Related Randomized Controlled Trials Research Articles

Commercial Chinese polyherbal preparation: current status and future perspectives.

With the modernization of traditional Chinese medicine (TCM) industry, the investment in research and development of new commercial Chinese polyherbal preparations (CCPPs) is increasing, and the varieties of CCPPs are growing. CCPPs play an increasingly important role in the TCM industry. This study has comprehensively summarized and analyzed the current situation of CCPPs that has been on the market in China, and provided suggestions for the research and promotion of CCPPs. This study took the CCPPs approved for marketing in domestic drug database of the National Medical Products Administration (NMPA) as the research object, and combined with the publication of related randomized controlled trials (RCTs) of CCPPs in 2020-2022 and the sales of CCPPs in domestic chain pharmacies, statistical analysis was carried out on the drug name, pharmaceutical companies, dosage form, number of flavors, CBDs, ICD-11 classification of diseases treated, etc. Currently, 58,409 approvals for CCPPs have been issued in China, involving 9,986 varieties of CCPPs, 2,896 pharmaceutical companies and 39 dosage forms. The number of flavors of prescriptions of CCPPs varies from 1 to 90, among which Glycyrrhiza glabra L. [Fabaceae; Glycyrrhizae radix et rhizoma] and Angelica sinensis (Oliv.) Diels [Apiaceae; Angelicae sinensis radix] are the most widely used. The study found that the CCPPs with the most diverse variety is CCPPs for the treatment of respiratory diseases, some CCPPs can treat multiple system diseases. According to the survey, the sales of CCPPs for respiratory diseases in the chain pharmacies account for more than 1/3 of the total sales of the chain pharmacies, while the number of published randomized controlled trials (RCTs) on CCPPs for circulatory diseases was the largest. The approval process of CCPPs should be further standardized, and the transformation of TCM prescriptions into CCPPs should be promoted. In the approval process of CCPPs, it is suggested to strengthen the supervision of drug names to clarify the differences between the CCPPs of same name but different prescriptions. Improve the effectiveness and safety of CCPPs by improving the quality of CBDs. It is suggested to optimize the design of new drug research program of CCPPs to avoid waste of research resources.

Effectiveness of manual therapy combined with dry needling in the treatment of cervicogenic headache: A systematic review and meta-analysis

Background & Objective: Headache is a common symptom and disease. Cervicogenic headache (CH) is a common type of headache that can be effectively treated with both manual therapy (MT) and dry needling (DN). However, the results of MT plus DN (MDN) for CH remain controversial. We performed a meta-analysis to evaluate the efficacy of MDN for CH. Methods: A systematic search from database inception to June 1, 2023 on clinical outcome of MDN and MT in the treatment of CH was conducted. Four databases were searched, including Pubmed (Medline), Web of Science, Embase, and Cochrane Library related randomized controlled trials (RCTs). Main outcomes included numeric pain rating scale (NPRS) in the post-treatment, the first month and the third month, extension and flexion in the post-treatment, headache frequency in the first month and the third month, neck disability index (NDI) in the first month and the third month. Results: Three studies involving 263 patients out of 68 studies were conducted. The pooled data showed that there was significant differences in NPRS in the post-treatment, the first month and the third month, extension in the post-treatment, flexion in the post-treatment between MDN group and MT group, but there was no statistically significant difference in the headache frequency in the first month and the third month, NDI in the first month and the third month. Conclusion: Current evidence suggests that MDN may be superior to MT in improving NPRS, extension, and flexion.

Comparison of vonoprazan and proton pump inhibitors for the treatment of gastric endoscopic submucosal dissection-induced ulcer: an updated systematic review and meta-analysis

BackgroundBoth vonoprazan and proton pump inhibitors (PPIs) are currently used to treat artificial ulcers after gastric endoscopic submucosal dissection. However, evidence-based medicine proving the efficacy of vonoprazan is still lacking. Therefore, this meta-analysis aimed to compare the efficacy of vonoprazan and PPIs for the treatment of artificial ulcers after gastric endoscopic submucosal dissection.MethodsThe PubMed, EMBASE and Cochrane Library databases were searched up to September 2023 for related randomized controlled trials (RCTs). RCTs that compared the efficacy of vonoprazan and PPIs in treating artificial gastric ulcers after gastric endoscopic submucosal dissection were included. Two independent reviewers screened the included studies, extracted the data and assessed the risk of bias. The following outcomes were extracted for comparison: ulcer healing rate, ulcer shrinkage rate, delayed postoperative bleeding rate, and ulcer perforation rate.ResultsNine randomized controlled trials involving 926 patients were included. The pooled results showed that vonoprazan had a significantly lower rate of delayed postoperative bleeding than did PPIs (RR = 0.46; 95% CI = 0.23–0.91; P = 0.03). No significant differences were found in terms of ulcer healing, shrinkage rates, or ulcer perforation rates between vonoprazan and PPIs.ConclusionsCompared with PPIs, vonoprazan is superior at reducing delayed postoperative bleeding after endoscopic submucosal dissection. However, further studies are needed to prove the efficacy of vonoprazan.Systematic Review RegistrationIdentifier CRD42024509227.

Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project

BackgroundThe negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life.MethodsThis article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN Trial in Barcelona (Spain) is targeting people 18+ from low socio-economic urban areas; the RECETAS-PRG Trial in Prague (Czech Republic) is addressing community-dwelling older adults over 60 years of age, and the RECETAS-HLSNK trial is reaching older people in assisted living facilities. Each trial will recruit 316 adults suffering from loneliness at least sometimes and randomize them to nature-based social interventions called “Friends in Nature” or to the control group. “Friends in Nature” uses modifications of the “Circle of Friends” methodology based on group processes of peer support and empowerment but including activities in nature. Participants will be assessed at baseline, at post-intervention (3 months), and at 6- and 12-month follow-up after baseline. Primary outcomes are the health-related quality-of-life according to 15D measure and The De Jong Gierveld 11-item loneliness scale. Secondary outcomes are health and psychosocial variables tailored to the specific target population. Nature exposure will be collected throughout the intervention period. Process evaluation will explore context, implementation, and mechanism of impact. Additionally, health economic evaluations will be performed.DiscussionThe three RECETAS trials will explore the effectiveness of nature-based social interventions among lonely people from various ages, social, economic, and cultural backgrounds. RECETAS meets the growing need of solid evidence for programs addressing loneliness by harnessing the beneficial impact of nature on enhancing wellbeing and social connections.Trial registrationBarcelona (Spain) trial: ClinicalTrials.gov, ID: NCT05488496. Registered 29 July 2022.Prague (Czech Republic) trial: ClinicalTrials.gov, ID: NCT05522140. Registered August 25, 2022.Helsinki (Finland) trial: ClinicalTrials.gov, ID: NCT05507684. Registered August 12, 2022.

Willow Bark (Salix spp.) Used for Pain Relief in Arthritis: A Meta-Analysis of Randomized Controlled Trials.

This study intends to assess the analgesic effects, physical facilitation, and safety of willow bark use in patients with arthritis. Our study was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PubMed, Scopus, EMBASE, Web of Science, Cochrane, and ClinicalTrials.gov were searched for relative randomized controlled trials (RCTs) describing the efficacy or adverse events of willow bark in patients with arthritis until 12 April 2023. We used Cochrane ROB 2.0 and the Grading of Recommendations, Assessment, Development, and Evaluations system to evaluate the quality of studies and evidence. The meta-analysis was carried out by the fix-effects model. This study included five studies with six RCTs consisting of 329 patients with arthritis. The results showed significant differences in pain relief and improvement in physical status for patients with arthritis between willow bark treatment and placebo groups, and no significant differences in the risk of all adverse events in patients with arthritis between willow bark treatment and placebo. Owing to the potential bias, the certainty and evidence of our findings are still inadequate. Therefore, further RCTs are needed to confirm our results.

Cognitive behavioural therapy for functional abdominal pain disorders in children and adolescents: A systematic review of randomized controlled trials

AimAlthough Cognitive behavioural therapy (CBT) potentially holds efficacy in addressing functional abdominal pain disorders (FAPDs) amongst children and adolescents, the persistent efficacy is uncertain. MethodsWe searched three databases to identify related randomized controlled trials (RCTs). Meta-analysis was performed using RevMan and Stata. Subgroup analyses were mainly conducted based on follow-up time. The GRADE approach was used to evaluate the certainty of the evidence. ResultsA total of 14 RCTs evaluating 858 patients were included. All RCTs were rated as having a high risk of bias. Compared with control groups, CBT was associated with improvement of general functional impairment (standardized mean difference (SMD) = -0.77, 95% CI [-1.12, −0.42], p < 0.05), higher treatment success (relative risk (RR) = 2.35, 95% CI [1.50, 3.69], p < 0.05), improvement of abdominal pain symptoms (SMD = −0.48, 95% CI [-0.73, −0.23], p < 0.05), QoL (SMD = 0.42, 95% CI [0.20, 0.64], p < 0.05), and psychological states (SMD = −0.95, 95% CI [-1.62, −0.27], p < 0.05). ConclusionThis meta-analysis provides low to moderate quality evidence that CBT could significantly improve clinical outcomes and QoL for children and adolescents with FAPDs with improvement persisting until short-term follow-up. However, there were discrepancies regarding CBT's effects at mid- and long-term follow-up across different outcomes. More high-quality and longer-duration studies are thus warranted to explore the effectiveness of CBT in the future. Systematic review registration on prosperoCRD42022369353.

Antioxidant Effects of Selenium in Adult Critically Ill Patients

Oxidative stress is the fundamental etiology of inflammation and organ failure, and unfavorable consequences characterize critical illness. We searched systematically up to September 2021 to find related randomized controlled trials (RCTs) that investigated the effects of selenium in antioxidant markers of the critically ill. A total of 10 RCTs were included. The results indicated that selenium administration has no significant effects on glutathione peroxidase activity (standardized mean difference [SMD]: 1.67, 95% confidence interval [CI]: −0.01 to 3.35) and C-reactive protein levels (SMD: −0.21 mg/L, 95% CI: −0.45 to 0.03). Further trials are needed to prove the potential effects of selenium administration on antioxidant and inflammation markers.

The Majority of Sports Medicine and Arthroscopy-Related Randomized Controlled Trials Reporting Nonsignificant Results Are Statistically Fragile

To evaluate the robustness of sports medicine and arthroscopy related randomized controlled trials (RCTs) reporting nonsignificant results by calculating the reverse fragility index (RFI) and reverse fragility quotient (RFQ). All sports medicine and arthroscopic-related RCTs from January 1, 2010, through August 3, 2021, were identified. Randomized-controlled trials comparing dichotomous variables with a reported P value ≥ .05 were included. Study characteristics, such as publication year and sample size, as well as loss to follow-up and number of outcome events were recorded. The RFI at a threshold of P < .05 and respective RFQ were calculated for each study. Coefficients of determination were calculated to determine the relationships between RFI and the number of outcome events, sample size, and number of patients lost to follow-up. The number of RCTs in which the loss to follow-up was greater than the RFI was determined. Fifty-four studies and 4,638 patients were included in this analysis. The mean sample size and loss to follow-up were 85.9 patients and 12.5 patients, respectively. The mean RFI was 3.7, signifying that a change of 3.7 events in one arm was needed to flip the results of the study from non-significant to significant (P < .05). Of the 54 studies investigated, 33 (61%) had a loss to follow-up greater than their calculated RFI. The mean RFQ was 0.05. A significant correlation between RFI with sample size (R2= 0.10, P= .02) and the total number of observed events (R2= 0.13, P<.01) was found. No significant correlation existed between RFI and loss to follow-up in the lesser arm (R2= 0.01, P=.41). The RFI and RFQ are statistical tools that allow the fragility of studies reporting nonsignificant results to be appraised. Using this methodology, we found that the majority of sports medicine and arthroscopy-related RCTs reporting nonsignificant results are fragile. RFI and RFQ serve as tools that can be used to assess the validity of RCT results and provide additional context for appropriate conclusions.

The effects of Nordic Walking on health in adults: A systematic review

Objective: Nordic walking is a physical activity gaining more and more interest among adults. The aim of the study was to conduct a systematic review to determine the effects of Nordic walking on the physical and mental health of adults Method: We identified Nordic walking related randomized controlled trials (RCTs) in the electronic databases PubMed, EBSCO and CNKI, however 19 from 47 studies were selected for evaluation and systematic review based on relevant data. Results: Most of the study subjects were in the middle-aged and elderly clinical population, and three studies included non-clinical populations. The intervention was conducted most often three times a week for 8 weeks or more. The main effects of Nordic Walking were physical and psychological beniphytes, in particular the improvement of circulatory and respiratory and quality of life. All studies reported at least one beneficial effect of Nordic walking compared to the control group. Conclusion: Nordic walking has some beneficial effects on the physical and mental health of adults with or without clinical symptoms.

Empagliflozin for the treatment of non-alcoholic fatty liver disease: a meta-analysis of randomized controlled trials.

The efficacy of empagliflozin for non-alcoholic fatty liver disease remains controversial. This meta-analysis aims to explore the influence of empagliflozin versus placebo on the treatment of non-alcoholic fatty liver disease and we have searched PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through July 2021 for related randomized controlled trials (RCTs). Three RCTs involving 212 patients are included in the meta-analysis. Compared with control group for non-alcoholic fatty liver disease, empagliflozin treatment has no improvement in controlled attenuation parameter (CAP) score, hepatic steatosis and liver stiffness measurement (LSM) score, alanine aminotransferase (ALT), aspartate-aminotransferase (AST), low density lipoprotein (LDL) or triglyceride (TG). These indicate that empagliflozin treatment may be not effective for non-alcoholic fatty liver disease.

Comparative Efficacy of Dapagliflozin and Empagliflozin of a Fixed Dose in Heart Failure: A Network Meta-Analysis.

BackgroundThe efficacy of dapagliflozin and empagliflozin in sodium-glucose cotransport-2 inhibitors (SGLT-2i) in patients with heart failure (HF) has been discovered. However, which drug could improve varied prognostic outcomes has not been elucidated. Hence, we compared their efficacies on the prognostic improvement of HF.MethodsDatabases including PubMed, EMBASE, Scopus, Google Scholars, and the Cochrane Library were searched for all related randomized controlled trials (RCTs) published from inception to 13 October 2021. Network meta-analyses were performed to generate matrices to show the effect size for pairwise comparison regarding all the interventions.ResultsEventually a total of 11 RCTs were included in this study. For the primary endpoints, dapagliflozin was comparable with empagliflozin in hospitalization for HF, and empagliflozin (OR=0.70, 95%CI: 0.59–0.84) decreased the risk of exacerbation of HF over dapagliflozin. For the secondary endpoints, dapagliflozin was comparable with empagliflozin in cardiovascular (CV) death /hospitalization for HF, and for CV death, dapagliflozin (OR=0.78, 95%CI: 0.65–0.92) significantly reduced mortality over the placebo. For the tertiary endpoints, dapagliflozin (OR=0.80, 95%CI: 0.66–0.98) significantly decreased the mortality over empagliflozin in all-cause death, and neither drug significantly increased the risk of hypoglycemia.RecommendationsOverall, 10 mg/day dapagliflozin may be the optimal recommendation for its premium and comprehensive effect on improving the prognosis of patients with HF compared to 10 mg/day empagliflozin.

Effect of mechanical ventilation and pulmonary rehabilitation in patients with ICU-acquired weakness: a systematic review and meta-analysis.

ICU-acquired weakness (ICU-AW) is characterized by neuromuscular damage such as limb weakness, yet the cause of ICU-AW remains unclear, which significantly increases the time a patient spends on mechanical ventilation (MV)/in ICU and can even affect a patient's survival rate and quality of life after being discharged. Pulmonary rehabilitation (PR)-related measures can effectively improve the ICU-AW situation, but in the specific implementation actions, many obstacles have been produced, and the treatment effect has been controversial, especially in the application process of mechanically ventilated patients. This study aims to confirm the efficacy of using MV alongside PR for patients with ICU-AW. We obtained related randomized controlled trials (RCTs) from Chinese and English databases. All RCTs relevant to the use of PR in ICU-AW patients were retrieved from the following databases from their date of inception through January 31th, 2021: PubMed, EMBASE, The Cochrane Central Register of Controlled Trials, CINAHL, Joanna Briggs Institute (JBI), Web of Science, The Wanfang Database, and CNKI. This literature underwent screening, quality evaluation, and index data extraction by two independent researchers. The evaluation data were meta-analyzed with RevMan 5.3 software (Cochrane, London, UK). In total, we analyzed 15 articles which included 1,710 patients. We found that using PR alongside MV can effectively improve a patient's Medical Research Council (MRC) muscle strength score [mean difference (MD) =4.92, P=0.07], reduce the prevalence of ICU-AW [odds ratio (OR) =0.24, P<0.001], and shorten both MV duration [standardized mean difference (SMD) =-1.50, P<0.001] and ICU stay (SMD =-0.68, P=0.03). Implementing PR alongside MV can effectively reduce ICU-AW in patients. However, our standardized cluster PR study still requires further clarification to confirm how various intervention methods can reduce ICU-AW.

Systematic review and Meta-analysis of efficacy and safety of gastrodin in treatment of tension-type headache

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P&lt;0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P&lt;0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P&lt;0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P&lt;0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P&lt;0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P&lt;0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.

Comparison of efficacy and safety of complementary and alternative therapies for primary trigeminal neuralgia: A protocol for a Bayesian network meta analysis.

Background:Primary trigeminal neuralgia (PTN) is a type of peripheral neuralgia that seriously affects people's lives. In recent years, complementary therapies and alternative therapies have played a significant role in treating PTN. However, there is a lack of comparison among all the complementary and alternative therapies at present. Thus, the aim of this study is to discuss the efficacy and safety of diverse complementary and alternative therapies by Bayesian network meta-analysis (NMA).Methods:We will retrieve the Chinese and English databases to gather related randomized controlled trials (RCTs) of complementary and alternative therapies for treating PTN. The deadline is November 2020. Two independent researchers will be in charge of screening qualified literature, extracting data, and independently evaluating bias risks involved in the research. Pairwise meta-analysis and Bayesian network meta-analysis will be performed to assess all evidence. Then, we will use STATA16.0 as well as WinBUGS1.4.3 software for data analysis. Besides, the quality of NMA evidence will be classified by grading of recommendations assessment development and evaluation (GRADE).Results:This study will compare and rank the efficacy and safety of different complementary and alternative therapies in treating primary trigeminal neuralgia.Conclusion:Complementary and alternative therapies play an essential role in treating primary trigeminal neuralgia. We expect our study will furnish meaningful evidence support for clinicians and patients.Protocol registration number:INPLASY2020120026.Ethical approval:Since the study is based on published or registered RCTs, ethical approval and patient informed consent are abandoned.

Double antithrombotic therapy for prevention of bleeding and ischemic events after percutaneous coronary intervention in patients with atrial fibrillation: A meta-analysis.

Background:The efficacy of double antithrombotic therapy (DAT) vs. triple antithrombotic therapy (TAT) for prevention of bleeding and ischemic events in patients with atrial fibrillation following percutaneous coronary intervention (PCI) is unclear in those subgroups defined by the 5 factors (i.e., sex, age, race, history of diabetes, and type of P2Y12 inhibitor). We aimed to assess the efficacy of DAT vs TAT in these patient subgroups.Methods:We searched PubMed and relevant websites to include related randomized controlled trials (RCTs). Two endpoints of interest were clinically significant bleeding and major adverse cardiac events (MACE). Meta-analysis was performed stratified by 5 factors of interest (i.e., sex, age, race, history of diabetes, and type of P2Y12 inhibitor) to obtain pooled hazard ratio (HR) and 95% confidence interval (CI). Meta-regression analysis was conducted to evaluate subgroup effects. We detected publication bias by Egger test and funnel plots.Results:We included 4 RCTs for meta-analysis. DAT vs TAT significantly reduced the risk of clinically significant bleeding (HR 0.56, 95% CI 0.50–0.63). This effect of DAT was observed in most subgroups of interest (HR ranged from 0.54 to 0.69), and was consistent across various subgroups defined by each of the 5 factors of interest (Psubgroup ranged from 0.290 to 0.794). DAT vs TAT led to the similar risk of MACE (HR 0.98, 95% CI 0.89–1.08). This effect of DAT was observed in all subgroups of interest (all 95% CIs of HRs were across 1.0), and was consistent across various subgroups defined by each of the 5 factors of interest (Psubgroup ranged from 0.308 to 0.828). Publication bias was found only in one subgroup.Conclusions:Compared with TAT, DAT significantly reduces the risk of clinically significant bleeding and leads to the similar risk of MACE in patients with atrial fibrillation following PCI, irrespective of sex, age, race, history of diabetes, and type of P2Y12 inhibitor used at baseline.

Effect of Phosphodiesterase-5 Inhibitors on the Treatment of Male Infertility: A Systematic Review and Meta-Analysis.

PurposeMale infertility is a worldwide problem with limitations in the treatment. Phosphodiesterase-5 inhibitors (PDE5is) is the first choice for the treatment of erectile dysfunction, more and more studies show that it has a certain effect on male infertility in recent years. But there was currently no high quality of systematic review to evaluate the effects of PDE5is on semen quality.Materials and MethodsWe retrieved the electronic databases of MEDLINE, PubMed, Web of Science, EMBASE, etc. Related randomized controlled trials (RCTs) were collected and selected up to May 20, 2020. We have searched literature with terms “male infertility”, “phosphodiesterase-5 inhibitors”, “PDE5i”, “Tadalafil”, “Sildenafil”, “Vardenafil”, “Udenafil”, “Avanafil”, “semen”, and “sperm”. Mean value and its standard deviation were used to perform quantitative analysis. All statistical analyses were conducted by RevMan 5.3 and Stata software.ResultsThere were a total of 1,121 participants in the nine included studies. There was a statistically significant improvement treated with PDE5is compared with sham therapy, which including sperm concentration (mean difference [MD]=1.96, 95% confidence interval [CI]=1.70–2.21, p<0.001; MD=3.22, 95% CI=1.96–4.48, p<0.001), straight progressive motility (%) Grade A (MD=3.71, 95% CI=2.21–5.20, p<0.001), sperm motility (MD=8.09, 95% CI=7.83–8.36, p<0.001), morphologically normal spermatozoa (%) (MD=0.67, 95% CI=0.20–1.15, p=0.005; MD=1.27, 95% CI=0.02–2.52, p=0.05), sperm abnormalities (%) (MD=−0.64, 95% CI=−0.81–−0.47, p<0.001), and progressive motile sperm (MD=5.34, 95% CI=3.87–6.81, p<0.001).ConclusionsIn this meta-analysis of nine RCTs, treatment with PDE5is could improve some indicators of male sperm.

Effectiveness and Safety of Chinese Herbal Injections Combined with Fluoropyrimidine and Oxaliplatin-based Chemotherapy for Advanced Colorectal Cancer: A Systematic Review and Meta-analysis of 63 Randomized Controlled Trials.

Purpose: To investigate effectiveness and safety of Chinese herbal injections (CHIs) in conjunction with fluoropyrimidine and oxaliplatin-based chemotherapy (FOBC) for advanced colorectal cancer (CRC).Methods: A comprehensive search was conducted in 7 electronic databases for related randomized controlled trials (RCTs) from inception to April 30, 2021. The quality of each trial was assessed according to the Cochrane Handbook for Systematic Reviews of Interventions, the differences in effectiveness and safety outcomes between two groups were evaluated, and the results were expressed as the risk ratios (RRs) and 95% confidence interval (CI). Subgroup analyses were performed according to the types of CHIs, and Review Manager 5 was used to statistically analyze the outcomes.Results: 63 studies involving 9 CHIs and 4733 patients were included in this review. The meta-analysis results suggested that compared with FOBC therapy, CHIs plus FOBC therapy showed significant improvements in objective response rate (ORR) (RR=1.34, 95% CI: 1.27-1.42, P<0.00001), disease control rate (DCR) (RR=1.09, 95%CI: 1.06-1.11, P<0.00001), 1-year survival rate (RR=2.27, 95% CI: 1.23-4.18, P=0.009) and quality of life (QoL) (RR=1.21, 95% CI: 1.14-1.28, P<0.00001), and decreases in the incidence of chemotherapy-induced leukopenia (RR=0.64, 95% CI: 0.50-0.82, P<0.0005), nausea and vomiting (RR=0.65, 95% CI: 0.51-0.83, P=0.0005) and diarrhea (RR=0.34, 95% CI: 0.20-0.58, P<0.0001).Conclusion: From the evidence available, CHIs could increase ORR, DCR and 1-year survival rate, improve QoL and relieve chemotherapy-induced leukopenia, nausea and vomiting and diarrhea when combined with FOBC in advanced CRC treatment, Nevertheless, on account of the limitations, more rigorous RCTs with high-quality methodology were needed to further confirm the results.

Efficacy of Chinese herbal injections combined with fluoropyrimidine and oxaliplatin-based chemotherapy for advanced colorectal cancer: A protocol for systematic review and meta-analysis of randomized controlled trials.

Background:Fluoropyrimidine combined with oxaliplatin-based chemotherapy have become the first-line treatment for advanced colorectal cancer (CRC). Chinese herbal injections (CHIs), as an important part of TCM, have been widely applied as adjunctive treatments to chemotherapy in patients with advanced CRC. However, the efficacy of this combination therapy has not been evaluated comprehensively.Methods:We will conduct this systematic review and meta-analysis in accordance with the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. 7 databases will be searched for related randomized controlled trials (RCTs) from their inception to August 31, 2020: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), SinoMED and Wanfang Database. Two researchers will perform study selection, data extraction, and assessment of risk of bias independently. The primary outcomes are the disease control rate (DCR) and the objective response rate (ORR), the secondary outcomes are progression-free survival (PFS), survival rate, quality of life (QoL) and adverse effects. Cochrane Review Manager (RevMan 5.3) software will be used to analyze the outcomes.Results and Conclusion:This systematic review will evaluate the efficacy of CHIs and fluoropyrimidine and oxaliplatin-based chemotherapy for advanced CRC so as to provide valuable evidence to the application of CHIs in advanced CRC.Systematic review registration:INPLASY registration number: INPLASY2020100050.

The safety and efficacy of endoscopic endonasal approach in the treatment of recurrent craniopharyngioma: A protocol for systematic review and meta-analysis.

Background:Craniopharyngioma is the most challenging brain tumor with a high recurrence rate. Some scholars have shown that endoscopic endonasal approach (EEA) can achieve a higher total tumor resection rate and significantly reduce the incidence of complications and mortality. However, there is still no consensus on the surgical approach for recurrent craniopharyngioma. The purpose of this study is to evaluate the safety and efficacy of EEA in the treatment of recurrent craniopharyngioma.Methods:We will search 7 electronic databases (PubMed, EMBASE, Web of Science, the Cochrane Library, PsycINFO, AMED, Scopus) to collect related randomized controlled trials (RCTs). The resection rate, recurrence rate and progression-free survival rate will be regarded as the primary outcome, and the incidence of complications will be regarded as the secondary outcome. Endnote Software X9.0 will be used to filter articles, Review Manager Software 5.2 and STATA software 16.0 will be used for analysis and synthesis.Results:We will integrate existing studies to assess the safety and efficacy of EEA in the treatment of recurrent craniopharyngioma.Conclusion:Our study will provide EEA as an effective and safe treatment for recurrent craniopharyngioma.Registration number:International Prospective Register of Systematic Reviews (PROSPERO): CRD42020199860

Effect of telephone-based health education intervention models on cervical cancer screening compliance: A protocol for systematic review and meta-analysis.

Background:Screening is an effective strategy for preventing and controlling the cervical cancer. Unfortunately, women are often less likely to adhere to cervical cancer screening procedures. Related research shows that the telephone-based health education model can improve the compliance of screening. At present, however, this practice is lack of persuasion. Therefore, this study makes a systematic meta-analysis on whether the telephone-based health education model can improve the compliance of screening by women.Methods:Retrievals will be made on PubMed, Web of Science, the Cochrane Library, EMBASE, and some clinical trial registration websites, and information on related randomized controlled trials (RCTs) will collected. After 2 researchers independently screen the literatures, they will extract the data and evaluate the bias risk contained in the collected studies, before meta-analysis is carried out with RevMan 5.3 software.Results:The available evidence will be systematically reviewed in terms of compliance with cervical cancer screening.Conclusion:The findings of this study will produce comprehensive evidence to identify whether the telephone-based health education model can improve women's compliance with cervical cancer screening.