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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) is the largest national professional body for Chinese medicine practitioners in Australia yet little is known about specific practice characteristics of its members. Method: In December 2006, a four-page questionnaire was mailed to all association members listed on the AACMA database for that year. The questionnaire sought to obtain information on the demographics and practice characteristics of the AACMA members. In total 1 520 questionnaires were mailed out to the AACMA members, of which 386 were returned. Results: The age distribution for respondents was bimodal, with those in the 46-50 and 31-35 brackets being the highest reported ranges. With regard to education, most respondents stated they had obtained their practice qualifications in Australia (n = 279; 73%), while 46 (12%) replied they had received their qualification from overseas. Most respondents replied that they had obtained a Bachelor degree (n = 207; 54%) while 58 (15%) reported having a Diploma and 37 an Advanced Diploma (9%). Concerning practice characteristics, nearly 70% (n = 268) reported that they practised more than 20 hours per week, with significantly more females working fewer than 20 hours compared to males (p = 0.006). When a breakdown of the pattern of modality use was undertaken, approximately 31% (n = 121) of respondents reported using a combination of both acupuncture and Chinese herbal medicine, while 20% (n = 77) stated they used acupuncture solely while only 0.5% (n = 2) used herbal medicine alone. The remainder used various combinations involving acupuncture, Chinese herbal medicine, Chinese remedial massage (Tuina) and/or Western remedial massage. Conclusion: This is the first time a survey of members of a particular Chinese medicine (CM) association has been undertaken in Australia. To further develop CM, a large scale survey needs to be undertaken to further define and establish the social demographics and practices of the newly nationally registered CM profession. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that ‘consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues’ and that ‘further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture’. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk–benefit. [ABSTRACT FROM PUBLISHER]

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). [ABSTRACT FROM AUTHOR]

Aim: To examine the reliability of Traditional Chinese Medicine (TCM) tongue inspection by evaluation of inter- and intrapractitioner agreement levels for specific tongue characteristics, achieved by a group of TCM practitioners. Method: Ten (10) realistic tongue slides and a set of questionnaires were used to examine the agreement levels among 30 TCM practitioners in two data collection sessions. Statistical analysis involved descriptive statistics, predominantly percentage frequency agreement with the agreement level of ≥80% set as the criterion for an acceptable level of reliability. Results: Overall, both inter- and intrapractitioner agreement levels were low. Only on 19 occasions (17.3%) in session 1 and 21 occasions (19.1%) in session 2 were interpractitioner (between a practitioner) agreement levels of ≥80% achieved. Moreover, virtually all (15 occasions in session 1 and 14 occasions in session 2) of these questions involved simple dichotomous response choices, and the practitioners achieved levels of ≥80% reliability in only 5% of occasions where more complex response choices were offered. In terms of intrapractitioner (within a practitioner) agreement, the highest agreement level was achieved for the dichotomous response choice questions on presence of coat and presence of crack, with the 29 and 20 practitioners achieving ≥80% intrapractitioner agreement, respectively. Only 2 subjects achieved higher than 80% intrapractitioner agreement level for all tongue slides on all questions, with the highest intrapractitioner agreement level being 88% followed by 82%. The findings showed that the TCM tongue inspection for specific characteristics examined was not a reliable diagnostic method, at least for the group of TCM practitioners involved in this study. Conclusions: The findings suggest that a major contribution to the low levels of inter- and intrapractitioner agreements stems from inadequate operational definitions of both the tongue characteristics studied and of the inspection regions of the tongue. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Moxibustion is a widely used adjunct therapy within Chinese medicine in many Asian countries, as well as Australia. A variety of diseases are treated with moxibustion as well as a range of application methods used, ranging from moxa roll to warm needle. Few studies have looked at the types of diseases and methods used when administering moxibustion. Method: The clinic database at the University of Technology Sydney (UTS) Chinese medicine clinic was mined for the type of disease using the International Classification of Primary Care (ICPC) as well as the most commonly used application methods when moxibustion was applied within a treatment. The period assessed was from January 1998 to December 2014. Results: The six most common disease areas where moxibustion had been administered were in the categories of neurological, digestive, respiratory, musculoskeletal, psychological and general diseases. In total 104,676 treatments had been recorded in the database across these six disease areas with moxibustion being used in 9.3% (n=9,733) of all the recorded treatments in these six disease areas. In addition, the moxa roll was most commonly used (6%) followed by direct moxa (1.3%), moxa box (1.2%) and warm needle (0.8%). Conclusion: More research is needed into the efficacy, safety and underlying mechanism of moxibustion therapy. This will lead to a better understanding of moxibustion and familiarisation by the public of its role in treating a variety of diseases. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: Traditional Chinese Medicine (TCM), a modern interpretation of Chinese medicine, developed in the 1950s. It differentiates biomedical diseases into patterns. Each pattern comprises symptom/signs that have their own unique treatment protocol. Most TCM research has used fixed formula treatments for Western-defined diseases with outcomes often measured using objective biomedical markers. More recently, a number of trials have attempted to accommodate TCM clinical practice within the framework of rigorous evidence-based medical research. The aim of this article is to describe a novel outcome measure based on TCM patterns that was used in a pilot study for people with hepatitis C virus (HCV). Methods: Sixteen (16) participants with HCV were enrolled in a randomized, controlled pilot study and allocated to a treatment or control group. TCM pattern diagnosis was obtained at baseline and used to guide acupuncture treatment for the treatment group. Each individual's primary, secondary, and tertiary TCM patterns were identified, which involved the systematic evaluation of the participant's information against the TCM patterns and conversion of the pattern to a percentage. Baseline and postintervention percentages for the three TCM patterns for the two groups were compared to assess change. Results: There was a significant mean percentage decrease in pattern expression at week 12 compared to baseline for the secondary and tertiary patterns of the treatment group (56.3% versus 47.5%; p = 0.045 and 48.1% versus 33.6%; p = 0.037, respectively). No significant change was found for the primary, secondary, or tertiary patterns for the control group or for the primary pattern associated with the treatment group. Conclusions: The quantification of TCM patterns in this study permitted statistical evaluation of TCM pattern change. Previously, TCM pattern identification had only been used as a basis for developing the treatment protocol in clinical trials. This is the first time it has been employed as a novel outcome measure. [ABSTRACT FROM AUTHOR]

A response by Christine A. Berle and colleagues to a letter to the editor regarding their article "A novel approach to evaluate Traditional Chinese Medicine outcomes using pattern identification" in the 2010 issue is presented.