Bupropion SR enhances weight loss: a 48-week double-blind,placebo- controlled trial

OBJECTIVE: To critically examine the efficacy of bupropion SR for weight loss. RESEARCH METHODS AND PROCEDURES: This 24-week multicenter, double-blind, placebo-controlled study randomized obese adults to placebo, bupropion SR 300, or 400 mg/d. Subjects were counseled on energy-restricted diets, meal replacements, and exercise. During a 24-week extension, placebo subjects were randomized to bupropion SR 300 or 400 mg/d in a double-blinded manner. RESULTS: Of 327 subjects enrolled, 227 completed 24 weeks; 192 completed 48 weeks. Percentage losses of initial body weight for subjects completing 24 weeks were 5.0%, 7.2%, and 10.1% for placebo, bupropion SR 300, and 400 mg/d, respectively. Compared with placebo, net weight losses were 2.2% (p = 0.0468) and 5.1% (p < 0.0001) for bupropion SR 300 and 400 mg/d, respectively. The percentages of subjects who lost >or=5% of initial body weight were 46%, 59%, and 83% (p vs. placebo < 0.0001) for placebo, bupropion SR 300, and 400 mg/d, respectively; weight losses of >or=10% were 20%, 33%, and 46% (p vs. placebo = 0.0008) for placebo, bupropion SR 300, and 400 mg/d, respectively. Withdrawals, changes in pulse and blood pressure did not differ significantly from placebo at 24 weeks. Subjects who completed 48 weeks maintained mean losses of initial body weight of 7.5% and 8.6% for bupropion SR 300 and 400 mg/d, respectively. DISCUSSION: Bupropion SR 300 and 400 mg/d were well-tolerated by obese adults and were associated with a 24-week weight loss of 7.2% and 10.1% and sustained weight losses at 48 weeks.     

Bupropion for weight loss: an investigation of efficacy and tolerability in overweight and obese women

OBJECTIVE: On the basis of the clinical observations that bupropion facilitated weight loss, we investigated the efficacy and tolerability of this drug in overweight and obese adult women. RESEARCH METHODS AND PROCEDURES: A total of 50 overweight and obese (body mass index: 28.0 to 52.6 kg/m(2)) women were included. The core component of the study was a randomized, double-blind, placebo-controlled comparison for 8 weeks. Bupropion or placebo was started at 100 mg/d with gradual dose increase to a maximum of 200 mg twice daily. All subjects were prescribed a 1600 kcal/d balanced diet and compliance was monitored with food diaries. Responders continued the same treatment in a double-blind manner for an additional 16 weeks to a total of 24 weeks. There was additional single-blind follow-up treatment for a total of 2 years. RESULTS: Subjects receiving bupropion achieved greater mean weight loss (last-observation-carried-forward analysis) over the first 8 weeks of the study (p = 0.0001): 4.9% +/- 3.4% (n = 25) for bupropion treatment compared with 1.3% +/- 2.4% (n = 25) for placebo treatment. For those who completed the 8 weeks, the comparison was 6.2% +/- 3.1% (n = 18) vs. 1.6% +/- 2.9% (n = 13), respectively(p = 0.0002), with 12 of 18 of the bupropion subjects (67%) losing over 5% of baseline body weight compared with 2 of 13 in the placebo group (15%; p = 0.0094). In the continuation phase, 14 bupropion responders who completed 24 weeks achieved weight loss of 12.9% +/- 5.6% with fat accounting for 73.5% +/- 3.7% of the weight lost and no change in bone mineral density as assessed by DXA. Bupropion was generally well-tolerated in this sample. DISCUSSION: Bupropion was more effective than placebo in achieving weight loss at 8 weeks in overweight and obese adult women in this preliminary study. Initial responders to bupropion benefited further in the continuation phase.     

Bupropion SR vs placebo for smoking cessation in health care professionals

OBJECTIVE: To evaluate bupropion SR for smoking cessation in physicians and nurses. METHODS: This double-blind prospective 26-center, 12-country trial randomized 687 subjects to smoking cessation counselling with bupropion SR or placebo for 7 weeks. The participants were followed for 52 weeks. RESULTS: Bupropion SR was superior to placebo (50% vs 40%, P=0.013) on the 4-week primary outcome variable. Due to a high placebo response in this health care population, statistical differences were not maintained after treatment was discontinued. CONCLUSIONS: Bupropion SR is effective and well tolerated in health care professionals. Relapse prevention measures are needed to attain long-term abstinence.     

Bupropion sustained release (SR) for the treatment of hypoactive sexual desire disorder (HSDD) in nondepressed women

This article describes the results of the first report of bupropion sustained release (SR) in nondepressed females with hypoactive sexual desire disorder (HSDD). Eligible females entered a 4-week, single-blind, placebo baseline phase. Subjects, all of whom did not respond to placebo, continued in a single-blind active treatment phase where they received bupropion SR for up to 8 additional weeks. We assessed HSDD by using investigator ratings of sexual desire and sexual functioning. Of the 51 evaluable subjects who entered the active treatment phase, 29% responded to treatment with bupropion SR. Bupropion SR was generally well tolerated. Pending the results of further study, bupropion SR may offer a treatment option for women with HSDD.     

Using extended cognitive behavioral treatment and medication to treat dependent smokers

Objectives. We evaluated smoking-cessation efficacy of an extended course of sustained-release bupropion (bupropion SR) and cognitive-behavioral treatment (CBT).Methods. Participants who smoked at least 10 cigarettes per day and who smoked within 30 minutes of arising (n = 406) completed a 12-week smoking-cessation treatment including group counseling, nicotine-replacement therapy, and bupropion SR. Participants were then randomly assigned to 1 of 5 conditions: (1) no further treatment, (2) active bupropion SR for 40 weeks, (3) placebo for 40 weeks, (4) active bupropion SR and 11 sessions of CBT for 40 weeks (A-CBT), or (5) placebo and 11 sessions of CBT for 40 weeks. Participants were assessed at baseline and at weeks 12, 24, 52, 64, and 104.Results. A-CBT was not superior to the other 3 extended treatments. From weeks 12 through 104, all extended treatment conditions were superior to standard treatment. At weeks 64 and 104, the 2 CBT conditions produced significantly higher abstinence rates than did the other 3 conditions.Conclusions. Brief contact with providers can increase abstinence during treatment. CBT may increase long-term abstinence after extended treatment is terminated.Researchers and clinicians have come to expect low rates of long-term cigarette abstinence subsequent to tobacco-dependence treatment—usually 25% or less at 1 year, even with combination therapy.^1,2 These low rates may be attributable to a failure to conceputalize tobacco dependence as an addiction with a chronic, relapsing course. The implications of a chronic-disease model suggest that longer, more extended courses of tobacco-dependence treatment may result in higher long-term cigarette abstinence rates.Three studies have examined the efficacy of extended administration of sustained-release bupropion (bupropion SR). Hays et al. treated participants for 7 weeks with open-label bupropion SR and then randomly assigned only cigarette-abstinent participants (59% of the sample) to active or placebo bupropion SR for an additional 45 weeks. Cigarette abstinence was significantly higher in the active drug condition (55.1%) than in the placebo drug condition (42.3%) after 1 year of therapy, but the conditions did not differ at 2-year follow-up (41.6% for active drug; 40.0% for placebo).³ In a second study, smokers were treated with nicotine patches calibrated to individual cigarette intake. Abstinent participants (31% of the sample) were then randomly assigned to either active or placebo bupropion SR for 6 months. Abstinence rates did not differ between conditions at 6 months (25% for placebo; 28% for active drug).⁴ Cox et al.⁵ randomized abstinent smokers who had been treated with 7 weeks of bupropion SR to either continued bupropion SR for the remainder of 1 year or to placebo. Active drug produced greater cigarette abstinence at the end of treatment when compared with placebo (55.89% vs 43.58%), but there were no differences at 1-year follow-up (42.34% vs 42.95%). Thus, it appears that extended bupropion SR provides an increase in abstinence rates while being administered, but this effect is lost after medication termination.Extended administration of varenicline has also been studied. Williams et al. administered either varenicline or placebo over 1 year and found that varenicline was superior to placebo at both 12 weeks (76.5% to 72.2%) and 52 weeks (37.8% to 34.1%).⁶ Tonstad et al.⁷ randomized abstinent smokers who had been treated with 12 weeks of varenicline to either continued varenicline or to placebo for an additional 12 weeks. Continuous cigarette abstinence rates were higher for the varenicline group than for the placebo group for weeks 13 through 24 (70.5% to 49.6%) and for weeks 13 through 52 (43.6% to 36.9%). Thus, the therapeutic effects of extended varenicline may last past the period of administration.In earlier work, our group studied extended administration of nortriptyline. We assigned smokers to 1 of 4 treatment conditions in a 2 × 2 factorial design (nortriptyline vs placebo by brief treatment vs extended treatment). Participants in extended treatment continued taking drug or placebo and received monthly individual counseling sessions through week 52. At week 52, abstinence rates were 56% for extended nortriptyline and 57% for extended placebo. Both conditions produced abstinence rates that exceeded those of short-term treatment.Three studies have investigated the effects of extended cognitive-behavioral treatment (CBT). Killen et al.⁸ treated smokers for 12 weeks with open-label bupropion SR, nicotine patch, and weekly relapse-prevention training. All participants, independent of smoking status, were then offered 4 relapse-prevention sessions and continued on either active or placebo drug for an additional 14 weeks. There were no differences in abstinence rates between conditions at 1 year. In a second study⁹ participants received bupropion SR, nicotine patch, and CBT for 8 weeks and were then randomly assigned to receive either 12 weeks of CBT plus voicemail monitoring and telephone counseling or telephone-based general support. The investigators reported significant differences at 20 weeks (45% vs 29%) but not at 52 weeks (31% vs 27%).Recently, we studied 402 people who smoked at least 10 cigarettes per day and who were 50 years old or older.¹⁰ All completed a 12-week treatment that included group counseling, nicotine gum, and bupropion SR, and all were then randomly assigned to 1 of 4 follow-up conditions: (1) standard treatment (no further treatment), (2) extended nicotine-replacement therapy (NRT) with 40 weeks of nicotine gum availability, (3) extended CBT (11 cognitive behavioral sessions over a 40-week period), or (4) extended CBT plus extended NRT (11 CBT sessions plus 40 weeks of nicotine gum availability). The extended CBT condition produced high cigarette-abstinence rates that were maintained throughout the 2-year study period (week 24 = 58.3%; week 52 = 55.0%; week 64 = 54.6%; week 104 = 54.8%). The extended CBT condition was significantly more effective than extended NRT and standard treatment across that period. No other treatment condition was significantly different from standard treatment. These findings suggest that extended CBT can produce high and stable cigarette abstinence rates. Medication does not appear to play a major role in maintaining abstinence when combined with CBT.In the current study, we evaluated a CBT intervention similar to that described by Hall et al.¹⁰ We also evaluated the efficacy of long-term bupropion SR versus placebo. We proposed the following hypotheses: (1) at all assessments after baseline, the active bupropion extended CBT (A-CBT) condition would produce higher point prevalence abstinence rates than placebo with extended CBT (P-CBT), placebo alone, active bupropion alone, or standard treatment (our primary hypothesis); and (2) at all assessments after the end of extended treatment, the 2 conditions that included CBT (combined with active or placebo bupropion) would produce abstinence rates superior to those produced by the 3 conditions that did not include CBT.     

Dietary herbal supplements with phenylephrine for weight loss

This study was designed to evaluate the efficacy and safety of a dietary herbal supplement containing citrus aurantium and phenylephrine in the treatment of obesity. Two pilot studies enrolled healthy subjects with body mass indexes 25-40 kg/m(2) to similar 8-week weight loss programs. Safety was assessed by physical examination and laboratory tests at screening and 8 weeks. The first pilot study randomized eight subjects to citrus aurantium (herbal phenylephrine) or placebo. Body composition by DEXA scan, waist circumference, and resting metabolic rate (RMR) were measured at baseline and 8 weeks. Food intake and appetite ratings were measured at baseline and week 2. The second pilot study randomized 20 subjects to two 2-hour RMR tests a week apart after phenylephrine (20 mg) or placebo followed by phenylephrine (20 mg) three times a day for 8 weeks. In the first pilot study, the citrus aurantium group gained 1.13 +/- 0.27 (mean +/- SEM) kg compared with 0.09 +/- 0.28 kg in the placebo group (P < .04). RMR at baseline rose more in the citrus aurantium group, 144.5 +/- 15.7 kcal/24 hours, than the placebo group, 23.8 +/- 28.3 kcal/24 hours (P < .002), but not at 8 weeks. DEXA, waist circumference, food intake, and hunger ratings were not different. In the second pilot study, the phenylephrine group lost 0.8 +/- 3.4 kg in 8 weeks (not significant), and RMR increased more in the phenylephrine group (111.5 +/- 32.6 vs. 37.4 +/- 22.7 kcal/24 hours, P = .02). There were no significant safety issues in either study. Although no toxicity was seen, these pilot studies suggest phenylephrine is not efficacious for weight loss.     

Effect of pramlintide on weight in overweight and obese insulin-treated type 2 diabetes patients

OBJECTIVE: Several randomized, placebo-controlled, double-blind trials in insulin-treated patients with type 2 diabetes have shown that adjunctive therapy with pramlintide reduces hemoglobin (Hb)A1c with concomitant weight loss. This analysis further characterizes the weight-lowering effect of pramlintide in this patient population. RESEARCH METHODS AND PROCEDURES: This pooled post hoc analysis of two long-term trials included all patients who were overweight/obese at baseline (BMI > 25 kg/m2), and who were treated with either 120 microg pramlintide BID (n = 254; HbA1c 9.2%; weight, 96.1 kg) or placebo (n = 244; HbA1c 9.4%; weight, 95.0 kg). Statistical endpoints included changes from baseline to week 26 in HbA1c, body weight, and insulin use. RESULTS: Pramlintide treatment resulted in significant reductions from baseline to week 26, compared with placebo, in HbA1c and body weight (both, p < 0.0001), for placebo-corrected reductions of -0.41% and -1.8 kg, respectively. Approximately three times the number of patients using pramlintide experienced a > or = 5% reduction of body weight than with placebo (9% vs. 3%, p = 0.0005). Patients using pramlintide also experienced a proportionate decrease in total daily insulin use (r = 0.39, p < 0.0001). The greatest placebo-corrected reductions in weight at week 26 were observed in pramlintide-treated patients with a BMI >40 kg/m2 and in those concomitantly treated with metformin (both, p < 0.001), for placebo-corrected reductions of -3.2 kg and -2.5 kg, respectively. DISCUSSION: These findings support further evaluation of the weight-lowering potential of pramlintide in obese patients with type 2 diabetes.     

安非他酮与米氮平治疗抑郁症伴有焦虑疗效比较

目的比较安非他酮与米氮平对抑郁症伴焦虑的疗效及其安全性。方法103例抑郁症患者分为2组。安非他酮组53例，其中男性27例，女性26例，年龄（34±11）岁，本次抑郁病期3～8个月。予安非他酮300～450mg，po，qd；米氮平组50例，其中男性26例，女性24例，年龄（38±11）岁，本次抑郁病期3～11个月，予米氮平30—45mg，po，qd；均6周为1个疗程。结果对抑郁症状的治疗，安非他酮组显效率71．7％，米氮平组显效率74．0％，疗效差异无统计学意义（P〉0．05）；对焦虑症状的治疗，安非他酮组显效率48％，米氮平组显效率76％，疗效差异有统计学意义（P〈0．05）。整体药物不良反应发生率2组相当。结论安非他酮与米氮平对治疗抑郁症安全有效，但抗焦虑作用米氮平优于安非他酮。     

Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis

Objectives: To evaluate varenicline's efficacy for smoking cessation versus bupropion SR and placebo and to explore whether factors typically predictive of abstinence influence varenicline's efficacy versus placebo, as measured by the week 9-12 continuous abstinence rate (CAR9-12). Methods: Smokers in 2 randomized, placebo-controlled trials received varenicline 1 mg BID (n=696), bupropion SR 150 mg BID (n=671), or placebo (n=685) for 12 weeks. Nontreatment followup lasted 40 weeks. Results: CAR(9-12) was greater for varenicline (44.0%) versus bupropion SR (29.7%; P<0.0001) and placebo (17.7%; P<0.0001). CAR(9-12) for varenicline versus placebo was not affected by age, gender, or nicotine dependence level. Conclusions: Varenicline was more efficacious than bupropion SR or placebo. Varenicline's efficacy versus placebo was not influenced by factors predictive of abstinence.     

Evening ready-to-eat cereal consumption contributes to weight management

OBJECTIVES: Post dinner snacking may constitute a significant proportion of total daily energy intake and contribute to overweight and obesity in some individuals (night snackers). This study tested the hypothesis that providing a structured snack in the form of a "ready-to-eat" breakfast cereal would help regulate excess energy intake and contribute to weight loss in night snackers. METHODS: Adults (18 to 65 years of age, BMI kg/m2 > or = 25), with self-reported night snacking behaviors, were randomized into a cereal group (CR) and a no-cereal group (NC). During a period of 4 weeks, the cereal group was instructed to consume a serving of ready-to-eat cereal with low-fat milk 90 minutes after their evening meal. Concurrently, the non-cereal group continued their regular diet ad libitum. RESULTS: At baseline, there were no significant differences between groups for age, body weight, body mass index, daily caloric intake, or evening caloric intake. There was a correlation between number of days of compliance with post-dinner cereal consumption and weight loss (r = -0.36, p = 0.057). After 4 weeks, the compliant subjects (cereal intake > or = 20 d) lost -1.85 +/- 3.56 lbs vs. -0.39 +/- 3.1 lb for the NC group (p = 0.06). Compared to baseline, the compliant CR group reduced their total daily caloric intake by -396.50 +/- 641.6 kcal (p < 0.02), whereas, the NC group experienced a reduction of -23.22 +/- 889.60 kcal/day during the same period (p = ns). Reduction in post-dinner calorie intake for the compliant CR group was significantly greater compared to the NC group (-141.74 +/- 385.58 kcal vs. 85.82 +/- 374.70 kcal; p = 0.042). CONCLUSION: Eating ready-to-eat cereal after the evening meal may attenuate caloric intake in night snackers and promote weight loss in compliant individuals.     

Pilot Randomized Trial of Bupropion for Adolescent Methamphetamine Abuse/Dependence

PurposeTo perform a pilot clinical trial of bupropion for methamphetamine abuse/dependence among adolescents.MethodsNineteen adolescents with methamphetamine abuse (n = 2) or dependence (n = 17) were randomly assigned to bupropion SR 150 mg twice daily or placebo for 8 weeks with outpatient substance abuse counseling.ResultsBupropion was well-tolerated except for one female in the bupropion group who was hospitalized for suicidal ideation during a methamphetamine relapse. Adolescents receiving bupropion and females provided significantly fewer methamphetamine-free urine tests compared to participants receiving placebo (p = .043) and males (p = .005) respectively.ConclusionsResults do not support the feasibility of additional trials of bupropion for adolescent methamphetamine abuse/dependence. Future studies should investigate the influence of gender on adolescent methamphetamine abuse and treatment outcomes.     

Bupropion SR for relapse prevention: a "slips-allowed" analysis

OBJECTIVE: To assess the efficacy of bupropion SR on smoking abstinence using a "slips allowed" analysis. METHODS: Retrospective analysis, which did not consider brief episodic "slips" as a return to regular smoking, of data from a multicenter, randomized, doubleblind, placebo-controlled relapse prevention study. RESULTS: Using a slips-allowed analysis, median time to relapse on bupropion SR was 65 weeks versus 30 weeks on placebo. This is compared to 32 and 20 weeks, respectively, using a traditional analysis not allowing for slips. CONCLUSION: Bupropion SR is efficacious for the prevention of smoking relapse. A slips-allowed analysis may provide a more clinically relevant assessment of efficacy.     

Fluoxetine: a randomized clinical trial in the maintenance of weight loss

Because current weight-reduction treatments have considerable recidivism, a therapy that could help patients maintain weight loss would be of benefit. A six-center, randomized, double-blind trial compared the effects of the specific serotonin uptake inhibitor, fluoxetine hydrochloride, and placebo on maintenance of weight loss. Obese outpatients who had lost > or = 3.6 kg after 8 weeks of single-blind fluoxetine 60 mg/day in the qualification phase (N=317 [70.4% of patients entered]; mean +/- standard deviation [SD] weight loss, 6.8 +/- 2.8 kg) were randomly assigned to fluoxetine 20 mg/day (N=104), fluoxetine 60 mg/day (N=106), or placebo (N=107) for 40 weeks (maintenance phase). Patients received minimal nutrition/dietary counseling. Qualification phase clinic visits were biweekly; maintenance phase visits were monthly for 4 months, then bimonthly for 6 months. Patients treated with fluoxetine 60 mg/day continued to lose weight for 8 additional weeks (16 weeks total; maximum mean +/- SD weight loss, 7.2 +/- 4.6 kg); those treated with fluoxetine 20 mg/day or placebo began to regain weight. Mean weights remained below baseline values at week 48 (all groups); treatment differences were not statistically significant. Study completion rates were comparable (fluoxetine 20 mg/day, 67.3%; fluoxetine 60 mg/day, 56.6%; placebo, 67.3%; p = 0.175). Among commonly reported adverse events (> 10% incidence), only asthenia was reported statistically significantly (p < 0.050) more frequently with fluoxetine than with placebo. Few patients discontinued for any single adverse event. Fluoxetine 60 mg/day was effective for a longer period than fluoxetine 20 mg/day or placebo in maintaining weight loss. Overall, fluoxetine was safe and well tolerated.     

Efficacy of orlistat 60 mg on weight loss and body fat mass in US Army soldiers

A higher body mass index is associated with exercise-related injuries and increased risk for musculoskeletal and connective tissue disorders, which are relevant to military personnel. Studies show the efficacy of orlistat 60 mg for promoting weight and body fat loss in civilians; however, its efficacy among predominantly young, male soldiers is unknown. This study's objective was to examine the effect of a 6-month, standard education-based weight-management program with and without orlistat 60 mg on changes in weight and body fat in overweight soldiers. Data were collected for this randomized, controlled trial from March 2008 to November 2010 at Fort Bragg, NC. Participants were enrolled in an education-based weight management program (n=435; 75% men) and were randomized to placebo or orlistat 60 mg, three capsules daily with meals. All participants were recommended to maintain a reduced-energy, low-fat diet. Among study completers (14% retention rate; placebo n=22, orlistat n=35) members of both groups lost significant weight from baseline (placebo ?3.0±5.2 kg; orlistat ?3.2±4.7 kg; P<0.01), but only the orlistat group lost fat mass (?2.5±3.9 kg; P<0.001), whereas the placebo group lost lean mass (?1.4±2.7 kg; P <0.01). An intent-to-treat analysis (≥1 follow-up body weight measure) demonstrated that the orlistat group lost more fat mass vs the placebo group (?1.3±2.9 kg vs ?0.6±1.8 kg, respectively; P<0.05), but less lean mass (?0.2±2.0 kg vs ?0.8±1.8 kg, respectively; P<0.01). Orlistat 60 mg may be an effective adjunct to an education-based weight management program in a mostly young, male soldier population.     

Exercise treatment for depression: efficacy and dose response

BACKGROUND: This study, conducted between 1998 and 2001 and analyzed in 2002 and 2003, was designed to test (1) whether exercise is an efficacious treatment for mild to moderate major depressive disorder (MDD), and (2) the dose-response relation of exercise and reduction in depressive symptoms. DESIGN: The study was a randomized 2x2 factorial design, plus placebo control. SETTING/PARTICIPANTS: All exercise was performed in a supervised laboratory setting with adults (n =80) aged 20 to 45 years diagnosed with mild to moderate MDD. INTERVENTION: Participants were randomized to one of four aerobic exercise treatment groups that varied total energy expenditure (7.0 kcal/kg/week or 17.5 kcal/kg/week) and frequency (3 days/week or 5 days/week) or to exercise placebo control (3 days/week flexibility exercise). The 17.5-kcal/kg/week dose is consistent with public health recommendations for physical activity and was termed "public health dose" (PHD). The 7.0-kcal/kg/week dose was termed "low dose" (LD). MAIN OUTCOME MEASURES: The primary outcome was the score on the 17-item Hamilton Rating Scale for Depression (HRSD(17)). RESULTS: The main effect of energy expenditure in reducing HRSD(17) scores at 12 weeks was significant. Adjusted mean HRSD(17) scores at 12 weeks were reduced 47% from baseline for PHD, compared with 30% for LD and 29% for control. There was no main effect of exercise frequency at 12 weeks. CONCLUSIONS: Aerobic exercise at a dose consistent with public health recommendations is an effective treatment for MDD of mild to moderate severity. A lower dose is comparable to placebo effect.     

Modest lifestyle intervention and glucose tolerance in obese African Americans

OBJECTIVE: Previous studies have demonstrated the benefit of short-term diets on glucose tolerance in obese individuals. The purpose of this study was to evaluate the effectiveness of modest lifestyle changes in maintaining improvements in glucose tolerance induced by short-term energy restriction in obese African Americans with impaired glucose tolerance or type 2 diabetes mellitus. RESEARCH METHODS AND PROCEDURES: An intervention group (n = 45; 47 +/- 1 year [mean +/- SE]), 105 +/- 4 kg; body mass index: 39 +/- 1 kg/m(2)) received an energy-restricted diet (943 +/- 26 kcal/d) for 1 week, followed by a lifestyle program of reduced dietary fat (-125 kcal/d) and increased physical activity (+125 kcal/d) for 1 year. Body weight and plasma concentrations of glucose, insulin, and C-peptide during an oral glucose tolerance test were measured at baseline, 1-week, and 4-month intervals. A control group (n = 24; 48 +/- 1 year; 110 +/- 5 kg; body mass index: 41 +/- 2 kg/m(2)) underwent these measurements at 4-month intervals. RESULTS: No changes in weight or glucose tolerance were observed in the control group. The intervention group had significant (p < 0.05) improvements in body weight and glucose tolerance in response to the 1-week diet, which persisted for 4 months (p < 0.001 vs. control for change in weight). A total of 19 subjects (42%) continued the intervention program for 1 year, with sustained improvements (weight: -4.6 +/- 1.0 kg; p < 0.001 vs. control; oral glucose tolerance test glucose area: -103 +/- 44 mM. min; p < 0.05 vs. control). DISCUSSION: A modest lifestyle program facilitates weight loss and enables improvements in glucose tolerance to be maintained in obese individuals with abnormal glucose tolerance. However, attrition was high, despite the mild nature of the program.     

Nutritional assessment and follow-up of residents with and without dementia in nursing homes in the Limousin region of France: A health network initiative

Introduction

Limousin in France has the second oldest regional population in Europe, with people over 65-years-old who have Alzheimer??s disease accounting for more than 9%. In France as a whole, a large number of residents in nursing homes (NH) have dementia, leading to many nutritional problems. LINUT is a health network that assesses the nutritional status of elderly NH residents and provides support where necessary. Aims of the present study were to use this network to evaluate the nutritional status of NH residents with and without dementia and to review changes after 4 months of intervention.

Methods

A cross-sectional survey was conducted by a doctor and a dietician at baseline (T0) and 4 months (T4) among residents at the 26 NH in Limousin that agreed to take part. The evaluation criteria included presence of dementia, depression and autonomy, weight, height, body mass index, Mini Nutritional Assessement (MNA?), and a 3-day survey of food intake.

Results

The 346 residents assessed at T0 were aged 87.9±6.9 years, 83.4% were women, 66.8% had dementia, 53.3% were malnourished and 27.4% obese. Autonomy was not affected by obesity. Residents with dementia had a lower Activities of Daily Living score and a lower weight than non-demented individuals (2.2±1.2 vs. 2.7±1.7 p=0.03 and 60.1±16.3 vs. 64.7±20.0 kg p=0.03, respectively), were more often malnourished (56.1% vs. 46.4% p=0.004) and less often obese (22.0% vs. 39.1% p=0.004) but consumed more protein (62.6±17.8 vs. 58.2±16.9 g/d p=0.04, 1.1±0.4 vs. 1.0±0.4 g/kg/d p=0.005). Energy intake was at the lower limit of French recommendations (26.4±8.8 vs. >25.0 kcal/kg/d). Assessment of all residents at T4 showed improved MNA? (+0.4 points/month p=0.02), protein intake (+3.3 g/d p=0.0007), and energy intake (+41.4 kcal/d p=0.01 and 0.1 kcal/kg/d p=0.03). Variations in prevalences of malnutrition and obesity were not statistically significant. MNA? increased in the dementia group (+0.29±0.8 points/month p=0.003). All other changes were comparable, and nutritional status did not differ more between the two groups at T4 than at T0.

Conclusion

The prevalence of dementia was high in the population studied. Malnutrition was the main problem, particularly if residents had dementia. Protein intake was satisfactory, but energy intake often insufficient. The nutritional status of dementia patients improved after 4 months of follow-up, suggesting that effective action to support such services would be worthwhile.     

Randomized placebo-controlled trial of long-term treatment with sibutramine in mild to moderate obesity.

OBJECTIVE: The researchers assessed the long-term weight reduction efficacy, tolerability, and safety of sibutramine used once daily in conjunction with behavior modification to treat mild to moderate obesity. STUDY DESIGN: This was a double-blind randomized placebo-controlled parallel-group comparative study of sibutramine 10 mg or 15 mg (or placebo) once daily for 1 year, given with dietary advice. POPULATION: A total of 485 obese men and women with uncomplicated obesity were included (mean age=42 years, mean body mass index=32.7 kg/m2). OUTCOMES MEASURED: The outcomes were mean weight loss, percentage losing more than 5% or 10% of their body weight, and adverse drug effects. RESULTS: Among patients completing the study, those taking sibutramine 10 mg or 15 mg had greater mean weight loss compared with placebo at 12-month assessment (P < or = .001). Changes in body weight from baseline to end point were -1.6 kg for those taking placebo, -4.4 kg for those taking sibutramine 10 mg (P < or =.01, last observation carried forward [LOCF]), and -6.4 kg for those taking sibutramine 15 mg (P < or =.001, LOCF). For placebo patients, 20% lost 5% or more of their body weight compared with 39% of patients taking sibutramine 10 mg and 57% taking sibutramine 15 mg. Only 7% of the patients taking placebo lost 10% or more of their body weight, compared with 19% taking sibutramine 10 mg and 34% taking sibutramine 15 mg (P <.001 for both 10 mg and 15 mg vs placebo, and for both > or =5% and > or =10%). CONCLUSIONS: Sibutramine 10 mg or 15 mg once daily given with dietary advice produces and maintains statistically and clinically significantly greater weight loss than dietary advice alone (placebo) throughout a 12-month treatment period, and is safe and well tolerated.     

Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects

OBJECTIVE: To examine the safety and efficacy of topiramate (TPM) for maintaining weight following a low-calorie diet. RESEARCH METHODS AND PROCEDURES: Obese subjects (30 < or = BMI < 50 kg/m(2)) 18 to 75 years old received a low-calorie diet for 8 weeks. Those who lost > or =8% of their initial weight received TPM (96 or 192 mg/d) or placebo; all were on a lifestyle modification plan. Sixty weeks of medication were planned. Sponsor ended study early to develop a new controlled-release formulation with the potential to enhance tolerability and simplify dosing in this patient population. Efficacy was analyzed in subjects who completed 44 weeks of treatment before study termination. RESULTS: Of the 701 subjects enrolled, 80% lost > or =8% of their initial body weight and were randomized; 293 were analyzed for efficacy. Most withdrawals were due to premature termination of the study. Subjects receiving TPM lost 15.4% (96 mg/d) and 16.5% (192 mg/d) of their enrollment weight by week 44, compared with 8.9% in the placebo group (p < 0.001). Subjects on TPM continued to lose weight after the run-in, whereas those on placebo regained weight. Significantly more TPM subjects lost 5%, 10%, or 15% of their randomization weight than placebo. Most adverse events were related to the central nervous system. DISCUSSION: During a treatment period of 44 weeks, TPM was generally well tolerated, and subjects maintained weight loss initially achieved by a low-calorie diet-and produced additional clinically significant weight loss beyond that achieved by a low-calorie diet.     

Effects of dietary supplements on depressive symptoms in older patients: a randomised double-blind placebo-controlled trial

BACKGROUND & AIMS: The effect of nutritional supplements on mental health in older patients has received little attention so far. The aims of this trial were therefore to test the effect of nutritional support on older patient's depressive symptoms and cognitive function. METHODS: In this prospective, double-blind, placebo-controlled study, we randomly assigned 225 hospitalised acutely ill older patients to receive either normal hospital diet plus 400 mL oral nutritional supplements (106 subjects) or normal hospital diet plus a placebo (119 subjects) daily for 6 weeks. The composition of the supplement was such as to provide 995 kcal for energy and 100% of the Reference Nutrient Intakes for a healthy old person for vitamins and minerals. Outcome measures were 6 weeks and 6 months changes in nutritional status, depressive symptoms and cognitive state. RESULTS: Randomisation to the supplement group led to a significant increase in red-cell folate and plasma vitamin B12 concentrations, in contrast to a decrease seen in the placebo group. There were significant differences in symptoms of depression scores in the supplement group compared with the placebo group at 6 months (p = 0.021 for between groups difference). The effect of supplement was seen in all patient groups including those with no symptoms of depression, mild depression and those with severe depression (p = 0.007). There was no evidence of a difference in cognitive function scores at 6 months. CONCLUSION: Oral nutritional supplementation of hospitalised acutely ill older patients led to a statistically significant benefit on depressive symptoms.