小儿单纯性肥胖与胰岛素水平及高敏C反应蛋白的关系

目的:探讨胰岛素(INS)及高敏C反应蛋白(hs-CRP)水平的变化在儿童单纯性肥胖中的价值。方法:将达州市中心医院2008年3月～2011年3月50例单纯性肥胖儿童设为观察组,同期50例健康体检儿童设为对照组,利用免疫发光法和免疫比浊法测定两组儿童的血清INS、hs-CRP水平,同时对体重指数(BMI)、INS、hs-CRP三个指标进行相关性分析。结果:①观察组儿童血清INS水平为(36.04±10.98)mIU/L,hs-CRP水平为(4.79±0.23)mg/L、体重指数为(30.77±4.53)kg/m2;对照组儿童血清INS水平为(20.81±17.57)mIU/L,hs-CRP水平为(1.44±0.06)mg/L,体重指数为(22.11±2.52)kg/m2,观察组血清INS、hs-CRP、BMI均明显高于对照组(P<0.01);②观察组儿童血清hs-CRP水平与INS、BMI均呈正相关(P<0.05)。结论:肥胖与胰岛素抵抗、炎性反应有明显相关性,随着体重指数的降低,肥胖儿童内分泌功能可逐渐趋向正常,早期发现及时干预有重要意义。     

超重和肥胖人群血清脂联素水平变化与高血压病的关系

目的研究血清脂联素水平与超重、肥胖及与高血压病的关系。方法对深圳地区21岁~60岁人群共21578人进行体重指数(BM I),腰围(WC),腰臀围比(WHR)及血压(HP)测量,按体重指数(BM I)将其分成三大组:正常非肥胖组(BM I≤24kg/m2)共14817人;超重组(2495 cm的人群为133‰。(χ12=821.26,P<0.005),(χ22=500.16,P<0.005)。血清脂联素浓度在肥胖人群及高血压病肥胖患者均显著低于正常人群[脂联素:单纯性肥胖组(7.16±1.41)mg/L,高血压病肥胖组(7.18±1.45)mg/L vs.正常非肥胖组(9.22±0.61)mg/L,F=3.217,P<0.05]。血清脂联素浓度在超重人群与正常人群之间无显著性差异[脂联素:超重组(7.71±1.73)mg/L vs.正常非肥胖组(9.22±0.61)mg/L,P=0.097>0.05]。在高血压病肥胖患者中,脂联素浓度与体重指数、腰围、腰臀围比、、收缩压之间呈显著负相关。结论脂联素水平下降与肥胖、血压之间存在一定的相关性;保持BM I和WC在正常范围,是预防高血压病发生的有效措施之一。     

牛磺酸对大鼠染铅所致贫血的疗效

[目的 ]探讨牛磺酸 (Tau)对大鼠染铅所致贫血的治疗作用。 [方法 ] 40只Wistar大鼠随机均分为 5组 :①空白对照组 ;②染铅组 :醋酸铅 40mg/(kg·d)连续灌胃 4周 ;③Tau治疗 1、2、3组 :与染铅组相同处理 4周后分别以 10 0、40 0、80 0mg/(kg·d)Tau灌胃 4周。实验第 8周末测定各组大鼠血红蛋白 (Hb)含量及红细胞 (RBC)数 ,并处死动物 ,颈动脉取血 ,测定血铅和血清丙二醛 (MDA)含量、超氧化物歧化酶 (SOD)水平。 [结果 ]①Tau 10 0mg/kg组和Tau 40 0mg/kg组大鼠Hb分别为 ( 13 1.98± 6.83 )g/L和 ( 13 6.2 5± 5 .97)g/L ,与染铅组大鼠Hb( 118.74± 5 .3 5 )g/L相比明显升高 ,差异有显著性(P <0 .0 1)。②Tau 10 0mg/kg、Tau 40 0mg/kg组大鼠RBC分别为 ( 4 .71± 0 .40 )× 10 12 /L和 ( 4 .89± 0 .44 )× 10 12 /L ,与染铅组大鼠RBC( 3 .5 3± 0 .19)× 10 12 /L相比明显升高 ,差异有显著性 (P <0 .0 1)。③Tau 10 0mg/kg、Tau 40 0mg/kg组大鼠血铅水平分别为 ( 2 .47± 0 .2 8) μmol/L、( 2 .3 4± 0 .48) μmol/L ,与染铅组大鼠血铅 ( 3 .5 4± 0 .75 ) μmol/L相比明显降低 ,差异有显著性 (P <0 .0 5 )。④Tau 10 0mg/kg和 40 0mg/kg组大鼠血清MDA含量分别为 ( 4 .96± 0 .5 5 )nmol/ml和 ( 4 .45     

儿童单纯肥胖症门诊治疗效果观察

【目的】　观察门诊治疗肥胖儿童的可行性及治疗效果。　【方法】　以WHO身高标准体重值为肥胖判断标准。自 1997年 12月～ 1999年 8月共治疗单纯性肥胖儿童 15 8例 ,治疗方法为控制饮食、改变饮食行为、中等程度 (心率 14 5～ 15 5次 /分 )有氧运动、减少静坐时间、健康教育等 ,首诊制订一周治疗方案 ,每周复诊 1次 ,根据患儿对治疗方案的执行情况制订下 1周治疗计划。采用个案分析方法 ,对不同年龄、不同肥胖度及是否有合并症等设定不同的治疗目标。　【结果】　治疗时间少于 4周者 98例 ,治疗时间在 4周及以上者 160例 (分别占就诊人数的 3 7.9%和62 .1% )。上述 160例肥胖儿童中 ,治疗后体重下降者 12 7例 ,减重幅度为 0 .5～ 7.5kg ,平均减重 (3 .5± 2 .9)kg ,体重不变或上升者 3 3例 ;体块指数 (bodymassindexBMI)下降者 15 8例 ,下降幅度为 0 .2～ 5 .6,平均下降 (1.8± 1.1)。BMI值不变者 2例。治疗时间较长者 (9周以上 )治疗效果较好。　【结论】　在门诊对肥胖儿童使用包括饮食调整、有氧运动、行为矫正和健康教育在内的综合疗法有较好的可行性并能获得一定疗效     

柿叶辅助米非司酮配伍米索前列醇终止1O～16周妊娠的临床研究

目的探索柿叶辅助米非司酮配伍米索前列醇终止10～16周妊娠的有效性和安全性.方法320例孕10～16周要求药物终止妊娠的妇女,随机分成2组.组Ⅰ 160例,米非司酮75 mg 1次/d,连服2 d,第3 d晨阴道内放置米索0.6 mg,每12 h重复1次,最多3次;组Ⅱ160例,药物用法同组Ⅰ,放置米索后2 h口服柿叶煎剂250 ml,2次/d,连服5 d.结果组Ⅰ、组Ⅱ24h内流产成功率分别为92.4%和97.5%,有显著性差异(P＜0.05).组Ⅰ和组Ⅱ完全流产未清宫者阴道出血持续时间分别为15.8±9.4和8.0±5.8 d,清宫者分别为9.2±6.1 d和7.6±6.3 d;不完全流产清宫者为10.1±7.5 d和8.4±6.6 d.两组阴道持续出血时间和月经恢复时间差异有显著性(P＜0.05～0.001).结论柿叶辅助米非司酮配伍米索前列醇终止10～16周妊娠可做为一种常规方法推荐在临床应用.     

缓释与常规剂型丙戊酸钠治疗癫痫的疗效比较

目的比较丙戊酸钠缓释片及常规剂型治疗癫痫的疗效及安全性。方法115例癫痫病人分为2组,缓释组59例,男性39例,女性20例,年龄(16.4±9.6)岁,给丙戊酸钠缓释片(24.5±3.6)mg/(kg.d);常规组56例,男性37,女性19例,年龄(15.4±10.1)岁,给丙戊酸钠片(25±3.8)mg/(kg.d),于24周后评定疗效。结果缓释组控制率55.9%,总有效率93.2%;常规组控制率30.4%,总有效率75.0%(χ2=7.65,7.22,均P<0.05),差异均有统计学意义。结论丙戊酸钠缓释片治疗癫痫效果优于丙戊酸钠常规剂型,且服用方便,前者较后者具有更好的依从性。     

肥胖与排卵功能关系的临床观察

目的:研究体重指数对排卵功能的影响。方法:将被确定为单纯性肥胖所致不孕的104例妇女随机分为对照组52例、实验组52例,通过控制体重、降低体重指数,观察两组排卵的改善情况。结果:对照组52例,均无体重改善,自发排卵2例,占4%。实验组52例,体重平均减轻(5.55±1.31)kg,自发排卵12例,占24%。结论:通过降低体重指数,可改善排卵功能,是单纯性肥胖不孕患者改善排卵的有效治疗方法。     

正常热量高蛋白饮食对肥胖和2型糖尿病患者代谢指标及胃肠激素的影响

目的 观察正常热量高蛋白饮食对肥胖和2型糖尿病患者代谢指标及胃肠激素的影响。方法 单纯性肥胖患者30例（OB组),2型糖尿病患者40例(T2DM组),均给予正常热量高动物蛋白饮食24周,观察两组患者治疗前后体重、体脂、血生化指标及100 g馒头餐前后血胃促生长素、胰高血糖素样肽-1（GLP-1）的变化。结果 OB组、T2DM组治疗24周后较治疗前体重 ［(78.23±7.51)kg与(80.83±8.13)kg,P=0.016;(80.45±7.48)kg与(83.26±9.35）kg,P=0.011］、体重指数［(31.03±2.72)kg/m2与(32.01±2.95)kg/m2,P=0.033; (32.63±2.81)kg/m2与(33.86±3.03)kg/m2,P=0.043］、腰围［(93.65±6.23)cm与(97.30±7.81)cm,P=0.041; (97.02±7.43)cm与(101.87±9.87)cm,P=0.034］、脂肪含量［(30.42±6.18)kg与(32.47±5.91)kg,P=0.022; (34.23±7.03)kg与(36.64±6.83)kg,P=0.032］、空腹胰岛素［FINS(10.81±3.69）mmol/L与(13.58±4.86)mmol/L,P=0.012;(9.58±3.51)mmol/L与(10.82±4.28)mmol/L,P=0.015］、胰岛素抵抗指数［HOMA-IR(2.42±0.83)与(3.16±1.21),P=0.019; (3.15±0.74)与(4.13±0.67),P=0.024］、甘油三酯［(1.24±0.32)mmol/L 与(1.49±0.52)mmol/L,P=0.046;(1.86±1.05)mmol/L与(2.46±1.85)mmol/L,P=0.034］ 均明显下降,T2DM组空腹血糖［(6.73±1.25)mmol/L与(8.63±2.81)mmol/L,P=0.010],糖化血红蛋白［(6.44±0.47)%与(7.38±0.33)%,P=0.031］亦显著降低。治疗24周OB组、T2DM组空腹及餐后2 h胃促生长素、GLP-1均高于0周［空腹胃促生长素：（4.98±0.89)μg/L与（3.95±0.98)μg/L,P=0.021;（4.23±1.67)μg/L 与（3.15±1.01)μg/L,P=0.025;餐后2 h胃促生长素：（2.98±0.96)μg/L与（2.56±0.83)μg/L,P=0.046;（2.83±1.03)μg/L与（1.95±0.92)μg/L,P=0.033;空腹GLP-1：（6.06±0.63)μg/L与（5.13±0.59)μg/L,P=0.041;（5.23±0.71)μg/L与（4.49±0.53)μg/L,P=0.039;餐后2 h GLP-1：（10.01±1.01)μg/L 与（7.68±0.94)μg/L,P=0.007;（8.87±0.94)μg/L与（6.59±0.87)μg/L,P=0.013］。结论 正常热量高蛋白饮食可有效减肥、降糖,GLP-1分泌增加可能是其减肥、降糖的主要作用机制之一。     

兰美抒治疗儿童头癣的疗效临床观察

目的了解兰美抒治疗儿童头癣的疗效和安全性。方法治疗组31例头癣患儿每天饭后口服1次兰美抒,体重小于20kg,62.5mg/天;体重为20～40kg,125mg/天,体重大于40kg,250mg/天,连服6周;26例对照组口服灰黄霉素治疗10周。结果兰美抒治疗第6周停药时临床治愈率与治疗4周时相比,疗效显著提高(P<0.05);与对照组疗效相比,治疗第6、10周疗效明显高于对照组(P<0.05);与对照组比较,副作用有显著性降低(P<0.05)。结论兰美抒治疗儿童头癣疗效高、安全。     

应用计算机辅助精子分析系统检测镉对大鼠精子运动能力的影响

目的　为镉的雄性生殖毒性评价筛选出敏感指标 ,以便对其生殖毒性进行早期监测。方法　应用氯化镉对成年雄性SD大鼠进行腹腔染毒 (连续 7d) ,染毒剂量分别为 0 .2、0 .4、0 .8mg/kg体重 (以镉计 )。对大鼠进行睾丸精子头计数 ,并计算每日精子生成量。应用计算机辅助精子分析(CASA)系统对附睾尾精子运动能力进行检测。结果　 0 .8mg/kg染镉组大鼠睾丸精子头计数和每日精子生成量为 (16 .45± 3 .0 1) 10 6/g和(2 .6 5± 0 .5 1) 10 6·d-1·g-1,比对照组 [(119.2 0± 14.5 1) 10 6/g和(19.5 1± 2 .37) 10 6·d-1·g-1]明显降低 ,0 .2mg/kg染镉组大鼠附睾尾精子曲线运动速度 (VCL)即明显降低 ,0 .4mg/kg染镉组大鼠精子运动能力的改变更为显著 ,差异均有显著性 (P <0 .0 5或P <0 .0 1)。 0 .8mg/kg染镉组未见活动精子。结论　精子运动参数是镉雄性生殖毒性评价较敏感的观察指标 ,CASA系统是雄性生殖毒理学研究的有力工具     

Six-month treatment of obesity with sibutramine 15 mg; a double-blind, placebo-controlled monocenter clinical trial in a Hispanic population

OBJECTIVE: To evaluate the safety and efficacy of sibutramine 15 mg by mouth once per day in obese patients over a period of 6 months. RESEARCH METHODS AND PROCEDURES: A monocenter, double-blind, placebo controlled, parallel, prospective clinical trial was carried out. Sixty-nine male and female obese patients (body mass index [BMI] > 30 kg/m2) aged 16 to 65 years entered the trial. RESULTS: 22 of 35 patients in the sibutramine group and 9 of 34 patients in the placebo group completed the trial. The high dropout rate in the sibutramine group was due to adverse events in 3 cases, lack of efficacy (as judged by patients) in 7, loss to follow-up in 2, and an orthopedic device being worn in 1; in the placebo group the dropouts were ascribed to lack of efficacy (as judged by patients) in 17 cases and to loss to follow-up in 8 cases. Using the method of last observation carried forward, the weight loss in the sibutramine group was 10.27 kg (95% confidence intervals [95% CI] 7.66; 13.07) and 1.26 kg (95% CI 0.3; 2.23) in the placebo group. The BMI loss was 4.17 kg/m2 (95% CI 3.11; 5.22) in the sibutramine group and 0.53 kg/m2 (95% CI 0.13; 0.92) in the placebo group. The waist circumference reduction was 12.51 cm (95% CI 9.25; 15.77) in the sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the control group (p<0.05 by paired Student's t test for all the intragroup comparisons). Twenty-three sibutramine patients had 34 adverse events, the most frequent adverse events in the sibutramine group were upper respiratory tract infections (n = 6) and constipation (n = 6); 16 placebo patients had 21 adverse events. Three sibutramine patients withdrew their informed consent when they had adverse events. DISCUSSION: The results show that sibutramine induces significant loss of body weight and waist circumference. Cardiovascular function was not significantly affected by sibutramine. Sibutramine was well tolerated by most of the patients.     

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.     

Sibutramine produces dose-related weight loss

OBJECTIVE: Sibutramine is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. In animals, it reduces food intake and increases thermogenesis and preliminary data in human beings showed weight loss. This paper reports a 24-week dose-ranging study to determine the effect of sibutramine on body weight of patients with obesity. RESEARCH METHODS AND PROCEDURES: Seven clinical centers screened 1463 patients with obesity and randomized 1047 to 24 weeks of treatment with 1 of 6 doses of sibutramine (1, 5, 10, 15, 20, or 30 mg) or placebo once daily. Six hundred eighty-three patients completed the study. A two-week placebo run-in period was used to initiate a standardized program of diet, physical activity, and lifestyle changes. RESULTS: Weight loss was dose-related and statistically significant vs. placebo (p<0.05) across all time-points for a 5 mg/day to 30 mg/day dosage of sibutramine. At week 24, percent weight loss from baseline for completers was: placebo, 1.2%; 1 mg, 2.7%; 5 mg, 3.9%; 10 mg, 6.1%; 15 mg, 7.4%; 20 mg, 8.8%; and 30 mg, 9.4%. Weight loss achieved at week 4 was predictive of weight loss achieved at week 24. Patients losing weight demonstrated an increase in serum high density lipoprotein cholesterol and reductions in serum triglycerides, total cholesterol, low density lipoprotein cholesterol, and uric acid. Small mean increases in blood pressure and pulse rate (with considerable individual variability) were observed in patients treated with sibutramine. The most frequent adverse events were dry mouth, anorexia, and insomnia. DISCUSSION: Sibutramine administered once daily for 24 weeks in the weight loss phase of treatment for uncomplicated obesity produced dose-related weight loss and was well tolerated. Improvements in serum lipids and uric acid accompany sibutramine-induced weight loss. Most of the adverse events observed on sibutramine are related to its pharmacology, including small mean increases in blood pressure and heart rate.     

A 6-month randomized,placebo-controlled,dose-ranging trial of topiramate for weight loss in obesity

OBJECTIVE: To evaluate the efficacy and safety of topiramate (TPM) for weight loss in healthy obese subjects. RESEARCH METHODS AND PROCEDURES: A randomized, double-blind, placebo-controlled, dose-ranging trial was conducted. Three hundred eighty-five subjects, 18 and 75 years of age, were randomized to receive either placebo or TPM at 64, 96, 192, or 384 mg daily. Dosing began at 16 mg once daily. In week 2, the dose was increased to 16 mg twice daily. Thereafter, the dose was raised every week by 32 mg/d (16 mg twice daily) until subjects reached their target dose. Twenty-four weeks after beginning treatment, all subjects were tapered off treatment by a dose reduction of 50% per week. All participants received the same lifestyle program. RESULTS: Mean percent weight loss from baseline to week 24 was -2.6% in placebo-treated patients vs. -5.0%, -4.8%, -6.3%, and -6.3% in the 64, 96, 192, and 384 mg/d TPM groups, respectively. Greater percentages of TPM-treated patients lost at least 5% or 10% of body weight compared with placebo. The most frequent adverse events were related to the central or peripheral nervous system, including paresthesia, somnolence, and difficulty with memory, concentration, and attention. Most events were dose-related, occurred early in treatment, and usually resolved spontaneously; only 21% receiving TPM withdrew due to adverse events compared with 11% on placebo. DISCUSSION: TPM produced significantly greater weight loss than placebo at all doses.     

Effects of sibutramine on binge eating,hunger, and fullness in a laboratory human feeding paradigm

OBJECTIVE: The purpose of this study was to evaluate the effects of sibutramine vs. placebo on binge-eating behavior, hunger, and satiety in patients who had problems with binge eating. RESEARCH METHODS AND PROCEDURES: Seven adult subjects who had problems with binge eating (mean age, 42 years) were randomly assigned to receive alternating sibutramine and placebo in a double-blind placebo-controlled crossover study. This involved two 4-week dosing periods separated by a 2-week washout. RESULTS: Subjects lost weight on sibutramine but not on placebo. There was a significant difference in the number of kilocalories consumed between the sibutramine and placebo conditions, with a significant reduction of intake during binge-eating episodes on sibutramine. DISCUSSION: Sibutramine suppresses intake during binge-eating episodes. This effect is demonstrable in a human feeding laboratory paradigm.     

Effect of a dietary herbal supplement containing caffeine and ephedra on weight, metabolic rate, and body composition

OBJECTIVE: To evaluate the effect of a dietary supplement containing herbal caffeine (70 mg/dose) and ephedra (24 mg/dose; C&E) on metabolic rate, weight loss, body composition, and safety parameters. RESEARCH METHODS AND PROCEDURES: In phase I, 12 healthy subjects with a BMI of 25 to 35 kg/m2 had resting metabolic rate (RMR) measured for 2 hours after ingesting C&E or a placebo on two occasions 1 week apart, followed by a 1-week washout before phase II. In phase II, these 12 and 28 additional subjects were randomized to a 12-week, double-blind trial comparing C&E (3 times/day) to placebo. In phase III, the C&E group was given open-label C&E for 3 months, and the placebo group was given C&E for 6 months. RESULTS: In phase I, C&E gave an average 8 +/- 0.1% (SE) rise in RMR over 2 hours compared with placebo (p < 0.01). In phase II, weight loss at 12 weeks was 3.5 +/- 0.6 kg with C&E compared with 0.8 +/- 0.5 kg with placebo (p < 0.02). The percentage fat lost, shown by DXA, was 7.9 +/- 2.9% with C&E and 1.9 +/- 1.1% with placebo (p < 0.05). Pulse decreased more in the placebo group that in the C&E group (p < 0.03). There were no differences in lipid levels or blood pressure. In phase III, there was a 6-month loss of 7.3% and 7.8% of initial body weight for the groups on placebo and C&E during phase II, respectively. There were no serious adverse events. DISCUSSION: C&E increased RMR significantly by 8% compared with placebo, promoted more weight and fat loss than placebo, and was well tolerated.     

Absence of cardiac valve dysfunction in obese patients treated with sibutramine.

OBJECTIVE: Serotonin-releasing agents prescribed as weight-loss medications have been implicated as a cause of acquired aortic and mitral valve abnormalities. Sibutramine hydrochloride (MERIDIA) is a serotonin and norepinephrine reuptake inhibitor with proven efficacy of weight reduction. The purpose of this study was to determine the incidence of cardiac valve disease in sibutraminetreated patients. RESEARCH METHODS AND PROCEDURES: Obese patients with type 2 diabetes mellitus enrolled in an ongoing double-blind, placebo-controlled, parallel-arm, 12-month study of sibutramine (followed by a 12-month open label extension) underwent transthoracic echocardiographic imaging and color Doppler interrogation for assessment of cardiac valve anatomy and function. RESULTS: A total of 210 patients were evaluated. Of these, 133 were receiving sibutramine (72 in the double-blind period), and 77 were receiving placebo. The mean+/-Standard Deviation age was 54+/-9 years, and the mean duration of treatment was 229+/-117 days (approximately 7.6 months). The prevalence of left-sided cardiac valve dysfunction was low and similar for the two treatment groups (sibutramine 3/133, or 2.3%; placebo 2/77, or 2.6%). All five cases were cases of aortic insufficiency; four were mild, one was severe (in a placebo patient). All three sibutramine cases were patients over age 50; two had a history of systemic hypertension. CONCLUSION: The prevalence of left-sided cardiac valve dysfunction was not higher than background in obese patients treated with sibutramine for an average of 7.6 months.     

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.     

Effects of sibutramine plus orlistat in obese women following 1 year of treatment by sibutramine alone: a placebo-controlled trial

OBJECTIVE: This study assessed whether adding orlistat to sibutramine would induce further weight loss in patients who previously had lost weight while taking sibutramine alone. RESEARCH METHODS AND PROCEDURES: Patients were 34 women with a mean age of 44.1 +/- 10.4 years, weight of 89.4 +/- 13.8 kg, and body mass index (BMI) of 33.9 +/- 4.9 kg/m2 who had lost an average of 11.6 +/- 9.2% of initial weight during the prior 1 year of treatment by sibutramine combined with lifestyle modification. Patients were randomly assigned, in double-blind fashion, to sibutramine plus orlistat or sibutramine plus placebo. In addition to medication, participants were provided five brief lifestyle modification visits during the 16-week continuation trial. RESULTS: Mean body weight did not change significantly in either treatment condition during the 16 weeks. The addition of orlistat to sibutramine did not induce further weight loss as compared with treatment by sibutramine alone (mean changes = +0.1 +/- 4.1 kg vs. +0.5 +/- 2.1 kg, respectively). DISCUSSION: These results must be interpreted with caution because of the study's small sample size. The findings, however, suggest that the combination of sibutramine and orlistat is unlikely to have additive effects that will yield mean losses > or =15% of initial weight, as desired by many obese individuals.