Biofield Therapies: Guidelines for Reporting Clinical Trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, eg, External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONsolidated Standards of Reporting Trials (CONSORT) 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield Therapies: Guidelines for Reporting Clinical Trials.

Highlights Guidelines have been created to improve the reporting of clinical trials of biofield therapies, e.g. External Qigong, Healing Touch, Reiki, and Therapeutic Touch. Appropriate use of these guidelines is likely to strengthen the evidence base for biofield therapies as well as increase their usage as stand-alone practices and as complementary therapies within mainstream healthcare.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Biofield therapies: Guidelines for reporting clinical trials.

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

Effect of expectancy and personality on cortical excitability in Parkinson's disease.

Our previous studies in Parkinson's disease have shown that both levodopa and expectancy of receiving levodopa reduce cortical excitability. We designed this study to evaluate how degree of expectancy and other individual factors modulate placebo response in Parkinson's patients. Twenty-six Parkinson's patients were randomized to 1 of 3 groups: 0%, 50%, and 100% expectancy of receiving levodopa. All subjects received placebo regardless of expectancy group. Subjects completed the NEO-Five Factor Inventory, General Perceived Self-Efficacy Scale, and Perceived Stress Scale. Cortical excitability was measured by the amplitude of motor-evoked potential (MEP) evoked by transcranial magnetic stimulation. Objective physical fatigue of extensor carpi radialis before and after placebo levodopa was also measured. Responders were defined as subjects who responded to the placebo levodopa with a decrease in MEP. Degree of expectancy had a significant effect on MEP response (P < .05). Subjects in the 50% and 100% expectancy groups responded with a decrease in MEP, whereas those in the 0% expectancy group responded with an increase in MEP (P < .05). Responders tended to be more open to experience than nonresponders. There were no significant changes in objective physical fatigue between the expectancy groups or between responders and nonresponders. Expectancy is associated with changes in cortical excitability. Further studies are needed to examine the relationship between personality and placebo effect in Parkinson's patients. © 2013 Movement Disorder Society.

AcuTrials®: an online database of randomized controlled trials and systematic reviews of acupuncture.

BACKGROUND: The growing quantity of Complementary and Alternative Medicine literature requires databases enabled with increasingly powerful search capabilities. To address this need in the area of acupuncture research, a bibliographic database of randomized controlled trials (RCTs) and systematic reviews called AcuTrials® has been developed by the Oregon College of Oriental Medicine. AcuTrials® introduces a comprehensive keyword thesaurus that categorizes details of treatment protocols and research design to an extent not currently available in MEDLINE or other databases. DESCRIPTION: AcuTrials®, which went live in January of 2010 and is updated monthly, currently contains over 1250 articles from more than 300 journals. Articles included are English language RCTs and systematic reviews that report on medical conditions in human subjects treated by needle acupuncture. Study details are indexed by 14 key domains, such as acupuncture style and needling protocol, to create an acupuncture-relevant, searchable keyword catalogue. Keywords follow the National Library of Medicine (NLM) MeSH terminology when possible, and new keywords were created in cases where no appropriate MeSH terms were available. The resulting keyword catalogue enables users to perform sensitive, targeted searches for particular aspects of acupuncture treatment and research design. CONCLUSIONS: AcuTrials® provides an extensive and innovative keyword catalogue of acupuncture research, allowing users to efficiently navigate, locate and assess the evidence base in ways not currently possible with other databases. By providing a more powerful suite of search options, the AcuTrials® database has the potential to enhance the accessibility and quality of acupuncture research.

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.

Randomized Controlled Trials of Acupuncture (1997-2007): An Assessment of Reporting Quality with a CONSORT- and STRICTA-Based Instrument.

The present study describes the development of a comprehensive quality of reporting assessment tool and its application to acupuncture RCTs from 1997-2007. This Oregon CONSORT STRICTA Instrument (OCSI) is based on the revised CONSORT guidelines as modified by the STRICTA recommendations for acupuncture trials. Each of the resulting 27 OCSI items were applied to English language prospective RCTs that compared acupuncture, using manual and/or electro-stimulation, to no treatment, a sham procedure, or usual biomedical care. The 333 RCTs that met inclusion criteria were dispersed among 27 countries and 141 journals. Mean quality of reporting score for all articles was 63.0% (SD 16.5). Mean OCSI scores revealed a 30.9% improvement over the ten-year period (P < .001). Our findings suggest that to enhance quality of reporting, authors should better attend to seven specific OCSI items in three categories: practitioner training, adverse events, and aspects of randomization and blinding (n = 5). The broad diversity in geographical origin, publication site and quality of reporting, viewed in light of the considerable room for improvement in mean OCSI scores, emphasizes the importance of making STRICTA as well as CONSORT more widely known to journals and to the acupuncture research community.

Paradoxes in acupuncture research: strategies for moving forward.

In November 2007, the Society for Acupuncture Research (SAR) held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation) the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1) "top down" as multi-component "whole-system" interventions and (2) "bottom up" as mechanistic studies that focus on understanding how individual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement.

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word 'controlled' in STRICTA is replaced by 'clinical', to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

[Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement (Chinese version)].

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

Inter-Rater Agreement of Biofield Tuning: Testing a Novel Health Assessment Procedure.

Objectives: Practitioners of Biofield Tuning assess health status of their clients by detecting off-the-body biofield perturbations using tuning fork (TF) vibrations. This study tested inter-rater agreement (IRA) on location of these perturbations. Design: Three Biofield Tuning practitioners, in randomized order, identified locations of the 4-5 "strongest" perturbations along each of 4 sites for the same series of 10 research subjects. Setting/Location: An Integrative Health and Medicine Center in La Jolla, CA. Subjects: Adult volunteers with no serious current illness and no prior experience of a Biofield Tuning session. Interventions: Practitioners used an activated 174 Hz unweighted TF to "comb" the same four sites per subject, located on the left and right sides of the base of the spine and the heart. Outcome Measures: Practitioners identified and vocalized the distance from the body of perturbations along each site. Distances were recorded by a research assistant in the clinic room. No health information related to perturbation sites was discussed with the subjects. Results: Practitioners reported 6.3 ± 0.6 (mean ± standard deviation) perturbations per combed site per subject, with no significant difference among the raters. The overall level of IRA was low based initially on a first-pass, nonstatistical, analysis of results, with "agreement" defined within a tolerance of ±2 inches. In this approach agreement was 33%. More rigorous statistical analysis, including a statistical test using a Monte Carlo approach, strongly supported the conclusion of poor IRA. Conclusions: IRA was low despite attempts to balance the real-world practice of Biofield Tuning with the constraints of research. For example, while IRA necessitates multiple assessments of the same subject, no information exists as to whether an initial assessment may affect subsequent assessments. Our study exemplifies the challenges faced when attempting to fit interventions with incompletely understood procedures and mechanisms into conventional research designs.

Learning activities to enhance research literacy in a CAM college curriculum.

As complementary and alternative medicine (CAM) therapies become increasingly accepted healthcare options, it is of major importance for CAM institutions to enhance research literacy and an evidence-based perspective in their curricula. A research education program for students and faculty at the Oregon College of Oriental Medicine (OCOM), developed in collaboration with the Oregon Health & Science University School of Nursing, has been supported by an R25 award from the National Center for Complementary and Alternative Medicine (NCCAM). A key initiative of OCOM's grant is the design of learning activities that infuse a research perspective into nonresearch courses in both the traditional Chinese medicine and biomedicine curricula. This approach was pilot-tested in course sequences chosen from each of the 3 years of the master's degree program. Learner-centered activities included Infusing Evidence and Reflection Into Introductory Qigong Classes (Year 1: Qigong), Using Evidence to Inform Acupuncture Point Selection (Year 2: Point Actions and Indications), and Media and Research in Western Clinical Medicine (Year 3: Western Clinical Diagnosis). Among the lessons learned are the need to infuse learning activities into the curriculum in a manner that minimizes interactivity redundancy and reinforces learning, the importance for faculty to communicate to students the rationale for introducing the learning activities, and the value of creating a learning activity design template to guide faculty recognition of essential elements in design and evaluation and to provide sustainable overviews of the learning activities.

Electrical properties of acupuncture points and meridians: a systematic review.

According to conventional wisdom within the acupuncture community, acupuncture points and meridians are special conduits for electrical signals. This view gained popularity after anecdotal reports and clinical studies asserted that these anatomical structures are characterized by lower electrical impedance compared to adjacent controls. To ascertain whether evidence exists to support or refute this claim, we conducted a systematic review of studies directly evaluating the electrical characteristics of acupuncture structures and appropriate controls. We searched seven electronic databases until August 2007, hand-searched references, and consulted technical experts. We limited the review to primary data human studies published in English. A quality scoring system was created and employed for this review. A total of 16 articles representing 18 studies met inclusion criteria: 9 examining acupuncture points and 9 examining meridians. Five out of 9 point studies showed positive association between acupuncture points and lower electrical resistance and impedance, while 7 out of 9 meridian studies showed positive association between acupuncture meridians and lower electrical impedance and higher capacitance. The studies were generally poor in quality and limited by small sample size and multiple confounders. Based on this review, the evidence does not conclusively support the claim that acupuncture points or meridians are electrically distinguishable. However, the preliminary findings are suggestive and offer future directions for research based on in-depth interpretation of the data.

Research scholars program: a faculty development initiative at the Oregon College of Oriental Medicine.

BACKGROUND: The Research Scholars Program (RSP) was created at the Oregon College of Oriental Medicine (OCOM) to provide faculty development in research literacy, research-informed clinical practice, and research participation skills. The RSP is part of a broad effort, funded by a National Institutes of Health/National Center for Complementary and Alternative Medicine R25 education grant, to infuse an evidence-based perspective into the curriculum at schools of complementary and alternative medicine. The RSP arose from the realization that this curriculum reform would first necessitate faculty training in both research appreciation and pedagogy. OCOM's grant, Acupuncture Practitioner Research Education Enhancement, is a partnership with the Oregon Health & Science University School of Nursing (OHSU SON). DESIGN: The RSP was developed initially as a collaborative effort among the OCOM Dean of Research (R.H.), OCOM Director of Research Education (S.F.), and an OHSU SON education specialist (K.L.). The 9-month, 8 hours per month seminar-style RSP provides the opportunity for a cohort of OCOM faculty and staff to explore research-related concepts and content as well as pedagogical practices that emphasize interactive, learner-centered teaching. The RSP adheres to a competency-based approach as developed by the Education Committee of the grant. As a tangible outcome, each Research Scholar designs a sustainable learning activity that infuses a research perspective into their courses, clinic supervision, or other sphere of influence at the college. In this paper, we describe the creative process and the lessons learned during the planning and initial implementation of the RSP. CONCLUSIONS: We view the early successes of the RSP as encouraging signs that research literacy and an evidence-based perspective are becoming increasingly accepted as needed skill sets for present-day practitioners of acupuncture and Oriental medicine.

Electrical skin impedance at acupuncture points.

OBJECTIVES: To test whether electrical skin impedance at each of three acupuncture points (APs) is significantly lower than at nearby sites on the meridian (MP) and off the meridian (NP). DESIGN: Two instruments - Prognos (MedPrevent GmbH, Waldershof, Germany), a constant-current (DC) device, and PT Probe (designed for this study), a 100-Hz sinusoidal-current (AC) device-were used to record electrical impedance at three APs (right Gallbladder 14, right Pericardium 8, and left Triple Energizer 1), and two control sites for each AP. Each AP, MP, and NP was measured four times in random order with each device. SETTING: The study was conducted over a period of 4 days at the Oregon College of Oriental Medicine (OCOM). SUBJECTS: Twenty (20) healthy adults (14 women and 6 men), all recruited from the OCOM student body and faculty, participated in the study. RESULTS: The Prognos measurements had an intraclass correlation (ICC) = 0.84 and coefficient of variation (CV) = 0.43. The PT Probe had ICC = 0.81 and CV = 0.31. Impedance values at APs were not significantly less than at MPs or NPs. Impedance values at MPs were also not significantly less than NPs, although their individual p values were <0.05 in 4 of 6 cases. There was a significant trend of increasing impedance with repeated measurements with both the Prognos (p =0.003) and the PT Probe (p= 0.003). CONCLUSIONS: Within the reliability limits of our study methods, none of the three APs tested has lower skin impedance than at either of the nearby control points. These results are not consistent with previous studies that detected lower skin impedance at APs than nearby sites. Further study is necessary to determine whether MPs have lower skin impedance than nearby NPs. Our study suggests caution is warranted when developing, using, and interpreting results from electrodermal screening devices. Further studies are needed to clarify the clinically important and controversial hypothesis that APs are sites of lower impedance.

Implications for education in complementary and alternative medicine: a survey of entry attitudes in students at five health professional schools.

INTRODUCTION: The National Institutes of Health provided grants to the Oregon Health & Science University (OHSU) and 14 other allopathic academic health centers for the development of curricula in complementary and alternative medicine (CAM). A key component of the curriculum evaluation for OHSU was provided by a survey assessing attitudes toward CAM and selected personality characteristics of entering students in chiropractic, naturopathic, Oriental, and allopathic medicine in the Pacific Northwest and Upper Midwest. METHODS: A survey containing a variety of assessments of attitudes toward CAM and the personality traits of adventurousness and tolerance to ambiguity was administered to students entering four Portland, Oregon doctoral-level health professional schools and an allopathic medical school in the Upper Midwest (University of Nebraska College of Medicine) during the 2004-2005 academic year. RESULTS: Students of naturopathy (n = 63) and Oriental Medicine (n = 71) were the most "CAM positive," adventurous and tolerant of ambiguity, and Midwestern allopathic medical students (n = 58) the least. In general, chiropractic students (n = 89) and allopathic medical students from the Pacific Northwest (n = 95) were intermediate in CAM attitudes between these two groups (all p < 0.05). Female students were more "CAM positive" in all schools compared to male students. CONCLUSIONS: Students have high levels of interest in CAM upon entrance to their schools. Health professional discipline, geographic location, personality qualities, and gender appear to influence CAM attitudes in entering students.

Response to a proposal for an integrative medicine curriculum.

BACKGROUND: A paper entitled "Core Competencies in Integrative Medicine for Medical School Curricula: A proposal," published in Academic Medicine, stimulated a broad discussion among complementary and alternative medicine (CAM) educators. This discussion led to a formal process for responding to the issues raised by the paper. METHODS: Representatives from the Academic Consortium for Complementary and Alternative Health Care (ACCAHC) and the Oregon Collaborative for Complementary and Integrative Medicine (OCCIM) formed the ACCAHC/OCCIM Task Force to participate in a Delphi process of consultation and deliberation. This process led to a broad, cross-discipline agreement on important points to include in a response to the integrative medicine (IM) curriculum proposal. RESULTS: Five key areas of concern emerged: (1) the definition of IM as presented in the paper; (2) lack of clarity about the goals of the proposed IM curriculum; (3) lack of recognition of the breadth of whole systems of health care; (4) omission of competencies related to collaboration between MDs and CAM professionals in patient care; and (5) omission of potential areas of partnership in IM education. CONCLUSIONS: A major overall theme emerging from the Delphi process was a desire for closer collaboration between conventional medical schools and CAM academic institutions in developing IM curricula. Several cross-disciplinary venues for addressing the Delphi Task Force themes include the National Center for Complementary and Alternative Medicine's R-25 Initiatives, and the National Education Dialogue. OCCIM is presented as an example of a successful lateral integration approach.

Neurobiological correlates of acupuncture: November 17-18, 2005.

The "Neurobiological Correlates of Acupuncture" Conference was convened November 17-18, 2005 in Bethesda, Maryland. The conference was sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). Its goals were to encourage exchange of ideas regarding the direction of neuroimaging in acupuncture research as well as to discuss some of the challenges in this field. The use of neuroimaging, a relatively recent advance in the study of acupuncture, holds the promise of localizing and characterizing brain activity associated with acupuncture interventions in real time and in a minimally invasive way. Among the main challenges to research into the biological mechanisms of acupuncture are the multiple treatment variables and the difficulties of selecting appropriate experimental controls. Despite these challenges, numerous findings from acupuncture neuroimaging experiments were presented and discussed at the conference on topics related to possible signaling networks, sham acupuncture controls, acupoint specificity, acupuncture analgesia, acupuncture-associated brain response, and the potential for using neuroimaging in conjunction with translational and clinical acupuncture research. Future directions in acupuncture neuroimaging research, as recommended by conference participants, should focus on (1) continuing exploration of acupuncture signaling networks; (2) establishing standards and recommendations for performing and reporting acupuncture neuroimaging results; (3) enabling data sharing in the acupuncture neuroimaging community; (4) gaining a better understanding of placebo and control groups in acupuncture neuroimaging experiments; and (5) developing biomarkers that relate to physiologically and/or clinically relevant acupuncture responses to neuroimaging results.

Developing a traditional chinese medicine diagnostic structure for post-traumatic stress disorder.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a common, disabling condition with many diverse symptoms including anxiety, depression, insomnia, and body pain. These symptoms are likely to be helped by treatment with Traditional Chinese Medicine (TCM); however, PTSD is not yet a recognized disorder (bing ming) in Chinese medicine. In preparation for a phase II clinical trial comparing TCM and cognitive behavioral therapy (CBT) treatment of PTSD symptoms, a TCM diagnostic pattern framework for persons who meet the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) definition of PTSD was sought. METHODS: Three approaches were used to identify the most likely TCM pattern differentiations for PTSD: an English-language TCM textbook review on the conditions "depression," "anxiety," and "insomnia"; a survey of 20 experienced practitioners of TCM; and TCM assessments of 21 individuals affected by PTSD. Two TCM practitioners synthesized the information into a list of pattern differentiations. RESULTS: The most likely pattern differentiations for PTSD were Heart Shen disturbance caused by Heat, Fire, or a constitutional deficiency; Liver Qi stagnation; and Kidney deficiency. Secondary patterns identified were outcomes of long-term Liver Qi stagnation-Liver overacting on Spleen/Stomach, Liver Fire, Phlegm Fire, Phlegm-Damp, and Heart Fire-and constitutional deficiencies in the Heart, Kidney, and Spleen organ systems. CONCLUSIONS: The use of extant literature, expert knowledge, and clinical TCM diagnoses contributed to the development of a TCM diagnostic structure for PTSD. The results can inform the clinical practice of TCM. The method can be used to guide research design involving different diagnostic systems.