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Background Testosterone deficiency (TD) may induce a series of clinical symptoms. Studies have shown that testosterone supplementation may prevent these unfavourable symptoms and improve patients’ quality of life. Given the conflicting findings across studies, this systematic review aims to evaluate the effects and risks associated with testosterone supplementation in middle-aged or aging males with TD. Methods Electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane. Library were searched to December 2019. The risk of bias of individual included studies and the quality of the aggregate evidence were assessed using the GRADE approach. Our primary outcome was bone mineral density (BMD). Meta-analyses were performed. This systematic review was reported according to the PRISMA statement. Results A total of 52 randomized controlled trials (RCTs) were included. When compared with placebo, testosterone supplementation did not increase total BMD (short-term: 1081 participants, MD − 0.01 g/cm2, 95% CI − 0.02 g/cm2 to 0.01 g/cm2; long-term: 156 participants, MD 0.04 g/cm2, 95% CI − 0.07 g/cm2 to 0.14 g/cm2), lumbar spine, hip, or femur neck BMD. Furthermore, testosterone supplementation did not decrease the risk of falling or fracture. Lastly, it was found that testosterone supplementation did not increase the risk of cardiovascular events (1374 participants, RR 1.28, 95% CI 0.62 to 2.64), all-cause mortality (729 participants, RR 0.55, 95% CI 0.29 to 1.04), or prostatic events. However, testosterone supplementation may improve sexual function and quality of life (1328 participants, MD -1.32, 95% CI − 2.11 to − 0.52). Conclusions The effect of testosterone supplementation on BMD and the risk of falls or fracture remains inconclusive. However, supplementation may benefit patients in the areas of sexual function and quality of life without increasing the risk of cardiovascular events, all-cause mortality, or prostatic events. RCTs with a longer follow-up period are still required. Trial registration We registered our protocol in PROSPERO (CRD42018109738).

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 126 kb)

Background: During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, organs in the lower body such as the viscera and spinal cord are at risk of ischemia even when antegrade cerebral perfusion (ACP) is performed. Combining ACP with retrograde inferior vena caval perfusion (RIVP) during TARS may improve outcomes by providing the lower body with oxygenated blood. Methods: This is a multi-center, randomized, controlled trial of 500 patients scheduled for TARS. Patients were randomly allocated to a moderate hypothermia circulatory arrest (MHCA) group, who received selective ACP with moderate hypothermia during TARS; or to an RIVP group, who received the combination of RIVP and selective ACP under moderate hypothermia during TARS. The primary outcome was a composite of early mortality and major complications, including paraplegia, postoperative renal failure, severe liver dysfunction, postoperative prolonged intubation (>48 h), and gastrointestinal complications. Discussion: This study aims to assess whether RIVP combined with selective ACP leads to superior outcomes than selective ACP alone for patients undergoing TARS under moderate hypothermia. This study seeks to provide high-quality evidence for RIVP to be used in patients with acute type A aortic dissection undergoing TARS.

IntroductionThere is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. According to the theory of traditional Chinese medicine and preliminary clinical evidence, the patients’ acupoints and tender points may become sensitised when the body suffers from a disease state; stimulation of such sensitive points could lead to a disease improvement. It is thus hypothesised that acupuncture at highly sensitised points on patients with KOA would achieve better treatment outcomes than acupuncture at low/non-sensitised points. Previously, we conducted a pilot trial to prove the feasibility of further investigation.Methods and analysisA three-arm, parallel, multicentre randomised controlled trial of 666 patients will be conducted at four hospitals of China. Eligible patients with KOA who consent to participate will be randomly assigned to a high-sensitisation group (patients receive acupuncture treatment at high-sensitive points), a low/non-sensitisation group (patients receive acupuncture treatment at low/non-sensitive points) or a waiting-list group (patients receive standard acupuncture treatment after the study is concluded) via a central randomisation system using 1:1:1 ratio. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat and per-protocol population. The primary analyses will test if acupuncture at highly sensitised points would achieve statistically better treatment outcomes than acupuncture at low/non-sensitised points and no acupuncture (ie, waiting list), respectively. A small number of prespecified subgroup analyses will be conducted.Ethics and disseminationEthics approval has been granted by the Bioethics Subcommittee of West China Hospital, Sichuan University: 2017 (Number 228). Results will be expected to be published in peer-reviewed journals.Trial registration numberNCT03299439.

Objective: According to current guidelines, there is no clear second-line treatment for advanced liver cancer. In practice, clinicians have attempted to use thalidomide(TLD) combined with transcatheter arterial chemoembolization (TACE) for treating liver cancer. This study aims to assess the clinical efficacy and safety of TLD combined with TACE in patients with intermediate or advanced hepatocellular carcinoma. Methods: Medline, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), database of ClinicalTrials.gov, CBM, CNKI, VIP and Wanfang database were searched for eligible studies. Criteria for inclusion in our meta-analysis included a study that patients diagnosed with intermediate or advanced HCC, the use of TACE plus TLD or its derivatives, and the availability of outcome data for survival. A meta-analysis was conducted to summarize the evidences of randomized controlled trials (RCTs). And finally, the GRADE approach was used to assess the quality of these evidences. Results: Twelve RCTs involving 894 Hepatocellular Carcinoma (HCC) patients were included. The meta-analysis results showed that TACE plus TLD was significantly superior than TACE alone in terms of 12-month survival rate (OR=2.55, 95% CI: 1.78-3.64, P

Objective To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs. Method RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63-item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P < 0.05 was considered statistically significant. SPSS was used for all analyses. Results A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). Significant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post-CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT-promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively). Conclusion Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.

Objective: To explore the relationship between the external validity and the internal validity of hypertension RCTs conducted in China. Methods: Comprehensive literature searches were performed in Medline, Embase, Cochrane Central Register of Controlled Trials (CCTR), CBMdisc (Chinese biomedical literature database), CNKI (China National Knowledge Infrastructure/China Academic Journals Full-text Database) and VIP (Chinese scientific journals database) as well as advanced search strategies were used to locate hypertension RCTs. The risk of bias in RCTs was assessed by a modified scale, Jadad scale respectively, and then studies with 3 or more grading scores were included for the purpose of evaluating of external validity. A data extract form including 4 domains and 25 items was used to explore relationship of the external validity and the internal validity. Statistic analyses were performed by using SPSS software, version 21.0 (SPSS, Chicago, IL). Results: 226 hypertension RCTs were included for final analysis. RCTs conducted in university affiliated hospitals (P

To investigate the association between bisphenol A (BPA) and polycystic ovary syndrome (PCOS).A systematic review and meta-analysis using STATA software for observational studies.Nine studies involving 493 PCOS patients and 440 controls were included in this review. The meta-analysis demonstrated that PCOS patients had significantly higher BPA levels compared with control groups (standardized mean difference (SMD): 2.437, 95% confidence interval (CI): (1.265, 3.609), p .001). For studies of serum samples detected by enzyme-linked immunosorbent assay (ELISA), subgroup analyses according to ethnicity, body mass index (BMI), sample size, detection method (high-performance liquid chromatography (HPLC) and ELISA), PCOS-to-control ratio and study quality displayed that high BPA levels were significantly associated with Caucasian PCOS patients (SMD: 0.615, 95% CI: (0.308, 0.922), p .001), high BMI (SMD: 0.512, 95% CI: (0.180, 0.843), p = .002), high quality (SMD: 0.624, 95% CI: (0.391, 0.856), p .001), and high HOMA-IR (SMD: 0.467, 95% CI: (0.121, 0.813), p = .008).Serum BPA may be positively associated with women with PCOS and BPA might be involved in the insulin-resistance and hyperandrogenism of PCOS. More evidence from high quality studies, advanced detection methods, and larger cohorts for observational trials are needed to further confirm the association between BPA and PCOS.

Purpose: This study compared the efficacy of an α-blocker monotherapy alone with a combination of α-blocker plus 5α-reductase in treatment of benign prostatic hyperplasia (BPH). Methods: Medline (PubMed), EMBASE, CENTRAL (Cochrane databases) and Google Scholar were searched until May 2015 using the following search terms: ([α-blocker] AND 5α-reductase inhibitor) AND benign prostatic hyperplasia; and benign prostatic hyperplasia AND (adrenergic alpha blockers OR 5 alpha reductase inhibitor). Randomized controlled trials (RCTs) that included men with a clinical diagnosis of BPH were included. Eligible studies had to have an intervention group that received combination therapy (5α reductase inhibitor plus α-blocker) and a control group that received only α-blocker. Quality assessment and sensitivity analysis were performed. Results: Six studies were included. Combination therapy was found to significantly reduce urinary retention incidence rate (OR=0.286, 95%CI: 0.199 - 0.412, P

Objectives. To critically appraise the efficacy and safety of Kangfuxinye enema combined with mesalamine for the ulcerative colitis (UC) patients and in addition to grade the quality of evidence by using the GRADE (grading of recommendations, assessment, development, and evaluation) approach. Methods. A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP, and WanFang Databases. The search restrictions were patients with UC and RCTs. Studies including other treatments except Kangfuxinye with mesalamine were excluded. Results. Nineteen studies met the inclusion criteria. We found significant benefits of Kangfuxinye combined with mesalamine against mesalamine alone in improving response rate as well as reducing the recurrence rate and inflammation rate; meanwhile, the increase of the adverse events rate was not observed. Furthermore, the symptoms remission rate and the cure time were insignificant statistically. Additionally, GRADE results indicated that the quality of evidence regarding the above 6 outcomes was rated from very low to moderate quality. Conclusions. Although Kangfuxinye enema seems effective and safe for treating UC patients in this systematic review, Kangfuxinye enema combined with mesalamine was weakly recommended due to very low to moderate quality of available evidence by the GRADE approach.

To investigate the association between estradiol therapy and incidence of breast cancer, taking into consideration of different types of combined progestogen, the duration of exposure and the type of regimen.A systematic review and meta-analysis.A total of 14 studies were included in our study. In estradiol-only therapy analysis, meta-analysis resulted a pooled OR =0.90, 95% CI (0.40, 2.02) from the RCTs and pooled OR = 1.11, 95% CI (0.98, 1.27) from observational studies. However, in the analysis of estradiol-progestogen therapy, the risk of breast cancer varies according to the type of progestogen and the duration with more than five years (OR = 2.43, 95% CI (1.79, 3.29)) presented a higher risk than using less than five years (OR = 1.49, 95% CI (1.03, 2.15)).Estradiol-only therapy carries no risk for breast cancer, while the breast cancer risk varies according to the type of progestogen. Estradiol therapy combined with medroxyprogesterone, norethisterone and levonorgestrel related to an increased risk of breast cancer, estradiol therapy combined with dydrogesterone and progesterone carries no risk. The breast cancer risk rise progressively by prolonged use, furthermore, comparing to sequential therapy, continuous therapy carries a higher risk.

Background To appraise critically whether published trials of ShenXiong glucose injection for patients with acute ischemic stroke (AIS) are of sufficient quality, and in addition to rate the quality of evidence by using the GRADE approach (grading of recommendations, assessment, development, and evaluation, GRADE). Methods A literature search was performed in the Cochrane Library, MEDLINE, EMBASE, CBM, Chinese TCM (traditional Chinese medicine) Database, CNKI, VIP, WanFang Databases until January 2015. The limits were patients with AIS and randomized controlled trials (RCTs) or quasi-RCTs. Studies by which patients suffering intracerebral haemorrhage were excluded. Results Twelve studies fulfilled the inclusion criteria. We found significant benefits of ShenXiong glucose injection compared with conventional treatment in improving activities of daily living function at 4 weeks (MD = 34.12, 95 % CI: 29.07, 39.17), neurological function deficit at 2 weeks (MD = −5.39, 95 % CI: −6.90, −3.87), 4 weeks (MD = −5.16, 95 % CI: −6.49, −3.83), and clinical effects at 4 weeks (RR = 1.17, 95 % CI: 1.10, 1.24). No trials reported the effects of ShenXiong glucose injection on the risk of early, deterioration, or quality of life. No adverse events were reported within the whole follow-up period. Conclusions The use of ShenXiong glucose injection may improve rehabilitation for patients with acute ischemic stroke, however, as the GRADE approach indicated low to moderate quality of available evidence as well as insufficient information about harm and patients preference, the recommendations were not provided for ShenXiong glucose injection taking as a therapeutic intervention to patients with acute ischemic stroke. Electronic supplementary material The online version of this article (doi:10.1186/s12906-016-1038-8) contains supplementary material, which is available to authorized users.

Objective. The aim of this study is to measure the reliability and external validity of AMSTAR by applying it to a sample of TCM systematic reviews.Study Design and Methods. We tested the agreement, reliability, construct validity, and feasibility of AMSTAR through comparisons with OQAQ. Statistical analyses were performed by using SPSS 13.0.Results. A random of sample with 41 TCM systematic reviews was selected from a database. The interrater agreement of the individual items of AMSTAR was moderate with a mean kappa of 0.50 (95% CI: 0.26, 0.73). The ICC for AMSTAR against OQAQ (total score of 9 items, excluding item 10) was 0.87 (95% CI: 0.76, 0.93).Conclusions. Although there is room for improvement on few items, the new tool is reliable, valid, and easy to use for methodological quality assessment of systematic reviews on TCM.

Traditional Chinese medicine (TCM) is one of the rarely existing ancient traditional medicines that hold systematic theories as well as preventative and therapeutic methods for diseases in practice. From the 1950s, such research methods as mathematics, statistics, and data mining (DM) have been gradually introduced to TCM studies, making it more scientific. Meanwhile, the distinct features of TCM theories and diagnostic-model have constantly challenged the methodology of statistics. This paper introduces the following scientific features of traditional Chinese therapeutics: 1) its goal is to balance the functions and conditions of human body; 2) it emphasizes on holism and individualization; 3) it stresses the longitudinal regulation and evaluation mode, which is a circle of syndrome diagnosis, treatment and evaluation; 4) the interventions of TCM are abundant, compound and natural; and 5) humanistic thought is everywhere. Some statistical problems are raised based on these features. First, complex statistical methods that can analyze subjective indexes and latent variables, multidimensional and multistage data, non-equilibrium designed studies, and longitudinal data are required. Second, comprehensive evaluation on multiple-target mechanism has been brought in by combination treatment. Third, there is a need to analyze how humanity and related cultural factors may influence the effect of interventions. Thus, promoting implemented studies of statistics as well as carrying out the TCM scientific propositions have become the common expectations of both TCM and modern medicine.

Background. Early childhood caries (ECC) is the presence of caries in primary teeth in children 71 months of age or younger. Despite a decreasing prevalence of caries in China, ECC and related risk factors in China have not been well studied. Aims. This study aimed to investigate the status of ECC in children living in Xiamen city in China and to analyse the associated social and behaviour determinants. Design. A stratified random sample consisted of 1523 children with normal birth records. Clinical examination was performed to record caries at the surface level. Parents filled in questionnaires regarding eating habits, family status, childcare provider, and oral intervention. Results. Prevalence of ECC in studied child population was 56.8–78.31%, with an increasing tendency with age. The following factors were found to be significantly associated with ECC: age, candy, carbonated drink, bedtime eating, late start of brushing, low education of parents, private childcare, increased number of siblings, rural residence, and lack of oral health knowledge. Using a stepwise forward logistic regression analysis, a prediction model was established. Conclusion. Early childhood caries in children living in Xiamen city was strongly associated with eating habits, family- and childcare-related factors and tooth-brushing. The ECC-high-risk group is children in rural private childcare facilities.

Objective To assess the reporting quality of acupuncture trials for knee osteoarthritis (KOA), and explore the factors associated with the reporting. Method Three English and four Chinese databases were searched from inception to December 2016 for randomized control trials testing effects of acupuncture for knee osteoarthritis. We used the standard CONSORT (2010 version), CONSORT Extension for Non-Pharmacological Treatments, and STRICTA for measuring the quality of reporting. Using pre-specified study characteristics, we undertook regression analyses to examine factors associated with the reporting quality. Results A total of 318 RCT reports were included. For the standard CONSORT, ten items were substantially under-reported (reported in less than 5% of RCTs), including specification of important changes to methods after trial commencement (0.6%), description of any changes to trial outcomes (0.0%), implementation of interim analyses and stopping guidelines (0.6%), statement about why the trial ended or was stopped (1.6%), statement about the registration status (4.4%), accessibility of full trial protocol (4.7%), implementation of randomization (4.7%), description of the similarity of interventions (3.5%), conduct of ancillary analyses (3.8%) and presentation of methods for additional analyses (4.4%). Four of the STRICTA items were under-reported (reported in less than 10% of RCTs), including description of acupuncture style (8.5%), presentation of extent to which treatment varied (1.3%), statement of practitioner background (7.2%) and rationale for the control (9.1%). For CONSORT Extension, the reporting was poor across all items (reported in less than 10% of trials). Trials including authors with expertise in epidemiology or statistics, published in English, or enrolling patients from multiple centers were more likely to have better reporting. Conclusions The reporting in RCTs of acupuncture for KOA was generally poor. To improve the reporting quality, journals should encourage strict adherence to the reporting guidelines.

ObjectiveTo assess risk of bias and to investigate methodological issues concerning the design, conduct and analysis of randomised controlled trials (RCTs) testing acupuncture for knee osteoarthritis (KOA).MethodsPubMed, EMBASE, Cochrane Central Register of Controlled Trials and four major Chinese databases were searched for RCTs that investigated the effect of acupuncture for KOA. The Cochrane tool was used to examine the risk of bias of eligible RCTs. Their methodological details were examined using a standardised and pilot-tested questionnaire of 48 items, together with the association between four predefined factors and important methodological quality indicators.ResultsA total of 248 RCTs were eligible, of which 39 (15.7%) used computer-generated randomisation sequence. Of the 31 (12.5%) trials that stated the allocation concealment, only one used central randomisation. Twenty-five (10.1%) trials mentioned that their acupuncture procedures were standardised, but only 18 (7.3%) specified how the standardisation was achieved. The great majority of trials (n=233, 94%) stated that blinding was in place, but 204 (87.6%) did not clarify who was blinded. Only 27 (10.9%) trials specified the primary outcome, for which 7 used intention-to-treat analysis. Only 17 (6.9%) trials included details on sample size calculation; none preplanned an interim analysis and associated stopping rule. In total, 46 (18.5%) trials explicitly stated that loss to follow-up occurred, but only 6 (2.4%) provided some information to deal with the issue. No trials prespecified, conducted or reported any subgroup or adjusted analysis for the primary outcome.ConclusionThe overall risk of bias was high among published RCTs testing acupuncture for KOA. Methodological limitations were present in many important aspects of design, conduct and analyses. These findings inform the development of evidence-based methodological guidance for future trials assessing the effect of acupuncture for KOA.

Recognition of the need for systematically developed clinical practice guidelines (CPGs) has increased dramatically over the past 20 years. CPGs have focused primarily on the effectiveness of interventions, explicitly or implicitly addressing the following question: Will adherence to a recommendation do more good than harm? At times they have also focused on the cost-effectiveness of interventions: Are the net benefits worth the costs? They rarely have focused on equity: Are the recommendations fair? The Knowledge Plus Project of the International Clinical Epidemiology Network attempts to improve the process of CPG development by formulating strategies to consider not just technical issues (effectiveness, and efficiency) but sociopolitical dimensions as well (equity and local appropriateness). This article discusses a proposed lens for users to evaluate how well CPGs address issues of equity.

To examine the reporting characteristics and key methodological factors of randomized controlled trials (RCTs) in the field of traditional Chinese medicine and assess whether use of the Consolidated Standards of Reporting Trials (CONSORT) statement is associated with improvement in the quality of reports of RCTs.RCTs published in two major traditional Chinese medicine journals were retrieved and were systematically reviewed. Of those journals, one adopted the CONSORT statement (Journal of Chinese Integrative Medicine (JCIM)) and one did not (Chinese Journal of Integrative Medicine (CJIM)). Items within the CONSORT 2001 and the CONSORT 2010 statements were taken to develop a 63-item coding manual. The Jadad scale was also used to assess methodological quality of RCTs. Two observers assessed the reporting of reports and extracted data independently. P0.05 was considered statistically significant. SPSS was used for all analyses.A total of 76 RCTs were included for the analysis (38 from JCIM and 38 from CJIM). Significant improvements both in the overall quality of reporting (CONSORT score) and reporting of methodological items (Jadad scale) over time were observed in adopter journal (JCIM) (P = 0.001). Overall CONSORT score of studies published during 2010 to 2011 (post-CONSORT) increased 15.30 averagely with 95%CI 8.34 to 22.26 (P = 0.001). Of those, items addressed on reporting of methodological quality were different significantly too. JCIM had more 1.30 items addressed than CJIM in average (95% CI 0.52 to 2.08, P = 0.003). In the multivariate analysis regression, the page length and CONSORT-promoting status have statistically significant associated with the (P = 0.001 and P = 0.040, respectively).Although a large room needs to improve the reporting of randomized clinical trials in traditional Chinese medicine, the impact for improvement of reporting of TCM RCTs has been proven in some extent.

Shuganjieyu capsule is a pure herbal pharmaceutical product for depression. Our objective was to explore the effectiveness and safety of Shuganjieyu capsule for the treatment of major depressive disorder in adults.Eight computerized databases were searched. In addition, randomized controlled trials (RCTs) on Shuganjieyu capsule were hand-searched on seven key Chinese journals. Data were extracted and evaluated by two reviewers independently. Analysis was performed by intention-to-treat where possible. Prespecified subgroup analyses were different-dose regimens, patient spectrum, publication status, and treatment duration.Seven RCTs with 595 participants were included. Shuganjieyu capsule was superior than placebo in terms of response rate (RR = 2.42, 95% CI: 1.55-3.79; P = 0.0001), remission rate (RR = 4.29, 95% CI: 1.61-11.45; P = 0.004), the scores of the mean change from baseline of the HAM-D17 (MD = -4.17, 95% CI: -5.61 to -2.73; P0.00001) and from baseline of traditional Chinese medicine (TCM) syndrome score scale scores (MD = -6.00, 95% CI: -8.25 to -3.75; P0.00001). In addition, Shuganjieyu plus venlafaxine had a significantly higher response rate (RR = 1.56, 95% CI: 1.29-1.88; P0.00001) and was superior in terms of the scores of the mean change from baseline of the treatment emergent symptoms scale scores (MD = -0.74, 95% CI:-1.12 to -0.35; P = 0.0002) than venlafaxine alone.Shuganjieyu capsule is superior to placebo in terms of overall treatment effectiveness and safety. Both response rate and remission rate among patients treated with the combination of Shuganjieyu plus venlafaxine were significantly higher than those treated with venlafaxine alone. Due to the considerable risk of bias in majority of trials, recommendations for practice should be cautious, and additional, well-designed RCTs are needed in next step.

ObjectiveTo explore external validity of randomized controlled trials (RCTs) of hypertension within China from the view of sample representation.MethodsComprehensive literature searches were performed in Medline, Embase, Cochrane Central Register of Controlled Trials (CCTR) et al and advanced search strategies were used to locate hypertension RCTs as well as observational studies conducted in China during 1996 to 2009 synchronously. The risk of bias in RCTs and observational studies was assessed by two modified scales respectively, and then both types of studies with 3 or more grading scores were included for the purpose of evaluating of external validity. Following that the study characteristics relative to sample representation were extracted from RCTs and observational studies synchronously, and the later were taken as external references for validating sample representation of RCTs.Results226 hypertension RCTs and 21 observational studies were included for final analysis. Comparing samples with observational studies, the mean age of samples within RCTs was 54.46 years, significantly lower than that of observational studies (66.35 years) (P=0.002). The average disease course in patients of RCTs was 3.89 years and grade III hypertensive patients accounted for 17%; both were lower than that of the observational studies (12.96 years, PConclusionSample characteristics within hypertension RCTs were significantly different from those in observational studies. The samples in most RCTs were under-represented. It's feasible to take samples of observational studies as a mirror of the actual composition of hypertension patients in the real world, if the reporting of observational studies is abundant and available.

This paper is aimed to analyze the correlation between serum free testosterone (FT) and total testosterone (TT) to acquire a cutoff about using total testosterone to diagnose hyperandrogenism in Chengdu females. We investigated 1854 women by cluster sampling method, detected their serum FT levels and TT levels, scored relative items, analyzed the correlation and made the ROC curve to get a cutoff of TT levels. Serum FT had a linear correlation with serum TT (r = 0.597, r2 = 0.356, P0.001). The cutoff value was 0.635 ng/mL. The specificity and sensitivity were 76.3% and 77.24%, respectively. No correlation found between serum FT and Ferriman-Gallway Score (P = 0.392). Positive correlations were seen between serum FT and Plewig-Kligman Score (r = 0.137, P0.001), serum TT and Ferriman-Gallway Score (r = 0.069, P = 0.003) and serum TT and Plewig-Kligman Score (r = 0.092, P0.001). There is a linear correlation between serum FT and TT. We can diagnose hyperandrogenism according to the serum TT cutoff value (0.635 ng/mL). Its clinical symptoms are not paralleled with the biochemical test results.

Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women. The data on this syndrome in a Chinese community are limited. Methods: A community-based cross-sectional survey was undertaken. Cluster-randomized sampling was used. Female residents of Chengdu aged between 12 and 44 were included according to the constituent ratio of the female population of Sichuan province. We used three diagnostic criteria to determine the prevalence: the National Institutes of Health diagnostic criteria of PCOS (NIH-1990), the revised Rotterdam diagnostic criteria of PCOS (Rott-2003), and the recommended diagnostic criteria of PCOS by the Androgen Excess Society (AES-2006). Results: 1,645 participants were included. The prevalence of PCOS in women aged between 12 and 44 was 7.1, 11.2 and 7.4%, respectively, according to the three different criteria. After the onset of puberty, the prevalence of PCOS increased rapidly from 12 to 14 years of age, peaked between 15 and 24 and decreased gradually thereafter and reached its lowest point before menopause. Conclusions: The prevalence of PCOS in this study was in the PCOS prevalence range from existing studies. According to the trend of prevalence, PCOS might be a temporary condition.

Postoperative pancreatic fistula (POPF) is one of the most common major complications after pancreaticoduodenectomy (PD). Ulinastatin is an intrinsic trypsin inhibitor and mainly used to treat acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure. The study aims to investigate the efficacy of ulinastatin on pancreatic fistula and other complications after PD. This prospective, randomized, double-blind, placebo-controlled trial was conducted in West China Hospital of Sichuan University from December 2012 to December 2014. A total of 106 consecutive patients undergoing PD were randomly assigned to receive ulinastatin or placebo during and after the surgery for 5 days. Baseline clinical characteristics and outcomes of patients were recorded and analyzed. Ninety-two patients including 42 in the ulinastatin group and 50 in the placebo group were available for outcome assessment. The POPF rates were comparable between ulinastatin group (43%) and placebo group (26%), whereas the severe pancreatic fistula rate (grade B + C) was significantly less in ulinastatin group than that in placebo group (7% vs 24%, P = 0.045). For patients with small pancreatic duct diameter (≤3 mm), ulinastatin could significantly reduce the risk of POPF (P = 0.022). Ulinastatin had protective effects for patients undergoing PD on the prevention of severe postoperative pancreatic fistula.

Supplemental Digital Content is available in the text, The aim of the study was to comprehensively examine the efficacy and safety of noninvasive ventilation used at the pulmonary infection control (PIC) window for acute respiratory failure (ARF) in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Seven electronic databases and relevant resources were searched to identify randomized controlled trials (RCTs) comparing patients using noninvasive ventilation at PIC window with those continuing receiving invasive ventilation. Retrieved citations were screened, risk of bias was assessed, and data were extracted by 2 independent review authors. Overall effect sizes were synthesized by using meta-analyses. Quality of evidence was rated by using Grading of Recommendations, Assessment, Development and Evaluation approach. A total of 17 trials involving 959 participants were included for this review. Compared with continuous invasive ventilation, noninvasive ventilation used at PIC window significantly reduced mortality, ventilator-associated pneumonia, weaning failures, reintubations, duration of invasive ventilation, total duration of mechanical ventilation, length of stay (LOS) in intensive care unit, and LOS in hospital as well as hospital costs. Of these, mortality significantly decreased (risk ratio = 0.27, 95% confidence interval: 0.17–0.42, P

Early childhood caries (ECC) is the presence of caries in primary teeth in children 71 months of age or younger. Despite a decreasing prevalence of caries in China, ECC and related risk factors in China have not been well studied.This study aimed to investigate the status of ECC in children living in Xiamen city in China and to analyse the associated social and behaviour determinants.A stratified random sample consisted of 1523 children with normal birth records. Clinical examination was performed to record caries at the surface level. Parents filled in questionnaires regarding eating habits, family status, childcare provider, and oral intervention.Prevalence of ECC in studied child population was 56.8-78.31%, with an increasing tendency with age. The following factors were found to be significantly associated with ECC: age, candy, carbonated drink, bedtime eating, late start of brushing, low education of parents, private childcare, increased number of siblings, rural residence, and lack of oral health knowledge. Using a stepwise forward logistic regression analysis, a prediction model was established.Early childhood caries in children living in Xiamen city was strongly associated with eating habits, family- and childcare-related factors and tooth-brushing. The ECC-high-risk group is children in rural private childcare facilities.

Objectives To examine the clinical characteristics, treatment, and survival of adult patients with renal sarcoma treated at our institution during the past 2 decades. Methods A retrospective review of the demographic, presentation, treatment, and outcome data for 41 adult patients with renal sarcoma treated at our institution from January 1989 to December 2009 was performed. The clinicopathologic parameters were analyzed to determine their effect on survival. Results Of the 41 patients, 18 were women and 23 were men. Their median age was 42 years (range 19-76). The median tumor size was 13 cm (range 4-35); 29 cases (70.7%) were high grade. The predominant histologic subtype was leiomyosarcoma (39.0%). At diagnosis, 6 patients (14.6%) had metastatic disease. Surgical resection was performed in 34 patients (82.9%), with negative margins in 22 (53.7%). After a median follow-up of 24 months (range 3-80), 3 patients (8.1%) had survived disease free, 11 (29.7%) were alive with disease, and 23 (62.2%) had died of disease. The overall 1-, 3-, and 5-year survival rate was 86.3%, 40.7%, and 14.5%, respectively, and the median survival was 28 months. The median survival after recurrence was 10 months (range 4-24) and that after metastasis 8 months (range 0-22). On univariate analyses, nonmetastatic disease (P = .001) and surgical resection (P = .000) were predictive of a favorable outcome. On multivariate analyses, surgical resection was the only independent predictor of survival (hazard ratio 35.629, P = .022). Conclusions Adult renal sarcoma accounts for 0.8% of renal cancer cases and has a poor prognosis. Early diagnosis and surgical resection offer patients the best chance of survival.

Background The prevalence of depression in women with polycystic ovary syndrome (PCOS) is high; one study has shown it to be four times that of women without PCOS. Therefore, systematic evaluation of the effectiveness and safety of antidepressants for women with PCOS is important. Objectives To evaluate the effectiveness and safety of antidepressants in treating depression and other symptoms in women with PCOS. Search methods We searched the following databases from inception to June 2012: the Cochrane Menstrual Disorders and Subfertility Group Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO and Chinese National Knowledge Infrastructure, the metaRegister of Controlled Trials (controlled-trials.com), the National Institute of Health Clinical Trials register (clinicaltrials.gov) and the World Health Organization International Trials Registry Platform search portal (www.who.int/trialsearch/Default.aspx). Selection criteria Only randomised controlled trials (RCTs) studying the effectiveness and safety of antidepressants for women with PCOS were included in this review. Data collection and analysis The methodological quality of the trials was assessed independently by two review authors, in parallel with data extraction. The risk of bias in the included study was assessed in six domains: 1. sequence generation; 2. allocation concealment; 3. blinding of participants, personnel and outcome assessors; 4. completeness of outcome data; 5. selective outcome reporting; 6. other potential sources of bias. Main results We found no studies reporting any of our primary review outcomes (depression and allied mood disorder scores, quality of life and adverse events). Only one study with 16 women was eligible for inclusion. This study compared sibutramine versus fluoxetine in women with PCOS, and reported only endocrine and metabolic outcomes. It was unclear whether the participants had psychological problems at baseline. No significant difference was found between the groups for any of the measured outcomes. Authors' conclusions There is no evidence on the effectiveness and safety of antidepressants in treating depression and other symptoms in women with PCOS.

Background Thymic carcinoma or advanced thymoma is a rare cancer of the thymus gland that tends to be aggressive and infiltrate neighbouring organs, making total resection very difficult. Induction or adjuvant chemotherapy, or both, are often used in a multimodality approach to treat people affected by this condition, but the effectiveness of chemotherapy for thymic carcinoma or advanced thymoma remains uncertain. Objectives To assess the role of chemotherapy in adults with thymic carcinoma or advanced thymoma. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2012, Issue 7), MEDLINE (accessed via Ovid from 1966 to July 2012), EMBASE (accessed via Ovid, from 1980 to July 2012), Latin American and Caribbean Literature on Health Sciences (LILACS), the Chinese Biological Medicine Database (CBM, 1978 to July 2012), China National Knowledge Infrastructure (CNKI, 1980 to July 2012) and the Chinese scientific periodical database VIP Information (VIP, 1989 to July 2012). There was no language restriction in searching for studies. Selection criteria We planned to include randomised controlled trials (RCTs) of trials using chemotherapy (either single-agent or combination chemotherapy plus surgery, radiotherapy or not) for thymic carcinoma and/or advanced thymoma. We planned to include all adults (aged 18 years and over) diagnosed with thymic carcinoma and/or with Masaoka stage III or IV thymic tumours. The intended primary outcomes were overall survival (OS) and progression-free survival (PFS). Data collection and analysis Two review authors independently evaluated the search results according to the inclusion and exclusion criteria. There were no studies identified for inclusion and therefore no data extraction was completed. Main results No RCTs were eligible for inclusion in this review. We report details of excluded prospective studies in an additional table and try to provide some useful evidence regarding current practice. Authors' conclusions There were no RCTs eligible for inclusion in this review. In current practice the most common regimen for adult patients with thymic carcinoma or advanced thymoma is cisplatin-based chemotherapy. Considering the condition is rare, it is suggested that an international group is set up to organise and evaluate prospective collection of data from cohorts of patients to inform current clinical practice.

To explore the life style and diet of pregnant women related to gestational diabetes mellitus (GDM) in order to provide scientific evidences for the prevention of GDM.A total of 450 subjects were recruited in a 1:2 matched case-control study including 150 pregnant women diagnosed as GDM and 300 normal pregnant women. All subjects participated in a questionnaire survey on socio-demographic characteristics, pregnancy relevant status, dietary structure and lifestyle. Conditional logistic regression analysis and t-test were used for the evaluation of relevant factors.There was a statistic significance of the difference between the two groups on total calorie, carbohydrate, fat and protein intakes per day (Por = 0.01). Twenty-three factors based on univariate analysis were associated with the occurrence of GDM. Seven factors were entered into the last logistic multivariate regression model. High blood pressure (OR = 28.50), adverse pregnant history (OR = 3.10), obesity before pregnancy (OR = 2.80), too much consumption of fruits (OR = 2.40), family history of DM (OR = 1.86) and favorite of sweets (OR = 1.68) were risk factors for GDM, while the consumption of more white meat was a protective factor (OR = 0.62).The occurrence of GDM was influenced by some adverse lifestyles, unreasonable dietary structure and other factors, such as hypertension, over weight before gestation and family history of DM. Measures should be taken to avoid and eliminate these risk factors.

ResumenAntecedentesLa prevalencia de depresión en pacientes con síndrome de ovario poliquístico (SOPQ) es alta; un estudio ha revelado que supera en cuatro veces la de las pacientes sin SOPQ. Por lo tanto, es importante la evaluación sistemática de la efectividad y la seguridad de los antidepresivos para las pacientes con SOPQ.ObjetivosEvaluar la efectividad y la seguridad de los antidepresivos en cuanto al tratamiento de la depresión y otros síntomas en pacientes con SOPQ.Métodos de búsquedaSe realizaron búsquedas en las siguientes bases de datos desde su inicio hasta junio de 2012: el registro de ensayos del Grupo Cochrane de Trastornos Menstruales y Subfertilidad (Cochrane Menstrual Disorders and Subfertility), el Registro Cochrane Central de Ensayos Controlados (Cochrane Central Register of Controlled Trials), MEDLINE, EMBASE, PsycINFO y Chinese National Knowledge Infrastructure, el metaRegister of Controlled Trials (controlled-trials.com), el National Institute of Health Clinical Trials register (clinicaltrials.gov) y en el portal de búsqueda de la World Health Organization International Trials Registry Platform (www.who.int/trialsearch/Default.aspx).Criterios de selecciónSólo se incluyeron en la revisión los ensayos controlados aleatorios (ECA) que estudiaban la efectividad y la seguridad de los antidepresivos en pacientes con SOPQ.Obtención y análisis de los datosLa calidad metodológica de los ensayos fue evaluada de forma independiente por dos revisores, de forma paralela a la extracción de datos. El riesgo de sesgo en los estudios incluidos se evaluó en seis dominios: 1. generación de secuencia: 2. ocultación de la asignación; 3. cegamiento de los participantes, personal y evaluadores de resultados; 4. completitud de los datos de resultado; 5. informe selectivo de los resultados; 6. otras fuentes potenciales de sesgo.Resultados principalesNo se encontraron estudios que informaran ninguno de los resultados primarios de la revisión (puntuaciones de la depresión y del trastorno del estado de ánimo relacionado, calidad de vida y eventos adversos). Sólo un estudio con 16 mujeres era elegible para la inclusión. Este estudio comparó sibutramina versus fluoxetina en pacientes con SOPQ, e informó sólo resultados endócrinos y metabólicos. Estuvo poco claro si las participantes tenían problemas psicológicos al inicio. No se hallaron diferencias significativas entre los grupos para ninguno de los resultados medidos.Conclusiones de los autoresNo existen pruebas sobre la efectividad y la seguridad de los antidepresivos para el tratamiento de la depresión y otros síntomas en pacientes con SOPQ.Resumen en términos sencillosEfecto de los antidepresivos para las mujeres con síndrome de ovario poliquísticoLa prevalencia de depresión en pacientes con síndrome de ovario poliquístico (SOPQ) es alta; un estudio ha revelado que supera en cuatro veces la de las pacientes sin SOPQ. Por lo tanto, es importante la evaluación sistemática de la efectividad y la seguridad de antidepresivos en pacientes con SOPQ. No se hallaron pruebas que apoyen el uso o el no uso de los antidepresivos en pacientes con SOPQ, con o sin depresión. Deberían llevarse a cabo ensayos controlados aleatorios bien diseñados y bien realizados con doble cegamiento.