Nontouch biofield therapy: a systematic review of human randomized controlled trials reporting use of only nonphysical contact treatment.

UNLABELLED: OBJECTIVE AND CONTEXT: This review was designed to assess the quality and review the outcomes of randomized controlled trials (RCTs) of biofield therapies (external qigong, Healing Touch, Johrei, Reiki, and Therapeutic Touch) that report using only nonphysical touch forms of treatment. RCTs of nonphysical contact biofield therapies have the potential to contribute to an evidence base for health-promoting effects mediated through mechanisms outside the present understanding of biomedicine. METHODS: Articles meeting inclusion criteria were identified from database and reference list searches and evaluated for a range of reporting and design items. Data were extracted to determine the range of protocol parameters and treatment outcomes. The final set of included RCTs were evaluated via a modified 5-item Jadad scale as well as by a set of 20 criteria that included items relevant to the early-phase nature of the trials and to the examination of nonphysical touch biofield therapy interventions. RESULTS: Of 90 RCTs that assessed effectiveness of a biofield therapy in humans, 28 trials involving 1775 participants met additional inclusion criteria (most importantly a clearly reported use of only nonphysical contact treatment). The research designs of these 28 trials revealed marked heterogeneity in regard to condition treated, number and duration of treatments, nature of the control/comparison group, and outcome measures. Finally, 10 trials were excluded on the basis of low quality assessment scores. Twelve of the remaining 18 trials (7 Therapeutic Touch, 3 external qigong, 1 Reiki, and 1 Healing Touch) reported at least one primary outcome with statistically significant beneficial treatment outcomes. CONCLUSIONS: The pilot study nature of essentially all the identified nonphysical contact biofield therapy RCTs, as reflected by low sample sizes alone, precludes drawing robust conclusions. Given this perspective, the finding that two thirds of the higher-scoring trials demonstrated at least partial effectiveness favors a continued research effort, especially in light of the translational value of biofield clinical trials for studies exploring the nature and physiologic basis of biofield healing.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.

BACKGROUND: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. METHODS: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. RESULTS: Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. CONCLUSION: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.

Activating lay health influencers to promote tobacco cessation.

OBJECTIVE: To evaluate the effect of tobacco cessation brief-intervention (BI) training for lay "health influencers," on knowledge, self-efficacy and the proportion of participants reporting BI delivery post-training. METHODS: Randomized, community-based study comparing In-person or Web-based training, with mailed materials. RESULTS: In-person and Web-training groups had significant post-training cessation knowledge and self-efficacy gains. All groups increased the proportion of individuals reporting BIs at follow-up, with no significant between-group differences. Irrespective of participants' prior intervention experience, 80%-86% reported BIs within the past 90 days; 71%-79% reported >1 in the past 30. CONCLUSIONS: Web and In-person training significantly increase health influencer cessation knowledge and self-efficacy. With minimal prompting and materials, even persons without BI experience can be activated to encourage tobacco cessation.

Families United/Familias Unidas: family group office visits to reduce risk factors for type 2 diabetes.

PURPOSE: The purpose of the Families United/Familias Unidas study was to evaluate the feasibility and efficacy of group office visits on reducing diabetes risk in a multiethnic, primary care population. METHODS: Adults, ages 18 to 70 years, with any diabetes risk factor were recruited to attend 12 group office visits over 6 months. Each participant identified 1 support person, age 14 to 70 years, to accompany them. Data were collected at baseline, postintervention, 6 months, and 12 months. Primary outcome measures were reduction in the total number of predefined, modifiable risk factors (ie, body mass index ≥25 kg/m(2); waist circumference ≥88 cm [women], ≥102 cm [men]; blood pressure ≥140/90 mm Hg; hemoglobin A1C ≥5.7%; fasting insulin ≥15 µU/mL; glycemic index ≥52.5% [women], ≥53.4% [men]; and physical activity <150 min/wk). RESULTS: Thirty-nine participants/supporters completed the intervention (mean age 47.8 ± 12.3 years, 69.2% female, 61.5% white, 35.9% Latino). Risk reduction analysis included only participants/supporters who remained paired at the intervention's end (n = 36). At baseline, primary participants (n = 18) had an average of 4.8 ± 1.6 (standard error) predefined risk factors; supporters (n = 18), 4.1 ± 1.4. Primary participants' risk factors decreased approximately 15% immediately after the 6-month intervention (absolute reduction of 1.1 risk factors) and increased to ~20% reduction 1 year postintervention (absolute reduction of 1.4 risk factors). Risk reduction was primarily due to decreases in dietary glycemic index and fasting insulin levels. CONCLUSIONS: Group visits provide an innovative and potentially efficacious model of diabetes prevention in multiethnic patients with heterogeneous risk factors.

Description of a clinical stream of back-pain patients based on electronic medical records.

Back pain consists of a spectrum of conditions, with no common etiology and therefore no dominant method of treatment. The purpose of this study is to describe the complexity of a collection of 8000 back pain patients who appeared in an integrative medicine clinic, as a prelude to conducing comparative effectiveness research on CAM alternatives to conventional therapy. Approximately 23% of all clinic patients were diagnosed at some time with back pain. Nearly half had treatment periods of less than one month, while more than 25% were treated for back pain for more than two years. Women were represented more than twice as often as men. The initial diagnosis categories that occurred most frequently were lumbar symptoms, cervical symptoms, and a general category, with smaller numbers having lumbar anatomic, thoracic symptom, brachial neuritis, or sciatica diagnoses. There were few strong relationships between initial diagnosis pattern and length of back pain treatment period. While 77% of back pain patients presented with diagnoses in only a single category, there were many composite categories each of which was sparsely represented. Between 50% and 75% of patients used some CAM service, depending on their initial diagnosis pattern. Patients with complex initial diagnosis patterns strongly tended to chose CAM, and among CAM-users those with complex diagnoses tended toward chiropractic, as opposed to acupuncture or bodywork. The CAM usage patterns of men and women were highly similar. Again among CAM users, 82% used only a single type of CAM service, and multiple service uses tend to be combined at random. Between two-thirds and three-quarters of multiple CAM service users had very simple temporal patterns of use, dominated by use of one type of CAM at a time.

Intervention in overweight children improves body mass index (BMI) and physical activity.

BACKGROUND: Childhood obesity is a growing epidemic in family medicine with few clinical treatment options. We implemented and evaluated a group office-visit intervention by family physicians for overweight children and their parents, emphasizing nutrition and physical activity within a resiliency psychosocial model. METHODS: The intervention lasted for 3 months, with half of the children crossing over to intervention after 6 months in the study. Participants included 35 children who met eligibility criteria of being in third through fifth grades and having a body mass index (BMI) above the 85th percentile. The 3-month, 12-session intervention, "Choices," included topics on nutrition, physical activity, and resiliency. The sessions were developed for delivery by a family physician and a nutritionist who received training in positive psychology and resilience skills. Main outcome measures were BMI z scores for age and sex and z scores for weight by age and sex, as well as qualitative interviews to understand individual and family processes. RESULTS: The intervention resulted in a significant effect on one primary outcome, BMI z score (-0.138 per 9 months [P = .017]) and a trend toward significance on the weight for age z score (-0.87 per 9 months [P = .09]). The net shift of activity from the low metabolic equivalents (METs) to the high METs had an intervention effect of 2.84 METs (P = .037). Families reported lasting changes in behaviors and attitudes. DISCUSSION: The innovative approach used in this study demonstrated modest efficacy in reducing BMI z score, changing physical activity levels, and possibly shifting family dynamics.

Commentary on Mathie RT et al. Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study.

Although many researchers agree that applying conventional drug-trial quality criteria to CAM studies lacks plausibility, few take on the burden of devising alternative criteria in a specific area of CAM. This commentary points out strengths and weaknesses in the approach taken in the work of Mathie and colleagues to do this for homeopathy.

From medical records to clinical science.

Medical records contain an abundance of information, very little of which is extracted and put to clinical use. Increasing the flow of information from medical records to clinical practice requires methods of analysis that are appropriate for large nonintervention studies. The purpose of this article is to explain in nontechnical language what these methods are, how they differ from conventional statistical analyses, and why the latter are generally inappropriate. This is important because of the current volume of nonintervention study analyses that either use incorrect methods or misuse correct methods. A set of guidelines is suggested for use in nonintervention clinical research.

Analysis of nonintervention studies: technical supplement.

Methods for analyzing data in nonintervention clinical studies are substantially different from those that are appropriate for randomized clinical trials. Although the latter methods are well known, the former are not. A systematic approach for dealing with statistical confounding in nonintervention research has been developed over the past 30 to 40 years, and the essence of this theory constitutes the contents of this article. An accompanying, less technical article explains the implications of these results for clinical research.

Comparative effectiveness of traditional Chinese medicine and psychosocial care in the treatment of temporomandibular disorders-associated chronic facial pain.

UNLABELLED: This dual-site study sought to identify the appropriate role for traditional Chinese medicine (TCM; acupuncture and herbs) in conjunction with a validated psychosocial self-care (SC) intervention for treating chronic temporomandibular disorders (TMD)-associated pain. Participants with Research Diagnostic Criteria for Temporomandibular Disorders-confirmed TMD (n = 168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, and current pain; each visual analog scale [VAS] 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety. TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, -.60 [standard deviation of the estimate .26], P = .020) and greater reduction in interference with social activities (-.81 [standard deviation of the estimate .33], P = .016). In 2 of 5 treatment trajectory groups, more than two thirds of participants demonstrated clinically meaningful responses (≥30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167). PERSPECTIVE: This short-term comparative effectiveness study of chronic facial pain suggests that TCM is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.

Families United/Familias Unidas: development and implementation of a family-based group office visit model for the primary prevention of type 2 diabetes.

PURPOSE: The purpose of this study is to describe the development and implementation of a new diabetes prevention intervention that combines the benefits of family support with the group office model. Intensive lifestyle modification can effectively delay the onset of type 2 diabetes, yet health providers are challenged in translating these results to their patients. The group outpatient visit model can provide a means to address prevention issues in a financially sustainable manner. METHODS: Materials from the Diabetes Prevention Program and a previously developed group office visit program were combined to create the Families United/Familias Unidas curriculum. The session content utilized a multiculturally tailored approach designed to help participants decrease portion size, decrease carbohydrate intake, increase physical activity, and increase resiliency. Adults aged 18 to 70 were recruited who had any diabetes risk factors but did not have diabetes. Eligible participants enlisted a support person, aged 14 to 70, to join them in the 6-month group office visit intervention. RESULTS: Twenty-nine pairs (n = 58) of primary participants plus support persons were recruited. Participants' average age was 45; 74% were female; 56.9% identified themselves as white and 37.9% as Hispanic/Latino. Over one-third had 4 or more diabetes risk factors. Twelve family group office visits were delivered over 6 months. The attendance rate for those who attended at least one session was 72%. CONCLUSIONS: Group office visits can provide a new sustainable model for diabetes prevention and are a natural fit for primary care physicians in collaboration with other health care professionals, such as dieticians or diabetes educators.

Reductions in pain medication use associated with traditional Chinese medicine for chronic pain.

CONTEXT: Participants in a randomized trial of traditional Chinese medicine (TCM) for temporomandibular joint dysfunction (TMD) had a linear decline in pain over 16 TCM visits. OBJECTIVE: To investigate whether reductions in pain among participants receiving TCM can be explained by increased use of pain medications, or whether use of pain medications also declined in this group. DESIGN: One hundred sixty-eight participants with TMD were treated with TCM or enhanced self-care according to a stepped-care design. Those for whom self-care failed were sequentially randomized to further self-care or TCM. This report includes 111 participants during their first 16 TCM visits. The initial 8 visits occurred more than once a week; participants and practitioners determined the frequency of subsequent visits. OUTCOME MEASURES: Average pain (visual analog scale, range 0-10) and morphine and aspirin dose equivalents. RESULTS: The sample was 87% women and the average age was 44 ± 13 years. Average pain of narcotics users (n = 21) improved by 2.73 units over 16 visits (p < 0.001). Overall narcotics use trended downward until visit 11 (-3.27 doses/week, p = 0.156), and then trended upward until week 16 (+4.29 doses/week, p = 0.264). Among those using narcotics, use of nonsteroidal anti-inflammatory drugs (NSAIDs) declined linearly over visits 1-16 (-1.94 doses/week, p = 0.002).Among the top quartile of NSAID-only users (n = 22), average pain decreased linearly over 16 visits (-1.52 units, p = 0.036). Overall NSAID doses/week declined between visits 1 and 7 (-9.95 doses/week, p < 0.001) and then remained stable through 16 visits. NSAID use also declined among the third quartile (n = 23) and remained low and stable among the lower half (sorted by total intake) of NSAID users. CONCLUSIONS: Among the heaviest NSAID users, we observed a short-term reduction in NSAID use that was sustained as TCM visits became less frequent. There was no indication that pain reduction during TCM treatment was influenced by drug use.

Effectiveness Guidance Document (EGD) for acupuncture research - a consensus document for conducting trials.

BACKGROUND: There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. METHODS: Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. RESULTS: Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. CONCLUSION: The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

A community-based intervention to prevent obesity beginning at birth among American Indian children: study design and rationale for the PTOTS study.

Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that American Indian (AI) children have higher rates of overweight and obesity than children of other races/ethnicities. The Prevention of Toddler Obesity and Teeth Health Study (PTOTS) is a community-partnered randomized controlled trial designed to prevent obesity beginning at birth in AI children. PTOTS was developed to test the effectiveness of a multi-component intervention designed to: promote breastfeeding, reduce sugar-sweetened beverage consumption, appropriately time the introduction of healthy solid foods, and counsel parents to reduce sedentary lifestyles in their children. A birth cohort of 577 children from five AI tribes is randomized by tribe to either the intervention (three tribes) or the comparison condition (two tribes). The strengths and weaknesses of PTOTS include a focus on a critical growth phase, placement in the community, and intervention at many levels, using a variety of approaches.

Nonlinear dynamical systems effects of homeopathic remedies on multiscale entropy and correlation dimension of slow wave sleep EEG in young adults with histories of coffee-induced insomnia.

BACKGROUND: Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG. METHODS: Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stages 3 and 4 slow wave sleep EEG sampled in artifact-free 2-min segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects. RESULTS: MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings. CONCLUSIONS: Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns.

Acupuncture and chiropractic care for chronic pain in an integrated health plan: a mixed methods study.

BACKGROUND: Substantial recent research examines the efficacy of many types of complementary and alternative (CAM) therapies. However, outcomes associated with the "real-world" use of CAM has been largely overlooked, despite calls for CAM therapies to be studied in the manner in which they are practiced. Americans seek CAM treatments far more often for chronic musculoskeletal pain (CMP) than for any other condition. Among CAM treatments for CMP, acupuncture and chiropractic (A/C) care are among those with the highest acceptance by physician groups and the best evidence to support their use. Further, recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy--suggests the need to evaluate real world outcomes associated with promising non-pharmacological/non-surgical CAM treatments for CMP, which are often well accepted by patients and increasingly used in the community. METHODS/DESIGN: This multi-phase, mixed methods study will: (1) conduct a retrospective study using information from electronic medical records (EMRs) of a large HMO to identify unique clusters of patients with CMP (e.g., those with differing demographics, histories of pain condition, use of allopathic and CAM health services, and comorbidity profiles) that may be associated with different propensities for A/C utilization and/or differential outcomes associated with such care; (2) use qualitative interviews to explore allopathic providers' recommendations for A/C and patients' decisions to pursue and retain CAM care; and (3) prospectively evaluate health services/costs and broader clinical and functional outcomes associated with the receipt of A/C relative to carefully matched comparison participants receiving traditional CMP services. Sensitivity analyses will compare methods relying solely on EMR-derived data versus analyses supplementing EMR data with conventionally collected patient and clinician data. DISCUSSION: Successful completion of these aggregate aims will provide an evaluation of outcomes associated with the real-world use of A/C services. The trio of retrospective, qualitative, and prospective study will also provide a clearer understanding of the decision-making processes behind the use of A/C for CMP and a transportable methodology that can be applied to other health care settings, CAM treatments, and clinical populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01345409.

Reliability of AcuGraph system for measuring skin conductance at acupoints.

OBJECTIVE: There are many commercially available instruments for measuring electrical conductance, but there is little information about their reliability. The aim of this study was to quantify measurement variability and assess reliability of the AcuGraph system-a commonly used electrodermal screening device. METHODS: Four experiments were conducted to measure variability in electrical conductance readings obtained by the AcuGraph system. The first involved measuring known resistors. The second measured non-human organic matter. The third was a test-retest assessment of the Yuan-Source and Jing-Well points in 30 healthy volunteers who were measured by a single operator. The fourth was an interoperator reliability evaluation of seven acupuncturists at the Yuan-Source and Jing-Well acupoints on four individuals at two time points. RESULTS: Against known resistors, the AcuGraph had an average coefficient of variability (CV) of 1.8% between operators and test-retests. On non-human organic material the AcuGraph had an average CV of 0.9% and 2.8%. When a single operator tested 30 participants, the average reliability for the Yuan-Source points was 0.86 and 0.76 for Jing-Well points with a CV of 23.2% and 25.9% respectively. The average CV for the seven acupuncturists was 24.5% on Yuan-Source points and 23.7% on Jing-Well points. CONCLUSIONS: The AcuGraph measures known resistors and organic matter accurately and reliably. Skin conductance at acupoints recorded by one operator was also reliable. There was less consistency in electrodermal recordings obtained by seven different operators. Operator training and technical improvements to the AcuGraph may improve consistency among operators.

Occurrence and co-occurrence of types of complementary and alternative medicine use by age, gender, ethnicity, and education among adults in the United States: the 2002 National Health Interview Survey (NHIS).

BACKGROUND: There are widespread assumptions that a large proportion of American adults use a variety of complementary and alternative medicine (CAM) therapies. The goal of this study is to explore the clustering or linkages among CAM categories in the general population. Linkset analysis and data from the 2002 National Health Interview Survey (NHIS) were used to address two specific aims. First, the dominant linkages of CAM categories used by the same individual were delineated, and population estimates were generated of the percentage of American adults using different linksets of CAM categories. Second, it was determined whether dominant linkages of CAM modalities differ by age, gender, ethnicity, and education. METHODS: Linkset analysis, a method of estimating co-occurrence beyond chance, was used on data from the 2002 NHIS (N = 29,862) to identify possible sets of CAM use. RESULTS: Most adults use CAM therapies from a single category. Approximately 20% of adults combined two CAM categories, with the combination of mind-body therapies and biologically based therapies estimated to be most common. Only 5% of adults use therapies representing three or more CAM categories. Combining therapies across multiple CAM categories was more common among those 46-64, women, whites, and those with a college education. CONCLUSIONS: The results of this study allow researchers to refine descriptions of CAM use in the adult population. Most adults do not use a wide assortment of CAM; most use therapies within a single CAM category. Sets of CAM use were found to differ by age, gender, ethnicity, and education in ways consistent with previous research.