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, 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.

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.

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.

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.

Unanticipated Insights into Biomedicine from the Study of Acupuncture.

Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies.

Biofield Science and Healing: History, Terminology, and Concepts.

Biofield science is an emerging field of study that aims to provide a scientific foundation for understanding the complex homeodynamic regulation of living systems. By furthering our scientific knowledge of the biofield, we arrive at a better understanding of the foundations of biology as well as the phenomena that have been described as "energy medicine." Energy medicine, the application of extremely low-level signals to the body, including energy healer interventions and bio-electromagnetic device-based therapies, is incomprehensible from the dominant biomedical paradigm of "life as chemistry." The biofield or biological field, a complex organizing energy field engaged in the generation, maintenance, and regulation of biological homeodynamics, is a useful concept that provides the rudiments of a scientific foundation for energy medicine and thereby advances the research and practice of it. An overview on the biofield is presented in this paper, with a focus on the history of the concept, related terminology, key scientific concepts, and the value of the biofield perspective for informing future research.

Clinical Studies of Biofield Therapies: Summary, Methodological Challenges, and Recommendations.

Biofield therapies are noninvasive therapies in which the practitioner explicitly works with a client's biofield (interacting fields of energy and information that surround living systems) to stimulate healing responses in patients. While the practice of biofield therapies has existed in Eastern and Western cultures for thousands of years, empirical research on the effectiveness of biofield therapies is still relatively nascent. In this article, we provide a summary of the state of the evidence for biofield therapies for a number of different clinical conditions. We note specific methodological issues for research in biofield therapies that need to be addressed (including practitioner-based, outcomes-based, and research design considerations), as well as provide a list of suggested next steps for biofield researchers to consider.

Manual and electrical needle stimulation in acupuncture research: pitfalls and challenges of heterogeneity.

In the field of acupuncture research there is an implicit yet unexplored assumption that the evidence on manual and electrical stimulation techniques, derived from basic science studies, clinical trials, systematic reviews, and meta-analyses, is generally interchangeable. Such interchangeability would justify a bidirectional approach to acupuncture research, where basic science studies and clinical trials each inform the other. This article examines the validity of this fundamental assumption by critically reviewing the literature and comparing manual to electrical acupuncture in basic science studies, clinical trials, and meta-analyses. The evidence from this study does not support the assumption that these techniques are interchangeable. This article also identifies endemic methodologic limitations that have impaired progress in the field. For example, basic science studies have not matched the frequency and duration of manual needle stimulation to the frequency and duration of electrical stimulation. Further, most clinical trials purporting to compare the two types of stimulation have instead tested electroacupuncture as an adjunct to manual acupuncture. The current findings reveal fundamental gaps in the understanding of the mechanisms and relative effectiveness of manual versus electrical acupuncture. Finally, future research directions are suggested to better differentiate electrical from manual simulation, and implications for clinical practice are discussed.

Nontouch biofield therapy: a systematic review of human randomized controlled trials reporting use of only nonphysical contact treatment.

UNLABELLED: OBJECTIVE AND CONTEXT: This review was designed to assess the quality and review the outcomes of randomized controlled trials (RCTs) of biofield therapies (external qigong, Healing Touch, Johrei, Reiki, and Therapeutic Touch) that report using only nonphysical touch forms of treatment. RCTs of nonphysical contact biofield therapies have the potential to contribute to an evidence base for health-promoting effects mediated through mechanisms outside the present understanding of biomedicine. METHODS: Articles meeting inclusion criteria were identified from database and reference list searches and evaluated for a range of reporting and design items. Data were extracted to determine the range of protocol parameters and treatment outcomes. The final set of included RCTs were evaluated via a modified 5-item Jadad scale as well as by a set of 20 criteria that included items relevant to the early-phase nature of the trials and to the examination of nonphysical touch biofield therapy interventions. RESULTS: Of 90 RCTs that assessed effectiveness of a biofield therapy in humans, 28 trials involving 1775 participants met additional inclusion criteria (most importantly a clearly reported use of only nonphysical contact treatment). The research designs of these 28 trials revealed marked heterogeneity in regard to condition treated, number and duration of treatments, nature of the control/comparison group, and outcome measures. Finally, 10 trials were excluded on the basis of low quality assessment scores. Twelve of the remaining 18 trials (7 Therapeutic Touch, 3 external qigong, 1 Reiki, and 1 Healing Touch) reported at least one primary outcome with statistically significant beneficial treatment outcomes. CONCLUSIONS: The pilot study nature of essentially all the identified nonphysical contact biofield therapy RCTs, as reflected by low sample sizes alone, precludes drawing robust conclusions. Given this perspective, the finding that two thirds of the higher-scoring trials demonstrated at least partial effectiveness favors a continued research effort, especially in light of the translational value of biofield clinical trials for studies exploring the nature and physiologic basis of biofield healing.

Faculty development initiatives to advance research literacy and evidence-based practice at CAM academic institutions.

OBJECTIVES: To present the varied approaches of 9 complementary and alternative medicine (CAM) institutions (all grantees of the National Center for Complementary and Alternative Medicine) used to develop faculty expertise in research literacy and evidence-based practice (EBP) in order to integrate these concepts into CAM curricula. DESIGN: A survey to elicit information on the faculty development initiatives was administered via e-mail to the 9 program directors. All 9 completed the survey, and 8 grantees provided narrative summaries of faculty training outcomes. RESULTS: The grantees found the following strategies for implementing their programs most useful: assess needs, develop and adopt research literacy and EBP competencies, target early adopters and change leaders, employ best practices in teaching and education, provide meaningful incentives, capitalize on resources provided by grant partners, provide external training opportunities, and garner support from institutional leadership. Instructional approaches varied considerably across grantees. The most common were workshops, online resources, in-person short courses, and in-depth seminar series developed by the grantees. Many also sent faculty to intensive multiday extramural training programs. Program evaluation included measuring participation rates and satisfaction and the integration of research literacy and EBP learning objectives throughout the academic curricula. Most grantees measured longitudinal changes in beliefs, attitudes, opinions, and competencies with repeated faculty surveys. CONCLUSIONS: A common need across all 9 CAM grantee institutions was foundational training for faculty in research literacy and EBP. Therefore, each grantee institution developed and implemented a faculty development program. In developing the framework for their programs, grantees used strategies that were viewed critical for success, including making them multifaceted and unique to their specific institutional needs. These strategies, in conjunction with the grantees' instructional approaches, can be of practical use in other CAM and non-CAM academic environments considering the introduction of research literacy and EBP competencies into their curricula.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.

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.

Biofield-based therapies: a systematic review of physiological effects on practitioners during healing.

BACKGROUND: Several recent reviews have reached guardedly positive conclusions about the effectivenessof biofield therapies in healthcare.(1,2) These studies mainly involved randomized controlled trials to determine changes in condition-related outcome measures, but few addressed the biological basis of these effects. STUDY OBJECTIVE AND RATIONALE: We performed a systematic review of studies designed to examine whether biofield therapists undergo physiological changes as they enter the healing state. If reproducible changes can be identified, they may serve as markers to reveal events that correlate with the healing process. METHODS: Databases were searched for controlled or non-controlled studies of biofield therapies in which physiological measurements were made on practitioners in a healing state, with or without a healee present. Design and reporting criteria, developed in part to reflect the pilot nature of the included studies, were applied using a yes (1.0), partial (0.5), or no (0) scoring system. RESULTS: Of 67 identified studies, the inclusion criteria were met by 22, 10 of which involved human healees. Overall, the studies were of moderate to poor quality and many omitted information about the training and experience of the healer. The most frequently measured biomarkers were electroencephalography (EEG) and heart rate variability (HRV). EEG changes were inconsistent and not specific to biofield therapies. HRV results suggest an aroused physiology for Reconnective Healing, Bruyere healing, and Hawaiian healing but no changes were detected for Reiki or Therapeutic Touch. CONCLUSIONS: Despite a decades-long research interest in identifying healing-related biomarkers in biofield healers, little robust evidence of unique physiological changes has emerged to define the healers׳ state.

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.

A prospective patient-centered data collection program at an acupuncture and oriental medicine teaching clinic.

OBJECTIVE: Large-scale patient-reported outcomes research investigating the role of acupuncture and Oriental medicine (AOM) in general practice is limited, despite the growing use of AOM in the United States. This article describes the development and refinement of a prospective, patient-centered outcomes data collection program at an Oriental medicine college and presents demographic and clinical data. SETTING/LOCATION: Individualized acupuncture treatment at the Oregon College of Oriental Medicine teaching clinic in Portland, Oregon. METHODS: A prospective patient-centered data collection program was implemented in 2007 using the Measure Your Medical Outcomes Profile (MYMOP) questionnaire and college-developed demographic and conditions forms. The forms were completed by patients on the first and fifth clinic visit. The program was revised after two years to streamline the data entry process and to include three Patient Reported Outcome Measurement Information System (PROMIS) questionnaires measuring pain, general health, and physical functioning. OUTCOME MEASURES: Outcome measures were patient demographics, chief complaints, MYMOP, and PROMIS data collected at first visit. RESULTS: Demographics were similar to those reported in other AOM settings. The majority of patients were Caucasian females and expressed confidence in acupuncture treatment. The most common chief complaint was joint and muscle pain. Additionally, we found that mean scores at baseline for global physical and mental health and physical functioning were all lower than U.S. averages. In contrast to some studies, we found that the majority of patients had previous experience with acupuncture. CONCLUSIONS: An ongoing, prospective data collection program can be successfully developed and implemented at an AOM college. The program will ultimately provide large-scale, patient-reported outcomes on patients seeking AOM treatment at the student clinic.

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.

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.