Supplementary Health Research Articles

DSHEA 1994 – Celebrating 30 Years of Dietary Supplement Regulation in the United States

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA’s statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as ‘outdated’ regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.

Market concentration of the Brazilian hospital medical supplementary health system

BackgroundThe Brazilian supplementary health market has undergone transformations in recent years due to constant mergers and acquisitions of by large corporations, contributing to the increase in market concentration, especially in the poorest and least developed regions of the country. Thus, given the care it provides and its economic relevance, understanding the fundamentals of these movements, the likely consequences and trends for the health market are relevant, important, and strategic.ObjectiveTo understand the general and specific context of Brazilian supplementary health, its scenarios, and trends, with emphasis on the analysis of market concentration and recent mergers and acquisitions.MethodologyThe research is applied, descriptive and exploratory and uses secondary data from various sources, submitted to quantitative data analysis methods. The data are organized into three groups: historical and regulatory documents; industry data; and market.ResultsThe results show the growing concentration of the market promoted by large publicly traded corporations, the growing relevance of tech startups on the healthcare landscape, the predominant use of the relative valuation model, with implicit multiples for asset pricing and the prevalence of corporate health plans.ConclusionThe growing concentration of the system projects a market with fewer options and less competitiveness, since the growth of large operators is evident, in addition to the relevant increase in the number of complaints from users of the system, which signals the growing gap between the expectations of users and the levels of quality care offered. The study also highlights the predominance of corporate health plans, revealing the direct relationship between access to supplementary health services and employability rates. The analysis of M&A operations, in addition to the increase in market concentration, reveals the prevalence of the use of the relative valuation model and implicit multiples for the pricing of traded assets. This denotes the future expectation of wealth generation, at least equivalent to the historical series of the sector, on the part of investors, whose frustration may signal the decreasing attractiveness of resources and M&A operations in the sector in the coming years.

Health-Related Quality of Life in Rugby Athletes: The Role of Dietary Supplements and Their Consumption.

This study investigates dietary supplement use among rugby players and their general health, focusing on prevalence and underlying motivations. Involving 92 athletes, it examines the relationship between supplement usage, motivations, and health outcomes using the 36-item Short Form Health Survey and a 24-item ad hoc questionnaire. Findings reveal a high frequency of supplement usage, motivated by desires to enhance performance, appearance, and mood. Significant differences in health-related quality of life are found between users and non-users, particularly in mental health, social functioning, and emotional stability. Motivations like performance enhancement and body shape manipulation were linked to altered health perceptions, indicating the psychosocial impacts of supplementation. This study emphasizes the need to consider the holistic effects of supplements on athlete well-being, advocating for a balanced approach prioritizing both physical and mental health. It calls for increased awareness among athletes, coaches, and sports professionals about the potential risks and benefits of supplement use and the importance of informed decision-making. Additionally, it highlights the need for further research to understand the mechanisms of supplement use and its impact on athlete health, aiming to enhance sports science and promote overall athlete well-being in competitive environments.

Effectiveness of a task-sharing collaborative care model for the detection and management of depression among adults receiving antiretroviral therapy in primary care facilities in South Africa: A pragmatic cluster randomised controlled trial

BackgroundHIV is characterised by high rates of comorbidity with mental health conditions including depression, as such, the detection and treatment of comorbid depression is critical to achieve viral load suppression. This study evaluated the effectiveness of a collaborative care intervention for depression among adults with comorbid depression symptoms receiving ART in primary health care (PHC) facilities. MethodsWe conducted a pragmatic cluster-randomised trial in 40 clinics in the North West province of South Africa. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Participants were ≥ 18 years, receiving ART, and had depression symptoms indicated by Patient Health Questionnaire-9 (PHQ-9) score ≥ 9. Intervention clinics received: i) supplementary mental health training and clinical communication skills for PHC nurses; ii) workshops for PHC doctors on treating depression; and iii) lay counselling services. Using mixed effects regression models, we assessed co-primary outcomes of PHQ-9 response at 6 months (≥50 % reduction in baseline PHQ-9 score) and viral load suppression at 12 months (viral load<1000 copies/mL). ResultsThe intervention had no effect in PHQ-9 response (49 % vs 57 %, risk difference (RD) = −0.08, 95 % CI = -0.19; 0.03, p = 0.184) or viral load suppression (85 % vs 84 %, RD = 0.02, 95 % CI = −0.01; 0.04, p = 0.125). Nurses referred 4298 clinic patients to counsellors, however, only 66/1008 (7 %) of intervention arm participants were referred to counsellors at any point during the study. LimitationsThe highly pragmatic approach of this trial limited exposure to the counselling component of the intervention and referral to doctors for initiation of antidepressant treatment was extremely low. ConclusionThe trial showed no effect of a district-based intervention to strengthen collaborative care for depression. The trial revealed the extent of the treatment gap in the context of scaling up mental health services. Trial registrationClinicalTrials.gov (NCT02407691); Pan African Clinical Trials Registry (201504001078347).

The National Center for Natural Products Research (NCNPR) at 30: A Legacy of Pioneering Research in Natural Products and Dietary Supplements

Since its establishment in 1994, the National Center for Natural Products Research (NCNPR) at the University of Mississippi has made notable contributions to the field of natural product research, coinciding with the passage of the Dietary Supplement Health and Education Act. Over the past three decades, the Center has focused on studying plants, herbs, and other natural materials for applications in medicine, agriculture, and nutraceuticals, particularly in the area of botanical dietary supplements. NCNPR scientists have been actively engaged in developing and improving quality control measures to help ensure the safety of dietary supplements in response to a growing market. The Center’s research efforts have led to its designation as a U.S. Food and Drug Administration Center of Excellence, reflecting its role in advancing scientific understanding of natural products. Through collaborations with various stakeholders and regulators, NCNPR has contributed to shaping the regulatory landscape for botanical dietary supplements, highlighting both their potential health benefits and associated risks, such as product adulteration. The Center’s influence is also evident internationally, as demonstrated by its annual International Conference on the Science of Botanicals, which will mark its 26th year in April 2025. This overview outlines NCNPR’s role in supporting research, regulation, and safety in the natural products field.

Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial

BackgroundImmigrant Latinas (who are foreign-born but now reside in the USA) are at greater risk for developing postpartum depression than the general perinatal population, but many face barriers to treatment. To address these barriers, we adapted the Mothers and Babies Course—an evidence-based intervention for postpartum depression prevention—to a virtual group format. Additional adaptations are inclusion of tailored supplemental child health content and nutrition benefit assistance. We are partnering with Early Learning Centers (ELC) across the state of Maryland to deliver and test the adapted intervention.MethodsThe design is a Hybrid Type I Effectiveness-Implementation Trial. A total of 300 participants will be individually randomized to immediate (N = 150) versus delayed (N = 150) receipt of the intervention, Mothers and Babies Virtual Group (MB-VG). The intervention will be delivered by trained Early Learning Center staff. The primary outcomes are depressive symptoms (measured via the Center for Epidemiologic Studies-Depression Scale), parenting self-efficacy (measured via the Parental Cognition and Conduct Towards the Infant Scale (PACOTIS) Parenting Self-Efficacy subscale), and parenting responsiveness (measured via the Maternal Infant Responsiveness Instrument) at 1-week, 3-month, and 6-month post-intervention. Depressive episodes (Structured Clinical Interview for DSM-V- Disorders Research Version) at 3-month and 6-month post-intervention will also be assessed. Secondary outcomes include social support, mood management, anxiety symptoms, perceived stress, food insecurity, and mental health stigma at 1-week, 3-month, and 6-month post-intervention. Exploratory child outcomes are dysregulation and school readiness at 6-month post-intervention. Intervention fidelity, feasibility, acceptability, and appropriateness will also be assessed guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.DiscussionThis study will be one of the first to test the efficacy of a group-based virtual perinatal depression intervention with Latina immigrants, for whom stark disparities exist in access to health services. The hybrid effectiveness-implementation design will allow rigorous examination of barriers and facilitators to delivery of the intervention package (including supplemental components) which will provide important information on factors influencing intervention effectiveness and the scalability of intervention components in Early Learning Centers and other child-serving settings.Registration.ClinicalTrials.gov NCT05873569.

Evaluating accuracy and reproducibility of ChatGPT responses to patient-based questions in Ophthalmology: An observational study.

Chat Generative Pre-Trained Transformer (ChatGPT) is an online large language model that appears to be a popular source of health information, as it can provide patients with answers in the form of human-like text, although the accuracy and safety of its responses are not evident. This study aims to evaluate the accuracy and reproducibility of ChatGPT responses to patients-based questions in ophthalmology. We collected 150 questions from the "Ask an ophthalmologist" page of the American Academy of Ophthalmology, which were reviewed and refined by two ophthalmologists for their eligibility. Each question was inputted into ChatGPT twice using the "new chat" option. The grading scale included the following: (1) comprehensive, (2) correct but inadequate, (3) some correct and some incorrect, and (4) completely incorrect. Totally, 117 questions were inputted into ChatGPT, which provided "comprehensive" responses to 70/117 (59.8%) of questions. Concerning reproducibility, it was defined as no difference in grading categories (1 and 2 vs 3 and 4) between the 2 responses for each question. ChatGPT provided reproducible responses to 91.5% of questions. This study shows moderate accuracy and reproducibility of ChatGPT responses to patients' questions in ophthalmology. ChatGPT may be-after more modifications-a supplementary health information source, which should be used as an adjunct, but not a substitute, to medical advice. The reliability of ChatGPT should undergo more investigations.

Investigating the carcinogenic and non-carcinogenic health hazards of heavy metal ions in Spinacia oleracea grown in agricultural soil treated with biochar and humic acid.

This study addressed the bioaccumulation and human health risk among the consumption of Spinacia oleracea grown in agricultural soil treated with humic acid (189-2310ppm) and biochars (0.00-5.10%.wt). The biochars came from two local feedstocks of rice-husk (RH) and sugar-beet-pulp (SBP) pyrolyzed at temperatures 300 and 600°C. Total concentrations of Cu, Cd, and Ni found in both the soil and biomass/biochar exceeded global safety thresholds. The bioaccumulation levels of HMs in spinach leaves varied, with Fe reaching the highest concentration at 765.27mgkg-1 and Cd having the lowest concentration at 3.31mgkg-1. Overall, the concentrations of Zn, Cd, Pb, and Ni in spinach leaves exceeded the safety threshold limits, so that its consumption is not recommended. The assessment of hazard quotient (HI) for the HMs indicated potential health hazards for humans (HI > 1) from consuming the edible parts of spinach. The biochar application rates of 4.35%wt and 0.00%.wt resulted in the highest (3.69) and lowest (3.15) HI values, respectively. The cumulative carcinogenic risk (TCR) ranged from 0.0085 to 0.0119, exceeding the cancer risk threshold. Introducing 5.10%wt biomass/biochar resulted in a 36% rise in TCR compared to the control. The utilization of humic acid alongside HMs-polluted biochars results in elevated levels of HMs bioaccumulation exceeding the allowable thresholds in crops (with a maximum increase of 49% at 2000ppm humic acid in comparison to 189ppm). Consequently, this raised the HI by 46% and the TCR by 22%. This study demonstrated that the utilization of HMs-polluted biochars could potentially pose supplementary health hazards. Moreover, it is evident that the utilization of HMs-polluted biochars in treating metal-contaminated soil does not effectively stabilize or reduce pollution.

The role of ICDS services on early childhood development: A cross-sectional study in Hyderabad, Telangana.

Integrated child development services (ICDS) include supplementary nutrition, nutrition and health education, health check-ups, immunization, preschool education, and referral services targeted at beneficiaries including pregnant and lactating mothers, children below six years, and women of reproductive age. Specific interventions are implemented to support children for a higher developmental outcome. The aims of this study are (1) to compare the development of ICDS beneficiaries in the age group of 4-6 years with the dropouts, (2) to assess caregiver practices among mothers of beneficiaries and the dropouts, and (3) to understand the perceptions of Anganwadi workers (AWWs) on early child development (ECD) and ICDS services. A cross-sectional study was conducted for two months in select Anganwadi centers (AWCs) of Hyderabad. AWCs were selected through multi-stage sampling. Respondents included 114 mothers and five AWWs. Quantitative data was collected by a questionnaire and qualitative data through an interview guide. Proportions were estimated for description. STATA 14.0 was used to find out correlates of development in children through unpaired t-test, Chi-square test, and logistic regression. Thematic analysis was done for qualitative data. About 68.42% and 33.33% of children from the beneficiary group were found to show normal cognitive and emotional development when compared to the dropout group (59.65% and 21.05%, respectively). KAP assessment revealed no significant difference between the mothers of dropouts and beneficiaries. Lack of infrastructure and poor attention to preschool activities were identified as reasons for dropout. Improving infrastructure, capacity building of AWWs, and reducing their workload will help in focusing on ECD-related activities at ICDS centers.

Testing the amount of nicotinamide mononucleotide and urolithin A as compared to the label claim

Healthy Longevity Medicine aims to optimize health by targeting aging processes across the lifespan. Addressing accelerated aging involves adaptation of lifestyle and the use of geroprotective drugs and supplements, including nutritional supplements and bioactive compounds. The Food and Drug Administration, under the Dietary Supplement Health and Education Act, categorizes bioactive compounds and medicinal products as dietary supplements. While numerous companies sell ingredients that can be deemed geroprotectors, there's limited oversight in their quality control. Governmental safety authorities only verify the presence of prohibited compounds, not the accuracy of ingredients listed on labels.Here, Nicotinamide mononucleotide and Urolithin A supplements, easily accessible online or in pharmacies, were tested for their active ingredient content. Results showed a significant deviation from the labeled amounts, ranging from + 28.6% to -100%. This indicates a considerable disparity in the quality of geroprotective supplements.To address this variability, collaboration between and within societies representing healthcare professionals, industry and regulatory bodies is imperative to ensure the quality of geroprotective supplements.

II Brazilian Society of Rheumatology consensus for lupus nephritis diagnosis and treatment

ObjectiveTo develop the second evidence-based Brazilian Society of Rheumatology consensus for diagnosis and treatment of lupus nephritis (LN).MethodsTwo methodologists and 20 rheumatologists from Lupus Comittee of Brazilian Society of Rheumatology participate in the development of this guideline. Fourteen PICO questions were defined and a systematic review was performed. Eligible randomized controlled trials were analyzed regarding complete renal remission, partial renal remission, serum creatinine, proteinuria, serum creatinine doubling, progression to end-stage renal disease, renal relapse, and severe adverse events (infections and mortality). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to develop these recommendations. Recommendations required ≥82% of agreement among the voting members and were classified as strongly in favor, weakly in favor, conditional, weakly against or strongly against a particular intervention. Other aspects of LN management (diagnosis, general principles of treatment, treatment of comorbidities and refractory cases) were evaluated through literature review and expert opinion.ResultsAll SLE patients should undergo creatinine and urinalysis tests to assess renal involvement. Kidney biopsy is considered the gold standard for diagnosing LN but, if it is not available or there is a contraindication to the procedure, therapeutic decisions should be based on clinical and laboratory parameters. Fourteen recommendations were developed. Target Renal response (TRR) was defined as improvement or maintenance of renal function (±10% at baseline of treatment) combined with a decrease in 24-h proteinuria or 24-h UPCR of 25% at 3 months, a decrease of 50% at 6 months, and proteinuria < 0.8 g/24 h at 12 months. Hydroxychloroquine should be prescribed to all SLE patients, except in cases of contraindication. Glucocorticoids should be used at the lowest dose and for the minimal necessary period. In class III or IV (±V), mycophenolate (MMF), cyclophosphamide, MMF plus tacrolimus (TAC), MMF plus belimumab or TAC can be used as induction therapy. For maintenance therapy, MMF or azathioprine (AZA) are the first choice and TAC or cyclosporin or leflunomide can be used in patients who cannot use MMF or AZA. Rituximab can be prescribed in cases of refractory disease. In cases of failure in achieving TRR, it is important to assess adherence, immunosuppressant dosage, adjuvant therapy, comorbidities, and consider biopsy/rebiopsy.ConclusionThis consensus provides evidence-based data to guide LN diagnosis and treatment, supporting the development of public and supplementary health policies in Brazil.

Does supplemental private health insurance impact health care utilization and seeking behavior of residents covered by social health insurance? Evidence from China National Health Services Survey

BackgroundSupplemental private health insurance (PHI) plays a crucial role in complementing China’s social health insurance (SHI). However, the effectiveness of incorporating PHI as supplementary coverage lacks conclusive evidence regarding its impact on healthcare utilization and seeking behavior among SHI-covered individuals. Therefore, investigating the effects of supplementary PHI on health care utilization and seeking behavior of residents covered by social health insurance is essential to provide empirical evidence for informed decision-making within the Chinese healthcare system.MethodsData from the 2018 China National Health Services Survey were analyzed to compare outpatient and inpatient healthcare utilization and choices between PHI purchasers and non-purchasers across three SHI schemes: urban employee-based basic medical insurance (UEBMI), urban resident-based basic medical insurance (URBMI), and the new rural cooperative medical scheme (NRCMS). Using the Andersen Healthcare Services Utilization Behavior Model as the theoretical framework,binary logistic regression and multinomial logistic regression (MNL) models were employed to assess the impact of PHI on healthcare utilization and provider preferences.ResultsAmong UEBMI, URBMI, and NRCMS participants with PHI, outpatient visit rates were 17.9, 19.8, and 21.7%, and inpatient admission rates were 12.4, 9.9, and 12.9%, respectively. Participants without PHI exhibited higher rates for outpatient visits (23.6, 24.3, and 25.6%) and inpatient admissions (15.2, 12.8, and 14.5%). Binomial logistic regression analyses revealed a higher probability of outpatient visits and inpatient admissions among UEBMI participants with PHI (p < 0.05). NRCMS participants with PHI showed a lower probability of outpatient visits but a higher probability of inpatient admissions (p < 0.05). Multinomial logistic regression indicated that NRCMS participants with PHI were more likely to choose higher-level hospitals, with a 17% increase for county hospitals and 27% for provincial or higher-level hospitals compared to primary care facilities.ConclusionThe findings indicate that the possession of PHI correlated with increased utilization of outpatient and inpatient healthcare services among participants covered by UEBMI. Moreover, for participants under the NRCMS, the presence of PHI is linked to a proclivity for seeking outpatient care at higher-level hospitals and heightened utilization of inpatient services. These results underscore the nuanced influence of supplementary PHI on healthcare-seeking behavior, emphasizing variations across individuals covered by distinct SHI schemes.

Impact and intervention of postoperative complications after gastric cancer surgery from a health economics perspective

Gastric cancer ranks as the third most prevalent malignant tumor in our nation, imposing a substantial health and economic burden. The occurrence of postoperative complications in gastric cancer not only hinders patient recovery but also significantly increases the medical expenditures of patients, contributing supplementary health economic challenges to both society and healthcare institutions. Conducting health economic analysis on postoperative complications in gastric cancer provides evidence for the formulation of health policies, offers guidance for hospital cost control, and furnishes economic insights for the development of new technologies in the prevention and treatment of complications. This paper, through a thorough review of domestic and international literature, comprehensively examines the impact of complication severity on healthcare expenses, delineates the principal contributors to healthcare costs in patients with postoperative complications, and proposes practical strategies to alleviate the health economic burden resulting from such complications. Furthermore, this study delves into and analyzes the health economic considerations associated with postoperative complications within the framework of the Diagnosis Related Groups (DRG) billing model.

The need and acceptability of a youth mental health mentoring model to supplement adolescent outpatient mental health services

Youth mental health challenges in the United States continue to escalate at an alarming rate. To address this crisis, there is an urgent need to develop innovative strategies for delivering effective mental health care to youth. The aim of this study was to assess the need and acceptability of a youth mental health mentoring model for adolescents engaged in outpatient mental health services. Participants included adolescents currently engaged in outpatient mental health services (n = 3, 14–17 years old; 66 % Black; 100 % cisgender boys), parents/guardians of adolescents currently engaged in mental health services (n = 4; 50 % Black; 100 % cisgender women), clinicians who provide adolescent mental health services in an outpatient setting (n = 5; 100 % White cisgender women), and potential paraprofessional mental health mentors recruited from a large land-grant University (n = 5; 40 % White; 60 % cisgender women). All participants were recruited from an urban setting in the midwestern United States. Data collection occurred remotely. Following protocols that were approved by an Institutional Review Board, participant groups were provided an overview of the proposed model and asked a series of open-ended questions in four separate focus groups to gauge the perceived need and acceptability of this type of program model. Thematic data analysis was used to analyze data. Across participant groups, results indicated a clear need for supplemental mental health services and high acceptability of the proposed youth mental health mentoring model. Participants offered specific recommendations for model development, especially related to mentor selection, training and supervision.

Impact of the genomic signature of 70-genes for breast cancer in the public system and in supplementary health care in a country of medium socioeconomic development

IntroductionThe financial impact of breast cancer has been discussed due to its high incidence and the increased costs of systemic therapy and is even more relevant in countries with low and medium socioeconomic development. ObjectiveTo evaluate the financial viability of using the MammaPrint™ (MP) genetic signature in a public and private system in a country with a medium socioeconomic development index. Material and methodA pharmacoeconomic trial with a cost-benefit analysis evaluating the reduction in costs of chemotherapy, support drugs, and materials used during chemotherapy infusion in high-risk hormone receptor-positive (HR+) breast cancer patients submitted to analysis using the MammaPrint™ genetic signature. ResultsThe value of using MammaPrint™ in the Unified Health System (SUS) would bring an additional cost of US$ 1,334.56 per patient in the over-50 age group. In private medicine, the use of MammaPrint™ in the same population would result in cost savings ranging from US$ 2,422.53 to US$ 9,989.95 per patient. ConclusionThe use of MP in RH + breast cancer patients with high clinical risk and low genomic risk in Brazil leads to significant savings in resources when applied to supplementary healthcare. In the SUS, reducing the costs of MP for large-scale use could make its application viable. These values need to be re-evaluated in each institution, using the methodology applied in the trial, adjusting according to costs, to obtain a result that reflects its reality.

The territorial nature of the Primary Health Care of Brazil's Unified Health System (SUS): the proliferation of community medical clinics in the Metropolitan Region of Belém, State of Pará, Brazil

The scope of this article is an analysis of the proliferation of community medical clinics in the municipalities that comprise the Metropolitan Region of Belem. An investigation was conducted into the performance of the primary health care network of Brazil's Unified Health System, with a view to getting a better understanding of the reasons for, and origins of, the proactive stance of the community health sector. The discussion is based on the review of primary and secondary data, obtained via fieldwork in 119 community clinics in the Metropolitan Region of Belem, and information from Brazil's Unified Health System data center. It was revealed that the community health clinic sector has benefited extensively in recent years from the intensification of underfunding of Brazil's Unified Health System, especially the primary health care network, which is undergoing a process of fragmentation. This is directly responsible for the reduction and disruption of multiprofessional primary health care teams, in addition to the losses suffered in the supplementary health sector. The community clinics adopt an spontaneous and contradictory care model created by the private sector to meet the repressed demand of Brazil's Unified Health System.

TIME TO THINK “BOTSIMILAR”

Dear Reader, Ever since the Dietary Supplement Health and Education Act (DSHEA) was notified in the US in 1994, discussion on botanicals for wellness continues. Botanicals to be used for providing wellness health benefits opened up a large market for consumer benefits. Nations like India and China who have long documented history of safe use (HoSU) of botanicals started to explore the US market for supplements. Botanical products, mostly single herb based and their extracts formulated as tablets, capsules, liquids and in some cases food formats such as granules, powders, became the focus of innovations. Till 2016, India did not have any regulations for Nutraceuticals or Supplements. The industry innovated through the acquisition of traditional Ayurvedic licenses for such products. Bolstered by government support, which propelled regulatory amendments, allowing products to be labelled according to the destination country regulations, thereby driving growth in this sector

Patient Safety Indicators During the Initial COVID-19 Pandemic Surge in the United States.

The COVID-19 pandemic presented a challenge to inpatient safety. It is unknown whether there were spillover effects due to COVID-19 into non-COVID-19 care and safety. We sought to evaluate the changes in inpatient Agency for Healthcare Research and Quality patient safety indicators (PSIs) in the United States before and during the first surge of the pandemic among patients admitted without COVID-19. We analyzed trends in PSIs from January 2019 to June 2020 in patients without COVID-19 using data from IBM MarketScan Commercial Database. We included members of employer-sponsored or Medicare supplemental health plans with inpatient, non-COVID-19 admissions. The primary outcomes were risk-adjusted composite and individual PSIs. We analyzed 1,869,430 patients admitted without COVID-19. Among patients without COVID-19, the composite PSI score was not significantly different when comparing the first surge (Q2 2020) to the prepandemic period (e.g., Q2 2020 score of 2.46 [95% confidence interval {CI}, 2.34-2.58] versus Q1 2020 score of 2.37 [95% CI, 2.27-2.46]; P = 0.22). Individual PSIs for these patients during Q2 2020 were also not significantly different, except in-hospital fall with hip fracture (e.g., Q2 2020 was 3.42 [95% CI, 3.34-3.49] versus Q4 2019 was 2.45 [95% CI, 2.40-2.50]; P = 0.01). The first surge of COVID-19 was not associated with worse inpatient safety for patients without COVID-19, highlighting the ability of the healthcare system to respond to the initial surge of the pandemic.

Economic and budgetary impact evaluation of isavuconazole (Cresemba®) versus voriconazole (Vfend®) for the treatment of patients with possible invasive aspergillosis from the perspective of the Brazilian supplementary health system.

This study aims to evaluate the cost-utility and the budgetary impact of isavuconazole compared to voriconazole in patients with suspected invasive aspergillosis (IA) from the perspective of the Brazilian supplementary health system (SHS). In this model, a decision tree was developed and included patients with possible IA. Efficacy parameters were extracted from the clinical studies. Drug acquisition, hospitalization costs and adverse events were also collected. Alternative 3- and 10-year time horizon scenarios were used. In addition, deterministic and probabilistic sensitivity analyses were simulated. A budget impact analysis of isavuconazole versus voriconazole was performed, assuming a time horizon of 5 years. In addition, sensitivity analyses were conducted to assess the robustness of the model. Results are reported in Brazilian Real (BRL), year values 2022. The economic analysis of the base case showed that isavuconazole is associated with a saving of 95,174.00 BRL per patient compared to voriconazole. All other simulated scenarios showed that isavuconazole is dominant versus comparators when considering a willingness to pay 40,688.00 BRL/Quality-Adjusted Life Years (QALY). The results were considered robust by the sensitivity analyses. The budget impact analysis showed that the incorporation of isavuconazole generates savings to the SHS, compared to voriconazole, of approximately 20.5 million BRL in the first year. This reaches about 54 million BRL in the fifth incorporation year, considering the market penetration of 20% in the first year, and 50% in the fifth year. Compared with voriconazole, isavuconazole is regarded as a dominant treatment strategy for patients with suspected IA and generates savings for the SHS.

Low uptake of gynecological consultation following domestic or sexual violence: A case-control study during pregnancy follow-up

ObjectiveThe aim of this study was to examine the association between exposure to domestic and sexual violence and low uptake of gynecological consultation. Study designBetween October 2021 and October 2022, a case-control studywas conducted in mother andchild centers and sexual health centers in the Paris, France area. The case group included pregnant women who did not have a scheduled gynecological consultation in the past two years. The control group included pregnant women who had a scheduled gynecological consultation in the past two years. Pregnant women were interviewed using a standardized questionnaire about a history of domestic and sexual violence, the date of their last gynecological consultation and the gynecological health. ResultsA total of 405 pregnant women were included in the case group (n = 129) or in the control group (n = 276). After adjustment for age, couple, social security, supplementary health insurance, dyspareunia, abnormal vaginal discharge, dysmenorrhea, regular pelvic pain, mastodynia, vulvodynia and history of difficult delivery, a history of intimate partner violence was associated with the absence of a gynecological consultation in the past two years (OR 2.13; CI95% 1.21–3.73, p = 0.008). A history of sexual violence, regardless of age, was associated with the absence a gynecological consultation in the past two years (OR 1.92; CI95% 1.05–3.49, p = 0.03). The absence of a gynecological consultation was associated with dyspareunia and domestic or sexual violence (p < 0.0001 and p < 0.0001, respectively). ConclusionsThis study highlighted the association between domestic and sexual violence and the absence of gynecological consultations in the past two years. It underlines the importance of screening for domestic and sexual violence during gynecological consultations and its impacts on mental health, in particular psychotraumatic symptoms, and on gynecological health, in particular dyspareunia.