Is Chinese Medicine Facing a Potential Workforce Crisis in Australia? Demographic Changes in the Profession over the Last Decade.

Background: As a prominent part of complementary and alternative medicine, Chinese Medicine (CM) has proved its strengths in treating a diverse range of acute and chronic medical conditions and is at present recognized in 196 countries and territories worldwide. In 2012, Australia regulated the CM profession under the National Regulation and Accreditation Scheme (NRAS) by legislation and reports quarterly demographic information about individual CM practitioners so to ensure public interest, although research examining the change of CM workforce in Australia has been scarce. Objective: This study aims to investigate the construction of the CM workforce in Australia and more importantly, evaluated its development in the last decade to capture the trajectory and trend in the present period and future potential changes. Methods: Data were sourced from the Australian Health Practitioner Regulation Agency (AHPRA) annual reports and the Chinese Medicine Board of Australia (CMBA) registration statistics from 2012 to 2023. A descriptive analysis was conducted with demographic variables, including profession, age, and gender, and chi-square tests and linear regression modeling were carried out to assess the variations between regions and across years. Results: The population of CM practitioners in 2022/2023 stagnated with slight decrease to 4,823, in contrast to the increase rate of 2.9% in the whole health care community. The number of young CM registrants (<35 y) shrank by 37.5% from 691 in 2012 to 432 in 2023. In comparison with other health care professions, CM comprises the smallest proportion of the population aged younger than 25 (0.2%) and the largest proportion aged older than 65 years (16.2%), advancing into an aging era. Conclusions: This study indicates a worrying potential decline in CM workforce in Australia, which is likely to be further exacerbated by the lack of new graduates and rise of median age among practitioners. Meanwhile, continued advancement in Western medicine technology and standards requires substantial efforts to increase both a better understanding of CM and demonstration of its efficacy. Furthermore, greater effort is needed to recruit and educate new young CM practitioners in Australia and to broaden the international training pipeline for a sustainable development of CM practice.

Effects of Qigong Therapy on the Anaerobic Threshold in Patients with Stable Coronary Artery Disease: A Randomized Controlled Trial.

Objective: This study aims to identify whether Qigong (QG) rehabilitation therapy can significantly improve the cardiac function of patients with stable coronary artery disease (SCAD) compared with routine therapy. Thus, a randomized controlled trial was conducted to evaluate the curative effects of a three-month QG rehabilitation therapy on cardiac rehabilitation. Patients and Methods. In this trial, a total of 68 patients with SCAD were randomly divided into the QG group (34 patients) and the control (CON) group (34 patients). Patients in the CON group received routine cardiologic medication without any special intervention. Based on the treatment in the CON group, patients in the QG group were provided additionally with a 12-week traditional Chinese medicine (TCM) cardiac rehabilitation QG exercise training program. The outcomes of these patients were assessed at baseline and after 12 weeks of intervention through the treadmill (anaerobic threshold (AT)) test. Results: After 12 weeks of intervention, the AT, volume of oxygen (VO2), oxygen uptake/kilogram (VO2/kg), metabolic equivalents (METS), and oxygen pulse (VO2/HR) of patients in the QG group were significantly higher than those of patients in the CON group (P < 0.05). Conclusion: QG therapy can achieve certain curative effects and safety for patients with SCAD. This trial is registered with Clinicaltrials.gov identifier (ChiCTR1800015823).

Clinical reasoning in traditional medicine exemplified by the clinical encounter of Korean medicine: a narrative review.

BACKGROUND: Clinical reasoning is generally defined to be a way of thinking for diagnostic or therapeutic decision making in clinical practice. Different cognitive models have been proposed for the clinical reasoning which takes place during the clinical encounter with a patient. This may have similarities with similar approaches used in Traditional Korean Medicine (TKM). Jinchal, the clinical encounter, has specific features in TKM and different Jinchal processes are closely related to several underlying cognitive models in clinical reasoning. It is a necessary process to see the patient, but in TKM, the method has a characteristic aspect and emphasis is placed on importance. METHODS: Experts consensus were reached through panel discussion. Narrative description on the concept of clinical reasoning and explanation on Jinchal process in TKM were suggested. RESULTS: This article analyses the Jinchal process using theoretical concepts from four authentic KM schools of clinical reasoning which are currently used in contemporary practice. CONCLUSION: Future research should focus on the similarities and differences in understanding clinical reasoning in KM as well as the broader field of traditional East Asian Medicine.

A pre-trial evaluation of blinding for a Chinese herbal medicine trial.

BACKGROUND: Blinding is considered an important methodological characteristic in clinical trials to minimise bias and maximise the validity of a trial. Unlike pharmaceutical substances, most herbal medicines have distinctive sensory specifications, including odour and taste, which can be quite challenging when developing a placebo control to match the specific characteristics of herbal substances being examined. The present study was, therefore, designed to evaluate whether the participants could differentiate an active herbal capsule (Ganopoly combination) from a placebo material capsule. The aim of this study was to develop a suitable placebo substance for encapsulation to be used in a future herbal medicine clinical trial. METHODS: The current study was improved upon the previous investigation, and several modifications were made to the placebo substance in order to mimic the herbal substance characteristics. Prior to conducting the study, a refined placebo substance was developed using commonly consumed culinary agents. Sixty-two healthy volunteers participated in the study and were randomly provided one of the two substances. Individuals were asked to evaluate the three sensory characteristics of the allocated capsule (visual appearance, odour, and taste), and determine whether they believed the substance to be a 'herbal' or a 'placebo' substance. RESULTS: The study provided evidence on the success of blinding for only two sensory characteristics, namely, visual appearance (95% CI -0.15, 0.34) and odour (95% CI -0.34, 0.15). In contrast, the findings related to the taste indicated that participants correctly guessed the herbal substance compared to the placebo substance to a significantly higher proportion than would have been expected by chance alone (95% CI 0.14, 0.60). CONCLUSION: The failure to blind participants for taste highlights the difficulties in preparing placebo herbal substances that match as closely as possible to a real herbal substance. Blinding is particularly challenging where herbal medicines have different sensory characteristics.

A multi-center international study of acupuncture for lateral elbow pain - Results of a randomized controlled trial.

BACKGROUND: Lateral elbow pain (LEP) due to tendinosis is one of the most common musculoskeletal pains of the upper limbs, yet there is no satisfactory treatment. This study was an international, prospective, multi-centre, randomized, controlled, clinical trial to evaluate the efficacy of acupuncture compared to sham laser in the treatment of LEP. METHODS: The study used a parallel and stratified design (1:1 allocation using a computer-generated sequence) and was participant-, outcome assessor- and statistician-blinded. Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centres in Australia, China, Hong Kong and Italy. The treatment group received manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham laser acupuncture at the same acupoints. The primary endpoint was disabilities of the arm, shoulder, and hand (DASH) questionnaire score at the three-week post-treatment follow-up visit. Three VAS scales (pain at rest, pain on motion and pain during exertion) were secondary outcomes measures. Ninety-six subjects were allocated to either the treatment group (n = 47) or control group (n = 49) and were all included in the analysis. RESULTS: At the follow-up visit, we found significant differences in DASH score between the two groups (p = .015). The median change to baseline for the treatment group was -11.7 (interval: -50.83 to 23.33), and for the control group -7.50 (interval: -36.67 to 29.10). The estimated effect size was 0.47, indicating a medium effect. Significant differences were also found for secondary outcome measures for VAS of pain. There were no severe adverse events. Our findings suggest that acupuncture has a moderate efficacy in the treatment of LEP. CONCLUSIONS: Acupuncture was shown to be efficacious in improving the function of the arm associated with lateral elbow tendinosis. Both the DASH score and the pain VAS on two occasions (at rest and during motion) showed a significant change over time indicating acupuncture as a potential treatment for LEP due to tendinosis.

Anxiety related to De Qi psychophysical responses as measured by MASS: A sub-study embedded in a multisite randomised clinical trial.

Acupuncture has been broadly applied in the management of many diseases and conditions; however, its mechanism of action has been partially elucidated. Additionally, assessment of psychophysical responses in the acupuncture therapy is not common regarding anxiety disorder studies. Taken together, the therapeutic effect of acupuncture appears when De Qi psychophysical response is experienced following stimulation of the afferent sensory nerves. The present study investigates the level of anxiety perceived at different occasions in acupuncture and mock laser group. Furthermore, it examines the relationship between perceived De Qi psychophysical response and the level of anxiety experienced during administration of each intervention. The study was embedded in a two-arm parallel design multi-center, randomized clinical trial, the Tennis Elbow Acupuncture-International Study-China, Hong Kong, Australia, Italy. Participants' level of anxiety was measured using a validated instrument, the Massachusetts General Hospital Acupuncture Sensation Mood Scale. Ninety-six participants with Lateral Elbow Pain were randomly allocated into two groups; the acupuncture treatment group (n = 47) and the inactive mock laser control group (n = 49). Data were collected immediately following the interventions at the first and the ninth session within the clinical trial. Acupuncture with De Qi did not induce higher level of anxiety compared to prior administration of acupuncture. In fact, participants were more relaxed after receiving acupuncture than those who received mock laser. There was also a weak association between participants' perception of anxiety during acupuncture and the MASS De Qi Index in session nine only (p < 0.01). Further investigation of the result revealed weak positive correlation between anxiety perceived during administration of acupuncture and the following De Qi characteristics; 'soreness' (p < 0.01), 'Deep pressure' (p < 0.05), 'Heaviness' (p < 0.05), and 'Fullness/distension' (p < 0.05). Acupuncture can be regarded as a potential therapy for preoperative anxiety through its possible regulatory function of emotion. While culture may not alter the expectation of the individual regarding anxiety, symptomology associated with anxiety should be understood within the context of the cultural background.

An experimental study in distinguishing an authentic herbal substance from sham herbal substances.

OBJECTIVES: An unblinded randomised trial can result in biased treatment effect estimates and lead to erroneous conclusions on the efficacy of the therapeutic intervention. Unlike pharmaceutical substances, Chinese herbal medicines have special characteristics including texture, colour, odour and taste as the origin of these constituents are different. In addition, its distinctive odour makes blinding of Chinese herbal medicine RCTs very difficult, as the placebo substance needs to match the special characteristics of the herbal substance being investigated. For these reasons, two studies were undertaken to evaluate whether a participant could distinguish a herbal intervention capsule (Ganopoly combination) when compared to three types of capsules containing culinary materials following a visual, odour and taste evaluation. DESIGN: Study One, was a pilot involving eleven participants (n = 11) while Study Two, involved eighty one participants (n = 81) and was conducted to make improvements on Study One. For both studies, participants were asked to identify which of four capsules were a herbal substance following a visual, smell and taste evaluation. RESULTS: For study One it was found that for both odour (p = .484) and visual appearance (p = .077) the number of participants selecting the herbal substance was not significantly different from what may have been selected by chance. This was not the case for taste where significantly more participants selected capsule B as the herbal substance (p = .004). For Study Two test it was found that all three evaluations for odour, visual appearance and taste significantly more participants selected the herbal substance (p < .0001 in all cases). This indicates that the participant guesses were not evenly distributed across the four choices and suggests a failure to blind. CONCLUSION: The failure to blind participants highlights the difficulties in preparing sham herbal substances that look, smell and taste like the real herbal substance.

Treatment of Sciatica Following Uterine Cancer with Acupuncture: A Case Report.

For women, gynaecological or obstetrical disorders are second to disc prolapse as the most common cause of sciatica. As not many effective conventional treatments can be found for sciatica following uterine cancer, patients may seek assistance from complementary and alternative medicine. Here, we present a case of a woman with severe and chronic sciatica secondary to uterine cancer who experienced temporary relief from acupuncture.

Investigation of the Phenomenon of Propagated Sensation along the Channels in the Upper Limb Following Administration of Acupuncture and Mock Laser.

BACKGROUND: Similar to De Qi psychophysical responses, propagated sensation along the channels (PSC) is considered an important phenomenon in traditional Chinese acupuncture. In acupuncture clinical trials, different acupuncture manipulation techniques are used to enhance the propagation of sensation along the channels to facilitate an optimum therapeutic result. AIM: To examine and compare the PSC reported by participants in a clinical trial following the administration of acupuncture and inactive mock laser. METHODS: The study was embedded in a two-arm parallel design multicenter, randomized clinical trial, the Tennis Elbow Acupuncture-International Study-China, Hong Kong, Australia, Italy (TEA IS CHAI). Needle sensations were measured using a validated instrument, the Massachusetts General Hospital Acupuncture Sensation Spreading Scale. Ninety-six participants with lateral elbow pain were randomly allocated into two groups in a 1:1 ratio; the acupuncture treatment group (n = 47) and the mock laser control group (n = 49). Participants in both groups received the intervention at two acupoints, LI10 and LI11, consisting of 2 minutes of either standardized needle manipulation or mock laser at each acupoint with a rest period between each intervention period. Data were collected immediately following the interventions at the first and the ninth session within the clinical trial. RESULTS: Although participants in both groups perceived PSC radiating to similar sites along the upper limb, the frequency of the reported radiation sites among the two intervention groups for both radiation up the limb (p < 0.05) and radiation down the limb (p < 0.001) were statistically significantly different. Among the radiating sensation sites recorded within the two study groups, the sensations were reported as radiating a greater distance down the forearm to the wrist compared to up the arm. Evaluation of PSC across the four study sites revealed a statistically significant difference in frequency of the reported radiation down the limb sites in each study group and radiation up the limb sites only in control group only (p < 0.001). CONCLUSION: The findings of the study demonstrated that the PSC phenomenon is not just associated with needling but can be perceived when using a mock laser. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry reference: ACTRN12613001138774 on 11th of October 2013.

Psychophysical responses in patients receiving a mock laser within context of an acupuncture clinical trial: an interoceptive perspective.

BACKGROUND: The psychophysical responses induced by verum acupuncture are characterized by a constellation of unique subjective sensory responses commonly termed De Qi. Furthermore, a variety of sham interventions have been used as a control for acupuncture clinical trials. Indeed, one such control has been mock laser which has been used as control intervention in several acupuncture clinical controlled trials. The current study aim was to examine the De Qi sensory responses and its related characteristics elicited from acupuncture and compare them to those reported following sham laser in participants enrolled in a clinical trial. METHODS: The study was embedded in a multi-center, two-arm randomised clinical trial, which evaluated the effect of acupuncture on lateral elbow pain. De Qi was assessed using the Massachusetts General Hospital Acupuncture Sensation Scale (MASS). Ninety-six participants were randomly allocated to receive either acupuncture (n = 47) or mock laser (n = 49) at the acupoints LI 10 and LI 11. RESULTS: Participants in both intervention groups reported similar De Qi psychophysical characteristics; however, both intensity and frequency of the individually perceived De Qi characteristics were significantly higher in the acupuncture group. 'Soreness', 'deep pressure', and 'fullness-distension' in the acupuncture group and 'tingling', and 'sharp pain' in mock laser group, were identified as the leading characteristics. Similar level of MASS De Qi Index (MDI) scores were reported for 'Hong Kong-China' and 'Australia-Italy' with a significantly higher level of De Qi reported by 'Hong Kong-China'. Furthermore, two distinct De Qi categories were identified, namely De Qi (in line with classical sensory responses of Suan, Ma, Zhang, and Zhong) and pain. CONCLUSIONS: Subjective 'somatic or interoceptive awareness' should be taken into account when De Qi psychophysical responses are examined. The study accentuates the necessity and the significance of further research into interoception phenomenon which may contribute to a better understanding of the placebo effect and De Qi psychophysical responses. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry reference: ACTRN12613001138774 on 11th of October 2013.

Reliability of the NICMAN Scale: An Instrument to Assess the Quality of Acupuncture Administered in Clinical Trials.

BACKGROUND: The aim of this study was to examine the reliability of a scale to assess the methodological quality of acupuncture administered in clinical research. METHODS: We invited 36 acupuncture researchers and postgraduate students to participate in the study. Firstly, participants rated two articles using the scale. Following this initial stage, modifications were made to scale items and the exercise was repeated. Interrater reliability was assessed for individual items using the Fleiss kappa statistic, whilst the overall scale used the intraclass correlation coefficient statistic. A threshold agreement of ≥0.61 was acceptable. RESULTS: We received 26 responses and a 72% response rate. The first phase of testing found moderate reliability with intraclass correlation coefficients of 0.46 and 0.55 for the articles. The interrater reliability of the scales varied between and within the researchers (0.35, 0.60) and was more consistent with the postgraduate students (0.54, 0.54). Five items on the scale scored below the threshold and were revised for further testing. In this phase the intraclass correlation coefficient demonstrated variability between articles but improved to achieve reliability above the agreed threshold. CONCLUSION: This study provides evidence of the reliability of the NICMAN scale although improvements to a small number of items remain.

Moxibustion for the treatment of osteoarthritis: An updated systematic review and meta-analysis.

The aim of this study was to update previous reviews and examine recent evidence from randomised clinical trials (RCTs) of the use of moxibustion for osteoarthritis (OA). Twelve databases were searched from inception through to September 2016 with no language limits applied. Data extraction and risk-of-bias assessments were performed by two independent reviewers. A total of 19 RCTs met all inclusion criteria and were evaluated. Three RCTs compared the effects of moxibustion with those of sham moxibustion in patients with knee OA (KOA) and found favourable effects of moxibustion on pain reduction (n=305; SMD, -0.46; 95% CI: -0.86 to -0.06, P=0.02, I2=65%), including at follow-up (n=305; SMD, -0.36; 95% CI: -0.70 to -0.01, P=0.04, I2=54%). Eleven RCTs compared the effects of moxibustion with those of conventional oral drug therapies. Eight RCTs reported a total symptom score and the meta-analysis showed superior effects of moxibustion compared with drug therapies for this measure (n=691; SMD, -0.24; 95% CI: -0.78 to 0.29; P=0.37, I2=91%) and response rate (n=758 knees; RR, 1.10; 95% CI: 1.05-1.16, P <0.0001, I2=0%). Three RCTs found superior or equivalent effects of moxibustion on symptom score compared with intra-articular injection or topical drug therapy. The existing trial evidence is sufficiently convincing to suggest that moxibustion, compared with sham moxibustion and oral drugs, is effective for pain reduction and symptom management in KOA. The level of evidence is moderate, given the high risk of bias and small sample size.

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy.

Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1-3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months' duration) lateral elbow pain. Four study sites, in the People's Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

Acupuncture Treatment of Lateral Elbow Pain: A Nonrandomized Pilot Study.

In planning for a large-scale multicenter trial to evaluate the effect of acupuncture for the treatment of lateral elbow pain, a pilot study was conducted. This was a prospective, investigator- and patient-blinded, nonrandomized, placebo controlled trial. Subjects were evaluated at baseline, before fourth, seventh, and ninth treatment, and at a two-week posttreatment follow-up. The treatment group received unilateral acupuncture at LI 10 and LI 11 at the affected side with manual needle manipulation; the control group received sham-laser acupuncture at the same acupoints. Measures included (i) disabilities of the arm, shoulder, and hand (DASH) questionnaire, (ii) pain-free grip strength (PFGS), and (iii) a visual analogue scale (VAS) for pain. Significant differences in DASH score, PFGS, and VAS between treatment and control group were found at the ninth treatment (n = 20 for each group, P < 0.05). Only DASH showed significant differences compared to the control for all the measurement time points after treatment commenced and appears to be a sensitive and appropriate primary outcome measure for the future multisite trial. Results from this pilot study provided relevant information about treatment efficacy, credibility of control treatment, and sensitivity of different outcome measures for the planning of the future trial.

Alternative medicine and doping in sports.

Athletes are high achievers who may seek creative or unconventional methods to improve performance. The literature indicates that athletes are among the heaviest users of complementary and alternative medicine (CAM) and thus may pioneer population trends in CAM use. Unlike non-athletes, athletes may use CAM not just for prevention, treatment or rehabilitation from illness or injuries, but also for performance enhancement. Assuming that athletes' creative use of anything unconventional is aimed at "legally" improving performance, CAM may be used because it is perceived as more "natural" and erroneously assumed as not potentially doping. This failure to recognise CAMs as pharmacological agents puts athletes at risk of inadvertent doping.The general position of the World Anti-Doping Authority (WADA) is one of strict liability, an application of the legal proposition that ignorance is no excuse and the ultimate responsibility is on the athlete to ensure at all times whatever is swallowed, injected or applied to the athlete is both safe and legal for use. This means that a violation occurs whether or not the athlete intentionally or unintentionally, knowingly or unknowingly, used a prohibited substance/method or was negligent or otherwise at fault. Athletes are therefore expected to understand not only what is prohibited, but also what might potentially cause an inadvertent doping violation. Yet, as will be discussed, athlete knowledge on doping is deficient and WADA itself sometimes changes its position on prohibited methods or substances. The situation is further confounded by the conflicting stance of anti-doping experts in the media. These highly publicised disagreements may further portray inconsistencies in anti-doping guidelines and suggest to athletes that what is considered doping is dependent on the dominant political zeitgeist. Taken together, athletes may believe that unless a specific and explicit ruling is made, guidelines are open to interpretation. Therefore doping risk-taking behaviours may occur because of the potential financial, social and performance gains and the optimistically biased interpretation (that trying alternatives is part of the "spirit of sport") and doping risk-taking behaviours may occur.This discussion paper seeks to situate the reader in a world where elite level sports and CAM intersects. It posits that an understanding of the underlying motivation for CAM use and doping is currently lacking and that anti-doping rules need to be repositioned in the context of the emerging phenomenon and prevalence of CAM use.

Acupuncture for the treatment of cancer pain: a systematic review of randomised clinical trials.

PURPOSE: Controlling cancer-related pain is an important component in the palliative care of cancer patients. The objective of this review was to assess the effectiveness of acupuncture for treating cancer pain. METHODS: Fourteen databases were searched from their inception through April 2011. Randomised clinical trials (RCTs) were included if acupuncture was used as the sole treatment or as a part of a combination therapy for cancer pain. Studies were included if they were controlled with a placebo or controlled against a drug-therapy or no-treatment group. The Cochrane criteria were used to assess the risk of bias. RESULTS: A total of 15 RCTs met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The majority of acupuncture treatments or combination therapies with analgesics exhibited favourable effects compared with conventional treatments in individual studies. However, a meta-analysis suggested that acupuncture did not generate a better effect than drug therapy (n = 886; risk ratio (RR), 1.12; 95% CI 0.98 to 1.28; P = 0.09). The comparison between acupuncture plus drug therapy and drug therapy alone demonstrated a significant difference in favour of the combination therapy (n = 437; RR, 1.36; 95% CI 1.13 to 1.64; P = 0.003). The results of this systematic review provide no strong evidence for the effectiveness of acupuncture in the management of cancer pain. CONCLUSION: The total number of RCTs included in the analysis and their methodological quality were too low to draw firm conclusions. Future rigorous RCTs will be necessary to assess the clinical efficacy of acupuncture in this area.

An innovative method to accommodate Chinese medicine pattern diagnosis within the framework of evidence-based medical research.

Pattern diagnosis is an integral aspect of Chinese medicine (CM). CM differentiates biomedical diseases into patterns, based upon the patient's symptoms and signs. Pattern identification (PI) is used to diagnose, direct the treatment principle and determine the treatment protocol. Most CM research has used fixed formula treatments for Western-defined diseases with outcomes measured using objective biomedical markers. This article presents an innovative method used in a randomised controlled pilot study using acupuncture for participants with hepatitis C virus. Each participant's CM patterns were identified and quantified at baseline which directed the treatment protocol for the treatment group. Data identified that while each participant expressed different patterns at baseline all participants displayed multiple patterns. Six patterns showed some expression by all 16 participants; Liver (Gan) yin vacuity expressing a group aggregate mean percentage of 47.2, binding depression of Liver qi 46.9, and Liver Kidney (Shen) yin vacuity 45.1. Further sub category gender grouping revealed that pattern ranking changed with gender; Liver yin vacuity (male 53.4%, female 51.93%), binding depression of Liver qi (male 50.0%, female 42.86%) and Liver Kidney yin vacuity (male 42.9%, female 47.96%). The quantification of CM patterns described in this article permitted statistical evaluation of presenting CM patterns. Although this methodology is in its infancy it may have potential use in the integration of PI with rigorous evidence based clinical research. Biomedical markers often do not relate to symptom/signs and therefore this innovative measure may offer an additional CM evaluation methodology and further CM PI understanding.

Hwangryunhaedoktang in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, two-centre trial--study protocol.

BACKGROUND: Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. It has a clear impact on a patient's quality of life. Many patients are worried about the use of usual care techniques, such as corticosteroids and antihistamine due to the widespread fear of adverse effects. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. Hwangryunhaedoktang is among the most strongly preferred and widely used herbal medicines for Atopic Dermatitis in Korea, as it causes very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for Hwangryunhaedoktang, which is approved as an herbal medication by the Korean Food and Drug Administration, in adult patients with Atopic Dermatitis. METHODS/DESIGNS: This study is a randomised, double blind, placebo-controlled, two-centre trial with two parallel arms (Hwangryunhaedoktang and a placebo). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka by two different Oriental medicine doctors. We will include participants experiencing typical conditions of intermittent or continuous Atopic Eczema for six or more months. Participants will receive Hwangryunhaedoktang or a placebo-drug for eight weeks. The total duration of each arm is eleven weeks. Each participant will be examined for signs and symptoms of Atopic Dermatitis before and after taking medication. A follow-up to evaluate the maintenance of safety will be performed two weeks after the final administration of medication. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with consolidated standards of reporting trials guidelines. It will provide evidence for the clinical efficacy and safety evaluation of Hwangryunhaedoktang in adult patients with Atopic Dermatitis. Moreover, we will also employ health-related quality of life questionnaires to assess the changes in quality of life.

Development of an instrument to assess the quality of acupuncture: results from a Delphi process.

BACKGROUND: Quality acupuncture influences the outcomes of clinical research, and issues associated with effective administration of acupuncture in randomized controlled trials need to be addressed when appraising studies. OBJECTIVE: The study objective was to achieve consensus on domains and items for inclusion in a rating scale to assess quality acupuncture administered in clinical research. STUDY DESIGN AND SUBJECTS: An active group of Australian acupuncture researchers initially identified a pool of items assessing quality. The Delphi consensus process was then used to select and reduce the number of items, and an additional expert panel of 42 researchers were invited to participate. Participants initially ranked items along a five-point scale for the first Delphi round, and indicated an agree or disagree response during the second round. For an item to be retained into the second round, an item had to attain greater than 80% agreement that the item described a dimension of quality acupuncture and related study design. RESULTS: Thirty-two (32) experts agreed to participate in the study. After two rounds of the Delphi process, consensus was reached on 14 domains and 26 items relating to quality acupuncture. Domains, items, and minimum standards related to study design; rationale of the intervention; criteria relating to needling stimulation either manual or electrostimulation; duration and frequency of treatment; and practitioner training. CONCLUSIONS: Items for inclusion in an instrument to assess quality acupuncture in clinical research were identified. Further development of the instrument including relative weighting of items and reliability testing is under way.