The importance of regulating the education and training of Traditional Chinese Medicine practitioners and a potential role for ISO/TC 249.

As Traditional Chinese Medicine (TCM) transcends its cultural boundaries and becomes widely used in many countries around the world, one of the major risks to the growing use of TCM internationally is the damage caused to its reputation and to community safety when TCM practitioners are not adequately trained. Ensuring the quality and competency of TCM practitioners is a fundamental requirement. This paper covers (1) the current level of regulation of education and training of TCM practitioners particularly in countries with well developed health systems; (2) the progress of self regulatory standards for education and training developed by international organizations and (3) the potential role of ISO/TC 249 in assisting these initiatives.

Standardizing therapeutic parameters of acupuncture for pain suppression in rats: preliminary study.

BACKGROUND: Despite acupuncture's wide and successful use, it is still considered as lacking scientifically rigorous evidence, especially with respect to its effectiveness. To address this problem, it is necessary to re-examine the practice of acupuncture using scientific methodology. The standardization of acupuncture practices may offer a solution. As a preliminary step towards the standardization of acupuncture stimulation in animal experiments, this study attempted to clarify the various therapeutic parameters that contribute to acupuncture's efficacy. METHODS: This study identified specific acupoints, temporal point of needling, rotation of the needle, duration of acupuncture, and diameter of the needle as the parameters, through formalin test. In this test, acupuncture was performed on either the ST36 or LR2 point immediately after pain induction and 5 minutes after pain induction. RESULTS: The formalin test yielded no significant suppression of pain in the case of ST36 and LR2 acupuncture stimulation immediately following pain induction. When acupuncture was applied 5 minutes after pain induction, however, the ST36 stimulation resulted in a significant decrease in pain, while the LR2 stimulation produced no change. The duration of acupuncture, but not the diameter of the needle, was also significant. As for the rotation of the needle, there was no significant difference in the pain reduction achieved in the rotation and non-rotation groups. CONCLUSIONS: We determined that specific acupoint, temporal point of needling, and duration of treatment are important factors in the inhibition of pain. These finding strongly suggest that in animal experiments, the application of a set of appropriate therapeutic parameters can significantly influence the outcome.

Accuracy of acupuncture point location among first-year acupuncture students: A pilot study evaluating the impact of training and use of an adjustable ruler.

BACKGROUND: The proportional method of acupuncture point location (APL) currently taught at Endeavor College of Natural Health and advocated by the World Health Organization Regional Office for the Western Pacific (WPRO) was found to be imprecise and/or inaccurate in previous student studies. The ruler and elastic methods of APL were identified as more accurate or precise than the proportional method of APL but were not well received by student participants. Use of an adjustable ruler may overcome barriers to uptake of the more accurate APL methods. This pilot study was the first to evaluate the comparative accuracy of the adjustable ruler and the proportional methods of APL in first-year students at a major Australian acupuncture training college. METHODS: After 10 weeks of in-class instruction in both proportional and adjustable ruler methods of APL, student participants (n = 14) attempted location of three acupuncture points (LI10, SP6 and ST38) on a volunteer using both APL methods of interest. A self-administered questionnaire and lecturer field notes elucidated attitudes to implementation of both APL methods. RESULTS: Points marked using the adjustable ruler were closer to the correct location than those marked using the proportional method across all three acupuncture points. Students and lecturers rated the adjustable ruler more highly than the proportional method for ease of learning and ease of use. CONCLUSION: Encouraging results with the adjustable ruler method warrant further larger scale studies. Use of the adjustable ruler method of APL should be considered for use in point location training at educational institutions teaching traditional acupuncture.

[Status of acupuncture service quality control].

In order to guarantee and improve the quality of acupuncture service, the developments of the control of acupuncture service quality in the World Health Organization (WHO) and various countries were summarized. A number of normative documents that could improve acupuncture service security and effectiveness have been developed in WHO and many countries, in which, acupuncture training, safety manipulation and the guidelines for clinical practice of disease have been included. There are great differences in the qualification authentication and management of acupuncture practitioners among different countries. In China and South Korea, the official government departments are in charge of the management, but, in most of the countries, the qualification attestation examination of acupuncture is conduced mainly by the national/local industry organizations authorized by the state and operated by the commissioned experts. The medical service quality evaluation system is complicated. Because of the specific characteristics of acupuncture discipline itself, it is necessary to develop the service quality assessment system and the standard which is especially adaptable in acupuncture discipline.

Brain imaging of acupuncture: comparing superficial with deep needling.

The difference between superficial and deep needling at acupuncture points has yet to be mapped with functional magnetic resonance imaging (fMRI). Using a 3T MRI, echo planar imaging data were acquired for 17 right-handed healthy volunteer participants. Two fMRI scans of acupuncture needling were taken in random order in a block design, one for superficial and one for deep needling on the right hand at the acupuncture point LI-4 (Hegu), with the participant blind to the order. For both scans needle stimulation was used. Brain image analysis tools were used to explore within-group and between-group differences in the blood oxygen level dependent (BOLD) responses. The study demonstrated marked similarities in BOLD signal responses between superficial and deep needling, with no significant differences in either activations (increases in BOLD signal) or deactivations (decreases in BOLD signal) above the voxel Z score of 2.3 with corrected cluster significance of P=0.05. For both types of needling, deactivations predominated over activations. These fMRI data suggest that acupuncture needle stimulation at two different depths of needling, superficial and deep, do not elicit significantly different BOLD responses. This data is consistent with the equivalent therapeutic outcomes that are claimed by proponents of Japanese and Chinese styles of acupuncture that utilise superficial and deep needling, respectively.

A Survey of Licensed Acupuncturists in the San Francisco Bay Area: Prevalence of Treating Oncology Patients.

BACKGROUND: Many cancer patients seek traditional Chinese medicine (TCM), the prevalence varying with diagnosis, comorbidities, and demographics. Interventions sought include acupuncture, massage, herbs, diet, and exercise, usually combined with conventional therapies. It is not known what proportion of TCM practitioners care for cancer patients, their cancer specific training or caseload, what interventions they employ, their outcomes, and their communication patterns with conventional oncologists. METHODS: A survey was mailed to all 2213 licensed acupuncturists in the 9-county San Francisco Bay Area gathering descriptive statistics. RESULTS: A total of 472 (21%) responded by mail or web-based Research Electronic Data Capture (REDCap) tool. Most respondents (77%) reported caring for patients with cancer, with 29% reporting having 6 to 10 years of practice experience, and 44.2% having 0 to 20 hours of training specific to the needs of patients with cancer. Improving quality of life was reported by 94% as what their treatment offered cancer patients as well as the area where treatment was felt to have the greatest impact. The most useful TCM modalities were acupuncture (98%), herbs (79%), diet (72%), moxibustion (46%), and meditation instruction (44%). Absence of adverse reactions was noted by 95%. Ninety-one percent reported "never" or "hardly ever" having been contacted by patients' oncologists to discuss treatment. CONCLUSIONS: Many acupuncturists seeing cancer patients have significant clinical experience and have sought specialized training. Improved communication is needed between TCM practitioners and oncologists sharing care of cancer patients.

Specific acupuncture sensation correlates with EEGs and autonomic changes in human subjects.

Sympathetic overactivation is suggested to be associated with chronic pain syndrome, and acupuncture is frequently applied in therapy for this syndrome. Furthermore, the forebrain including the various cerebral cortices has been implicated in inhibitory and facilitatory control of pain as well as autonomic functions. We investigated relationships among specific sensations induced by acupuncture manipulation, effects on sympathetic and parasympathetic autonomic functions, and EEG changes. An acupuncture needle was inserted into the right trapezius muscle of the subjects, and acupuncture manipulation was repeated to induce specific acupuncture sensation repeatedly while the needle was left in the muscle. Acupuncture manipulation significantly decreased heart rate (HR), and increased systolic blood pressure (SBP). Spectral analysis indicated that acupuncture manipulation significantly decreased low frequency components (LF) of both HR variability (HRV) and SBP variability (SBPV), and significantly reduced ratio of LF to high frequency component (HF) of HRV (LF/HF, index of sympathetic activity). Furthermore, there was a significant negative correlation between changes in LF/HF ratio of HRV and the number of specific acupuncture sensations reported, and a significant positive correlation between HF of HRV and the number of acupuncture sensations. Analyses of EEG data indicated that acupuncture manipulation non-specifically increased power of all spectral bands except the gamma band. Furthermore, changes in HF (index of parasympathetic activity) and total power (overall activity of the autonomic nervous system) of HRV were positively correlated with changes in theta, alpha, and gamma power, while changes in LF of SBPV and LF/HF of HRV were negatively correlated with changes in power of all spectral bands. These results are consistent with the suggestion that autonomic changes induced by manipulation inducing specific acupuncture sensations might be mediated through the central nervous system, especially through the forebrain as shown in EEG changes, and are beneficial to relieve chronic pain by inhibiting sympathetic nervous activity.

Experiences of acupuncturists in a placebo-controlled, randomized clinical trial.

BACKGROUND: This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials. METHODS: We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use. At the end of this study, we conducted written structured interviews with 8 participating acupuncturists. The acupuncturists were not aware of the study's results at the time of these interviews. The questions focused on their experiences in the study, adherence to study protocols, their thoughts about the technical and ethical issues involved in using a sham needling device, and their expectations of trial outcomes. The questions were motivated by expressions of concerns the acupuncturists raised in feedback groups during the course of the study, and our desire to improve further trials. RESULTS: The acupuncturists differed widely in their comfort levels with the research methods used, their adherence to the study protocol, and their expectations of trial outcomes. CONCLUSIONS: We conclude that careful monitoring of acupuncturists, including observation of treatments and frequent meetings to support them throughout the trial, is necessary to maintain a high degree of quality control.

[Differences and international standardization between acupuncture as therapy and as specialty].

The purpose of this study is to explore the differences of definition and clinical roles as well as international standardization between acupuncture as therapy and as specialty, which can provide reference evidence for specialization and internationalization of acupuncture. Owing to the clinical efficacy and safety, the credibility and controversy both exist in acupuncture; moreover, there is a lack of fair definition and international precedent regarding acupuncture specialty. Therefore, it is particularly essential to objectively compare the differences of definitions and clinical roles as well as criteria of international standardization for acupuncture as therapy and as specialty. It is believed acupuncture standardization can draw lessons from the international medical standards, evidence-based medicine and acupuncture theory from the following three major projects:acupuncture safety and contraindications; acupuncture indications and treatment guidelines; acupuncture indication classified into 3 levels of evidence-based acupuncture disease spectrum, as objective evidence of indication of acupuncture specialty.

[The current situation of acupuncture definition in international organizations and legislation of some countries].

Acupuncture is developing rapidly in the world, and more attention is paid on acupuncture in various countries. Because of the cultural differences, there are different views on acupuncture between China and the west, which has brought influence and challenge to the development of acupuncture in the world. Acupuncture-related research is becoming increasingly extensive and complex, but the definition of acupuncture is lack of unified standards. The definition of acupuncture is in urgent need. Based on the analysis of acupuncture definition in the 201 international organizations of 48 countries on five continents and legislation of representative countries, this paper summarized the development status of acupuncture in foreign countries, and put forward that the definition of acupuncture should adopt the model of small connotation and large extension, integrate discipline superiority, expand the scope of acupuncture, and focus on the overall situation.

Beyond needling--therapeutic processes in acupuncture care: a qualitative study nested within a low-back pain trial.

BACKGROUND: In the medical and scientific literature, there is a dearth of reports about how acupuncturists work and deliver care in practice. An informed characterization of the treatment process is needed to support the appropriate design of evaluative studies in acupuncture. METHODS: The design was that of a nested qualitative study within a pragmatic clinical trial. Six acupuncturists who treated up to 25 patients each were interviewed after the treatment phase of the trial to obtain an account of their experiences of providing acupuncture care to patients with low back pain referred by their GP. Using semistructured interviews and a topic guide, data were collected and analyzed for both a priori and emergent themes. This paper focuses on practitioners' accounts of the goals and processes of care, and describes the strategies employed in addition to needling and other hands-on treatments. RESULTS: From the interview data, it is clear that a coherent body of theoretical knowledge informed clinical decisions and practice, and that the goals of treatment went beyond the alleviation of immediate pain-related symptoms. Acupuncturists in this study all described a pattern of patient-centered care based on a therapeutic partnership. Study participants confirmed the importance of three processes that characterized acupuncture care in this trial, each contributing to the goal of a positive long-term outcome; building a therapeutic relationship; individualizing care; and facilitating the active engagement of patients in their own recovery. Acupuncturists described elements of care that characterized these processes including establishing rapport, facilitating communication throughout the period of care, using an interactive diagnostic process, matching treatment to the individual patient, and the use of explanatory models from Chinese medicine to aid the development of a shared understanding of the patient's condition and to motivate lifestyle changes that reinforce the potential for a recovery of health. Acupuncturists did not view these therapeutic goals, processes, and strategies as a departure from their usual practice. CONCLUSIONS: This study suggests that acupuncture care for patients with chronic conditions such as low back pain is likely to be a complex intervention that utilizes a number of patient-centered strategies to elicit longterm therapeutic benefits. Research designed to evaluate the effectiveness of acupuncture as it is practiced in the UK needs to accommodate the full range of therapeutic goals and related treatment processes.

[Investigation for use of The Name and Location of Acupoints(GB/T 12346-2006), national standard].

To understand the use in recent 10 years of The Name and Location of Acupoints(GB/T 12346-2006),a standard of The People's Republic of China,so as to provide the evidence for its further establishment and revision,we investigated and analyzed the application of The Name and Location of Acupoints through relevant literature and the textbook. It is found that making use of the standard is being realized in various types of articles and it is described in almost all the textbooks. Implementing the standard intensively promotes the standardization of acupuncture-moxibustion education and clinical manipulation as well as the academic exchange domestically and overseas. In turn,its scientificalness and authority are further strengthened.

[Doubting the twirling angle of filiform needle in Science of Acupuncture and Moxibustion textbooks and National Standards].

In National Standards (GB) as well as the textbooks used in TCM universities, the twirling angles of acupuncture manipulation vary a lot. By reviewing the previous editions of textbooks from 3 publication houses and comparing the relevant contents, the author calculated the arc lengths of various twirling angles based on the specification of filiform needle in National Standards (GB) and International Standards (ISO). The conclusion is that the twirling angles mentioned in National Standards (GB) and textbooks are too small and not in compliance with the clinical practice. Hence, it is not advisable to propose a rigid specific provision of twirling angle in acupuncture manipulation.

[Science of Acupuncture and Moxibustion should include standards related to acupuncture and moxibustion].

The development of Science of Acupuncture and Moxibustion should be in accord with the trend of standardization and internationalization of the science of acupuncture and moxibustion. Based on the arrangement of chapters and sections in the textbook, 29 national standards, 6 standards or guidelines made by World Health Or- ganization(WHO) and 1 standard out of International Standardization Organization (ISO) are classified and intro- duced. It is suggested that the above contents should be considered as the evidence when the textbook is reedited. Also, it is proposed that humanization should be supplemented and the newest research findings should be traced.

The practice of acupuncture: who are the providers and what do they do?

PURPOSE: This study provides basic information about the training and practices of licensed acupuncturists. METHODS: Randomly selected licensed acupuncturists in Massachusetts and Washington state were interviewed and asked to record information on 20 consecutive patient visits. RESULTS: Most acupuncturists in both states had 3 or 4 years of academic acupuncture training and had received additional "postgraduate" training as well. Acupuncturists treated a wide range of conditions, including musculoskeletal problems (usually back, neck, and shoulder) (33% in Massachusetts and 47% in Washington), general body symptoms (12% and 9%, respectively) such as fatigue, neurological problems (10% and 12%, respectively) (eg, headaches), and psychological complaints (10% and 8%, respectively) (especially anxiety and depression). Traditional Chinese medicine (TCM) was the predominant style of acupuncture used in both states (79% and 86%, respectively). Most visits included a traditional diagnostic assessment (more than 99%), regular body acupuncture (95% and 93%, respectively), and additional treatment modalities (79% and 77%, respectively). These included heat and lifestyle advice (66% and 65%, respectively), most commonly dietary advice and exercise recommendations. Chinese herbs were used in about one third of visits. Although most patients self-referred to acupuncture, about one half received concomitant care from a physician. Acupuncturists rarely communicated with the physicians of their patients who were providing care for the same problem. CONCLUSIONS: This study contributes new information about acupuncturists and the care they provide that should be useful to clinicians interested in becoming more knowledgeable about complementary or alternative medical therapies available to their patients.

Credentialing complementary and alternative medical providers.

Since the late 19th century, state legislatures and professional medical organizations have developed mechanisms to license physicians and other conventional nonphysician providers, establish standards of practice, and protect health care consumers by establishing standardized credentials as markers of competence. The popularity of complementary and alternative medical (CAM) therapies presents new challenges. This article describes the current status of, and central issues in, efforts to create models for health care credentialing of chiropractors, acupuncturists, naturopaths, massage therapists, and other CAM practitioners. It also suggests a strategy of CAM provider credentialing for use by physicians, health care administrators, insurance companies, and national professional organizations. The credentialing debate reflects fundamental questions about who determines which providers and therapies will be accepted as safe, effective, appropriate, and reimbursable. More nationally uniform credentialing mechanisms are necessary to ensure high standards of care and more generalizable clinical research. However, the result of more uniform licensure and credentialing may be excessive standardization and a decrease in individualization of services. Thus, increased standardization of credentialing for CAM practitioners may alter CAM practice substantially. Furthermore, even credentialed providers can deliver ineffective therapy. The suggested framework balances the desire to protect the public from dangerous practices against the wish to grant patients access to reasonably safe and effective therapies.

Acupuncture: theory, efficacy, and practice.

Traditionally, acupuncture is embedded in naturalistic theories that are compatible with Confucianism and Taoism. Such ideas as yin-yang, qi, dampness, and wind represent East Asian conceptual frameworks that emphasize the reliability of ordinary, human sensory awareness. Many physicians who practice acupuncture reject such prescientific notions. Numerous randomized, controlled trials and more than 25 systematic reviews and meta-analyses have evaluated the clinical efficacy of acupuncture. Evidence from these trials indicates that acupuncture is effective for emesis developing after surgery or chemotherapy in adults and for nausea associated with pregnancy. Good evidence exists that acupuncture is also effective for relieving dental pain. For such conditions as chronic pain, back pain, and headache, the data are equivocal or contradictory. Clinical research on acupuncture poses unique methodologic challenges. Properly performed acupuncture seems to be a safe procedure. Basic-science research provides evidence that begins to offer plausible mechanisms for the presumed physiologic effects of acupuncture. Multiple research approaches have shown that acupuncture activates endogenous opioid mechanisms. Recent data, obtained by using functional magnetic resonance imaging, suggest that acupuncture has regionally specific, quantifiable effects on relevant brain structures. Acupuncture may stimulate gene expression of neuropeptides. The training and provision of acupuncture care in the United States are rapidly expanding.

[The trajectory of the introduction and regulation of acupuncture in Brazil: recollections of the challenges and struggles]. / A trajetória da introdução e regulamentação da acupuntura no Brasil: memórias de desafios e lutas.

Based on the life experiences of acupuncturists, the scope of this study was to examine the struggle to obtain regulation of the practice of acupuncture in Brazil. The method used was Oral Live History, the core issue being the dimension of the human experience involved in this trajectory of struggles and challenges. We conducted ten interviews, following the set of procedures demanded by the Oral History technique. The information contained in the narratives was analyzed and, taking the interpretive approach called immersion/crystallization as a benchmark, the central themes of the work were established, based on which which the discussion was developed. The results indicate the emergence of highly controversial themes involving political, corporate and cultural aspects, which constitute central elements within a historical process still under development.

Standardisation of moxibustion: challenges and future development.

International organisations such as WHO and the International Organization for Standardization are increasingly committed to the development of traditional Chinese medicine (TCM). Moxibustion is an integral modality of acupuncture that has been in use for thousands of years. It stands out as a health choice due to its potential effects in disease prevention, health promotion and maintenance, as well as affordability and accessibility. As the use of moxibustion increases, concerns are being raised regarding its safety and quality. The need to establish standards to protect patient safety is paramount in all medical fields. As a form of medical practice, it is essential to develop moxibustion standards in the areas of terminology, moxibustion products, treatment rooms and practice to ensure its harmonisation and safe usage. The evidence base guiding policy and decision making has to be based on evidence from basic and clinical research. Promoting strategic basic and clinical research on the safety and effectiveness of moxibustion will answer some of the fundamental questions surrounding moxibustion, create a climate of awareness and acceptance and, in turn, drive its standardisation.

[Principles and Methods for Formulating National Standards of "Regulations of Acupuncture-nee- dle Manipulating techniques"].

The national standard of "Regulations of Acupuncture-needle Manipulating Techniques" is one of the national Criteria of Acupuncturology for which a total of 22 items have been already established. In the process of formulation, a series of common and specific problems have been met. In the present paper, the authors expound these problems from 3 aspects, namely principles for formulation, methods for formulating criteria, and considerations about some problems. The formulating principles include selection and regulations of principles for technique classification and technique-related key factors. The main methods for formulating criteria are 1) taking the literature as the theoretical foundation, 2) taking the clinical practice as the supporting evidence, and 3) taking the expounded suggestions or conclusions through peer review.