Effect of combined use of a low-carbohydrate, high-protein diet with omega-3 polyunsaturated fatty acid supplementation on glycemic control in newly diagnosed type 2 diabetes: a randomized, double-blind, parallel-controlled trial.

Background: The combined effect of a low-carbohydrate, high-protein (LCHP) diet and omega-3 (n-3) polyunsaturated fatty acid (PUFA) supplementation on patients with type 2 diabetes (T2D) is not known. Objective: The aim of this study was to evaluate the effect of an LCHP diet combined with ω-3 (LCHP+ω-3) on glycemic control in patients with T2D. Design: In this randomized, double-blind, parallel-controlled trial, 122 newly diagnosed participants with T2D were randomly assigned to receive a high-carbohydrate, low-protein diet with low ω-3 PUFAs [control (CON)], an LCHP, ω-3, or LCHP+ω-3 diet for 12 wk. The ratio of carbohydrate to protein was 42:28 in the LCHP and LCHP+ω-3 diet and 54:17 in the CON and ω-3 diet. The participants were given 6 g fish oil/d (containing 3.65 g docosahexaenoic acid, eicosapentaenoic acid, and docosapentaenoic acid/d) in the ω-3 and LCHP+ω-3 diet groups or 6 g corn oil/d (placebo) in the CON and LCHP diet groups. Results: Compared with the CON diet group, greater decreases in glycated hemoglobin (HbA1c) and fasting glucose were observed in all of the other 3 diet groups at 12 wk. Of note, HbA1c reduction in the LCHP+ω-3 diet group (-0.51%; 95% CI: -0.64%, -0.37%) was greater than that in the LCHP (P = 0.03) and ω-3 (P = 0.01) diet groups at 12 wk. In terms of fasting glucose, only the LCHP+ω-3 diet group showed a significant decrease at 4 wk (P = 0.03 compared with CON). Moreover, the reduction in fasting glucose in the LCHP+ω-3 diet group (-1.32 mmol/L; 95% CI: -1.72, -0.93 mmol/L) was greater than that in the LCHP (P = 0.04) and ω-3 (P = 0.03) diet groups at 12 wk. Conclusions: The LCHP+ω-3 diet provided greater effects on HbA1c and fasting glucose and faster effects on fasting glucose than both the LCHP and ω-3 diets, indicating the potential necessity of combining an LCHP diet with ω-3 PUFAs in T2D control. This trial was registered at chictr.org.cn/ as ChiCTR-TRC-14004704.

Role of contact force in ischemic scar-related ventricular tachycardia ablation; optimal force required and impact of left ventricular access route.

BACKGROUND: Contact force-sensing technology has become a widely used addition to catheter ablation procedures. Neither the optimal contact force required to achieve adequate lesion formation in the ventricle, nor the impact of left ventricular access route on contact force has been fully clarified. PATIENTS AND METHODS: Consecutive patients (n = 24) with ischemic cardiomyopathy who underwent ablation for scar-related ventricular tachycardia were included in the study. All ablations (n = 25) were performed using irrigated contact force-sensing catheters (Smart Touch, Biosense Webster). Effective lesion formation was defined as electrical unexcitability post ablation at sites which were electrically excitable prior to ablation (unipolar pacing at 10 mA, 2 ms pulse width). We explored the contact force which achieved effective lesion formation and the impact of left ventricular access route (retrograde aortic or transseptal) on the contact force achieved in various segments of the left ventricle. Scar zone was defined as bipolar signal amplitude < 0.5 mV. RESULTS: Among 427 ablation points, effective lesion formation was achieved at 201 points (47.1%). Contact force did not predict effective lesion formation in the overall group. However, within the scar zone, mean contact force ≥ 10 g was significantly associated with effective lesion formation [OR 3.21 (1.43, 7.19) P = 0.005]. In the 12-segment model of the left ventricle, the retrograde approach was associated with higher median contact force in the apical anterior segment (31 vs 19 g; P = 0.045) while transseptal approach had higher median force in the basal inferior segment (25 vs 15 g; P = 0.021). In the 4-segment model, the retrograde approach had higher force in the anterior wall (28 vs 16 g; P = 0.004) while the transseptal approach had higher force in the lateral wall (21 vs 18 g; P = 0.032). There was a trend towards higher force in the inferior wall with the transseptal approach, but this was not statistically significant (20 vs 15 g; P = 0.063). CONCLUSIONS: In patients with ischemic cardiomyopathy, a mean contact force of 10 g or more within the scar zone had the best correlation with electrical unexcitability post ablation in our study. The retrograde aortic approach was associated with better contact force over the anterior wall while use of a transseptal approach had better contact force over the lateral wall.

Aspirin or Rivaroxaban for VTE Prophylaxis after Hip or Knee Arthroplasty.

BACKGROUND: Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. METHODS: We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). RESULTS: A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], -0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, -0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, -1.07 to 0.47; P=0.43). CONCLUSIONS: Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108 .).

An Integrated Management Approach to Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia resulting in mortality and morbidity. Gaps in oral anticoagulation and education of patients regarding AF have been identified as areas that require improvement. METHODS AND RESULTS: A before-and-after study of 433 patients with newly diagnosed AF in the 3 emergency departments in Nova Scotia from January 1, 2011 until January 31, 2014 was performed. The "before" phase underwent the usual-care pathway for AF management; the "after" phase was enrolled in a nurse-run, physician-supervised AF clinic. The primary outcome was a composite of death, cardiovascular hospitalization, and AF-related emergency department visits. A propensity analysis was performed to account for differences in baseline characteristics. RESULTS: A total of 185 patients were enrolled into the usual-care group, and 228 patients were enrolled in the AF clinic group. The mean age was 64±15 years and 44% were women. In a propensity-matched analysis, the primary outcome occurred in 44 (26.2%) patients in the usual-care group and 29 (17.3%) patients in the AF clinic group (odds ratio 0.71; 95% CI [0.59, 1]; P=0.049) at 12 months. Prescription of oral anticoagulation was increased in the CHADS2 ≥2 group (88.4% in the AF clinic versus 58.5% in the usual-care group, P<0.01). CONCLUSIONS: Adoption of this integrated management approach for the burgeoning population of AF may provide an overall benefit to cardiovascular morbidity and mortality.

Effects of aerobic training, resistance training, or both on psychological health in adolescents with obesity: The HEARTY randomized controlled trial.

OBJECTIVE: To determine the effects of aerobic training, resistance training, and combined training on mood, body image, and self-esteem in adolescents with obesity. METHOD: After a 4-week prerandomization treatment, 304 postpubertal adolescents (91 males, 213 females) with obesity ages 14-18 years were randomized to 1 of 4 groups for 22 weeks: aerobic training (n = 75), resistance training (n = 78), combined aerobic and resistance training (n = 75), or nonexercising control (n = 76). All participants received dietary counseling, with a daily energy deficit of 250 kcal. Mood was measured using the Brunel Mood Scale. Body image was assessed using the Multiple Body Self-Relations Questionnaire, and physical self-perceptions and global self-esteem were measured using the Harter Physical Self-Perceptions Questionnaire. RESULTS: Median adherence was 62%, 56%, and 64% in aerobic, resistance, and combined training, respectively. Resistance and combined training produced greater improvements than control on vigor, and resistance training reduced depressive symptoms. All groups improved on body image and physical self-perceptions, but combined showed greater increases than control on perceived physical conditioning, while only resistance training showed greater increases than controls on global self-esteem. Both combined and resistance training demonstrated greater increases in perceived strength than control. Psychological benefits were more related to better adherence and reductions in body fat than changes in strength or fitness. CONCLUSION: Resistance training, alone or in combination with aerobic training, may provide psychological benefits in adolescents with overweight or obesity, and therefore could be an alternative to aerobic training for some individuals in the biological and psychological management of adolescent obesity.

Green tea for weight loss and weight maintenance in overweight or obese adults.

BACKGROUND: Preparations of green tea are used as aids in weight loss and weight maintenance. Catechins and caffeine, both contained in green tea, are each believed to have a role in increasing energy metabolism, which may lead to weight loss. A number of randomised controlled trials (RCTs) evaluating the role of green tea in weight loss have been published; however, the efficacy of green tea preparations in weight loss remains unclear. OBJECTIVES: To assess the efficacy and safety of green tea preparations for weight loss and weight maintenance in overweight or obese adults. SEARCH METHODS: We searched the following databases from inception to specified date as well as reference lists of relevant articles: The Cochrane Library (Issue 12, 2011), MEDLINE (December 2011), EMBASE (December 2011), CINAHL (January 2012), AMED (January 2012), Biological Abstracts (January 2012), IBIDS (August 2010), Obesity+ (January 2012), IPA (January 2012) and Web of Science (December 2011). Current Controlled Trials with links to other databases of ongoing trials was also searched. SELECTION CRITERIA: RCTs of at least 12 weeks' duration comparing green tea preparations to a control in overweight or obese adults. DATA COLLECTION AND ANALYSIS: Three authors independently extracted data, assessed studies for risk of bias and quality, with differences resolved by consensus. Heterogeneity of included studies was assessed visually using forest plots and quantified using the I(2) statistic. We synthesised data using meta-analysis and descriptive analysis as appropriate; subgroup and sensitivity analyses were conducted. Adverse effects reported in studies were recorded. MAIN RESULTS: Due to the level of heterogeneity among studies, studies were divided into two groups; those conducted in Japan and those conducted outside Japan. Study length ranged between 12 and 13 weeks. Meta-analysis of six studies conducted outside Japan showed a mean difference (MD) in weight loss of -0.04 kg (95% CI -0.5 to 0.4; P = 0.88; I(2) = 18%; 532 participants). The eight studies conducted in Japan were not similar enough to allow pooling of results and MD in weight loss ranged from -0.2 kg to -3.5 kg (1030 participants) in favour of green tea preparations. Meta-analysis of studies measuring change in body mass index (BMI) conducted outside Japan showed a MD in BMI of -0.2 kg/m(2) (95% CI -0.5 to 0.1; P = 0.21; I(2) = 38%; 222 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed a reduction in BMI ranging from no effect to -1.3 kg/m(2) (1030 participants), in favour of green tea preparations over control. Meta-analysis of five studies conducted outside Japan and measuring waist circumference reported a MD of -0.2 cm (95% CI -1.4 to 0.9; P = 0.70; I(2) = 58%; 404 participants). Differences among the eight studies conducted in Japan did not allow pooling of results and showed effects on waist circumference ranging from a gain of 1 cm to a loss of 3.3 cm (1030 participants). Meta-analysis for three weight loss studies, conducted outside Japan, with waist-to-hip ratio data (144 participants) yielded no significant change (MD 0; 95% CI -0.02 to 0.01). Analysis of two studies conducted to determine if green tea could help to maintain weight after a period of weight loss (184 participants) showed a change in weight loss of 0.6 to -1.6 kg, a change in BMI from 0.2 to -0.5 kg/m(2) and a change in waist circumference from 0.3 to -1.7 cm. In the eight studies that recorded adverse events, four reported adverse events that were mild to moderate, with the exception of two (green tea preparations group) that required hospitalisation (reported as not associated with the intervention). Nine studies reported on compliance/adherence, one study assessed attitude towards eating as part of the health-related quality of life outcome. No studies reported on patient satisfaction, morbidity or cost. AUTHORS' CONCLUSIONS: Green tea preparations appear to induce a small, statistically non-significant weight loss in overweight or obese adults. Because the amount of weight loss is small, it is not likely to be clinically important. Green tea had no significant effect on the maintenance of weight loss. Of those studies recording information on adverse events, only two identified an adverse event requiring hospitalisation. The remaining adverse events were judged to be mild to moderate.

A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain.

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

Complementary and alternative therapies for back pain II.

BACKGROUND: Back and neck pain are important health problems with serious societal and economic implications. Conventional treatments have been shown to have limited benefit in improving patient outcomes. Complementary and Alternative Medicine (CAM) therapies offer additional options in the management of low back and neck pain. Many trials evaluating CAM therapies have poor quality and inconsistent results. OBJECTIVES: To systematically review the efficacy, effectiveness, cost-effectiveness, and harms of acupuncture, spinal manipulation, mobilization, and massage techniques in management of back, neck, and/or thoracic pain. DATA SOURCES: MEDLINE, Cochrane Central, Cochrane Database of Systematic Reviews, CINAHL, and EMBASE were searched up to 2010; unpublished literature and reference lists of relevant articles were also searched. study selection: All records were screened by two independent reviewers. Primary reports of comparative efficacy, effectiveness, harms, and/or economic evaluations from randomized controlled trials (RCTs) of the CAM therapies in adults (age ≥ 18 years) with back, neck, or thoracic pain were eligible. Non-randomized controlled trials and observational studies (case-control, cohort, cross-sectional) comparing harms were also included. Reviews, case reports, editorials, commentaries or letters were excluded. DATA EXTRACTION: Two independent reviewers using a predefined form extracted data on study, participants, treatments, and outcome characteristics. RESULTS: 265 RCTs and 5 non-RCTs were included. Acupuncture for chronic nonspecific low back pain was associated with significantly lower pain intensity than placebo but only immediately post-treatment (VAS: -0.59, 95 percent CI: -0.93, -0.25). However, acupuncture was not different from placebo in post-treatment disability, pain medication intake, or global improvement in chronic nonspecific low back pain. Acupuncture did not differ from sham-acupuncture in reducing chronic non-specific neck pain immediately after treatment (VAS: 0.24, 95 percent CI: -1.20, 0.73). Acupuncture was superior to no treatment in improving pain intensity (VAS: -1.19, 95 percent CI: 95 percent CI: -2.17, -0.21), disability (PDI), functioning (HFAQ), well-being (SF-36), and range of mobility (extension, flexion), immediately after the treatment. In general, trials that applied sham-acupuncture tended to produce negative results (i.e., statistically non-significant) compared to trials that applied other types of placebo (e.g., TENS, medication, laser). Results regarding comparisons with other active treatments (pain medication, mobilization, laser therapy) were less consistent Acupuncture was more cost-effective compared to usual care or no treatment for patients with chronic back pain. For both low back and neck pain, manipulation was significantly better than placebo or no treatment in reducing pain immediately or short-term after the end of treatment. Manipulation was also better than acupuncture in improving pain and function in chronic nonspecific low back pain. Results from studies comparing manipulation to massage, medication, or physiotherapy were inconsistent, either in favor of manipulation or indicating no significant difference between the two treatments. Findings of studies regarding costs of manipulation relative to other therapies were inconsistent. Mobilization was superior to no treatment but not different from placebo in reducing low back pain or spinal flexibility after the treatment. Mobilization was better than physiotherapy in reducing low back pain (VAS: -0.50, 95 percent CI: -0.70, -0.30) and disability (Oswestry: -4.93, 95 percent CI: -5.91, -3.96). In subjects with acute or subacute neck pain, mobilization compared to placebo significantly reduced neck pain. Mobilization and placebo did not differ in subjects with chronic neck pain. Massage was superior to placebo or no treatment in reducing pain and disability only amongst subjects with acute/sub-acute low back pain. Massage was also significantly better than physical therapy in improving back pain (VAS: -2.11, 95 percent CI: -3.15, -1.07) or disability. For subjects with neck pain, massage was better than no treatment, placebo, or exercise in improving pain or disability, but not neck flexibility. Some evidence indicated higher costs for massage use compared to general practitioner care for low back pain. Reporting of harms in RCTs was poor and inconsistent. Subjects receiving CAM therapies reported soreness or bleeding on the site of application after acupuncture and worsening of pain after manipulation or massage. In two case-control studies cervical manipulation was shown to be significantly associated with vertebral artery dissection or vertebrobasilar vascular accident. CONCLUSIONS: Evidence was of poor to moderate grade and most of it pertained to chronic nonspecific pain, making it difficult to draw more definitive conclusions regarding benefits and harms of CAM therapies in subjects with acute/subacute, mixed, or unknown duration of pain. The benefit of CAM treatments was mostly evident immediately or shortly after the end of the treatment and then faded with time. Very few studies reported long-term outcomes. There was insufficient data to explore subgroup effects. The trial results were inconsistent due probably to methodological and clinical diversity, thereby limiting the extent of quantitative synthesis and complicating interpretation of trial results. Strong efforts are warranted to improve the conduct methodology and reporting quality of primary studies of CAM therapies. Future well powered head to head comparisons of CAM treatments and trials comparing CAM to widely used active treatments that report on all clinically relevant outcomes are needed to draw better conclusions.