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.

A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial.

INTRODUCTION: Aging is typically associated with progressive multi-system impairment that leads to decreased physical and cognitive function and reduced adaptability to stress. Due to its capacity to characterize complex dynamics within and between physiological systems, the emerging field of complex systems biology and its array of quantitative tools show great promise for improving our understanding of aging, monitoring senescence, and providing biomarkers for evaluating novel interventions, including promising mind-body exercises, that treat age-related disease and promote healthy aging. MATERIAL AND METHODS: An ongoing, two-arm randomized clinical trial is evaluating the potential of Tai Chi mind-body exercise to attenuate age-related loss of complexity. A total of 60 Tai Chi-naïve healthy older adults (aged 50-79) are being randomized to either six months of Tai Chi training (n=30), or to a waitlist control receiving unaltered usual medical care (n=30). Our primary outcomes are complexity-based measures of heart rate, standing postural sway and gait stride interval dynamics assessed at 3 and 6months. Multiscale entropy and detrended fluctuation analysis are used as entropy- and fractal-based measures of complexity, respectively. Secondary outcomes include measures of physical and psychological function and tests of physiological adaptability also assessed at 3 and 6months. DISCUSSION: Results of this study may lead to novel biomarkers that help us monitor and understand the physiological processes of aging and explore the potential benefits of Tai Chi and related mind-body exercises for healthy aging.

Tai chi in patients with heart failure with preserved ejection fraction.

Although exercise is an important component of heart failure management, optimal regimens, particularly in heart failure with preserved ejection fraction (HFPEF), are uncertain. Tai chi (TC) is a mind-body exercise that may have potential benefits but has not been studied in this population. The authors randomized 16 patients with HFPEF to either 12 weeks TC or aerobic exercise. Assessments included peak oxygen uptake, 6-minute walk, quality of life, echocardiography, mood, and self-efficacy at baseline and at 12 weeks. Cardiorespiratory measures during exercise were obtained to characterize training intensities. Baseline characteristics were as follows: age 66±12 years, E/A ratio 1.3±0.7, and E/e' ratio 15.9±4.8. Overall, adherence was excellent (89% attendance). Change in peak oxygen uptake was similar between groups after 12 weeks, but 6-minute walk distance increased more after TC (69±46 m vs 10±31 m, P=.02). While both groups had improved Minnesota Living With Heart Failure scores and self-efficacy, Profile of Mood States (POMS)-Depression scores improved more with TC (-1.7±2.8 vs 1.6±3, P=.05). Cardiorespiratory assessment during TC showed lower oxygen uptake (4.3 mL/kg/min vs 9.4 mL/kg/min, P<.01), respiratory rate, and heart rate. TC is feasible and safe in HFPEF. Therepeutic endpoints appear similar with TC relative to aerobic exercise despite a lower aerobic training workload.

Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study.

OBJECTIVE: To determine the feasibility of a randomized controlled trial of the effect of a tai chi program on quality of life and exercise capacity in patients with COPD. METHODS: We randomized 10 patients with moderate to severe COPD to 12 weeks of tai chi plus usual care (n = 5) or usual care alone (n = 5). The tai chi training consisted of a 1-hour class, twice weekly, that emphasized gentle movement, relaxation, meditation, and breathing techniques. Exploratory outcomes included disease-specific symptoms and quality-of-life, exercise capacity, pulmonary function tests, mood, and self-efficacy. We also conducted qualitative interviews to capture patient narratives regarding their experience with tai chi. RESULTS: The patients were willing to be randomized. Among 4 of the 5 patients in the intervention group, adherence to the study protocol was excellent. The cohort's baseline mean ± SD age, percent-of-predicted FEV1, and ratio of FEV1 to forced vital capacity were 66 ± 6 y, 50 ± 12%, and 0.63 ± 0.14, respectively. At 12 weeks there was significant improvement in Chronic Respiratory Questionnaire score among the tai chi participants (1.4 ± 1.1), compared to the usual-care group (-0.1 ± 0.4) (P = .03). There were nonsignificant trends toward improvement in 6-min walk distance (55 ± 47 vs -13 ± 64 m, P = .09), Center for Epidemiologic Studies Depression Scale (-9.0 ± 9.1 vs -2.8 ± 4.3, P = .20), and University of California, San Diego Shortness of Breath score (-7.8 ± 3.5 vs -1.2 ± 11, P = .40). There were no significant changes in either group's peak oxygen uptake. CONCLUSIONS: A randomized controlled trial of tai chi is feasible in patients with moderate to severe COPD. Tai chi exercise as an adjunct to standard care warrants further investigation.

A treatment trial of acupuncture in IBS patients.

OBJECTIVES: This study aimed to compare the effects of true and sham acupuncture in relieving symptoms of irritable bowel syndrome (IBS). METHODS: A total of 230 adult IBS patients (75 % females, average age: 38.4 years) were randomly assigned to 3 weeks of true or sham acupuncture (6 treatments) after a 3-week "run-in" with sham acupuncture in an "augmented" or "limited" patient-practitioner interaction. A third arm of the study included a waitlist control group. The primary outcome was the IBS Global Improvement Scale (IBS-GIS) (range: 1 - 7); secondary outcomes included the IBS Symptom Severity Scale (IBS-SSS), the IBS Adequate Relief (IBS-AR), and the IBS Quality of Life (IBS-QOL). RESULTS: Although there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS (41 vs. 32 % , P = 0.25), both groups improved significantly compared with the waitlist control group (37 vs. 4 % , P = 0.001). Similarly, small differences that were not statistically significant favored acupuncture over the other three outcomes: IBS-AR(59 vs. 57 % , P = 0.83), IBS-SSS (31 vs. 21 % , P = 0.18), and IBS-QOL (17 vs. 13 % , P = 0.56). Eliminating responders during the run-in period did not substantively change the results. Side effects were generally mild and only slightly greater in the acupuncture group. CONCLUSIONS: This study did not find evidence to support the superiority of acupuncture compared with sham acupuncture in the treatment of IBS.

Adequate relief in a treatment trial with IBS patients: a prospective assessment.

OBJECTIVES: Adequate relief (AR) of irritable bowel syndrome (IBS) symptoms (IBS-AR) has been used as a primary end point in many randomized controlled trials of IBS and is considered by the Rome III committee to be an acceptable primary end point. However, controversy exists on whether baseline severity confounds the effect of the treatment outcome. The aim (1) is to compare a subjective report of IBS-AR with global assessment of improvement (IBS-GAI), change in IBS symptom severity scale (IBS-SSS), and IBS quality of life (IBS-QOL); (2) to explore whether initial IBS symptom severity influences the ability of these outcome measures to detect differences post treatment; and (3) to determine whether psychological symptoms influence the sensitivity of these measures, in a randomized controlled treatment trial. METHODS: A total of 289 adult IBS patients were recruited to a treatment trial. Baseline IBS-SSS scores were used to classify IBS severity as mild (<175), moderate (175-300), or severe (>300). Questionnaires were completed at baseline and after 3 weeks of treatment with sham acupuncture or wait-list control. RESULTS: IBS baseline severity (IBS-SSS) significantly affected the proportion of patients who reported IBS-AR at 3 weeks (mild, 70%; moderate, 49.7%; severe, 38.8%) (P<0.05). However, once the patients who reported IBS-AR at baseline (28.0%) were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting IBS-AR. Baseline severity did not have a significant effect on patients reporting moderate or significant improvement on the IBS-GAI (mild, 30%; moderate, 25.3%; severe, 18.8%) (P=NS). Psychological symptoms had no significant correlations with responders after adjusting for baseline severity. CONCLUSIONS: These data suggest that IBS-AR as an end point is inversely related to baseline symptom severity. However, if patients who report AR at screening were excluded from study participation, baseline symptom severity was no longer confounded with a report of AR at the study end point.

A qualitative analysis of adolescents' experiences of active and sham Japanese-style acupuncture protocols administered in a clinical trial.

INTRODUCTION: Acupuncture is a complex holistic intervention in which patient-practitioner relationships and healing changes occur in interactive, iterative ways. Qualitative research is one way to capture such complexity. This study sought to understand better the experiences of adolescents involved in acupuncture treatment. MATERIALS AND METHODS: We included a qualitative substudy as part of a pilot randomized sham-controlled study of the use of Japanese acupuncture to treat chronic pelvic pain in adolescent girls. Seven (7) interviews were attained. Themes were double-coded and analyzed using qualitative analysis software. RESULTS: Regardless of treatment arm, all subjects reported positive study-related changes, often attributed to positive qualities of the patient-practitioner relationship. Participants in both the sham and verum acupuncture treatment arms reported in the narratives that they were unsure of their study assignment. In contrast, the study's close-ended success of blinding question suggests that some participants were sure of their treatment allocation. CONCLUSIONS: As we continue to study acupuncture using sham controls, we need a better understanding of the possible affects of sham treatments on both treatment outcomes and success of blinding. Qualitative research is one-way to explore subtle emergent changes in participants' experiences.

Effectiveness of recruitment in clinical trials: an analysis of methods used in a trial for irritable bowel syndrome patients.

A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews. We also report the fraction of cost each method consumed and fraction of recruitment each method generated. Our cost per call from potential participants varied from $3-$103 and cost per enrollment participant varied from $12-$584. Using a novel metric, the efficacy index, we found that physician referrals and flyers were the most effective recruitment method in our trial. Despite some methods being more efficient than others, all methods contributed to the successful recruitment. The iterative use of the efficacy index during a recruitment campaign may be helpful to calibrate and focus on the most effective recruitment methods.