Prostate cancer: a risk factor for COVID-19 in males?: A protocol for systematic review and meta analysis.

INTRODUCTION: COVID-19 is now a global pandemic. Although there are very few studies describing the characteristics of SARS-CoV-2 infections in patients with prostate cancer, these patients are likely to be more susceptible to COVID-19 than healthy people because of their immunosuppressed state. However, there is no evidence that prostate cancer is a risk factor for COVID-19. METHODS: We searched the Wanfang database, the China Science Journal Citation Report (VIP database), the China National Knowledge Infrastructure (CNKI), Web of Science, EMBASE, PubMed, and the Cochrane Library for studies related to the topic. We designed a standardized data extraction sheet and used Epidata software 3.1 for data extraction. In accordance with the Cochrane 5.1.0 standard, both a quality assessment and a risk assessment were carried out for the research meeting the inclusion criteria. The data were analyzed using Revman 5.3 and Stata 13.0 software. RESULTS: The study integrated existing research findings and a meta-analysis of the data to investigate the prevalence of prostate cancer in males infected with SARS-CoV-2 and the adverse clinical outcomes in male patients with or without COVID-19. CONCLUSION: The results of this research may provide a basis for judging if prostate cancer is a risk factor for males infected with SARS-CoV-2, and the findings can effectively help to prevent COVID-19 in patients with prostate cancer. ETHICS AND DISSEMINATION: Ethics approval is not required for this systematic review as it will involve the collection and analysis of secondary data. The results of the review will be reported in international peer-reviewed journals PRORPERO REGISTRATION NUMBER:: CRD42020194071.

Evidence for the medicinal value of Squama Manitis (pangolin scale): A systematic review.

BACKGROUND: Squama Manitis (pangolin scale) has been used in traditional Chinese medicine for thousands of years. However, its efficacy has not been systematically reviewed. This review aims to fill the gap. METHODS: We searched six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database (CNKI), WanFang Database and SinoMed from inception to May 1, 2020. Search terms included "pangolin", "Squama Manitis", "Manis crassicaudata", "Manis javanica", "Malayan pangolins", "Manis pentadactyla", "Ling Li", "Chuan Shan Jia", "Shan Jia", "Pao Jia Zhu", "Jia Pian" and "Pao Shan Jia". The Cochrane Risk of Bias (RoB) assessment tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the risk of bias of the included randomized controlled trials (RCTs) and case control studies (CCSs). RESULTS: After screening, 15 articles that met the inclusion criteria were finally included. There were 4 randomized controlled trials, 1 case control study, 3 case series and 7 case reports. A total of 15 different diseases were reported in these studies, thus the data could not be merged to generate powerful results. Two RCTs suggested that Squama Manitis combined with herbal decoction or antibiotics could bring additional benifit for treating postpartum hypogalactia and mesenteric lymphadenitis. However, this result was not reliable due to low methodological quality and irrational outcomes. The other two RCTs generated negative results. All the non-RCTs did not add any valuable evidence to the efficacy of Squama Manitis beacause of small samples, incomplete records, non-standardized outcome detection. In general, currently available evidence cannot support the clinical use of Squama Manitis. CONCLUSION: There is no reliable evidence that Squama Manitis has special medicinal value. The removal of Squama Manitis from Pharmacopoeia is rational.

Bibliometric analysis of researches on traditional Chinese medicine for coronavirus disease 2019 (COVID-19).

BACKGROUND: The coronavirus disease 2019 (COVID-19) has caused a worldwide pandemic, and traditional Chinese medicine (TCM) has played an important role in response. We aimed to analyze the published literature on TCM for COVID-19, and provide reference for later research. METHODS: This study searched the CBM, CNKI, PubMed, and EMBASE from its establishment to March 11, 2020. VOSviewer 1.6.11 and gCLUTO 2.0 software were used to visually analyze the included studies. RESULTS: A total of 309 studies were included, including 61 journals, 1441 authors, 277 institutions, and 27 provinces. Research collaborations among regions were among those close in geographical distance. The collaborations of institutions and authors were more likely to be restricted to the same region. Among the authors with frequency greater than two (65 authors), only 19 authors had connection with others. More than 70% (358/491) of keywords were only presented once, and 20 keywords were shown more than 10 times. Five research topics were identified: Data mining method based analysis on the medication law of Chinese medicine in prevention and management of COVID-19; exploration of active compounds of Chinese medicine for COVID-19 treatment based on network pharmacology and molecular docking; expert consensus and interpretation of COVID-19 treatment; research on the etiology and pathogenesis of COVID-19; and clinical research of TCM for COVID-19 treatment. CONCLUSION: The research hotspots were scattered, and the collaboration between authors and institutions needed to be further strengthened. To improve the quality and efficiency of research output, the integration of scientific research and resources, as well as scientific collaboration are needed.

Chinese medical drugs for coronavirus disease 2019: A systematic review and meta-analysis.

BACKGROUND: Integration of Chinese medical drugs (CMD) and western medicine (WM) has been widely used in the treatment of Coronavirus Disease 2019 (COVID-19). This systematic review aimed to evaluate the efficacy and safety of CMD for COVID-19. METHOD: A literature search was performed in six databases from injection to June 2020. Both randomized controlled trials (RCTs) and quasi-RCTs were considered as eligible. The quality of included RCTs were assessed by Cochrane Risk of Bias Tool, and Review Manager 5.3 software was used to do meta-analysis. RESULT: Eleven studies with 1259 patients were included in this study. CMD included herbal decoction and Chinese patent medicine. The methodological quality was evaluated as generally unclear. The results of meta-analysis showed that the integration of CMD and WM had better efficacy than WM in number of patients turned to severe and critical type (RR = 0.47, 95% CI=[0.32, 0.69], P < 0.0001), length of hospital stay (MD= -7.95, 95% CI=[-14.66, -1.24], P = 0.02), defervescence time (MD= -1.20, 95% CI=[-2.03, -0.38], P = 0.004), cough resolution rate (RR = 1.37, 95% CI=[1.15, 1.64], P = 0.0004), fatigue resolution rate (RR = 1.37, 95% CI=[1.02, 1.83], P = 0.04), and tachypnea resolution rate (RR = 2.20, 95% CI=[1.11, 4.39], P = 0.02). As for safety, there was no significant difference between two groups. CONCLUSION: CMD may bring potential benefit to patients suffered from COVID-19. However, the quality of included trials is not good enough. High quality study with core outcome set are still required.

[Analysis on pattern of prescriptions and syndromes of traditional Chinese medicine for prevention and treatment of COVID-19].

To investigate the regularity of prescription and clinical syndromes by analyzing the diagnosis and treatment protocols of traditional Chinese medicine(TCM) for coronavirus disease 2019(COVID-19), so as to provide references for syndrome differentiation and relevant researches. The diagnosis and treatment protocols of COVID-19 published by national and regional health authorities were searched, and information was extracted in regard to disease stages, type of syndromes, and prescriptions, etc. Frequency statistics and relative analysis were used to analyze the rule of syndrome differentiation and prescription with TCM, and further discussion on the pathogenesis and progress of the disease. A total of 26 diagnosis and treatment protocols of TCM for COVID-19 were retrieved after screening(including 1 national scheme and 25 regional ones), among which 16 contained aspects of both prevention and treatment, 7 only involved treatment contents and 3 were prevention schemes. The courses of COVID-19 can be divided into early stage, middle stage, severe stage and recovery stage. The pathogeny of COVID-19 in TCM is damp-toxin, with the core pathogenesis of damp-toxin retention in lung and Qi repression. Its pathological features can be summarized as "damp, toxin, obstruction, deficiency". The location of the disease is lung, always involving spleen and stomach, and may further affect heart and kidney in severe cases. The major treatments for each course are Fanghua Shizuo, Xuanfei Touxie(early stage); Qingre Jiedu, Xuanxie Feire(middle stage); Kaibi Gutuo, Huiyang Jiuni(severe stage); Qingjie Yure, Yiqi Yangyin(recovery stage). There were many diagnosis and treatment protocols for COVID-19 have been published, which generally followed the national edition, through with certain personalities in different regional protocols. There were common features with respect to the disease stage, syndrome differentiation, therapeutic principles and methods, as well as prescriptions; the treatment were generally carried out against the core pathogenesis and progress of the disease. Along with the deepening recognition of COVID-19, the diagnosis and treatment protocols are still need further concretization and standardization. We hope researchers and decision-makers can pay more attention to the treatment of Huayu Tongluo in severe and recovery period.

[Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019].

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.

Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID).

Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine (TCM), evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019 novel coronavirus (2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.