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.

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.

Comparison of traditional Chinese medicine education between mainland China and Australia-a case study.

OBJECTIVE: To analyze and compare the curriculum and delivery of a Chinese and Australian university-level Chinese medicine program. METHODS: A review of PubMed and the Chinese National Knowledge Infrastructure for relevant educational papers was undertaken. Online and paper documents available at the University of Technology Sydney (UTS) and the Chengdu University of Traditional Chinese Medicine (CDUTCM) were read and analyzed. In addition, in-depth interviews with academics from the two universities were conducted during 2014 to 2015. RESULTS: The two Chinese medicine programs share the common goal of providing health services to the local community, but differ in some aspects when the curricula are compared. Areas such as student profile, curriculum structure, teaching approaches and education quality assurance were found to be different. The UTS program adopts a "flipped learning" approach with the use of educational technology aiming at improving learning outcomes. On the other hand, the CDUTCM has better clinical facilities and specialist physician resources. CONCLUSION: A better understanding of the different curricula and approaches to Chinese medicine education will facilitate student learning and educational outcomes.

Investigating the effects of three needling parameters (manipulation, retention time, and insertion site) on needling sensation and pain profiles: a study of eight deep needling interventions.

Introduction. In traditional Chinese acupuncture, needle sensation (deqi) is purported to contribute to a therapeutic outcome. While researchers have attempted to define deqi qualitatively, few have examined the effects of needling parameters on its intensity. Methods. 24 healthy subjects completed eight interventions scheduled at least one week apart, which involved manual acupuncture to LI4 or a designated nonacupoint (NAP) on the hand, with real or simulated manipulation each three minutes and needle retentions of one or 21 minutes. Intensities of needling sensation and pain were reported every three minutes and sensation qualities were reported post-intervention. Results. Immediately after needle insertion, similar levels of mean needle sensation and of pain were reported independent of intervention. At subsequent measurement times, only two interventions (one at LI4 and one at NAP) maintained statistically significantly elevated needle sensation and pain scores and reported higher numbers of needle sensation descriptors. For both, the needle was retained for 21 minutes and manipulated every three minutes. Neither intervention differed significantly in terms of levels of pain, and needle sensation or numbers and qualities of needle sensation described. Conclusion. In this group of healthy subjects, the initial needling for all eight interventions elicited similar levels of needle sensation and pain. These levels were only maintained if there was ongoing of needle manipulation and retention of the needle. By contrast, the strength of needle sensation or pain experienced was independent of insertion site.

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.