Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study.

Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial. This placebo-controlled, double-blind, crossover study further assessed the effects of baclofen on binge eating. Twelve individuals who self-reported binge eating completed the study. Data were collected during a run-in period (no drug or placebo), placebo phase (48 days), and baclofen phase (titrated up to 60 mg daily or the maximum tolerated dose, 48 days). All the participants were exposed to all conditions. Participants completed a binge diary daily, and the Binge Eating Scale (BES), Food Craving Inventory-II (FCI-II), and Hospital Anxiety and Depression Scale (HADS) at regular intervals throughout the study. Baclofen significantly reduced binge frequency relative to placebo and run-in (P<0.05). This confirms results from the previous open-label trial. Baclofen also produced slight, but significant, increases in depression symptomatology as assessed by the HADS. Binge severity (BES scores) and craving (FCI-II scores) were significantly reduced during placebo and baclofen phases, that is both measures exhibited significant placebo effects. Tiredness, fatigue, and upset stomach were the most commonly reported side-effects. These results indicate that baclofen may be a useful treatment for binge eating in some patients.

Practices associated with weight loss versus weight-loss maintenance results of a national survey.

BACKGROUND: Few studies have examined the weight-control practices that promote weight loss and weight-loss maintenance in the same sample. PURPOSE: To examine whether the weight control practices associated with weight loss differ from those associated with weight-loss maintenance. METHODS: Cross-sectional survey of a random sample of 1165 U.S. adults. The adjusted associations of the use of 36 weight-control practices in the past week with success in weight loss (≥10% lost in the past year) and success in weight-loss maintenance (≥10% lost and maintained for ≥1 year) were examined. RESULTS: Of the 36 practices, only 8 (22%) were associated with both weight loss and weight-loss maintenance. Overall, there was poor agreement (kappa=0.22) between the practices associated with weight loss and/or weight-loss maintenance. For example, those who reported more often following a consistent exercise routine or eating plenty of low-fat sources of protein were 1.97 (95% CI=1.33, 2.94) and 1.76 (95% CI=1.25, 2.50) times more likely, respectively, to report weight-loss maintenance but not weight loss. Alternatively, those who reported more often doing different kinds of exercises or planning meals ahead of time were 2.56 (95% CI=1.44, 4.55) and 1.68 (95% CI=1.03, 2.74) times more likely, respectively, to report weight loss but not weight-loss maintenance. CONCLUSIONS: Successful weight loss and weight-loss maintenance may require two different sets of practices. Designing interventions with this premise may inform the design of more effective weight-loss maintenance interventions.

Using positive deviance for determining successful weight-control practices.

Based on positive deviance (examining the practices of successful individuals), we identified five primary themes from 36 strategies that help to maintain long-term weight loss (weight control) in 61 people. We conducted in-depth interviews to determine what successful individuals did and/or thought about regularly to control their weight. The themes included weight-control practices related to (a) nutrition: increase water, fruit, and vegetable intake, and consistent meal timing and content; (b) physical activity: follow and track an exercise routine at least 3x/week; (c) restraint: practice restraint by limiting and/or avoiding unhealthy foods; (d) self-monitor: plan meals, and track calories/weight progress; and (e) motivation: participate in motivational programs and cognitive processes that affect weight-control behavior. Using the extensive data involving both the practices and practice implementation, we used positive deviance to create a comprehensive list of practices to develop interventions for individuals to control their weight.

The Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project: Rationale and design.

This paper outlines the rationale and design of the Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project, in which detailed biologic profiling of three hundred and fifty obese individuals (body mass index (BMI): 30-50 kg/m(2)) will be conducted as they lose weight via seven distinct interventions. These profiles will be compared to those of fifty normal, healthy, control participants (BMI: 18.5-24.9 kg/m(2)). The interventions include the following: Roux-en-Y gastric bypass surgery, dietary interventions of differing macronutrient composition and diverse pharmacologic interventions. Outcome variables include eight conventional metabolites and CRP measured by standard clinical chemistry techniques, twenty hormones of energy balance and fuel homeostasis measured by radioimmunoassay (RIA) or by enzyme-linked Immunosorbent assay (ELISA), ten pro- and anti-inflammatory cytokines measured using Luminex xMAP technology, one hundred and one intermediary metabolites measured by targeted mass-spectrometry-based methods, and physiologic variables such as body composition measured by dual energy X-ray absorptiometry (DEXA), air displacement plethysmography, and abdominal computerized tomography (CT), insulin sensitivity measured by intravenous glucose tolerance test (IV-GTT) and metabolic rate measured by indirect calorimetry. Results from this study will expand our knowledge of the biology of obesity and weight regulation and may lead to targeted strategies for its treatment and control.

Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia.

A phase I clinical trial was conducted to determine the safety, pharmacokinetic parameters, and efficacy of orally administered isoflavones (genistein and daidzein, potential cancer chemotherapeutic agents) over a 3-mo period in men with prostate neoplasia. Twenty men, ages 40 and above, with stage B, C, or D adenocarcinoma of the prostate were treated with a multiple-dose regimen of a soy isoflavone formulation (delivering approximately 300 or 600 mg/day genistein and half this much daidzein) for 84 days. The delivered dose of isoflavones was more than 10-fold higher than that typically taken by prostate cancer patients. In men with prostate cancer, relatively minor side effects of chronic isoflavone treatment were observed including some estrogenic effects (breast changes, increased frequency of hot flashes). Serum dehydroepiandrosterone was decreased by 31.7% (P = 0.0004) at the end of treatment. Except for those subjects whose prostate-specific antigen (PSA) values were below 0.4 ng/ml, subjects had a history of increasing PSA levels prior to the trial. This increase continued during the trial both while on soy isoflavones and after treatment was discontinued. On average the rate of rise accelerated after soy isoflavones were discontinued, but that difference did not attain statistical significance. Genistein and daidzein were rapidly cleared from plasma and excreted in urine. Pharmacokinetic data for chronic dose administration were similar to single-dose administration for the isoflavones investigated except that we observed slightly longer circulation time for daidzein.

Binge eating, quality of life and physical activity improve after Roux-en-Y gastric bypass for morbid obesity.

BACKGROUND: Severe obesity has been associated with disordered eating, impaired quality of life (QoL), and decreased physical activity. This study examines changes in these variables 6 months after Roux-en-Y gastric bypass (RYGBP). METHODS: 40 morbidly obese patients were evaluated at baseline and at 6 months after RYGBP on the following measures: Binge Eating Scale, Three Factor Eating Questionnaire, Impact of Weight on Quality of Life-Lite (IWQoL-Lite), and the Baseline Questionnaire of Activity. RESULTS: 6 months after RYGBP, weight loss averaged 26.7%, and scores on measures of disordered eating, weight-related QoL, and physical activity showed statistically significant improvement from baseline. At the time of follow-up, 100% of participants achieved a score on the Binge Eating Scale that indicated no binge eating problems, and weight-related QoL scores approached those obtained by a reference sample of community volunteers. There were also improvements in the level of self-reported physical activity and television watching behavior. CONCLUSIONS: RYGBP resulted in significant improvements in disordered eating, weight-related QoL, and physical activity in addition to weight loss.