Effect of recombinant human growth hormone on exercise capacity in patients with HIV-associated wasting on HAART

Over 700 patients with HIV-associated wasting while receiving HAART were randomly assigned to double-blind treatment for 12 weeks with recombinant human growth hormone (rhGH) daily or on alternate days, or to placebo. Maximum exercise intensity increased by a median of 2.35kJ in the alternate-days group and 2.60 kJ in the daily group but decreased by 0.25kJ in the placebo group. The median difference between the daily and placebo groups was 2.85 kJ (P < .0001). These improvements suggest that rhGH treatment may enable patients with wasting to perform activities of daily living that would be exhausting without rhGH treatment.     

The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency

In a double-blind, placebo-controlled trial, we studied the effects of six months of growth hormone replacement in 24 adults with growth hormone deficiency. Most of the patients had acquired growth hormone deficiency during adulthood as a consequence of treatment for pituitary tumors, and all were receiving appropriate thyroid, adrenal, and gonadal hormone replacement. The daily dose of recombinant human growth hormone (rhGH) was 0.07 U per kilogram of body weight, given subcutaneously at bedtime. The mean (+/- SE) plasma concentration of insulin-like growth factor I increased from 0.41 +/- 0.05 to 1.53 +/- 0.16 U per liter during rhGH treatment. Treatment with rhGH had no effect on body weight. The mean lean body mass, however, increased by 5.5 +/- 1.1 kg (P less than 0.0001), and the fat mass decreased by 5.7 +/- 0.9 kg (P less than 0.0001) in the group treated with growth hormone; neither changed significantly in the placebo group. The basal metabolic rate, measured at base line and after one and six months of rhGH administration, increased significantly; the respective values were 32.4 +/- 1.4, 37.2 +/- 2.2, and 34.4 +/- 1.6 kcal per kilogram of lean body mass per day (P less than 0.001 for both comparisons). Fasting plasma cholesterol levels were lower (P less than 0.05) in the rhGH-treated group than in the placebo group, whereas plasma triglyceride values were similar in the two groups throughout the study. We conclude that growth hormone has a role in the regulation of body composition in adults, probably through its anabolic and lipolytic actions.     

Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study

OBJECTIVE: To evaluate the efficacy and safety of oxandrolone in promoting body weight and body cell mass (BCM) gain in HIV-associated weight loss. METHODS: Randomized, double-blind, placebo-controlled trial. Two hundred sixty-two HIV-infected men with documented 10% to 20% weight loss or body mass index < or =20 kg/m were randomized to placebo or to 20, 40, or 80 mg of oxandrolone daily. After 12 weeks, subjects were allowed to receive open-label oxandrolone at a dose of 20 mg for another 12 weeks. RESULTS: Body weight increased in all groups, including the group receiving placebo, during the double-blind phase (1.1 +/- 2.7, 1.8 +/- 3.9, 2.8 +/- 3.3, and 2.3 +/- 2.9 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively; all P < 0.014 vs. baseline). BCM increased from baseline in all groups (0.45 +/- 1.7, 0.91 +/- 2.2, 1.5 +/- 2.5, and 1.8 +/- 1.8 kg in placebo and 20-, 40-, and 80-mg oxandrolone groups, respectively). At 12 weeks, only the gain in weight at the 40-mg dose of oxandrolone and the gain in BCM at the 40- and 80-mg doses of oxandrolone were greater than those in the placebo group, however. Oxandrolone treatment was associated with significant suppression of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and total and free testosterone levels. Treatment was generally well tolerated but accompanied by significant increases in transaminases and low-density lipoprotein as well as decreases in high-density lipoprotein. CONCLUSION: Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss.     

Water and small solute excretion in continuous peritoneal dialysis patients with lean body mass exceeding 90% of body weight as estimated from creatinine kinetics.

Lean body mass computed from creatinine kinetics (LBM) is an index of somatic nutrition and correlates with other nutrition indices in CAPD. However, LBM exceeding 90% of body weight (LBM/W > or = 0.9) may be an index of non-compliance, rather than nutrition. To test this hypothesis, we analyzed fluid and solute excretion in 40 CAPD patients with LBM/W > or = 0.9 (group A). The comparison group (group B) consisted of 885 CAPD patients with LBM/W < 0.9. Group A was younger (38.3+/-14.8 vs 54.7+/-14.7 yr) and had a lower percent of women (23.5% vs 41.1%) and diabetic subjects (17.5% vs 42.6%) than group B (at P < or = 0.019). Group A also had lower body mass index (22.7+/-2.7 vs 25.8+/-5.1 kg/m2, P <0.001) and serum albumin (33.0+/-6.7 vs 35.2+/-5.5 g/L, P = 0.014). Despite similar prescribed daily fill volumes (group A 8.3+/-2.4, group B 8.5+/-2.2 L/24 h) and similar D/P urea and creatinine values, group A had higher daily drain volume (11.0+/-3.6 vs 9.6+/-2.1 L/24 h, P < 0.001). Renal clearances were similar, while peritoneal and total clearances were apparently higher in group A. Creatinine excretion was higher in group A (27.4+/-5.1 vs 13.6+/-4.1 mg/kg x 24 h, P < 0.001), with a large part of the excess creatinine excretion in group A being accounted for by peritoneal excretion. The combination of an apparently high daily ultrafiltration volume (2.7 L/24 h on the average), unrealistically high creatinine excretion rate, and relatively poor nutrition (low body mass index and serum albumin) in group A is consistent with non-compliance. We suggest that the finding of LBM/W > or = 0.9 during a clearance study in CAPD should trigger an investigation for non-compliance.     

Recombinant Mammalian Cell-Derived Somatropin

Recombinant mammalian cell-derived somatropin (hereafter referred to as somatropin) is human growth hormone produced by recombinant DNA technology. Somatropin, an established treatment for growth hormone-deficient children of short stature, has recently been shown to have beneficial effects in adult patients with HIV-associated wasting. This condition is characterised by the preferential loss of lean body mass (LBM) with relative conservation of body fat. Somatropin produces protein anabolic and anticatabolic effects in patients with HIV-associated wasting. In HIV-infected male patients with this condition, increased nitrogen retention, decreased protein oxidation, increased lipid oxidation, increased bodyweight and increased resting energy expenditure were evident after treatment with subcutaneous somatropin 0.1 mg/kg/day for 7 days. Statistically significant increases in LBM, bodyweight (vs baseline and placebo) and work output (vs placebo) during treadmill exercise (a measure of physical function), and a significant decrease in body fat (vs baseline and placebo) occurred in similar patients who received somatropin for 12 weeks in a large double-blind randomised trial. These patients received concomitant antiretroviral therapy for the duration of the trial. Available data indicate that somatropin does not increase HIV replication in patients with HIV disease who are receiving concomitant antiretroviral medication. The inconclusive results of quality-of-life assessments in patients with HIV-associated wasting receiving treatment with somatropin may have been related to the lack of a suitable instrument for measuring quality of life in this patient population. Further investigation is required to definitively establish the effects of the drug on this outcome measure. Adverse events commonly observed with somatropin administered over 相似文献   

Value of measuring muscle performance to assess changes in lean mass with testosterone and growth hormone supplementation

We hypothesized that treatment with testosterone (T) and recombinant human growth hormone (rhGH) would increase lean mass (LM) and muscle strength proportionally and an in a linear manner over 16 weeks. This was a multicenter, randomized, controlled, double-masked investigation of T and rhGH supplementation in older (71 ± 4 years) community-dwelling men. Participants received transdermal T at either 5 or 10 g/day as well as rhGH at 0, 3.0 or 5.0 μg/kg/day for 16 weeks. Body composition was determined by dual-energy X-ray absorptiometry (DEXA) and muscle performance by composite one-repetition maximum (1-RM) strength and strength per unit of lean mass (muscle quality, MQ) for five major muscle groups (upper and lower body) at baseline, week 8 and 17. The average change in total LM at study week 8 compared with baseline was 1.50 ± 1.54 kg (P < 0.0001) in the T only group and 2.64 ± 1.7 (P < 0.0001) in the T + rhGH group and at week 17 was 1.46 ± 1.48 kg (P < 0.0001) in the T only group and 2.14 ± 1.96 kg (P < 0.0001) in the T + rhGH group. 1-RM strength improved modestly in both groups combined (12.0 ± 23.9%, P < 0.0001) at week 8 but at week 17 these changes were twofold greater (24.7 ± 31.0%, P < 0.0001). MQ did not significantly change from baseline to week 8 but increased for the entire cohort, T only, and T + rhGH groups by week 17 (P < 0.001). Despite sizeable increases in LM measurements at week 8, tests of muscle performance did not show substantive improvements at this time point.     

Increasing risk of 5% or greater unintentional weight loss in a cohort of HIV-infected patients, 1995 to 2003

Although the incidence of most AIDS-defining opportunistic infections, including HIV wasting syndrome, has dramatically decreased since the introduction of highly active antiretroviral therapy (HAART), previous studies have shown that weight loss and wasting are still common in HIV-infected persons. We examined the 6-month risk and determinants of > or =5% weight loss during the period when the use of combination antiretroviral therapy and HAART was commonplace among 713 participants enrolled in the Nutrition for Healthy Living cohort in Boston, Massachusetts between 1995 and 2003. There was a significant 50% increase in the 6-month risk of > or =5% weight loss in the later HAART years (1998-2003) compared with the early HAART years (1995-1997) among most of the participants who reported they were not trying to lose weight (P = 0.002). In addition to calendar time, several other variables were significantly independently associated with risk of > or =5% weight loss, including use of injection drugs; living below the federal poverty level; higher body mass index (BMI; > or =25 kg/m(2)); lower CD4 cell count; higher HIV viral load; and presence of diarrhea, nausea, or fever. The characteristics of weight loss in the later HAART years did not differ from the early HAART years with respect to initial body composition (eg, weight, BMI, triceps skinfold thickness) or changes in body composition during the periods of weight loss. In summary, we have found that the risk of > or =5% unintentional weight loss over 6-month intervals is on the rise in our cohort of HIV-infected participants, despite better control of HIV infection in recent years. Although we still do not know the exact cause of this increase, the fact that it exists indicates the need for clinicians who take care of HIV-infected patients to continue to pay attention to weight loss among particular segments of their patient population. This is particularly important because recent studies have shown that even a 5% weight loss in 6 months markedly increases the risk of death.     

Effects of weight, body composition, and testosterone on bone mineral density in HIV-infected women

Recent studies suggest that bone loss occurs among HIV-infected women. This study examined the effects of reduced androgen levels, changes in weight, body composition, and menstrual dysfunction on bone mineral density (BMD) among 152 HIV-infected women characterized by normal weight (>90% ideal body weight [IBW], n = 124) and low weight (相似文献   

Fat distribution in HIV-infected women in the United States: DEXA substudy in the Women's Interagency HIV Study

Surveys in HIV-infected men on antiretroviral therapy (ART) consistently demonstrate decreased levels of peripheral fat, with variable effects on central fat. This substudy of the Women's Interagency HIV Study was undertaken to examine fat distribution in a well-characterized cohort of HIV-positive and HIV-negative women in the United States. Whole-body dual-energy x-ray absorptiometry scanning with standardized regional analysis was performed in 271 nonpregnant women. Results were compared in the following groups: HIV negative (n = 88); and HIV positive on no ART (n = 70), highly active ART with a protease inhibitor (HAART/PI) (n = 48), or non-PI-containing HAART (n = 53). The groups were well matched with respect to race, with the majority of women coming from racial/ethnic minorities. The majority of both HIV-positive and HIV-negative women were overweight (body mass index [BMI] >/=25 kg/m), and many were obese (BMI >30 kg/m). Leg fat in both groups on HAART was significantly lower than in HIV-negative women (P = 0.01 and <0.0001 vs. HIV-negative for HAART/PI and HAART/no PI, respectively), whereas trunk fat was lower only in HAART/no PI (P = 0.0004 vs. HIV-negative). Thus, consistent with reports in men, lower levels of peripheral (leg) fat are seen in HIV-infected women on HAART, despite the high prevalence of obesity in this population.     

A randomized, controlled trial of theophylline in patients with severe chronic obstructive pulmonary disease

To assess the effects of theophylline in chronic obstructive pulmonary disease, we conducted a randomized, placebo-controlled, double-blind, crossover trial in 60 patients with severe but stable disease. The patients (mean age, 61 years) were studied before and after two months of placebo and two months of treatment with a sustained-release preparation of theophylline (10 mg per kilogram of body weight per day), administered orally. The two treatments were administered in a random order and separated by an eight-day washout period. After taking theophylline for two months (mean plasma concentration, 14.8 mg per liter), as compared with the two months of placebo, the patients had significant improvements in dyspnea, pulmonary gas exchange (partial pressure of arterial oxygen, 66 vs. 61 mm Hg [P less than 0.0001]; partial pressure of arterial carbon dioxide, 44 vs. 49 mm Hg [P less than 0.0001]), vital capacity (63 percent vs. 58 percent of the predicted value [P less than 0.0001]), and forced expiratory volume in one second (36 percent vs. 32 percent of the predicted value [P less than 0.0001]), with no significant change in airway resistance or functional residual capacity. Minute ventilation increased by a mean of 18 percent (P less than 0.0001) in the patients taking theophylline because of increased tidal volume, with no change in respiratory frequency. The respiratory-muscle performance of the patients taking theophylline improved by approximately 29 percent (P less than 0.0001), as indicated by a decline in the ratio of inspiratory pleural pressure during quiet breathing to maximal pleural pressure. We conclude that theophylline improves respiratory function and dyspnea in patients with severe chronic obstructive pulmonary disease and that these improvements are probably due to better respiratory-muscle performance.     

Weight loss and survival in HIV-positive patients in the era of highly active antiretroviral therapy

Weight loss and wasting have long been established as strong predictors of mortality in HIV-infected patients. Today, despite the effectiveness of highly active antiretroviral therapy (HAART), there is evidence that HIV-related wasting is still an important comorbidity in many patients. We conducted a study to determine if wasting is still associated with decreased survival in patients receiving HAART and which parameter (weight, fat-free mass [FFM], body cell mass [BCM], or fat mass [FM]) is most strongly associated with mortality. The study population consisted of 678 HIV-positive participants enrolled in the Nutrition for Healthy Living study. Weight, FFM, BCM, and FM were assessed for all participants at 6-month intervals. At each follow-up visit, percent losses of each parameter were calculated from values at baseline and the previous visit. Cox proportional hazards models were used to estimate and compare the relative risks of death for each parameter, adjusting for potential confounders such as HAART use, body mass index, and CD4 cell counts. In analyses examining the parameters separately and together in the same model, weight loss emerged as the strongest independent predictor of mortality. Weight loss of >or=10% from baseline or the previous visit was significantly associated with a four- to sixfold increase in mortality compared with maintenance or gaining of weight. Even one episode of weight loss of >or=3% from baseline or >or=5% from the previous visit was predictive of mortality. In summary, despite the apparent benefits of HAART use on HIV-related survival, weight loss remains an independent predictor of mortality. In addition, FFM or BCM estimated using bioelectrical impedance analysis does not add further prognostic value over weight loss.     

Spotlight on Mammalian Cell-Derived Somatropin in HIV-Associated Wasting

HIV-associated wasting, characterized by progressive loss of lean body mass and bodyweight, remains a significant problem in the era of highly active antiretroviral therapy. Loss of body cell mass, a component of lean body mass, is associated with decreased survival. Somatropin (recombinant human growth hormone) derived from mammalian cells (Serostim) is the only US FDA-approved treatment indicated to increase lean body mass, bodyweight, and physical endurance in HIV-associated wasting. Somatropin 0.1 mg/kg/day administered subcutaneously for 12 weeks effectively increased work output, bodyweight, and lean body mass, and improved health-related quality of life, compared with placebo, and had a generally manageable tolerability profile in a large randomized study in patients with HIV-associated wasting. Potential areas for further research include determination of longer-term efficacy and tolerability, the cost effectiveness of treatment, the optimal somatropin dosage, management of patients after 12 weeks' therapy, and whether maintenance strategies might exist to maintain accrued lean body mass with lower doses of somatropin. Nevertheless, indications to date are that somatropin is likely to have an important role in the treatment of patients with HIV-associated wasting.     

Different response of body weight change according to ketonuria after fasting in the healthy obese

The relationship between obesity and ketonuria is not well-established. We conducted a retrospective observational study to evaluate whether their body weight reduction response differed by the presence of ketonuria after fasting in the healthy obese. We used the data of 42 subjects, who had medical records of initial urinalysis at routine health check-up and follow-up urinalysis in the out-patient clinic, one week later. All subjects in the initial urinalysis showed no ketonuria. However, according to the follow-up urinalysis after three subsequent meals fasts, the patients were divided into a non-ketonuria group and ketonuria group. We compared the data of conventional low-calorie diet programs for 3 months for both groups. Significantly greater reduction of body weight (-8.6 ± 3.6 kg vs -1.1 ± 2.2 kg, P < 0.001), body mass index (-3.16 ± 1.25 kg/m(2) vs -0.43 ± 0.86 kg/m(2), P < 0.001) and waist circumference (-6.92 ± 1.22 vs -2.32 ± 1.01, P < 0.001) was observed in the ketonuria group compared to the non-ketonuria group. Fat mass and lean body mass were also more reduced in the ketonuria group. In addition, serum free fatty acid concentration after intervention in the ketonuria group showed significant more increment than in the non-ketonuria group. The presence of ketonuria after fasting may be a predicting factor of further body weight reduction.     

Effects of growth hormone on abnormal visceral adipose tissue accumulation and dyslipidemia in HIV-infected patients

BACKGROUND: Some HIV-infected patients develop fat maldistribution with visceral adipose tissue (VAT) accumulation and metabolic abnormalities. No medical treatment is approved by the US Food and Drug Administration to reduce VAT. METHODS: In this double-blind trial, 245 HIV-infected patients with excess VAT were randomized to receive placebo (PL), recombinant human growth hormone (r-hGH) at a dose of 4 mg daily (DD) or 4 mg on alternate days (AD) for 12 weeks. For weeks 12 to 24, DD patients were rerandomized to PL (DD-PL) or AD (DD-AD), AD patients continued on AD (AD-AD), and PL patients were switched to DD (PL-DD). RESULTS: From baseline to week 12, VAT decreased significantly compared with PL in DD (-8.6%, P < 0.001) but not in AD (-4.2%, P = 0.052). Trunk-to-limb fat ratio decreased significantly in both (P < 0.001) compared with PL, as did total cholesterol and non-high-density lipoprotein (HDL) cholesterol (-4.5% and -7.5% in DD, -4.3% and -6.2% in AD). At week 24, all groups displayed significant (P < 0.05) reductions in VAT (-5.3% to -9.5%) and trunk fat (-7.8% to -22.8%). DD-AD and AD-AD also displayed significant (P < 0.05) reductions in non-HDL cholesterol. CONCLUSIONS: These results suggest that r-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT. The optimal regimen to sustain these effects awaits determination.     

Building your body to survive: the use of anabolic steroids for HIV therapy

The loss of lean body mass (LBM) that is commonly associated with wasting syndrome has been linked to death in HIV disease. Bioelectrical Impedance Analysis (BIA) is a simple, inexpensive and painless technique used to assess body composition. The test gives a good reading of body cell mass, fat mass, and body water, and can be used to detect loss of LBM when it first occurs. BIA is a useful tool in managing and preventing wasting. Other factors that influence LBM include testosterone levels and anabolic steroids. Anabolic steroids, synthetic analogs of testosterone, are a Class III regulated drug. The use of anabolic steroids is controversial, and abuse by athletes led to the drugs being banned for many uses. A list of approved steroids, their actions, and potential problems associated with their use is included. Another table rates the major steroids for their effectiveness in AIDS therapy.     

Changes in body habitus and serum lipid abnormalities in HIV-positive women on highly active antiretroviral therapy (HAART).

Twenty-one women (propositi) who expressed serious concerns about changes in body habitus during highly active antiretroviral therapy (HAART) were evaluated by thorough physical examination, anthropometric measurements, and serum lipid and endocrine assays. The same evaluations were carried out in a comparison group of 21 women who received HAART but did not complain of changes in habitus. No significant demographic differences were found between the propositi and the comparison group, nor were there significant differences in CD4 count or plasma viral load (PVL) between the two groups. Lipid analyses were also performed on plasma obtained prior to HAART from 12 of the women. The frequency of changes reported by the 21 propositi were increase in abdominal size (90%), increase in breast size (71%), weight gain of >5 kg (43%), peripheral fat wasting (43%), buttock fat wasting (38%) and development of cervicodorsal fat pad (19%). A subset of patients in the comparison group experienced increase in abdominal size (29%) and weight gain >5 kg (19%), but none experienced clinically detectable peripheral or buttock fat wasting, increased breast size, or development of cervicodorsal fat pads. Mean waist circumference, waist-to-hip ratios (WHR), body fat, and body mass index (BMI) were above the desirable range for women in both propositi and the comparison group. Levels of total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol associated with increased cardiovascular risk were found in 48%, 62%, 45%, and 33%. respectively, of the propositi, with similar findings in the comparison group. Fasting insulin levels were elevated in 4 propositi and 6 of the comparison group; mean insulin levels were within the normal range for both groups. In the comparison of lipids for the subset of patients before and after HAART therapy, HAART was associated with significant increases in total cholesterol, apolipoprotein B, and HDL cholesterol. Changes in body habitus caused by redistribution of fat occur commonly in women receiving HAART. Serum lipid abnormalities also are common during HAART and appear to be as frequent in women who do not experience clinically apparent body fat redistribution as in those who do. The observed changes in body fat distribution and in serum lipid levels are alterations that have been strongly correlated with increased risk for cardiovascular disease. Therefore, an understanding of the basis of these phenomena, and the risks with which they may be associated in this population, will be important for therapeutic decision making in women with HIV disease.     

Body composition changes during lactation in HIV-infected and HIV-uninfected South African women

BACKGROUND: The nutritional consequences of HIV infection in lactating women are unknown. OBJECTIVE: To measure the body composition of South African lactating women in relation to HIV status. METHODS: Fat-free mass (FFM) and fat mass (FM) using bioimpedance spectrometry (BIS) and anthropometric measurements were obtained at 8 and 24 weeks postpartum in 92 HIV-infected (HIVpos) and 50 HIV-uninfected (HIVneg) lactating mothers. RESULTS: At 8 weeks, HIVpos and HIVneg mothers were not significantly different in height (159.7 vs. 158.9 cm), weight (62.7 vs. 63.9 kg), body mass index (BMI; 24.6 vs. 25.3 kg/m), FFM (40.7 vs. 42.8 kg), or FM (21.6 vs. 22.0 kg), respectively. In HIVpos women, the median CD4 count was 621 (range: 101-1585) cells/muL; 95% had CD4 counts >200 cells/muL. Between 8 and 24 weeks, HIVpos mothers had a mean weight loss of 1.4 kg in contrast to a 0.4-kg weight gain in HIVneg mothers (P < 0.01). There were no significant group differences with regard to change in FFM (0.3 vs. 0.1 kg; P = 0.9) and FM (-1.5 vs. -0.3 kg; P = 0.2). CONCLUSION: HIVpos South African breast-feeding mothers without severe immune suppression lost weight and subcutaneous fat between 8 and 24 weeks postpartum, whereas HIVneg mothers gained weight. FFM was maintained postpartum in HIVpos and HIVneg mothers.     

Effectiveness of green tea on weight reduction in obese Thais: A randomized, controlled trial

This study was undertaken to investigate the effects of green tea on weight reduction in obese Thais. A randomized, controlled trial involving 60 obese subjects (body mass index, BMI > 25 kg/m2) was conducted. All subjects consumed a Thai diet containing 3 meals (8373.6 kJ/day) for 12 weeks, prepared by the Nutritional Unit at Srinagarind Hospital. The diet contained 65% carbohydrates, 15% protein, and 20% fat. Body weight, BMI, body composition, resting energy expenditure, and substrate oxidation were measured at baseline, and during weeks 4, 8, and 12 of the study. Serum levels of leptin and urine VMA were measured at baseline and during the 12th week. Differences over time and between the treatments (green tea or placebo) over time were determined using two-factor ANOVA with repeated measures. In comparing the two groups, differences in weight loss were 2.70, 5.10, and 3.3 kg during the 4th, 8th, and 12th weeks of the study, respectively. At the 8th and 12th weeks of the study, body weight loss was significantly different (P < 0.05). At the 8th week, the difference in resting energy expenditure was 183.38 kJ/day (P < 0.001), the difference in the respiratory quotient was 0.02 (P < 0.05), and no significant differences existed in satiety score, food intake, or physical activity. Urine VMA was significantly different in the 12th week of the study (P < 0.05). We conclude that green tea can reduce body weight in obese Thai subjects by increasing energy expenditure and fat oxidation.     

Randomized, double-blind six-month trial of prednisone in Duchenne's muscular dystrophy

We performed a randomized, double-blind, controlled six-month trial of prednisone in 103 boys with Duchenne's muscular dystrophy (age, 5 to 15 years). The patients were assigned to one of three regimens: prednisone, 0.75 mg per kilogram of body weight per day (n = 33); prednisone, 1.5 mg per kilogram per day (n = 34); or placebo (n = 36). The groups were initially comparable in all measures of muscle function. Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function. Improvement began as early as one month and peaked by three months. At six months the high-dose prednisone group, as compared with the placebo group, had improvement in the time needed to rise from a supine to a standing position (3.4 vs. 6.2 seconds), to walk 9 m (7.0 vs. 9.7 seconds), and to climb four stairs (4.0 vs. 7.1 seconds), in lifting a weight (2.1 vs. 1.2 kg), and in forced vital capacity (1.7 vs. 1.5 liters) (P less than 0.001 for all comparisons). There was an increase in urinary creatinine excretion (261 vs. 190 mg per 24 hours), which suggested an increase in total muscle mass. However, the prednisone-treated patients who had required long-leg braces (n = 5) or wheelchairs (n = 11) continued to require them. The most frequent side effects were weight gain, cushingoid appearance, and excessive hair growth. We conclude from this six-month study that prednisone improves the strength and function of patients with Duchenne's muscular dystrophy. However, further research is required to identify the mechanisms responsible for these improvements and to determine whether prolonged treatment with corticosteroids may be warranted despite their side effects.     

Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study

BackgroundAtopic dermatitis (AD) is associated with a substantial burden on quality of life (QoL).ObjectiveTo evaluate the effects of tralokinumab on health-related QoL in patients with moderate-to-severe AD using patient-reported outcomes.MethodsThis was a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study in adults with moderate-to-severe AD. The patients received subcutaneous tralokinumab or placebo (1:1:1:1) every 2 weeks for 12 weeks and class 3 topical corticosteroid cream or ointment at least once daily from the run-in to end of follow-up. Patient-reported outcome end points were change from baseline to week 12 in the Dermatology Life Quality Index (dermatology life quality index (DLQI); prespecified secondary objective), the Short Form 36 Health Survey (SF-36) version 2, and sleep interference numeric rating scale score (prespecified exploratory objectives).ResultsA total of 204 patients were randomized to placebo (n = 51) or tralokinumab (45 mg, n = 50; 150 mg, n = 51; 300 mg, n = 52). Tralokinumab 300 mg every 2 weeks improved total Dermatology Life Quality Index vs placebo at week 12 (placebo-adjusted mean change, ?3.51 [95% confidence interval, ?6.00 to ?1.02]). At week 12, both the mental component summary (4.23 [0.98-7.47]) and the physical component summary (4.26 [1.83-6.69]) and all 8 domains of the Short Form 36 Health Survey were improved in patients treated with tralokinumab 300 mg vs placebo. Sleep interference was improved at week 12 with all tralokinumab doses vs placebo.ConclusionTralokinumab improved health-related QoL in patients with moderate-to-severe atopic dermatitis, providing further evidence of the value of targeting interleukin-13 in such patients.Trial RegistrationClinicalTrials.gov identifier: NCT02347176; https://clinicaltrials.gov/ct2/show/NCT02347176.