Significant Difference In Weight Change Research Articles

Effects of calcium supplementation on body weight: a meta-analysis

Whether calcium supplementation can reduce body weight and prevent obesity remains unclear because of inconsistent reports. We performed a meta-analysis to investigate the correlations between calcium supplementation and changes in body weight on the basis of age, sex, body mass index (BMI) of the subjects, and length of calcium intervention. PubMed, EMBASE, Web of Knowledge, and China National Knowledge Infrastructure databases were systematically searched to select relevant studies that were published from January 1994 to March 2016. Both randomized controlled trials and longitudinal studies of calcium supplementation were included, and random- or fixed-effects models in a software program were used for the data analysis. Thirty-three studies involving a total of 4733 participants were included in this meta-analysis. No significant differences in weight changes were shown between calcium intervention and control groups (mean: -0.01 kg; 95% CI -0.02, 0.00 kg; P = 0.12). However, negative correlations between calcium supplementation and weight changes were shown in children and adolescents (mean: -0.26 kg; 95% CI: -0.41, -0.11 kg; P < 0.001) and in adult men and either premenopausal or old (>60 y of age) women (mean: -0.91 kg; 95% CI: -1.38, -0.44 kg; P < 0.001) but not in postmenopausal women (mean: -0.14 kg; 95% CI: -0.54, 0.26 kg; P = 0.50). When BMI was considered, a negative correlation between calcium supplementation and weight changes was observed in subjects with normal BMI (mean: -0.53 kg; 95% CI: -0.89, -0.16 kg; P = 0.005) but not in overweight or obese subjects (mean: -0.35 kg; 95% CI: -0.81, 0.11 kg; P = 0.14). Compared with the control groups, no differences in weight changes were shown in the calcium-intervention groups when the lengths of calcium interventions were <6 mo (mean: -0.09 kg; 95% CI: -0.45, 0.26 kg; P = 0.60) or ≥6 mo (mean: -0.01 kg; 95% CI: -0.02, 0.01 kg; P = 0.46). Increasing calcium intake through calcium supplements can reduce body weight in subjects who have a normal BMI or in children and adolescents, adult men, or premenopausal women.

Probiotics for the control of obesity – Its effect on weight change

Obesity is a growing epidemic worldwide. Evidence so far demonstrates that the bacteria that are commonly found in the human gastrointestinal tract affect nutrient acquisition and energy regulation. This suggests that an important role is played by gut microbiota in the development of obesity. Our main goal was to assess if a probiotic diet leads to a significant difference in weight change in non-obese and obese people, and in experimental models. Search was undertaken in PubMed, Scopus, ISI Web of knowledge, Cochrane Central Register of Controlled Trials, Google scholar, meta-Register of Controlled Trials, ClinicalTrials.gov and by scanning reference lists of articles, without publication date imposed, for randomised clinical trials studying the administration of probiotics to obese or overweight patients and experimental studies in experimental models and healthy humans. Search terms included probiotics, obesity, weight, BMI, weight gain, weight loss, weight change, probiotic diet and probiotic therapy. In an unblended standardized manner, 2 reviewers analysed the searched studies, using the defined inclusion and exclusion criteria, and performed extraction of data, in an independent way, using predefined data fields. We've identified, through searching databases specified in methods, 269 records. A total of 4 clinical trials and 14 experimental studies were included in the systematic review. Among the 4 randomized clinical trials only one showed statistically significant results. L. rhamnosus CGMCC 1.3724 was efficient in reducing weight in females, but not in males - Mean weight loss 12 week/24 week (kg): Males-probiotic: 4/5.4; Males-placebo: 3.05/4.43; Females-probiotic: 4.4/5.2; Females- placebo: 2.6/2.5 (P<0.05 only on females). In our systematic review, we found that probiotic effect in body weight is specie and strain specific. L. gasseri BNR17, reduced the weight gain compared to controls; L. gasseri L66-5 promoted weight gain, L. rhamnosus GGMCC is the only one that had a positive effect in weight loss in humans. Probiotic effect in body weight was species and strain specific. On the other hand L. plantarum LG42, L. gasseri SBT2055 and L. plantarum co-therapy with KY103 and L. curvatus HY7601 had an anti-obesity effect in animal models.

Abstract P4-14-24: Optimization of intermittent high dose lapatinib administration with or without capecitabine: A rational approach to drug dosing and scheduling using Norton-Simon modeling

Abstract Background: Systemic treatment of central nervous system (CNS) metastases remains a challenge partially due to poor drug penetration. Lapatinib and capecitabine are drugs with modest efficacy in treatment of brain metastases from HER2-positive (+) breast cancer (BC) and were shown to cross the blood-tumor barrier in clinical craniotomy specimens (Lin N et al., CCR 2009, Morikawa A et al., Neuro Oncol 2015). However, intratumoral drug concentrations observed were sub-optimal and heterogeneous. Administration of shorter-duration, high dose tyrosine kinase inhibitor is proposed as a way to improve efficacy and tolerability based on Norton-Simon modeling and drug exposure in the CNS (Traina T et al., JCO 2008, Grommes C et al., Neuro Oncol 2011, Chien AJ et al., J Clin Oncol 2014) . In this study, we examined optimization of high dose lapatinib administration with or without capecitabine to inform the design of a phase I trial for BC patients with HER2+ CNS metastases. Methods: Mice bearing BT-474 BC xenograft tumors were treated with various lapatinib doses and schedules. A standard continuous daily dose (100mg/kg) was compared to various intermittent dosing schedules (at 100mg/kg, 400mg/kg, and 800mg/kg). In addition, high dose lapatinib (800mg/kg) was administered with capecitabine either concurrently or in tandem. Xenografts were treated when tumors reached 100mm3. Tumor volumes were evaluated for antitumor efficacy, and mice weights were measured for toxicity. Significance testing for between-group comparisons was conducted using a mixed effect model for repeated measures. Results: Intermittent schedules of lapatinib at 100mg/kg given as 3 days on/11 days off (3/11), 5 days on/9 days off (5/9), and 7 days on/7days off (7/7) had a similar efficacy in tumor control: percent change in tumor volume of 225% (7/7), 222% (5/9), and 223% (3/11) (NS). Therefore, the 3 days on (with 4 days off or 11 days off ) schedule was subsequently chosen to evaluate for tolerability and antitumor efficacy of higher lapatinib dose. The 3 days on/4 days off (3/4) group at 800mg/kg demonstrated the highest tumor reduction (-69%) compared to the daily continuous dosing group (-18%) (p=0.04), but a trend toward higher toxicity was observed (p=0.12). Evaluation of concurrent vs. tandem administration of capecitabine with lapatinib at 800mg/kg given in 3 days on/11 days off was conducted. The concurrent treatment was discontinued early due to high toxicity. However, tandem administration of capecitabine with high dose lapatinib was tolerable without a significant difference in weight changes (p=0.62). Conclusions: The intermittent schedule allows delivery of high dose lapatinib, which has better anti-tumor activity than standard continuous dosing. If given intermittently, high dose lapatinib is tolerable, even with capecitabine if given in tandem/sequence. Based on the result of these experiments, a phase I trial of high dose lapatinib using 3 days on/11 days off schedule in tandem with capecitabine is currently proposed for treatment of HER2-positive BC patient with CNS metastases. Citation Format: Morikawa A, De Stanchina E, Patil S, Chandarlapaty S, Li BT, Norton L, Seidman AD. Optimization of intermittent high dose lapatinib administration with or without capecitabine: A rational approach to drug dosing and scheduling using Norton-Simon modeling. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-14-24.

Preoperative factors and 3-year weight change in the Longitudinal Assessment of Bariatric Surgery (LABS) consortium

BackgroundLimited data guide the prediction of weight loss success or failure after bariatric surgery according to presurgery factors. There is significant variation in weight change after bariatric surgery and much interest in identifying preoperative factors that may contribute to these differences. This report evaluates the associations of a comprehensive set of baseline factors and 3-year weight change. Setting: Ten hospitals in 6 geographically diverse clinical centers in the United States. MethodsAdults undergoing a first bariatric surgical procedure as part of clinical care by participating surgeons were recruited between 2006 and 2009. Participants completed research assessments utilizing standardized and detailed data collection on over 100 preoperative and operative parameters for individuals undergoing Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB). Weight was measured 3 years after surgery. Percent weight change for RYGB or LAGB from baseline to 3 years was analyzed as both a continuous and dichotomous outcome with cut points at 25% for RYGB and 10% for LAGB. Multivariable linear and logistic regression models were used to identify independent baseline predictors of the continuous and categorical outcomes, respectively. ResultsThe median weight loss 3 years after surgery for RYGB (n = 1513) participants was 31.5% (IQR: 24.6%–38.4%; range, 59.2% loss to .9% gain) of baseline weight and 16.0% (IQR: 8.1%–23.1%; range, 56.1% loss to 12.5% gain) for LAGB (n = 509) participants. The median age was 46 years for RYGB and 48 years for LAGB; 80% of RYGB participants and 75% of LAGB participants were female; and the median baseline body mass index (BMI) was 46 kg/m2 for RYGB and 44 kg/m2 for LAGB. For RYGB, black participants lost 2.7% less weight compared with whites and participants with diabetes at baseline had 3.7% less weight loss at year 3 than those without diabetes at baseline. There were small but statistically significant differences in weight change for RYGB in those with abnormal kidney function and current or recent smoking. For LAGB participants, those with a large band circumference had 75% greater odds of experiencing less than 10% weight loss after adjusting for BMI and sex. ConclusionsFew baseline variables were associated with 3-year weight change and the effects were small. These results indicate that baseline variables have limited predictive value for an individual’s chance of a successful weight loss outcome after bariatric surgery.Trial registration: NCT00465829, ClinicalTrials.gov.

Ursodeoxycholic acid for cystic fibrosis-related liver disease.

Abnormal biliary secretion leads to the thickening of bile and the formation of plugs within the bile ducts; the consequent obstruction and abnormal bile flow ultimately results in the development of cystic fibrosis-related liver disease. This condition peaks in adolescence with up to 20% of adolescents with cystic fibrosis developing chronic liver disease. Early changes in the liver may ultimately result in end-stage liver disease with people needing transplantation. One therapeutic option currently used is ursodeoxycholic acid. To analyse evidence that ursodeoxycholic acid improves indices of liver function, reduces the risk of developing chronic liver disease and improves outcomes in general in cystic fibrosis. We searched the Cochrane CF and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also contacted drug companies.Date of the most recent search of the Group's trials register: 29 May 2014. Randomised controlled trials of the use of ursodeoxycholic acid for at least three months compared with placebo or no additional treatment in people with cystic fibrosis. Two authors independently assessed trial eligibility and quality. Ten trials have been identified, of which three trials involving 118 participants were included; the dose of ursodeoxycholic acid ranged from 10 to 20 mg/kg/day for up to 12 months. The complex design used in two trials meant that data could only be analysed for subsets of participants. There was no significant difference in weight change, mean difference -0.90 kg (95% confidence interval -1.94 to 0.14) based on 30 participants from two trials. Improvement in biliary excretion was reported in only one trial and no significant change after treatment was shown. There were no data available for analysis for long-term outcomes such as death or need for liver transplantation. There are few trials assessing the effectiveness of ursodeoxycholic acid. There is insufficient evidence to justify its routine use in cystic fibrosis.

Effectiveness of a physical activity and weight loss intervention for middle-aged women: healthy bodies, healthy hearts randomized trial.

Physical inactivity is a significant risk factor for cardiovascular disease and remains highly prevalent in middle-aged women. We hypothesized that an interventionist-led (IL), primary-care-based physical activity (PA) and weight loss intervention would increase PA levels and decrease weight to a greater degree than a self-guided (SG) program. We conducted a randomized trial. Ninety-nine inactive women aged 45-65 years and with BMI ≥ 25 kg/m(2) were recruited from three primary care clinics. The interventionist-led (IL) group (n = 49) had 12 weekly sessions of 30 min discussions with 30 min of moderate-intensity PA. The self-guided (SG) group (n = 50) received a manual for independent use. Assessments were conducted at 0, 3, and 12 months; PA and weight were primary outcomes. Weight was measured with a standardized protocol. Leisure PA levels were assessed using the Modifiable Activity Questionnaire. Differences in changes by group were analyzed with a t-test or Wilcoxon rank-sum test. Mixed models were used to analyze differences in changes of outcomes by group, using an intention-to-treat principle. Data from 98 women were available for analysis. At baseline, mean (SD) age was 53.9 (5.4) years and 37 % were black. Mean weight was 92.3 (17.7) kg and mean BMI was 34.7 (5.9) kg/m(2). Median PA level was 2.8 metabolic equivalent hours per week (MET-hour/week) (IQR 0.0, 12.0). At 3 months, IL women had a significantly greater increase in PA levels (7.5 vs. 1.9 MET-hour/week; p = 0.02) than SG women; there was no significant difference in weight change. At 12 months, the difference between groups was no longer significant (4.7 vs. 0.7 MET-hour/week; p = 0.38). Mixed model analysis showed a significant (p = 0.048) difference in PA change between groups at 3 months only. The IL intervention was successful in increasing the physical activity levels of obese, inactive middle-aged women in the short-term. No significant changes in weight were observed.

Outcome Analysis of Hemoglobin A1c, Weight, and Blood Pressure in a VA Diabetes Education Program

ObjectiveTo determine the effect of a specific diabetes education class (Basics) on hemoglobin A1c values, weight, and systolic blood pressure. DesignIn this retrospective study, the researchers compared 2 groups of male veterans with a recent diagnosis of type 2 diabetes. One group received diabetes group education (n = 175) over a 4-month period, and the other received standard diabetes management follow-up (n = 184). SettingOutpatient clinic setting in the Midwest. InterventionsBasics class compared with standard level of care. Main Outcome MeasuresPre- and post-laboratory values for hemoglobin A1c, weight, and systolic blood pressure. AnalysisMultivariate analysis of covariance and follow-up univariate statistics for significant differences. ResultsFindings revealed significant differences in hemoglobin A1c (P < .001) and weight (P < .001) in the treatment group compared with the control group. No significant difference was found in systolic blood pressure readings between the 2 groups. There was a significant difference in weight change between groups, with the treatment group demonstrating greater weight loss. Conclusions and ImplicationThere was an association between participation in the Basics diabetes education curriculum and reduction of hemoglobin A1c values. Some participants also had added benefit of significant weight loss.

A pilot study of endoluminal US for stool liquefaction

There is a need to cleanse patients who are poorly prepared for colonoscopy safely and efficiently during the procedure to minimize rescheduling. US is already being used in catheter-based intravascular thrombolysis, and time-reversal acoustic (TRA) has been explored in assisting drug delivery to the brain. To explore the efficacy and safety of a miniaturized endoluminal US device in stool dissolution as a means to salvage poor bowel preparation. Proof of concept experimental study. Animal laboratory. Low-frequency US and TRAs. Feasibility, efficacy, and safety of US to liquefy stools exvivo. Depending on parameters, such as pulse rate, acoustic intensity, and duration, increases in liquefaction speeds by a factor of 50 and 100 times were obtained. There was a significant difference in weight change between the 20-kHz-treated sample compared with controls (P≤ .0001). There was no difference in sloughing of mucosa and mechanical injury among the US, water spray, and control groups. Animal model. Endoluminal US can liquefy stools at acoustic exposure levels that do not damage exvivo colonic mucosa. Endoluminal US should be able to dissolve stools more rapidly than water spray alone, thereby optimizing colonoscopic evaluation invivo.

Restricting night-time eating reduces daily energy intake in healthy young men: a short-term cross-over study

Few experimental data are available to support the notion that reducing night-time eating changes total daily energy intake (EI) or body weight in healthy adults. The present study primarily examined the short-term effect of night eating restriction (NER) on daily EI in healthy young men. It secondarily examined body weight and moods associated with NER. Using a cross-over design, twenty-nine men (20·9 (sd 2·5) years; 24·4 (sd 2·5) kg/m²) initiated a 2-week NER intervention (elimination of EI from 19.00 to 06.00 hours) and a 2-week control condition, counterbalanced and separated by a 1-week washout period. EI and macronutrient intake were assessed using computerised, multiple-pass 24 h food recalls, body weight via a digital scale and mood using the Profile of Mood States survey. Of the twenty-nine participants, twenty-seven (93 %) completed all aspects of the study. During the NER condition, the participants consumed less total energy per d than during the control condition (10 125 v. 11 146 kJ/d; F= 6·41; P= 0·018). During the NER condition, no energy was reported consumed between 19.00 and 06.00 hours; however, during the control condition, the energy intake of participants was 2920 (sd 1347) kJ/d between 19.00 and 06.00 hours. There was a significant difference in weight change between the NER (-0·4 (sd 1·1) kg) and control (+0·6 (sd 0·9) kg) conditions (F= 22·68; P< 0·001). Differences in total mood score or mood subscales between the NER and control conditions were not apparent (P>0·05). These findings provide support for NER decreasing short-term EI in healthy young men.

Weight Management Interventions Targeting Young Women: A Systematic Review

Young women are at high risk of weight gain. The aim of this systematic review was to evaluate randomized controlled trials of weight management interventions specifically targeting young women. Nine databases were searched for randomized controlled trials conducted from 1980 to December 2011 that recruited women aged 18 to 35 years, evaluated a weight management intervention, and reported weight as the primary outcome. Eight studies of moderate to poor quality met the inclusion criteria. Three interventions were specifically designed for young women and compared behavioral weight gain prevention interventions to control groups. Four of the five remaining studies evaluated weight gain prevention interventions, including daily weighing with feedback (n=2), a science course (n=1), and an exercise programs (n=1). The single weight loss intervention lowered the energy density of the participants' diet (n=1). Intervention lengths ranged from 4 weeks to 1 year, and only three studies followed-up with participants after the intervention. Retention rates ranged from 54% to 100% at post-intervention follow-up, with over half of the studies' retention rates <80%. Five studies reported significant differences in weight change in the intervention group (−1.9 kg to +0.1 kg) compared with controls (−0.2 kg to +3.1 kg) after the intervention. The available evidence suggests weight management interventions targeting young women are limited in number and quality and are highly heterogeneous. Therefore, their overall effectiveness cannot be established at this time. High-quality randomized controlled trials evaluating interventions that are tailored to the unique needs of young women, and that can be disseminated broadly, are urgently needed to address the unmet needs of this high-risk group.

Evaluation of the Effect of Two Systemic Doses of HESA-A on Prevention of Induced Tongue Neoplasm in Rats.

Background and aims. The aim of the present study was to compare the inhibitory effects of two systemic doses of HESA-A on prevention of 4-NQO-induced tongue neoplasms in rats. This study evaluated weight and histopathological changes. Materials and methods. Forty-eight male Sprague Dawley rats were divided into four groups of A, B, C and D of each 12 rats. The rats in groups B to D received 30 ppm of 4-Nitroquinoline-1-oxide (4-NQO) in drinking water for 12 weeks. When feeding with 4-NQO was initiated, the rats in groups B and C received HESA-A at doses of 250 and 500 mg/kg, respectively, 3 times a week. Body weights were measured three times a week. At the end, the rats were euthanized and the tongue was removed. Histological evaluations for carcinogenesis were carried out under a light microscope. Results. The mean body weights of rats in groups B, C and D were significantly lower than that in group A (P < 0.05). There were no significant differences in weight changes between groups B, C and D. In the present study, after 12 weeks of treatment, Tongue specimens in groups B and C did not exhibit severe dysplastic changes; however, concurrent hyperplasia, without atypia and mild-to-moderate dysplastic changes were detected. These changes were significantly less than those in group D, with significant differences between group D and groups A, B and C (P<0.001, P<0.01 and P<0.05, respectively). Conclusion. HESA-A has dose-dependent inhibitory effects on the development of neoplasms of the tongue.

Clinical consequences of switching from olanzapine to risperidone and vice versa in outpatients with schizophrenia: 36-month results from the worldwide schizophrenia outpatients health outcomes (W-SOHO) study

BackgroundWith many atypical antipsychotics now available in the market, it has become a common clinical practice to switch between atypical agents as a means of achieving the best clinical outcomes. This study aimed to examine the impact of switching from olanzapine to risperidone and vice versa on clinical status and tolerability outcomes in outpatients with schizophrenia in a naturalistic setting.MethodsW-SOHO was a 3-year observational study that involved over 17,000 outpatients with schizophrenia from 37 countries worldwide. The present post hoc study focused on the subgroup of patients who started taking olanzapine at baseline and subsequently made the first switch to risperidone (n=162) and vice versa (n=136). Clinical status was assessed at the visit when the first switch was made (i.e. before switching) and after switching. Logistic regression models examined the impact of medication switch on tolerability outcomes, and linear regression models assessed the association between medication switch and change in the Clinical Global Impression-Schizophrenia (CGI-SCH) overall score or change in weight. In addition, Kaplan-Meier survival curves and Cox-proportional hazards models were used to analyze the time to medication switch as well as time to relapse (symptom worsening as assessed by the CGI-SCH scale or hospitalization).Results48% and 39% of patients switching to olanzapine and risperidone, respectively, remained on the medication without further switches (p=0.019). Patients switching to olanzapine were significantly less likely to experience relapse (hazard ratio: 3.43, 95% CI: 1.43, 8.26), extrapyramidal symptoms (odds ratio [OR]: 4.02, 95% CI: 1.49, 10.89) and amenorrhea/galactorrhea (OR: 8.99, 95% CI: 2.30, 35.13). No significant difference in weight change was, however, found between the two groups. While the CGI-SCH overall score improved in both groups after switching, there was a significantly greater change in those who switched to olanzapine (difference of 0.29 points, p=0.013).ConclusionOur study showed that patients who switched from risperidone to olanzapine were likely to experience a more favorable treatment course than those who switched from olanzapine to risperidone. Given the nature of observational study design and small sample size, additional studies are warranted.

Effectiveness of male-only weight loss and weight loss maintenance interventions: A systematic review with meta-analysis

Summary The objectives of this systematic review were to investigate the effectiveness of male-only weight loss and weight loss maintenance interventions and to identify intervention characteristics associated with effectiveness. In May 2011, a systematic literature search with no date restrictions was conducted across eight databases. Twenty-four articles describing 23 studies met the eligibility criteria. All studies included a weight loss intervention and four studies included an additional weight loss maintenance intervention. Study quality was mostly poor for weight loss studies (median = 3/10, range = 1–9) and weight loss maintenance studies (median = 3.5/10, range = 1–6). Twenty-three of 31 individual weight loss interventions (74%) from the eligible studies were considered effective. Meta-analysis revealed a significant difference in weight change favouring weight loss interventions over no-intervention controls at the last reported assessment (weighted mean difference −5.66 kg [−6.35, −4.97], Z = 16.04 [P 2.7 contacts/month), group face-to-face contact and inclusion of a prescribed energy restriction. Preliminary evidence suggests men-only weight loss programmes may effectively engage and assist men with weight loss. However, more high-quality studies are urgently needed to improve the evidence base, particularly for maintenance studies.

Impact of Participant and Interventionist Race Concordance on Weight Loss Outcomes

We have previously shown that racial composition of behavioral intervention groups does not affect achieved weight loss. However, it is unclear if the race of the interventionist affects intervention outcomes. The objective of this analysis is to estimate the impact of race concordance between participant and interventionist on weight change in the initial weight loss phase (phase 1) of the Weight Loss Maintenance trial (WLM).A total of 1,685 overweight or obese adults (body mass index [BMI] 25–45 kg/m2) who were taking medication for hypertension and/or dyslipidemia participated in Phase I of the WLM trial. All participants received a 6-month intensive behavioral intervention in groups of 15–20 facilitated by a trained interventionist. The main outcome is change in weight at 6 months.Participants were on average 55 years of age, 67% female and 44% AA. Three of seventeen interventionists were AA, 14 were non-AA. Seventy-three percent of participants shared race concordance with the interventionist. There was a small but statistically significant difference in weight change of participants who were the same race as the interventionist (−5.84 kg, SE 0.17) compared to those who were not race concordant (−5.04 kg, SE 0.33), a difference of 0.8kg, (p= 0.04). The impact of concordance on weight change differed by race (i.e., interaction of race and concordance was significant, p= 0.02).In a post-hoc analysis of a group-based behavioral intervention, race concordance for Non-AA participants was associated with slightly greater weight loss. Race concordance was not associated with weight loss for AA participants.

Is PEG Tube Really the Way To Go: A Comparison of Symptoms Among Subjects With Head and Neck Cancer (760)

1.To evaluate the effect of having a PEG tube in patients with head and neck cancer on their symptoms.2.To determine palliative care consult triggers of patients with head and neck cancer. Subjects with head and neck cancer (HNC) often undergo feeding tube placement (commonly Percutaneous Endoscopic Gastrostomies-PEG) prior to initiation of chemo-radiation to maintain weight and improve treatment tolerability. Long-term use of PEG was associated with complications like persistent dysphagia and increased need for pharyngoesophageal dilatation, adversely impacting subjects’ long term quality of life (QOL). To evaluate impact of PEG on symptoms and to identify triggers and extent of utilization of palliative care consult (PCC) in caring for HNC subjects. Retrospective electronic chart review, extracting data over 1 year from diagnosis, or until death, whichever comes first. Of 84 veterans discussed at ENT tumor board meetings (7/2009 till 6/2010), 47 with new HNC included. N = 47; 2 females. 33 had PEG. Most common presenting symptoms: mass (N = 32; 69.6%), dysphagia/odynophagia (N = 27; 57.4%), anorexia/weight loss (N = 23; 48.9%). PEG placed prior to initiation of treatment in all but one subject. 72.9% had PEG > 12 months. Frequency of interruptions of treatments, ECOG, cancer staging were the same regardless of PEG status. PEG group had more outpatient visits (P = 0.03.) Dysphagia/odynophagia more frequently reported by PEG group during/after completion of treatment (P = 0.004). No significant difference in weight change (P = 0.15) nor survival. 17 subjects (36.2%) had PCC; 15 for hospice referral/assistance in disposition; 2 for pain management. Subjects with more advanced cancer, worse ECOG, shorter survival had PCC (P = 0.01, <0.0001, 0.0028 respectively.) In this HNC cohort, PEG placement did not make a difference in weight or survival, but subjects with PEG reported more dysphagia/odynophagia during/after treatment. PCC was not requested on bases of symptom burden.

Effectiveness of male‐only weight loss and weight loss maintenance interventions: a systematic review with meta‐analysis

The objectives of this systematic review were to investigate the effectiveness of male-only weight loss and weight loss maintenance interventions and to identify intervention characteristics associated with effectiveness. In May 2011, a systematic literature search with no date restrictions was conducted across eight databases. Twenty-four articles describing 23 studies met the eligibility criteria. All studies included a weight loss intervention and four studies included an additional weight loss maintenance intervention. Study quality was mostly poor for weight loss studies (median = 3/10, range = 1-9) and weight loss maintenance studies (median = 3.5/10, range = 1-6). Twenty-three of 31 individual weight loss interventions (74%) from the eligible studies were considered effective. Meta-analysis revealed a significant difference in weight change favouring weight loss interventions over no-intervention controls at the last reported assessment (weighted mean difference -5.66 kg [-6.35, -4.97], Z = 16.04 [P < 0.00001]). Characteristics common to effectiveness were younger sample (mean age ≤ 42.8 years), increased frequency of contact (> 2.7 contacts/month), group face-to-face contact and inclusion of a prescribed energy restriction. Preliminary evidence suggests men-only weight loss programmes may effectively engage and assist men with weight loss. However, more high-quality studies are urgently needed to improve the evidence base, particularly for maintenance studies.

Clinical Effectiveness of Biphasic Insulin Aspart 30:70 Versus Biphasic Human Insulin 30 in UK General Clinical Practice: A Retrospective Database Study

BackgroundPremixed, or biphasic, insulins containing varying proportions of rapid- and intermediate-acting insulin components have been developed to limit the number of daily injections for patients who require both prandial and basal insulin injections. ObjectivesThis study was conducted to determine whether there were differences in glycosylated hemoglobin (HbA1c), weight change, hypoglycemia occurrence, and treatment discontinuation between patients treated with biphasic insulin aspart 30 (BIAsp-30) or biphasic human insulin 30 (BHI-30) in UK general practice. MethodsData were from >350 general practices from the United Kingdom. Patients were stratified by treatment regimen, diabetes type, and insulin status (naive or experienced). Changes in HbA1c and weight were compared from baseline (the date of the first prescription for either insulin) through 180 days of follow-up using ANCOVA. Hypoglycemia incidence rate ratios were compared, and the adjusted likelihood of hypoglycemia was evaluated by logistic regression. Rates of treatment discontinuation were compared using the Cox proportional hazards model. ResultsThe study included data from 7720 patients, of whom 1333 (17.3%) had type 1 diabetes and 4457 (57.7%) were male. Patients' mean (SD) age was 57.9 (19.8) years, and their mean body mass index was 29.5 (6.2) kg/m2. The difference in HbA1c reduction was significant for BIAsp-30 compared with BHI-30 in insulin-naive patients with type 1 diabetes (0.57%; P = 0.045), insulin-naive patients with type 2 diabetes (–0.17%; P = 0.003), and insulin-experienced patients with type 2 diabetes (–0.23%; P = 0.007). The difference between insulins was not significant in insulin-experienced patients with type 1 diabetes. Five hundred ninety-four patients (7.7%) experienced at least one hypoglycemic event. The incidence rate ratio for reported hypoglycemia was significantly lower with BIAsp-30 compared with BHI-30 in insulin-naive patients with type 2 diabetes (0.74; 95% CI, 0.62–0.89; P = 0.001); the difference between insulins was not significant in the other groups. The adjusted hazard ratio for treatment discontinuation was significant for BIAsp-30 versus BHI-30 in insulin-experienced patients with type 2 diabetes (0.693; 95% CI, 0.543–0.884; P = 0.003), whereas the hazard ratios for the other groups did not reach statistical significance. There were no significant differences in weight change between BIAsp-30 and BHI-30 in any of the groups. ConclusionsIn this analysis, BIAsp-30 was associated with improved glycemic control (HbA1c) compared with BHI-30 in insulin-naive patients with type 1 or type 2 diabetes and insulin-experienced patients with type 2 diabetes. BIAsp-30 was associated with reduced hypoglycemia in insulin-naive patients with type 2 diabetes and lower rates of treatment discontinuation in insulin-experienced patients with type 2 diabetes. Cambridgeshire Research Ethics Committee: REC 08/H0305/47.

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Convection-enhanced delivery of free gadolinium with the recombinant immunotoxin MR1-1

A major obstacle in glioblastoma (GBM) therapy is the restrictive nature of the blood-brain barrier (BBB). Convection-enhanced delivery (CED) is a novel method of drug administration which allows direct parenchymal infusion of therapeutics, bypassing the BBB. MR1-1 is a novel recombinant immunotoxin that targets the GBM tumor-specific antigen EGFRvIII and can be delivered via CED infusion. However, drug distribution via CED varies dramatically, which necessitates active monitoring. Gadolinium conjugated to diethylenetriamine penta-acetic acid (Gd-DTPA) is a commonly used MRI contrast agent which can be co-infused with therapies using CED and may be useful in monitoring infusion leak and early distribution. Forty immunocompetent rats were implanted with intracerebral cannulas that were connected to osmotic pumps and subsequently randomized into four groups that each received 0.2% human serum albumin (HSA) mixed with a different experimental infusion: (1) 25 ng/ml MR1-1; (2) 0.1 micromol/ml Gd-DTPA; (3) 25 ng/ml MR1-1 and 0.1 micromol/ml Gd-DTPA; (4) 250 ng/ml MR1-1 and 0.1 micromol/ml Gd-DTPA. The rats were monitored clinically for 6 weeks then necropsied and histologically assessed for CNS toxicity. All rats survived the entirety of the study without clinical or histological toxicity attributable to the study drugs. There was no statistically significant difference in weight change over time among groups (P > 0.999). MR1-1 co-infused with Gd-DTPA via CED is safe in the long-term setting in a pre-clinical animal model. Our data supports the use of Gd-DTPA, as a surrogate tracer, co-infused with MR1-1 for drug distribution monitoring in patients with GBM.

Protective effect of yogurt extract on dental enamel demineralization in vitro

Casein phosphopeptides (CPPs) are phosphorylated casein-derived peptides produced synthetically by proteolytic digestion of alpha(s1)-, alpha(s2)- and beta-casein. The anticariogenic activity of CPPs is due to their ability to stabilize high levels of amorphous calcium phosphate (ACP) on tooth surface, preventing demineralization and enhancing remineralization of enamel caries. The aim of this study was to test the in vitro ability of natural CPPs (contained in yogurt) to prevent demineralization and promote remineralization of dental enamel. Eighty human molars were used. After standardizing an in vitro demineralization procedure for producing artificial caries (Group 1: pH 4.8; Group 2: pH 3.97), this procedure was used on teeth, but with the addition of natural CPPs (Group 3: pH 4.8; Group 4: pH 3.97). The effects of these procedures were evaluated by quantitative analysis (change in weight and calcium titration) and qualitative analysis (SEM). Statistical analysis of the results was performed using ANOVA. Statistical analysis showed significant differences in weight changes between the groups with and without natural CPPs. The SEM observation showed the protective effects of natural CPPs. The results demonstrated that CPPs contained in yogurt have an inhibitory effect on demineralization and promote the remineralization of dental enamel.