The Case for Whole-Person Integrative Care.

Rationale: There is a need for medicine to deliver more whole-person care. This is a narrative review of several models of whole-person care and studies that illustrate the business case for whole-person models in primary care. Objectives: To provide an overview of what whole-person care models exist and explore evidence to support these models. Study Selection: Representative whole-person care models widely used in the United States are summarized and evaluated. Selected studies focused on outpatient primary care with examples from programs that integrate the delivery of conventional medical care, complementary and alternative medicine, and self-care within the context of social and cultural environments. Methods: Pubmed search conducted December 2020-February 2021. Two iterative searches using terms for "Whole Health Veterans Administration," "integrative medicine," "integrative health," "complementary and alternative medicine," and, as they related to the outcomes, of "health outcomes," "cost-effectiveness," "cost reduction," "patient satisfaction," and "physician satisfaction." Additional studies were identified from an initial search and the authors' experience of over 50 years. We looked for studies of whole-person care used in general primary care, those not using a single modality and only from United States practices. Results: A total of 125 (out of 1746) studies were found and met our inclusion criteria. We found that whole-person models of primary care exist, are quite heterogeneous in their approaches, and routinely report substantial benefits for improving the patient experience, clinical outcomes and in reducing costs. Conclusions: Evidence for the benefit of whole-person care models exist but definitions are quite heterogenous and unfocused. There is a need for more standardization of whole-person models and more research using whole systems approaches rather than reductionistic attempts using isolated components.

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review.

OBJECTIVE: To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures. DESIGN: Systematic review with meta-analysis. METHODS: Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS: Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = -0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = -0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions. CONCLUSIONS: There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

Measuring nonspecific factors in treatment: item banks that assess the healthcare experience and attitudes from the patient's perspective.

PURPOSE: Nonspecific factors that accompany healthcare treatments, such as patients' attitudes and expectations, are important parts of the experience of care and can influence outcomes. However, no precise, concise, and generalizable instruments to measure these factors exist. We report on the development and calibration of new item banks, titled the Healing Encounters and Attitudes Lists (HEAL), that assess nonspecific factors across a broad range of treatments and conditions. METHODS: The instrument development methodology of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) was used. Patient focus groups and clinician interviews informed our HEAL conceptual model. Literature searches of eight databases yielded over 500 instruments and resulted in an initial item pool of several thousand items. After qualitative item analysis, including cognitive interviewing, 296 items were included in field testing. The calibration sample included 1657 respondents, 1400 obtained through an Internet panel and 257 from conventional and integrative medicine clinics. Following exploratory and confirmatory factor analyses, the HEAL item banks were calibrated using item response theory. RESULTS: The final HEAL item banks were Patient-Provider Connection (57 items), Healthcare Environment (25 items), Treatment Expectancy (27 items), Positive Outlook (27 items), and Spirituality (26 items). Short forms were also developed from each item bank. A six-item short form, Attitudes toward Complementary and Alternative Medicine (CAM), was also created. CONCLUSIONS: HEAL item banks provided substantial information across a broad range of each construct. HEAL item banks showed initial evidence of predictive and concurrent validity, suggesting that they are suitable for measuring nonspecific factors in treatment.

Randomized effectiveness trial of a brief course of acupuncture for posttraumatic stress disorder.

BACKGROUND: Initial posttraumatic stress disorder (PTSD) care is often delayed and many with PTSD go untreated. Acupuncture appears to be a safe, potentially nonstigmatizing treatment that reduces symptoms of anxiety, depression, and chronic pain, but little is known about its effect on PTSD. METHODS: Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the 2 treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data. RESULTS: Mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC (PCLΔ=19.8±13.3 vs. 9.7±12.9, P<0.001; CAPSΔ=35.0±20.26 vs. 10.9±20.8, P<0.0001). Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust. CONCLUSIONS: Acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.

Implementing Whole Person Primary Care: Results from a Year-Long Learning Collaborative.

PURPOSE: The National Academies of Medicine report on Implementing High-Quality Primary Care calls for a transformation of the primary care to a "whole person" model that is person-centered, relationship-based and takes into account the social, spiritual, emotional and behavioral aspects of health. However, our current delivery tools, such as the SOAP Note, do not sufficiently capture and organize the delivery of these elements in practice. To explore how to remedy this, an Integrative Health Learning Collaborative (IHLC) was established to implement and test new tools for changing primary care practices toward whole person care. METHODS: The IHLC comprised primary care practices committed to changing to a whole person care model of care along with a panel of experts in integrative health and change management. The IHLC met virtually monthly. Representatives from each practice and an assigned expert met to strategize and adapt the tools to their environment and practice. The practices used previously developed tools (the HOPE Note toolkit), change management tools, and quality improvement techniques to introduce, implement, and evaluate the changes. RESULTS: Sixteen clinics completed the process after 1 year. Overall, practices used the HOPE Note tools in 942 patients. Participants reported changes on the effectiveness of the collaborative (1) on clinical practice, (2) on the skills and attitudes of participants; and (3) the support in change management. CONCLUSIONS: This online learning collaborative supported practices implementing a whole person care model in primary care and improved the understanding, skills, and delivery ability of whole person care in all clinics completing the program.

Methodological complexities associated with systematic review of healing relationships.

BACKGROUND/CONTEXT: There is growing recognition within the field of medicine that healing and healing relationships are important and that developing evidence-based medicine approaches to healing should be an important aspect of this emerging field, including the use of systematic reviews. Health care leaders charged with developing healing initiatives in hospitals often are frustrated in their attempts to find rigorous reviews of the literature to support their programs. OBJECTIVE: The objective of this project was to conduct a systematic review that asked, "What is the return on investment to hospitals that implement programs aimed at enhancing healing relationships?" METHODS: A comprehensive literature search using several electronic databases was conducted to locate studies that evaluated hospital-based programs involving "healing relationships." All studies found were evaluated as to their relevance to the study and screened for methodological quality. RESULTS: Research investigators found broad heterogeneity across the 80 included studies with regard to stated aims, target populations, outcomes measured, measurement tools employed, and evaluation methods used. Only 10 articles were categorized as being methodologically strong. CONCLUSIONS: Results of the systematic review highlighted challenges in synthesizing knowledge about healing that included absence of widely accepted definitions and language around "healing", locating literature published across many different disciplines, and absence of standards for conducting rigorous program evaluations in hospitals. A less formal qualitative review of included studies also revealed themes in the literature that provide clues about the professional, social, cultural, and historical influences that have helped to shape the evidence base to date.

Enzyme stabilization by glass-derived silicates in glass-exposed aqueous solutions.

OBJECTIVES: To analyze the solutes leaching from glass containers into aqueous solutions, and to show that these solutes have enzyme activity stabilizing effects in very dilute solutions. METHODS: Enzyme assays with acetylcholine esterase were used to analyze serially succussed and diluted (SSD) solutions prepared in glass and plastic containers. Aqueous SSD preparations starting with various solutes, or water alone, were prepared under several conditions, and tested for their solute content and their ability to affect enzyme stability in dilute solution. RESULTS: We confirm that water acts to dissolve constituents from glass vials, and show that the solutes derived from the glass have effects on enzymes in the resultant solutions. Enzyme assays demonstrated that enzyme stability in purified and deionized water was enhanced in SSD solutions that were prepared in glass containers, but not those prepared in plastic. The increased enzyme stability could be mimicked in a dose-dependent manner by the addition of silicates to the purified, deionized water that enzymes were dissolved in. Elemental analyses of SSD water preparations made in glass vials showed that boron, silicon, and sodium were present at micromolar concentrations. CONCLUSIONS: These results show that silicates and other solutes are present at micromolar levels in all glass-exposed solutions, whether pharmaceutical or homeopathic in nature. Even though silicates are known to have biological activity at higher concentrations, the silicate concentrations we measured in homeopathic preparations were too low to account for any purported in vivo efficacy, but could potentially influence in vitro biological assays reporting homeopathic effects.

A new model of care to return holism to family medicine.

Family medicine's leadership in primary care is slipping as it loses its vision of whole-person care. This model of care can help us better manage and combat chronic disease.

Systematic assessment of the quality of research studies of conventional and alternative treatment(s) of primary headache.

BACKGROUND: Diversity of treatments used for headache, and varied quality of research conduct and reporting make it difficult to accurately assess the literature and to determine the best treatment(s) for patients. OBJECTIVES: To compare the quality of available research evidence describing the effects and outcomes of conventional, and complementary and alternative medicine (CAM) approaches to treating primary (migraine, tension, and/or cluster-type) headache. STUDY DESIGN: A systematic review of quality of research studies of conventional and alternative treatment(s) of primary headache. METHODS: Randomized, controlled clinical trials (RCTs) of treatment(s) of chronic primary headache (in English between 1979 to June 2004) were searched through MEDLINE, PsycInfo, EMBASE, Cochrane Library, and the NIH databases. Studies were evaluated using standard approaches for assessing and analyzing quality indicators. RESULTS: 125 studies of conventional, and 121 CAM treatments met inclusion criteria. 80% of studies of conventional treatment(s) reported positive effects (p<0.05), versus 73% of studies of CAM approaches (chi(2) = 3.798, 1 df, p=0.051). Overall, the literature addressing the treatment of primary headache received a mean Jadad score of 2.72 out of 5 (SD 1.1). The mean Jadad score for studies of conventional therapeutics was significantly better than for those studies of CAM approaches: 3.21 +/- 0.9 vs 2.23 +/- 1.1 (t=7.72, 246 df, mean difference 0.98, p < 0.0005). CONCLUSIONS: Studies of conventional treatments scored higher on reporting quality than studies of CAM approaches. It is possible that these differences may reflect distinctions in 1) methodologic integrity, 2) therapeutic paradigm(s), and/or 3) bias(es) in the approach(es) used to evaluate certain types of therapies. Each of these possibilities -- and the implications -- is addressed and considered.

The Myth of the Placebo Response.

The placebo response is a myth. It does not exist in reality, and continuing to name it is hindering the optimal application of science to healing in medicine. On the surface, it is obvious that, when defined as a biological response to an inert pill (like a sugar pill), the idea of a "response" to a placebo is impossible. Inert treatments by definition do not produce responses. So why do we continue to ponder why people get better from taking inert substances and base our acceptance of legitimate treatments on demonstrating that they go beyond that response? The problem arises because we have flawed assumptions of the value that reductionistic science and the demonstration of specific effects has for healing. To support those flawed assumptions, we support the idea of "the placebo response." This causes confusion among patients, clinicians, regulators, and even scientists. Legitimate medical treatments have become defined as those that do more than produce a placebo response. An entire pharmaceutical industry and its regulators attempt to control and profit by proving that small molecules produce a clinical effect greater than the placebo response. Billions of dollars are made when that is proven, often even when the size of the response in the active over the placebo group is miniscule. The fact is people heal and that inherent healing capacity is both powerful and influenced by mental, social, and contextual factors that are embedded in every medical encounter since the idea of treatment began. In this chapter, I argue that our understanding of healing and ability to enhance it will be accelerated if we stop using the term "placebo response" and call it what it is-the meaning response, and its special application in medicine called the healing response.

Hormetic responses in neural systems: consideration, contexts, and caveats.

Dr. Edward Calabrese asserts that hormetic responses occur in neural systems, and provides ample review of evidence to support this claim. In this essay, we survey Dr. Calabrese's findings, illustrate the somewhat provocative premise of hormesis, and posit that while evidence suggests that amplification of low-dose effects are operative in neural systems, it is equally important to consider observations and claims of hormesis in greater detail, and framed within the "cultural" and epistemic contexts of science. We offer specific caveats to avoid the overgeneralization of findings, oversimplification of putative effects or mechanisms, and the dogmatic adherence to a restrictive methodologic orientation. Finally, we assert that any meaningful discussion of hormesis must be grounded to methodologic rigor, yet openness, and must allow for a self-critical and self-revisionist epistemic approach. We attempt to show that the work presented by Calabrese takes a first and important step toward the initiation of dialectic, allows for the exchange of ideas, strives toward reconciliation of differences and the amelioration of error, and seeks intellectual synthesis.

Clinical and analytical toxicology of dietary supplements: a case study and a review of the literature.

The use of dietary supplements has grown dramatically in the last decade. A large number of dietary and herbal supplements escape regulatory and quality control; components of these preparations are poisonous and may contain, among other toxins, heavy metals. Uncontrolled use of dietary and herbal supplements by special populations, such as the military, may therefore pose a health risk. Clinical symptoms are not always properly attributed to dietary supplements; patients often do not mention supplement use to their health care provider. Therefore, a health risk estimate is hard to make on either the individual or the population level. The literature on this issue was reviewed and discussed in the light of a representative clinical-chemical case study. This case study was performed on a host of preparations that were used by one single individual in the military. Both essential (chromium, copper, zinc, and iron) and poisonous (arsenic, lead, and nickel) trace elements were determined using inductively coupled plasma combined with optical emission spectrometry (ICP-OES) or with mass spectrometry (ICP-MS). Arsenic and lead were detected at exposure levels associated with health risks. These health risks were detected predominantly in hormone-containing supplements and the herbs and botanicals used for performance enhancement. To the extent that this is a representative sample, there is an underestimation of supplement use and supplement risk in the US military, if not in the general population. Since clinical symptoms may be attributed to other causes and, unless patients are specifically asked, health care providers may not be aware of their patients' use of dietary supplements, a strong support of laboratory diagnostics, such as a toxicological screening of blood or urine, is required. In addition, screening of the preparations themselves may be advised.

Should we explore the clinical utility of hormesis?

The idea that low-dose adaptive effects as described in hormesis can be used clinically has been discussed for hundreds if not thousands of years. Paracelsus famous adage that ;the dose makes the poison' and the common folk saying that one can be cured by ;the hair of the dog that bit you' speak to this idea. So why has so little research been done on the possible clinical utility of hormesis? What areas of clinical hormesis seem to be the most promising to explore? This article examines these concepts and proposes some initial areas or research where the possible utility of hormeiss might be investigated.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

BACKGROUND: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. OBJECTIVES: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. STUDY DESIGN/METHODS: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. RESULTS: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. CONCLUSIONS: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

Can specific biological signals be digitized?

At the request of the United States Defense Advanced Research Projects Agency, we attempted to replicate the data of Professor Jacques Benveniste that digital signals recorded on a computer disc produce specific biological effects. The hypothesis was that a digitized thrombin inhibitor signal would inhibit the fibrinogen-thrombin coagulation pathway. Because of the controversies associated with previous research of Prof. Benveniste, we developed a system for the management of social controversy in science that incorporated an expert in social communication and conflict management. The social management approach was an adaptation of interactional communication theory, for management of areas that interfere with the conduct of good science. This process allowed us to successfully complete a coordinated effort by a multidisciplinary team, including Prof. Benveniste, a hematologist, engineer, skeptic, statistician, neuroscientist and conflict management expert. Our team found no replicable effects from digital signals.