Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

The diagnostic role of diffusional kurtosis imaging in glioma grading and differentiation of gliomas from other intra-axial brain tumours: a systematic review with critical appraisal and meta-analysis.

PURPOSE: We aim to illustrate the diagnostic performance of diffusional kurtosis imaging (DKI) in the diagnosis of gliomas. METHODS: A review protocol was developed according to the (PRISMA-P) checklist, registered in the international prospective register of systematic reviews (PROSPERO) and published. A literature search in 4 databases was performed using the keywords 'glioma' and 'diffusional kurtosis'. After applying a robust inclusion/exclusion criteria, included articles were independently evaluated according to the QUADAS-2 tool and data extraction was done. Reported sensitivities and specificities were used to construct 2 × 2 tables and paired forest plots using the Review Manager (RevMan®) software. A random-effect model was pursued using the hierarchical summary receiver operator characteristics. RESULTS: A total of 216 hits were retrieved. Considering duplicates and inclusion criteria, 23 articles were eligible for full-text reading. Ultimately, 19 studies were eligible for final inclusion. The quality assessment revealed 9 studies with low risk of bias in the 4 domains. Using a bivariate random-effect model for data synthesis, summary ROC curve showed a pooled area under the curve (AUC) of 0.92 and estimated sensitivity of 0.87 (95% CI 0.78-0.92) in high-/low-grade gliomas' differentiation. A mean difference in mean kurtosis (MK) value between HGG and LGG of 0.22 (95% CI 0.25-0.19) was illustrated (p value = 0.0014) with moderate heterogeneity (I2 = 73.8%). CONCLUSION: DKI shows good diagnostic accuracy in the differentiation of high- and low-grade gliomas further supporting its potential role in clinical practice. Further exploration of DKI in differentiating IDH status and in characterising non-glioma CNS tumours is however needed.

An overview on the methodological and reporting quality of dose-response meta-analysis on cancer prevention.

BACKGROUND: Dose-response meta-analysis (DRMA) has been widely used in exploring cancer risk factors. Understanding the quality of published DRMAs on cancer risk factors may be beneficial for informed prevention for cancer. METHODS: We searched eligible DRMAs from 1st January 2011 to 31st-July-2017. The modified AMSTAR 1.0 (15 items) and PRISMA checklist (26 items) were used to evaluate the methodological and reporting quality of included DRMAs. We compared the adherence rate of these items by journal type, publication years, region, and funding information, in prior. RESULTS: We included 260 DRMAs. Colorectal, breast, prostate, and lung were the four most commonly investigated cancers. For methodological quality, 6 out of 15 items were adhered by less than 30% of the DRMAs, 2 by less than 60%, only 7 of which by 80% or more. For reporting quality, 3 out of 26 items were adhered by less than 30% of the DRMAs, 1 by less than 80% (> 30%), and 20 of which by 80% or more. Those published in general journal, published more recently, and received any financial support have better methodological (Rate differences, RDs = 10-36%; P < 0.05) and reporting adherence (RDs = 12-36%; P < 0.05). DRMAs by Asian author tend to be less qualified than by European and American. CONCLUSIONS: The methodological quality of DRMAs on cancer risk factors is worrisome that the findings of them may be deflective; more efforts are needed to improve the validity of it.

Role of diffusional kurtosis imaging in grading of brain gliomas: a protocol for systematic review and meta-analysis.

INTRODUCTION: Central nervous system (CNS) gliomas are the most common primary intra-axial brain tumours and pose variable treatment response according to their grade, therefore, precise staging is mandatory. Histopathological analysis of surgical tumour samples is still deemed as the state-of-the-art staging technique for gliomas due to the moderate specificity of the available non-invasive imaging modalities. A recently evolved analysis of the tissue water diffusion properties, known as diffusional kurtosis imaging (DKI), is a dimensionless metric, which quantifies water molecules' degree of non-Gaussian diffusion, hence reflects tissue microenvironment's complexity by means of non-invasive diffusion-weighted MRI acquisitions. The objective of this systematic review and meta-analysis is to explore the performance of DKI in the presurgical grading of gliomas, both regarding the differentiation between high-grade and low-grade gliomas as well as the discrimination between gliomas and other intra-axial brain tumours. METHODS AND ANALYSIS: We will search PubMed, Medline via Ovid, Embase and Scopus in July 2018 for research studies published between January 1990 and June 2018 with no language restrictions, which have reported on the performance of DKI in diagnosing CNS gliomas. Robust inclusion/exclusion criteria will be applied for selection of eligible articles. Two authors will separately perform quality assessment according to the quality assessment of diagnostic accuracy studies-2 tool. Data will be extracted in a predesigned spreadsheet. A meta-analysis will be held using a random-effects model if substantial statistical heterogeneity is expected. The heterogeneity of studies will be evaluated, and sensitivity analyses will be conducted according to individual study quality. ETHICS AND DISSEMINATION: This work will be based on published studies; hence, it does not require institutional review board approval or ethics clearance. The results will be published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42018099192.

Restrictive Versus Liberal Strategy for Red Blood-Cell Transfusion: A Systematic Review and Meta-Analysis in Orthopaedic Patients.

BACKGROUND: Current guidelines recommend restrictive criteria for red blood-cell transfusion in most clinical settings. However, patients undergoing orthopaedic surgery may require distinct transfusion criteria since benefits and potential harm often vary considerably based on patient characteristics and surgical procedures. We aimed to assess the efficacy and safety of restrictive transfusion in patients undergoing orthopaedic surgery, especially in important subgroups. METHODS: Electronic databases were searched to identify randomized controlled trials investigating restrictive (mostly a hemoglobin level of 8.0 g/dL or symptomatic anemia) versus liberal (mostly a hemoglobin level of 10.0 g/dL) transfusion in patients undergoing orthopaedic surgery. For the primary outcome of cardiovascular events, we performed random-effects meta-analyses to synthesize the evidence and to assess the effects in different subgroups according to patient characteristics (with versus without preexisting cardiovascular disease) and surgical procedures (hip fracture surgery versus elective arthroplasty). RESULTS: Ten trials involving 3,968 participants who underwent hip or knee surgery were included. Mean participant age ranged from 68.7 to 86.9 years. Compared with liberal transfusion, restrictive transfusion increased the risk of cardiovascular events (8 trials; 3,618 participants; relative risk [RR], 1.51; 95% confidence interval [CI], 1.16 to 1.98; p = 0.003; with no heterogeneity across all trials), irrespective of preexisting cardiovascular disease (pinteraction = 0.63). In a subgroup analysis, the increase was observed in patients undergoing hip fracture surgery (RR, 1.51; 95% CI, 1.08 to 2.10; p = 0.02), but did not reach significance in those undergoing elective arthroplasty (RR, 1.53; 95% CI, 0.96 to 2.44; p = 0.07). To minimize the bias caused by variations in transfusion threshold, we conducted an analysis that only included trials using 8.0 g/dL hemoglobin or symptomatic anemia as the threshold for restrictive transfusion and obtained identical results (6 trials; 2,872 participants; RR, 1.51; 95% CI, 1.09 to 2.08; p = 0.01; I = 0%). The 2 arms did not differ with respect to the rates of all infections, 30-day mortality, thromboembolic events, wound infection, pulmonary infection (mainly pneumonia), and cerebrovascular accidents (mainly stroke). CONCLUSIONS: In patients undergoing orthopaedic surgery, when compared with liberal transfusion, restrictive transfusion increases the risk of cardiovascular events irrespective of preexisting cardiovascular disease. Importantly, the increased risk was observed in patients undergoing hip fracture surgery but did not reach significance in those undergoing elective arthroplasty. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Association between intraoperative hypotension and 30-day mortality, major adverse cardiac events, and acute kidney injury after non-cardiac surgery: A meta-analysis of cohort studies.

BACKGROUND: The association between intraoperative hypotension (IOH) and postoperative outcomes is not fully understood. We performed a meta-analysis to determine whether IOH is associated with increased risk of 30-day mortality, major adverse cardiac events (MACEs) and acute kidney injury (AKI) after non-cardiac surgery. METHODS: We searched PubMed and Embase through May 2016 to identify cohort studies that investigated the association between IOH and risk of 30-day mortality, MACEs, or AKI in adult patients after non-cardiac surgery. Ascertainment of IOH and assessment of outcomes were defined by the individual study. Considering the level of clinical heterogeneity, adjusted odds ratios (ORs) with 95% confidence interval (CIs) were pooled using a random-effects model. This meta-analysis is registered on PROSPERO (CRD42016049405). RESULTS: We included 14 cohort studies that were heterogeneous in terms of definition of IOH. IOH alone was associated with increased risk of 30-day mortality (OR 1.29 [95% CI, 1.19-1.41]), MACEs (OR 1.59 [95% CI, 1.23-2.05]), especially myocardial injury (OR 1.67 [95% CI, 1.31-2.13]), and AKI (OR 1.39 [95% CI, 1.09-1.77]). Triple low (IOH coincident with low bispectral index and low minimum alveolar concentration) also predicts increased risk of 30-day mortality (OR 1.32 [95% CI, 1.03-1.68]). CONCLUSIONS: IOH alone significantly increases the risk of postoperative 30-day mortality, MACEs, especially myocardial injury, and AKI in adult patients after non-cardiac surgery. Triple low also predicts increased risk of 30-day mortality after non-cardiac surgery. These findings provide evidence that IOH should be recognized as an independent risk factor for postoperative adverse outcomes after non-cardiac surgery.

Early vasopressor use following traumatic injury: a systematic review.

OBJECTIVES: Current guidelines suggest limiting the use of vasopressors following traumatic injury; however, wide variations in practice exist. Although excessive vasoconstriction may be harmful, these agents may help reduce administration of potentially harmful resuscitation fluids. This systematic review aims to compare early vasopressor use to standard resuscitation in adults with trauma-induced shock. DESIGN: Systematic review. DATA SOURCES: We searched MEDLINE, EMBASE, ClinicalTrials.gov and the Central Register of Controlled Trials from inception until October 2016, as well as the proceedings of 10 relevant international conferences from 2005 to 2016. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials and controlled observational studies that compared the early vasopressor use with standard resuscitation in adults with acute traumatic injury. RESULTS: Of 8001 citations, we retrieved 18 full-text articles and included 6 studies (1 randomised controlled trial and 5 observational studies), including 2 published exclusively in abstract form. Across observational studies, vasopressor use was associated with increased short-term mortality, with unadjusted risk ratios ranging from 2.31 to 7.39. However, the risk of bias was considered high in these observational studies because patients who received vasopressors were systematically sicker than patients treated without vasopressors. One clinical trial (n=78) was too imprecise to yield meaningful results. Two clinical trials are currently ongoing. No study measured long-term quality of life or cognitive function. CONCLUSIONS: Existing data on the effects of vasopressors following traumatic injury are of very low quality according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. With emerging evidence of harm associated with aggressive fluid resuscitation and, in selected subgroups of patients, with permissive hypotension, the alternatives to vasopressor therapy are limited. Observational data showing that vasopressors are part of usual care would provide a strong justification for high-quality clinical trials of early vasopressor use during trauma resuscitation. TRIAL REGISTRATION NUMBER: CRD42016033437.

Impact of bariatric surgery on renal functions in patients with type 2 diabetes: systematic review of randomized trials and observational studies.

BACKGROUND: The impact of bariatric surgery on renal functions in patients with type 2 diabetes (T2D) remains uncertain. OBJECTIVES: To assess the impact of bariatric surgery on renal functions in patients with T2D. SETTING: Systemic review and meta-analysis of randomized trials and observational studies. METHODS: We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) from inception to April 3, 2016. We included studies assessing bariatric surgery for renal functions in patients with T2D. We analyzed changes in renal functions before and after surgery and compared outcomes between surgeries versus nonsurgical treatments. RESULTS: Twenty-nine studies (4 randomized controlled trials, 5 cohort studies, 20 before-and-after studies; all at moderate to high risk of bias) were eligible, involving 18,172 patients. Analyses of changes before and after surgeries suggested a significantly lower proportion of albuminuria (difference -21.2%, 95% confidence interval [CI] -28.8% to -13.5%), 24-hour urine albumin excretion rate (weighted mean difference -48.78 mg/24 hr, 95% CI -75.32 to -22.24) and urine albumin-to-creatinine ratio (uACR) (weighted mean difference -16.10 mg/g, 95% CI -22.26 to -9.94) after surgery. Compared with nonsurgical treatment, bariatric surgery was associated with a statistically lower level of uACR and lower risk of new-onset albuminuria (odds ratio .18, 95% CI .03-.99 from randomized controlled trials). The effects on glomerular filtration rate, serum creatinine, creatinine clearance, and risk of end-stage renal disease were not statistically significant. CONCLUSIONS: Low-quality evidence suggests that bariatric surgery possibly improves albuminuria and uACR in patients with T2D; its effects on other outcomes were uncertain. Well-conducted, adequately powered, randomized controlled trials are warranted to examine the effect of bariatric surgery on renal functions in the T2D population.

COX-2 rs689466, rs5275, and rs20417 polymorphisms and risk of head and neck squamous cell carcinoma: a meta-analysis of adjusted and unadjusted data.

BACKGROUND: Numerous case-control studies have been performed to investigate the association between three cyclooxygenase-2 (COX-2) polymorphisms (rs20417 (-765G > C), rs689466 (-1195G > A), and rs5275 (8473 T > C)) and the risk of head and neck squamous cell carcinoma (HNSCC). However, the results were inconsistent. Therefore, we conducted this meta-analysis to investigate the association. METHODS: We searched in PubMed, Embase, and Web of Science up to January 20, 2015 (last updated on May 12, 2016). Two independent reviewers extracted the data. Odds ratios (ORs) with their 95 % confidence intervals (CIs) were used to assess the association. All statistical analyses were performed using the Review Manager (RevMan) 5.2 software. RESULTS: Finally 8 case-control studies were included in this meta-analysis. For unadjusted data, an association with increased risk was observed in three genetic models in COX-2 rs689466 polymorphism; however, COX-2 rs5275 and rs20417 polymorphisms were not related to HNSCC risk in this study. The pooled results from adjusted data all revealed non-significant association between these three polymorphisms and risk of HNSCC. We also found a similar result in the subgroup analyses, based on both unadjusted data and adjusted data. CONCLUSION: Current results suggest that COX-2 rs689466, rs5275, and rs20417 polymorphisms are not associated with HNSCC. Further large and well-designed studies are necessary to validate this association.

Cisplatin for testicular germ cell tumors: a rapid review.

OBJECTIVE: Cisplatin is one of efficacious medicines for TGCT, but is not in 18th WHO EML now. The Union for International Cancer Control recommended cisplatin to the 19th WHO EML for TGCT. To evaluate the effectiveness, safety and cost of cisplatin for TGCT according to the requirements of WHO EML Expert Committee, and to provide the evidence whether cisplatin should be included in WHO EML. METHOD: We searched The Cochrane Library, PubMed, EMbase, NHS EED, US National Guideline Clearinghouse (NGC) and WHO guidelines. Guidelines and systematic reviews (SRs) on cisplatin for TGCT were included. Two reviewers selected studies and extracted relevant information independently. Quality of SRs was appraised through AMSTAR. RESULTS: Seven guidelines and four SRs were included in this rapid review. Quality of SRs was moderate according to AMSTAR. The results showed that: (a) effectiveness: cisplatin-based chemotherapy significantly improved in response rates and overall survival for more advanced disease (stage II and stage III). Bleomycin, etoposide, and cisplatin (BEP)-one of the most widely used of cisplatin-based chemotherapy regimens should be considered as the standard treatment of good-prognosis patients with survival rates of 90% and as the best option for intermediate- or poor-prognosis patients with survival rates of 75% and 50%, respectively. (b) Safety: nephrotoxicity, ototoxicity and peripheral neuropathy are common adverse effects of cisplatin. (c) Cost: there was no relevant study about cost of cisplatin for TGCT. But the affordability of cispaltin is good for Chinese patients, due to it is in health insurance directory of China. CONCLUSIONS: We recommend cisplatin to be listed in 19th WHO EML for TGCT, due to adequate evidence of effectiveness and good affordability.

Periodontal Disease and Incident Lung Cancer Risk: A Meta-Analysis of Cohort Studies.

BACKGROUND: Periodontal disease is linked to a number of systemic diseases such as cardiovascular diseases and diabetes mellitus. Recent evidence has suggested periodontal disease might be associated with lung cancer. However, their precise relationship is yet to be explored. Hence, this study aims to investigate the association of periodontal disease and risk of incident lung cancer using a meta-analytic approach. METHODS: PubMed, Scopus, and ScienceDirect were searched up to June 10, 2015. Cohort and nested case-control studies investigating risk of lung cancer in patients with periodontal disease were included. Hazard ratios (HRs) were calculated, as were their 95% confidence intervals (CIs) using a fixed-effect inverse-variance model. Statistical heterogeneity was explored using the Q test as well as the I(2) statistic. Publication bias was assessed by visual inspection of funnel plots symmetry and Egger's test. RESULTS: Five cohort studies were included, involving 321,420 participants in this meta-analysis. Summary estimates based on adjusted data showed that periodontal disease was associated with a significant risk of lung cancer (HR = 1.24, 95% CI = 1.13 to 1.36; I(2) = 30%). No publication bias was detected. Subgroup analysis indicated that the association of periodontal disease and lung cancer remained significant in the female population. CONCLUSION: Evidence from cohort studies suggests that patients with periodontal disease are at increased risk of developing lung cancer.

Tea Consumption and Risk of Bladder Cancer: A Dose-Response Meta-Analysis.

Background and Objective: Controversial results of the association between tea (black tea, green tea, mate, and oolong tea) consumption and risk of bladder cancer were reported among epidemiological studies. Thus, we performed a meta-analysis of observational studies to investigate the association. Methods: We searched the PubMed and Embase for studies of tea consumption and bladder cancer that were published in any language up to March, 2016. Cohort or case-control studies were included in the meta-analysis. All statistical analyses were performed in Stata 12.0 software. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated to assess the relationship between tea consumption and risk of bladder cancer. Results: Totally, 25 case-control studies (15 643 cases and 30 795 controls) and seven prospective cohort studies (1807 cases and 443 076 participants) were included. The meta-analysis showed that tea consumption was not significantly associated with bladder cancer risk (OR = 0.96, 95% CI 0.86-1.06) (in a comparison of highest vs. lowest category). No non-linearity association was observed between tea consumption and bladder cancer risk (P = 0.51 for non-linearity). Specific analysis for black tea, green tea, and mate yielded similar results. The dose-response analysis showed the summary OR for an increment of 1 cup/day of tea consumption was 1.01 (95% CI 0.97-1.05). Conclusion: Results based on current meta-analysis indicated that no significant association was observed between tea consumption and risk of bladder cancer.

Periodontal disease and carotid atherosclerosis: A meta-analysis of 17,330 participants.

BACKGROUND AND OBJECTIVES: The association between periodontal disease and carotid atherosclerosis has been evaluated primarily in single-center studies, and whether periodontal disease is an independent risk factor of carotid atherosclerosis remains uncertain. This meta-analysis aimed to evaluate the association between periodontal disease and carotid atherosclerosis. METHODS: We searched PubMed and Embase for relevant observational studies up to February 20, 2015. Two authors independently extracted data from included studies, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for overall and subgroup meta-analyses. Statistical heterogeneity was assessed by the chi-squared test (P<0.1 for statistical significance) and quantified by the I(2) statistic. Data analysis was conducted using the Comprehensive Meta-Analysis (CMA) software. RESULTS: Fifteen observational studies involving 17,330 participants were included in the meta-analysis. The overall pooled result showed that periodontal disease was associated with carotid atherosclerosis (OR: 1.27, 95% CI: 1.14-1.41; P<0.001) but statistical heterogeneity was substantial (I(2)=78.90%). Subgroup analysis of adjusted smoking and diabetes mellitus showed borderline significance (OR: 1.08; 95% CI: 1.00-1.18; P=0.05). Sensitivity and cumulative analyses both indicated that our results were robust. CONCLUSIONS: Findings of our meta-analysis indicated that the presence of periodontal disease was associated with carotid atherosclerosis; however, further large-scale, well-conducted clinical studies are needed to explore the precise risk of developing carotid atherosclerosis in patients with periodontal disease.

Plasmakinetic resection technology for the treatment of benign prostatic hyperplasia: evidence from a systematic review and meta-analysis.

The aim of this study was to compare plasmakinetic resection of the prostate (PKRP) with transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH) in terms of efficacy and safety. Published RCTs were searched from PubMed, Embase, Science Citation Index, and Cochrane Library up to April 10, 2014. After methodological quality assessment and data extraction, meta-analysis was performed using the STATA 12.0 software. 18 reports of 16 RCTs were included in this analysis. Meta-analyses showed that PKRP significantly improved Qmax at 12 months, but no significant difference was found for other efficacy outcomes. In terms of safety, treatment of PKRP was associated with reduced drop in serum sodium, lower TUR syndrome, reduced need of blood transfusion, clot retention, and shorter catheterization time and hospital stay; in contrast, there were no significant differences in the analysis of operative time, postoperative fever, and long-term postoperative complications. In summary, current evidence suggests that, although PKRP and TURP are both effective for BPH, PKRP is associated with additional potential benefits in efficacy and more favorable safety profile. It may be possible that PKRP may replace the TURP in the future and become a new standard surgical procedure.