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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Training and practice of Traditional East Asian Medicine (TEAM) varies globally although similar diagnostic methods are used based on patients presenting signs and symptoms. These methods assist in determining disease patterns and treatment principles. The use of diagnostic principles and pattern identification (PI) was explored in this survey of TEAM practice across different countries. A web-based survey was disseminated to acupuncture professional membership organisations in UK, Australia, Italy, Korea and China using a Survey Monkey link between December 2015 and September 2017. The 618 fully completed responses were available for comparison (UK 66, Australia 106, China 87, Italy 226, Korea 133). Demographic characteristics varied; UK practitioners were more likely to be female (71%) compared to the other countries (51-59%), Koreans tended to be under 40yrs (80%), compared to elsewhere (14-27%). Korean, UK and Australian respondents had fewer practitioners with biomedical training, 95% of the Italians had a biomedical qualification. TEAM diagnostic methods were more likely practised in the UK and Australian samples (> 90%) but were lowest for the Italian sample (78%). TCM differential diagnosis was the predominant type of PI. PI was rated essential by 85% of Chinese practitioners, versus 32% Koreans, 45% Italians, 67% UK and 68% Australian respondents. This first international survey about acupuncturists use of PI demonstrated wide variation. The sample was limited to certain countries and relied on dissemination by specific professional bodies and participants completing an electronic questionnaire which may have affected responses but provides a platform for future studies. [ABSTRACT FROM AUTHOR]

Pattern differentiation is a critical component for traditional Chinese medicine (TCM) diagnosis and treatment. However, the issue of whether pattern differentiation is appropriately applied in TCM interventional trials, including Chinese herbal medicine (CHM) interventions and non-herbal TCM interventions, is unclear. The aim of this study was to i) systematically review the current status of pattern differentiation used in WHO-registered clinical trials for different types of TCM interventions; and ii) provide suggestions for improving the use of pattern differentiation in future clinical trial design. The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) database was searched for all TCM interventional trials registered up to 31 December 2017. In this systematic review trials with a TCM pattern differentiation in their design were included. Descriptive statistics were collated to demonstrate the characteristics of pattern differentiation applied for different TCM interventional trials. Among 2955 TCM interventional trials registered during 1999–2017, 376 (12.7%) trials included pattern differentiation. Of 376 trials, the use of pattern differentiation was identified in; –the title (30.6%), objective (50.5%), participants inclusion (100%), outcomes (43.6%) and study background (12.5%). Further, 85.4% reported the specific name of the TCM intervention, 10.6% provided the intervention's targeted pattern, 83.8% reported the specific name of the TCM pattern, 7.2% presented diagnostic criteria for the pattern studied, and 19.1% adopted a pattern-related outcome as primary outcome for evaluation. The reporting and application of pattern differentiation in TCM trials were inadequate and confusing, which was mainly due to lack of clarity regarding study design, objectives, diagnostic criteria and outcomes. [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]