scholarly journals Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

2021 ◽  
Vol 2021 ◽  
pp. 1-20
Author(s):  
Juan Zhong ◽  
Shuqin Liu ◽  
Dan Lai ◽  
Tao Lu ◽  
Yifeng Shen ◽  
...  

Background. The treatment effects and safety of ear acupressure (EAP) for patients with allergic rhinitis (AR) have yet to be clarified. Objective. To evaluate the effects and safety of EAP in AR patients. Design. Systematic review of published studies. Methods. A total of 24 English and Chinese databases (PubMed, EMBASE (Excerpta Medical Database), Cochrane Central Register of Controlled Trials, CINAHL, Informit, ScienceDirect, LILACS (Latin American and Caribbean Health Sciences), ProQuest, AMED, Blackwell Synergy, PsycINFO, Panteleimon, AcuBriefs, KoreaMed, IndMed, Ingenta, mRCT, ISI Web of Knowledge, ERIC, VIP Information (http://www.cqvip.com), China National Knowledge Infrastructure (http://www.cnki.net), Cochrane Library, Chinese Cochrane Centre Controlled Trials Register Platform, and Wanfang Chinese Digital Periodical and Conference Database) were searched from their respective inceptions to August 2020 to collect randomized controlled trials of ear acupressure for allergic rhinitis. We performed literature inclusion, data extraction, and trial quality evaluations. Methodological quality was assessed according to the Cochrane Handbook. Revman5.3 was used for all analyses. Results. A total of 203 trials were identified and eleven studies involved 1094 participants aged 3–70 years. EAP was better than control group interventions in terms of effectiveness (risk ratio (RR): 0.51; 95% confidence interval (CI): 0.36–0.70; P < 0.0001 ). EAP was superior to sham EAP in terms of improvement of the total nasal symptom score (RR: −0.50; 95% CI: −0.96–0.05; P = 0.03), sneezing score (RR: −0.36; 95% CI: −0.59–0.12; P = 0.003), global QoL score (RR: 0.42; 95% CI: 0.04–0.08; P = 0.03), and eye symptom score (RR: −0.36; 95% CI: −0.67–0.05; P = 0.02). Conclusions. Despite the positive results, it is premature to confirm the efficacy of EAP for treating AR. More high-quality studies are needed to confirm safety and efficacy.


Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 345
Author(s):  
Filipe Manuel Clemente ◽  
Rodrigo Ramirez-Campillo ◽  
Hugo Sarmento

This systematic review with meta-analysis was conducted to assess the effects of small-sided games (SSGs)-based programs on the systolic and diastolic blood pressure of untrained hypertensive adults. The data sources utilized were Web of Science, Scopus, SPORTDiscus, and PubMed. The eligibility criteria were: (i) randomized controlled trials including a control group and an intervention group exclusively using soccer SSGs; (ii) intervention and control groups including an untrained hypertensive adult population; (iii) articles written in English; and (iv) only full-text and original articles. The database search initially identified 241 titles. From those, five articles were eligible for the systematic review and meta-analysis. The included randomized controlled studies involved five individual experimental groups and 88 participants, and 68 participants in the five control groups. The results showed a large and beneficial effect of SSG on systolic (ES = 1.69; 95% CI = 0.71 to 2.66; p = 0.001; I2 = 85.2%; Egger’s test p = 0.101) and diastolic blood pressure (ES = 2.25; 95% CI = 1.44 to 3.06; p < 0.001; I2 = 74.8%; Egger’s test p = 0.118) when compared to the control groups. The findings of the current systematic review and meta-analysis revealed consistent beneficial effects of recreational soccer SSGs on untrained men and women from the hypertensive population, although high levels of heterogeneity.


Author(s):  
Kesley Pablo Morais de Azevedo ◽  
Victor Hugo de Oliveira ◽  
Gidyenne Christine Bandeira Silva de Medeiros ◽  
Ádala Nayana de Sousa Mata ◽  
Daniel Ángel García ◽  
...  

The aim of this study was to analyze the evidence available in the literature about the effects of exercise on brain-derived neurotrophic factor levels in adolescents. The literature searches were conducted in PubMed, Embase, Scopus, ScienceDirect, Web of Science, SportDiscus, the Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL. Randomized controlled trials and non-randomized controlled trials performed with adolescents (10–19 years) who underwent different exercise programs and who evaluated BDNF levels before and after the intervention were included. We included six studies, four RCTs and two non-RCTs in the systematic review with a total of 407 adolescents. In two randomized trials and one non-RCT, the intervention groups showed significant improvements in BDNF levels compared with the control group. The results presented in the meta-analysis indicate that despite the positive effect in favor of the intervention, there were no significant differences (standardized mean difference 0.28 ng/mL, 95% confidence interval −0.28 to 0.85; p = 0.32, I² = 0%). The results presented in our review indicate that aerobic exercise programs practiced in moderate- or high-intensity are promising strategies to increase BDNF levels in adolescents. However, further studies are required to support this finding.


2020 ◽  
Vol 19 ◽  
pp. 153303382096745
Author(s):  
Yukun Wang ◽  
Dejiu Kong ◽  
Chaokun Wang ◽  
Jing Chen ◽  
Jing Li ◽  
...  

Objective: We aimed to evaluate immune-related adverse events occurring in clinical trials of anti-programmed cell death 1 (PD-1) drugs, compared with control treatments, including chemotherapy, targeted drugs, or placebo. Further we compared the occurrence of immune -related events in patients treated with different anti-PD-1 drugs. Data Sources: Randomized controlled trial (RCT) data were sourced from PubMed, Embase, and the Cochrane Central Register of Controlled Trials combined with https://clinicaltrials.gov . Methods: Randomized controlled trial of anti-PD-1 drugs compared with control treatments published between January 1, 1970 and March 1,2019, were searched and data on trial patient characteristics, and adverse events extracted, reviewed, and subjected to meta-analysis. Results: Eighteen Randomized controlled trials were included in our study. The Randomized controlled trials compared nivolumab (n = 12), pembrolizumab (n = 6), with chemotherapy (n = 13), targeted drugs (n = 2), or placebo (n = 3). Compared with the control group, the risk of any immune-related adverse events in patients treated with anti-PD-1 drugs was increased (RR, 2.65; 95% confidence interval, 1.84–3.83; P < 0.00001). Of the immune-related adverse events, the risk rates of pneumonitis (risk ratio, 2.10; 95% CI, 0.85-5.18), colitis (2.96;1.62-5.38), hypophysitis(4.79;1.54-14.89), hypothyroidism(7.87;5.36-11.57), hyperthyroidism (7.03;4.35-11.34), rash (1.58;0.98-2.54), pruritus (2.28; 1.38-3.76), and hepatitis (9.31;2.18-39.85) were increased by anti-PD-1 drugs. Further, the risk of immune-related adverse events was similar for patients treated with pembrolizumab and nivolumab ( P = 0.14). Conclusions: In addition to previously reported organ-specific immune-related adverse events, we found that the risk of hyperthyroidism was also increased, in anit-PD-1-treated patients, relative to control treatments. The risk of total immune-related adverse events, was similar for pembrolizumab and nivolumab.


2020 ◽  
Author(s):  
Yue Chang ◽  
Zhezhe Cui ◽  
Guanghong Yang ◽  
Xin Zhang ◽  
Lei Tang

Abstract Background The global health system is improperly using antibiotics. We aimed to examine the effectiveness of implementing a feedback intervention for the unreasonable control of antibiotic prescriptions. Methods Relevant literature published in the databases of Pubmed, Google Scholar, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Journal Full-text (CNKI), Science Direct, Proquest and Wanfang was searched. Data were independently filtered and extracted based on the pre-designed inclusion and exclusion criteria by two reviewers. The Cochrane collaborative bias risk tool was used to evaluate the quality of the included study. RevMan 5.3 software was used for meta-analysis. Results Nine relevant randomized controlled trials were included in this study, of which 1 was written in Chinese and 8 in English. Tabulation resulted in a total of 238,196 prescriptions (103,370 in the intervention group and 134,826 in the control group) from seven countries: China, the United States, England, Spain, Norway, Germany, and France. The meta-analysis showed that the antibiotic prescription rate in the intervention group was significantly lower than that in the control group after the feedback intervention, and the difference was statistically significant (risk difference = -0.12, 95% CI = -0.16, -0.07, P <0.01). Due to the large heterogeneity of the results, subgroup analysis was performed according to the study area, whether prescription recommendations were given to doctors by peer experts, and the intervention mode. Conclusion Implementing feedback interventions in hospitals can effectively reduce antibiotic prescription rates. Adding multiple feedback interventions to educational interventions may be a more reasonable control method.Registrations: This systematic review was registered in PROSPERO, registration number: CRD42020192560.


2021 ◽  
Author(s):  
Fu-An Yang ◽  
Hung-Lun Chen ◽  
Chih-Wei Peng ◽  
Tsan-Hon Liou ◽  
Reuben Escorpizo ◽  
...  

Abstract Phonophoresis is an alternative treatment for knee osteoarthritis. However, evidence supporting the advantages of phonophoresis remains inconsistent. This systematic review and meta-analysis was conducted to illustrate the effect of phonophoresis. The PubMed, Cochrane Library, and Embase databases were searched for relevant studies from the date of their inception to 28 June, 2021. The eligibility criteria were: (1) randomized controlled trials (RCTs); (2) patients diagnosed as having knee osteoarthritis; (3) treatment with either phonophoresis or therapeutic ultrasound with placebo gels; and (4) reporting clinical and functional outcomes. Continuous variables are expressed as standardized mean differences (SMDs) with 95% confidence intervals (CIs). Analysis was performed using RevMan 5.3 software. The analysis included nine RCTs covering a total of 423 patients. The intervention group significantly outperformed the control group in visual analog scale score [SMD = −0.65, 95% CI (−1.04, −0.25), P = 0.001], Western Ontario and McMaster Universities Arthritis Index (WOMAC) score [SMD = −0.71, 95% CI (−1.26, −0.16), P = 0.01], and walk test score [SMD = −0.67, 95% CI (−1.21, −0.13), P = 0.02]. As a result, phonophoresis might alleviate pain and improve function in the short term. Further high-quality, large-scale RCTs are required to confirm the benefits.


2016 ◽  
Vol 46 (16) ◽  
pp. 3263-3274 ◽  
Author(s):  
Y. T. Nigatu ◽  
Y. Liu ◽  
M. Uppal ◽  
S. McKinney ◽  
S. Rao ◽  
...  

Common mental disorders (CMDs) are highly prevalent in the working population, and are associated with long-term sickness absence and disability. Workers on sick leave with CMDs would benefit from interventions that enable them to successfully return to work (RTW). However, the effectiveness of RTW interventions for workers with a CMD is not well studied. The objective of this review is to assess the effectiveness of existing workplace and clinical interventions that were aimed at enhancing RTW. A systematic review of studies of interventions for improving RTW in workers with a CMD was conducted. The main outcomes were proportion of RTW and sick-leave duration until RTW. Randomized controlled trials (RCTs) were identified from Medline/PubMed, PsycINFO, EMBASE, SocINDEX, and Human resource and management databases from January 1995 to 2016. Two authors independently selected studies, assessed risk of bias and extracted data. We pooled studies that we deemed sufficiently homogeneous in different comparison groups and assessed the overall quality of the evidence. We reviewed 2347 abstracts from which 136 full-text articles were reviewed and 16 RCTs were included in the analysis. Combined results from these studies suggested that the available interventions did not lead to improved RTW rates over the control group [pooled risk ratio 1.05, 95% confidence interval (CI) 0.97–1.12], but reduced the number of sick-leave days in the intervention group compared to the control group, with a mean difference of −13.38 days (95% CI −24.07 to −2.69).


2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.


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