Baduanjin Mind-Body Exercise for Cancer-Related Fatigue: Protocol for a Remotely Delivered Randomized Wait-List Controlled Feasibility Study.

BACKGROUND: People living with a cancer diagnosis often experience cancer-related fatigue (CRF). Between 9% and 45% of people report CRF as moderate to severe, negatively impacting their quality-of-life (QOL). The evidence-base for managing CRF recommends exercise-related therapies over pharmaceutical interventions. One such exercise-like therapy is Baduanjin mind-body exercise (MBE), which has additional benefits. A remotely delivered program may further benefit people with CRF. The primary objective of this pilot will test study feasibility of a remotely delivered Baduanjin MBE exercise program for people living with CRF. METHODS: This is a randomized wait-list controlled pilot study and will take place in Sydney, Australia. Subject to informed consent, 40 adults with moderate CRF levels and receiving or previously received adjuvant chemotherapy, will undertake a home-based 8-week Baduanjin MBE program supported by online resources and instructors. The primary feasibility outcomes are recruitment, enrollment, retention, and adherence rates; and safety as measured by tolerance and adverse-event frequency. Clinical outcomes (eg, changes in CRF, QOL, and participant perceptions) are assessed at pre-intervention, week 1, week 4, week 8, and post-intervention. Analyses follows the Intent-to-Treat (all participants as per randomization) and per-protocol (participants adhering to the protocol). Missing data will be imputed from previous data entries and regression models may be tested to predict missing outcomes. DISCUSSION: To our knowledge, this is the first study evaluating the feasibility and effects of Baduanjin MBE on CRF using a remote delivery method. These feasibility data will inform a fully powered future trial investigating evidence of effect on CRF and QOL.Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR 12623000177651).Ringgold ID: 651498 Chinese Medicine Centre.

The efficacy of imagery in the rehabilitation of people with Parkinson's disease: protocol for a systematic review and meta-analysis.

BACKGROUND: Parkinson's disease (PD) is a neurodegenerative disorder of the nervous system that affects movement. Individuals with PD commonly experience difficulty initiating movements, slowness of movements, decreased balance, and decreased standing ability. It has been shown that these motor symptoms adversely affect the independence of individuals with PD. Imagery is the cognitive process whereby a motor action is internally reproduced and repeated without overt physical movement. Recent studies support the use of imagery in improving rehabilitation outcomes in the PD population. However, these data have inconsistencies and have not yet been synthesised. The study will review the evidence on the use of imagery in individuals with PD and to determine its efficacy in improving rehabilitation outcomes. METHODS: Randomised controlled clinical trials comparing the effects of imagery and control on activities, body structure and function, and participation outcomes for people with PD will be included. A detailed computer-aided search of the literature will be performed from inception to June 2021 in the following databases: MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Library, Web of Science, and Scopus. Two independent reviewers will screen articles for relevance and methodological validity. The Physiotherapy Evidence Database (PEDro) scale will be utilised to evaluate the risk of bias of selected studies. Data from included studies will be extracted by two independent reviewers through a customised, pre-set data extraction sheet. Studies using imagery with comparable outcome measures will be pooled for meta-analysis using the random effect model with 95% CI. If individual studies are heterogeneous, a descriptive review will analyse variance in interventions and outcomes. A narrative data analysis will be considered where there is insufficient data to perform a meta-analysis. DISCUSSION: Several studies investigating imagery in the PD population have drawn dissimilar conclusions regarding its effectiveness in rehabilitation outcomes and clinical applicability. Therefore, this systematic review will gather and critically appraise all relevant data, to generate a conclusion and recommendations to guide both clinical practice and future research on using imagery in the rehabilitation of people with PD. FUNDING: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021230556.

Zao Ren An Shen capsule for insomnia: a double-blind, randomized, placebo-controlled trial.

STUDY OBJECTIVES: The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. METHODS: We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for 4 weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events (AEs). Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. RESULTS: A nonsignificant (p > .05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with AEs was not significantly different (p > .05) between the two groups. Except for subjective sleep onset latency, which had a nonsignificant (p > .05) medium effect (Cohen's d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen's d < .4) and nonsignificant (p > .05). The acceptability and tolerability were high in the active group. CONCLUSIONS: ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.Registration: This clinical trial was registered in Australia New Zealand Clinical Trial Registry (registration number ACTRN12619000140156) under the name "Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial" (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376730&isReview=true).

Mind-Body Therapies for Cancer Patients Living with Depression, Anxiety or Insomnia (MIRACLE): A Systematic Review with Individual Participant Data Network Meta-Analysis.

Depression, anxiety, and insomnia are common in cancer patients. Mind-body therapies (MBTs) are promising forms of treatment for cancer patients living with depression, anxiety, and insomnia. The objective of this study is to assess the effectiveness and acceptability of MBTs in cancer patients living with depression, anxiety, or insomnia. EMBase, PubMed, Cinahl, PsychINFO, IndMED, CSI-NISCAIR, CNKI, Clinicaltrial.gov, ChiCTR, and CTRI will be searched until October 2020 for relevant studies. Randomized controlled studies in which MBTs were tested in a cancer population will be selected. The authors of the selected studies will be contacted to obtain individual participant data. The participants who reached a defined clinical threshold for depression, anxiety, or insomnia will be selected for the three sub-studies on depression, anxiety, and insomnia, respectively. Pairwise and network meta-analyses will be used to assess the changes in depression, anxiety, sleep quality, and completion rate. We will assess the effect of the treatment dose (number and frequency of interventions) on effectiveness. The results of this study will inform clinical decision-making for the treatment of psychological disturbances in cancer patients. If MBTs are found effective, they will potentially be recommended as treatments for cancer patients with psychological symptoms.

Association of husbands' education status with unintended pregnancy in their wives in southern Ethiopia: A cross-sectional study.

BACKGROUND: Unintended pregnancy rates are substantially higher in developing regions, have significant health consequences, and disproportionately affect subgroups with socio-economic disadvantage. We aimed to examine whether there is an association between husbands' education status and their wives unintended pregnancy in southern Ethiopia. METHODS: The data source for this study was from a cross-sectional study on iron-folate supplementation and compliance in Wolaita, South Ethiopia. Data were collected from October to November 2015 in 627 married pregnant women regarding their husbands' education status, socio-demographic characteristics, and if they wanted to become pregnant at the time of survey using an interviewer administered questionnaire. Logistic regression was used to estimate Odds Ratios (ORs) with associated z-tests and 95% Confidence Intervals (95% CI) for variables associated with unintended pregnancy. RESULTS: The proportion of unintended pregnancy in this sample was 20.6%. Husbands' education status, age, residence, and using family planning methods were associated with unintended pregnancy (all P-values < 0.05). Multivariable models consistently showed that being married to a husband with at least some college or university education was associated with a decreased OR for unintended pregnancy after controlling for age and use of family planning at conception period (OR 0.36 [95%CI: 0.17, 0.82]) and age and rural residence (OR 0.40 [95%CI: 0.18, 0.90]). CONCLUSION: Unintended pregnancy among Ethiopian woman was consistently associated with being married to least educated husbands in southern Ethiopia. Increasing age and living in a rural vs urban area were also independently associated with unintended pregnancy. Strategies for addressing family planning needs of women with poorly educated husbands should be the subject of future research.

Investigation on Advanced Non-Small-Cell Lung Cancer among Elderly Patients Treated with Chinese Herbal Medicine versus Chemotherapy: A Pooled Analysis of Individual Data.

PURPOSE: Many patients with advanced non-small-cell lung cancer (NSCLC) seek help from Chinese herbal medicine (CHM). The purpose of this study was to investigate the survival between CHM and chemotherapy (CT) treatment of patients aged ≥60 years with advanced Epidermal Growth Factor Receptor (EGFR) wild type NSCLC and Karnofsky Performance Status (KPS) ≥ 60. METHODS: We extracted individual data of all eligible patients from 1 randomized control trial and 2 cohort studies and performed a pooled analysis. Survival outcomes of patients were compared between CHM group and CT group using Cox regression model stratified for study. RESULTS: A total of 486 patients were included in the study, including 262 patients in the CHM group and 224 patients in the CT group. The median overall survival time was 10.9 (95% confidence intervals [CI]: 8.9-13.0) months in CHM group and 9.8 (95% CI: 8.1-11.5) days in CT group (p=0.592). The adjusted hazard ratio (HR) and 95% CI for CHM compared to CT are 0.98 (0.87, 1.10, p=0.751) in the stratified Cox regression model. Stratified analysis showed a trend that previously treated elderly patients with EGFR wild type advanced NSCLC probably gain greater survival benefit from CHM (adjusted HR:0.83, 95% CI: 0.68-1.01, p=0.063). CONCLUSIONS: There might be no significant difference in survival for elderly patients with advanced EGFR wild type NSCLC between the CHM and CT groups in the current study. And previously treated elderly patients with advanced NSCLC probably receive greater benefit from CHM. However, limited by the design and unpreplanned study hypothesis, the results must be confirmed by randomized control trial before making a conclusion.

Predictors of and barriers to adherence in a 16-week randomised controlled trial of Bikram yoga in stressed and sedentary adults.

BACKGROUND: Bikram yoga may enhance health outcomes in healthy adults and those at risk for chronic disease, however, challenges remain in achieving optimal adherence to this practice. This study investigated factors influencing adherence to a 16-week Bikram yoga intervention in stressed and sedentary adults. METHODS: Experimental group participants (n = 29) were instructed to attend 3-5 Bikram yoga classes weekly for 16 weeks. Baseline demographics, behaviours and health measures were investigated as predictors of adherence. Barriers were assessed via documentation of adverse events, and exit survey responses. RESULTS: Participants (38.2 ± 10.1 years) were predominantly overweight-obese (83%), female (79%), and attended 27 ± 18 classes. Higher adherence was associated with older age (p = 0.094), less pain (p = 0.011), fewer physical limitations (p = 0.011), poorer blood lipid profile, and higher heart rate variability (HRV; total power, (p = 0.097)). In multi-variable analysis, three variables: age (ß = 0.492, p = 0.006), HRV (ß = 0.413, p = 0.021) and pain (ß = 0.329, p = 0.048) remained predictors of adherence. Difficulty committing to the trial, lack of enjoyment and adverse events were barriers to adherence. CONCLUSIONS: These findings should be considered in the development of future Bikram yoga trials to facilitate higher levels of adherence, which may enhance health outcomes and inform community practice. Future trials should investigate and address additional barriers and facilitators of Bikram yoga practice.

The effects of acupuncture on the secondary outcomes of anxiety and quality of life for women undergoing IVF: A randomized controlled trial.

INTRODUCTION: Studies have shown in vitro fertilization (IVF) treatment to have a significant impact on women's quality of life. In addition, anxiety is experienced during IVF treatment and prior to knowing the outcome from a treatment cycle. Although support services are available at many IVF clinics, the uptake of these opportunities may not be high. Acupuncture is used by women undertaking IVF treatment in the belief that it improves their reproductive outcomes, and some studies suggest that it may reduce anxiety. The objective of this study was to examine the effects of acupuncture compared with sham acupuncture on quality of life and anxiety for women undergoing an IVF cycle. MATERIAL AND METHODS: A multicenter randomized controlled trial was conducted in Australia and New Zealand. Women were eligible if they were aged 18-42 years, undergoing a fresh IVF cycle and not using acupuncture. Recruitment occurred between June 2011 and October 2015. Women were randomized to acupuncture or a sham acupuncture control group and three treatments were administered, the first treatment between day 6 and 8 of ovarian stimulation, and two treatments were given on the day of embryo transfer. The primary outcome was livebirth. Secondary outcomes included quality of life and anxiety, and were assessed at baseline, on the day of embryo transfer and 14 weeks from trial entry. RESULTS: In all, 848 women were randomized to the trial, 608 women underwent an embryo transfer, of which 526 (86%) received all three treatments. Adjusted analysis found that women receiving acupuncture reported reduced anxiety following embryo transfer (mean difference [MD] -1.1, 95% CI -2.2 to -0.1, P = 0.03). Unadjusted analysis of quality of life did not differ between groups following embryo transfer. Adjusted analyses by per protocol found a significant positive change for the acupuncture group for the general health MOS Short Form 36 (SF36) domain (MD 2.6, 95% CI 0.5-4.7, P = 0.01) following embryo transfer. The benefit was not sustained at 14 weeks (MD 0.1, 95% CI -2.7 to 2.9). CONCLUSIONS: Acupuncture may reduce anxiety at embryo transfer. Quality of life did not differ between the groups. Women experience reduced emotional well-being 3 months following the IVF cycle, highlighting ongoing unmet psycho-social needs.

Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial.

Importance: Acupuncture is widely used by women undergoing in vitro fertilization (IVF), although the evidence for efficacy is conflicting. Objective: To determine the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births. Design, Setting, and Participants: A single-blind, parallel-group randomized clinical trial including 848 women undergoing a fresh IVF cycle was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016. Interventions: Women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and 2 treatments were administered prior to and following embryo transfer. The sham control used a noninvasive needle placed away from the true acupuncture points. Main Outcomes and Measures: The primary outcome was live birth, defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g. Results: Among 848 randomized women, 24 withdrew consent, 824 were included in the study (mean [SD] age, 35.4 [4.3] years); 371 [45.0%] had undergone more than 2 previous IVF cycles), 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]). Conclusions and Relevance: Among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF. Trial Registration: anzctr.org.au Identifier: ACTRN12611000226909.

A Cohort Study to Examine the Use of Chinese Herbal Medicine in Combination With Conventional Therapies for Patients With Hepatocellular Carcinoma in China.

BACKGROUND: Hepatocellular carcinoma (HCC) is one of the major malignancies associated with high mortality rates. Chinese herbal medicine (CHM) alone, or in combination with conventional therapies (CT), has been widely used for patients with HCC in China. This study aims to explore how integrative therapy (IT) through the combination of CHM and CT affects the survival of patients with intermediate-advanced HCC. METHODS: A retrospective cohort study was performed at the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Data of consecutive patients diagnosed with intermediate-advanced HCC and a specific traditional Chinese medicine diagnostic pattern between January 2006 and December 2013 were retrieved from the electronic medical record system at the hospital. Patients were divided into 3 groups based on the therapies used, that is, IT, CHM alone, and CT alone, and the survival times of these patients was compared. RESULTS: A total of 328 patients were included in this study. Median follow-up period was 26.4 months (95% confidence interval [CI] = 22.7-38.9). Median overall survival was 11.0 months for IT, 8.6 months for CHM, and 9.4 months for CT groups ( P < .001). The adjusted hazard ratio (HR) of death for the IT group was 0.55 (95% CI = 0.38-0.79, P = .001) relative to the CT group and 0.68 (95% CI = 0.52-0.90, P = .007) relative to the CHM group, after adjusting for the factors that impact prognosis. Stratified analysis shows that IT can significantly lower the risk of death, especially for patients with good performance status (PS) and Child-Pugh class A. CONCLUSIONS: It was indicated that the integrative approach with combination of CHM and CT might improve survival for patients with intermediate-advanced HCC, especially for patients with good PS and Child-Pugh class A. However, a randomized controlled trial is warranted for a conclusive statement.

Effect of a 16-week Bikram yoga program on perceived stress, self-efficacy and health-related quality of life in stressed and sedentary adults: A randomised controlled trial.

OBJECTIVES: The purpose of this study was to investigate the effect of 16 weeks of Bikram yoga on perceived stress, self-efficacy and health related quality of life (HRQoL) in sedentary, stressed adults. DESIGN: 16 week, parallel-arm, randomised controlled trial with flexible dosing. METHODS: Physically inactive, stressed adults (37.2±10.8 years) were randomised to Bikram yoga (three to five classes per week) or control (no treatment) group for 16 weeks. Outcome measures, collected via self-report, included perceived stress, general self-efficacy, and HRQoL. Outcomes were assessed at baseline, midpoint and completion. RESULTS: Individuals were randomised to the experimental (n=29) or control group (n=34). Average attendance in the experimental group was 27±18 classes. Repeated measure analyses of variance (intention-to-treat) demonstrated significantly improved perceived stress (p=0.003, partial η2=0.109), general self-efficacy (p=0.034, partial η2=0.056), and the general health (p=0.034, partial η2=0.058) and energy/fatigue (p=0.019, partial η2=0.066) domains of HRQoL in the experimental group versus the control group. Attendance was significantly associated with reductions in perceived stress, and an increase in several domains of HRQoL. CONCLUSIONS: 16 weeks of Bikram yoga significantly improved perceived stress, general self-efficacy and HRQoL in sedentary, stressed adults. Future research should consider ways to optimise adherence, and should investigate effects of Bikram yoga intervention in other populations at risk for stress-related illness. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12616000867493. Registered 04 July 2016. URL: http://www.anzctr.org.au/ACTRN12616000867493.aspx.

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp2  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

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.

Effect of a 16-week Bikram yoga program on heart rate variability and associated cardiovascular disease risk factors in stressed and sedentary adults: A randomized controlled trial.

BACKGROUND: Chronic activation of the stress-response can contribute to cardiovascular disease risk, particularly in sedentary individuals. This study investigated the effect of a Bikram yoga intervention on the high frequency power component of heart rate variability (HRV) and associated cardiovascular disease (CVD) risk factors (i.e. additional domains of HRV, hemodynamic, hematologic, anthropometric and body composition outcome measures) in stressed and sedentary adults. METHODS: Eligible adults were randomized to an experimental group (n = 29) or a no treatment control group (n = 34). Experimental group participants were instructed to attend three to five supervised Bikram yoga classes per week for 16 weeks at local studios. Outcome measures were assessed at baseline (week 0) and completion (week 17). RESULTS: Sixty-three adults (37.2 ± 10.8 years, 79% women) were included in the intention-to-treat analysis. The experimental group attended 27 ± 18 classes. Analyses of covariance revealed no significant change in the high-frequency component of HRV (p = 0.912, partial η 2 = 0.000) or in any secondary outcome measure between groups over time. However, regression analyses revealed that higher attendance in the experimental group was associated with significant reductions in diastolic blood pressure (p = 0.039; partial η 2 = 0.154), body fat percentage (p = 0.001, partial η 2 = 0.379), fat mass (p = 0.003, partial η 2 = 0.294) and body mass index (p = 0.05, partial η 2 = 0.139). CONCLUSIONS: A 16-week Bikram yoga program did not increase the high frequency power component of HRV or any other CVD risk factors investigated. As revealed by post hoc analyses, low adherence likely contributed to the null effects. Future studies are required to address barriers to adherence to better elucidate the dose-response effects of Bikram yoga practice as a medium to lower stress-related CVD risk. TRIAL REGISTRATION: Retrospectively registered with Australia New Zealand Clinical Trials Registry ACTRN12616000867493 . Registered 04 July 2016.

Guttiferone K suppresses cell motility and metastasis of hepatocellular carcinoma by restoring aberrantly reduced profilin 1.

Hepatocellular carcinoma (HCC) is an aggressive malignancy and the 5-year survival rate of advanced HCC is < 10%. Guttiferone K (GUTK) isolated from the Garcinia genus inhibited HCC cells migration and invasion in vitro and metastasis in vivo without apparent toxicity. Proteomic analysis revealed that actin-binding protein profilin 1 (PFN1) was markedly increased in the presence of GUTK. Over-expression of PFN1 mimicked the effect of GUTK on HCC cell motility and metastasis. The effect of GUTK on cell motility was diminished when PFN1 was over-expressed or silenced. Over-expression of PFN1 or incubation with GUTK decreased F-actin levels and the expression of proteins involved in actin nucleation, branching and polymerization. Moreover, a reduction of PFN1 protein levels was common in advanced human HCC and associated with poor survival rate. In conclusion, GUTK effectively suppresses the motility and metastasis of HCC cells mainly by restoration of aberrantly reduced PFN1 protein expression.

INDIVIDUALIZED YOGA FOR REDUCING DEPRESSION AND ANXIETY, AND IMPROVING WELL-BEING: A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: Depression and anxiety are leading causes of disability worldwide. Current treatments are primarily pharmaceutical and psychological. Questions remain about effectiveness and suitability for different people. Previous research suggests potential benefits of yoga for reducing depression and anxiety. The aim of this study is to investigate the effects of an individualized yoga intervention. METHODS: A sample of 101 people with symptoms of depression and/or anxiety participated in a randomized controlled trial comparing a 6-week yoga intervention with waitlist control. Yoga was additional to usual treatment. The control group was offered the yoga following the waitlist period. Measures included Depression Anxiety Stress Scale (DASS-21), Kessler Psychological Distress Scale (K10), Short-Form Health Survey (SF12), Scale of Positive and Negative Experience (SPANE), Flourishing Scale (FS), and Connor-Davidson Resilience Scale (CD-RISC2). RESULTS: There were statistically significant differences between yoga and control groups on reduction of depression scores (-4.30; 95% CI: -7.70, -0.01; P = .01; ES -.44). Differences in reduced anxiety scores were not statistically significant (-1.91; 95% CI: -4.58, 0.76; P = .16). Statistically significant differences in favor of yoga were also found on total DASS (P = .03), K10, SF12 mental health, SPANE, FS, and resilience scores (P < .01 for each). Differences in stress and SF12 physical health scores were not statistically significant. Benefits were maintained at 6-week follow-up. CONCLUSION: Yoga plus regular care was effective in reducing symptoms of depression compared with regular care alone. Further investigation is warranted regarding potential benefits in anxiety. Individualized yoga may be particularly beneficial in mental health care in the broader community.

Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C. METHODS: We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16. RESULTS: There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated. CONCLUSIONS: In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo. Clinical trial registration no: ACTRN12609000558224.

Establishing key components of yoga interventions for reducing depression and anxiety, and improving well-being: a Delphi method study.

BACKGROUND: Previous research suggests benefits of yoga in reducing depression and anxiety. However, common concerns in reviews of the research include lack of detail, rationale and consistency of approach of interventions used. Issues related to heterogeneity include amount, types and delivery of yoga interventions. This study aims to document consensus-based recommendations for consistency of yoga interventions for reducing depression and anxiety. METHODS: The Delphi method was used to establish consensus from experienced yoga teachers. Thirty-three eligible teachers were invited to participate, from four different countries. Two rounds of an online survey were sent to participants. The first round sought initial views. The second round sought consensus on a summary of those views. Survey questions related to frequency and duration (dosage) of the yoga, approaches and techniques to be included or avoided, and training and experience for yoga teachers. RESULTS: Twenty-four teachers agreed to participate. Eighteen completed the second round (n = 18). General consensus (>75% of participants in agreement) was achieved on parameters of practice (dosage): an average of 30 to 40 minutes, to be done 5 times per week, over a period of 6 weeks. Numerous recommendations for yoga techniques to include or avoid were collected in the first round. The second round produced a consensus statement on those recommendations. Breath regulation and postures were considered very important or essential for people with depression; and relaxation, breath regulation and meditation being very important or essential for people with anxiety. Other recommended components also achieved consensus. There was also general consensus that it is very important or essential for teachers to have a minimum of 500 training hours over 2 years, at least 2 years teaching experience, training in developing personalised yoga practices, training in yoga for mental health, and professional supervision or mentoring. CONCLUSIONS: The Delphi process has achieved a consensus statement on the application of yoga for reducing anxiety and depression. This consensus provides a checklist for identification of commonalities and evaluation of past research. Future research can proceed to develop and evaluate consensus-based yoga intervention protocols for the reduction of anxiety and depression, and improvements in well-being.

Interrater reliability of chinese medicine diagnosis in people with prediabetes.

Background. Achieving reproducibility in research design is challenging when patient cohorts under study are inconsistently defined. Traditional Chinese medicine (TCM) diagnosis is one example where inconsistency between practitioners has been found. We hypothesise that the use of a validated instrument may improve consistency. Biochemical biomarkers may also be used enhance reliability. Methods. Twenty-seven participants with prediabetes were assessed by two TCM practitioners using a validated instrument (TEAMSI-TCM). Inter-rater reliability was summarised using percentage agreement and the kappa coefficient. One-way ANOVA and Tukey's post hoc test were used to test links between TCM diagnosis and biomarkers. Results. The two practitioners agreed on primary diagnosis of 70% of participants. kappa = 0.56 (P < 0.001). The three predominant TCM diagnostic patterns for people with prediabetes were Yin deficiency, Qi and Yin deficiency and Spleen qi deficiency. The Spleen Qi deficiency with Damp cohort had statistically significant higher fasting glucose, higher insulin, higher insulin resistance, higher HbA1c and lower HDL than those with Qi and Yin deficiency. Conclusions. Using the TEAMSI-TCM resulted in moderate interrater reliability between TCM practitioners. This study provides initial evidence of variation in the biomarkers of people with prediabetes according to the different TCM patterns which may suggest a route to further improving interrater reliability.