RicoOMIS® measures of mindfulness and related concepts.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241290771"},"PeriodicalIF":0.0,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459545/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142395692","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 Experience and Attitudes Toward Electronic Intake and Patient-Reported Outcomes Within an Outpatient Whole Health Center.","authors":"Tracy L Segall, Samuel N Rodgers-Melnick, Jessica Surdam, Roshini Srinivasan, Jeffery A Dusek","doi":"10.1177/27536130241280181","DOIUrl":"10.1177/27536130241280181","url":null,"abstract":"<p><p><b>Background:</b> The use of electronic intake forms within the electronic health record (EHR) is an emerging method for routinely collecting patient-reported outcomes (PRO). However, few studies have evaluated experiences/perspectives toward electronic forms among outpatients receiving care within Integrative Health and Medicine (IHM) clinics. The study purpose was to understand patients' perspectives of electronic intake and PRO forms in the outpatient IHM setting. <b>Methods:</b> Electronic intake (e.g., treatment expectations, medical history, chief complaints, prior experience with integrative modalities) and PRO forms (i.e., Patient Reported Outcome Measurement Information System [PROMIS]-29, Perceived Stress Scale 4, Oswestry Disability Index) were designed in collaboration with clinic leadership and the Information Technology team. Semi-structured interviews were used to gather perspectives of the functionality and acceptability of the forms among outpatients receiving care at the IHM center. Interviews were coded to describe themes regarding perceptions and suggestions for improvement. <b>Results:</b> Qualitative interviews were completed with 10 participants (median age 51 years, 70% female, 30% Black/African American). Participants considered electronic intake and PRO forms as relevant to their health concerns, valuable for conveying important health information to providers, and easy to navigate. Suggested changes to the intake form included adding relevant open-ended questions, save and print functions, and examples and definitions to prompt responses. <b>Conclusion:</b> Participants felt the electronic format was a feasible and acceptable method of collecting patient information and PROs. Future goals are to implement the revised forms in a common EHR to patients receiving care at multiple IHM clinics across the United States.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241280181"},"PeriodicalIF":0.0,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142333814","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 Validation Study of the Mindfulness-Based Interventions Teaching Assessment Criteria for Assessing Mindfulness-Based Intervention Teacher Skill: Inter-Rater Reliability and Predictive Validity.","authors":"Frederick M Hecht, Rebecca S Crane, Patricia Moran, Willem Kuyken, Wendy Hartogensis, Judson Brewer","doi":"10.1177/27536130241275962","DOIUrl":"https://doi.org/10.1177/27536130241275962","url":null,"abstract":"<p><strong>Background: </strong>Prior data suggests the Mindfulness-Based Interventions: (MBI) Teaching Assessment Criteria (MBI:TAC) has good inter-rater reliability, but many raters knew teacher experience level.</p><p><strong>Objective: </strong>We sought to further evaluate the MBI-TAC's inter-rater reliability and obtain preliminary data on predictive validity.</p><p><strong>Methods: </strong>We videorecorded 21 MBSR teachers from academic and community settings. We trained 19 experienced MBI teachers in using the MBI:TAC. MBSR teachers were rated by three assessors; teachers and their assessors did not know one another. To assess predictive validity, MBSR students in courses taught by 18 of the MBSR teachers were invited to complete PROMIS-29 measures before the MBSR course, at the end of the course (month 2), and month 4.</p><p><strong>Results: </strong>Intraclass correlation coefficients (ICCs) representing a single rater ranged from 0.33 to 0.56 on the 6 MBI:TAC domains. Using an average of two raters, ICC estimates ranged from 0.48 to 0.71 and ICCs generalizing to an average of three raters ranged from 0.6 to 0.8. Among n = 152 participating MBSR students, we found improvements from baseline to 2 months and 4 months in PROMIS measures of Anxiety, Depression, Fatigue, Sleep, and Social Role function (range in improvement 2.3 to 6.3, <i>P</i> < 0.0001 for all comparisons except Social Role at 2 months, <i>P</i> = 0.007). Higher MBI:TAC ratings were associated with greater improvements in anxiety among MBSR students from baseline to 2 months, with a -0.31 lower participant anxiety score per 1 unit increase in MBI:TAC composite teaching rating (95% CI -0.58, -0.05, <i>P</i> = 0.019), but we did not find statistically significant relationships with improvements in other PROMIS-29 domains.</p><p><strong>Conclusions: </strong>ICCs indicated good reliability using an average of three ratings, but inter-rater reliability was only fair using a single rater. We found initial validation that higher MBI:TAC ratings predicted greater improvements in anxiety symptoms in MBSR participants.</p>","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241275962"},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11423373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142333813","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":"Efficacy and Safety of <i>Bacillus coagulans</i> LBSC in Drug Induced Constipation Associated With Functional Gastrointestinal Disorder: A Double-Blind, Randomized, Interventional, Parallel, Controlled Trial a Clinical Study on <i>Bacillus coagulans</i> LBSC for Drug Induced Constipation Associated With FGIDs.","authors":"Ankit Rathi, Ravikiran Pagare","doi":"10.1177/27536130241286511","DOIUrl":"https://doi.org/10.1177/27536130241286511","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Active drugs and nutraceutical supplements commonly induce various gastrointestinal illnesses, and constipation is a major gastrointestinal symptom accompanied with functional gastrointestinal disorders. Drug-induced imbalance in gut microbiota may play critical role in such physiological disturbances. Probiotics have been known for resuming normal and healthy gut microbiome.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To investigate the clinical efficacy and safety of &lt;i&gt;Bacillus coagulans&lt;/i&gt; LBSC in the treatment of drug induced constipation associated with functional gastrointestinal disorder (FGID) symptoms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled trial with 168 patients experiencing drug induced constipation associated with FGID symptoms (DICAWFGID) screened through Rome IV criteria were randomized into 2 arms, i.e. placebo arm (n = 28) and atorvastatin, atenolol, metformin, amitriptyline, and calcium in test arm (n = 28/arm). Patients in both arms received similar dosages (1 g sachet, 3 times a day) for 35 days. The occurrence of constipation using Bristol Stool Form Scale, assessment of degree of constipation on 4-point Likert scale, occurrence of hard stool and degree of stool expulsion on 3-point scale, and defecation frequency were primary endpoints. While, secondary outcomes consisted of the changes in severity of FGID symptoms, visual analogue scale and tolerance to IP, along with reports of adverse events (AEs) and severe adverse events (SAEs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;There was a significant reduction in occurrence of constipation (≥98.6% and &lt;i&gt;P&lt;/i&gt;-value &lt;0.05) in test arm over the placebo arm. Assessment of co-primary endpoints showed significant improvements in degree of stool consistency (&lt;i&gt;P&lt;/i&gt;-value 0.0232; CI: 0.1870, 1.1629), borderline significantly superior in degree of stool expulsion (&lt;i&gt;P&lt;/i&gt;-value 0.0553; CI: 0.0378, -0.4939), while the other co-primary efficacy endpoints displayed considerably improved advancement (non-significant, &lt;i&gt;P&lt;/i&gt;-value ≥0.05). The intra group analysis of symptoms at start of treatment (SOT) and end of treatment (EOT) revealed a significant reduction in scores for occurrence of constipation and degree of constipation, whereas significant improvement in the scores for degree of stool consistency and degree of stool expulsion (&lt;i&gt;P&lt;/i&gt;-value &lt;0.001) after the intervention period. In secondary endpoints, the processed responses clearly signified a considerable positive improvement (non-significant, &lt;i&gt;P&lt;/i&gt;-value ≥0.05) in other symptoms of constipation associated with FGIDs as determined by the changes in the EOT-SOT score. The study data also highlighted the safety o&lt;i&gt;f Bacillus coagulans&lt;/i&gt; LBSC at the studied dose. No AEs and/or SAEs were documented during the investigation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;At the studied dose, &lt;i&gt;Bacillus coagulans&lt;/i&gt; LBSC was safe for or","PeriodicalId":73159,"journal":{"name":"Global advances in integrative medicine and health","volume":"13 ","pages":"27536130241286511"},"PeriodicalIF":0.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11409293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142302552","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}