Self-Administered Acupressure for Probable Knee Osteoarthritis in Middle-Aged and Older Adults: A Randomized Clinical Trial.

Importance: The effects of self-administered acupressure (SAA) on knee osteoarthritis (OA) pain remain unclear. Objective: To evaluate the effectiveness of SAA taught via a short training course on reducing knee OA pain in middle-aged and older adults. Design, Setting, and Participants: This randomized clinical trial was conducted among community-dwelling individuals in Hong Kong who were aged 50 years or older with probable knee OA from September 2019 to May 2022. Interventions: The intervention included 2 training sessions for SAA with a brief knee health education (KHE) session, in which participants practiced acupressure twice daily for 12 weeks. The control group (KHE only) received only education about maintaining knee health on the same schedule and duration. Main Outcomes and Measures: The primary outcome was the numerical rating scale (NRS) pain score at 12 weeks. Other outcomes included Western Ontario and McMaster University Osteoarthritis Index, Short Form 6 Dimensions (SF-6D), Timed Up and Go, and Fast Gait Speed tests. Results: A total of 314 participants (mean [SD] age, 62.7 [4.5] years; 246 [78.3%] female; mean [SD] knee pain duration, 7.3 [7.6] years) were randomized into intervention and KHE-only groups (each 157). At week 12, compared with the KHE-only group, the intervention group had a significantly greater reduction in NRS pain score (mean difference [MD], -0.54 points; 95% CI, -0.97 to -0.10 points; P = .02) and higher enhancement in SF-6D utility score (MD, 0.03 points; 95% CI, 0.003 to 0.01 points; P = .03) but did not have significant differences in other outcome measures. The cost-effectiveness acceptability curve demonstrated a greater than 90% probability that the intervention is cost-effective at a willingness to pay threshold of 1 GDP per capita. Conclusions and Relevance: In this randomized clinical trial, SAA with a brief KHE program was efficacious and cost-effective in relieving knee pain and improving mobility in middle-aged and older adults with probable knee OA. Trial Registration: ClinicalTrials.gov Identifier: NCT04191837.

Cognitive behavioural therapy for insomnia as an early intervention of mood disorders with comorbid insomnia: A randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of small-group nurse-administered cognitive behavioural therapy for insomnia (CBTI) as an early intervention of mood disorders with comorbid insomnia. METHODS: A total of 200 patients with first-episode depressive or bipolar disorders and comorbid insomnia were randomized in a ratio of 1:1 to receiving 4-session CBTI or not in a routine psychiatric care setting. Primary outcome was Insomnia Severity Index. Secondary outcomes included response and remission status; daytime symptomatology and quality of life; medication burden; sleep-related cognitions and behaviours; and the credibility, satisfaction, adherence and adverse events of CBTI. Assessments were conducted at baseline, 3, 6, and 12-month. RESULTS: Only a significant time-effect but no group-by-time interaction was found in the primary outcome. Several secondary outcomes had significantly greater improvements in CBTI group, including higher depression remission at 12-month (59.7% vs. 37.9%, χ2 = 6.57, p = .01), lower anxiolytic use at 3-month (18.1% vs. 33.3%, χ2 = 4.72, p = .03) and 12-month (12.5% vs. 25.8%, χ2 = 3.26, p = .047), and lesser sleep-related dysfunctional cognitions at 3 and 6-month (mixed-effects model, F = 5.12, p = .001 and .03, respectively). Depression remission rate was 28.6%, 40.3%, and 59.7% at 3, 6, and 12-month, respectively in CBTI group and 28.4%, 31.1%, and 37.9%, respectively in no CBTI group. CONCLUSION: CBTI may be a useful early intervention to enhance depression remission and reduce medication burden in patients with first-episode depressive disorder and comorbid insomnia.

Self-administered acupressure for insomnia disorder: A randomized controlled trial.

BACKGROUND: Insomnia is a significant health problem in the community. Self-administered acupressure (SAA) may be an alternative strategy to alleviate insomnia. PURPOSE: This study is the first to investigate the effects of SAA delivered through a training course in alleviating insomnia disorder compared with sleep hygiene education (SHE). METHODS: A randomized controlled trial was conducted on 200 participants with insomnia disorder. The eligible participants were randomized into the SAA or SHE group. Both groups attended the allocated training courses (two sessions, 2 h each) and then were followed up at weeks 4 and 8. The primary outcome was the severity of insomnia symptoms and related daytime impairment as measured by the Insomnia Severity Index (ISI). Other measures included a 7-day sleep diary and actigraphy, Hospital Anxiety and Depression Scale (HADS), and Short-Form Six-Dimension (SF6D). RESULTS: The SAA group showed a significantly greater improvement in ISI score than the SHE group at week 4 (mean difference: -1.89 units, 95% CI: 0.85, 2.93; Cohen's d = 0.51, p < 0.001) and week 8 (mean difference: -2.89 units, 95% CI: 1.67, 4.11; d = 0.67, p < 0.001). In addition, the SAA group showed a greater reduction in the HADS anxiety score and HADS depression score and increase in SF6D at week 8. CONCLUSIONS: SAA taught in a short training course is a feasible and effective approach to improve sleep and related daytime impairment and mood problems in individuals with insomnia disorder.

Prevalence and Prognostic Importance of Massive Tricuspid Regurgitation in Patients Undergoing Tricuspid Annuloplasty With Concomitant Left-Sided Valve Surgery: A Study on Rheumatic Valvular Heart Disease.

BACKGROUND: The presence of tricuspid regurgitation (TR) is very common in patients with concomitant left-sided valve disease. Recent studies have advocated an additional grading of massive TR that is beyond severe. The present study sought to characterize the spectrum of TR in patients undergoing tricuspid annuloplasty (TA) and to evaluate the prognostic value of TR severity for post-operative outcome following TA. METHODS: A total of 176 patients who underwent TA with combined left-sided valve surgery, secondary to rheumatic valvular heart disease, were prospectively evaluated. The severity of TR was quantified by effective regurgitant orifice area (EROA) using the proximal isovelocity surface area method. Patients were categorized as having non-massive TR (EROA < 0.6 cm2) or massive TR (EROA ≥ 0.6 cm2). Adverse outcome was defined as all-cause mortality or heart failure requiring hospital admission following TA. RESULTS: A total of 55 (31%) patients were considered to have massive TR. Patients with massive TR had a greater right ventricular dimension but a smaller left ventricular dimension compared with those with non-massive TR. After a median follow-up of 39 months, 35 adverse events occurred. Cox-regression analysis showed that both continuous EROA and dichotomized EROA (massive vs. non-massive TR) were independently associated with adverse events even after multivariable adjustment. Further, Harrell C index demonstrated that the addition of massive TR provided better discrimination ability of a prediction model to known prognosticators following TA. CONCLUSIONS: Massive TR is common and up to 31% of study population had massive TR. Massive TR was associated with adverse outcome in patients undergoing TA. Classification of the severity of TR by quantitative measures and identification of massive TR in patients with concomitant left-sided valve disease are essential when considering the optimal timing of corrective surgery.

Semi-Individualized Acupuncture for Insomnia Disorder and Oxidative Stress: A Randomized, Double-Blind, Sham-Controlled Trial.

BACKGROUND: Acupuncture is an alternative treatment for improving sleep, and it may attenuate oxidative stress, which is a possible pathophysiological factor in insomnia. The aim of this study was to examine the efficacy and safety of a semi-individualized acupuncture in improving sleep and explore its effect on oxidative stress parameters in adults with insomnia disorder. METHODS: In this randomized sham-controlled trial, 140 participants were randomly assigned to either a 4-week semi-individualized traditional acupuncture (TA) or noninvasive sham acupuncture (SA). The primary outcome measure was the sleep-diary-derived sleep efficiency. Other outcomes included sleep diary and actigraphy, Insomnia Severity Index, anxiety and depressive symptoms, and quality of life. Blood samples were taken to measure oxidative stress parameters (malondialdehyde, glutathione peroxidase, paraoxonase, and arylesterase). RESULTS: Although no significant difference was found in the primary outcome measure, both sleep-diary-derived and actigraphy-derived total sleep time (TST) were significantly increased in the TA group at 1-week posttreatment (mean difference in sleep diary = 22.0 min, p = 0.01, actigraphy = 18.8 min, p = 0.02). At 5-week posttreatment follow-up, a significantly higher proportion of participants in the TA group showed sleep-diary-derived sleep efficiency (SE) ≥ 85% than in the SA group (55.6% versus 36.4%, p = 0.03). CONCLUSION: TA and SA did not significantly differ in improving subjective sleep efficiency in individuals with insomnia disorder. However, the TA group showed a short-term effect on improving TST as measured by both sleep diary and actigraphy at 1-week posttreatment, but there were no differences in the oxidative stress parameters. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia; Identifier NCT03447587; URL: https://clinicaltrials.gov/ct2/show/NCT03447587.

Sex-specific pattern of left ventricular hypertrophy and diastolic function in patients with type 2 diabetes mellitus.

AIMS: Few prospective studies have evaluated sex-specific pattern, natural progression of left ventricular (LV) remodelling, and diastolic dysfunction in patients with type 2 diabetes (T2DM). The aim of this study was to study the sex-specific prevalence, longitudinal changes of LV remodelling, and diastolic dysfunction in patients with T2DM. Further, the prognostic value of diastolic function in women and men was also evaluated. METHODS AND RESULTS: A total of 350 patients with T2DM (mean age 61 ± 11 years; women, 48.3%) was recruited. Detailed echocardiography was performed at baseline and after 25 months. A major adverse cardiovascular event (MACE) was defined as cardiovascular death, heart failure hospitalization, or myocardial infarction. Despite a similar age, prevalence of hypertension and body mass index, women had a higher prevalence of LV hypertrophy and diastolic dysfunction at baseline and follow-up compared with men. A total of 21 patients developed MACE (5 cardiovascular death, 9 hospitalization for heart failure, and 7 myocardial infarction) during a median follow-up of 56 months. Women with diastolic dysfunction had a higher incidence of MACE than those with normal diastolic function but this association was neutral in men. Multivariable Cox-regression analysis indicated that diastolic dysfunction was associated with MACE in women [hazard ratio = 6.30; 95% confidence interval (CI) = 1.06-37.54; P < 0.05] but not men (hazard ratio = 2.29, 95% CI = 0.67-7.89; P = 0.19). CONCLUSION: LV hypertrophy and diastolic dysfunction, both at baseline and follow-up, were more common in women than men. Pre-clinical diastolic dysfunction was independently associated with MACE only in women with T2DM but was neutral in men.

Mental Health Impacts of the COVID-19 Pandemic on International University Students, Related Stressors, and Coping Strategies.

Background: The coronavirus disease 2019 (COVID-19) pandemic has disrupted university teaching globally. The mental health impacts on international university students have been overlooked. Aims: This study examined the differences in COVID-19-related stressors and mental health impacts between international university students studying in the UK or USA who returned to their home country or region (returnees) and those who stayed in their institution country (stayers), and identified COVID-19-related stressors and coping strategies that were predictors of mental health. Method: An online questionnaire survey was conducted from April 28 through May 12, 2020 using an exponential, non-discriminative snowball sampling strategy (registered at the National Institutes of Health: NCT04365361). Results: A total of 124 full-time international university students (36.3% male) were included: 75.8% had returned to their home country or region for reasons related to COVID-19; 77.4% were pursuing a bachelor's program, and 53.2% were in programs with practicum component. 84.7% of all students had moderate-to-high perceived stress, 12.1% had moderate-to-severe symptoms of anxiety and depression, and 17.7% had moderate-to-severe symptoms of insomnia. Compared with returnees, stayers had significantly higher stress from COVID-19-related stressors such as personal health and lack of social support (Cohen's d: 0.57-1.11), higher perceived stress [10-item Perceived Stress Scale (PSS-10)] {22.6 ± 6.2 vs. 19.1 ± 6.1, ß [95% confidence interval (CI)]: 4.039 (0.816, 7.261), Cohen's d: 0.52}, and more severe insomnia symptoms [Insomnia Severity Index (ISI)] [11.8 ± 6.1 vs. 7.6 ± 5.2, ß (95% CI): 3.087 (0.262, 5.912), Cohen's d: 0.45], with moderate-to-large effect sizes. Compared with males, females reported significantly higher stress from uncertainties about academic program (Cohen's d: 0.45) with a small effect size. In the total sample, stress related to academics (e.g., personal attainment, uncertainties about academic program, and changes in teaching/learning format), health (including personal health and health of family and friends), availability of reliable COVID-19-related information, and lack of social support predicted more negative mental health impacts. Resilience, positive thinking, and exercise were predictors of less severe mental health impacts. Conclusions: Stayers experienced more adverse mental health impacts than returnees. We call on educators and mental health professionals to provide appropriate support for international students, particularly the stayers, during the pandemic.

A Community-Based Lifestyle-Integrated Physical Activity Intervention to Enhance Physical Activity, Positive Family Communication, and Perceived Health in Deprived Families: A Cluster Randomized Controlled Trial.

Background: Zero-time exercise (ZTEx) is an approach integrating simple strength- and stamina-enhancing physical activity into daily life. The study evaluated the effectiveness of a community-based lifestyle-integrated physical activity intervention using ZTEx to enhance participants' physical activity, family communication, perceived health and happiness, and family harmony. Methods: A parallel group, cluster randomized controlled trial was conducted in a sample of 673 participants from eight Integrated Family Service Centers in Hong Kong. The experimental group (n = 316) received a physical activity intervention. The control group (n = 357) received information on healthy eating. Both groups received three face-to-face intervention sessions (totalling 6 h and 30 min) and 16 text messages. The primary outcome was the change in days spent engaged in ZTEx. Secondary outcomes included changes in sitting time, days engaged in moderate or vigorous physical activities, family communication (encouraging and engaging family members in ZTEx), dietary habits, perceived health and happiness, and family harmony. Self-administered questionnaires were used at baseline and at 3, 6, and 12 months. Mixed effects models with intention-to-treat analysis was used. Results: Compared with the control group at 3 months, the experimental group showed significantly greater increases of 1.3 days spent doing ZTEx (Cohen's d: 0.60), 0.3 days spent doing moderate physical activity (Cohen's d: 0.08), 0.3 days encouraging family members to do ZTEx (Cohen's d: 0.16), and 0.7 days doing ZTEx with family members (Cohen's d: 0.39) during the 7 days prior. At 3 months, the experimental group also showed a significantly greater improvement in perceived health, by a score of 0.2 (Cohen's d: 0.14). The effect sizes ranged from small to medium, with similar intervention effects at the 6-month and 1-year assessments. Compared with the experimental group, the control group showed a significantly greater reduction of 0.4 days on which sweetened beverages were consumed (95% CI: 0.01, 0.9, p < 0.05, Cohen's d: 0.28). The qualitative results supported the quantitative findings. Conclusions: Our findings show that a community-based lifestyle-integrated physical activity (PA) intervention can enhance physical activity, family communication, and perceived health in deprived families in Hong Kong. Trial registration: The research protocol was retrospectively registered at the National Institutes of Health (identifier number: NCT02601534) on November 10, 2015.

Nonapical Right Ventricular Pacing Is Associated with Less Tricuspid Valve Interference and Long-Term Progress of Tricuspid Regurgitation.

BACKGROUND: Tricuspid regurgitation (TR) is a well-known complication after permanent pacemaker implantation. The aim of this study was to compare the degree of TR and the relationship of lead position across the tricuspid valve (TV) between patients with right ventricular apical (RVA) and non-RVA pacing determined by three-dimensional echocardiography. METHODS: Conventional and three-dimensional echocardiography was performed in 284 patients to determine the change in TR severity following permanent pacemaker implantation. Transvenous lead locations were based on fluoroscopic images. This was a retrospective study, and the selected pacing mode was not randomized. RESULTS: RVA pacing had more frequent severe TR (37.9% vs 25.7%, P = .03) compared with non-RVA pacing. Severe TR occurred in 9.7%, 12.6%, and 58.8% of patients when the lead passed through the middle, between the commissures, and impinging the TV leaflets, respectively. Non-RVA leads were more likely to be positioned in the middle of the TV (30.3% vs 12.1%, P < .01) and had the lowest chance of leaflet impingement (33.6% vs 51.5%, P < .01) compared with RVA leads. RVA pacing was associated with worsening of grade ≥2 TR severity compared with non-RVA pacing (42.4% vs 27.6%, P < .01). A TV lead passage angle of -15° to 15° minimized TR. CONCLUSIONS: Pacing-induced TR is more prevalent with RVA than non-RVA pacing. Preferential lead impingement on the TV leaflet, as determined by TV lead passage angle, can explain the development and progression of pacing-induced TR.

Electroacupuncture trigeminal nerve stimulation plus body acupuncture for chemotherapy-induced cognitive impairment in breast cancer patients: An assessor-participant blinded, randomized controlled trial.

Chemotherapy causes various side effects, including cognitive impairment, known as 'chemobrain'. In this study, we determined whether a novel acupuncture mode called electroacupuncture trigeminal nerve stimulation plus body acupuncture (EA/TNS + BA) could produce better outcomes than minimum acupuncture stimulation (MAS) as controls in treating chemobrain and other symptoms in breast cancer patients. In this assessor- and participant-blinded, randomized controlled trial, 93 breast cancer patients under or post chemotherapy were randomly assigned to EA/TNS + BA (n = 46) and MAS (n = 47) for 2 sessions per week over 8 weeks. The Montreal Cognitive Assessment (MoCA) served as the primary outcome. Digit span test was the secondary outcomes for attentional function and working memory. The quality of life and multiple functional assessments were also evaluated. EA/TNS + BA treated group had much better performance than MAS-treated group on reverse digit span test at Week 2 and Week 8, with medium effect sizes of 0.53 and 0.48, respectively, although no significant differences were observed in MoCA score and prevalence of chemobrain between the two groups. EA/TNS + BA also markedly reduced incidences of diarrhoea, poor appetite, headache, anxiety, and irritation, and improved social/family and emotional wellbeing compared to MAS. These results suggest that EA/TNS + BA may have particular benefits in reducing chemotherapy-induced working memory impairment and the incidence of certain digestive, neurological, and distress-related symptoms. It could serve as an effective intervention for breast cancer patients under and post chemotherapy (trial registration: https://www.clinicaltrials.gov: NCT02457039).

Prognostic Value of Tricuspid Valve Geometry and Leaflet Coaptation Status in Patients Undergoing Tricuspid Annuloplasty: A Three-Dimensional Echocardiography Study.

BACKGROUND: The advent of three-dimensional echocardiography (3DE) enables detailed evaluation of the tricuspid valve (TV) apparatus; nonetheless, the clinical value of preoperative 3DE is unknown in patients undergoing tricuspid annuloplasty (TA). The aim of this study was to evaluate the prognostic value of TV geometric parameters and leaflet coaptation status evaluated by 3DE in patients undergoing TA. METHODS: A total of 122 patients who underwent TA during left-sided heart valve surgery were prospectively evaluated. Detailed 3DE was performed before surgery. Adverse outcome was defined as the occurrence of heart failure requiring hospital admission or all-cause mortality following TA. RESULTS: A total of 33 adverse events (17 heart failures and 16 deaths) occurred during a median follow-up of 36 months. Tethering volume (hazard ratio = 1.32; 95% CI = 1.05-1.66; P = .01) and ratio of total leaflet length to closure length (hazard ratio = 1.07; 95% CI = 1.03-1.12; P < .01) were associated with adverse events after adjustment for age, sex, and tricuspid regurgitation vena contracta width. Receiver-operator characteristic curve analysis revealed that tethering volume (area under curve = 0.73) and ratio of total leaflet length to closure length (area under curve = 0.75) were most associated with adverse events at 1-year follow-up. The presence of either a large tethering volume or a low ratio of total leaflet length to closure length was predictive of an adverse outcome 1 year following TA. CONCLUSIONS: Our study suggests that 3DE-derived TV tethering volume and ratio of total leaflet length to closure length are important preoperative measures associated with adverse events in patients undergoing TA.

Cumulative Rheumatic Inflammation Modulates the Bone-Vascular Axis and Risk of Coronary Calcification.

Background Rheumatic diseases are related to both abnormal bone turnover and atherogenesis, but a mechanistic link was missing. Methods and Results We investigated the effect of cumulative rheumatic inflammation ( CRI ) on risk of coronary calcification in a retrospective cohort of 145 rheumatoid arthritis patients. A time-adjusted aggregate CRI score was derived by conglomerating all quarterly biomarker encounters of serum C-reactive protein over 60 months immediately preceding computed tomography coronary angiography. Flow cytometry was performed to measure the osteocalcin-positive ( OCN +) CD 34+ KDR + and OCN + CD 34+ circulating endothelial progenitor cells ( EPCs ). Conventional early circulating EPCs CD 34+ CD 133+ KDR + was determined. Coronary calcification was defined as any Agatston score >0. 50% of patients (n=72/145) had coronary calcification. CRI score was associated with presence of coronary calcification ( P=0.004) (multivariable-adjusted: highest versus lowest quartile: odds ratio=5.6 [95% CI 1.1-28.9], P=0.041). Receiver operating characteristics curve revealed divergent behavior of OCN -expressing circulating EPCs ( OCN + CD 34+ EPCs : area under the curve=0.60, P=0.034; OCN + CD 34+ KDR + EPCs : area under the curve=0.59, P=0.053, positive predictors) versus conventional early EPCs ( CD 34+ CD 133+ KDR +: area under the curve=0.60, P=0.034, negative predictor) for coronary calcification, which persisted after multivariable adjustments ( OCN + CD 34+ KDR + [>75th percentile]: odds ratio=7.2 [95% CI 1.8-27.9], P=0.005; OCN + CD 34+ EPCs [>75th percentile]: odds ratio=6.0 [95% CI 1.5-23.3], P=0.010; CD 34+ CD 133+ KDR + [>75th percentile: odds ratio=0.3 [95% CI 0.1-1.0], P=0.053). Intriguingly, the CRI score was associated with increased OCN + CD 34+ EPCs (highest versus lowest quartile: B=+25.6 [95% CI 0.8-50.5] [×103/mL peripheral blood], P=0.043), but reduced CD 34+ CD 133+ KDR + EPCs (highest versus lowest quartile: B=-16.2 [95% CI -31.5 to -0.9], P=0.038). Conclusions Preceding 60 months of CRI is associated with increased risk of coronary calcification and altered OCN expression in circulating EPCs .

Osteogenic circulating endothelial progenitor cells are linked to electrocardiographic conduction abnormalities in rheumatic patients.

BACKGROUND: Osteogenic circulating endothelial progenitor cells (EPC) play a pathogenic role in cardiovascular system degeneration through promulgating vasculature calcification, but its role in conduction disorders as part of the cardiovascular degenerative continuum remained unknown. AIM: To investigate the role of osteocalcin (OCN)-expressing circulating EPCs in cardiac conduction disorders in the unique clinical sample of rheumatoid arthritis (RA) susceptible to both abnormal bone metabolism and cardiac conduction disorders. METHODS: We performed flow cytometry studies in 134 consecutive asymptomatic patients with rheumatoid arthritis to derive osteogenic circulating OCN-positive (OCN+) CD34+KDR+ vs. CD34+CD133+KDR+ conventional EPC. Study endpoint was the prespecified combined endpoint of electrocardiographic conduction abnormalities. RESULTS: Total prevalence of cardiac conduction abnormality was 9% (n = 12). All patients except one had normal sinus rhythm. One patient had atrial fibrillation. No patient had advanced atrioventricular (AV) block. Prevalence of first-degree heart block (>200 ms), widened QRS duration (>120 ms) and right bundle branch block were 6.7%, 2.1%, and 2.2% respectively. Circulating osteogenic OCN+ CD34+ KDR+ EPCs were significantly higher among patients with cardiac conduction abnormalities (p = 0.039). Elevated OCN+ CD34+ KDR+ EPCs> 75th percentile was associated with higher prevalence of cardiac conduction abnormalities (58.3% vs. 20.02%, p = 0.003). Adjusted for potential confounders, elevated OCN+ CD34+ KDR+ EPCs> 75th percentile remained independently associated with increased risk of cardiac conduction abnormalities (OR = 4.4 [95%CI 1.2-16.4], p = 0.028). No significant relation was found between conventional EPCs CD34+CD133+KDR+ and conduction abnormalities (p = 0.36). CONCLUSIONS: Elevated osteogenic OCN+ CD34+ KDR+ EPCs are independently associated with the presence of electrocardiographic conduction abnormalities in patients with rheumatoid arthritis, unveiling a potential novel pathophysiological mechanism.

Impact of obesity on longitudinal changes to cardiac structure and function in patients with Type 2 diabetes mellitus.

AIMS: Few prospective studies have evaluated the natural progression of left ventricular (LV) remodelling in patients with Type 2 diabetes mellitus (T2DM). The aim of this study was to evaluate the impact of obesity on longitudinal cardiac structural and functional changes in patients with T2DM. METHODS AND RESULTS: This study comprised of 274 patients with T2DM (mean age, 62.2 ± 11.4 years; male, 51.5%). Echocardiographic parameters including LV geometry, systolic, and diastolic functions were measured at baseline and follow-up. The median follow-up was 24 months (from 12 months to 48 months). The entire cohort showed a significant increase in LV wall thickness, LV mass (LVM), and prevalence of concentric hypertrophy (19.6-27.3%). Further, systolic function and diastolic function had deteriorated at follow-up assessment. Multivariable adjusted linear regression demonstrated that baseline body mass index (BMI) predicted longitudinal change to LVM (ß = 0.29, P < 0.01) and LV ejection fraction (ß = -0.15, P < 0.05). Patients were divided into three groups according to their BMI: normal weight (BMI <23 kg/m2), overweight (BMI between 23 kg/m2 and 27.5 kg/m2), or obese (BMI ≥27.5 kg/m2). Importantly, obesity at baseline predicted a greater longitudinal increase in LVM and decrease in LV ejection fraction compared with overweight and normal weight patients. CONCLUSION: Being obese at baseline was associated with greater longitudinal increase in LV mass and greater deterioration in LV systolic function.

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.

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial.

OBJECTIVE: To evaluate the feasibility and clinical effects of a lifestyle-integrated exercise, namely zero-time exercise (ZTEx), on improving insomnia in inactive adults with insomnia disorder. METHODS: In this pilot randomized controlled trial, 37 physically inactive adults (mean age: 49.9 years; SD: 13.6 91.9% female) fulfilling the diagnostic criteria of insomnia disorder recruited from the community were randomly assigned to ZTEx training or sleep hygiene education (SHE) groups. Subjects in the ZTEx group (n = 18) attended two 2-hour training lessons to learn ZTEx which they then practiced daily for eight weeks. Subjects in the SHE group (n = 19) attended two lessons of the same schedule and duration. The primary outcome measure was the Insomnia Severity Index (ISI). RESULTS: The ZTEx group had lower ISI scores than the SHE group, with a large between-group effect size of 0.93-1.10 at weeks two, four, six, and eight, but the difference became non-significant at week eight, suggesting a loss of efficacy two months after the training. For secondary outcomes, no significant between-group differences were found in sleep parameters by sleep diary or objective actigraphy. The adherence to the ZTEx training course was satisfactory, with 83% of the group completing two sessions and 78% continuing to practice ZTEx for five days or more per week during the eight-week intervention period. CONCLUSION: The simple and brief ZTEx training showed high acceptability and exercise compliance and the first evidence of efficacy in reducing insomnia severity in inactive adults with insomnia disorder. Confirmatory trials with longer follow-up are justified. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, #NCT03155750.

Prognostic Value of Hepatorenal Function By Modified Model for End-stage Liver Disease (MELD) Score in Patients Undergoing Tricuspid Annuloplasty.

BACKGROUND: The Model for End-stage Liver Disease excluding international normalized ratio (MELD-XI) score and the modified MELD score with albumin replacing international normalized ratio (MELD-Albumin) score, which reflect both liver and renal function, have been reported as predictors of adverse events in liver and heart disease. Nonetheless, their prognostic value in patients undergoing tricuspid annuloplasty has not been addressed. METHODS AND RESULTS: A total of 394 patients who underwent tricuspid annuloplasty were evaluated. Baseline clinical, laboratory, and echocardiographic parameters were recorded. Adverse outcome was defined as the occurrence of heart failure requiring admission or all-cause mortality. Patients who underwent tricuspid annuloplasty had a high prevalence of preoperative hepatorenal dysfunction that was more common in patients with severe tricuspid regurgitation than those with mild to moderate tricuspid regurgitation. The MELD-XI and MELD-Albumin scores were excellent predictors of 1-year adverse outcome (area under the curve: 0.69 and 0.75, respectively). Kaplan-Meier survival curve demonstrated that a high score on MELD-XI (≥12.0) and MELD-Albumin (≥10.7) was associated with an increased risk of adverse events. During a median follow-up of 40 months, both MELD-XI and MELD-Albumin scores were significantly associated with adverse outcome, even after adjusting for potential confounding factors. Significant improvement of hepatorenal function at 1 year postoperation was noted only in patients who had no adverse events, not in those who experienced an adverse outcome. CONCLUSIONS: Both MELD-XI score and MELD-Albumin score can provide useful information to predict adverse outcome in patients undergoing tricuspid annuloplasty. The present study supports monitoring of modified MELD score to improve preoperative risk stratification of these patients.

Clinical Benefit of Valvular Surgery in Patients with Chronic Kidney Disease.

Concomitant chronic kidney disease (CKD) is common in patients with significant valvular heart disease (VHD). This study sought to evaluate the clinical benefit of valvular surgery in patients with concomitant CKD.We evaluated 349 patients with significant VHD who were referred for surgery. Patients were divided into those with CKD stage ≥ 3 (CKD patients; n = 88) and those with CKD stage 1 or 2 (no CKD patients; n = 261). 63 patients did not receive surgery, of which 20 patients had CKD and 43 had no CKD. Mortality and change in eGFR were assessed after a median follow-up of 21 months.In the whole study population, 25% of the patients had CKD and these patients had higher mortality than those with no CKD. The annual mortality rates of patients with CKD who did and did not undergo surgery were 7.9% and 28.0%, respectively. In patients with no CKD, the annual mortality rates of those who did and did not undergo surgery were 1.8% and 2.3%, respectively. Importantly, surgery was associated with significant survival benefit in patients with CKD (log-rank test, P < 0.01), but was neutral in patients with no CKD. Multivariable analysis confirmed the survival benefit of valvular surgery in all patients, which was most significant in patients with CKD. Furthermore, eGFR was preserved in patients who underwent valvular surgery but declined significantly in those who did not.CKD is common in patients with significant VHD and, if left untreated surgically, these patients exhibit a high mortality.

Predictors of Daytime Consequences of Insomnia: The Roles of Quantitative Criteria and Nonrestorative Sleep.

BACKGROUND: The implications of removing nonrestorative sleep (NRS) and adding quantitative criteria in the most recent diagnostic criteria of insomnia disorder remain unresolved. The study was aimed to investigate how nighttime quantitative measures of sleep quality and NRS relate to daytime functioning in a general population sample. SAMPLING AND METHODS: Data of 905 subjects (mean age = 47.0 years; 64.5% females) in a population-based survey who had insomnia symptoms or NRS at least 1 night in a typical week were analyzed to evaluate their relationship with "functional impairment," "concerns/distress," and "interference with daily activities" over the past 30 days. Receiver-operating characteristic curve analysis was performed, while controlling for age and gender. RESULTS: Moderate to severe NRS was the first-level predictor of all 3 daytime variables. Insomnia frequency ≥3 times per week and sleep onset latency ≥10-20 min were second-level predictors. CONCLUSIONS: We found that NRS was more important than insomnia symptoms in determining daytime consequences of insomnia. On the basis of our findings we express concerns whether the removal of NRS from the most recent diagnostic criteria may lead to its underrecognition, but support the quantitative criteria on insomnia frequency of at least 3 nights per week.

Predictive value of acute kidney injury for major adverse cardiovascular events following tricuspid annuloplasty: A comparison of three consensus criteria.

BACKGROUND: Tricuspid annuloplasty (TA) is increasingly being performed, but the clinical outcome is unsatisfactory. Acute kidney injury (AKI) is a common complication following cardiac surgery and predicts outcome. Nonetheless the occurrence rate and prognostic value of AKI after TA are unclear. METHODS: This study reviewed 339 consecutive patients (age 65±11 years; male 42%) who underwent TA. The incidence of AKI was defined according to risk/injury/failure/loss/end stage (RIFLE), acute kidney injury network (AKIN), and kidney disease improving global outcomes (KDIGO) criteria, respectively. Major adverse cardiovascular events (MACE) was defined as death, heart failure, stroke, and myocardial infarction (MI). The influence of AKI on MACE was evaluated as a short-term outcome and outcome beyond 30 days. RESULTS: The incidence of AKI, defined according to RIFLE, AKIN, and KDIGO was 57%, 52%, and 53%, respectively. MACE occurred in 94 cases (21 deaths, 63 heart failure requiring hospitalization, 7 stroke, and 3 MI). For short-term outcome, AKI defined by all three scoring systems was independently associated with MACE and death (p<0.01 for both), but not heart failure, stroke, or MI. For outcome beyond 30 days, AKI by all three criteria was associated with MACE and heart failure. Only AKI by AKIN and KDIGO, but not RIFLE, was independently associated with death. CONCLUSION: Our data suggest AKI affects over half of all patients who undergo TA, and has a major and long-lasting impact on survival, MACE, and heart failure. Use of AKIN and KDIGO is more useful than the RIFLE criteria when determining the prognostic value of AKI for mortality beyond 30 days.