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The overdiagnosis of prostate cancer (PCa) caused by nonspecific elevation serum prostate-specific antigen (PSA) and the overtreatment of indolent PCa have become a global problem that needs to be solved urgently. We aimed to construct a prediction model and provide a risk stratification system to reduce unnecessary biopsies. In this retrospective study, clinical data of 1807 patients from three Chinese hospitals were used. The final model was built using stepwise logistic regression analysis. The apparent performance of the model was assessed by receiver operating characteristic curves, calibration plots, and decision curve analysis. Finally, a risk stratification system of clinically significant prostate cancer (csPCa) was created, and diagnosis-free survival analyses were performed. Following multivariable screening and evaluation of the diagnostic performances, a final diagnostic model comprised of the PSA density and Prostate Imaging-Reporting and Data System (PI-RADS) score was established. Model validation in the development cohort and two external cohorts showed excellent discrimination and calibration. Finally, we created a risk stratification system using risk thresholds of 0.05 and 0.60 as the cut-off values. The follow-up results indicated that the diagnosis-free survival rate for csPCa at 12 months and 24 months postoperatively was 99.7% and 99.4%, respectively, for patients with a risk threshold below 0.05 after the initial negative prostate biopsy, which was significantly better than patients with higher risk. Our diagnostic model and risk stratification system can achieve a personalized risk calculation of csPCa. It provides a standardized tool for Chinese patients and physicians when considering the necessity of prostate biopsy.

Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group ( p = 0.037). Notably, the SFJD group significantly attenuated fever/chills ( p = 0.04) and headache ( p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group ( p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration : https://www.isrctn.com/ , identifier ISRCTN14236594.

This study aimed to synthesize the evidence of the comparative effectiveness and safety of ( ) preparations combined with renin-angiotensin system inhibitors (RASi) for diabetic kidney disease (DKD). Eight databases were searched from their inception to May 2023. Systematic reviews (SRs) of preparations combined with RASi for DKD were identified. Randomized controlled trials (RCTs) from the included SRs and additional searching were performed for data pooling. Cochrane risk-of-bias 2 (RoB 2) tool and AMSTAR 2 were used to evaluate the methodological quality of RCTs and SRs, respectively. A Bayesian network meta-analysis was performed to compare the add-on effect and safety of preparations for DKD. The certainty of evidence was graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. Fourteen SRs were included, whose methodological quality was assessed as high (1/14) or critically low (13/14). After combining additional searching, 157 RCTs were included, involving 13,143 participants. The quality of the RCTs showed some concerns (155/157) or high risk (2/157). Jinshuibao capsules and tablets, Bailing capsules and tablets, and Zhiling capsules were evaluated. Compared to RASi, adding either of the capsular preparations resulted in a decreased 24-h urinary total protein levels. preparations ranked differently in each outcome. Jinshuibao capsules plus RASi were beneficial in reducing urinary protein, serum creatinine, serum urea nitrogen, and blood glucose levels, with moderate-certainty evidence. No serious adverse events were observed after adding to RASi. Combining capsular preparations with RASi appeared to be associated with decreased urinary total protein levels in DKD patients. Further high-quality studies are needed to confirm. INPASY202350066.

ObjectivesTo analyse the relationship between serum uric acid (SUA), all-cause and cardiovascular (CV) mortality in peritoneal dialysis (PD) patients to inform clinical practice and future research.DesignA systematic review of observational studies.Data sourcesPubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), SinoMed, Chinese Science and Technology Journal Database (VIP) and Wan Fang databases were searched from their inception to January 2021 for cohort and case–control studies reporting SUA and mortality in patients with PD.MethodsThe Newcastle-Ottawa Quality Assessment Scale was used to appraise quality of cohort and case–control studies. Effect estimates were presented as HRs with 95% CIs in a meta-analysis using STATA V.16.0. Data not suitable for pooling were synthesised qualitatively.ResultsFourteen cohort studies with 24 022 patients were included. No case–control studies were identified. For prospective cohort studies, pooled results for the highest SUA category were significantly greater than the lowest for all-cause (one study; 1278participants; HR 1.79; 95% CI 1.17 to 2.75) and CV mortality (one study; 1278 participants; HR 2.63; 1.62–4.27). An increase of 1 mg/dL in SUA level was associated with a 16% increased risk of all-cause mortality (one study; 1278 participants; HR 1.16; 1.03–1.32) and 34% increased CV mortality risk (one study; 1278 participants; HR 1.34; 1.16–1.55). For retrospective cohort studies, the highest SUA category did not demonstrate an elevated all-cause (five studies; 4570 participants; HR 1.09; 0.70–1.70) or CV mortality (three studies; 3748 participants; HR 1.00; 0.44–2.31) compared with the lowest SUA category. Additionally, there was no increase in all-cause (eight studies; 11 541 participants; HR 0.94; 0.88–1.02) or CV mortality (three studies; 7427 participants; HR 0.90; 0.76–1.06) for every 1 mg/dL increase in SUA level.ConclusionsResults of prospective and retrospective cohort studies were inconsistent. Consequently, prospective, multicentre, long-term follow-up studies are required to confirm the relationship between SUA and mortality in patients with PD.

Background: Shengmai San (SMS) is a traditional Chinese medicine formula used for supplementing Qi and Yin and can mitigate symptoms related to malignant arrhythmia and heart failure. This systematic review aimed at exploring the effectiveness and safety of SMS for viral myocarditis (VMC). Methods: Eight databases from their inception to June 2023 were searched to identified randomized controlled trials (RCTs) focusing on SMS for VMC. The Cochrane Risk of Bias Tool was used to assess methodological quality. Mean difference (MD), standardized mean difference (SMD), and risk ratio (RR) with 95% confidence interval (CI) were calculated and input into the meta‐analysis using RevMan 5.4. Results: Forty‐four RCTs were included involving 4298 participants. The interventions included 29 types of modified SMS decoctions and 15 patent medicines. Overall study quality was low. Compared with western medicine (WM), SMS was associated with higher recovery rate from palpitations (RR 2.3, 95% CI 1.59, 3.33, 2 RCTs, n = 89), chest pain (RR 1.57, 95% CI [1.17, 2.09], 2 RCTs, n = 89), and lower cTnI (MD −0.82 ng/ml, 95% CI −0.98, −0.66, 1 RCT, n = 60). SMS plus WM was more effective than WM in palpitation recovery rate (RR 1.52, 95% CI 1.21, 1.92, 3 RCTs, n = 136), dyspnea recovery rate (RR 1.47, 95% CI 1.12, 1.94, 3 RCT, n = 267), ECG (RR 1.43, 95% CI 1.32, 1.55, 20 RCT, n = 2035), CK‐MB (MD −6.36, 95% CI −8.43, −4.28, 8 RCT, n = 946), and cTnI (MD −0.06, 95% CI −0.06, −0.05, 3 RCT, n = 307). No serious adverse events were reported using SMS alone or in combination with WM. Conclusion: SMS used alone or combined with WM may have potential effectiveness on symptom alleviation, ECG recovery rate, myocardial injury markers, and cardiac function, but the effectiveness is uncertain due to the low quality and absence of placebo‐controlled trials. The exact efficacy of SMS for VMC needs to be confirmed by high‐quality double‐blind RCTs in the future.

Background Henoch-Schönlein purpura nephritis (HSPN) is listed as the most common secondary glomerular diseases among children. Approximately 15 to 20% of children eventually could develop into chronic renal failure. Chinese patent herbal medicine Huaiqihuang (HQH) has been widely used in children with HSPN. This study aimed to evaluate the effectiveness and safety of HQH for HSPN in children, so as to provide evidence for clinical use. Methods Randomized controlled trials (RCTs) on HQH for HSPN in children were searched in eight Chinese and English databases from their inception to December 2020. We included children with HSPN received HQH combined with conventional medicine. Cochrane “Risk of bias” tool was used to assess methodological quality, and “Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach” to summarize the certainty of evidence for main findings. Effect estimates were presented as risk ratio (RR), mean difference (MD) or standardized mean difference (SMD) with 95% confidence interval (CI) in meta-analyses using RevMan 5.3. Data not suitable for statistical pooling were synthesized qualitatively. Results In total seven RCTs were identified. Compared with conventional medicine alone, HQH plus conventional medicine showed the better effect in improving clinical cure rate (RR 1.58; 95%CI 1.17 to 2.14; n  = 6) and total effective rate (RR 1.34; 1.16 to 1.54; n  = 6); reducing urine sediment erythrocyte count (MD -9.23; − 10.76 to − 7.69; n  = 3) and urine β2 micro-globulin level (MD -0.09; − 0.12 to − 0.06; n  = 2). No serious adverse event was recorded in all included trials. Conclusions Limited evidence showed HQH combined with conventional medicine had a beneficial effect for children with HSPN, and the side effects were mild. HQH may be a promising complementary therapy. However, long term follow-up, high quality and multicenter RCTs are required to confirm the findings.

•Tuina is an nonpharmacological and non-invasive therapy, without the side-effects compared with medicines.•Tuina combined with routine treatments may be superior to routine treatments for improving overall symptom of IBS-diarrhea. This systematic review assessed whether Tuina (therapeutic massage) is more effective and safer than no treatment or routine medical treatment for irritable bowel syndrome (IBS). Eleven databases were searched for randomized controlled trials of IBS diagnosed based on Manning or Rome criteria. Tuina with or without routine treatments (RTs) was tested against RTs. The Cochrane risk of bias was evaluated for each trial. RevMan 5.3 was used to conduct a meta-analysis. A total of 8 trials (5 IBS-diarrhea and 3 IBS-constipation) with 545 participants using 8 different manipulations were included. All trials were published in Chinese. For overall symptom improving rate (> 30 % improvement in overall symptom scores), it had not been shown that Tuina was significantly better than RTs (RR 1.23, 95 % CI 0.94–1.60, 197 participants, 3 studies, I2 = 65 %) for IBS-diarrhea, and Tuina combined with RTs showed more benefit than RTs alone (RR 1.29, 95 % CI 1.08–1.54, 115 participants, 3 studies) for IBS-diarrhea. All trials did not report adverse effect in relation to Tuina. Risk of bias was generally unclear across all domains. Tuina combined with RTs may be superior to RTs for improving overall symptom of IBS-diarrhea. Due to the existing methodological issues and the heterogeneity of Tuina manipulation, current findings need to be confirmed in large scale, multicenter, and robust randomized trials (especially on outcome assessing blinding and allocation concealment).

•26 randomized trials testing traditional Chinese Pediatric Tui Na for children under five years of age with acute diarrhea were identified.•Pediatric Tui Na therapy appears to be effective in relieving symptoms of acute diarrhea in children under five years old.•Considering moderate to low quality of evidence and insufficient reporting, further large, rigorous and adequately reported trials are needed. To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. Systematic review and meta-analysis of randomized clinical trials. We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. ‘Clinical cure’ is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane’s Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29–1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49–2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34–1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD −0.40 h, 95% CI −15.31 to −5.48 h, n = 410, 6 trials) and daily stool frequency (MD −1.71times, 95% CI −2.37 to −1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings.

Background According to the current clinical guidelines, chemoradiotherapy is considered the standard treatment for locally advanced non‐small cell lung cancer (NSCLC). We analyzed the prognostic effect of adjuvant chemotherapy (ACT) in resected patients using the new eighth tumor node metastasis (TNM) staging systems based on the Surveillance, Epidemiology and End Results database. Methods We identified 3008 patients with stage IIIA NSCLC (T4N0M0) who underwent sublobar resection, lobectomy, or pneumonectomy. Covariates affecting treatment selection or survival were included as part of propensity score models for matching and weighting. The effect of ACT on survival was assessed, stratified by postoperative radiation therapy (PORT) use, tumor size, and age. Results Analyses of 2016 patients were conducted with standardized differences in covariates < 10% after matching. ACT was associated with significantly improved five‐year overall survival (51.1% vs. 39.7%; P = 0.0260) in patients aged 21–65 with > 7 cm tumors, even after adjusting for the presence or absence of the superior sulcus (P = 0.0003). No significant outcomes were observed using other stratifications in the matched analysis. Moreover, ACT with PORT conferred a potential survival benefit in 21–65‐year‐old patients with 0–7 cm tumors (for all causes of death: hazard ratio 0.414, 95% confidence interval 0.251–0.684). Conclusion In this population‐based cohort, ACT prolonged the survival of patients aged 21–65 with a tumor > 7 cm, with or without PORT. Inverse probability of treatment weighting can estimate the treatment effect and is suitable for use with survival data.

Background Due to limitations of conventional medicine for atopic eczema (AE), complementary and alternative medicine (CAM) is widely used as an alternative, maintaining, or simultaneous treatment for AE. We aimed to evaluate the beneficial and harmful effects of CAM for children with AE under 14 years old. Methods We searched for randomized trials on CAM in 12 Chinese and English databases from their inception to May 2018. We included children (< 14 years) diagnosed with AE, who received CAM therapy alone or combined with conventional medicine. We extracted data, and used the Cochrane “Risk of bias” tool to assess methodological quality. Effect was presented as relative risk (RR) or mean difference (MD) with 95% confidence interval (CI) using RevMan 5.3. Results Twenty-four randomized controlled trials involving 2233 children with AE were included. Methodological quality was of unclear or high risk of bias in general. The trials tested 5 different types of CAM therapies, including probiotics, diet, biofilm, borage oil, and swimming. Compared to placebo, probiotics showed improved effect for the SCORAD index (MD 9.01, 95% CI 7.12–10.90; n = 5). For symptoms and signs such as itching, skin lesions, CAM combined with usual care was more effective for symptom relief ≥95% (RR 1.47, 95% CI 1.30–1.68; n = 8), and for ≥50% symptoms improvement (RR 1.34, 1.25–1.45; n = 9) compared to usual care. There was no statistic significant difference between CAM and usual care on ≥95% improvement or ≥ 50% improvement of symptoms. However, swimming, diet and biofilm showed improvement of clinical symptoms compared with usual care. At follow-up of 8 weeks to 3 years, CAM alone or combined with usual care showed lower relapse rate (RR 0.38, 0.28–0.51, n = 2; RR 0.31, 0.24–0.40, n = 7; respectively) compared to usual care. Twelve out of 24 trials reported no occurrence of severe adverse events. Conclusions Low evidence demonstrates that some CAM modalities may improve symptoms of childhood AE and reduce relapse rate. Safety remains unclear due to insufficient reporting. Further well-designed randomized trials are needed to confirm the potential beneficial effect and to establish safety use.