Virtually delivered Mindfulness-Oriented Recovery Enhancement (MORE) reduces daily pain intensity in patients with lumbosacral radiculopathy: a randomized controlled trial.

Introduction: Lumbosacral radiculopathy (LR), also known as sciatica, is a common type of radiating neurologic pain involving burning, tingling, and numbness in the lower extremities. It has an estimated lifetime prevalence as high as 43%. Objectives: The objective of this randomized controlled trial was to evaluate the impact of virtually delivered Mindfulness-Oriented Recovery Enhancement (MORE) on patients with LR during the COVID-19 pandemic. Methods: Potentially eligible patients were identified using electronic health record queries and phone screenings. Participants were then randomized to MORE or treatment-as-usual (TAU) for 8 weeks, with pain intensity assessed daily. At baseline and follow-up visits, participants completed questionnaires assessing the primary outcome, disability, as well as quality of life, depression, mindful reinterpretation of pain, and trait mindfulness. Results: In our study, patients undergoing virtual delivery of MORE had greater improvements in daily pain intensity (P = 0.002) but not in disability (P = 0.09), depression (P = 0.26), or quality of life (P = 0.99 and P = 0.89, SF-12 physical and mental component scores, respectively), relative to TAU patients. In addition, patients in MORE experienced significantly greater increases in mindful reinterpretation of pain (P = 0.029) and trait mindfulness (P = 0.035). Conclusion: Among patients with lumbar radiculopathy, MORE significantly reduced daily pain intensity but did not decrease disability or depression symptoms. Given the long duration of symptoms in our sample, we hypothesize the discrepancy between changes in daily pain intensity and disability is due to fear avoidance behaviors common in patients with chronic pain. As the first trial of a mindfulness intervention in patients with LR, these findings should inform future integrative approaches to LR treatment, particularly when considering the increasing use of virtual interventions throughout the COVID-19 pandemic.

Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study.

OBJECTIVE: The aim of the study was to assess the feasibility and acceptability of acupuncture's augmentation of lidocaine therapy in the treatment of provoked localized vulvodynia (PLV). MATERIALS AND METHODS: For 12 weeks, women with moderate to severe PLV were randomized to either 18 sessions of traditional acupuncture (TA) or non-TA (NTA). All participants applied lidocaine 5% cream 4 times daily to the vestibule. Feasibility was assessed by recruitment, enrollment, assessment completion, and blinding. Acceptability was assessed by study visit attendance and satisfaction. The primary outcome was change in tampon test scores from baseline to week 12 and follow-up at week 24. RESULTS: Nineteen women enrolled and 14 completed the study. Five withdrew because of lidocaine reaction (n = 2), inability to insert tampon (n = 1), starting a new medication (n = 1), or change in vulvar diagnosis (n = 1). Participants in both groups reported pain reduction for 12 weeks. There was no statistically significant difference between groups. Women in the TA group (n = 7) experienced less pain from baseline to 12 weeks (mean difference [MD] = 42.4 ± 19.4 and MD = 35.7 ± 17.8 at week 24). In the non-TA group (n = 7), women experienced a within-group MD of 28.7 ± 28.5 at 12 weeks and an MD of 36.7 ± 17.7. CONCLUSIONS: In this early-phase research, acupuncture augmentation of lidocaine was acceptable. The study procedures, with modifications, may be feasible for future investigation. Both acupuncture techniques showed a favorable effect; however, the contribution to pain relief is undetermined.

Why and How Should We Integrate Biomarkers into Complex Trials? A Discussion on Paradigms and Clinical Research Strategies.

BACKGROUND: Research in complementary and alternative medicine (CAM) encounters a variety of challenges, such as potentially synergistic, multimodal, and complex interventions which are often dependent on the relationship between practitioner and patient, on specific settings, and on patients' individual preferences, expectations, beliefs, and motivations. Moreover, patients seeking CAM care often suffer from chronic disease conditions, and multiple symptoms and/or pathologies. On the other hand, CAM interventions are often challenged as being solely dependent on subjective and nonspecific factors without biologically based mechanisms of action. If we agree that biomarkers as outcomes are important for the understanding of CAM interventions, a hypothesis- and strategy-driven process for the selection of the most appropriate biomarkers is needed. METHODS: This paper presents the results of an expert panel on how to integrate biomarkers in whole system research of an interdisciplinary workshop on research methodology in CAM held in November 2012. RESULTS: The following main CAM research challenges were identified: (a) finding appropriate biomarkers, which are able to picture the complex pathophysiological pathways and likewise complex interventions under study; (b) integrating these biomarkers into clinical trials in CAM; and (c) identifying the biomarkers specific to the particular CAM intervention being applied. CONCLUSION: The paper provides a disease/condition/symptom- and intervention-driven strategy regarding how to identify the outcomes of interest and possible related biomarkers. The research approach presented here allows the selected biomarkers to be grounded in conventional physiology/pathophysiology as well as complementary and alternative concepts, including traditional systems of medicine. The goal is to provide researchers in the field with a framework on how to integrate biomarkers into complex trials.

Randomized Controlled Trial of Acupuncture for Women with Fibromyalgia: Group Acupuncture with Traditional Chinese Medicine Diagnosis-Based Point Selection.

Background: Group acupuncture is a growing and cost-effective method for delivering acupuncture in the United States and is the practice model in China. However, group acupuncture has not been tested in a research setting. Objective: To test the treatment effect of group acupuncture vs group education in persons with fibromyalgia. Design: Random allocation two-group study with repeated measures. Setting: Group clinic in an academic health center in Portland, Oregon. Subjects: Women with confirmed diagnosis of fibromyalgia (American College of Radiology 1990 criteria) and moderate to severe pain levels. Methods: Twenty treatments of a manualized acupuncture treatment based on Traditional Chinese Medicine diagnosis or group education over 10 weeks (both 900 minutes total). Weekly Revised Fibromyalgia Impact Questionnaire (FIQR) and Global Fatigue Index at baseline, five weeks, and 10 weeks and a four-week follow-up were assessed. Results: Thirty women were recruited, with 78% reporting symptoms for longer than 10 years. The mean attendance was 810 minutes for acupuncture and 861 minutes for education. FIQR total, FIQR pain, and Global Fatigue Index all had clinically and statistically significant improvement in the group receiving acupuncture at end of treatment and four weeks post-treatment but not in participants receiving group education between groups. Conclusions: Compared with education, group acupuncture improved global symptom impact, pain, and fatigue. Furthermore, it was a safe and well-tolerated treatment option, improving a broader proportion of patients than current pharmaceutical options.

Tibetan Herbal Tea Agar-35 Reduces Negative Affect and Anxiety: A Placebo-Controlled Pilot Study.

INTRODUCTION: Herbal medicine and other forms of complementary and alternative medicine (CAM) are used to treat symptoms of psychiatric disorders in the United States, including anxiety and mood problems. In Traditional Tibetan Medicine anxiety and depression are commonly treated with an herbal compound known as Agar-35. OBJECTIVE: The objective of this pilot study was to explore whether Agar-35 tea would improve anxiety, affect, stress, and rumination. METHODS: Undergraduate psychology students (N=14) were randomized to drink either Agar-35 tea (n=6) or placebo tea (n=8) for 7 nights. RESULTS: The results indicated that Agar-35 significantly reduced participants' negative affect compared to placebo, U = 6.0, p = .019, effect size, r = .63. Further, Agar-35 also reduced anxiety (trending toward significance), U = 10.0, p = .071, effect size, r = .48. CONCLUSION: In accordance with its use in Tibetan Medicine, these preliminary findings suggest that Agar-35 may benefit aspects of psychological health.

Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia.

OBJECTIVE: Fibromyalgia is a chronic pain condition with few effective treatments. Many fibromyalgia patients seek acupuncture for analgesia; however, its efficacy is limited and not fully understood. This may be due to heterogeneous pathologies among participants in acupuncture clinical trials. We hypothesized that pressure pain tenderness would differentially classify treatment response to verum and sham acupuncture in fibromyalgia patients. DESIGN: Baseline pressure pain sensitivity at the thumbnail at baseline was used in linear mixed models as a modifier of differential treatment response to sham versus verum acupuncture. Similarly, needle-induced sensation was also analyzed to determine its differential effect of treatment on clinical pain. METHODS AND PATIENTS: A cohort of 114 fibromyalgia patients received baseline pressure pain testing and were randomized to either verum (N = 59) or sham (N = 55) acupuncture. Participants received treatments from once a week to three times a week, increasing in three-week blocks for a total of 18 treatments. Clinical pain was measured on a 101-point visual analog scale, and needle sensation was measured by questionnaire throughout the trial. RESULTS: Participants who had higher pain pressure thresholds had greater reduction in clinical pain following verum acupuncture while participants who had lower pain pressure thresholds showed better analgesic response to sham acupuncture. Moreover, patients with lower pressure pain thresholds had exacerbated clinical pain following verum acupuncture. Similar relationships were observed for sensitivity to acupuncture needling. CONCLUSIONS: These findings suggest that acupuncture efficacy in fibromyalgia may be underestimated and a more personalized treatment for fibromyalgia may also be possible.

Mindful Yoga Pilot Study Shows Modulation of Abnormal Pain Processing in Fibromyalgia Patients.

Published findings from a randomized controlled trial have shown that Mindful Yoga training improves symptoms, functional deficits, and coping abilities in individuals with fibromyalgia and that these benefits are replicable and can be maintained 3 months post-treatment. The aim of this study was to collect pilot data in female fibromyalgia patients (n = 7) to determine if initial evidence indicates that Mindful Yoga also modulates the abnormal pain processing that characterizes fibromyalgia. Pre- and post-treatment data were obtained on quantitative sensory tests and measures of symptoms, functional deficits, and coping abilities. Separation test analyses indicated significant improvements in heat pain tolerance, pressure pain threshold, and heat pain after-sensations at post-treatment. Fibromyalgia symptoms and functional deficits also improved significantly, including physical tests of strength and balance, and pain coping strategies. These findings indicate that further investigation is warranted into the effect of Mindful Yoga on neurobiological pain processing.

Fibromyalgia Impact and Mindfulness Characteristics in 4986 People with Fibromyalgia.

CONTEXT AND OBJECTIVE: A growing body of literature suggests that mindfulness techniques may be beneficial in fibromyalgia. A recent systematic review and meta-analysis of six trials indicated improvement in depressive symptoms and quality of life, calling for increased rigor and use of standardized measures in future trials. The purpose of the study was to examine the relationship between mindfulness [as measured by the Five Facet Mindfulness Questionnaire (FFMQ)] and fibromyalgia impact [as measured by the Revised Fibromyalgia Impact Questionnaire (FIQR)]. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional survey was conducted with adults diagnosed with fibromyalgia from a national fibromyalgia advocacy foundation e-mail list. RESULTS: A total of 4986 respondents represented all 50 states in the United States and 30 countries. FIQR scores demonstrated moderate to severe fibromyalgia with the majority of subjects (59%) scoring ≤60. Scores on the FFMQ subscales ranged from 20.8 to 27.3, with highest scores for the observe subscale. All subscale correlations were small to moderate and indicated that more severe fibromyalgia impact was associated with less mindfulness except in the observe scale (r = .15, P > .000). No clinical or demographics explained as much variance in the FIQR total as any of the mindfulness subscales. CONCLUSIONS: Fibromyalgia patients experience symptoms that may be alleviated by mindfulness interventions. Baseline values for the observe subscale of the FFMQ were unexpectedly high. Further research is needed to know if this may be due to non-mindful observations and should be noted when the FFMQ is used in fibromyalgia clinical trials.

Impact of whole systems traditional Chinese medicine on in-vitro fertilization outcomes.

Patients undergoing IVF may receive either acupuncture or whole-systems traditional Chinese medicine (WS-TCM) as an adjuvant IVF treatment. WS-TCM is a complex intervention that can include acupuncture, Chinese herbal medicine, dietary, lifestyle recommendations. In this retrospective cohort study, 1231 IVF patient records were reviewed to assess the effect of adjuvant WS-TCM on IVF outcomes compared among three groups: IVF with no additional treatment; IVF and elective acupuncture on day of embryo transfer; or IVF and elective WS-TCM. The primary outcome was live birth. Of 1069 non-donor cycles, WS-TCM was associated with greater odds of live birth compared with IVF alone (adjusted odds ratio [AOR] 2.09; 95% confidence interval [CI] 1.36 to 3.21), or embryo transfer with acupuncture only (AOR 1.62; 95% CI 1.04 to 2.52). Of 162 donor cycles, WS-TCM was associated with increased live births compared with all groups (odds Ratio [OR] 3.72; 95% CI 1.05 to 13.24, unadjusted) or embryo transfer with acupuncture only (OR 4.09; 95% CI: 1.02 to 16.38, unadjusted). Overall, IVF with adjuvant WS-TCM was associated with greater odds of live birth in donor and non-donor cycles. These results should be taken cautiously as more rigorous research is needed.

Interest in yoga among fibromyalgia patients: an international internet survey.

Studies in circumscribed clinical settings have reported the adoption of yoga by many fibromyalgia (FM) patients. However, it is unclear from existing studies which types of yoga practices FM patients are typically engaging in and the extent to which they experience yoga as helpful or not. The purpose of this study was to survey FM patients in many different regions to inquire about their engagement in various yoga practices, the perceived benefits, and the obstacles to further practice. A 13-question Internet survey of persons self-identified as FM patients was conducted among subscribers to 2 electronic newsletters on the topic of FM. Respondents (N = 2543) replied from all 50 U.S. states and also from Canada, Australia, and the United Kingdom, and from more than two dozen other countries. On average, respondents were 57 years of age and 96% were female, with an average time since diagnosis of 13 years. Of these respondents, 79.8% had considered trying yoga and 57.8% had attended 1 yoga class. The respondents' classes typically focused almost exclusively on yoga poses, with minimal training in meditation, breathing techniques, or other practices. The most commonly cited benefits were reduced stiffness, relaxation, and better balance. The most frequently cited obstacles were concerns about the poses being too physically demanding and fear that the poses would cause too much pain. These findings confirm strong interest in yoga across a geographically diverse range of FM patients. However, concerns about yoga-induced pain and yoga poses being too difficult are common reasons that FM patients do not engage in yoga exercises. This study supports the need for yoga programs tailored for FM patients to include modification of poses to minimize aggravating movements and substantive training in meditation and other yoga-based coping methods to minimize pain-related fear.

A pilot study of myofascial release therapy compared to Swedish massage in fibromyalgia.

Fibromyalgia (FM) is characterized by widespread muscle pain and soft tissue tenderness. However, a lack of definitive muscle pathology has made FM both a diagnostic and a treatment puzzle. Much of the evidence for pathology in FM lies in the central nervous system - in particular abnormal amplification of pain signals in the spinal cord - a manifestation of central sensitization. An emerging body of evidence posits that peripheral pain generated from the muscles and fascia may trigger and maintain central sensitization in FM. Since FM patients so frequently seek manual therapy to relieve muscle symptoms, the present study compared two different manual therapy techniques in a parallel study of women with FM. Eight subjects received myofascial release (MFR) while four subjects received Swedish massage, 90 min weekly for four weeks. Overall symptom burden and physical function were assessed by the Fibromyalgia Impact Questionnaire Revised (FIQ-R). A unique challenge for the manual therapist in treating conditions involving central sensitization is to determine if localized pain reduction can be achieved with targeted therapy in the context of ongoing widespread pain. Localized pain improvement was measured by a novel questionnaire developed for this study, the modified Nordic Musculoskeletal Questionnaire (NMQ). Between-group differences in FIQ-R did not reach statistical significance, but the total change scores on FIQ-R for the MFR group (mean = 10.14, SD = 16.2) trended in the hypothesized and positive direction compared to the Swedish massage group (mean = 0.33, SD = 4.93) yielding a positive Aikin separation test. Although overall modified NMQ scores improved in both groups there were no consistent focal areas of improvement for the Swedish massage group. In contrast, the MFR group reported consistent pain reductions in the neck and upper back regions on the NMQ. These data support the need for larger randomized controlled trials of MFR versus other massage techniques and support the assessment of localized pain reduction in future manual therapy studies in FM.

Complementary and alternative exercise for fibromyalgia: a meta-analysis.

Complementary and alternative medicine includes a number of exercise modalities, such as tai chi, qigong, yoga, and a variety of lesser-known movement therapies. A meta-analysis of the current literature was conducted estimating the effect size of the different modalities, study quality and bias, and adverse events. The level of research has been moderately weak to date, but most studies report a medium-to-high effect size in pain reduction. Given the lack of adverse events, there is little risk in recommending these modalities as a critical component in a multimodal treatment plan, which is often required for fibromyalgia management.

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.

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.

Follow-up of yoga of awareness for fibromyalgia: results at 3 months and replication in the wait-list group.

OBJECTIVES: Published preliminary findings from a randomized-controlled trial suggest that an 8-week Yoga of Awareness intervention may be effective for improving symptoms, functional deficits, and coping abilities in fibromyalgia. The primary aims of this study were to evaluate the same intervention's posttreatment effects in a wait-list group and to test the intervention's effects at 3-month follow-up in the immediate treatment group. METHODS: Unpaired t tests were used to compare data from a per protocol sample of 21 women in the immediate treatment group who had completed treatment and 18 women in the wait-list group who had completed treatment. Within-group paired t tests were performed to compare posttreatment data with 3-month follow-up data in the immediate treatment group. The primary outcome measure was the Fibromyalgia Impact Questionnaire Revised (FIQR). Multilevel random-effects models were also used to examine associations between yoga practice rates and outcomes. RESULTS: Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment group, with the FIQR Total Score improving by 31.9% across the 2 groups. Follow-up results showed that patients sustained most of their posttreatment gains, with the FIQR Total Score remaining 21.9% improved at 3 months. Yoga practice rates were good, and more practice was associated with more benefit for a variety of outcomes. DISCUSSION: These findings indicate that the benefits of Yoga of Awareness in fibromyalgia are replicable and can be maintained.

A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients.

Previous researchers have found that 10-form Tai chi yields symptomatic benefit in patients with fibromyalgia (FM). The purpose of this study was to further investigate earlier findings and add a focus on functional mobility. We conducted a parallel-group randomized controlled trial FM-modified 8-form Yang-style Tai chi program compared to an education control. Participants met in small groups twice weekly for 90 min over 12 weeks. The primary endpoint was symptom reduction and improvement in self-report physical function, as measured by the Fibromyalgia Impact Questionnaire (FIQ), from baseline to 12 weeks. Secondary endpoints included pain severity and interference (Brief Pain Inventory (BPI), sleep (Pittsburg sleep Inventory), self-efficacy, and functional mobility. Of the 101 randomly assigned subjects (mean age 54 years, 93 % female), those in the Tai chi condition compared with the education condition demonstrated clinically and statistically significant improvements in FIQ scores (16.5 vs. 3.1, p = 0.0002), BPI pain severity (1.2 vs. 0.4, p = 0.0008), BPI pain interference (2.1 vs. 0.6, p = 0.0000), sleep (2.0 vs. -0.03, p = 0.0003), and self-efficacy for pain control (9.2 vs. -1.5, p = 0.0001). Functional mobility variables including timed get up and go (-.9 vs. -.3, p = 0.0001), static balance (7.5 vs. -0.3, p 0.0001), and dynamic balance (1.6 vs. 0.3, p = 0.0001) were significantly improved with Tai chi compared with education control. No adverse events were noted. Twelve weeks of Tai chi, practice twice weekly, provided worthwhile improvement in common FM symptoms including pain and physical function including mobility. Tai chi appears to be a safe and an acceptable exercise modality that may be useful as adjunctive therapy in the management of FM patients. (ClinicalTrials.gov Identifier, NCT01311427).

Traditional Chinese medicine diagnoses in a sample of women with fibromyalgia.

BACKGROUND: Traditional Chinese medicine (TCM) offers various treatment modalities guided by TCM diagnoses. In the United States, acupuncture is a commonly employed TCM method for treating a variety of chronic illnesses. Three systematic reviews have been reported recently, reaching differing conclusions about the efficacy of acupuncture for the treatment of fibromyalgia (FM). Among the FM acupuncture studies considered in these reviews, none used TCM diagnosis as an inclusion/exclusion criterion or adjusted treatment based on TCM diagnosis. Overlooking TCM diagnosis may be a reason for such disparate results. PRIMARY STUDY OBJECTIVE: To obtain TCM diagnoses in a sample of women meeting 1990 American College of Rheumatology criteria for FM who were recruited for a yoga study and to investigate whether there is significant variability. METHODS/DESIGN: Two TCM practitioners conducted baseline TCM diagnostic examinations on 56 women with FM. A consensus diagnosis was reached based on standardised history, palpation and examination. Canonical discriminate analysis identified two baseline items which predicted TCM diagnosis. SETTING: School of Nursing, Oregon Health & Science University. PARTICIPANTS: Women, ages 23-75, with FM recruited to a yoga intervention study. RESULTS: Three primary TCM diagnoses were found in the population: Qi and Blood Deficiency (46.4%, CI 33.0% to 60.36%), Qi and Blood Stagnation (26.8%, CI 15.8% to 40.3%), and Liver Qi Stagnation (19.6%, CI 10.2% to 32.4%). CONCLUSION: It is likely that previous studies of FM were treating a heterogeneous study population where variable results might be expected. Future acupuncture studies should either control for TCM diagnosis or consider its usefulness as an inclusion/exclusion criterion.

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.