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BACKGROUND: Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. AIM: To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. DESIGN OF STUDY: Randomised controlled trial. SETTING: General practices in Reading, UK. METHOD: Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. RESULTS: Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. CONCLUSIONS: This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication. [ABSTRACT FROM AUTHOR]

In the last 50 years science has provided new perspectives on the ancient art of herbal medicine. The present article discusses ways in which the evidence base for the professional use of 'Western' herbal medicine, as therapy to treat disease, known as phytotherapy, can be strengthened and developed. The evidence base for phytotherapy is small and lags behind that for the nutritional sciences, mainly because phytochemicals are ingested as complex mixtures that are incompletely characterised and have only relatively recently been subject to scientific scrutiny. While some methodologies developed for the nutritional sciences can inform phytotherapy research, opportunities for observational studies are more limited, although greater use could be made of patient case notes. Randomised clinical trials of single-herb interventions are relatively easy to undertake and increasing numbers of such studies are being published. Indeed, enough data are available on three herbs (ginkgo (Ginkgo biloba), St John's wort (Hypericum perforatum) and saw palmetto (Serenoa repens)) for meta-analyses to have been undertaken. However, phytotherapy is holistic therapy, using lifestyle advice, nutrition and individually-prescribed mixtures of herbs aimed at reinstating homeostasis. While clinical experience shows that this approach is applicable to a wide range of conditions, including chronic disease, evidence of its efficacy is scarce. Strategies for investigating the full holistic approach of phytotherapy and its main elements are discussed and illustrated through the author's studies at the University of Reading. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study aimed to investigate the efficacy of St. John's wort extract (SJW) as a treatment for premenstrual symptoms. DESIGN: The study was a randomized, double-blinded, placebo-controlled trial, with two parallel treatment groups. After a no-treatment baseline cycle, volunteers were randomized to either SJW or placebo for a further two menstrual cycles. SETTINGS/LOCATION: A postal trial conducted from The University of Reading, Berkshire, England. SUBJECTS: One hundred and sixty-nine (169) normally menstruating women who experienced recurrent premenstrual symptoms were recruited onto the study. One hundred and twenty-five (125) completed the protocol and were included in the analysis. INTERVENTIONS: Six hundred milligrams (600) mg of SJW (standardized to contain 1800 microg of hypericin) or placebo (containing lactose and cellulose). OUTCOME MEASURE: A menstrual diary was used to assess changes in premenstrual symptoms. The anxiety-related subgroup of symptoms of this instrument was used as the primary outcome measure. RESULTS: After averaging the effects of treatment over both treatment cycles it was found that there was a trend for SJW to be superior to placebo. However, this finding was not statistically significant. CONCLUSION: The possibility that this nonsignificant finding resulted from insufficient statistical power in the study, rather than a lack of efficacy of SJW, is discussed. Following this discussion the recommendation is made that, in future, similar studies should be powered to detect a minimum clinically relevant difference between treatments. [ABSTRACT FROM AUTHOR]

To investigate single and combined effects of daily dietary supplementation with 50 mg of vitamin B6 and 200 mg magnesium (as MgO) for one cycle for the relief of mild premenstrual symptoms, a randomized, double-blind, placebo-controlled, crossover design was used. Forty-four women with an average age of 32 years took part in the study. Each woman was randomly assigned, according to a Latin square design, to take consecutively all four of the following treatments daily for one menstrual cycle: (1) 200 mg Mg, (2) 50 mg vitamin B6, (3) 200 mg Mg + 50 mg vitamin B6 and (4) placebo. Throughout the study, each volunteer kept a daily record of symptoms using a 5-point ordinal scale in a menstrual diary of 30 symptoms. Symptoms were grouped into six categories: anxiety, craving, depression, hydration, other, and total. Urinary magnesium output for 24 hours was estimated using the Mg/creatinine concentration ratio. ANOVA showed no overall difference between individual treatments, but predefined treatment comparisons using factorial contrasts in ANOVA showed a significant effect of 200 mg/day Mg + 50 mg/day vitamin B6 on reducing anxiety-related premenstrual symptoms (nervous tension, mood swings, irritability, or anxiety) (p = 0.040). Urinary Mg output was not affected by treatment. A small synergistic effect of a daily dietary supplementation with a combination of Mg + vitamin B6 in the reduction of mild premenstrual anxiety-related symptoms was demonstrated during treatment of 44 women for one menstrual cycle. In view of the modest effect found, further studies are needed before making general recommendations for the treatment of premenstrual symptoms. The study indicated that absorption from MgO was poor and daily supplementation for longer than 1 month is necessary for tissue repletion. [ABSTRACT FROM AUTHOR]

BACKGROUND: Despite ample food supplies, the incidence of childhood underweight and stunting remains high in Uganda. Many factors contribute to this situation, but the role of low zinc intakes has not been adequately explored. OBJECTIVE: Our objective was to study the effect of zinc supplementation on growth and body composition of preschool children by using the outcome measures of weight, height, and midupper arm circumference (MUAC). DESIGN: The study was randomized, double-blind, placebo-controlled, parallel, and 8 mo long, and incorporated 6 mo of zinc supplementation. Children (n = 153) aged 55.8 +/- 11.2 mo from 3 randomly selected nursery schools of medium, low, and very low socioeconomic status in a suburb of Kampala took part. The intervention comprised 10 mg Zn (as ZnSO4) or placebo daily in freshly prepared fruit juice, Monday to Friday inclusive. RESULTS: Zinc supplementation increased MUAC by the end of the study (P = 0.029) and led to greater weight gain in children from the school of medium socioeconomic status at 3 and 8 mo (P = 0.019 and P = 0.038, respectively). There was no effect on weight gain of the children from the other schools. Zinc supplementation had no influence on height. Infection rates (of which 82% were recorded as malaria) were lower in the zinc-supplemented group than in control subjects (P = 0.063). CONCLUSIONS: Zinc supplementation may counter the age-related decrease in MUAC often observed in preschool children in developing countries. The study provides evidence that zinc may not be the most limiting nutrient for weight gain in children of poor nutritional status, but may become so as nutritional status improves. Copyright (c) 1998 American Society for Clinical Nutrition [ABSTRACT FROM AUTHOR]

OBJECTIVES: Does artichoke leaf extract (ALE) ameliorate symptoms of Irritable bowel syndrome (IBS) in otherwise healthy volunteers suffering concomitant dyspepsia? METHODS: A subset analysis of a previous dose-ranging, open, postal study, in adults suffering dyspepsia. Two hundred and eight (208) adults were identified post hoc as suffering with IBS. IBS incidence, self-reported usual bowel pattern, and the Nepean Dyspepsia Index (NDI) were compared before and after a 2-month intervention period. RESULTS: There was a significant fall in IBS incidence of 26.4% (p < 0.001) after treatment. A significant shift in self-reported usual bowel pattern away from 'alternating constipation/diarrhea' toward 'normal' (p < 0.001) was observed. NDI total symptom score significantly decreased by 41% (p < 0.001) after treatment. Similarly, there was a significant 20% improvement in the NDI total quality-of-life (QOL) score in the subset after treatment. CONCLUSION: This report supports previous findings that ALE ameliorates symptoms of IBS, plus improves health-related QOL. [ABSTRACT FROM AUTHOR]

Objective: To characterise telehealth use, reasons for using or not using telehealth and the factors associated with telehealth use among US adults with diabetes., Design: A cross-sectional study., Setting: Data were sourced from the 2022 Health Information National Trends Survey., Participants: US adults aged 18 years or older with self-reported diagnosis of diabetes (both type 1 and type 2)., Primary and Secondary Outcomes: Past 12-month utilisation of telehealth services, modality (eg, video, voice only), overall perception of quality of care, perceived trust in healthcare system and patient-centred communication score., Results: In an analysis of 1116 US adults with diabetes, representing 33.6 million individuals, 48.1% reported telehealth use in the past year. Telehealth users were likely to be younger, women, with higher income, and urban dwellers. Older adults (≥65 years) were less likely to use telehealth compared with those aged 18-49 years (OR 0.43, 95% CI 0.20 to 0.90). Higher income and more frequent healthcare visits were predictors of telehealth usage, with no significant differences across race, education or location. Across respondents with telehealth usage, 39.3% reported having video-only, 35.0% having phone (voice)-only and 25.7% having both modalities. The main motivations included provider recommendation, convenience, COVID-19 avoidance and guidance on in-person care needs. Non-users cited preferences for in-person visits, privacy concerns and technology challenges. Patient-reported quality-of-care outcomes were comparable between telehealth users and non-users, with no significant differences observed by telehealth modality or area of residence (metro status)., Conclusions: Around half of US adults with diabetes used telehealth services in the past year. Patient-reported care quality was similar for telehealth and in-person visits. However, further efforts are needed to address key barriers to telehealth adoption, including privacy concern, technology difficulties, and care coordination issues., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Diabetes disparities exist based on socioeconomic status, race, and ethnicity. The aim of this study is to compare two cohorts with diabetes from California and Florida to better elucidate how health outcomes are stratified within underserved communities according to state location, race, and ethnicity., Research Design and Methods: Two cohorts were recruited for comparison from 20 Federally Qualified Health Centers as part of a larger ECHO Diabetes program. Participant-level data included surveys and HbA1c collection. Center-level data included Healthcare Effectiveness Data and Information Set metrics. Demographic characteristics were summarized overall and stratified by state (frequencies, percentages, means (95% CIs)). Generalized linear mixed models were used to compute and compare model-estimated rates and means., Results: Participant-level cohort: 582 adults with diabetes were recruited (33.0% type 1 diabetes (T1D), 67.0% type 2 diabetes (T2D)). Mean age was 51.1 years (95% CI 49.5, 52.6); 80.7% publicly insured or uninsured; 43.7% non-Hispanic white (NHW), 31.6% Hispanic, 7.9% non-Hispanic black (NHB) and 16.8% other. Center-level cohort: 32 796 adults with diabetes were represented (3.4% with T1D, 96.6% with T2D; 72.7% publicly insured or uninsured). Florida had higher rates of uninsured (p<0.0001), lower continuous glucose monitor (CGM) use (18.3% Florida; 35.9% California, p<0.0001), and pump use (10.2% Florida; 26.5% California, p<0.0001), and higher proportions of people with T1D/T2D>9% HbA1c (p<0.001). Risk was stratified within states with NHB participants having higher HbA1c (mean 9.5 (95% CI 8.9, 10.0) compared with NHW with a mean of 8.4 (95% CI 7.8, 9.0), p=0.0058), lower pump use (p=0.0426) and CGM use (p=0.0192). People who prefer to speak English were more likely to use a CGM (p=0.0386)., Conclusions: Characteristics of medically underserved communities with diabetes vary by state and by race and ethnicity. Florida's lack of Medicaid expansion could be a factor in worsened risks for vulnerable communities with diabetes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Since its inception in 2003, the Project Extension for Community Healthcare Outcomes (ECHO) tele-education model has reached and improved outcomes for patients, providers, and health centers through interventions in >180 countries. Utilization of this model has recently increased due to the COVID-19 pandemic and a higher demand for remote education. However, limited research has examined the methodologies used to evaluate Project ECHO interventions., Methods: We conducted a scoping review to determine the extent and types of research methods used to evaluate outcomes and implementation success of Project ECHO interventions and to identify gaps and opportunities for future investigation. Using Arksey and O'Malley's scoping review framework and the PRISMA-ScR checklist, we reviewed study designs, temporality, analysis methods, data sources, and levels and types of data in 121 articles evaluating Project ECHO interventions., Results: Most interventions addressed substance use disorders (24.8%, n = 30), infectious diseases (24%, n = 29), psychiatric and behavioral health conditions (21.5%, n = 26), and chronic diseases (19%, n = 23). The most frequently reported evaluation methods included cohort studies (86.8%, n = 105), longitudinal designs (74.4%, n = 90), mixed methods analysis (52.1%, n = 63), surveys (61.2%, n = 74), process evaluation measures (98.3%, n = 119), and provider-level outcome measures (84.3%, n = 102). Few evaluations used experimental designs (1.7%, n = 2), randomization (5.8%, n = 7), or comparison groups (14%, n = 17), indicating limited rigor., Discussion: This scoping review demonstrates the need for more rigorous evaluation methods to test the effectiveness of the Project ECHO model at improving outcomes and standardized reporting guidelines to enhance the dissemination of evaluation data from future Project ECHO interventions., Competing Interests: Disclosures: The authors declare no conflict of interest., (Copyright © 2024 The Alliance for Continuing Education in the Health Professions, the Association for Hospital Medical Education, and the Society for Academic Continuing Medical Education.)

Background: People with diabetes have higher COVID-19 morbidity and mortality. These risks are amplified for underserved communities including racial/ethnic minorities and people with lower socioeconomic status. However, limited research has examined COVID-19 outcomes specifically affecting underserved communities with diabetes., Methods: From November 2021 to July 2022, adults with insulin-requiring diabetes at federally qualified health centers in Florida and California (n = 450) completed surveys examining COVID-19 outcomes and demographics. Surveys assessed COVID-19 severity, vaccination uptake, mask-wearing habits, income changes, and healthcare access changes. Surveys also included the full Coronavirus Anxiety Scale (CAS-19). Descriptive statistics were computed for all outcomes. Between-group comparisons for state and race/ethnicity were evaluated via Chi-Squared, Fisher's Exact, Cochran-Mantel-Haenszel, One-Way ANOVA, and t -tests. Logistic regression determined factors associated with COVID-19 vaccination uptake. Data were self-reported and analyzed cross-sectionally., Results: Overall, 29.7 % reported contracting COVID-19; of those, 45.3 % sought care or were hospitalized. Most (81.3 %) received ≥ 1 vaccine. Hispanics had the highest vaccination rate (91.1 %); Non-Hispanic Blacks (NHBs) had the lowest (73.9 %; p =.0281). Hispanics had 4.63x greater vaccination odds than Non-Hispanic Whites ([NHWs]; 95 % CI = [1.81, 11.89]). NHWs least often wore masks (18.8 %; p <.001). Participants reported pandemic-related healthcare changes (62 %) and higher costs of diabetes medications (41 %). Income loss was more frequent in Florida (76 %; p <.001). NHBs most frequently reported "severe" income loss (26.4 %; p =.0124). Loss of health insurance was more common among NHBs (13.3 %; p =.0416) and in Florida (9.7 %; p =.039). COVID-19 anxiety was highest among NHBs and Hispanics (IQR = [0.0, 3.0]; p =.0232) and in Florida (IQR = [0.0, 2.0]; p =.0435)., Conclusions: Underserved communities with diabetes had high COVID-19 vaccine uptake but experienced significant COVID-19-related physical, psychosocial, and financial impacts. NHBs and those in Florida had worse outcomes than other racial/ethnic groups and those in California. Further research, interventions, and policy changes are needed to promote health equity for this population., Competing Interests: JLM, AA, SLF, MJG, SW, BND, LF, MH, KGM, and AFW have nothing to declare. MJH has the following disclosures: Board Member for SAB Biotherapeutics, Inc. and Consultant for Sanofi and MannKind Corporation. DMM has the following disclosures: Advisory Panel for Medtronic, LifeScan Diabetes Institute, and MannKind Corporation; Consultant for Abbott; and Research Support from Dexcom, Inc. RAL has the following disclosures: Advisory Panel for Provention Bio, Inc. and Consultant for Abbott, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Tidepool, PhysioLogic Devices, and Morgan Stanley., (© 2024 The Authors.)

Background: The telementoring Project ECHO (Extension for Community Healthcare Outcomes) model has been shown to improve disease management in diabetes in many underserved communities. The authors aim to evaluate if ECHO could also be an effective tool for quality improvement (QI) of diabetes care in these communities., Methods: Thirteen clinics in underserved communities in California and Florida participating in Project ECHO Diabetes were recruited for a 12-month QI program. The program provided weekly tele-education sessions, including a didactic presentation and case-based discussion. In addition, clinics chose their own set of quality measures to improve and met remotely to discuss their efforts, successes, and setbacks every quarter with mentorship from QI experts., Results: Of the 31 QI initiatives attempted by different clinics, all had either made improvements (25 initiatives, 80.6%) or were in the process of making improvements (6 initiatives, 19.4%) in structural, process, and outcome measures. Examples of these measures include whether clinics have protocols to identify high-risk patients (structure), numbers of continuous glucose monitor prescriptions submitted by the clinics (process), and percentage of patients with diabetes whose most recent HbA1c are > 9% (outcome). For one measure, 40.0% of the clinics had achieved a higher percentage of cumulative HbA1c measurement in the third quarter of the year, compared to the fourth quarter in the previous year. The cost of QI implementation varied widely due to different number of personnel involved across sites., Conclusion: A QI program delivered via Project ECHO Diabetes can facilitate quality improvements in underserved communities., (Copyright © 2023 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Background: Research focused on disparities related to mental health comorbidities, especially among emerging adults with diabetes, is limited. Identifying associated factors of disparities could inform policy decisions to make diabetes-related interdisciplinary care more accessible for vulnerable groups., Method: Using data from the National Survey on Drug Use and Health (2015-2019), we examined disparities in presence of major depressive episode (MDE) and suicidal ideation among emerging adults with diabetes. Survey design-adjusted bivariate and multivariable logistic regression models were used for statistical analyses., Results: The study included 1,125 emerging adults (18-25 years old), with a history of type 1 diabetes (T1D) or type 2 diabetes (T2D). After controlling for sociodemographic and health-related characteristics, we found lower odds of having past-year major MDE for non-Hispanic Black (AOR, 0.42, p=0.032) compared to their non-Hispanic White counterparts. Females were 3.02 times more likely to have past-year MDE than males (AOR, 3.02, p=0.004). The odds of having past-year MDE were 1.96 times higher among individuals who identified as LGB (lesbian, gay, bisexual) (AOR, 1.96, P=0.038). There were no statistically significant disparities in suicidal ideation related to race/ethnicity, sex, education, and family income. However, individuals who identified as LGB had significantly higher likelihood of suicidal ideation than their heterosexual counterparts (AOR, 2.47, P=0.004)., Conclusion: Significant disparities related to MDE and suicidal ideation exist based on race/ethnicity, gender, and sexual orientation. Integration of a mental health professional into the multidisciplinary diabetes care team is critical for effective management of comorbid mental health conditions in younger patients with diabetes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Yadav, Hong, Westen, Marlow, Haller and Walker.)

Objectives: Individuals under-recruited in diabetes research studies include those not seen at endocrinology centres and those from rural, low socioeconomic and/or under-represented racial/ethnic groups. The purpose of this descriptive analysis is to detail recruitment and retention efforts of Project ECHO Diabetes clinical sites affiliated with Stanford University and University of Florida., Design: Prospective collection of participant engagement and qualitative analysis of barriers and facilitators of research engagement within Project ECHO Diabetes, a virtual tele-education programme for healthcare providers in the management of individuals with insulin-requiring diabetes., Setting: Data were collected at the patient level, provider level and clinic level between 1 May 2021 and 31 July 2022., Participants: Participants and study personnel were recruited from 33 Project ECHO Diabetes sites in California and Florida., Outcomes: We report study completion rates for participants recruited into 33 Project ECHO Diabetes sites. Using barrier analysis, a methodology designed for the real-time assessment of interventions and system processes to identify barriers and facilitators, study personnel identified significant barriers to recruitment and retention and mapped them to actionable solutions., Results: In total, 872 participants (California n=495, Florida n=377) were recruited with differing recruitment rates by site (California=52.7%, Florida=21.5%). Barrier analysis identified lack of trust, unreliable contact information, communication issues and institutional review board (IRB) requirements as key recruitment barriers. Culturally congruent staff, community health centre (CHC) support, adequate funding and consent process flexibility were solutions to address recruitment challenges. Barriers to retention were inconsistent postal access, haemoglobin A1c kit collection challenges, COVID-19 pandemic and broadband/connectivity issues. Additional funding supporting research staff and analogue communication methods were identified as solutions address barriers to retention., Conclusions: Funded partnerships with CHCs, trusted by their local communities, were key in our recruitment and retention strategies. IRB consent process flexibility reduced barriers to recruitment. Recruiting historically under-represented populations is feasible with funding aimed to address structural barriers to research participation., Competing Interests: Competing interests: RL has consulted for Abbott Diabetes Care, Biolinq, Capillary Biomedical, Deep Valley Labs, Morgan Stanley, Glooko, and Tidepool. DMM has received research support from the National Institutes of Health, JDRF, NSF and the Helmsley Charitable Trust; and his institution has received research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem and Roche. He has consulted for Abbott, the Helmsley Charitable Trust, Sanofi, Novo Nordisk, Eli Lilly, and Insulet, and is supported by grant number P30DK116074. MJH has reserved research support from the NIH, JDRF and the Helmsley Charitable Trust and has been a consultant for Mannkind and Sanofi. Theremaining authors have no potential conflicts of interest relevant to this article., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In the United States, there are over 37 million people with diabetes but only 8000 endocrinologists. Therefore, many people with diabetes receive care exclusively from primary care providers (PCPs). To democratize knowledge regarding insulin-requiring diabetes through tele-education, Stanford University and the University of Florida developed Project Extension for Community Healthcare Outcomes (ECHO) Diabetes., Objective: ECHO Diabetes uses a Hub and Spoke model connecting specialists (the "Hub") with PCPs (the "Spokes"). One-hour, weekly sessions include Hub diabetes didactic presentations and Spoke deidentified case presentations. Lessons learned during these sessions target provider knowledge and confidence surrounding diabetes management and patient care., Methods: Spokes were asked to provide short descriptions of people with diabetes whose diabetes management improved directly or indirectly from their providers' participation or their involvement with a Diabetes Support Coach (DSC). We provide a case series to describe individuals and outcomes. Because this study was not a randomized controlled trial and was a prospective observation of patients with the intervention delivered to providers, the trial is not registered in a public trials registry., Results: A case series of 11 people with diabetes was compiled from 10 PCPs and 1 DSC from California and Florida between 2021 and 2022. The principal impact of ECHO Diabetes is the education amplified from PCPs and DSCs to people with diabetes. In all cases, people with diabetes reported increased engagement and improved diabetes management. Several cases reflected increased access to diabetes technology, improvement in glycemic outcomes, and positive trends in mental health measures., Conclusions: This case series elucidates the potential value of the ECHO Diabetes program to people with diabetes who receive their diabetes care from PCPs. Those matched with a DSC saw clinically significant improvements in hemoglobin A 1c and mental health outcomes., (©Lauren Figg, Ananta Addala, Ishaan Jain, Claudia Anez, Paul Midney, Corin DeChirico, Colleen Symanski, Brian C Fitzgerald, Kristi Colbert, Terry Raymer, Candy Stockton-Joreteg, Elizabeth Murphy, Leah Collins, Cyd Bernstein, Melanie Hechavarria, Eleni P Sheehan, Angelina Bernier, Sarah C Westen, Korey K Hood, Dessi P Zaharieva, Marina Basina, Nicolas Cuttriss, Stephanie L Filipp, Matthew J Gurka, Ashby F Walker, David M Maahs, Michael J Haller, Rayhan A Lal. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 03.08.2023.)

Diabetes is a serious chronic disease with high associated burden and disproportionate costs to communities based on socioeconomic, gender, racial, and ethnic status. Addressing the complex challenges of global inequity in diabetes will require intentional efforts to focus on broader social contexts and systems that supersede individual-level interventions. We codify and highlight best practice approaches to achieve equity in diabetes care and outcomes on a global scale. We outline action plans to target diabetes equity on the basis of the recommendations established by The Lancet Commission on Diabetes, organising interventions by their effect on changing the ecosystem, building capacity, or improving the clinical practice environment. We present international examples of how to address diabetes inequity in the real world to show that approaches addressing the individual within a larger social context, in addition to addressing structural inequity, hold the greatest promise for creating sustainable and equitable change that curbs the global diabetes crisis., Competing Interests: Declaration of interests AFW is supported by The Leona M and Harry B Helmsley Charitable Trust (2005-03934) and the National Institutes of Health-National Institute of Diabetes and Digestive Kidney Disease (5P30DK111024-07). LM-B is supported by an Australian National Health and Medical Research Council (NHMRC) investigator grant (1194698), and leads projects that are funded by NHMRC, the Australian Department of Health, and the Australian Medical Research Future Fund. LEE and JAC are supported by the National Institutes of Health-National Institute of Diabetes and Digestive Kidney Disease (R01DK118038 and R01DK120861, awarded to LEE; K01DK131319, awarded to JAC). LEE and RJW are supported by the National Institute on Minority Health and Health Disparities (R01MD013826, awarded to LEE and RJW; R01MD017574, awarded to LEE). RJW is supported by the American Diabetes Association (1-19-JDF-075). ANW is supported by the National Institutes of Health-Fogarty International Centre (K43TW010698). ANW declares an honorarium received from Sanofi for serving as a panel member at an educational event on thyroid cancer. JCM receives honorarium from Servier Laboratories for serving on the advisory committee at educational events. OE is a health-care disparities adviser (on a temporary advisory board role) for Medtronic. OE has received research support through his organisation T1D Exchange from Medtronic, Vertex, Dexcom, and Eli Lilly. Medtronic supports components of T1DX-QI health equity work. The T1DX-QI is funded by The Leona M and Harry B Helmsley Charitable Trust. LAD has received research support to her institution from Dompé, Lilly, MannKind, Medtronic, Provention, and Zealand Pharma; and served as a consultant for Abata Therapeutics and Vertex. SA is supported by the National Institutes of Health-National Institute of Diabetes and Digestive Kidney Disease (R01DK132302, K23115896, and P30DK111022-07), JDRF, and The Leona M and Harry B Helmsley Charitable Trust. SA receives research devices, but not salary support from Dexcom and Abbott, and is a health-care disparities adviser (on a temporary advisory board role) for Medtronic and Beta Bionics. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Analog insulins, insulin pumps, and continuous glucose monitors (CGM) have revolutionized type 1 diabetes (T1D) treatment over the last 50 years. Nevertheless, less than 20% of patients in the United States reach guideline-based HbA1c targets. The dysfunctional delivery of U.S. health care has further worsened glycemic outcomes among structurally disadvantaged groups such as non-Hispanic Black and low-income populations. Administrative complexities resulting from mixed insurance coverage and delivery systems, incongruity between effective policies and reimbursement, structural racism, and implicit biases have led to high diabetes care-related costs, provider scarcity and burnout, and patient diabetes distress. The Extension for Community Healthcare Outcomes (ECHO) Diabetes tele-education outreach model was created to increase self-efficacy among primary care providers through a combination of weekly didactic sessions led by a team of diabetes experts and access to community-based peer coaches. As an evolution of ECHO Diabetes, Blue Circle Health has been established as a philanthropically funded health care delivery system, using a whole-person, individualized approach to T1D care for adults living in underserved communities. The program will provide direct-to-patient telehealth services, including diabetes education, management, and related psychological care regardless of ability to pay. Community-based diabetes support coaches will serve as the primary point of contact, or guide on the "Blue Circle Health Member Journey." Access to needed insulins, supplies, and CGMs will be provided at no cost to the individual. Through a continuous learning and improvement model, a person-centered, equitable, accessible, and effective health care delivery model will be built for people living with T1D.

Introduction: Project ECHO Diabetes is a tele-education learning model for primary care providers (PCPs) seeking to improve care for patients with diabetes from marginalized communities. Project ECHO Diabetes utilized expert "hub" teams comprising endocrinologists, dieticians, nurses, psychologists, and social workers and "spokes" consisting of PCPs and their patients with diabetes. This Project ECHO Diabetes model provided diabetes support coaches to provide additional support to patients. We sought to estimate the costs of operating a Project ECHO Diabetes hub, inclusive of diabetes support coach costs., Methods: Data from Project ECHO Diabetes from June 2021 to June 2022 and wages from national databases were used to estimate hub and diabetes support coach costs to operate a 6-month, 24-session Project ECHO Diabetes program at hubs (University of Florida and Stanford University) and spokes (PCP clinic sites in Florida and California)., Results: Hub costs for delivering a 6-month Project ECHO Diabetes program to five spoke clinics were $96,873. Personnel costs were the principal driver. Mean cost was $19,673 per spoke clinic and $11.37 per spoke clinic patient. Diabetes support coach costs were estimated per spoke clinic and considered scalable in that they would increase proportionately with the number of spoke clinics in a Project ECHO Diabetes cohort. Mean diabetes support coach costs were $6,506 per spoke clinic and $3.72 per patient. Total program costs per hub were $129,404. Mean cost per clinic was $25,881. Mean cost per patient was $15.03., Conclusion: Herein, we document real-world costs to operate a Project ECHO Diabetes hub and diabetes support coaches. Future analysis of Project ECHO Diabetes will include estimates of spoke participation costs and changes in health care costs and savings. As state agencies, insurers, and philanthropies consider the replication of Project ECHO Diabetes, this analysis provides important initial information regarding primary operating costs., (© 2023. The Author(s).)

The elderly constitute a vulnerable group for increased anxiety and poor diet during the COVID-19 pandemic. There is limited research on the levels of COVID-19-related anxiety and dietary habits including dietary supplementation practices among the elderly and very elderly in Greece. A cross-sectional survey was conducted in 364 non-institutionalized elderly (65-74 y) and very elderly (≥75 y) living in northern Greece, with the aim to investigate the use of dietary supplements and their association with other factors, particularly the COVID-19-related anxiety. Levels of anxiety were assessed with the use of the Coronavirus Anxiety Scale (CAS-5). The percentage of dietary supplement users was 62.6%. The most popular dietary supplements used were vitamin D followed by vitamin C and multivitamin and mineral supplements. Multivariate analysis showed that the very elderly and overweight individuals were less likely to consume vitamin D supplements. Approximately a third of the participants (33.8%) exhibited signs of COVID-19-related anxiety but only 8% showed dysfunctional levels of anxiety. Regression analysis indicated that women, former smokers, and people exhibiting any sign of COVID-19 anxiety were approximately two times more likely to consume dietary supplements of any kind (Gender: OR 2.34, 95% CI 1.30-4.19; Smoking: OR 2.15, 95% CI: 1.08-4.26; COVID-19 anxiety: OR 2.16, 95 % CI: 1.20-3.91). Our results provide useful insights into the current practices of dietary supplement use in this population group and could be used by dietetic and medical associations as well as public authorities in the formulation of targeted, safe, and effective interventions for the protection of public health.

Background: People with type 1 diabetes (T1D) face heightened risks for morbidity and mortality from the 2019 Coronavirus (COVID-19). They also have elevated risks for disparate psychological outcomes during the COVID-19 pandemic, given their predisposition to mental health disorders, including anxiety and depression, and skyrocketing rates of these conditions among the general population., Methods: To investigate the psychological ramifications of the COVID-19 pandemic on people with T1D globally, we conducted a scoping review of recent literature across eight online databases. Articles were screened via a rigorous process, and data pertaining to psychological outcomes were coded into thematic areas for analysis., Results: Forty articles presenting data from 27 countries and 14 categories of psychological outcomes affecting people with T1D were included in this review. Psychological outcomes, in order of most to least frequently identified, included: stress, anxiety, social factors, worry, distress, fear, sleep habits, quality of life, depression, attitudes regarding COVID-19, other psychological issues, mental health services utilization, burnout, and temperament. Recurring findings demonstrated significant increases in the prevalence of mental health conditions, changes in sleeping habits, reductions of social support, and extensive psychosocial concerns among people with T1D. Associations between patients' psychological issues and demographic characteristics, diabetes self-management behaviors, glycemic control, and overall wellbeing were evident., Conclusion: During the COVID-19 pandemic, people with T1D experienced pervasive psychological burdens. This review calls for further research examining the long-term impacts of the pandemic and strengthens awareness of the need for interventions to offset psychological challenges affecting people with T1D., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Introduction: In the US, many individuals with diabetes do not have consistent access to endocrinologists and therefore rely on primary care providers (PCPs) for their diabetes management. Project ECHO (Extension for Community Healthcare Outcomes) Diabetes, a tele-education model, was developed to empower PCPs to independently manage diabetes, including education on diabetes technology initiation and use, to bridge disparities in diabetes., Methods: PCPs (n=116) who participated in Project ECHO Diabetes and completed pre- and post-intervention surveys were included in this analysis. The survey was administered in California and Florida to participating PCPs via REDCap and paper surveys. This survey aimed to evaluate practice demographics, protocols with adult and pediatric T1D management, challenges, resources, and provider knowledge and confidence in diabetes management. Differences and statistical significance in pre- and post-intervention responses were evaluated via McNemar's tests., Results: PCPs reported improvement in all domains of diabetes education and management. From baseline, PCPs reported improvement in their confidence to serve as the T1D provider for their community (pre vs post: 43.8% vs 68.8%, p=0.005), manage insulin therapy (pre vs post: 62.8% vs 84.3%, p=0.002), and identify symptoms of diabetes distress (pre vs post: 62.8% vs 84.3%, p=0.002) post-intervention. Compared to pre-intervention, providers reported significant improvement in their confidence in all aspects of diabetes technology including prescribing technology (41.2% vs 68.6%, p=0.001), managing insulin pumps (41.2% vs 68.6%, p=0.001) and hybrid closed loop (10.2% vs 26.5%, p=0.033), and interpreting sensor data (41.2% vs 68.6%, p=0.001) post-intervention., Discussion: PCPs who participated in Project ECHO Diabetes reported increased confidence in diabetes management, with notable improvement in their ability to prescribe, manage, and troubleshoot diabetes technology. These data support the use of tele-education of PCPs to increase confidence in diabetes technology management as a feasible strategy to advance equity in diabetes management and outcomes., Competing Interests: DM has received research support from the National Institutes of Health, JDRF, NSF, and the Helmsley Charitable Trust; and his institution has received research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, the Helmsley Charitable Trust, Sanofi, Novo Nordisk, Eli Lilly, and Insulet, and is supported by grant number P30DK116074. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Addala, Filipp, Figg, Anez-Zabala, Lal, Gurka, Haller, Maahs, Walker and for the Project ECHO Diabetes Research Team.)

Community health workers (CHWs) provide vital support to underserved communities in the promotion of health equity by addressing barriers related to the social determinants of health that often prevent people living with diabetes from achieving optimal health outcomes. Peer support programs in diabetes can also offer people living with diabetes invaluable support through a shared understanding of the disease and by offsetting diabetes-related stigma. As part of a Project Extension for Community Healthcare Outcomes (ECHO) Diabetes program, participating federally qualified healthcare centers were provided diabetes support coaches (DSCs) to facilitate patient engagement. DSCs hold invaluable expert knowledge, as they live with diabetes themselves and reside in areas they serve, thus combining the CHW role with peer support models. The use of DSCs and CHWs during the coronavirus disease 2019 pandemic and beyond is highly effective at reaching underserved communities with diabetes and promoting health equity., (© 2022 by the American Diabetes Association.)

Objective: Disparities in type 1 diabetes related to use of technologies like continuous glucose monitors (CGMs) and utilization of diabetes care are pronounced based on socioeconomic status (SES), race, and ethnicity. However, systematic reports of perspectives from patients in vulnerable communities regarding barriers are limited., Research Design and Methods: To better understand barriers, focus groups were conducted in Florida and California with adults ≥18 years old with type 1 diabetes with selection criteria including hospitalization for diabetic ketoacidosis, HbA 1c >9%, and/or receiving care at a Federally Qualified Health Center. Sixteen focus groups were conducted in English or Spanish with 86 adults (mean age 42 ± 16.2 years). Transcript themes and pre-focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology and endocrinology care included 1 ) provider level (negative provider encounters), 2 ) system level (financial coverage), and 3 ) individual level (preferences)., Results: Over 50% of participants had not seen an endocrinologist in the past year or were only seen once including during hospital visits. In Florida, there was less technology use overall (38% used CGMs in FL and 63% in CA; 43% used pumps in FL and 69% in CA) and significant differences in pump use by SES ( P = 0.02 in FL; P = 0.08 in CA) and race/ethnicity ( P = 0.01 in FL; P = 0.80 in CA). In California, there were significant differences in CGM use by race/ethnicity ( P = 0.05 in CA; P = 0.56 in FL) and education level ( P = 0.02 in CA; P = 0.90 in FL)., Conclusions: These findings provide novel insights into the experiences of vulnerable communities and demonstrate the need for multilevel interventions aimed at offsetting disparities in diabetes., (© 2021 by the American Diabetes Association.)

Introduction: Project ECHO (Extension for Community Healthcare Outcomes) is a tele-education outreach model that seeks to democratize specialty knowledge to reduce disparities and improve health outcomes. Limited utilization of endocrinologists forces many primary care providers (PCPs) to care for patients with type 1 diabetes (T1D) without specialty support. Accordingly, an ECHO T1D program was developed and piloted in Florida and California. Our goal was to demonstrate the feasibility of an ECHO program focused on T1D and improve PCPs' abilities to manage patients with T1D., Research Design and Methods: Health centers (ie, spokes) were recruited into the ECHO T1D pilot through an innovative approach, focusing on Federally Qualified Health Centers and through identification of high-need catchment areas using the Neighborhood Deprivation Index and provider geocoding. Participating spokes received weekly tele-education provided by the University of Florida and Stanford University hub specialty team through virtual ECHO clinics, real-time support with complex T1D medical decision-making, access to a diabetes support coach, and access to an online repository of diabetes care resources. Participating PCPs completed pre/post-tests assessing diabetes knowledge and confidence and an exit survey gleaning feedback about overall ECHO T1D program experiences., Results: In Florida, 12 spoke sites enrolled with 67 clinics serving >1000 patients with T1D. In California, 11 spoke sites enrolled with 37 clinics serving >900 patients with T1D. During the 6-month intervention, 27 tele-education clinics were offered and n=70 PCPs (22 from Florida, 48 from California) from participating spoke sites completed pre/post-test surveys assessing diabetes care knowledge and confidence in diabetes care. There was statistically significant improvement in diabetes knowledge (p≤0.01) as well as in diabetes confidence (p≤0.01)., Conclusions: The ECHO T1D pilot demonstrated proof of concept for a T1D-specific ECHO program and represents a viable model to reach medically underserved communities which do not use specialists., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: In designing a Project ECHO™ type 1 diabetes (T1D) program in Florida and California, the Neighborhood Deprivation Index (NDI) was used in conjunction with geocoding of primary care providers (PCPs) and endocrinologists in each state to concurrently identify areas with low endocrinology provider density and high health risk/poverty areas. The NDI measures many aspects of poverty proven to be critical indicators of health outcomes., Methods: The data from the 2013-2017 American Community Survey (ACS) 5-year estimates were used to create NDI maps for California and Florida. In addition, geocoding and 30-minute drive-time buffers were performed using publicly available provider directories for PCPs and endocrinologists in both states by Google Geocoding API and the TravelTime Search Application Programming Interface (API)., Results: Based on these findings, we defined high-need catchment areas as areas with (1) more than a 30-minute drive to the nearest endocrinologist but within a 30-minute drive to the nearest PCP; (2) an NDI in the highest quartile; and (3) a population above the median (5199 for census tracts, and 1394 for census block groups). Out of the 12 181 census tracts and 34 490 census block groups in California and Florida, we identified 57 tracts and 215 block groups meeting these criteria as high-need catchment areas., Conclusion: Geospatial analysis provides an important initial methodologic step to effectively focus outreach efforts in diabetes program development. The integration of the NDI with geocoded provider directories enables more cost-effective and targeted interventions to reach the most vulnerable populations living with T1D., (© Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Lack of access to subspecialty care and persistent suboptimal outcomes for insulin-requiring patients with diabetes mandates development of innovative health care delivery models. The workforce shortage of endocrinologists in the United States results in primary care providers taking on the role of diabetes specialists despite lack of confidence and knowledge in complex diabetes management. The telementoring model Project ECHO amplifies and democratizes specialty knowledge to reduce disparities in care and improve health outcomes. Project ECHO can be applied to type 1 diabetes and other complex medical conditions to address health disparities and urgent needs of complex patients throughout the lifespan., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

People with type 1 diabetes may receive a significant portion of their care from primary care providers (PCPs). To understand the involvement of PCPs in delivering type 1 diabetes care, we performed surveys in California and Florida, two of the most populous and diverse states in the United States. PCPs fill insulin prescriptions but report low confidence in providing type 1 diabetes care and difficulty accessing specialty referrals to endocrinologists., (© 2020 by the American Diabetes Association.)

Pronounced health disparities exist in type 1 diabetes (T1D) based on socioeconomic status (SES) yet there are a lack of programs designed to promote health equity for vulnerable communities. The All for ONE (Outreach, Networks, and Education) mentoring program was piloted pairing college students and publicly insured teenagers with T1D to assess feasibility as a possible intervention. There were 22 mentors recruited (mean age 20 ± 2 years; 17 [77%] females; mean HbA1c 8.4 ± 1.5%) and matched with mentees based on gender. There were 42 teens randomized to treatment and control groups including 22 teens in the treatment group (age 14 ± 2 years; 17 [77%] females; HbA1c 9.8 ± 2.3%) and 20 teens in the control group (age 14 ± 2 years; 15 [75%] females; HbA1c 8.9 ± 2.0%) followed over 9 months. Outcome measures included HbA1c and the Children's Hope Scale. The intervention included automated text reminders for blood glucose monitoring, text exchanges, social events with education, and clinic visits with mentors/mentees. Mean change in HbA1c for teens was +0.09% in the intervention group, compared with +0.28% in the control group (P = .61); college students had a reduction in HbA1c of -0.22% (P = .38). Treatment group teens had marked improvement in their hope for the future compared to control group teens (P = .04) and were more likely to attend clinic visits (P = .02). This program established feasibility for a model that could be replicated and modified for other types of settings. Additional research is warranted to study the potential long-term benefits of participating in the All for ONE mentoring program., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Undergraduate students living with chronic diseases attending universities where major biomedical research takes place are critical stakeholders in these programs, yet they often remain sequestered from them. A directed research curriculum about Type 1 Diabetes (T1D) was developed to better engage undergraduate students with personal connections to the disease in a large medical university setting world renowned for its research in this area. The course had the following student learning outcomes: (1) gain knowledge of major T1D research programs; (2) exposure to careers in T1D research and clinical care; and (3) recognize bioethical issues in T1D research., Competing Interests: Conflict of InterestThe authors declare that they have no conflict of interest., (© International Association of Medical Science Educators 2019.)

Patient-centered approaches to disease management are consistently recognized as valuable tools for improving health outcomes, yet studies are rarely designed to elicit adolescent perspectives. This study sought to better understand the perspectives of youths with type 1 diabetes according to key demographic variables. We conducted an exploratory study through which 40 youths were provided with disposable cameras and prompted to take five photographs each that captured what diabetes meant to them and to provide narratives to accompany their photo choices. Demographic variables examined included sex, age, disease duration, socioeconomic status (SES), race, and glycemic control (A1C). Content analysis was used for photos and open-ended responses to assign photo index scores, which were then analyzed by demographic variables using Mann-Whitney U tests for statistical significance. Analysis of photos/narratives (n = 202) revealed five main types of representations depicted by at least 50% of the young people. "Challenge" photos included diabetes supplies as tethering, food as a source of frustration, and the body as a territory for disease encroachment. "Resilience" photos included coping mechanisms and symbols of resistance. Overall, these representations were consistent across demographic categories with two exceptions. Males took more food depictions than females (P <0.005) and had fewer coping depictions (P <0.05). Youths from more affluent households were more likely to take photos of resistance (P <0.05). The use of photo index scores expands previous studies using photography by comparing demographic variation within a sample. Our findings provide insight into coping strategies and indicate that SES may provide an advantage for affluent youths in meeting diabetes-specific challenges.

The benefits of animal-companion ties to well-being are consistently documented, yet few studies use patient-centered methodologies to examine how youth living with chronic illnesses rely on domestic pets for support. Youth with type 1 diabetes (T1D) aged 12 to 19 years (N=40) completed surveys involving a prompt to take five photos of "what diabetes means to you," with an accompanying narrative. Content analysis was conducted for photos/narratives and numeric variables analyzed including socio-economic status (SES: measured by total household income and years of parental education) and HbA1C. More than half of the youth participants took pictures of coping mechanisms, including pictures of their pets. In fact, pictures of pets outnumbered pictures of people three to one. Pet depictions were captured by youth from all SES levels. Youth with T1D identify pets as an important source of support. More research is needed to understand how pets may offset disease burden for youth with T1D.

IN BRIEF Low socioeconomic status (SES) is consistently identified as a major risk factor for poor health outcomes in youths with type 1 diabetes, yet little is known about the social factors that yield such disparities. This study used survey research to examine the role of SES by focusing on differential resourcing in social support systems for youths with type 1 diabetes and their parents/caregivers. We identified significant inequalities in social support systems and found that parents from lower-income households engage in few coping activities and rarely identify a primary care provider as the main point of contact when facing a diabetes-related problem. Our findings underscore the need to better connect low SES families to diabetes-specific professional resourcing and to raise awareness about the importance of extracurricular activities as a form of social support for youths.

Although practitioner-prescribed 'western' herbal medicine (phytotherapy) is a popular complementary therapy in the UK, no clinical studies have been reported on patient-orientated outcomes. The objective of this pilot study was to investigate the effects of phytotherapy on symptoms of osteoarthritis of the knee. A previous study of Chinese herbal medicine for the treatment of irritable bowel syndrome, published in the Journal of the American Medical Association, acted as a model in the development of the protocol of this investigation. Twenty adults, previously diagnosed with osteoarthritis of the knee, were recruited from two Inner London GP practices into this randomized, double-blind, placebo-controlled, pilot study carried out in a primary-care setting. All subjects were seen in consultation three times by a herbal practitioner who was blinded to the randomization coding. Each subject was prescribed treatment and given lifestyle advice according to usual practice: continuation of conventional medication where applicable, healthy-eating advice and nutrient supplementation. Individualized herbal medicine was prescribed for each patient, but only dispensed for those randomized to active treatment-- the remainder were supplied with a placebo. At baseline and outcome (after ten weeks of treatment), subjects completed a food frequency questionnaire and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee health and Measure Yourself Outcome Profile (MYMOP) wellbeing questionnaires. Subjects completing the study per protocol (n = 14) reported an increased intake of wholegrain foods (p = 0.045) and oily fish (p = 0.039) compared to baseline, but no increase in fruit and vegetables and dairy products intakes. There was no difference in the primary outcome measure of knee health assessed as the difference in the mean response (baseline-week 10) in WOMAC score between the two treatment groups. However, there was, compared with baseline, improvement in the active group (n = 9) for the mean WOMAC stiffness sub-score at week 5 (p = 0.035) and week 10 (p = 0.060) but not in the placebo group (n = 5). Furthermore, for the active, but not the placebo group, the mean WOMAC total and sub-scores all showed clinically significant improvement (> or = 20%) in knee symptoms at weeks 5 and 10 compared with baseline. Moreover, the mean MYMOP symptom 2 sub-score, mostly relating to osteoarthritis (OA), showed significant improvement at week 5 (p = 0.02) and week 10 (p = 0.008) compared with baseline for the active, but not for the placebo group. This pilot study showed that herbal medicine prescribed for the individual by a herbal practitioner resulted in improvement of symptoms of OA of the knee.

Cardiovascular diseases are the chief causes of death in the UK, and are associated with high circulating levels of total cholesterol in the plasma. Artichoke leaf extracts (ALEs) have been reported to reduce plasma lipids levels, including total cholesterol, although high quality data is lacking. The objective of this trial was to assess the effect of ALE on plasma lipid levels and general well-being in otherwise healthy adults with mild to moderate hypercholesterolemia. 131 adults were screened for total plasma cholesterol in the range 6.0-8.0 mmol/l, with 75 suitable volunteers randomised onto the trial. Volunteers consumed 1280 mg of a standardised ALE, or matched placebo, daily for 12 weeks. Plasma total cholesterol decreased in the treatment group by an average of 4.2% (from 7.16 (SD 0.62) mmol/l to 6.86 (SD 0.68) mmol/l) and increased in the control group by an average of 1.9% (6.90 (SD 0.49) mmol/l to 7.03 (0.61) mmol/l), the difference between groups being statistically significant (p=0.025). No significant differences between groups were observed for LDL cholesterol, HDL cholesterol or triglyceride levels. General well-being improved significantly in both the treatment (11%) and control groups (9%) with no significant differences between groups. In conclusion, ALE consumption resulted in a modest but favourable statistically significant difference in total cholesterol after 12 weeks. In comparison with a previous trial, it is suggested that the apparent positive health status of the study population may have contributed to the modesty of the observed response.