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1.  The effect of expectancy and personality on cortical excitability in Parkinson’s disease 
Background
Our previous studies in PD 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.
Methods
Twenty-six Parkinson’s patients were randomized to one of three 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.
Results
Degree of expectancy had a significant effect on MEP response (p<0.05). Subjects in the 50% and 100% expectancy groups responded with a decrease in MEP, while those in the 0% expectancy group responded with an increase in MEP (p<0.05). Responders tended to be more open to experience than non-responders. There were no significant changes in objective physical fatigue between the expectancy groups, or between responders and non-responders.
Conclusions
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.
doi:10.1002/mds.25471
PMCID: PMC3735617  PMID: 23630185
Parkinson’s disease; Levodopa; Expectancy; Cortical Excitability; Transcranial Magnetic Stimulation (TMS)
2.  Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document 
Trials  2014;15:169.
Background
There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.
Methods
The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.
Results
Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
Conclusion
The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.
doi:10.1186/1745-6215-15-169
PMCID: PMC4045891  PMID: 24885146
Comparative effectiveness research; Effectiveness guidance document; Chinese medicine research
3.  Comparative Effectiveness of Traditional Chinese Medicine (TCM) and Psychosocial Care in the Treatment of TMD-associated Chronic Facial Pain 
Summary
This dual-site study sought to identify the appropriate role for TCM (acupuncture and herbs) in conjunction with a validated psychosocial self-care intervention (SC) for treating chronic TMD-associated pain. Participants with RDC-TMD-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, current pain; each 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, −0.60 [SDE 0.26], p=0.020), and greater reduction in interference with social activities (−0.81 [SDE 0.33], p=0.016). In two of five treatment trajectory groups, more than 2/3 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 Traditional Chinese Medicine 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.
doi:10.1016/j.jpain.2012.08.002
PMCID: PMC3490702  PMID: 23059454
4.  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.
doi:10.1186/1472-6882-13-181
PMCID: PMC3750563  PMID: 23866767
Acupuncture; AcuTrials; CAM; Databases; Informatics; Evidence-based medicine
5.  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.
doi:10.1186/1472-6882-12-148
PMCID: PMC3495216  PMID: 22953730
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
6.  Reductions in Pain Medication Use Associated with Traditional Chinese Medicine for Chronic Pain 
The Permanente Journal  2012;16(3):18-23.
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.
PMCID: PMC3442756  PMID: 23012594
7.  How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain 
PLoS ONE  2012;7(2):e32399.
Background
For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.
Methods
We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.
Principal Findings
From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02–0.60), which improved after consensus discussions to 0.20–1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.
Conclusion
Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.
doi:10.1371/journal.pone.0032399
PMCID: PMC3289651  PMID: 22389699
8.  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.
doi:10.1155/2011/180805
PMCID: PMC2957136  PMID: 20976074
9.  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.
doi:10.1155/2011/183910
PMCID: PMC2952291  PMID: 20953418
10.  Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement 
PLoS Medicine  2010;7(6):e1000261.
Hugh MacPherson and colleagues present an updated reporting guideline called STRICTA, which stands for Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture.
doi:10.1371/journal.pmed.1000261
PMCID: PMC2882429  PMID: 20543992
11.  Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement 
Acupuncture in Medicine  2010;28(2):83-93.
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.
doi:10.1136/aim.2009.001370
PMCID: PMC3002761  PMID: 20615861
12.  A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders 
Objectives
To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research.
Design
A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC).
Setting/location
Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon.
Subjects
One hundred and sixty (160) women 25–55 years of age attending a KPNW TMD specialty clinic.
Interventions
Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided.
Outcome measures
TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0–10 where 10 is worst).
Results
Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = −1.11 ± 0.43, p = 0.010 and −1.02 ± 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (−1.07 ± 0.51, p = 0.037 and −1.27 ± 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference.
Conclusions
These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.
doi:10.1089/acm.2007.0738
PMCID: PMC2756304  PMID: 18564953
14.  A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders 
Abstract
Objectives
To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research.
Design
A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC).
Setting/location
Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon.
Subjects
One hundred and sixty (160) women 25–55 years of age attending a KPNW TMD specialty clinic.
Interventions
Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided.
Outcome measures
TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0–10 where 10 is worst).
Results
Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = −1.11 ± 0.43, p = 0.010 and −1.02 ± 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (−1.07 ± 0.51, p = 0.037 and −1.27 ± 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference.
Conclusions
These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.
doi:10.1089/acm.2007.0738
PMCID: PMC2756304  PMID: 18564953
15.  Electrical impedance along connective tissue planes associated with acupuncture meridians 
Background
Acupuncture points and meridians are commonly believed to possess unique electrical properties. The experimental support for this claim is limited given the technical and methodological shortcomings of prior studies. Recent studies indicate a correspondence between acupuncture meridians and connective tissue planes. We hypothesized that segments of acupuncture meridians that are associated with loose connective tissue planes (between muscles or between muscle and bone) visible by ultrasound have greater electrical conductance (less electrical impedance) than non-meridian, parallel control segments.
Methods
We used a four-electrode method to measure the electrical impedance along segments of the Pericardium and Spleen meridians and corresponding parallel control segments in 23 human subjects. Meridian segments were determined by palpation and proportional measurements. Connective tissue planes underlying those segments were imaged with an ultrasound scanner. Along each meridian segment, four gold-plated needles were inserted along a straight line and used as electrodes. A parallel series of four control needles were placed 0.8 cm medial to the meridian needles. For each set of four needles, a 3.3 kHz alternating (AC) constant amplitude current was introduced at three different amplitudes (20, 40, and 80 μAmps) to the outer two needles, while the voltage was measured between the inner two needles. Tissue impedance between the two inner needles was calculated based on Ohm's law (ratio of voltage to current intensity).
Results
At the Pericardium location, mean tissue impedance was significantly lower at meridian segments (70.4 ± 5.7 Ω) compared with control segments (75.0 ± 5.9 Ω) (p = 0.0003). At the Spleen location, mean impedance for meridian (67.8 ± 6.8 Ω) and control segments (68.5 ± 7.5 Ω) were not significantly different (p = 0.70).
Conclusion
Tissue impedance was on average lower along the Pericardium meridian, but not along the Spleen meridian, compared with their respective controls. Ultrasound imaging of meridian and control segments suggested that contact of the needle with connective tissue may explain the decrease in electrical impedance noted at the Pericardium meridian. Further studies are needed to determine whether tissue impedance is lower in (1) connective tissue in general compared with muscle and (2) meridian-associated vs. non meridian-associated connective tissue.
doi:10.1186/1472-6882-5-10
PMCID: PMC1142259  PMID: 15882468

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