Accelerating evidence generation: Addressing critical challenges and charting a path forward.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs.

Promoting salutogenic pathways to health through complementary and integrative health approaches.

Health restoration and disease prevention are important strategies to achieve health and well-being. This provides a conceptual overview of the key concepts of salutogenesis (health restoration), chronic stress, resilience, and emotional well-being, and describes how they are distinct and interrelated. We posit, and demonstrate through scientific evidence, that complementary and integrative health approaches, including mind and body interventions, can be used to mitigate the effects of chronic stress and promote salutogenic pathways.

The Evolution of Science and Regulation of Dietary Supplements: Past, Present, and Future.

Dietary supplement use in the United States is widespread and increasing, especially among certain population groups, such as older Americans. The science surrounding dietary supplements has evolved substantially over the last few decades since their formal regulation in 1994. Much has been learned about the mechanisms of action of many dietary supplement ingredients, but the evidence on their health effects is still building.

Unmet Need: Mechanistic and Translational Studies of Sickle Cell Disease Pain as a Whole-Person Health Challenge.

Sickle cell disease (SCD) is a lifelong monogenic, autosomal-recessive blood disease that predominantly affects individuals of African descent and those who self-identify as Black or Hispanic. Common SCD pathophysiological processes include adhesion, hemolysis, hypoxia, ischemia, oxidative stress, and vaso-occlusion, which often lead to substantial comorbidities and complications. Pain is one of the most common and significant clinical complications for individuals with SCD.

Integrated multicomponent interventions to support healthy aging of the whole person.

Healthy aging is an integrated "whole person" process that involves an individual's biology, behavior, and social/physical environment. With the recent development of antiaging drugs, careful consideration of the respective roles of pharmacologic and nonpharmacologic approaches to both health and aging is in order. Recent advances in understanding the cellular and molecular mechanisms of aging are providing new measures that can be used as clinical outcomes in studying the impact of antiaging interventions in humans.

NCCIH Priorities for Natural Products Research.

The National Center for Complementary and Integrative Health (NCCIH) is the lead agency within the U. S. federal government for complementary and integrative health research, which includes natural products.

Longitudinal Analysis of Complementary Health Approaches in Adults Aged 25-74 Years from the Midlife in the U.S. Survey Sample.

Complementary health approaches include herbal products and mind-body practices. Several studies have identified predictors for complementary health approach use, yet there are two gaps: (1) How does use change? (2) Do factors associated with use influence this change over time? Using the Midlife in the United States (MIDUS), we examined how sociodemographic factors affected use longitudinally, and whether these associations differed between new and continued/discontinued use of herbal products, meditation, chiropractic, and massage therapy. MIDUS is a national probability sample of adults aged 25 or older that has collected more than 20 years of longitudinal data, including the use of complementary health approaches.

National Center for Complementary and Integrative Health Perspectives on Clinical Research Involving Natural Products.

The sales of dietary supplements continue to increase year after year. Despite their use by a large percentage of Americans, there is little evidence for the vast majority of products regarding their safety or efficacy. National Center for Complementary and Integrative Health supports a broad range of research on dietary supplements, including clinical trials.

Pragmatic clinical trials offer unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care: Proceedings of a workshop.

The National Institutes of Health (NIH) Health Care Systems (HCS) Research Collaboratory hosted a workshop to explore challenges and strategies for the dissemination, implementation, and sustainability of findings from pragmatic clinical trials (PCTs) embedded in HCS. PCTs are designed to assess the impact of interventions delivered in usual or real-world conditions and leverage existing infrastructure to answer important clinical questions. The goal of the workshop was to discuss strategies for conducting impactful future PCTs that bridge the gap between evidence, practice, and policy.

The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change.

The goal of the NIH Science of Behavior Change (SOBC) Common Fund Program is to provide the basis for an experimental medicine approach to behavior change that focuses on identifying and measuring the mechanisms that underlie behavioral patterns we are trying to change. This paper frames the development of the program within a discussion of the substantial disease burden in the U.S.

Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States.

Although most pain is acute and resolves within a few days or weeks, millions of Americans have persistent or recurring pain that may become chronic and debilitating. Medications may provide only partial relief from this chronic pain and can be associated with unwanted effects. As a result, many individuals turn to complementary health approaches as part of their pain management strategy.

Building an evidence base in complementary and integrative healthcare for child and adolescent psychiatry.

Complementary and integrative strategies are widely used by families with children who have mental health diagnoses. The therapies used by these children include herbs, dietary supplements, massage, acupuncture, meditation, and naturopathy. The literature on efficacy of complementary and alternative approaches is of limited value, and studies are needed to test efficacy and safety.

Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study.

Background: Inflammatory bowel disease (IBD) is characterized by chronic intestinal inflammation in the absence of a recognized etiology. The primary therapies are medications that possess anti-inflammatory or immunosuppressive effects. Given the high use of complementary alternative medicines in pediatric IBD, a prospective tolerability study of curcumin, an herbal therapy with known anti-inflammatory effects, was conducted to assess possible dosage in children with IBD.

DoD-NCCAM/NIH workshop on acupuncture for treatment of acute pain.

The Department of Defense (DoD) and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) cosponsored a workshop that explored the possible benefits of acupuncture treatment for acute pain. One goal of the workshop was to establish a roadmap to building an evidence base on that would indicate whether acupuncture is helpful for treating active-duty military personnel experiencing acute pain. The workshop highlighted brief presentations on the most current research on acupuncture and acute pain mechanisms.

Detoxification in naturopathic medicine: a survey.

Objectives: This study sought to assess the use of clinical detoxification therapies used by licensed naturopathic doctors (NDs) in the United States.

Design: This was a qualitative, descriptive, online survey of a convenience sample of NDs.

Methods: An online survey was conducted of NDs who were licensed in the United States.

Building bridges: qualitative assessment of a clinical faculty exchange between a naturopathic and an allopathic medical training program.

Research Question: What are the perceived benefits of a clinical exchange experience designed as part of a program to promote acceptance and use of evidence-based medicine (EBM) in naturopathic clinical practice?

Methods: Nine faculty members participated in a focus group (n = 6) or a structured interview (n = 3) to assess experience in the program. Investigators independently analyzed transcribed notes for common experience themes. ANALYSIS AND INTERPRETATION: Six major themes emerged: integrating EBM into naturopathic clinical teaching, strengthening of professional relationships, exposure to clinical experiences outside the usual naturopathic scope, reaffirmation of naturopathic training and profession, observation of clinical and administrative resources and practices, and recommendations for future clinical exchanges.

Development of a symptom score for clinical studies to identify children with a documented viral upper respiratory tract infection.

The objective of this study was to develop a symptom scoring system for use in clinical studies that differentiates children with cold symptoms who have an identifiable viral etiology for their upper respiratory tract infection (URI) from those in whom no virus is detected. Nasal swabs for PCR testing for identification of respiratory viruses were obtained on children aged 2-11 y at baseline and when parents thought their child was developing a cold. Parental-recorded severity of specific symptoms in children with and without a documented viral URI were compared.

Research on integrative healthcare: context and priorities.

It is important that integrative healthcare research be conducted to optimize the effectiveness, safety, costs, and social and economic impact of prospective, personalized, patient-centered, comprehensive, and holistic healthcare that focuses on well-being as well as disease management, and that the research itself be well understood. The scope of this research extends beyond evaluation of specific therapies, to include evaluations of multimodality whole system intervention, practitioner-patient relationships, patient goals and priorities, promoting self-care and resilience, personalized diagnostic and therapeutic measures, practitioner well-being, the comparative effectiveness of different educational and outreach strategies in improving health and healthcare, and the environmental/social causes and consequence of health and healthcare. In this paper, we describe the state of the science of research on integrative healthcare, research needs, and opportunities offered by cutting-edge research tools.

Complementary and alternative medicine use and quality of life in pediatric diabetes.

Objectives: The objectives of this study were to explore the association between complementary and alternative medicine (CAM) use as reported by youth, and parents' and children's reported quality of life in youth with diabetes.

Design: The study design was a cross-sectional survey.

Setting: Youth in Washington State participated in the SEARCH for Diabetes in Youth study, a national, multisite epidemiological study designed to assess the prevalence and incidence of diabetes in U.

A survey of complementary and alternative medicine (CAM) awareness among neurosurgeons in Washington State.

Objectives: Use of complementary and alternative medicine (CAM) by the U.S. population increased significantly in the past 2 decades.

Hypericum perforatum (St John's wort) for attention-deficit/hyperactivity disorder in children and adolescents: a randomized controlled trial.

Context: Stimulant medication can effectively treat 60% to 70% of youth with attention-deficit/hyperactivity disorder (ADHD). Yet many parents seek alternative therapies, and Hypericum perforatum (St John's wort) is 1 of the top 3 botanicals used.

Objective: To determine the efficacy and safety of H.

Interest of naturopathic physicians in pediatric research.

Objectives: Naturopathic physicians' interest in participating in pediatric observational studies or clinical trials is unknown. Complementary and alternative medicine research may need to be conducted in the settings where these therapies are commonly used to fully understand their effects. Optimally, naturopathic physicians will participate in the research of naturopathic medical practice.

Complementary and alternative medical therapies for attention-deficit/hyperactivity disorder and autism.

Complementary and alternative medical (CAM) therapies are commonly used by parents for their children who have attention deficit hyperactivity disorder (ADHD) or autism spectrum disorders. The use of these therapies is well documented, yet the evidence of the safety and efficacy of these treatments in children is limited. This article describes the current evidence-based CAM therapies for ADHD and autism, focusing on nutritional interventions; natural health products, including essential fatty acids, vitamins, minerals, and other health supplements; biofeedback; and reducing environmental toxins.

Frequency and characteristics of pediatric and adolescent visits in naturopathic medical practice.

Objectives: This work sought to identify naturopathic physicians in Washington State who frequently provide pediatric care and to describe the conditions treated and therapies recommended for children.

Patients And Methods: A mailed survey of licensed naturopathic physicians residing in Washington State collected demographic information and practice descriptions. For naturopathic physicians treating > or = 5 pediatric patients per week, data were collected on the conditions seen and treatments provided to children during a 2-week period.