Interventions That Support or Involve Caregivers or Families of Patients with Traumatic Injury: a Systematic Review.

BACKGROUND: Almost 40 million family caregivers care for a loved one with severe physical or cognitive impairments. The purpose of this review is to summarize evidence about the benefits of interventions to support or involve family members/caregivers of patients with trauma-related injury on caregiver, patient, and household outcomes. METHODS: English-language peer-reviewed publications in MEDLINE, CINAHL, and PsycINFO from 1995 through December 2016 were identified. Eligible studies included RCT or quasi-experimental studies evaluating interventions designed to support or involve caregivers or family members of patients with TBI, PTSD, or polytrauma. Abstractions were completed by one reviewer and checked by a second; two reviewers independently assessed risk of bias using the Cochrane Effective Practice and Organization of Care Review Criteria. RESULTS: Thirteen studies (n = 9 TBI; n = 4 PTSD, n = 0 polytrauma) evaluated psychological or rehabilitation interventions involving caregivers. Interventions did not improve TBI patients' functional status (standardized mean difference [SMD], 0.29 [95% confidence interval [CI], - 0.51 to 1.08]) or psychological symptoms (SMD - 0.25, CI - 0.62 to 0.12). Qualitative analysis shows potential intervention benefit for TBI symptoms. Interventions did not improve TBI caregiver psychological symptoms (SMD - 0.26, CI - 0.57 to 0.05); however, qualitative analysis suggests mixed effects for caregiver burden and quality of life. Positive intervention effects on patients' PTSD symptoms, mental health service use, and PTSD caregivers' psychological symptoms were identified with certain interventions. Strength of evidence ranged from moderate to very low. DISCUSSION: Studies showed mixed patterns of intervention effects on caregiver and patient outcomes; evidence about intervention impact is inconclusive. This review is the first to identify caregiving interventions for patients with TBI and polytrauma and extends past reviews about patients with PTSD. Limitations include a small evidence base, low study quality, disparate methods, varied outcome measures, and high heterogeneity. PROSPERO Registration CRD42017053516.

Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review.

BACKGROUND: Recent changes to the U.S. Food and Drug Administration boxed warning for metformin will increase its use in persons with historical contraindications or precautions. Prescribers must understand the clinical outcomes of metformin use in these populations. PURPOSE: To synthesize data addressing outcomes of metformin use in populations with type 2 diabetes and moderate to severe chronic kidney disease (CKD), congestive heart failure (CHF), or chronic liver disease (CLD) with hepatic impairment. DATA SOURCES: MEDLINE (via PubMed) from January 1994 to September 2016, and Cochrane Library, EMBASE, and International Pharmaceutical Abstracts from January 1994 to November 2015. STUDY SELECTION: English-language studies that: 1) examined adults with type 2 diabetes and CKD (with estimated glomerular filtration rate less than 60 mL/min/1.73 m2), CHF, or CLD with hepatic impairment; 2) compared diabetes regimens that included metformin with those that did not; and 3) reported all-cause mortality, major adverse cardiovascular events, and other outcomes of interest. DATA EXTRACTION: 2 reviewers abstracted data and independently rated study quality and strength of evidence. DATA SYNTHESIS: On the basis of quantitative and qualitative syntheses involving 17 observational studies, metformin use is associated with reduced all-cause mortality in patients with CKD, CHF, or CLD with hepatic impairment, and with fewer heart failure readmissions in patients with CKD or CHF. LIMITATIONS: Strength of evidence was low, and data on multiple outcomes of interest were sparse. Available studies were observational and varied in follow-up duration. CONCLUSION: Metformin use in patients with moderate CKD, CHF, or CLD with hepatic impairment is associated with improvements in key clinical outcomes. Our findings support the recent changes in metformin labeling. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs. (PROSPERO: CRD42016027708).

The Impact of Interventions that Integrate Accelerometers on Physical Activity and Weight Loss: A Systematic Review.

BACKGROUND: Regular physical activity is important for improving and maintaining health, but sedentary behavior is difficult to change. Providing objective, real-time feedback on physical activity with wearable motion-sensing technologies (activity monitors) may be a promising, scalable strategy to increase physical activity or decrease weight. PURPOSE: We synthesized the literature on the use of wearable activity monitors for improving physical activity and weight-related outcomes and evaluated moderating factors that may have an impact on effectiveness. METHODS: We searched five databases from January 2000 to January 2015 for peer-reviewed, English-language randomized controlled trials among adults. Random-effects models were used to produce standardized mean differences (SMDs) for physical activity outcomes and mean differences (MDs) for weight outcomes. Heterogeneity was measured with I 2. RESULTS: Fourteen trials (2972 total participants) met eligibility criteria; accelerometers were used in all trials. Twelve trials examined accelerometer interventions for increasing physical activity. A small significant effect was found for increasing physical activity (SMD 0.26; 95 % CI 0.04 to 0.49; I 2 = 64.7 %). Intervention duration was the only moderator found to significantly explain high heterogeneity for physical activity. Eleven trials examined the effects of accelerometer interventions on weight. Pooled estimates showed a small significant effect for weight loss (MD -1.65 kg; 95 % CI -3.03 to -0.28; I 2 = 81 %), and no moderators were significant. CONCLUSIONS: Accelerometers demonstrated small positive effects on physical activity and weight loss. The small sample sizes with moderate to high heterogeneity in the current studies limit the conclusions that may be drawn. Future studies should focus on how best to integrate accelerometers with other strategies to increase physical activity and weight loss.

Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic Pain.

Systematic reviews (SRs) have the potential to contribute uniquely to the evaluation of sex and gender differences (termed "sex effects"). This article describes the reporting of sex effects by SRs on interventions for depression, type 2 diabetes mellitus, and chronic pain conditions (chronic low back pain, knee osteoarthritis, and fibromyalgia). It includes SRs published since 1 October 2009 that evaluate medications, behavioral interventions, exercise, quality improvement, and some condition-specific treatments. The reporting of sex effects by primary randomized, controlled trials is also examined. Of 313 eligible SRs (86 for depression, 159 for type 2 diabetes mellitus, and 68 for chronic pain), few (n = 29) reported sex effects. Most SRs reporting sex effects used metaregression, whereas 9 SRs used subgroup analysis or individual-patient data meta-analysis. The proportion of SRs reporting the sex distribution of primary studies varied from a low of 31% (n = 8) for low back pain to a high of 68% (n = 23) for fibromyalgia. Primary randomized, controlled trials also infrequently reported sex effects, and most lacked an adequate sample size to examine them. Therefore, all SRs should report the proportion of women enrolled in primary studies and evaluate sex effects using appropriate methods whenever power is adequate.

Electronic Interventions for Alcohol Misuse and Alcohol Use Disorders: A Systematic Review.

BACKGROUND: The use of electronic interventions (e-interventions) may improve treatment of alcohol misuse. PURPOSE: To characterize treatment intensity and systematically review the evidence for efficacy of e-interventions, relative to controls, for reducing alcohol consumption and alcohol-related impairment in adults and college students. DATA SOURCES: MEDLINE (via PubMed) from January 2000 to March 2015 and the Cochrane Library, EMBASE, and PsycINFO from January 2000 to August 2014. STUDY SELECTION: English-language, randomized, controlled trials that involved at least 50 adults who misused alcohol; compared an e-intervention group with a control group; and reported outcomes at 6 months or longer. DATA EXTRACTION: Two reviewers abstracted data and independently rated trial quality and strength of evidence. DATA SYNTHESIS: In 28 unique trials, the modal e-intervention was brief feedback on alcohol consumption. Available data suggested a small reduction in consumption (approximately 1 drink per week) in adults and college students at 6 months but not at 12 months. There was no statistically significant effect on meeting drinking limit guidelines in adults or on binge-drinking episodes or social consequences of alcohol in college students. LIMITATIONS: E-interventions that ranged in intensity were combined in analyses. Quantitative results do not apply to short-term outcomes or alcohol use disorders. CONCLUSION: Evidence suggests that low-intensity e-inter ventions produce small reductions in alcohol consumption at 6 months, but there is little evidence for longer-term, clinically significant effects, such as meeting drinking limits. Future e-interventions could provide more intensive treatment and possibly human support to assist persons in meeting recommended drinking limits. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical Patients: A Systematic Review.

BACKGROUND: Thromboprophylaxis regimens include pharmacologic and mechanical options such as intermittent pneumatic compression devices (IPCDs). There are a wide variety of IPCDs available, but it is uncertain if they vary in effectiveness or ease of use. This is a systematic review of the comparative effectiveness of IPCDs for selected outcomes (mortality, venous thromboembolism [VTE], symptomatic or asymptomatic deep vein thrombosis, major bleeding, ease of use, and adherence) in postoperative surgical patients. METHODS: We searched MEDLINE (via PubMed), Embase, CINAHL, and Cochrane CENTRAL from January 1, 1995, to October 30, 2014, for randomized controlled trials, as well as relevant observational studies on ease of use and adherence. RESULTS: We identified 14 eligible randomized controlled trials (2633 subjects) and 3 eligible observational studies (1724 subjects); most were conducted in joint arthroplasty patients. Intermittent pneumatic compression devices were comparable to anticoagulation for major clinical outcomes (VTE: risk ratio, 1.39; 95% confidence interval, 0.73-2.64). Limited data suggest that concurrent use of anticoagulation with IPCD may lower VTE risk compared with anticoagulation alone, and that IPCD compared with anticoagulation may lower major bleeding risk. Subgroup analyses did not show significant differences by device location, mode of inflation, or risk of bias elements. There were no consistent associations between IPCDs and ease of use or adherence. CONCLUSIONS: Intermittent pneumatic compression devices are appropriate for VTE thromboprophylaxis when used in accordance with current clinical guidelines. The current evidence base to guide selection of a specific device or type of device is limited.

Shared medical appointments for patients with diabetes mellitus: a systematic review.

OBJECTIVES: Shared medical appointments (SMAs) are an increasingly used system-redesign strategy for improving access to and quality of chronic illness care. We conducted a systematic review of the existing literature on SMA interventions for patients with diabetes in order to understand their impact on outcomes. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from January 1996 through April 2012. PubMed search updated June 2013. STUDY SELECTION: English-language peer-reviewed publications of randomized controlled trials (RCTs), nonrandomized cluster controlled trials, controlled before-and-after studies, or interrupted time-series designs conducted among adult patients with diabetes. Two independent reviewers used prespecified criteria to screen titles and abstracts for full text review. STUDY APPRAISAL AND SYNTHESIS METHODS: Two different reviewers abstracted data and rated study quality and strength of evidence. When possible, we used random-effects models to synthesize the effects quantitatively, reporting by a weighted difference of the means when the same scale was used across studies, and a standardized mean difference when the scales differed. We measured heterogeneity in study effects using Forest Plots, Cochran's Q, and I(2), and explored heterogeneity by using subgroup analyses for categorical variables and meta-regression analyses for continuous or discrete variables. Outcomes not suitable to meta-analysis were summarized qualitatively. RESULTS: Twenty-five articles representing 17 unique studies compared SMA interventions with usual care. Among patients with diabetes, SMAs improved hemoglobin A1c (∆ = -0.55 percentage points [95 % CI, -0.11 to -0.99]); improved systolic blood pressure (∆ = -5.2 mmHg [95 % CI, -3.0 to -7.4]); and did not improve LDL cholesterol (∆ = -6.6 mg/dl [95 % CI, 2.8 to -16.1]). Nonbiophysical outcomes, including economic outcomes, were reported too infrequently to meta-analyze, or to draw conclusions from. The A1c result had significant heterogeneity among studies, likely secondary to the heterogeneity among included SMA interventions. LIMITATION: Heterogeneity among the components of diabetes SMAs leads to uncertainty about what makes a particular SMA successful. CONCLUSION: SMA interventions improve biophysical outcomes among patients with diabetes. There was inadequate literature to determine SMA effects on patient experience, utilization, and costs.

Effects of nurse-managed protocols in the outpatient management of adults with chronic conditions: a systematic review and meta-analysis.

BACKGROUND: Changes in federal health policy are providing more access to medical care for persons with chronic disease. Providing quality care may require a team approach, which the American College of Physicians calls the "medical home." One new model may involve nurse-managed protocols. PURPOSE: To determine whether nurse-managed protocols are effective for outpatient management of adults with diabetes, hypertension, and hyperlipidemia. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, and CINAHL from January 1980 through January 2014. STUDY SELECTION: Two reviewers used eligibility criteria to assess all titles, abstracts, and full texts and resolved disagreements by discussion or by consulting a third reviewer. DATA EXTRACTION: One reviewer did data abstractions and quality assessments, which were confirmed by a second reviewer. DATA SYNTHESIS: From 2954 studies, 18 were included. All studies used a registered nurse or equivalent who titrated medications by following a protocol. In a meta-analysis, hemoglobin A1c level decreased by 0.4% (95% CI, 0.1% to 0.7%) (n = 8); systolic and diastolic blood pressure decreased by 3.68 mm Hg (CI, 1.05 to 6.31 mm Hg) and 1.56 mm Hg (CI, 0.36 to 2.76 mm Hg), respectively (n = 12); total cholesterol level decreased by 0.24 mmol/L (9.37 mg/dL) (CI, 0.54-mmol/L decrease to 0.05-mmol/L increase [20.77-mg/dL decrease to 2.02-mg/dL increase]) (n = 9); and low-density-lipoprotein cholesterol level decreased by 0.31 mmol/L (12.07 mg/dL) (CI, 0.73-mmol/L decrease to 0.11-mmol/L increase [28.27-mg/dL decrease to 4.13-mg/dL increase]) (n = 6). LIMITATION: Studies had limited descriptions of the interventions and protocols used. CONCLUSION: A team approach that uses nurse-managed protocols may have positive effects on the outpatient management of adults with chronic conditions, such as diabetes, hypertension, and hyperlipidemia. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Comparative effectiveness of new oral anticoagulants and standard thromboprophylaxis in patients having total hip or knee replacement: a systematic review.

BACKGROUND: Pharmacologic thromboprophylaxis reduces the risk for venous thromboembolism after total hip replacement (THR) or total knee replacement (TKR). New oral anticoagulants (NOACs), including direct thrombin inhibitors and factor Xa inhibitors, are emerging options for thromboprophylaxis after these procedures. PURPOSE: To compare the benefits and risks of NOACs versus standard thromboprophylaxis for adults having THR or TKR. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from January 2009 through March 2013. STUDY SELECTION: English-language systematic reviews. DATA EXTRACTION: Two independent reviewers abstracted data and rated study quality and strength of evidence. DATA SYNTHESIS: Six good-quality systematic reviews compared NOACs with low-molecular-weight heparin (LMWH) for thromboprophylaxis after THR or TKR. Risk for symptomatic deep venous thrombosis, but not risk for death or nonfatal pulmonary embolism, was reduced with factor Xa inhibitors compared with LMWH (4 fewer events per 1000 patients). Conversely, the risk for major bleeding increased (2 more events per 1000 patients). Outcomes of dabigatran did not significantly differ from those of LMWH. Indirect evaluation of NOACs by common comparison with LMWH showed nonsignificantly reduced risks for venous thromboembolism with rivaroxaban compared with dabigatran (risk ratio [RR], 0.68 [95% CI, 0.21 to 2.23]) and apixaban (RR, 0.59 [CI, 0.26 to 1.33]) but increased major bleeding. New oral anticoagulants have not been compared with warfarin, aspirin, or unfractionated heparin. LIMITATIONS: Head-to-head comparisons among NOACs were not available. Efficacy is uncertain in routine clinical practice. CONCLUSION: New oral anticoagulants are effective for thromboprophylaxis after THR and TKR. Their clinical benefits over LMWH are marginal and offset by increased risk for major bleeding. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review.

BACKGROUND: New oral anticoagulants (NOACs), including direct thrombin inhibitors (DTIs) and factor Xa (FXa) inhibitors, are emerging alternatives for prophylaxis and treatment of atrial fibrillation (AF) and venous thromboembolism (VTE). PURPOSE: To compare the benefits and harms of NOACs versus warfarin for AF and VTE. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from January 2001 through July 2012; U.S. Food and Drug Administration (FDA) database for adverse event reports. STUDY SELECTION: English-language, randomized, controlled trials (RCTs) comparing NOACs with warfarin for management of AF or VTE and observational studies and FDA reports on adverse effects. DATA EXTRACTION: Two independent reviewers abstracted data and rated study quality and strength of evidence. DATA SYNTHESIS: Six good-quality RCTs compared NOACs (2 DTI studies, 4 FXa inhibitor studies) with warfarin. In AF, NOACs decreased all-cause mortality (risk ratio [RR], 0.88 [95% CI, 0.82 to 0.96]); in VTE, NOACs did not differ for mortality or VTE outcomes. Across indications, adverse effects of NOACs compared with warfarin were fatal bleeding (RR, 0.60 [CI, 0.46 to 0.77]), major bleeding (RR, 0.80 [CI, 0.63 to 1.01]), gastrointestinal bleeding (RR, 1.30 [CI, 0.97 to 1.73]), and discontinuation due to adverse events (RR, 1.23 [CI, 1.05 to 1.44]). Subgroup analyses suggest a higher risk for myocardial infarction with DTIs than with FXa inhibitors. Bleeding risk for NOACs may be increased in persons older than 75 years or those receiving warfarin who have good control. LIMITATION: There were no head-to-head comparisons of NOACs and limited data on harms. CONCLUSION: New oral anticoagulants are a viable option for patients receiving long-term anticoagulation. Treatment benefits compared with warfarin are small and vary depending on the control achieved by warfarin treatment. PRIMARY FUNDING SOURCE: Department of Veterans Affairs.

Achieving health for a lifetime: a community engagement assessment focusing on school-age children to decrease obesity in Durham, North Carolina.

BACKGROUND: Obesity is a prominent problem in the United States and in North Carolina. One way of combating it is with community-engaged interventions that foster collaboration between health-oriented organizations and community residents. PURPOSE: Our purpose was to assemble a multifaceted group in Durham, North Carolina, to identify factors affecting obesity-related lifestyle behaviors; assess policies, resources, and the population's perception of the problem of obesity; and develop plans to improve health outcomes related to obesity. METHODS: A team consisting of more than 2 dozen partners was assembled to form Achieving Health for a Lifetime (AHL) in order to study and address obesity in the community, initially focusing on elementary school-age children. The team developed a resource guide by collecting information by telephone interviews of provider organizations; geospatial resource maps were created using high-resolution geographic information systems, Duke's Data Support Repository, and county and city records; and focus groups were conducted using the nominal group technique. RESULTS: The AHL team, in collaboration with 2 other teams focused on diabetes and cardiovascular disease, identified 32 resources for diabetes, 20 for obesity, and 13 for cardiovascular disease. Using Geographic Information Systems (GIS), the team identified an area of Durham that had only 1 supermarket, but 34 fast-food restaurants and 84 convenience stores. LIMITATIONS: The focus on particular neighborhoods means that the information obtained might not pertain to all neighborhoods. CONCLUSION: The AHL team was able to assemble a large community partnership in Durham that will allow the members of the community to continue to work toward making residents healthier. Communities facing similar challenges can learn from this experience.

Smoking cessation interventions for patients with depression: a systematic review and meta-analysis.

OBJECTIVES: We conducted a systematic literature review of smoking cessation interventions for patients with histories of depressive disorders or current significant depressive symptoms. We examined the comparative effectiveness of smoking cessation strategies on abstinence rates, differential effects of cessation strategies by depression status (i.e., history positive vs. current depression), and differential effects by gender. DATA SOURCES: Peer-reviewed literature in MEDLINE, Embase, PsycINFO, and Cochrane Library. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Randomized controlled trials or secondary analysis of RCT data comparing two or more smoking cessation interventions or intervention to control, and reporting cessation outcomes in adults with depression. STUDY APPRAISAL AND SYNTHESIS METHODS: Two trained researchers screened articles for inclusion. When possible, we estimated pooled risk ratios with 95% confidence intervals by using a random effects model with the Mantel-Haenszel method. We synthesized other studies qualitatively. We classified each intervention as antidepressants, nicotine replacement therapy (NRT), brief smoking cessation counseling, smoking cessation behavioral counseling, or behavioral mood management. RESULTS: We identified 16 unique RCTs, of which, only three trials recruited participants with current depression. Meta-analysis demonstrated a small, positive effect of adding behavioral mood management (RR = 1.41, 95% CI 1.01-1.96). All included antidepressant trials showed small, positive effects, but risk ratio summary was not significant (RR = 1.31, 95% CI 0.73-2.34). Three NRT trials demonstrated small, positive effects on smoking cessation rates. We found insufficient evidence to examine gender and depression status moderator effects. LIMITATIONS: Few RCTs exist that test smoking cessation interventions among adults with depression. To make meaningful comparisons, we created broad intervention categories that contained heterogeneity. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Few trials enrolled smokers with current depression. Most of data identified were from subgroup analyses of patients history-positive for depression. However, several promising interventions exist. Healthcare providers should consider encouraging their patients with significant depressive symptoms or depression histories to seek smoking cessation services that include NRT and behavioral mood management.

Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality.

OBJECTIVES: Existing cross-sectional quality measures for colorectal cancer (CRC) screening do not assess longitudinal adherence and thus may overestimate the quality of care. Our goal was to evaluate the adherence to repeated yearly fecal occult blood tests (FOBTs) in order to better understand the extent to which longitudinal adherence may impact screening quality. METHODS: This was a retrospective cohort analysis of 1,122,645 patients aged 50-75 years seen at any of the 136 Department of Veterans Affairs medical centers across the United States in 2000 and followed through 2005. The primary outcome was receipt of adequate CRC screening as defined by receipt of FOBTs in at least 4 out of 5 years or receipt of any number of FOBTs in addition to at least one colonoscopy, flexible sigmoidoscopy, or double-contrast barium enema. In a predefined subset of patients receiving exclusively FOBT, adherence with repeated testing was determined over the 5-year study period. RESULTS: Only 41.1% of men and 43.6% of women received adequate screening. Of the 384,527 men who received exclusively FOBT, 42.1% received a single FOBT, 26.0% received 2 tests, 17.8% received 3 tests, and only 14.1% were documented to have received at least 4 tests during the study period. Among the 10,469 female veterans receiving FOBT alone, rates were similar with only 13.7% completing at least 4 FOBTs in the 5-year study period. CONCLUSIONS: Adherence to repeated FOBT is low, suggesting that cross-sectional measurements of quality may overestimate the programmatic success of CRC screening.

Management of Menopause Symptoms with Acupuncture: An Umbrella Systematic Review and Meta-Analysis.

OBJECTIVES: Vasomotor symptoms (VMSs) are the most common symptoms reported during menopause. Although hormone therapy is effective for reducing VMSs, its use is restricted in some women. Many women with VMSs thus seek nonhormonal, nonpharmacologic treatment options such as acupuncture. DESIGN: An umbrella systematic review (SR) was conducted, supplemented by a search of published randomized controlled trials (RCTs), that assessed the effectiveness of acupuncture for VMSs, health-related quality of life (HRQOL), and adverse effects of treatment in perimenopausal or postmenopausal women. Meta-analyses were conducted using a random-effects model when data were sufficient. RESULTS: Three SRs and four new RCTs were identified that met eligibility criteria. Meta-analyses of this study revealed statistically significant standardized mean differences (SMDs) associated with acupuncture compared with no acupuncture at reducing VMS frequency (SMD -0.66, 95% confidence interval [CI] -1.06 to -0.26, I2 = 61.7%, 5 trials) and VMS severity (SMD -0.49, 95% CI -0.85 to -0.13, I2 = 18.1%, 4 trials) and improving HRQOL outcomes (SMD -0.93, 95% CI -1.20 to -0.67, I2 = 0.0%, 3 trials). SMDs were smaller or not statistically significant when acupuncture was compared with sham acupuncture. CONCLUSIONS: Evidence from RCTs supports the use of acupuncture as an adjunctive or stand-alone treatment for reducing VMSs and improving HRQOL outcomes, with the caveat that observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects. The safety of acupuncture in the treatment of VMSs has not been rigorously examined, but there is no clear signal for a significant potential for harm.

Effects of binge eating on satiation, satiety, and energy intake of overweight children.

BACKGROUND: Children who report episodes of binge eating gain more weight than do children not reporting binge eating. However, how binge eating affects children's food intake at meals is unknown. OBJECTIVE: We compared the energy intake and postmeal satiety of children with and without a history of binge eating during buffet meals. DESIGN: Sixty overweight children aged 6-12 y were categorized into those reporting past binge-eating episodes (n = 10) and those reporting no such episodes (n = 50). Children selected lunch twice from a multiple-item, 9835 kcal, buffet meal: after an overnight fast and after a standardized breakfast. Children ate ad libitum, until they reported they were full. The main outcome measures were energy intake during meals and duration of postmeal satiety, after adjustment for covariates, including age, race, sex, socioeconomic status, and body composition. RESULTS: After the overnight fast, children in the binge-eating group consumed more energy [x (+/-SD): 1748 +/- 581 compared with 1309 +/- 595 kcal; P = 0.04] and exhibited a shorter satiety duration (194 +/- 84 compared with 262 +/- 89 min; P = 0.03) than did children in the non-binge-eating group. After the standardized breakfast, binge-eating children reported a shorter satiety duration (75 +/- 62 compared with 132 +/- 62 min; P = 0.01) and consumed more energy at the postbreakfast meal (1874 +/- 560 compared with 1275 +/- 566 kcal; P = 0.004). CONCLUSION: The ability to consume large quantities of palatable foods, coupled with decreased subsequent satiety, may play a role in the greater weight gain found in binge-eating children.

Evidence Map of Yoga for Depression, Anxiety, and Posttraumatic Stress Disorder.

BACKGROUND: This study describes evidence of yoga's effectiveness for depressive disorders, general anxiety disorder (GAD), panic disorder (PD), and posttraumatic stress disorder (PTSD) in adults. We also address adverse events associated with yoga. METHODS: We searched multiple electronic databases for systematic reviews (SRs) published between 2008 and July 2014, randomized controlled trials (RCTs) not identified in eligible SRs, and ongoing RCTs registered with ClincalTrials.gov. RESULTS: We identified 1 SR on depression, 1 for adverse events, and 3 addressing multiple conditions. The high-quality depression SR included 12 RCTs (n = 619) that showed improved short-term depressive symptoms (standardized mean difference, -0.69, 95% confidence interval, -0.99 to -0.39), but there was substantial variability (I2 = 86%) and a high risk of bias for 9 studies. Three SRs addressing multiple conditions identified 4 nonrandomized studies (n = 174) for GAD/PD and 1 RCT (n = 8) and 2 nonrandomized studies (n = 22) for PTSD. We separately found 1 RCT (n = 13) for GAD and 2 RCTs (n = 102) for PTSD. Collectively, these studies were inconclusive for the effectiveness of yoga in treating GAD/PD and PTSD. The high-quality SR for adverse events included 37 primary reports (n = 76) in which inversion postures were most often implicated. We found 5 ongoing trials (3 for PTSD). CONCLUSIONS: Yoga may improve short-term depressive symptoms, but evidence for GAD, PD, and PTSD remain inconclusive.

Nonpharmacologic, nonherbal management of menopause-associated vasomotor symptoms: an umbrella systematic review (protocol).

BACKGROUND: Vasomotor symptoms such as hot flashes and night sweats are a common concern of perimenopausal and postmenopausal women and are associated with a decreased quality of life. These symptoms can be effectively managed with hormone therapy, but safety concerns limit its use. Thus, understanding the effectiveness of nonpharmacologic therapies such as acupuncture or yoga is critical to managing these common symptoms in older women. Our review seeks to address the following question: In women with menopause-associated vasomotor symptoms, what are the effects on health-related quality of life, vasomotor symptoms, and adverse events of the following nonpharmacologic, nonherbal interventions as compared with any inactive control or active comparator: (a) acupuncture, (b) yoga, tai chi, and qigong, (c) structured exercise, and (d) meditation, mindfulness-based practices, and relaxation? METHODS: We describe a protocol for an umbrella review approach, supplemented by evaluating randomized controlled trials (RCTs) published after the most recent good-quality systematic review for each of the eligible interventions. Specific interventions were chosen based on current literature and with input from a technical expert panel and organizational stakeholders. We will conduct a thorough literature search and perform a quality assessment of potentially included systematic reviews and RCTs. DISCUSSION: Our umbrella review, supplemented by an additional search for eligible RCTs, aims to synthesize existing evidence on the use of nonpharmacologic, nonherbal interventions to manage bothersome vasomotor symptoms in perimenopausal and postmenopausal women. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016029335.

Effects of exogenous leptin on satiety and satiation in patients with lipodystrophy and leptin insufficiency.

To examine leptin's role in human appetite regulation, we studied recombinant methionyl human leptin's effects on satiation and satiety in a model of leptin insufficiency, lipodystrophy. Eight females with hypoleptinemia and lipodystrophy were given sc injections of A-100 (maximal dose, 200% of that predicted to normalize serum leptin) for 4 months. Satiation and satiety were determined before and again during leptin treatment. Satiation was measured as the time to voluntary cessation of eating from a standardized food array after a 12-h fast. Satiety was determined as the time to hunger sufficient to consume a full meal after consumption of a standardized preload. During leptin treatment, satiation time decreased (41.2 +/- 18.2 to 19.5 +/- 10.6 min; P = 0.01), satiety time increased (62.9 +/- 64.8 to 137.8 +/- 91.6 min; P = 0.04), energy consumed to produce satiation decreased (2034 +/- 405 to 1135 +/- 432 kcal or 8.5 +/- 1.7 to 4.7 +/- 1.8 MJ; P < 0.01), and the amount of food desired in the postabsorptive state decreased (P < 0.02). Ghrelin concentrations also decreased during leptin administration (284.3 +/- 127.9 to 140.6 +/- 104.5 pmol/liter; P < 0.002). We conclude that increased leptin in patients with lipodystrophy results in less caloric, shorter, more satiating meals and longer-lived satiety. These data support the hypothesis that leptin plays an important, permissive role in human appetite regulation.

Comparison of methods to assess change in children's body composition.

BACKGROUND: Little is known about how simpler and more available methods to measure change in body fatness compare with criterion methods such as dual-energy X-ray absorptiometry (DXA) in children. OBJECTIVE: Our objective was to determine the ability of air-displacement plethysmography (ADP) and formulas based on triceps skinfold thickness (TSF) and bioelectrical impedance analysis (BIA) to estimate changes in body fat over time in children. DESIGN: Eighty-six nonoverweight and overweight boys (n = 34) and girls (n = 52) with an average age of 11.0 +/- 2.4 y underwent ADP, TSF measurement, BIA, and DXA to estimate body fatness at baseline and 1 +/- 0.3 y later. Recent equations were used to estimate percentage body fat by TSF measurement (Dezenberg equation) and by BIA (Suprasongsin and Lewy equations). Percentage body fat estimates by ADP, TSF measurement, and BIA were compared with those by DXA. RESULTS: All methods were highly correlated with DXA (P < 0.001). No mean bias for estimates of percentage body fat change was found for ADP (Siri equation) compared with DXA for all subjects examined together, and agreement between body fat estimation by ADP and DXA did not vary with race or sex. Magnitude bias was present for ADP relative to DXA (P < 0.01). Estimates of change in percentage body fat were systematically overestimated by BIA equations (1.37 +/- 6.98%; P < 0.001). TSF accounted for only 13% of the variance in percentage body fat change. CONCLUSION: Compared with DXA, there appears to be no noninvasive and simple method to measure changes in children's percentage body fat accurately and precisely, but ADP performed better than did TSF or BIA. ADP could prove useful for measuring changes in adiposity in children.