Health and Wellness Coaching and Sustained Gains: A Rapid Systematic Review.

The Transtheoretical Model of Change identifies key stages in behavior change, including a maintenance stage occurring when a behavior has been upheld for at least 6 months. Health and wellness coaching has demonstrated support for health behavior change, but maintenance of gains has received little attention. Our rapid systematic literature review characterizes both the research exploring sustained gains with health and wellness coaching and what is known about sustained gains after the completion of a health and wellness coaching engagement. Guided by The Cochrane Rapid Reviews Methods Group "Interim Guidance," we drew 231 studies from the 2018 and 2020 Sforzo et al "Compendium of the health and wellness coaching literature," and "Addendum…" appendices. Initial screening and coding for inclusion and exclusion criteria yielded 28 studies for data extraction. We examined studies across outcome categories (physiological, behavioral, psychological, and health risk assessment) to determine whether outcome measures were: not sustained; partially sustained; fully sustained; or improved from immediate post-intervention to a later follow-up period. Twenty-five of the 28 studies reviewed demonstrated partially, or fully, sustained or improved outcomes in one or more variables studied, with sustained gains demonstrated across outcome categories, strengthening confidence in HWC as a facilitator of lasting change.

Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.

BACKGROUND & AIMS: Many of the reported adverse events in clinical trials of irritable bowel syndrome are extraintestinal symptoms, which typically are assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment. METHODS: The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome. Participants were randomized to receive double-blind peppermint oil, double-blind placebo, or treatment as usual. Extraintestinal symptoms were assessed at baseline and at the end of the study. RESULTS: This analysis included 173 participants (30 received double-blind peppermint oil, 72 received treatment as usual, and 71 received double-blind placebo). At baseline, each group reported approximately 5 extraintestinal symptoms per participant. The number of symptoms per participant decreased to an average of 3 by the end-of-study visit, and this change was statistically significant in all groups (P < .001 for each group). When evaluating individual extraintestinal symptoms, the majority of participants did not report new/worse symptoms. In fact, between the baseline assessment and the final assessment, the average symptom severity decreased significantly in all 3 groups (P < .001). CONCLUSIONS: Our study suggests that participants with irritable bowel syndrome often experience extraintestinal symptoms at baseline and that these symptoms generally improve in severity over the course of a clinical trial, regardless of the treatment arm. Systematic assessment of extraintestinal symptoms at the beginning of a clinical trial is necessary to determine more definitively whether these symptoms may be considered an adverse event attributable to a study medication.

Patients' experiences treated with open-label placebo versus double-blind placebo: a mixed methods qualitative study.

BACKGROUND: There is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients' experiences with OLP, and no studies have directly compared patients' experiences in double-blind placebo (DBP) conditions. METHODS: This study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS). We randomly selected 33 participants for interviews concerning their experiences in the parent trial. The data were qualitatively analyzed using an iterative immersion/crystallization approach. We then compared the qualitative interview data to the quantitative IBS severity data assessed during the parent trial, using a mixed methods approach. RESULTS: Two prominent interview themes were identified: (1) the participants' feelings about their treatment allocation and (2) their reflections about the treatment. Both OLP and DBP participants mentioned hope and curiosity as major feelings driving them to engage with their treatment. However, while DBP participants tended to be more enthusiastic about their allocation, OLP participants were more ambivalent. Furthermore, OLP participants reflected more on their treatment, often involving noticeable cognitive and emotional processes of self-reflection. They offered a variety of explanations for their symptom improvement and were significantly less likely to attribute it to the treatment itself than DBP participants (Χ2 [3] = 8.28; p = .041). Similarly, the participants' retrospective narratives of symptom improvement were significantly correlated with their corresponding quantitative IBS severity scores only in DBP (p's ≤ .006) but not in OLP (p's ≥ .637). CONCLUSION: OLP and DBP participants share feelings of hope, uncertainty and curiosity but differ in the extent of conscious reflection. The counter-intuitive OLP prompts more self-examination, ambivalent feelings and active engagement compared to DBP. At the same time, OLP participants are more reluctant to attribute symptom improvement to their treatment. Our findings substantially add to the emerging picture of factors that distinguish OLP and DBP and their potential mechanisms.

SEAttle-based Research of Chinese Herbs for COVID-19 Study: A Whole Health Perspective on Chinese Herbal Medicine for Symptoms that may be Related to COVID-19.

INTRODUCTION: East Asian Medicine (EAM) is a Whole System medicine that includes Chinese herbal medicine (CHM). Chinese herbal medicine has been utilized to reduce symptom burden in infectious disease, with notable theoretical reformulations during pandemics of the 3rd, 13th, and 17th centuries. Today, Licensed Acupuncturists trained in CHM have utilized it to treat symptoms and sequelae of COVID-19. However, little is known about its use or efficacy by the public and health practitioners. Understanding and evaluating whole medicine systems of healthcare is inherently complex; there is international consensus for a descriptive, pragmatic approach. We are conducting a feasibility pilot study using a prospective, pragmatic, observational design using Whole Health and Whole Person perspectives. The complexity of COVID-19 reflects the impact on multiple homeoregulatory systems and provides a unique opportunity to assess the impact of interventions such as EAM on whole health. Observation of these EAM encounters will provide valuable qualitative and quantitative data on the interface of an extant Whole System medicine with a novel complex illness as a precursor to a randomized clinical trial. METHODS: This ongoing study observes a CHM clinic offering telehealth consultations to a diverse patient population since April, 2020. Patients who report symptoms potentially related to COVID-19 disease are consented for standardized collection and analysis of demographic and clinical data from each clinical encounter. RESULTS: To date, 61 patients engaged in 195 consultations (mean 3.3) with 49 reporting symptom resolution sufficient to complete treatment, and 4 withdrawals. Just over half (62%) were female, with an average age of 45.7 years. A wide variety of CHM formulas and EAM dietary and lifestyle modifications were provided. DISCUSSION: Adequate recruitment and retention suggest feasibility of the intervention and data collection. The rich dataset may facilitate the construction of Whole Health models of CHM's clinical impact, as well as integrative inquiry into CHM's effects on symptoms.

Diagnosis of Gulf War Illness Using Laser-Induced Spectra Acquired from Blood Samples.

Gulf War illness (GWI) is a chronic illness with no known validated biomarkers that affects the lives of hundreds of thousands of people. As a result, there is an urgent need for the development of an untargeted and unbiased method to distinguish GWI patients from non-GWI patients. We report on the application of laser-induced breakdown spectroscopy (LIBS) to distinguish blood plasma samples from a group of subjects with GWI and from subjects with chronic low back pain as controls. We initially obtained LIBS data from blood plasma samples of four GWI patients and four non-GWI patients. We used an analytical method based on taking the difference between a mean LIBS spectrum obtained with those of GWI patients from the mean LIBS spectrum of those of the control group, to generate a "difference" spectrum for our classification model. This model was cross-validated using different numbers of differential LIBS emission peaks. A subset of 17 of the 82 atomic and ionic transitions that provided 70% of correct diagnosis was selected test in a blinded fashion using 10 additional samples and was found to yield 90% classification accuracy, 100% sensitivity, and 83.3% specificity. Of the 17 atomic and ionic transitions, eight could be assigned unambiguously to species of Na, K, and Fe.

Intuitive eating buffers the link between internalized weight stigma and body mass index in stressed adults.

Internalized weight stigma (IWS) is independently associated with less intuitive eating (i.e., eating based on endogenous hunger/satiety cues) and higher Body Mass Index (BMI), and intuitive eating training is commonly conceptualized as protective against the effects of IWS on poor behavioral health. The 3-way relationship between IWS, intuitive eating, and BMI has yet to be examined, and it is unclear whether the link between IWS and BMI is buffered by high intuitive eating. This secondary preliminary analysis examined baseline data of stressed adults with poor diet (N = 75, 70% female, 64.1% White, 42.7% with overweight/obesity) in a parent clinical trial that tested the effects of yoga on diet and stress. Validated self-report surveys of IWS and intuitive eating were analyzed with objectively-assessed BMI. Moderated regression analyses using the SPSS PROCESS macro tested whether intuitive eating moderated the IWS-BMI link. The analysis revealed IWS was positively associated with BMI except among people with high intuitive eating. Results extend observational findings linking intuitive eating to lower BMI, and offer preliminary support for the hypothesis that this link may hold even among those with greater IWS. It's possible that individuals with lower BMI and greater IWS may gravitate more towards intuitive eating than those with greater BMI, and/or intuitive eating may be an important target for ameliorating the adverse association of IWS with behavioral and physical health indicators linked to BMI. Continued work is warranted in larger, more generalizable samples using causal and prospective designs.

Internalized weight stigma and intuitive eating among stressed adults during a mindful yoga intervention: associations with changes in mindfulness and self-compassion.

PURPOSE: Internalized weight stigma (IWS) is common in the United States of America across body weight categories, and is implicated in the development of distress and unhealthy eating behaviors (e.g. overeating, disordered eating) that can foster poor cardiometabolic health. While emerging intervention research shows early promise in reducing IWS, long-term efficacy is unclear and novel strategies remain needed. This analysis examined whether participation in a mindful yoga intervention was associated with reduced IWS and increased intuitive eating, an adaptive eating behavior, and whether these changes correlated with each other or with changes in mindfulness and self-compassion. METHODS: Participants were stressed adults with low fruit and vegetable intake (N = 78, 64.1% White, M. Body Mass Index 25.59 ± 4.45) enrolled in a parent clinical trial of a 12-week mindful yoga intervention. Validated self-report measures of IWS, intuitive eating, mindfulness, and self-compassion were administered at pre-treatment, mid-treatment (8 weeks), post-treatment (12 weeks), and 4-month follow-up (24 weeks). RESULTS: Linear mixed modeling revealed significant improvements in IWS and intuitive eating across the four timepoints (p < .001). Reduced IWS correlated with increased intuitive eating pre- to post-treatment (p = .01). Improved self-compassion and mindfulness correlated with intuitive eating (both p = . 04), but not IWS (p = .74 and p = .56, respectively). CONCLUSION: This study offers preliminary support for the hypothesis that mindful yoga may promote intuitive eating and reduce IWS among stressed adults with poor diet, and suggests that changes in these factors may co-occur over time. Further investigation with controlled designs is necessary to better understand the temporality and causality of these relationships.Trial registration: ClinicalTrials.gov identifier: NCT02098018.

Latent Factor Decomposition Model: Applications for Questionnaire Data.

The analysis of clinical questionnaire data comes with many inherent challenges. These challenges include the handling of data with missing fields, as well as the overall interpretation of a dataset with many fields of different scales and forms. While numerous methods have been developed to address these challenges, they are often not robust, statistically sound, or easily interpretable. Here, we propose a latent factor modeling framework that extends the principal component analysis for both categorical and quantitative data with missing elements. The model simultaneously provides the principal components (basis) and each patients' projections on these bases in a latent space. We show an application of our modeling framework through Irritable Bowel Syndrome (IBS) symptoms, where we find correlations between these projections and other standardized patient symptom scales. This latent factor model can be easily applied to different clinical questionnaire datasets for clustering analysis and interpretable inference.

Yoga participation associated with changes in dietary patterns and stress: A pilot study in stressed adults with poor diet.

BACKGROUND AND PURPOSE: Stress contributes to dietary patterns that impede health. Yoga is an integrative stress management approach associated with improved dietary patterns in burgeoning research. Yet, no research has examined change in dietary patterns, body mass index (BMI), and stress during a yoga intervention among stressed adults with poor diet. MATERIALS AND METHODS: Objectively-measured BMI and a battery of self-report questionnaires were collected at four time points during and following a 12-week yoga intervention (N = 78, 71% women, mean BMI = 25.69 kg/m2±4.59) - pre-treatment (T1), mid-treatment (6 weeks; T2), post-treatment (12 weeks; T3), and at 3-month follow-up (24 weeks; T4). RESULTS: T1 to T3 fruit and vegetable intake, BMI, and stress significantly declined in the overall sample. Reduction in vegetable intake was no longer significant after accounting for reductions in caloric intake, and reduction in caloric intake remained significant after accounting for reductions in stress. CONCLUSION: Findings may be interpreted as yoga either encouraging or adversely impacting healthy dietary patterns (i.e., minimizing likelihood of future weight gain vs. decreasing vegetable intake and overall caloric intake among individuals who may not need to lose weight, respectively). Continued research is warranted, utilizing causal designs.

Sex-Based Differences in Plasma Autoantibodies to Central Nervous System Proteins in Gulf War Veterans versus Healthy and Symptomatic Controls.

Veterans from the 1991 Gulf War (GW) have suffered from Gulf War illness (GWI) for nearly 30 years. This illness encompasses multiple body systems, including the central nervous system (CNS). Diagnosis and treatment of GWI is difficult because there has not been an objective diagnostic biomarker. Recently, we reported on a newly developed blood biomarker that discriminates GWI from GW healthy controls, and symptomatic controls with irritable bowel syndrome (IBS) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The present study was designed to compare levels of these biomarkers between men and women with GWI, as well as sex-specific effects in comparison to healthy GW veterans and symptomatic controls (IBS, ME/CFS). The results showed that men and women with GWI differ in 2 of 10 plasma autoantibodies, with men showing significantly elevated levels. Men and women with GWI showed significantly different levels of autoantibodies in 8 of 10 biomarkers to neuronal and glial proteins in plasma relative to controls. In summary, the present study addressed the utility of the use of plasma autoantibodies for CNS proteins to distinguish among both men and women veterans with GWI and other healthy and symptomatic control groups.

Using Plasma Autoantibodies of Central Nervous System Proteins to Distinguish Veterans with Gulf War Illness from Healthy and Symptomatic Controls.

For the past 30 years, there has been a lack of objective tools for diagnosing Gulf War Illness (GWI), which is largely characterized by central nervous system (CNS) symptoms emerging from 1991 Gulf War (GW) veterans. In a recent preliminary study, we reported the presence of autoantibodies against CNS proteins in the blood of veterans with GWI, suggesting a potential objective biomarker for the disorder. Now, we report the results of a larger, confirmatory study of these objective biomarkers in 171 veterans with GWI compared to 60 healthy GW veteran controls and 85 symptomatic civilian controls (n = 50 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and n = 35 irritable bowel syndrome (IBS)). Specifically, we compared plasma markers of CNS autoantibodies for diagnostic characteristics of the four groups (GWI, GW controls, ME/CFS, IBS). For veterans with GWI, the results showed statistically increased levels of nine of the ten autoantibodies against neuronal "tubulin, neurofilament protein (NFP), Microtubule Associated Protein-2 (MAP-2), Microtubule Associated Protein-Tau (Tau), alpha synuclein (α-syn), calcium calmodulin kinase II (CaMKII)" and glial proteins "Glial Fibrillary Acidic Protein (GFAP), Myelin Associated Glycoprotein (MAG), Myelin Basic Protein (MBP), S100B" compared to healthy GW controls as well as civilians with ME/CFS and IBS. Next, we summed all of the means of the CNS autoantibodies for each group into a new index score called the Neurodegeneration Index (NDI). The NDI was calculated for each tested group and showed veterans with GWI had statistically significantly higher NDI values than all three control groups. The present study confirmed the utility of the use of plasma autoantibodies for CNS proteins to distinguish among veterans with GWI and other healthy and symptomatic control groups.

"Honorable Toward Your Whole Self": Experiences of the Body in Fatigued Breast Cancer Survivors.

INTRODUCTION: Cancer Related Fatigue (CRF) is one of the most common and detrimental side effects of cancer treatment. Despite its increasing prevalence and severity CRF remains dismissed by the majority of clinicians. One reason for the apparent gap between clinical need and clinical undertaking is the penchant toward reductionist accounts of the disorder: a tendency to discount the interface between the lived experience of sufferers and the multi-dimensional etiology of CRF as it manifests adversely on a day-to-day basis. METHODS: In order to better understand the interplay between social, bodily, and emotional components of the disorder we undertook semi-structured interviews with thirteen Breast Cancer survivors suffering from CRF, and then subsequently analyzed their responses using Team Based Qualitative Analysis. RESULTS: Our analysis revealed multiple dimensions of the social and bodily underpinnings of fatigue. Most relevantly we found a consistent change in the level and quality of attention to bodily signals. This shift in awareness appeared to be directly connected to the experience of CRF and a newfound, "respect," for the needs of the body. Furthermore, we found that many of the practices that were described as helpful in alleviating fatigue were oriented around eliciting a sense of embodied awareness, examples being: dance, yoga, and shamanic ritual. This relationship with bodily sensations existed in conjunction with the anxiety and trauma that arose as a result of cancer treatment. CONCLUSION: Our analysis suggests that the quality of awareness and relationship to bodily experience in CRF is a functionally relevant component of the disorder and should be considered as an experiential target moving forward.

Efficacy of medium chain triglyceride oil dietary supplementation in reducing seizure frequency in dogs with idiopathic epilepsy without cluster seizures: a non-blinded, prospective clinical trial.

BACKGROUND: Despite appropriate antiseizure drug (ASD) treatment, around two-thirds of dogs with idiopathic epilepsy (IE) have seizures long-term and 20-30per cent of affected dogs remain poorly controlled. METHODS: The current study aim is to test in a field trial the efficacy and tolerability of a commercially available diet enriched with 6.5per cent medium chain triglyceride (MCT) oil in dogs (n=21) with at least a tier 1 idiopathic epilepsy diagnosis, without cluster seizures, in 10 veterinary practices across Europe. Each dog's quality of life (QoL), ataxia, sedation and frequency and severity of seizures were recorded by owners throughout the study. RESULTS: The mean seizure frequency per month, averaged over the entire 84-day study, significantly (P=0.04) decreased 32per cent compared with the baseline monthly seizure frequency recorded during the month immediately before feeding the diet. Similarly, the seizure days rate (days/month) also declined (P<0.001) by 42per cent. QoL was reported as very good to excellent (>8.5/10) in 20 of the 21 dogs before starting the diet and this remained unchanged during the trial. CONCLUSIONS: This study demonstrates the use of a diet enriched with MCTs as an adjunct to ASD treatment may have some antiseizure properties for dogs diagnosed with IE, as demonstrated in previous studies.

In-vivo imaging of neuroinflammation in veterans with Gulf War illness.

Gulf War Illness (GWI) is a chronic disorder affecting approximately 30% of the veterans who served in the 1991 Gulf War. It is characterised by a constellation of symptoms including musculoskeletal pain, cognitive problems and fatigue. The cause of GWI is not definitively known but exposure to neurotoxicants, the prophylactic use of pyridostigmine bromide (PB) pills, and/or stressors during deployment have all been suspected to play some pathogenic role. Recent animal models of GWI have suggested that neuroinflammatory mechanisms may be implicated, including a dysregulated activation of microglia and astrocytes. However, neuroinflammation has not previously been directly observed in veterans with GWI. To measure GWI-related neuroinflammation in GW veterans, we conducted a Positron Emission Tomography (PET) study using [11C]PBR28, which binds to the 18 kDa translocator protein (TSPO), a protein upregulated in activated microglia/macrophages and astrocytes. Veterans with GWI (n = 15) and healthy controls (HC, n = 33, including a subgroup of healthy GW veterans, HCVET, n = 8), were examined using integrated [11C]PBR28 PET/MRI. Standardized uptake values normalized by occipital cortex signal (SUVR) were compared across groups and against clinical variables and circulating inflammatory cytokines (TNF-α, IL-6 and IL-1ß). SUVR were validated against volume of distribution ratio (n = 13). Whether compared to the whole HC group, or only the HCVET subgroup, veterans with GWI demonstrated widespread cortical elevations in [11C]PBR28 PET signal, in areas including precuneus, prefrontal, primary motor and somatosensory cortices. There were no significant group differences in the plasma levels of the inflammatory cytokines evaluated. There were also no significant correlations between [11C]PBR28 PET signal and clinical variables or circulating inflammatory cytokines. Our study provides the first direct evidence of brain upregulation of the neuroinflammatory marker TSPO in veterans with GWI and supports the exploration of neuroinflammation as a therapeutic target for this disorder.

Tai Chi for heart attack survivors: qualitative insights.

OBJECTIVES: Cardiac rehabilitation (CR) programmes are standard of care for patients following a coronary event. While such exercise-based secondary prevention programme do offer benefits, they are used by less than 30% of eligible patients and attrition within these programmes is high. This project is a nested qualitative assessment of a pilot programme considering Tai Chi (TC) as an alternative to CR. We hypothesised that TC may overcome several key barriers to CR. METHODS: A semistructured focus group agenda was used to assess three key domains of feasibility: (1) patients' experiences, (2) reasons/barriers for not having attended CR and (3) any improvements in physical activity and other secondary outcomes (quality of life, weight, sleep). A thematic analysis was used to better understand the key concepts. RESULTS: This high-risk group of patients reported that they enjoyed TC exercise, and felt confident and safe doing it. TC practice was reported to support other types of physical activity allowing for a generalisation of positive effects. DISCUSSION: This analysis is consistent with published reports of TC practice improving mood and psychological well-being. Qualitative methods allowed us to find emergent experiential reports of behaviour change factors found in established behaviour change theories.

In the Eyes of Those Who Were Randomized: Perceptions of Disadvantaged Older Adults in a Tai Chi Trial.

BACKGROUND AND OBJECTIVES: Older adults living in subsidized housing have typically been excluded from exercise intervention studies. We conducted a qualitative study to explore the perceived physical, psychological, social, and economic factors that influenced participation in and adherence to a year-long Tai Chi intervention within an ongoing cluster-randomized controlled trial (RCT) for older adults living within subsidized housing facilities. RESEARCH DESIGN AND METHODS: Focus groups were held with participants of the RCT who were allocated to the trial's Tai Chi intervention. Individual phone interviews were conducted with those allocated to Tai Chi who had low adherence or who had withdrawn their participation from the study. Emergent themes were extracted using grounded-theory methods. RESULTS: In this qualitative study, we enrolled 41 participants who were allocated to the RCT's Tai Chi intervention: 38 completed and 3 withdrew from the study. Average Tai Chi class attendance was 64.3%. Pragmatic factors that led to higher adherence and retention included: locating classes within each facility; providing programs at no cost; and deployment of a skilled research support team. In addition, the use of an accessible, simplified Tai Chi program improved confidence, social support, self-efficacy, and self-reported improvements in physical and psychological well-being. DISCUSSION AND IMPLICATIONS: Perceived physical, psychological, social benefits, and self-efficacy likely enhance adherence and retention to research-based Tai Chi interventions for older adults. Delivering an on-site, no cost, and supportive program appears critical to overcoming financial and environmental barriers to participation for those living within subsidized housing.

Can Reliability of the Chinese Medicine Diagnostic Process Be Improved? Results of a Prospective Randomized Controlled Trial.

Background: The diagnostic framework and clinical reasoning process of Chinese medicine are central to the practice of acupuncture and other related disciplines. There is growing interest in integrating it into clinical trials of acupuncture and Chinese herbal medicine to guide individualized treatment protocols and evaluate outcomes. Strategies that enhance diagnostic reliability may contribute to this integration. Objectives: (1) To evaluate inter-rater reliability among practitioners of Traditional Chinese Medicine (TCM) when assessing women with dysmenorrhea using a structured assessment questionnaire (Traditional East Asian Medicine Structure Interview [TEAMSI]-TCM) compared to using a TCM questionnaire from routine clinical practice, not developed for research purposes (CONTROL); and (2) To evaluate the impact of training in the use of each approach on reliability. Design: Thirty-eight acupuncturists were asked to complete assessments of 10 subjects based on the viewing of a videotape of the initial assessment interview, a picture of the tongue, and a description of the pulse. Acupuncturists were randomized into one of four groups comparing the use of two questionnaires, TEAMSI-TCM versus CONTROL, and comparing training in the use of each versus no training. Analysis: The authors used Cohen's kappa to estimate agreement on TCM diagnostic categories relevant to dysmenorrhea between 2 practitioners with respect to questionnaires and training over all 10 patients and all 10 TCM diagnostic categories. For all analyses, the authors estimated kappa values for questionnaire, training, and experience level. Analysis of variance was used to test agreement among various groupings. Results: Regardless of the questionnaire used or training, analysis of inter-rater reliability indicated overall agreement to be low among practitioners (median 0.26). Kappa varied slightly by questionnaire and training, among 38 practitioners, but the difference was not statistically significant (p = 0.227 and p = 0.126, respectively). Conclusions: A structured assessment interview instrument designed for research purposes with or without training did not significantly improve reliability of TCM diagnosis of dysmenorrhea compared to a commonly used instrument. Challenges in assessing reliability in TCM remain.

Experimental Studies of Inter-Rater Agreement in Traditional Chinese Medicine: A Systematic Review.

Objectives: It has been recommended that clinical trials of Traditional Chinese Medicine (TCM) would be more ecologically valid if its characteristic mode of diagnostic reasoning were integrated into their design. In that context, however, it is also widely held that demonstrating a high level of agreement on initial TCM diagnoses is necessary for the replicability that the biomedical paradigm requires for the conclusions from such trials. Our aim was to review, summarize, and critique quantitative experimental studies of inter-rater agreement in TCM, and some of their underlying assumptions. Design: Systematic electronic searches were conducted for articles that reported a quantitative measure of inter-rater agreement across a number of rating choices based on examinations of human subjects in person by TCM practitioners, and published in English language peer-reviewed journals. Publications in languages other than English were not included, nor those appearing in other than peer-reviewed journals. Predefined categories of information were extracted from full texts by two investigators working independently. Each article was scored for methodological quality. Outcome measures: Design features across all studies and levels of inter-rater agreement across studies that reported the same type of outcome statistic were compared. Results: Twenty-one articles met inclusion criteria. Fourteen assessed inter-rater agreement on TCM diagnoses, two on diagnostic signs found upon traditional TCM examination, and five on novel rating schemes derived from TCM theory and practice. Raters were students of TCM colleges or graduates of TCM training programs with 3 or more years experience and licensure. Type of outcome statistic varied. Mean rates of pairwise agreement averaged 57% (median 65, range 19-96) across the 9 studies reporting them. Mean Cohen's kappa averaged 0.34 (median 0.34, range 0.07-0.59) across the seven studies reporting them. Meta-analysis was not possible due to variations in study design and outcome statistics. High risks of bias and confounding, and deficits in statistical reporting were common. Conclusions: With a few exceptions, the levels of agreement were low to moderate. Most studies had significant deficits of both methodology and reporting. Results overall suggest a few design features that might contribute to higher levels of agreement. These should be studied further with better experimental controls and more thorough reporting of outcomes. In addition, methods of complex systems analysis should be explored to more adequately model the relationship between clinical outcomes, and the series of diagnoses and treatments that are the norm in actual TCM practice.

Matrix Analysis of Traditional Chinese Medicine Differential Diagnoses in Gulf War Illness.

Objective: To qualitatively categorize Traditional Chinese Medicine (TCM) differential diagnoses in a sample of veterans with Gulf War Illness (GWI) pre- and postacupuncture treatment. Subjects and methods: The authors randomized 104 veterans diagnosed with GWI to a 6-month acupuncture intervention that consisted of either weekly or biweekly individualized acupuncture treatments. TCM differential diagnoses were recorded at baseline and at 6 months. These TCM diagnoses were evaluated using Matrix Analysis to determine co-occurring patterns of excess, deficiency, and channel imbalances. These diagnoses were examined within and between participants to determine patterns of change and to assess stability of TCM diagnoses over time. Results: Frequencies of diagnoses of excess, deficiency, and channel patterns were tabulated. Diagnoses of excess combined with deficiency decreased from 43% at baseline to 39% of the sample at 6 months. Excess+deficiency+channel imbalances decreased from 26% to 17%, while deficiency+channel imbalances decreased from 11% to 4% over the study duration. The authors observed a trend over time of decreased numbers of individuals presenting with all three types of differential diagnosis combinations. This may suggest that fewer people were diagnosed with concurrent excess, deficiency, and channel imbalances and perhaps a lessening in the complexity of their presentation. Conclusion: This is the first published article that organizes and defines TCM differential diagnoses using Matrix Analysis; currently, there are no TCM frameworks for GWI. These findings are preliminary given the sample size and the amount of missing data at 6 months. Characterization of the TCM clinical presentation of veterans suffering from GWI may help us better understand the potential role that East Asian medicine may play in managing veterans with GWI and the design of effective acupuncture treatments based on TCM. The development of a TCM manual for treating GWI is merited.