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We evaluated the association between the chronic severe back pain with disability and participation, in U.S. Adults using data from the US 2019 National Health Interview Survey. In our sample of 2,925 adults (weighted n: 20,468,134) who reported having chronic severe back pain, 60% reported mobility disability, 60% had work limitations, 34% were limited for social participation and 16% had self-care limitations. Older age (65+) was associated with mobility difficulties (OR 1.99, 95% CI 1.28,6.09) and work limitation (OR 2.21, 95% CI 1.61,3.05). Lower socioeconomic status was associated with increasing odds of disability across the 4 categories. Being obese was only associated with mobility difficulties (OR 1.95, 95% CI 1.41,2.71), while not working in the past week was associated with difficulties in mobility (OR 3.55, 95% CI 2.64,4.75), self-care (OR 3.34, 95% CI 2.20,5.08), and social participation (OR 3.20, 95% CI 2.13,4.80). Comorbidities were highly associated with limitations in all 4 categories. Those deeming their ability to manage their pain ineffective were twice as likely to have limitations in self-care, social and work participation but not mobility. Identifying factors associated with disability and limitation may help target appropriate management for persons with chronic pain at high risk for disability. PERSPECTIVE: We evaluated the association between the chronic severe back pain with disability and participation, in a representative sample of Americans. Identifying factors associated with a likelihood of disability may help target appropriate pain management for persons at high risk for disability due to chronic severe back pain.

Chronic pain is associated with reduced quality of life, increased medical expenditures, and significant economic costs. Chronic pain is among the most common chronic conditions in the United States, although estimates vary widely regarding its precise prevalence. Understanding the scope of the problem using the most contemporaneous data is therefore an important goal. This study sought to determine the prevalence of chronic pain and its impacts among adults in the United States using the National Health Interview Survey, a household-based annual survey of self-reported health status of U.S. adults that can be used to generate national-level estimates. Using a chronic pain module introduced in the 2019 edition of National Health Interview Survey, we found that 50.2 million adults (20.5%) reported pain on most days or every day. The most common pain locations were back pain and hip, knee, or foot pain. The most commonly used management strategies for chronic pain were physical therapy and massage. Respondents with chronic pain reported limitations in daily functioning, including social activities and activities of daily living. Respondents with chronic pain reported significantly more workdays missed compared with those without chronic pain (10.3 vs 2.8, P0.001). Overall, these findings indicate that more than 1 in 5 adults in America experiences chronic pain; additional attention to managing the burden of this disease is warranted.

Purpose: To explore medical diagnostic testing of new cases of musculoskeletal (MSK) conditions associated with chronic pain. Methods: We analyzed nationally representative cross-sectional data of people having visits with a new likely chronic MSK pain condition. We documented depression screening and prescribing of diagnostic imaging and blood tests and explored associations between patient and provider factors for each. Results: Over the 9 years of the survey, there were 11,994 initial visits for chronic MSK pain, an average of 36.8 million weighted visits per year or approximately 11.8% of the population. Proportions for depression screening, prescribed imaging, and blood tests were 1.79%, 36.34%, and 9.70%, respectively. People on any public health insurance had twice the increased relative odds to be screened for depression. Orthopedists had 3 times increased relative odds to prescribe imaging compared with family physicians; oncologists had 4 times increased relative odds to prescribe blood tests. Survey year was significantly associated with depression screening and ordering any type of imaging. Conclusions: Observed rates of depression screening and nonindicated imaging for patients with chronic MSK pain have fluctuated over time. The impact of these fluctuations on clinical practice is as yet unknown. The type of nonrecommended actions varied by specialty of physician.

ImportanceChronic pain risk and prognosis estimates are needed to inform effective interventions.ObjectiveTo estimate rates of chronic pain and high-impact chronic pain (HICP) incidence and persistence in US adults across demographic groups.Design, Setting, and ParticipantsThis cohort study examined a nationally representative cohort with 1 year of follow-up (mean [SD], 1.3 [0.3] years). Data from the 2019-2020 National Health Interview Survey (NHIS) Longitudinal Cohort were used to assess the incidence rates of chronic pain across demographic groups. The cohort was created using random cluster probability sampling of noninstitutionalized civilian US adults 18 years or older in 2019. Of 21 161 baseline participants in the 2019 NHIS who were randomly chosen for follow-up, 1746 were excluded due to proxy response(s) or lack of contact information, and 334 were deceased or institutionalized. Of the 19 081 remaining, the final analytic sample of 10 415 adults also participated in the 2020 NHIS. Data were analyzed from January 2022 to March 2023.ExposuresSelf-reported baseline sex, race, ethnicity, age, and college attainment.Main Outcomes and MeasuresPrimary outcomes were the incidence rates of chronic pain and HICP, and secondary outcomes were the demographic characteristics and rates across demographic groups. A validated measure of pain status (“In the past 3 months, how often did you have pain? Would you say never, some days, most days, or every day?”) yielded 3 discrete categories each year: pain free, nonchronic pain, or chronic pain (pain “most days” or “every day”). Chronic pain present in both survey years was considered persistent; HICP was defined as chronic pain that limited life or work activities on most days or every day. Rates were reported per 1000 person-years (PY) of follow-up, and age standardized based on the 2010 US adult population.ResultsAmong 10 415 participants included in the analytic sample, 51.7% (95% CI, 50.3%-53.1%) were female, 54.0% (95% CI, 52.4%-55.5%) were aged 18 to 49 years, 72.6% (95% CI, 70.7%-74.6%) were White, 84.5% (95% CI, 81.6%-85.3%) were non-Hispanic or non-Latino, and 70.5% (95% CI, 69.1%-71.9%) were not college graduates. Among pain-free adults in 2019, incidence rates of chronic pain and HICP in 2020 were 52.4 (95% CI, 44.9-59.9) and 12.0 (95% CI, 8.2-15.8) cases per 1000 PY, respectively. The rates of persistent chronic pain and persistent HICP in 2020 were 462.0 (95% CI, 439.7-484.3) and 361.2 (95% CI, 265.6-456.8) cases per 1000 PY, respectively.Conclusions and RelevanceIn this cohort study, the incidence of chronic pain was high compared with other chronic diseases. These results emphasize the high disease burden of chronic pain in the US adult population and the need for early management of pain before it becomes chronic.

Background The Trial to Assess Chelation Therapy (TACT) found that chelation therapy significantly reduced clinical events in patients with a history of myocardial infarction (MI). The initial report of TACT included the observation of an interaction between edetate disodium infusions and MI location, as well as diabetes. Thus, we examined in greater detail the effect of edetate disodium chelation therapy as a function of MI location and diabetes. Methods Patients (n = 1708) at least 6 weeks post-MI and age ≥ 50 were randomized to receive 40 infusions of a 500 mL chelation solution or placebo (median follow-up 55 months). The effect of edetate disodium on the primary outcome (all-cause mortality, MI, stroke, hospitalization for angina, or coronary revascularization) was assessed as a function of MI location using log-rank test and Cox regression model, adjusting for other prognostic variables. Results Among patients with post anterior MI (n = 674), chelation was associated with a lower risk of the primary endpoint (HR 0.63, 95% CI 0.47–0.86, p = 0.003) among anterior MI patients, but not in post non-anterior MI (n = 1034) patients (HR 0.96, 95% CI 0.77–1.20, p = 0.702) (p-for-interaction = 0.032). The point estimates for each component of the primary endpoint favored chelation therapy. The differing treatment effect in patients with post anterior vs. non-anterior MI was consistent among patients with or without diabetes and remained significant after adjusting for other prognostic variables (p Conclusions Edetate disodium infusions reduced the risk of cardiovascular events among patients with a prior anterior MI. Future studies should focus on replicating these results and understanding the mechanisms of benefit.

OBJECTIVE Using a nationally representative sample of adults and pain definitions consistent with the United States National Pain Strategy, we examined the associations of pain and cognitive impairment (CI) with each other and with measures of health status, physical impairment, social impairment, health care utilization, and dissatisfaction with health care. MATERIALS AND METHODS Prevalence estimates and multivariable logistic regression analyses of the 2017 National Health Interview Survey were performed. RESULTS As the level of reported pain increased from "no pain" to high-impact chronic pain (HICP), there was an increase in the prevalence of CI from 2.99% in those with no pain to 18.19% in those with HICP. Similarly, as the level of CI increased from no impairment to substantial CI, the prevalence of any pain increased from 62.44% to 83.20%. As pain severity and CI increased, we found increased prevalence for all outcomes examined, with the highest prevalence seen in participants with HICP and substantial CI. While 4.15% of individuals without either pain or CI reported poor/fair health, this increased to 33.98% in those with substantial CI or "dementia" but no pain, to 52.22% in those with HICP but no CI, and to 81.8% in individuals reporting both HICP and substantial CI or "dementia." DISCUSSION Our data suggest that individuals with comorbid chronic pain and CI are in a much higher state of self-reported disability than those with chronic pain or CI alone. Best practice guidelines are generally silent on multidisciplinary, integrated care for these comorbid conditions, increasing the potential for inadequate care.

The purpose of the study was to explore clinical management for new cases of musculoskeletal pain that are likely chronic. We used data from the National Ambulatory Medical Care Survey, 2007-2015, identifying visits with a new chronic musculoskeletal pain condition using predetermined ICD-9 codes. We documented prescribing of nonopioid pain medication, opioids, physical therapy (PT), counseling, and other nonpharmacologic treatments and explored associations between patient and provider factors for each of these treatments. There were 11,994 visits over the 9-year period for a new case of chronic musculoskeletal pain, representing an average of 36.8 million weighted visits per year or approximately 11.8% of the population. Proportions that were prescribed nonopioid medication, opioids, PT, counseling and other nonpharmacologic treatments were: 40.2, 21.5, 10.0, 15.2 and 14.3 respectively. Patient age was associated with type of treatment with a young to old gradient for other nonpharmacologic treatments, PT, opioids, counseling and other medications. Orthopedists were less likely to prescribe pharmacological treatments than family practice physicians and more likely to prescribe PT. Physicians who used the electronic medical record were more likely to prescribe opioids. Contrary to practice guidelines for managing musculoskeletal pain, many patients are prescribed opioids for a new chronic musculoskeletal problem. PERSPECTIVE: We outlined in a representative sample of Americans what treatments are being prescribed for new cases of likely chronic musculoskeletal pain. Opioid prescription was double that of physical therapy. Using the electronic medical record was associated with more opioid prescription- a novel finding that should be corroborated by future research.

We used data from the nationally representative Medical Expenditure Panel Survey to determine the 18-year trends in the overall rates of noncancer pain prevalence and pain-related interference, as well as in health care use attributable directly to pain management. The proportion of adults reporting painful health condition(s) increased from 32.9% (99.7% confidence interval [CI] = 31.6–34.2%;120 million adults) in 1997/1998 to 41.0% (99.7% CI = 39.2–42.4%; 178 million adults) in 2013/2014 (Ptrend Perspective Our data illustrate changes in the management of painful health conditions over the last 2 decades in the United States. Strong opioid use remains high, especially in those with severe pain-related interference. Additional education of health care providers and the public concerning the risk/benefit ratio of opioids appears warranted.

Objectives: 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. Design: 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. We employed the Andersen Model as a framework to identify predisposing, enabling, and health need factors associated with complementary health approach use based on previously identified and hypothesized factors. We ran Chi-square analyses to first test bivariate associations between our independent variables and four modalities to further guide logistic regression models. Results: Each of the four approaches examined saw substantial increases in prevalent use. However, only about 25% to 38% of individuals continued use from one wave to the next, whereas only 2%–9% of individuals who did not use a given approach in a wave reported use in the subsequent wave. Age, spiritual importance, and previous wave one use were all significantly associated with new use across all four modalities. Previous wave one use was associated with continued/discontinued use for all modalities. Age and education were significantly associated with discontinued use of chiropractic. Conclusion: We present the first longitudinal analysis of complementary health approaches in a nationally representative sample. These data distinguish between new and continued/discontinued use of complementary health approaches over time and provide insights into the interpretation of complementary health approach prevalence data, as well as important predictors of use.

To portray physician office visits by young Americans with chronic musculoskeletal pain; to describe clinical management in this group; and to explore factors associated with prescribed treatments.Using nationally representative data of ambulatory physician office visits (2007-2015 United States National Ambulatory Medical Care Survey), we identified and cross-sectionally analyzed visits by persons25 years of age diagnosed with a chronic musculoskeletal pain condition.There were 28.6 million visits over the 9-year period for chronic musculoskeletal pain for persons25 years of age, (average 3.2 million visits/year). There were more visits among older age groups, female persons, non-Hispanic White ethnicity/race, and those with more medical visits in the past year. Nonopioid medications were the most frequent treatments in all age groups (range 38.5%-48.8%). Opioids were rarely prescribed for children and adolescents but were prescribed in 23% of visits among young adults (18-24 years of age). Health education and counseling were consistently prescribed at 20% of visits and physical therapy (range 9.5%-23.7%) and other treatments were less frequently prescribed. Age, sex, payment source, and physician specialty were associated with various treatments.There were over 3 million annual visits for chronic musculoskeletal pain in young Americans; these increased with age. Pharmacologic treatment is used more than nonpharmacologic approaches, and opioid prescribing in the 18- to 24-year-old age group approaches estimates in adults with musculoskeletal pain.

Chronic pain, one of the most common reasons adults seek medical care (1), has been linked to restrictions in mobility and daily activities (2,3), dependence on opioids (4), anxiety and depression (2), and poor perceived health or reduced quality of life (2,3). Population-based estimates of chronic pain among U.S. adults range from 11% to 40% (5), with considerable population subgroup variation. As a result, the 2016 National Pain Strategy called for more precise prevalence estimates of chronic pain and high-impact chronic pain (i.e., chronic pain that frequently limits life or work activities) to reliably establish the prevalence of chronic pain and aid in the development and implementation of population-wide pain interventions (5). National estimates of high-impact chronic pain can help differentiate persons with limitations in major life domains, including work, social, recreational, and self-care activities from those who maintain normal life activities despite chronic pain, providing a better understanding of the population in need of pain services. To estimate the prevalence of chronic pain and high-impact chronic pain in the United States, CDC analyzed 2016 National Health Interview Survey (NHIS) data. An estimated 20.4% (50.0 million) of U.S. adults had chronic pain and 8.0% of U.S. adults (19.6 million) had high-impact chronic pain, with higher prevalences of both chronic pain and high-impact chronic pain reported among women, older adults, previously but not currently employed adults, adults living in poverty, adults with public health insurance, and rural residents. These findings could be used to target pain management interventions.

Background Previous studies have shown that individuals with diabetes exhibit accelerated cognitive decline. However, methodological limitations have limited the quality of this evidence. Heterogeneity in study design, cognitive test administration, and methods of analysis of cognitive data have made it difficult to synthesize and translate findings to practice. We analyzed longitudinal data from the Ginkgo Evaluation of Memory Study to test our hypothesis that older adults with diabetes have greater test-specific and domain-specific cognitive declines compared to older adults without diabetes. Methods Tests of memory, visuo-spatial construction, language, psychomotor speed, and executive function were administered. Test scores were standardized to z-scores and averaged to yield domain scores. Linear random effects models were used to compare baseline differences and changes over time in test and domain scores among individuals with and without diabetes. Results Among the 3,069 adults, aged 72-96 years, 9.3% reported diabetes. Over a median follow-up of 6.1 years, participants with diabetes exhibited greater baseline differences in a test of executive function (trail making test, Part B) and greater declines in a test of language (phonemic verbal fluency). For the composite cognitive domain scores, participants with diabetes exhibited lower baseline executive function and global cognition domain scores, but no significant differences in the rate of decline. Conclusions Identifying cognitive domains most affected by diabetes can lead to targeted risk modification, possibly in the form of lifestyle interventions such as diet and physical activity, which we know to be beneficial for improving vascular risk factors, such as diabetes, and therefore may reduce the risk of executive dysfunction and possible dementia.

Key Points Question Is alcohol consumption associated with the risk of dementia and cognitive decline in older adults with or without mild cognitive impairment? Findings In this cohort study of 3021 participants aged 72 years and older, alcohol intake within recommended limits was not significantly associated with a lower risk of dementia among participants with or without mild cognitive impairment at baseline. Among participants without mild cognitive impairment, daily low-quantity drinking was associated with lower dementia risk compared with infrequent higher-quantity drinking. Meaning These findings suggest that physicians caring for older adults need to carefully assess the full dimensions of drinking behavior and cognition when providing guidance to patients about their alcohol consumption., This cohort study examines the association between alcohol intake and risk of dementia among older adults with or without mild cognitive impairment., Importance Substantial heterogeneity and uncertainty exist in the observed associations between alcohol consumption and dementia. Objective To assess the association between alcohol consumption and dementia and the roles of mild cognitive impairment (MCI) and apolipoprotein E ε4 (APOE E4) genotype in modifying this association. Design, Setting, and Participants This cohort study used data from the Ginkgo Evaluation of Memory Study, conducted from 2000 to 2008 among US community-dwelling participants. This study analyzed 3021 participants aged 72 years and older who were free of dementia. Data analysis was performed from 2017 to 2018. Exposures Self-reported alcohol consumption, drinking frequency, and quantity. Main Outcomes and Measures Using multivariable proportional hazards regression and linear mixed models, the risk of dementia and the rate of change over time in the Modified Mini-Mental State Examination were estimated. Results Among 3021 participants, the median (interquartile range) age was 78 (76-80) years; 1395 (46.2%) were female. During a median (interquartile range) follow-up of 6.0 (4.9-6.5) years, 512 cases of dementia occurred. For 7.1 to 14.0 drinks per week compared with less than 1.0 drink per week, the hazard ratios for dementia were 0.63 (95% CI, 0.38-1.06) among 2548 participants without MCI and 0.93 (95% CI, 0.47-1.84) among 473 participants with MCI. Among participants with MCI, the hazard ratio for dementia was 1.72 (95% CI, 0.87-3.40) for more than 14.0 drinks per week compared with less than 1.0 drink per week. The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03). Among participants without MCI, daily low-quantity drinking was associated with lower dementia risk than infrequent higher-quantity drinking (hazard ratio, 0.45; 95% CI, 0.23-0.89; P = .02). Findings were consistent when stratified by sex, age, and APOE E4 genotype. Compared with drinking less than 1.0 drink per week, complete abstention (in participants without MCI) and the consumption of more than 14.0 drinks per week (in participants with MCI) were associated with lower Modified Mini-Mental State Examination scores (mean difference at follow-up compared with baseline, −0.46 point [95% CI, −0.87 to −0.04 point] and −3.51 points [95% CI, −5.75 to −1.27 points], respectively). Conclusions and Relevance In this study, complete abstention and consuming more than 14.0 drinks per week (compared with drinking

The NIH-funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stable patients age ≥50 who were ≥6 months post myocardial infarction to 40 infusions of an edetate disodium-based regimen or placebo. In 633 patients with diabetes, edetate disodium significantly reduced the primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.44-0.79, p 0.001). The principal secondary endpoint of a composite of cardiovascular death, myocardial infarction, or stroke was also reduced (HR 0.60, 95% CI 0.39-0.91, p = 0.017). It is unknown if the treatment effect differs by diabetes therapy.We grouped the subset of 633 patients with diabetes according to glucose-lowering therapy at time of randomization. The log-rank test was used to compare active therapy versus placebo. All treatment comparisons were performed using 2-sided significance tests at the significance level of 0.05 and were as randomized. Relative risks were expressed as HR with associated 95% CI, calculated using the Cox proportional hazards model.There were 162 (25.7%) patients treated with insulin; 301 (47.5%) with oral hypoglycemics only; and 170 (26.8%) receiving no pharmacologic treatment for diabetes. Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%) (HR 1.56, 95% CI 1.07-2.27, p = 0.022)] or oral hypoglycemics [61 (38%) vs 87 (29%) (HR 1.46, 1.05-2.03, p = 0.024)]. The primary endpoint occurred less frequently with edetate disodium based therapy versus placebo in patients on insulin [19 (26%) vs 42 (48%) (HR 0.42, 95% CI 0.25-0.74, log-rank p = 0.002)], marginally in patients on oral hypoglycemics [38 (25%) vs 49 (34%) (HR 0.66, 95% CI 0.43-1.01, log-rank p = 0.041)], and no significant difference in patients not treated with a pharmacologic therapy [23 (25%) vs 26 (34%) (HR 0.69, 95% CI 0.39-1.20, log-rank p = 0.225)]. The interaction between randomized intravenous treatment and type of diabetes therapy was not statistically significant (p = 0.203).Edetate disodium treatment in stable, post-myocardial infarction patients with diabetes suggests that patients on insulin therapy at baseline may accrue the greatest benefit.clinicaltrials.gov identifier: http://clinicaltrials.gov/ct2/show/NCT00044213?term=TACTrank=7 identifier Trial to Assess Chelation Therapy (TACT), NCT00044213.

Yoga, meditation, and use of chiropractors are types of complementary health approaches developed outside of mainstream Western medicine (1-2). Although complementary health approaches as a whole are not widely used among children, previous work has established a rise in the use of selected approaches over time (3). This report presents the most recent national estimates of use of the three most prevalent approaches during the past 12 months, among children aged 4-17 years in the United States. Comparable estimates from 2012 are also included to examine changes over time.

Background and aims Despite the enormous body of literature spanning more than 50 years describing results of pain experiments, very few have used qualitative methods to explore subjects’ thoughts while scoring experimental painful stimuli, and none in the available literature have used qualitative interviews to do so. The current study examined how participants in experimental pain research delineate pain ratings to better understand the unique influences of the experimental setting on pain scores. An additional aim was to highlight how individuals with fibromyalgia and healthy volunteers are differently influenced by characteristics of the experimental setting. Methods This was an inductive, qualitative study in which individual, semi-structured interviews were performed with 31 fibromyalgia patients and 44 healthy volunteers. Participants had taken part in a pain experiment during which a thermode was used to induce painful heat stimuli on two skin areas. There were two primary interview questions analyzed for this report: (1) “Thinking back to when you were getting the heat pain on your leg, what were you thinking about when deciding on your pain score?” and (2) Participants who said that it was difficult to decide on a pain score were asked to, “Describe what made it difficult to choose a number.” Thematic analysis was used to generate conceptual categories from textual data and find common themes. Results Three notable differences were found between fibromyalgia patients and healthy volunteers: (1) using current daily pain as a benchmark was seen more in patients, (2) wanting to appear strong in front of the study investigators was more common in healthy volunteers, and (3) becoming mentally fatigued from rating many stimuli was more common for fibromyalgia patients. Thoughts while scoring pain included: (1) comparing with previous or current pain, (2) self-monitoring of one’s ability to endure the pain, (3) focusing on the physical aspects of the pain, (4) knowing the experimental setting is safe, (5) focusing on the pain scale as an anchor, and (6) desire to appear strong. Additionally, five difficulties in scoring experimental pain were identified: (1) falling asleep, (2) mentally fatigued, (3) feeling as though they were guessing, (4) having to make a quick decision, and (5) difficulty in being consistent. Conclusions This study provides insights into the thoughts of participants in experimental pain research studies. Participants were distracted and influenced by the experimental setting and some factors differed for fibromyalgia patients versus healthy volunteers. Implications Understanding the ways in which the experimental setting influences pain ratings may help pain researchers better design and interpret studies. Researchers can use these findings to mitigate difficulties for participants in experimental research to add to its validity.

Using a simple approach for coding pain severity, the present study describes self-reported pain in U.S. adults. Data are included for 8,781 adults who completed the Functioning and Disability Supplement of the 2012 National Health Interview Survey. An internationally piloted pain severity coding system was used to group participants into 5 discrete ordered pain categories based on their pain persistence (days with pain in the last 3 months) and bothersomeness (little, a lot, somewhere in between): pain free and categories 1 (low) to 4 (high). It is estimated that 126.1 million adults reported some pain in the previous 3 months, with 25.3 million adults (11.2%) suffering from daily (chronic) pain and 23.4 million (10.3%) reporting a lot of pain. Based on the persistence and bothersomeness of their pain, 14.4 million adults (6.4%) were classified as having the highest level of pain, category 4, with an additional 25.4 million adults (11.3%) experiencing category 3 pain. Individuals with category 3 or 4 pain were likely to have worse health status, to use more health care, and to suffer from more disability than those with less severe pain. Associations were seen between pain severity and selected demographic variables including race, ethnicity, preferred language, sex, and age. Perspective U.S. estimates of pain prevalence are presented using a simple approach for assigning pain severity developed by the Washington Group on Disability Statistics. Concurrent validity is assessed. Although this approach is promising, additional work is required to determine the usefulness of the Washington Group pain categories for pain research or clinical practice.

This study provides prevalence estimates of plantar fasciitis in U.S. adults, as well as the types and frequencies of pharmaceutical treatment specifically for this pain. Data are from the 2013 National Health and Wellness Survey, a large (n = 75,000) internet panel survey designed to approximate the adult U.S.Strengths of associations are determined using multivariable logistic regression. It was estimated that .85% (95% confidence interval [CI] = .77-.92) of the sample reported diagnosed plantar fasciitis with pain in the past month. Higher prevalence of plantar fasciitis was seen in women (1.19%; referent) versus men (.47%), in those aged 45 to 64 (1.33%) versus those aged 18 to 44 (.53%; referent) years, and in the obese (1.48%) versus those with a body mass25 (.29%; referent). Prescription medications for pain were used by 41.04% of plantar fasciitis respondents, but only 6.31% attributed this use specifically to plantar fasciitis pain. Nonsteroidal anti-inflammatory drugs (4.01%) and opioids (2.21%) were the most prevalent prescription drugs used specifically for plantar fasciitis pain. Almost 70% of individuals with plantar fasciitis used over the counter (OTC) analgesics for general pain management, with OTC nonsteroidal anti-inflammatory drugs being used by 49.47% and acetaminophen by 26.93% of respondents. Individuals diagnosed by medical specialists had twice the odds of using prescription drugs as those diagnosed by other providers (odds ratio = 2.12; 95% CI = 1.01-4.46). Non-Hispanic black individuals were more likely to use prescription pain medications specifically for plantar fasciitis pain than non-Hispanic white individuals (odds ratio = 3.02; 95% CI = 1.05-8.70).The current study provides additional insights into the pain and disability associated with plantar fasciitis, as well as the pharmaceutical treatments being used for its management. Prescription as well as OTC medications are used to manage plantar fasciitis symptoms despite limited, if any, clinical trial data supporting their use.

Severe infections, often requiring ICU admission, have been associated with persistent cognitive dysfunction. Less severe infections are more common and whether they are associated with an increased risk of dementia is unclear. We determined the association of pneumonia hospitalization with risk of dementia in well-functioning older adults.Secondary analysis of a randomized multicenter trial to determine the effect of Gingko biloba on incident dementia.Five academic medical centers in the United States.Healthy community volunteers (n = 3,069) with a median follow-up of 6.1 years.None.We identified pneumonia hospitalizations using International Classification of Diseases, 9th Edition-Coding Manual codes and validated them in a subset. Less than 3% of pneumonia cases necessitated ICU admission, mechanical ventilation, or vasopressor support. Dementia was adjudicated based on neuropsychological evaluation, neurological examination, and MRI. Two hundred twenty-one participants (7.2%) incurred at least one hospitalization with pneumonia (mean time to pneumonia = 3.5 yr). Of these, dementia was developed in 38 (17%) after pneumonia, with half of these cases occurring 2 years after the pneumonia hospitalization. Hospitalization with pneumonia was associated with increased risk of time to dementia diagnosis (unadjusted hazard ratio = 2.3; CI, 1.6-3.2; p0.0001). The association remained significant when adjusted for age, sex, race, study site, education, and baseline mini-mental status examination (hazard ratio = 1.9; CI, 1.4-2.8; p0.0001). Results were unchanged when additionally adjusted for smoking, hypertension, diabetes, heart disease, and preinfection functional status. Results were similar using propensity analysis where participants with pneumonia were matched to those without pneumonia based on age, probability of developing pneumonia, and similar trajectories of cognitive and physical function prior to pneumonia (adjusted prevalence rates, 91.7 vs 65 cases per 1,000 person-years; adjusted prevalence rate ratio = 1.6; CI, 1.06-2.7; p = 0.03). Sensitivity analyses showed that the higher risk also occurred among those hospitalized with other infections.Hospitalization with pneumonia is associated with increased risk of dementia.

Background— The Trial to Assess Chelation Therapy (TACT) showed clinical benefit of an EDTA-based infusion regimen in patients aged ≥50 years with prior myocardial infarction. Diabetes mellitus before enrollment was a prespecified subgroup. Methods and Results— Patients received 40 infusions of EDTA chelation or placebo. A total of 633 (37%) patients had diabetes mellitus (322 EDTA and 311 placebo). EDTA reduced the primary end point (death, reinfarction, stroke, coronary revascularization, or hospitalization for angina; 25% versus 38%; hazard ratio, 0.59; 95% confidence interval [CI], 0.44–0.79; P P =0.002). All-cause mortality was reduced by EDTA chelation (10% versus 16%; hazard ratio, 0.57; 95% CI, 0.36–0.88; P =0.011), as was the secondary end point (cardiovascular death, reinfarction, or stroke; 11% versus 17%; hazard ratio, 0.60; 95% CI, 0.39–0.91; P =0.017). However, after adjusting for multiple subgroups, those results were no longer significant. The number needed to treat to reduce 1 primary end point over 5 years was 6.5 (95% CI, 4.4–12.7). There was no reduction in events in non–diabetes mellitus (n=1075; P =0.877), resulting in a treatment by diabetes mellitus interaction ( P =0.004). Conclusions— Post–myocardial infarction patients with diabetes mellitus aged ≥50 demonstrated a marked reduction in cardiovascular events with EDTA chelation. These findings support efforts to replicate these findings and define the mechanisms of benefit. However, they do not constitute sufficient evidence to indicate the routine use of chelation therapy for all post–myocardial infarction patients with diabetes mellitus. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00044213.

Background: Little is known about the characteristics of US children who are dietary supplement users. Objective: We described the prevalence and predictors of and reasons for giving children dietary supplements. Design: The study included children

This study provides national prevalence estimates of US military veterans with severe pain, and compares veterans with nonveterans of similar age and sex. Data used are from the 2010 to 2014 National Health Interview Survey on 67,696 adults who completed the Adult Functioning and Disability Supplement. Participants with severe pain were identified using a validated pain severity coding system imbedded in the National Health Interview Survey Adult Functioning and Disability Supplement. It was estimated that 65.5% of US military veterans reported pain in the previous 3 months, with 9.1% classified as having severe pain. Compared with veterans, fewer nonveterans reported any pain (56.4%) or severe pain (6.4%). Whereas veterans aged 18 to 39 years had significantly higher prevalence rates for severe pain (7.8%) than did similar-aged nonveterans (3.2%), veterans age 70 years or older were less likely to report severe pain (7.1%) than nonveterans (9.6%). Male veterans (9.0%) were more likely to report severe pain than male nonveterans (4.7%); however, no statistically significant difference was seen between the 2 female groups. The prevalence of severe pain was significantly higher in veterans with back pain (21.6%), jaw pain (37.5%), severe headaches or migraine (26.4%), and neck pain (27.7%) than in nonveterans with these conditions (respectively: 16.7%, 22.9%, 15.9%, and 21.4%). Although veterans (43.6%) were more likely than nonveterans (31.5%) to have joint pain, no difference was seen in the prevalence of severe pain associated with this condition. Perspective Prevalence of severe pain, defined as that which occurs “most days” or “every day” and bothers the individual “a lot,” is strikingly more common in veterans than in members of the general population, particularly in veterans who served during recent conflicts. Additional assistance may be necessary to help veterans cope with their pain.

This report examines the use of complementary health approaches among U.S. adults aged 18 and over who had a musculoskeletal pain disorder. Prevalence of use among this population subgroup is compared with use by persons without a musculoskeletal disorder. Use for any reason, as well as specifically to treat musculoskeletal pain disorders, is examined.Using the 2012 National Health Interview Survey, estimates of the use of complementary health approaches for any reason, as well as use to treat musculoskeletal pain disorders, are presented. Statistical tests were performed to assess the significance of differences between groups of complementary health approaches used among persons with specific musculoskeletal pain disorders. Musculoskeletal pain disorders included lower back pain, sciatica, neck pain, joint pain or related conditions, arthritic conditions, and other musculoskeletal pain disorders not included in any of the previous categories. Respondents could report having more than one disorder.In 2012, 54.5% of U.S. adults had a musculoskeletal pain disorder. The use of any complementary health approach for any reason among persons with a musculoskeletal pain disorder (41.6%) was significantly higher than use among persons without a musculoskeletal pain disorder (24.1%). Among adults with any musculoskeletal pain disorder, the use of natural products for any reason (24.7%) was significantly higher than the use of mind and body approaches (15.3%), practitioner-based approaches (18.2%), or whole medical system approaches (5.3%). The pattern of use of the above-mentioned groups of complementary health approaches was similar for persons without a musculoskeletal disorder. However, prevalence of use among these persons was significantly lower compared with persons with a musculoskeletal disorder. For treatment, the use of practitioner-based approaches among persons with any musculoskeletal pain disorder (9.7%) was more than three times as high as the use of any other group of approaches (0.7%-3.1%). The patterns of use of specific groups of complementary health approaches also differed among specific musculoskeletal pain disorders.

This report presents estimates of expenditures on complementary health approach use among the U.S. population. Estimates are presented for adults and children separately and combined, as well as stratified by type of approach and family income.Combined data from 44,743 individuals aged 4 years and over, collected as part of the 2012 National Health Interview Survey, were analyzed for this report. Sample data were weighted to produce national estimates that are representative of the civilian noninstitutionalized U.S. population. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level. Linear regression was used to assess trends in expenditures when stratifying by family income.An estimated 59 million persons aged 4 years and over had at least one expenditure for some type of complementary health approach, resulting in total out-of-pocket expenditures of $30.2 billion. More was spent on visits to complementary practitioners ($14.7 billion) than for purchases of natural product supplements ($12.8 billion) or self-care approaches ($2.7 billion). The mean per user out-of-pocket expenditure for visits to a complementary practitioner ($433) was significantly more than for purchases of natural product supplements ($368) or for self-care approaches ($257). Adults had higher mean annual out-of-pocket expenditures for visits to complementary practitioners than children ($442 and $291, respectively). Total out-of-pocket expenditures and mean per user out-of pocket expenditures for complementary health approaches increased significantly as family income increased. The mean per user out-of-pocket expenditure for complementary health approaches was $435 for persons with family incomes less than $25,000 and $590 for persons with family incomes of $100,000 or more.

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. This article examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S -adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.

Data from the 2002 and 2012 National Health Interview Surveys. Between 2002 and 2012, the use of acupuncture, chiropractic, and massage therapy increased among adults who did not have health insurance coverage for these complementary health approaches. No change in use was observed among those who had coverage for these approaches. While 60% of adults who saw a practitioner for chiropractic had at least some health insurance coverage for this approach, far fewer adults seeing a practitioner for acupuncture (25%) or massage therapy (15%) had coverage for these approaches. Adults who saw practitioners for acupuncture and chiropractic-and had health insurance coverage for these approaches-were more likely to have partial than complete coverage.

In October 2007, a National Center for Complementary and Alternative Medicine (NCCAM)–sponsored workshop, entitled “Applying Principles from Complex Systems to Studying the Efficacy of CAM Therapies,” was held at Georgetown University in Washington, DC. Over a 2-day period, the workshop engaged a small group of experts from the fields of complementary and alternative medicine (CAM) research and complexity science to discuss and examine ways in which complexity science can be applied to CAM research. After didactic presentations and small-group discussions, a number of salient themes and ideas emerged. This paper article describes the workshop program and summarizes these emergent ideas, which are divided into five broad categories: (1) introduction to complexity; (2) challenges to CAM research; (3) applications of complexity science to CAM; (4) CAM as a model of complexity applied to medicine; and (5) future directions. This discusses possible benefits and challenges associated with applying complexity science to CAM research. By providing an introductory framework for this collaboration and exchange, it is hoped that this article may stimulate further inquiry into this largely unexplored area of research.

The NIH sponsored a scientific workshop, "Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies," July 28-29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies.

Background Accumulating evidence suggests that Ginkgo biloba is cardioprotective, in part, through its vasodilatory and antihypertensive properties. However, definitive data on its blood pressure (BP)-lowering effects in humans is lacking. Methods We determined the effects of G. biloba extract (240 mg/day) on BP and incident hypertension in 3,069 participants (mean age, 79 years; 46% female; 96% white) from the Ginkgo Evaluation of Memory (GEM) study. We also examined whether the treatment effects are modified by baseline hypertension status. Results At baseline, 54% of the study participants were hypertensive, 28% were prehypertensive, and 17% were normotensive. Over a median follow-up of 6.1 years, there were similar changes in BP and pulse pressure (PP) in the G. biloba and placebo groups. Although baseline hypertension status did not modify the antihypertensive effects of G. biloba, it did influence the changes in BP variables observed during follow-up, with decreases in hypertensives, increases in normotensives, and no changes in prehypertensives. Among participants who were not on antihypertensive medications at baseline, there was no difference between treatment groups in medication use over time, as the odds ratio (95% confidence interval (CI)) for being a never-user in the G. biloba group was 0.75 (0.48-1.16). The rate of incident hypertension also did not differ between participants assigned to G. biloba vs. placebo (hazard ratio (HR), 0.99, 95% CI, 0.84-1.15). Conclusions Our data indicate that G. biloba does not reduce BP or the incidence of hypertension in elderly men and women.

OBJECTIVES: To analyze baseline data on concomitant use of prescription drugs and dietary supplements in elderly people from the Ginkgo Evaluation of Memory (GEM) Study, in which information was collected on all drugs and supplements used by participant. DESIGN: Cross-sectional correlation analysis. SETTING: GEM Study sites in California, Maryland, North Carolina, and Pennsylvania. PARTICIPANTS: Three thousand seventy ambulatory individuals aged 75 and older enrolled between September 2000 and June 2002. MEASUREMENTS: Use of prescription drugs and dietary supplements identified through bottles brought to the clinic. RESULTS: Almost three-quarters (74.2%) of the cohort combined use of at least one prescription drug and one dietary supplement, with 32.5% using three or more prescription drugs and three or more supplements. The 15 most-prevalent prescription drugs exhibited substantial concomitant use with dietary supplements, ranging from 77.6% for diuretics to 93.6% for estrogen preparations. Although supplements were taken concomitantly with all classes of prescription drugs, the use of supplements was more likely in individuals using nonsteroidal anti-inflammatory drugs, thyroid drugs, and estrogens. The use of drugs for diabetes mellitus was negatively associated with the use of supplements, with most of this attributed to low use in those taking multivitamins, glucosamine and chondroitin, and echinacea. CONCLUSION: There is substantial concomitant use of prescription drugs and dietary supplements in elderly people. Further investigations are needed to define the clinical importance of this concomitant use, especially in elderly patients who consume multiple prescription drugs or have experienced an adverse event secondary to their prescription medications.

This report presents national estimates of selected wellness-related reasons for the use of natural product supplements, yoga, and spinal manipulation among U.S. adults in 2012. Self-reported perceived health outcomes were also examined.Data from 34,252 adults aged 18 and over collected as part of the 2012 National Health Interview Survey were analyzed for this report. In particular, whether adults who used selected complementary health approaches did so to treat a specific health condition or for any of five wellness-related reasons was examined, as well as whether these adults perceived that this use led to any of nine health-related outcomes. Sampling weights were used to produce national estimates that are representative of the civilian noninstitutionalized U.S. adults population.Users of natural product supplements and yoga were more likely to have reported using the approach for a wellness reason than for treatment of a specific health condition, whereas more spinal manipulation users reported using it for treatment rather than for wellness. The most common wellness-related reason reported by user of each of the three approaches was for "general wellness or disease prevention." The majority of users of all three health approaches reported that they perceived this use improved their overall health and made them feel better. Yoga users perceived higher rates of all of the self-reported wellness-related health outcomes than users of natural product supplements or spinal manipulation.

Introduction: Treatment with edetate disodium has been in use for nearly 60 years for cardiovascular disease despite safety concerns, including deaths from hypocalcemia. No careful prospective evaluation of safety had been reported prior to the NIH-sponsored Trial to Assess Chelation Therapy (TACT). Methods: In TACT, 1,708 post-MI patients age ≥ 50 and creatinine ≤ 2.0 mg/dL were randomized doule blind to edetate-based chelation (n=839) or placebo (n=869). TACT implemented extensive site education prior to site activation. During the infusion period, there was close monitoring of vitals and labs, particularly creatinine and calcium, special lab-based (creatinine, calcium, and platelets) algorithms to delay infusions or reduce infusion rate when abnormal criteria were met, and early intervention to respond to safety concerns. Electronic and in-person monitoring took place to ensure adherence to TACT infusion protocols. Results: There were 100 (12%) serious adverse events (SAEs) in the edetate group and 127 (15%) in the placebo group (p=0.1009). Two deaths were possibly or definitely attributed, by the blinded safety monitor, to study therapy, 1 in the chelation group and 1 in the placebo group. Heart failure was reported in 57 edetate patients (7%) and 71 placebo patients (8%) (p=.28). Physical exams were identical over the course of the study, except for more tachycardia (heart rate >100) in the placebo arm (0.1% vs 1.3% p=0.006). There was more infusion site discomfort (1.5% vs. 0.6%, p=0.049) with chelation and more abdominal cramping with placebo (1.7% v. 3.3%, p= 0.029) Reductions in calcium ( Conclusions: The experience with 55,222 infusions of edetate disodium or placebo in TACT shows that this therapy is extremely safe when used according to the TACT safe infusion protocol. This finding will be pivotal in informing the design of the TACT2 confirmatory study.

National surveys suggest that millions of adults in the United States use complementary health approaches such as acupuncture, chiropractic manipulation, and herbal medicines to manage painful conditions such as arthritis, back pain, and fibromyalgia. Yet, national and per person out-of-pocket (OOP) costs attributable to this condition-specific use are unknown. In the 2007 National Health Interview Survey, the use of complementary health approaches, the reasons for this use, and the associated OOP costs were captured in a nationally representative sample of 5,467 adults. Ordinary least square regression models that controlled for comorbid conditions were used to estimate aggregate and per person OOP costs associated with 14 painful health conditions. Individuals using complementary approaches spent a total of $14.9 billion (standard error [SE] = $.9 billion) on these approaches to manage these painful conditions. Total OOP expenditures by those using complementary approaches for their back pain ($8.7 billion, SE=$.8 billion) far outstripped OOP expenditures for any other condition; the majority of these costs ($4.7 billion, SE=$.4 billion) were for visits to complementary providers. Annual condition-specific per person OOP costs varied from a low of $568 (SE = $144) for regular headaches to a high of $895 (SE = $163) for fibromyalgia. Perspective Adults in the United States spent $14.9 billion on complementary health approaches (eg, acupuncture, chiropractic manipulation, and herbal medicines) to manage painful conditions including back pain ($8.7 billion). This back pain estimate is almost one-third of the total conventional health care expenditure for back pain ($30.4 billion) and two-thirds higher than conventional OOP expenditures ($5.1 billion).

This report presents national estimates of the use of complementary health approaches among children aged 4-17 years in the United States. Selected modalities are compared for 2007 and 2012 to examine changes over time.Data from the 2007 and 2012 National Health Interview Survey (NHIS) were analyzed for this report. The combined sample included 17,321 interviews with knowledgeable adults about children aged 4-17 years. Point estimates and estimates of their variances were calculated using SUDAAN software to account for the complex sampling design of NHIS. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level.The use of complementary health approaches among children did not change significantly since 2007 (from 12.0% in 2007 to 11.6% in 2012). However, one approach, the use of traditional healers, showed a statistically significant decrease in use, from 1.1% in 2007 to 0.1% in 2012. No other significant decreases were identified. An increase in the use of yoga was observed during this period (from 2.3% in 2007 to 3.1% in 2012). Nonvitamin, nonmineral dietary supplements; chiropractic or osteopathic manipulation; and yoga, tai chi, or qi gong were the most commonly used complementary health approaches in both 2007 and 2012. Also consistent between 2007 and 2012 was that complementary health approaches were most frequently used for back or neck pain, head or chest cold, anxiety or stress, and other musculoskeletal conditions.

OBJECTIVES: To analyze baseline data from the Ginkgo Evaluation of Memory (GEM) study, in which information was collected on the use of all dietary supplements. DESIGN: Cross-sectional regression analysis. SETTING: GEM study sites in California, Maryland, North Carolina, and Pennsylvania. PARTICIPANTS: The GEM study enrolled 3,072 ambulatory individuals aged 75 and older between September 2000 and June 2002. MEASUREMENTS: Self-reported use of dietary supplements and use identified through bottles brought to the clinic. RESULTS: Respectively, 59.4%, 66.6%, and 27.4% of the GEM study cohort used a multivitamin, at least one individual vitamin or mineral supplement, and some type of nonvitamin/nonmineral dietary supplement (NVNMDS). In logistic regression models, multivitamin use was associated with female sex, a higher income, a higher modified Mini-Mental State Examination score, difficulty with mobility, and asthma history; use of any other vitamin or mineral was associated with female sex, white race, nonsmoking, more years of schooling, difficulty walking, a history of osteoporosis, and reading health and senior magazines; and NVNMDS use was associated with residing in California, having difficulties with muscle strength, and reading health and senior magazines. CONCLUSION: There were substantial differences between individuals who used vitamins and minerals and those who used NVNMDS. These data require that trial investigators pay close attention to participant use of off-protocol dietary supplements. In addition, these findings may help identify elderly individuals likely to combine NVNMDS and prescription drugs.

The epidemic of late life dementia, prominence of use of alternative medications and supplements, and initiation of efforts to determine how to prevent dementia have led to efforts to conduct studies aimed at prevention of dementia. The GEM (Ginkgo Evaluation of Memory) study was initially designed as a 5-year, randomized double-blind, placebo-controlled trial of Ginkgo biloba, administered in a dose of 120 mg twice per day as EGb761, in the prevention of dementia (and especially Alzheimer's disease) in normal elderly or those with mild cognitive impairment. The study anticipates 8.5 years of participant follow-up. Initial power calculations based on estimates of incidence rates of dementia in the target population (age 75+) led to a 3000-person study, which was successfully recruited at four clinical sites around the United States from September 2000 to June 2002. Primary outcome is incidence of all-cause dementia; secondary outcomes include rate of cognitive and functional decline, the incidence of cardiovascular and cerebrovascular events, and mortality. Following screening to exclude participants with incident dementia at baseline, an extensive neuropsychological assessment was performed and participants were randomly assigned to treatment groups. All participants are required to have a proxy who agreed to provide an independent assessment of the functional and cognitive abilities of the participant. Assessments are repeated every 6 months. Significant decline at any visit, defined by specific changes in cognitive screening scores, leads to a repeat detailed neuropsychological battery, neurological and medical evaluation and MRI scan of the brain. The final diagnosis of dementia is achieved by a consensus panel of experts. Side effects and adverse events are tracked by computer at the central data coordinating center and unblinded data are reviewed by an independent safety monitoring board. Studies such as these are necessary for this and a variety of other potential protective agents to evaluate their effectiveness in preventing or slowing the emergence of dementia in the elderly population.

A historic and critically important scientific workshop for all professions involved with manual therapies was held at the National Institutes of Health (NIH) on June 9 and 10, 2005. The conference was jointly sponsored and organized by the NIH and the Canadian Institutes of Health Research and was the first ever national or international research conference to focus on the biologic mechanisms that underlie a broad range of interventions, which can be described as "manual therapies." Leading scientific experts from North America and Europe presented their latest findings and theories related to 5 different areas of science relevant to manual therapies: neuroscience, biomechanics, endocrinology, imaging, and immunology. During the conference, breakout groups composed of scientists, physicians and therapists, and patient advocates were formed in the relevant disciplines. These groups developed consensus statements on key unanswered research questions, which were then submitted back to the conference for comment and approval. The outcomes of this workshop have subsequently been incorporated into a new initiative by the NIH and Canadian Institutes of Health Research for funding research on the biology of manual therapies. This editorial includes presentation summaries and 13 key consensus recommendations relating to mechanisms of action for manual therapies.

Objective—This report presents selected estimates of complementary and alternative medicine (CAM) use among U.S. adults, using data from the 2002 National Health Interview Survey (NHIS), conducted by the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS). Methods—Data for the U.S. civilian noninstitutionalized population were collected using computer-assisted personal interviews (CAPI). This report is based on 31,044 interviews of adults age 18 years and over. Statistics shown in this report were age adjusted to the year 2000 U.S. standard population. Results—Sixty-two percent of adults used some form of CAM therapy during the past 12 months when the definition of CAM therapy included prayer specifically for health reasons. When prayer specifically for health reasons was excluded from the definition, 36% of adults used some form of CAM therapy during the past 12 months. The 10 most commonly used CAM therapies during the past 12 months were use of prayer specifically for one’s own health (43.0%), prayer by others for one’s own health (24.4%), natural products (18.9%), deep breathing exercises (11.6%), participation in prayer group for one’s own health (9.6%), meditation (7.6%), chiropractic care (7.5%), yoga (5.1%), massage (5.0%), and diet-based therapies (3.5%). Use of CAM varies by sex, race, geographic region, health insurance status, use of cigarettes or alcohol, and hospitalization. CAM was most often used to treat back pain or back problems, head or chest colds, neck pain or neck problems, joint pain or stiffness, and anxiety or depression. Adults age 18 years or over who used CAM were more likely to do so because they believed that CAM combined with conventional medical treatments would help (54.9%) and/or they thought it would be interesting to try (50.1%). Most adults who have ever used CAM have used it within the past 12 months, although there is variation by CAM therapy.

Background Most knowledge of fibromyalgia comes from the clinical setting, where healthcare-seeking behavior and selection issues influence study results. The characteristics of fibromyalgia in the general population have not been studied in detail. Methods We developed and tested surrogate study specific criteria for fibromyalgia in rheumatology practices using variables from the US National Health Interview Survey (NHIS) and the modification (for surveys) of the 2010 American College of Rheumatology (ACR) preliminary fibromyalgia criteria. The surrogate criteria were applied to the 2012 NHIS and identified persons who satisfied criteria from symptom data. The NHIS weighted sample of 8446 persons represents 225.7 million US adults. Results Fibromyalgia was identified in 1.75% (95% CI 1.42, 2.07), or 3.94 million persons. However, 73% of identified cases self-reported a physician’s diagnosis other than fibromyalgia. Identified cases had high levels of self-reported pain, non-pain symptoms, comorbidity, psychological distress, medical costs, Social Security and work disability. Caseness was associated with gender, education, ethnicity, citizenship and unhealthy behaviors. Demographics, behaviors, and comorbidity were predictive of case status. Examination of the surrogate polysymptomatic distress scale (PSD) of the 2010 ACR criteria found fibromyalgia symptoms extending through the full length of the scale. Conclusions Persons identified with criteria-based fibromyalgia have severe symptoms, but most (73%) have not received a clinical diagnosis of fibromyalgia. The association of fibromyalgia-like symptoms over the full length of the PSD scale with physiological as well as mental stressors suggests PSD may be a universal response variable rather than one restricted to fibromyalgia.

Introduction: The NIH-funded Trial to Assess Chelation Therapy (TACT) reported a clinical benefit of EDTA-based chelation on cardiovascular (CV) outcomes in post-MI patients with diabetes (DM). We assessed the benefit of therapy by severity of diabetes. Methods: TACT, a multi-center, double-blind, placebo-controlled, 2 X 2 factorial trial of EDTA chelation and high-dose vitamins, enrolled pts age > 50 years with an MI at least 6 weeks prior and creatinine < 2.0. Median duration of follow-up was 55 months. The primary endpoint was death from any cause, MI, stroke, coronary revascularization, or hospitalization for angina. The major secondary clinical endpoint was cardiovascular death, MI, or stroke. The type of hypoglycemic therapy (insulin, oral, or none) was used as a surrogate for severity of diabetes. The log rank test and Cox model were used for treatment comparisons. This is a non-prespecified subgroup comparison. Results: TACT enrolled 1708 pts. Among the 633 (37%)with diabetes, 162 (26%) were on insulin, 301 (48%) not on insulin, but on oral hypoglycemic, and 170 (27%) on neither. For the overall subgroup of 633 pts with diabetes EDTA chelation significantly reduced the primary endpoint (HR 0.59 95% confidence intervals (CI) 0.44-0.79, p Conclusions: In post-MI pts with DM treated with standard therapies, the clinical benefit of EDTA-based chelation therapy was most pronounced among the patients with the most severe diabetes, those on insulin therapy. Additional work to understand mechanisms will be necessary.

Data from the National Health Interview Survey, 2012 Use of nonvitamin, nonmineral dietary supplements (17.9%) was greater than any other complementary health approach used by U.S. adults in 2012. The use of practitioner-based chiropractic or osteopathic manipulation was nearly twice as high in the West North Central region as in the United States overall. Use of nonvitamin, nonmineral dietary supplements was highest in the Mountain, Pacific, and West North Central regions. Use of yoga with deep breathing or meditation was approximately 40% higher in the Pacific and Mountain regions than in the United States overall. Complementary health approaches are defined as "a group of diverse medical and health care interventions, practices, products, or disciplines that are not generally considered part of conventional medicine". They range from practitioner-based approaches, such as chiropractic manipulation and massage therapy, to predominantly self-care approaches, such as nonvitamin, nonmineral dietary supplements, meditation, and yoga. This report presents estimates of the four most commonly used complementary health approaches among adults aged 18 and over in nine geographic regions, using data from the 2012 National Health Interview Survey adult alternative medicine supplement.

Abstract —The National Heart, Lung, and Blood Institute and the National Center for Complementary and Alternative Medicine recently cosponsored a workshop on the use of complementary and alternative medicine (CAM) in cardiovascular, lung, and blood research. In view of the increasing use of CAM by the general public, it is imperative to promote credible research by the established biomedical community. The goal of this workshop was to enhance the exchange of information and ideas between alternative medicine practitioners and scientists in cardiovascular, lung, and blood research and to foster collaborative research among these researchers. The workshop focused on 5 areas of research, including a historical and cultural perspective of CAM, methodological issues in clinical trials, herbal medicine, chelation therapy, mind/body (meditation) therapy, and acupuncture. CAM has become widely used without rigorously proven efficacy and safety. To protect the public, it was recommended that the fundamental mechanistic research for these CAM approaches be vigorously pursued and that any large-scale clinical trial be carefully executed to avoid any waste of resources and any unnecessary risk. It was felt that standardization of botanical products and procedure-based CAM intervention, such as acupuncture and meditation, is essential for meaningful basic and clinical research. Although botanical products properly consumed are perceived as generally safe, potential herb-drug interactions are a major safety concern. Clearly, many challenges need to be addressed by the scientific community before the public can be assured of the proper use of CAM.

The growing use of unsubstantiated complementary and alternative medicine therapies by people in the United States1 along with its increasing coverage by third party payers2 encouraged Congress to create the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health. The centre's mission is “to explore complementary and alternative healing practices in the context of rigorous science; to educate and training CAM researchers; and to disseminate authoritative information to the public and professionals.”3 To complete this mission, NCCAM supports publicly relevant and scientifically rigorous research to identify those complementary and alternative medicine practices that are safe and effective. The centre's resources, although generous ($68.3m (£46m) for fiscal year 2000), are not sufficient to study all complementary and alternative medicine practices. NCCAM therefore developed criteria to help prioritise the many possible research opportunities (box). As part of the evaluation process, NCCAM seeks advice from its national advisory council, complementary and alternative medicine and conventional clinicians, members of the scientific research community, the public, sister federal agencies, and other stakeholders. #### Summary points Many early clinical trials investigating complementary and alternative medicine have had serious flaws Clinical investigations of complementary and alternative medicine are made difficult by factors such as use of complex, individualised treatments and lack of standardisation of herbal medicines Other problems include difficulties in accruing, randomising, and retaining patients and in identifying appropriate placebo interventions Despite these complexities, rigorously designed clinical trials are possible, including pragmatic studies of complete complementary and alternative medicine systems Strong commitment is required from the research community to provide information about complementary and alternative medicines to the public and health professionals Staff at the centre are often asked why limited resources are being spent on research that is perceived as replicating previously published work, especially when other western countries have …