Short-term weight-centric effects of tea or tea extract in patients with metabolic syndrome: a meta-analysis of randomized controlled trials.
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ABSTRACT:
SUBMITTER: Zhong X
PROVIDER: S-EPMC4491851 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Project description:Background and objectivesAspirin is widely used for short-term treatment of pain, fever or colds, but there are only limited data regarding the safety of this use. To summarize the available data on this topic, we conducted a meta-analysis of the published clinical trial literature regarding the gastrointestinal adverse effects of short-term use of aspirin in comparison with placebo and other medications commonly used for the same purpose.Data sources and methodsAn extensive literature search identified 119,310 articles regarding possible adverse effects of aspirin, among which 23,131 appeared to possibly include relevant data. An automated text-mining procedure was used to score the references for potential relevance for the meta-analysis. The 3,983 highest-scoring articles were reviewed individually to identify those with data that could be included in this analysis. Ultimately, 78 relevant articles were identified that contained gastrointestinal adverse event data from clinical trials of aspirin versus placebo or an active comparator. Odds ratios (ORs) computed using a Mantel-Haenszel estimator were used to summarize the comparative effects on dyspepsia, nausea/vomiting, and abdominal pain, considered separately and also aggregated as 'minor gastrointestinal events'. Gastrointestinal bleeds, ulcers, and perforations were also investigated.ResultsData were obtained regarding 19,829 subjects (34 % treated with aspirin, 17 % placebo, and 49 % an active comparator). About half of the aspirin subjects took a single dose. Aspirin was associated with a higher risk of minor gastrointestinal events than placebo or active comparators: the summary ORs were 1.46 (95 % confidence interval [CI] 1.15-1.86) and 1.81 (95 % CI 1.61-2.04), respectively. Ulcers, perforation, and serious bleeding were not seen after use of aspirin or any of the other interventions.ConclusionsDuring short-term use, aspirin is associated with a higher frequency of gastrointestinal complaints than other medications commonly used for treatment of pain, colds, and fever. Serious adverse events were not observed with aspirin or any of the comparators.
| S-EPMC3627011 | biostudies-literature
Project description:Vortioxetine was approved by the U.S. Food and Drug Administration (FDA) in September 2013 for treating major depressive disorder (MDD). Thus far, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with MDD. We performed a meta-analysis to increase the statistical power of these studies and enhance our current understanding of the role of vortioxetine in the treatment of MDD.We performed an extensive search of databases and the clinical trial registry. The mean change in total scores on the 24-item Hamilton Rating Scale for Depression (HAM-D) and the Montgomery- Åsberg Depression Rating Scale (MADRS) from the baseline were the primary outcome measures. The secondary efficacy measures were the response and remission rates, as defined by a 50% or greater reduction in HAM-D/MADRS total scores and as a score of 10 or less in the MADRS and 7 or less in the HAM-D total scores at the end of treatment.We included 7 published and 5 unpublished short-term (6-12 wk) RCTs in our meta-analysis. Vortioxetine was significantly more effective than placebo, with an effect size (standardized mean difference [SMD]) of -0.217 (95% confidence interval [CI] -0.313 to -0.122) and with odds ratios (ORs) for response and remission of 1.652 (95% CI 1.321 to 2.067) and 1.399 (95% CI 1.104 to 1.773), respectively. Those treated with vortioxetine did not differ significantly from those treated with selective norepinephrine reuptake inhibitors/agomelatine with regard to the SMD of the primary outcome measure (0.081, -0.062 to 0.223) or for response (OR 0.815, 95% CI 0.585 to 1.135) and remission (OR 0.843, 95% CI 0.575 to 1.238) rates. Discontinuation owing to lack of efficacy (OR 0.541, 95% CI 0.308 to 0.950) was significantly less common among those treated with vortioxetine than among those who received placebo, whereas discontinuation owing to adverse events (AEs; OR 1.530, 95% CI 1.144 to 2.047) was significantly more common among those treated with vortioxetine than among those receiving placebo. There was no significant difference in discontinuation rates between vortioxetine and comparators owing to inefficacy (OR 0.983, 95% CI 0.585 to 1.650), whereas discontinuation owing to AEs was significantly less common in the vortioxetine than in the comparator group (OR 0.728, 95% CI 0.554 to 0.957).Studies examining the role of vortioxetine in the treatment of MDD are limited.Although our results suggest that vortioxetine may be an effective treatment option for MDD, they should be interpreted and translated into clinical practice with caution, as the meta-analysis was based on a limited number of heterogeneous RCTs.
| S-EPMC4409435 | biostudies-other
Project description:BACKGROUND: Preventing weight gain rather than treating established obesity is an important economic and public health response to the rapidly increasing rates of obesity worldwide. Treatment of established obesity is complex and costly requiring multiple resources. Preventing weight gain potentially requires fewer resources to reach broad population groups, yet there is little evidence for successful interventions to prevent weight gain in the community. Women with children are an important target group because of high rates of weight gain and the potential to influence the health behaviors in family members. METHODS: The aim of this cluster randomized controlled trial was to evaluate the short term effect of a community-based self-management intervention to prevent weight gain. Two hundred and fifty mothers of young children (mean age 40 years +/- 4.5, BMI 27.9 kg/m2 +/- 5.6) were recruited from the community in Melbourne, Australia. The intervention group (n = 127) attended four interactive group sessions over 4 months, held in 12 local primary schools in 2006, and was compared to a group (n = 123) receiving a single, non-interactive, health education session. Data collection included self-reported weight (both groups), measured weight (intervention only), self-efficacy, dietary intake and physical activity. RESULTS: Mean measured weight decreased significantly in the intervention group (-0.78 kg 95% CI; -1.22 to -0.34, p < 0.001). Comparing groups using self-reported weight, both the intervention and comparison groups decreased weight, -0.75 kg (95% CI; -1.57 to 0.07, p = 0.07) and -0.72 kg (95% CI; -1.59 to 0.14 p = 0.10) respectively with no significant difference between groups (-0.03 kg, 95% CI; -1.32 to 1.26, p = 0.95). More women lost or maintained weight in the intervention group. The intervention group tended to have the greatest effect in those who were overweight at baseline and in those who weighed themselves regularly. Intervention women who rarely self-weighed gained weight (+0.07 kg) and regular self-weighers lost weight (-1.66 kg) a difference of -1.73 kg (95% CI; -3.35 to -0.11 p = 0.04). The intervention reported increased physical activity although the difference between groups did not reach significance. Both groups reported replacing high fat foods with low fat alternatives and self-efficacy deteriorated in the comparison group only. CONCLUSION: Both a single health education session and interactive behavioral intervention will result in a similar weight loss in the short term, although more participants in the interactive intervention lost or maintained weight. There were small non-significant changes to physical activity and changes to fat intake specifically replacing high fat foods with low fat alternatives such as fruit and vegetables. Self-monitoring appears to enhance weight loss when part of an intervention. TRIAL REGISTRATION: ACTRN12608000110381.
| S-EPMC2683875 | biostudies-other
Project description:ObjectiveTo explore the short-term efficacy and tolerability of paroxetine in the treatment of panic disorder in adults.MethodsMultiple electronic databases were searched to find randomized controlled trials (RCTs) on paroxetine and panic disorder. The primary efficacy outcomes were: the mean change compared to the baseline in the total number of full panic attacks, Clinical Global Impression-Severity of Illness (CGI-S) score, and the proportion of participants with zero full panic attacks and with a 50% or greater reduction in the number of full panic attacks. The tolerability outcomes included withdrawal rate and the incidence of adverse events (AEs).Results13RCTs were included. The pooled analyses showed patients who received paroxetine experienced greater improvements in the number of full panic attacks (total: MD=-1.96, 95%CI -3.45 to -0.47, P=0.010; ≥50% reduction: OR=1.66, 95%CI 1.08 to 2.55, P=0.02; zero full panic attacks: OR=1.70, 95%CI 1.42 to 2.03, P < 0.00001) and CGI-S (MD=-0.37, 95%CI -0.74 to -0.01, P=0.05) than placebo. There was no evident difference in the total withdrawal rate (OR=0.91, 95%CI 0.76 to 1.08, P=0.26) and withdrawal rate due to AEs (OR=1.29, 95%CI 0.97 to 1.72, P=0.07) between the two groups. Withdrawal rate due to lack of efficacy or relapse (OR=0.44, 95%CI 0.31 to 0.63, P < 0.00001) and the incidence of serious AEs (OR=0.42, 95%CI 0.23 to 0.79, P=0.007) in the paroxetine group was lower than the placebo group. Meanwhile, the incidence of any treatment-emergent adverse events (TEAEs) (OR=1.32, 95%CI 1.05 to 1.64, P=0.02) in the paroxetine group was higher in comparison with the placebo.ConclusionsParoxetine is an effective and well-tolerated short-term treatment for adults with panic disorder.
| S-EPMC7136560 | biostudies-literature
Project description:Body weight in lower animals and humans is highly stable despite a very large flux in energy intake and expenditure over time. Conversely, the existence of higher-than-average variability in weight may indicate a disruption in the mechanisms responsible for homeostatic weight regulation.In a sample chosen for weight-gain proneness, we evaluated whether weight variability over a 6-mo period predicted subsequent weight change from 6 to 24 mo.A total of 171 nonobese women were recruited to participate in this longitudinal study in which weight was measured 4 times over 24 mo. The initial 3 weights were used to calculate weight variability with the use of a root mean square error approach to assess fluctuations in weight independent of trajectory. Linear regression analysis was used to examine whether weight variability in the initial 6 mo predicted weight change 18 mo later.Greater weight variability significantly predicted amount of weight gained. This result was unchanged after control for baseline body mass index (BMI) and BMI change from baseline to 6 mo and for measures of disinhibition, restrained eating, and dieting.Elevated weight variability in young women may signal the degradation of body weight regulatory systems. In an obesogenic environment this may eventuate in accelerated weight gain, particularly in those with a genetic susceptibility toward overweight. Future research is needed to evaluate the reliability of weight variability as a predictor of future weight gain and the sources of its predictive effect. The trial on which this study is based is registered at clinicaltrials.gov as NCT00456131.
| S-EPMC4625595 | biostudies-literature
Project description:OBJECTIVE:The objective of this study was to determine the effects of weight loss and weight loss maintenance (WLM) on weight-specific health-related quality of life in a 66-week trial. METHODS:Adults with obesity (N?=?137, 86.1% female, 68.6% black, mean age?=?46.1 years) who had lost???5% of initial weight in a 14-week intensive lifestyle intervention/low-calorie diet (LCD) program were randomly assigned to lorcaserin or placebo for an additional 52-week WLM program. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) scale (including five subscales), Patient Health Questionnaire-9 (depression), and Perceived Stress Scale were administered at the start of the 14-week LCD program, randomization, and week 52 of the randomized controlled trial (i.e., 66 weeks total). RESULTS:Significant improvements in all outcomes, except weight-related public distress, were found following the 14-week LCD program (P values <?0.05). Improvements were largely maintained during the 52-week randomized controlled trial, despite weight regain of 2.0 to 2.5 kg across treatment groups. Participants who lost???10% of initial weight achieved greater improvements in physical function, self-esteem, sexual life, and the IWQOL-Lite total score than those who lost <?5% and did not differ from those who lost 5% to 9.9%. CONCLUSIONS:Improvements in weight-specific health-related quality of life were achieved with moderate weight loss and were sustained during WLM.
| S-EPMC5970047 | biostudies-literature
Project description:BackgroundA few studies focused on statin therapy as specific prophylactic measures of contrast-induced nephropathy have been published with conflicting results. In this meta-analysis of randomized controlled trials, we aimed to assess the effectiveness of short-term high-dose statin treatment for the prevention of CIN and clinical outcomes and re-evaluate of the potential benefits of statin therapy.MethodsWe searched PubMed, OVID, EMBASE, Web of science and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials comparing short-term high-dose statin treatment versus low-dose statin treatment or placebo for preventing CIN. Our outcome measures were the risk of CIN within 2-5 days after contrast administration and need for dialysis.ResultsSeven randomized controlled trials with a total of 1,399 patients were identified and analyzed. The overall results based on fixed-effect model showed that the use of short-term high-dose statin treatment was associated with a significant reduction in risk of CIN (RR =0.51, 95% CI 0.34-0.76, p =0.001; I(2) = 0%). The incidence of acute renal failure requiring dialysis was not significant different after the use of statin (RR = 0.33, 95% CI 0.05-2.10, p = 0.24; I(2) = 0%). The use of statin was not associated with a significant decrease in the plasma C-reactive protein level (SMD -0.64, 95% CI: -1.57 to 0.29, P = 0.18, I(2) = 97%).ConclusionsAlthough this meta-analysis supports the use of statin to reduce the incidence of CIN, it must be considered in the context of variable patient demographics. Only a limited recommendation can be made in favour of the use of statin based on current data. Considering the limitations of included studies, a large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for statin in CIN prevention.
| S-EPMC3325242 | biostudies-literature
Project description:Adherence to healthy eating patterns (HEPs) is often short-lived and can lead to repetitive attempts of adopting-but not maintaining-HEPs. We assessed effects of adopting, abandoning, and readopting HEPs (HEP cycling) on cardiovascular disease risk factors (CVD-RF). We hypothesized that HEP cycling would improve, worsen, and again improve CVD-RF. Data were retrospectively pooled for secondary analyses from two randomized, crossover, controlled feeding trials (n = 60, 52 ± 2 years, 30.6 ± 0.6 kg/m²) which included two 5⁻6 week HEP interventions (Dietary Approaches to Stop Hypertension-style or Mediterranean-style) separated by a four-week unrestricted eating period. Ambulatory and fasting blood pressures (BP), fasting serum lipids, lipoproteins, glucose, and insulin were measured before and during the last week of HEP interventions. Fasting systolic BP and total cholesterol decreased (-6 ± 1 mm Hg and -19 ± 3 mg/dL, respectively, p < 0.05), returned to baseline, then decreased again (-5 ± 1 mm Hg and -13 ± 3 mg/dL, respectively, p < 0.05) when adopting, abandoning, and readopting a HEP; magnitude of changes did not differ. Ambulatory and fasting diastolic BP and high-density lipoprotein cholesterol concentrations followed similar patterns; glucose and insulin remained unchanged. Low-density lipoprotein cholesterol concentrations decreased with initial adoption but not readoption (-13 ± 3 and -6 ± 3, respectively, interaction p = 0.020). Healthcare professionals should encourage individuals to consistently consume a HEP for cardiovascular health but also encourage them to try again if a first attempt is unsuccessful or short-lived.
| S-EPMC6266045 | biostudies-literature
Project description:Evidence continues to demonstrate the role of obesity in prostate carcinogenesis and prognosis, underscoring the need to identify and continue to evaluate the effective interventions to reduce obesity in populations at high risk. The aim of the study was to determine the effect of daily consumption of decaffeinated green tea catechins (GTC) formulation (Polyphenon E® (PolyE)) for 1 year on biomarkers of obesity in men who are at high risk for prostate cancer.A randomized, double-blinded trial was conducted targeting 97 men diagnosed with HGPIN or ASAP. Subjects were randomized to receive GTC (PolyE) (n = 49) or placebo (n = 48) for 1 year. Anthropometric data were collected at baseline, 6 and 12 months and data analyzed to observe change in weight, body mass index (indicator of obesity) and waist: hip ratio (indicator of abdominal obesity).Decaffeinated GTC containing 400 mgs of the bioactive catechin, EGCG administered for 1 year to men diagnosed with ASAP and HGPIN appears to be bioavailable, well tolerated but not effective in reducing biomarkers of obesity including body weight, body mass index and waist: hip ratio.The results of our trial demonstrates that men who are obese and at high risk for prostate cancer should resort to effective weight management strategies to reduce obesity and not resort to ineffective measures such as taking supplements of green tea to reduce biomarkers of obesity. Changes in body mass index and abdominal obesity seen in other studies were potentially due to caffeine and not GTC.
| S-EPMC5716795 | biostudies-literature
Project description:PurposeConsidering the present controversies on the association between green coffee supplementation and cardio metabolic risk factors, this systematic review and meta-analysis was conducted to evaluate the effect of green coffee supplementation on cardio metabolic risk factors.MethodA systematic literature search was performed throughout the PubMed, Embase, Scopus, and Web of Science databases up to October 2019. As a result, all randomized controlled trials over the effect of green coffee supplementation on fasting blood sugar (FBS), insulin, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C - reactive protein (CRP), and homeostatic model assessment for insulin resistance (HOMA-IR) in adults were examined. Data were extracted from the relevant studies and analyzed using the random-effect or pooled model and standardized mean difference (SMD) with 95% confidence interval (CI).ResultsAfter excluding the irrelevant articles, 27 studies were included in the final analysis. Pooled results revealed that green coffee supplementation significantly reduced FBS (WMD = -2.28, 95% CI: -4.49 to -0.07, P = 0.043), insulin (WMD = -0.53, 95% CI: -0.93 to -0.14, P = 0.008), and triglyceride (WMD = -9.28, 95% CI: -14.93 to - 3.63, P = 0.001). Furthermore, green coffee supplementation increased the HDL levels (WMD = 1.33, 95% CI: 0.08 to 2.58, P = 0.037). However, the changes in HOMA-IR, LDL, and CRP levels were not significant (P > 0.05).ConclusionThis meta-analysis indicated that green coffee supplementation significantly decreased FBS, insulin, and triglyceride, but improved HDL. No statistically significant improvement was found in HOMA-IR, LDL, and CRP indices following the green coffee supplementation.
| S-EPMC7271291 | biostudies-literature