Intra-Rater and Inter-Rater Reliability of Tongue Coating Diagnosis in Traditional Chinese Medicine Using Smartphones: Quasi-Delphi Study.

BACKGROUND: There is a growing trend in the use of mobile health (mHealth) technologies in traditional Chinese medicine (TCM) and telemedicine, especially during the coronavirus disease (COVID-19) outbreak. Tongue diagnosis is an important component of TCM, but also plays a role in Western medicine, for example in dermatology. However, the procedure of obtaining tongue images has not been standardized and the reliability of tongue diagnosis by smartphone tongue images has yet to be evaluated. OBJECTIVE: The first objective of this study was to develop an operating classification scheme for tongue coating diagnosis. The second and main objective of this study was to determine the intra-rater and inter-rater reliability of tongue coating diagnosis using the operating classification scheme. METHODS: An operating classification scheme for tongue coating was developed using a stepwise approach and a quasi-Delphi method. First, tongue images (n=2023) were analyzed by 2 groups of assessors to develop the operating classification scheme for tongue coating diagnosis. Based on clinicians' (n=17) own interpretations as well as their use of the operating classification scheme, the results of tongue diagnosis on a representative tongue image set (n=24) were compared. After gathering consensus for the operating classification scheme, the clinicians were instructed to use the scheme to assess tongue features of their patients under direct visual inspection. At the same time, the clinicians took tongue images of the patients with smartphones and assessed tongue features observed in the smartphone image using the same classification scheme. The intra-rater agreements of these two assessments were calculated to determine which features of tongue coating were better retained by the image. Using the finalized operating classification scheme, clinicians in the study group assessed representative tongue images (n=24) that they had taken, and the intra-rater and inter-rater reliability of their assessments was evaluated. RESULTS: Intra-rater agreement between direct subject inspection and tongue image inspection was good to very good (Cohen κ range 0.69-1.0). Additionally, when comparing the assessment of tongue images on different days, intra-rater reliability was good to very good (κ range 0.7-1.0), except for the color of the tongue body (κ=0.22) and slippery tongue fur (κ=0.1). Inter-rater reliability was moderate for tongue coating (Gwet AC2 range 0.49-0.55), and fair for color and other features of the tongue body (Gwet AC2=0.34). CONCLUSIONS: Taken together, our study has shown that tongue images collected via smartphone contain some reliable features, including tongue coating, that can be used in mHealth analysis. Our findings thus support the use of smartphones in telemedicine for detecting changes in tongue coating.

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.

Anchorable phosphorylcholine copolymer synthesis and cell membrane mimetic antifouling coating fabrication for blood compatible applications.

Protein adsorption and platelet activation on biomedical devices contacting blood may lead to the formation of thrombus. The thrombogenicity of biomaterials could be minimized or prevented by anchoring a cell membrane mimetic antifouling coating (CMMAC). Here, we report the construction of a CMMAC by a newly designed 2-methacryloyloxyethyl phosphorylcholine (MPC) copolymer (PMPCC) containing 5-20 carboxylic long arm side chains. The long arm provides its end carboxylic group with more freedom and a larger reaction space for an easier and more efficient surface anchoring. With the assistance of mussel-inspired universal adhesive polydopamine (PDA), different material surfaces precoated with PDA can immobilize the PMPCC via multipoint anchoring of the randomly distributed carboxylic side chains. The multipoint anchoring results in a stabilized and condensed PDA-PMPCC coating. The phosphorylcholine zwitterions of the densely immobilized PMPCC polymers form a cell outer membrane mimetic interface in an aqueous environment, endowing excellent properties of resisting protein adsorption, platelet activation and blood cell adhesion. More importantly, the PDA-PMPCC-coated glass surface can suppress thrombus formation for more than 24 h, while the bare glass surface forms obvious thrombus in 6 h tested in the same blood. Furthermore, the fabrication of the PDA-PMPCC coating is simple and material-independent. Therefore, the simple synthesis, facile surface coating and excellent hemocompatibility of the PMPCC make it a promising material for biomimetic surface modification.

Down-regulation of miR-10b represses cell vitality in osteosarcoma and is inversely associated with prognosis via interacting with FAM46C: Running title: MiR-10b/FAM46C axis modulates OS progression.

The purpose of this exploration was to detect the biological effects of miR-10b/FAM46C pair on osteosarcoma (OS) development. By accessing to the Gene Expression Omnibus (GEO) database, we achieved expressional profiles of miR-10b and FAM46C. Kaplan-Meier method was applied to determine the overall survival rates of OS patients. MiR-10b mimic/inhibitor were utilized to alter miR-10b expression. Overexpression of FAM46C was induced by pcDNA3.1-FAM46C. QRT-PCR and western blot were conducted to assess the expression levels. Cell counting kit-8 (CCK-8) and transwell assays were employed to evaluate the proliferative, invasive and migratory properties of OS cells. Pearson correlation analysis was performed to confirm the association between miR-10b and FAM46C. Dual-luciferase reporter assay was conducted to determine the target of miR-10b. The overall survival of OS patients was inversely correlated with miR-10b expression. MiR-10b was increased in OS compared with normal controls. Depletion of miR-10b attenuated the proliferation, invasion and migration of MG-63 cells. FAM46C was considered as a target gene of miR-10b and inversely related with miR-10b. Overexpression of FAM46C could inhibit cell growth, invasion and migration in OS; furthermore, it also can enforced the miR-10b inhibitor-induced effects on cell behaviors of OS cells. Down-regulation of miR-10b played a suppressive effect on the cell activity in OS cells, which provides a novel insight into the advance of OS therapeutic therapies.

Electroacupuncture for tapering off long-term benzodiazepine use: A randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of using electroacupuncture as an adjunct treatment in enhancing the benzodiazepine cessation rate in long-term benzodiazepine users. METHODS: This was a randomized, assessor- and subject-blinded, controlled trial. One hundred and forty-four long-term benzodiazepine users were randomly assigned to receive either electroacupuncture or placebo acupuncture (a sham itervention using non-invasive placebo needles) combined with a gradual benzodiazepine tapering schedule for 4 weeks. The primary outcome was the cessation rate of benzodiazepine use. Subjects were assessed on their benzodiazepine usage, benzodiazepine withdrawal symptoms, insomnia severity, and anxiety and depressive symptoms at baseline, week 6 and week 16. RESULTS: The cessation rates of the electroacupuncture and placebo acupuncture groups at 12 weeks post-treatment were 9.17% and 10.83%, respectively. Both groups showed a reduction in benzodiazepine usage by a self-completed drug record at week 16 (compared to baseline: electroacupuncture group -40.23% versus placebo acupuncture group -48.76%). However, no significant between-group differences were found in the benzodiazepine cessation rate, reduction in benzodiazepine usage, and other secondary measures across all the study time points. CONCLUSIONS: Electroacupuncture showed a similar cessation rate in benzodiazepine use to that of non-invasive placebo acupuncture in long-term users during a 4-week gradual tapering schedule. The evidence did not support advantages of electroacupuncture over non-invasive placebo acupuncture on reducing insomnia, anxiety, depression, or other withdrawal symptoms during the gradual tapering schedule. Despite a 40% decrease in the benzodiazepine usage in both groups, the effects may be attributed to the non-specific effects of acupuncture. TRIAL REGISTRATION: ClinicalTrials.gov # NCT02475538.

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.

Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial.

BACKGROUND: Few high-quality, large-scale, controlled trials comparing the effectiveness and safety of acupuncture, auricular acupuncture and combined acupuncture treatment for insomnia are available. OBJECTIVE: To carry out a randomised, assessor-blinded, waitlist-controlled trial to test the superiority of combination treatment. METHODS: After in-person and polysomnography screening, 224 subjects (mean age 53.4 years; 75.4% female) with DSM-5 insomnia disorder, who were free from major psychiatric disorders and with sleep-diary-derived sleep efficiency averaged over 1 week of <85%, were randomised to acupuncture alone, acupuncture plus auricular acupuncture (combination treatment), or a waitlist in a 3:3:1 ratio. Standardised acupuncture and combination treatment were provided three times weekly for 3 weeks. The primary outcome was sleep-diary-derived sleep efficiency. Secondary outcomes included wrist actigraphy and self-reported scales on insomnia, anxiety and depression, fatigue, sleepiness and functioning. Assessments were conducted at baseline, 1 week, 4 weeks and 13 weeks after treatment. Participants on the waitlist were re-randomised to receive acupuncture or combination treatment after the second post-baseline assessment. RESULTS: There was no significant difference between acupuncture and combination treatment in the primary outcome and most secondary outcomes at all time points. However, both treatments were better than waitlist in reducing insomnia, anxiety/depressive symptoms and fatigue, and improving function. Within-group improvements were maintained at 13 weeks after treatment. Of 260 adverse events, 243 were mild (93.5%). Discontinuation due to adverse events was 2.1% and 3.1% for acupuncture and combination treatment, respectively. CONCLUSIONS: Limited by short-term treatment and follow-up, the attempt to augment acupuncture by auricular acupuncture was not supported. Acupuncture and combination treatment were safe and had mild hypnotic effects, which lasted for at least 13 weeks. TRIAL REGISTRATION NUMBER: NCT01891097; Results.

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.

Failure patterns and prognostic factors of patients with primary mucosal melanoma of the nasal cavity and paranasal sinuses.

OBJECTIVES: To analyse the failure patterns and prognostic factors influencing survival in patients with primary mucosal melanoma of the nasal cavity and paranasal sinuses. MATERIALS AND METHODS: Fifty-one patients were analysed retrospectively. Forty-eight, 33, 10, and 13 patients underwent surgery, radiotherapy, chemotherapy, and immunotherapy, respectively. Failure events, including local recurrence, regional relapse, distant metastases, and death, were examined. RESULTS: During follow-up (median: 59.0 months), 36 patients experienced failure after treatment, including local (n = 17), regional (n = 8), and distant organ (n = 23) metastases. The median failure times for local, regional, and distant metastases were 13.0, 14.0, and 8.0 months, respectively. The median survival times from local, regional, and distant failure to death were 10.5, 8.0, and 4.0 months, respectively. The 5-year overall survival rates of patients with and without distant organ metastases were 14.4% and 72.6%, respectively (p < .001). Multivariate analyses showed that radiotherapy increased local recurrence-free and regional relapse-free survival. Patients with stage IV tumours had reduced distant metastasis-free and overall survival compared to patients with stage I-III tumours. CONCLUSIONS: Distant metastasis was mainly owing to failure. Radiotherapy and the disease stage were prognostic factors for survival.

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.

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

BACKGROUND: Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. METHODS/DESIGN: The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. DISCUSSION: Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. TRIAL REGISTRATION: ClinicalTrials.gov NCT02475538 .

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.

Pattern Differentiation of Lateral Elbow Pain in Traditional Chinese Medicine: A Systematic Review.

BACKGROUND: Traditional Chinese Medicine (TCM) uses a sophisticated diagnostic system called pattern differentiation, which allows for the tailor-made treatment of individuals. OBJECTIVE: This study aimed to identify the commonly used TCM patterns for lateral elbow pain (LEP), as well as the clinical features associated with these patterns. METHOD: Journal literature in 15 major Chinese and English databases and textbooks from five medical libraries as well as Chinamaxx were reviewed. RESULTS: Five hundred and fifty-five full-text journal articles, as well as 465 textbooks, were retrieved for further assessment, but only eight studies and seven books that mentioned LEP patterns could be identified and included in this study. The top four patterns that were identified were the wind-cold-dampness pattern, the qi stagnation and blood stasis pattern, the dual deficiency of qi and blood pattern, and the retained dampness-heat pattern, each of which was associated with unique features that were made up of distinct signs and symptoms. CONCLUSIONS: The unique features identified for each of the major patterns might be the key to understanding TCM individualized treatment based on pattern differentiation. Furthermore, the approach taken in studying TCM pattern of LEP may also be useful for studying the TCM patterns of other musculoskeletal conditions.

High-risk factors of parotid lymph node metastasis in nasopharyngeal carcinoma: a case-control study.

BACKGROUND: Although parotid-sparing IMRT decreased the dose distribution of parotid, parotid region recurrence has been reported. Prophylactic irradiation in parotid area would be necessary in patients with high risk of parotid lymph node metastasis (PLNM). This study was to detect the high-risk factors of PLNM in nasopharyngeal carcinoma. METHODS: This was a 1:2 case-control study. All patients in this study were newly diagnosed NPC with N2-3 classification from January 2005 to December 2012. Cases were 22 sides with ipsilateral PLNM. Controls were 44 patients who were randomly selected from N2-3 disease in database. RESULTS: 20/1096 (1.82 %) NPC patients were found PLNM. Sum of the longest diameter for multiple lymph nodes (SLD) in level II was larger in case group than that in control group (6.0 cm vs. 3.6 cm, p = 0.003). Level II lymph node necrosis, level Va/b involvement, and rare neck areas involvement were more common in case group (p = 0.016, p = 0.034, and p < 0.001, respectively). RPN, level III, and level IV metastases showed no significant difference between the two groups. Multivariate analysis in logistic regression showed that only SLD ≥5 cm in II area (OR = 4.11, p = 0.030) and rare neck areas involvement (OR = 3.95, p = 0.045) were associated with PLNM in NPC patients. CONCLUSIONS: PLNM was an uncommon event in NPC patients. SLD ≥5 cm in level II and involvement in rare-neck areas may be potentially high-risk factors for PLNM. Sparing parotid in IMRT was not recommended for NPC patients with high risks of PLNM.

TCM Pattern Questionnaire for Lateral Elbow Pain: Development of an Instrument via a Delphi Process.

Individualized acupuncture treatment has been practiced for pain therapy. This study used acupuncture treatment for lateral elbow pain (LEP) as an example to study the diagnostic practice of individualized acupuncture treatment. A provisional version of LEP pattern questionnaire was developed based on a recent systematic review on TCM pattern diagnosis for LEP. A Delphi panel of 33 clinical experts from seven different countries was formed, and the Delphi survey was conducted in Chinese and English language for two rounds. Consensus was achieved from all 26 panelists who responded to the second round on 243 items of the instrument, which included a 72-question-long questionnaire. The mean level of expert consensus on the items of the final questionnaire was 85%. Consensus was found on four TCM patterns that could underlie LEP, namely, the wind-cold-dampness pattern, the qi stagnation and blood stasis pattern, the dual deficiency of qi and blood pattern, and the retained dampness-heat pattern. A list of signs and symptoms indicating one of the four TCM patterns and a list of preferred treatment modalities for each pattern were also generated. Our instrument shows considerable content validity. Further validity and reliability studies are under way.

The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial.

BACKGROUND: Obesity is an increasingly prevalent chronic condition that is associated with serious morbidity and mortality. Excess body weight is a risk factor contributing to diseases such as hypertension, heart disease, hypercholesterolaemia, diabetes mellitus, cerebrovascular disease, gall bladder disease, and some types of cancer. Almost all the Western anti-obesity drugs have adverse effects or body weight is regained upon cessation of therapy. Recent studies have found that acupuncture had a similar efficacy as the Western anti-obesity drugs with fewer reported adverse effects. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we design this study to explore the effectiveness and safety of acupuncture on weight control. METHODS/DESIGN: This is a pilot single-blinded, randomized, sham-controlled trial on acupuncture for body weight control. Seventy-two participants are randomly assigned to the acupuncture group or the control group. Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) are selected as acupuncture points. For the acupuncture group, disposable acupuncture needles will be inserted at a depth of 10-25 mm into the points and electrical stimulation with dense-disperse waves at 50 Hz and 10 V will be applied on the abdominal points. The bodily needles will be retained for 30 minutes. For subjects assigned to the control group, Streitberger's non-invasive acupuncture needles will be applied to serve as the sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of inserted. The duration of the treatment is 8 weeks with two sessions per week, and the follow-up period is 8 weeks. The primary outcome is the change in body weight before and after treatment. The secondary outcomes include changes in body mass index, waist circumference, hip circumference, and body fat percentage during the treatment and follow-up period. DISCUSSION: The study will compare the efficacy and safety of acupuncture with sham acupuncture on weight control, in the hope of obtaining evidence for utilizing acupuncture for body weight control. TRIAL REGISTRATION: NCT02516878 . Registered on 30 July 2015.

Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial.

The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

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.

Identification of Chinese medicine syndromes in persistent insomnia associated with major depressive disorder: a latent tree analysis.

BACKGROUND: Chinese medicine (CM) syndrome (zheng) differentiation is based on the co-occurrence of CM manifestation profiles, such as signs and symptoms, and pulse and tongue features. Insomnia is a symptom that frequently occurs in major depressive disorder despite adequate antidepressant treatment. This study aims to identify co-occurrence patterns in participants with persistent insomnia and major depressive disorder from clinical feature data using latent tree analysis, and to compare the latent variables with relevant CM syndromes. METHODS: One hundred and forty-two participants with persistent insomnia and a history of major depressive disorder completed a standardized checklist (the Chinese Medicine Insomnia Symptom Checklist) specially developed for CM syndrome classification of insomnia. The checklist covers symptoms and signs, including tongue and pulse features. The clinical features assessed by the checklist were analyzed using Lantern software. CM practitioners with relevant experience compared the clinical feature variables under each latent variable with reference to relevant CM syndromes, based on a previous review of CM syndromes. RESULTS: The symptom data were analyzed to build the latent tree model and the model with the highest Bayes information criterion score was regarded as the best model. This model contained 18 latent variables, each of which divided participants into two clusters. Six clusters represented more than 50 % of the sample. The clinical feature co-occurrence patterns of these six clusters were interpreted as the CM syndromes Liver qi stagnation transforming into fire, Liver fire flaming upward, Stomach disharmony, Hyperactivity of fire due to yin deficiency, Heart-kidney noninteraction, and Qi deficiency of the heart and gallbladder. The clinical feature variables that contributed significant cumulative information coverage (at least 95 %) were identified. CONCLUSION: Latent tree model analysis on a sample of depressed participants with insomnia revealed 13 clinical feature co-occurrence patterns, four mutual-exclusion patterns, and one pattern with a single clinical feature variable.