Medicine (Baltimore)
· 2022 Oct · PMID 36221344
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BACKGROUND: Vedolizumab is a humanized monoclonal antibody that inhibits gut-selective α4β7 integrins on the surface of leukocytes, preventing their trafficking into the gastrointestinal tract, and ultimately achieves th...BACKGROUND: Vedolizumab is a humanized monoclonal antibody that inhibits gut-selective α4β7 integrins on the surface of leukocytes, preventing their trafficking into the gastrointestinal tract, and ultimately achieves the effect of suppressing intestinal inflammation. This study aimed to evaluate the efficacy and safety of vedolizumab in the treatment of inflammatory bowel disease. METHODS: After a systematic review of relevant studies, the pooled relative risk (RR) and 95% confidence intervals (CIs) were calculated to evaluate the effect. Heterogeneity was explored using sensitivity analysis, univariate meta-regression, and subgroup analysis. Potential publication bias was evaluated using Egger test and trim-and-fill method. RESULTS: Nine randomized controlled trials involving 4268 participants were included in the meta-analysis. During induction therapy, vedolizumab was more effective than placebo in treating active ulcerative colitis and Crohn disease in terms of clinical response (RR = 1.55, 95%CI: 1.35-1.78), clinical remission (RR = 1.90, 95%CI: 1.50-2.41), and mucosal healing (RR = 1.53, 95%CI: 1.21-1.95). A superior effect in terms of durable Clinical or Crohn disease Activity Index-100 response (RR = 1.65, 95%CI: 1.20-2.26), clinical remission (RR = 1.92, 95%CI: 1.48-2.50), and glucocorticoid-free remission (RR = 2.22, 95%CI: 1.71-2.90) was found during maintenance treatment. Vedolizumab was not associated with any adverse events and was as safe as placebo in terms of the risk of serious adverse reactions. CONCLUSIONS: Vedolizumab may be safe and effective as an induction and maintenance therapy for the treatment of inflammatory bowel disease; however, further studies are needed to validate this conclusion.
Sapapsap B, Srisawat C, Suthumpoung P
… +4 more, Luengrungkiat O, Leelakanok N, Saokaew S, Kanchanasurakit S
Medicine (Baltimore)
· 2022 Sep · PMID 36086772
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BACKGROUND: Patients who had mechanical heart valves and an international normalized ratio (INR) of >5.0 should be managed by temporary cessation of vitamin K antagonist. This study aimed to investigate the safety of low...BACKGROUND: Patients who had mechanical heart valves and an international normalized ratio (INR) of >5.0 should be managed by temporary cessation of vitamin K antagonist. This study aimed to investigate the safety of low-dose vitamin K1 in patients with mechanical heart valves who have supratherapeutic INR. METHODS: CINAHL, Cochran Library, Clinical trial.gov, OpenGrey, PubMed, ScienceDirect, and Scopus were systematically searched from the inception up to October 2021 without language restriction. Studies comparing the safety of low-dose vitamin K1 treatment in patients with placebo or other anticoagulant reversal agents were included. We used a random-effect model for the meta-analysis. Publication bias was determined by a funnel plot with subsequent Begg's test and Egger's test. RESULTS: From 7529 retrieved studies, 3 randomized control trials were included in the meta-analysis. Pooled data demonstrated that low-dose vitamin K was not associated with thromboembolism rate (risk ratio [RR] = 0.94; 95% CI: 0.19-4.55) major bleeding rate (RR = 0.58; 95% CI: 0.07-4.82), and minor bleeding rate (RR = 0.60; 95% CI: 0.07-5.09). Subgroup and sensitivity analysis demonstrated the nonsignificant effect of low-dose vitamin K on the risk of thromboembolism. Publication bias was not apparent, according to Begg's test and Egger's test (P = .090 and 0.134, respectively). CONCLUSION: The current evidence does not support the role of low-dose vitamin K as a trigger of thromboembolism in supratherapeutic INR patients with mechanical heart valves. Nevertheless, more well-designed studies with larger sample sizes are required to justify this research question.
Wang H, Liu X, Wu Y
… +3 more, Yang C, Chen X, Wang W
Medicine (Baltimore)
· 2022 Jul · PMID 35905219
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BACKGROUND: Infant bronchiolitis has a high death rate in severe cases. In China, traditional Chinese medicine (TCM) is commonly used to treat infant bronchiolitis. However, it has not received enough international atten...BACKGROUND: Infant bronchiolitis has a high death rate in severe cases. In China, traditional Chinese medicine (TCM) is commonly used to treat infant bronchiolitis. However, it has not received enough international attention. OBJECTIVE: We aimed to assess the efficacy and safety of integrated TCM and Western medicine for treating infant bronchiolitis. METHODS: We conducted a systematic review through 7 databases that included randomized controlled trials on integrated TCM and Western medicine for treating bronchiolitis, published in English or Chinese before February 4, 2021. To assess the risk of bias, the Cochrane Collaboration tool was employed to determine the quality of the included studies. We investigated clinical efficacy endpoints, hospitalization time, rates of recurrence, and adverse reactions and meta-analyzed the odds ratio (OR), mean difference (MD), and relative risk (RR), respectively. We assessed the overall certainty of the effect estimates using the GRADE approach. This study is registered with PROSPERO (CRD42021245294). Ethical approval is not required. RESULTS: Forty-six studies (6427 children) were available for inclusion. We used 41 (5490 participants), 11 (1350 participants), 5 (1083 participants), and 11 (1295 participants) studies to analyze clinical efficacy endpoints (OR: 3.31; 95% confidence interval [CI]: 2.93, 3.74; P < .5), hospitalization time (MD: -2.10; 95% CI: -2.87, -1.34; P < .5), recurrence rate (RR: 0·41; 95% CI: 0.30, 0.56; P < .01), and adverse reaction rate (RR: 0.87; 95% CI: 0.55, 1.39; P = .57), respectively. CONCLUSIONS: Integrated TCM and Western medicine is superior to Western medicine alone for treating bronchiolitis in terms of clinical efficacy, hospitalization time, and recurrence rate, with no increase in the adverse reaction rate. TCM is useful as an alternative therapy for viral bronchiolitis. Although further studies are needed to establish specific protocols for the use of TCM in clinical practice, these results may strengthen guideline recommendations regarding the use of TCM.
Cao F, Zhang S, Huang J
… +3 more, Gan L, Zhuansun Q, Lin X
Medicine (Baltimore)
· 2022 Jul · PMID 35866780
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BACKGROUND: Postpartum stress urinary incontinence (PSUI) is a widespread complaint in postpartum women, which significantly affects their quality of life. Acupuncture has been widely used as an alternative complementary...BACKGROUND: Postpartum stress urinary incontinence (PSUI) is a widespread complaint in postpartum women, which significantly affects their quality of life. Acupuncture has been widely used as an alternative complementary therapy for the treatment of PSUI. This protocol is carried out to comprehensively explore the effectiveness and safety of acupuncture for treating PSUI. METHODS: Randomized clinical trials related to acupuncture treatment of PSUI will be searched in Chinese and English literature databases: PubMed, Web of Science, EMBASE, Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Wanfang Database, and the Technology Periodical Database. Changes in pelvic floor muscle strength compared with baseline will be accepted as the primary outcomes, and secondary outcomes will be the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, the urodynamic indexes, the incontinence quality of life questionnaire, and adverse effects of acupuncture. All publications will be screened and extracted by 2 reviewers independently. Quality of the eligible publications will be assessed according to the Cochrane Risk of Bias tool and statistical analyses will be conducted by using the Review Manager V.5.3. RESULTS: This study will provide a high-quality comprehensive evaluation for the clinical efficacy and safety of acupuncture for PSUI. CONCLUSION: This systematic review will provide comprehensive evidence of acupuncture treatment on specific outcomes for PSUI. ETHICS AND DISSEMINATION: Because of the study will not collect personal information, ethical approval will not be required. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION: INPLASY 202220045.
Lu R, Shi R, Zhang M
… +5 more, Shao X, Xue W, Guo Q, Wang C, Deng Y
Medicine (Baltimore)
· 2022 Apr · PMID 35475802
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BACKGROUND: With the advantages of miniature damage and optimal effectiveness, percutaneous coronary intervention (PCI) has been performed in a large number of coronary artery disease patients. However, recent studies ha...BACKGROUND: With the advantages of miniature damage and optimal effectiveness, percutaneous coronary intervention (PCI) has been performed in a large number of coronary artery disease patients. However, recent studies have indicated a higher incidence of depression on post-PCI patients. Acupuncture therapy is effective for depression. As a form of acupuncture, the auricular acupuncture has been used to relieve symptoms in patients with post-PCI depression, but its effectiveness and safety have not yet reached a definitive conclusion. Therefore, this systematic review and meta-analysis protocol is planned to evaluate the efficacy and safety of auricular acupuncture for depression in post-PCI patients. METHODS: Six English databases (PubMed, Web of Science, MEDLINE, EMBASE, Springer Cochrane Library, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wan Fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database, and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to February 1, 2022. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on the Hamilton Depression Scale and the Self-rating Depression Scale will be used as the main outcome measure. All-cause mortality, cardiac mortality, major adverse cardiovascular events, rehospitalisation rate, and Quality of Life Scale as the secondary outcome. Treatment Emergent Symptom Scale, general physical examination (temperature, pulse, respiration, blood pressure), routine examination of blood, urine and stool, electrocardiogram, liver and kidney function examination as the security indexes. RevMan 5.3.5 will be used for meta-analysis. RESULTS: This study will provide high-quality evidence to assess the efficacy and safety of auricular acupuncture for depression in post-PCI patients. CONCLUSION: This systematic review will explore whether auricular acupuncture is an effective and safe intervention for depression in post-PCI patients. INPLASY REGISTRATION NUMBER: INPLASY202230003.
Wang K, Jiang Z, Yu X
… +5 more, Shao Y, Liu H, Wu S, Kong L, Wang Z
Medicine (Baltimore)
· 2022 Mar · PMID 35451386
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BACKGROUND: More and more studies have shown that cognitive dysfunction is one of the main complications of diabetes. The disorder of glucose and lipid metabolism seriously damages brain function and accelerates the conv...BACKGROUND: More and more studies have shown that cognitive dysfunction is one of the main complications of diabetes. The disorder of glucose and lipid metabolism seriously damages brain function and accelerates the conversion to dementia. At present, there are no drugs that can directly treat diabetic cognitive dysfunction. All drugs for the treatment of this disease achieve the purpose of treatment through strict control of blood sugar levels. This method has great limitations. Traditional Chinese patent medicines (TCPMs) work through multiple targets and multiple pathways, which can not only effectively correct the state of glucose and lipid metabolism disorders, but also significantly improve cognitive ability, but there is a lack of systematic evaluation of their effectiveness and safety. We use the method of network meta-analysis to systematically and comprehensively compare the effectiveness and safety of different Chinese patent medicines. METHODS: We will comprehensively search the following databases, including Web of Science, PubMed, The Cochrane Library, EMBASE, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Wanfang database and China BioMedical Literature. We will include all randomized controlled trials that meet the inclusion criteria, starting from the establishment of the database until September 2021. Two researchers will independently screen the literature based on inclusion criteria. While extracting data, we also assess the risk of bias in the included studies. All the data and evidence obtained will be evaluated by the method of Bayesian network meta-analysis. RESULTS: This study will evaluate the effectiveness and safety of various TCPMs for diabetic cognitive dysfunction. CONCLUSION: The results of this study will provide valuable references for the clinical application of TCPMs, and assist clinicians in formulating more reasonable diagnosis and treatment strategies. ETHICS AND DISSEMINATION: This study does not require ethical approval. INTERNATIONAL PLATFORM OF REGISTERED SYSTEMATIC REVIEW AND METAANALYSIS PROTOCOLS REGISTRATION NUMBER: INPLASY202190008.
Zhang Y, Zhou Z, Wei D
… +6 more, Jiao Y, Zhu Q, Shi Y, Peng B, Zhang Y, Song A
Medicine (Baltimore)
· 2022 Feb · PMID 35363208
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BACKGROUND: Stress urinary incontinence (SUI) is one of the common diseases in female urinary system diseases, and the incidence is increasing year by year. Moxibustion therapy, as a kind of acupuncture therapy, has been...BACKGROUND: Stress urinary incontinence (SUI) is one of the common diseases in female urinary system diseases, and the incidence is increasing year by year. Moxibustion therapy, as a kind of acupuncture therapy, has been widely used in the clinical treatment of SUI, but its therapeutic effect and safety have not been scientifically and systematically evaluated. Therefore, the protocol of this systematic review we propose this time is to scientifically evaluate the effectiveness and safety of moxibustion in the treatment of female stress urinary incontinence (FSUI). METHODS: The following 8 electronic databases will be searched from establishment to December 2021: PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure, VIP Database, Wanfang Database, China Biology Medicine disc. All randomized controlled trials of moxibustion in the treatment of FSUI will be searched in the above electronic databases. Two reviewers will independently complete research selection, data extraction, and research quality evaluation. After screening the studies, the quality of the included studies will be evaluated according to the quality standards specified in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0). The primary outcome of included studies is the change from baseline in urine leakage measured by the 1-hour pad test. Secondary outcomes include: the short-form of the International Consultation on Incontinence Questionnaire, the mean 72-hour urinary incontinence episode frequency, self-assessment of the patient's treatment effect, severity of urinary incontinence, and adverse events. Two reviewers will independently conduct study selection, data extraction, risk of bias assessment, and study quality assessment. And the STATA 14.0 software will be implemented for data synthesis and meta-analysis. RESULTS: The result of this meta-analysis will be submitted to peer-reviewed journals for publication, and a comprehensive review of current evidence will be conducted. CONCLUSIONS: The conclusion of this systematic review will provide evidence for judging whether moxibustion is a safer and more effective intervention for female stress urinary incontinence. TRIAL REGISTRATION NUMBER: The protocol has been registered on INPLASY2021120052.
Debras C, Chazelas E, Srour B
… +16 more, Druesne-Pecollo N, Esseddik Y, Szabo de Edelenyi F, Agaësse C, De Sa A, Lutchia R, Gigandet S, Huybrechts I, Julia C, Kesse-Guyot E, Allès B, Andreeva VA, Galan P, Hercberg S, Deschasaux-Tanguy M, Touvier M
BACKGROUND: The food industry uses artificial sweeteners in a wide range of foods and beverages as alternatives to added sugars, for which deleterious effects on several chronic diseases are now well established. The saf...BACKGROUND: The food industry uses artificial sweeteners in a wide range of foods and beverages as alternatives to added sugars, for which deleterious effects on several chronic diseases are now well established. The safety of these food additives is debated, with conflicting findings regarding their role in the aetiology of various diseases. In particular, their carcinogenicity has been suggested by several experimental studies, but robust epidemiological evidence is lacking. Thus, our objective was to investigate the associations between artificial sweetener intakes (total from all dietary sources, and most frequently consumed ones: aspartame [E951], acesulfame-K [E950], and sucralose [E955]) and cancer risk (overall and by site). METHODS AND FINDINGS: Overall, 102,865 adults from the French population-based cohort NutriNet-Santé (2009-2021) were included (median follow-up time = 7.8 years). Dietary intakes and consumption of sweeteners were obtained by repeated 24-hour dietary records including brand names of industrial products. Associations between sweeteners and cancer incidence were assessed by Cox proportional hazards models, adjusted for age, sex, education, physical activity, smoking, body mass index, height, weight gain during follow-up, diabetes, family history of cancer, number of 24-hour dietary records, and baseline intakes of energy, alcohol, sodium, saturated fatty acids, fibre, sugar, fruit and vegetables, whole-grain foods, and dairy products. Compared to non-consumers, higher consumers of total artificial sweeteners (i.e., above the median exposure in consumers) had higher risk of overall cancer (n = 3,358 cases, hazard ratio [HR] = 1.13 [95% CI 1.03 to 1.25], P-trend = 0.002). In particular, aspartame (HR = 1.15 [95% CI 1.03 to 1.28], P = 0.002) and acesulfame-K (HR = 1.13 [95% CI 1.01 to 1.26], P = 0.007) were associated with increased cancer risk. Higher risks were also observed for breast cancer (n = 979 cases, HR = 1.22 [95% CI 1.01 to 1.48], P = 0.036, for aspartame) and obesity-related cancers (n = 2,023 cases, HR = 1.13 [95% CI 1.00 to 1.28], P = 0.036, for total artificial sweeteners, and HR = 1.15 [95% CI 1.01 to 1.32], P = 0.026, for aspartame). Limitations of this study include potential selection bias, residual confounding, and reverse causality, though sensitivity analyses were performed to address these concerns. CONCLUSIONS: In this large cohort study, artificial sweeteners (especially aspartame and acesulfame-K), which are used in many food and beverage brands worldwide, were associated with increased cancer risk. These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally. TRIAL REGISTRATION: ClinicalTrials.gov NCT03335644.
Wang X, Hou Y, Ding L
… +5 more, Zheng X, Sheng Y, Yu Q, Bi X, Yang J
Medicine (Baltimore)
· 2022 Feb · PMID 35212293
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BACKGROUND: As the outbreak of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly spread over the world, the World Health Organization has declared th...BACKGROUND: As the outbreak of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly spread over the world, the World Health Organization has declared the outbreak of COVID-19 an international public health emergency. Besides typical respiratory symptoms and signs of COVID-19, digestive symptoms and liver injury have been frequently reported during the course of the disease. The purpose of this study was to evaluate the efficacy and safety of moxibustion in the treatment of anorexia in patients with COVID-19. METHODS: According to the retrieval strategies, randomized controlled trials on moxibustion therapies for C19-A will be obtained from the China National Knowledge Infrastructure, WanFang Data, Chinese Scientific Journals Database, PubMed, Embase, and Cochrane Library, regardless of publication date or language. Studies will be screened based on inclusion and exclusion criteria, and the Cochrane risk bias assessment tool will be used to evaluate the quality of the literature. The network meta-analysis will be performed with the Markov chain Monte Carlo method and carried out with Stata 14.2 and WinBUGS 1.4.3 software. Ultimately, the quality of the evidence obtained from the results will be evaluated. RESULTS: This study will evaluate whether moxibustion therapy can effectively treat anorexia in patients with COVID-19. CONCLUSION: This study will provide evidence for whether moxibustion therapy is beneficial to the treatment of anorexia in patients with COVID-19. TRIAL REGISTRATION NUMBER: CRD42022302499.
Zeng X, Li Y, Lu L
… +3 more, Wen H, Wang G, Zuo C
Medicine (Baltimore)
· 2022 Feb · PMID 35212278
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INTRODUCTION: Prediabetes is a high-risk stage of transition to type 2 diabetes mellitus. Previous studies suggest that acupuncture has potential to prevent prediabetes' conversion to type 2 diabetes mellitus, which lack...INTRODUCTION: Prediabetes is a high-risk stage of transition to type 2 diabetes mellitus. Previous studies suggest that acupuncture has potential to prevent prediabetes' conversion to type 2 diabetes mellitus, which lack of high-quality evidence. Zuo's acupuncture, a kind of acupuncture technique, is formed through long-term and repeated clinical practice by professor Zuo Changbo who integrates the internal meaning of Dong extra acupoints and Taoist medicine principle according to the theories of traditional Chinese medicine. It is used clinically to increase the regression toward normo-glycemi on prediabetes. The objective of this trial is to clarify the clinical effectiveness and safety of Zuo acupuncture for prediabetes. METHODS AND ANALYSIS: This study is a prospective randomized controlled trial in which 60 patients with prediabetes will be randomly allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Prediabetes patients in the control group will receive prediabetes health education for lifestyle interventions, whereas patients in the acupuncture group will receive lifestyle interventions plus Zuo Daliji and Yueku stitch treatment. Twenty-four treatment sessions will be performed over 3 months. The primary outcome is conversion rate from prediabetes to normal blood glucose. Secondary outcomes include fasting plasma glucose, 2-hour plasma glucose, glycosylated hemoglobin and blood lipid concentration. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (permission number: YF2020-107-01) and the protocol conforms to the principles of the Declaration of Helsinki. Data collection will be completed by June 2022. Publications will be ready for submission in July 2022.
Talaei M, Faustini S, Holt H
… +15 more, Jolliffe DA, Vivaldi G, Greenig M, Perdek N, Maltby S, Bigogno CM, Symons J, Davies GA, Lyons RA, Griffiths CJ, Kee F, Sheikh A, Richter AG, Shaheen SO, Martineau AR
BACKGROUND: Prospective population-based studies investigating multiple determinants of pre-vaccination antibody responses to SARS-CoV-2 are lacking. METHODS: We did a prospective population-based study in SARS-CoV-2 vac...BACKGROUND: Prospective population-based studies investigating multiple determinants of pre-vaccination antibody responses to SARS-CoV-2 are lacking. METHODS: We did a prospective population-based study in SARS-CoV-2 vaccine-naive UK adults recruited between May 1 and November 2, 2020, without a positive swab test result for SARS-CoV-2 prior to enrolment. Information on 88 potential sociodemographic, behavioural, nutritional, clinical and pharmacological risk factors was obtained through online questionnaires, and combined IgG/IgA/IgM responses to SARS-CoV-2 spike glycoprotein were determined in dried blood spots obtained between November 6, 2020, and April 18, 2021. We used logistic and linear regression to estimate adjusted odds ratios (aORs) and adjusted geometric mean ratios (aGMRs) for potential determinants of SARS-CoV-2 seropositivity (all participants) and antibody titres (seropositive participants only), respectively. RESULTS: Of 11,130 participants, 1696 (15.2%) were seropositive. Factors independently associated with higher risk of SARS-CoV-2 seropositivity included frontline health/care occupation (aOR 1.86, 95% CI 1.48-2.33), international travel (1.20, 1.07-1.35), number of visits to shops and other indoor public places (≥ 5 vs. 0/week: 1.29, 1.06-1.57, P-trend = 0.01), body mass index (BMI) ≥ 25 vs. < 25 kg/m (1.24, 1.11-1.39), South Asian vs. White ethnicity (1.65, 1.10-2.49) and alcohol consumption ≥15 vs. 0 units/week (1.23, 1.04-1.46). Light physical exercise associated with lower risk (0.80, 0.70-0.93, for ≥ 10 vs. 0-4 h/week). Among seropositive participants, higher titres of anti-Spike antibodies associated with factors including BMI ≥ 30 vs. < 25 kg/m (aGMR 1.10, 1.02-1.19), South Asian vs. White ethnicity (1.22, 1.04-1.44), frontline health/care occupation (1.24, 95% CI 1.11-1.39), international travel (1.11, 1.05-1.16) and number of visits to shops and other indoor public places (≥ 5 vs. 0/week: 1.12, 1.02-1.23, P-trend = 0.01); these associations were not substantially attenuated by adjustment for COVID-19 disease severity. CONCLUSIONS: Higher alcohol consumption and lower light physical exercise represent new modifiable risk factors for SARS-CoV-2 infection. Recognised associations between South Asian ethnic origin and obesity and higher risk of SARS-CoV-2 seropositivity were independent of other sociodemographic, behavioural, nutritional, clinical, and pharmacological factors investigated. Among seropositive participants, higher titres of anti-Spike antibodies in people of South Asian ancestry and in obese people were not explained by greater COVID-19 disease severity in these groups.
Niu Y, Zheng W, Wang S
… +6 more, Zhao Q, Wei L, Zhao Y, Wang B, Ju Y, Wang F
Medicine (Baltimore)
· 2022 Feb · PMID 35147133
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BACKGROUND: Myopia are common health problems that people experience in daily life. Pediatric myopia has become a major international public health concern that has a negative impact on physical, mental health of patient...BACKGROUND: Myopia are common health problems that people experience in daily life. Pediatric myopia has become a major international public health concern that has a negative impact on physical, mental health of patients, and quality of life. Currently, there is no cure available. Press needle as an adjuvant therapy is currently undergoing clinical trials in different medical centers. However, no relevant systematic review or meta-analysis has been designed to evaluate the effects of press needle patching on early myopia. There is also a lack of systematic evaluation and analysis of acupoints and thumbtack needle. METHODS: We will electronically search Medline, Embase, PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and Wan-Fang Database from their inception to October 2021. In addition, we will manually retrieve other resources including the reference lists of identified publications, conference articles, and gray literature. The clinical randomized controlled trials or quasi-randomized controlled trials related to press needle for the treatment of early myopia will be included in the study. The language is limited to Chinese and English. Research selection, data extraction, and research quality assessment will be independently completed by 2 researchers. Data were synthesized by using afixed effect model or random effect model depend on the heterogeneity test. The total effective rate was the primary outcomes. RevMan V.5.3 statistical software will be used for meta-analysis. If it is not appropriate for a meta-analysis, then a descriptive analysis will be conducted. Data synthesis will use the risk ratio and the standardized or weighted average difference of continuous data to represent the results. RESULTS: This study will analyze the clinical effective rate, pesudomyopia outcomes, quality of life, improvement of clinical symptoms of pesudomyopia, and validity of thumbtack needle for patients with pesudomyopia. CONCLUSION: This systematic review will provide evidence to judge whether thumbtack needle is an effective intervention for patients with early myopia. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021243151.
Zhu L, Guan Z, Huang Y
… +7 more, Hua K, Ma L, Zhang J, Yang D, Perrot V, Li H, Zhang X
Medicine (Baltimore)
· 2022 Feb · PMID 35119037
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Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up...Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE.This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0-10 cm) or numerical range (0-10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures.A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458-4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623-20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449-27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events.Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated.Trial registration number: ClinicalTrials.gov, NCT01942369.
Yarmolinsky J, Díez-Obrero V, Richardson TG
… +23 more, Pigeyre M, Sjaarda J, Paré G, Walker VM, Vincent EE, Tan VY, Obón-Santacana M, Albanes D, Hampe J, Gsur A, Hampel H, Pai RK, Jenkins M, Gallinger S, Casey G, Zheng W, Amos CI, International Lung Cancer Consortium, PRACTICAL consortium, MEGASTROKE consortium, Smith GD, Martin RM, Moreno V
BACKGROUND: Epidemiological studies have reported conflicting findings on the potential adverse effects of long-term antihypertensive medication use on cancer risk. Naturally occurring variation in genes encoding antihyp...BACKGROUND: Epidemiological studies have reported conflicting findings on the potential adverse effects of long-term antihypertensive medication use on cancer risk. Naturally occurring variation in genes encoding antihypertensive drug targets can be used as proxies for these targets to examine the effect of their long-term therapeutic inhibition on disease outcomes. METHODS AND FINDINGS: We performed a mendelian randomization analysis to examine the association between genetically proxied inhibition of 3 antihypertensive drug targets and risk of 4 common cancers (breast, colorectal, lung, and prostate). Single-nucleotide polymorphisms (SNPs) in ACE, ADRB1, and SLC12A3 associated (P < 5.0 × 10-8) with systolic blood pressure (SBP) in genome-wide association studies (GWAS) were used to proxy inhibition of angiotensin-converting enzyme (ACE), β-1 adrenergic receptor (ADRB1), and sodium-chloride symporter (NCC), respectively. Summary genetic association estimates for these SNPs were obtained from GWAS consortia for the following cancers: breast (122,977 cases, 105,974 controls), colorectal (58,221 cases, 67,694 controls), lung (29,266 cases, 56,450 controls), and prostate (79,148 cases, 61,106 controls). Replication analyses were performed in the FinnGen consortium (1,573 colorectal cancer cases, 120,006 controls). Cancer GWAS and FinnGen consortia data were restricted to individuals of European ancestry. Inverse-variance weighted random-effects models were used to examine associations between genetically proxied inhibition of these drug targets and risk of cancer. Multivariable mendelian randomization and colocalization analyses were employed to examine robustness of findings to violations of mendelian randomization assumptions. Genetically proxied ACE inhibition equivalent to a 1-mm Hg reduction in SBP was associated with increased odds of colorectal cancer (odds ratio (OR) 1.13, 95% CI 1.06 to 1.22; P = 3.6 × 10-4). This finding was replicated in the FinnGen consortium (OR 1.40, 95% CI 1.02 to 1.92; P = 0.035). There was little evidence of association of genetically proxied ACE inhibition with risk of breast cancer (OR 0.98, 95% CI 0.94 to 1.02, P = 0.35), lung cancer (OR 1.01, 95% CI 0.92 to 1.10; P = 0.93), or prostate cancer (OR 1.06, 95% CI 0.99 to 1.13; P = 0.08). Genetically proxied inhibition of ADRB1 and NCC were not associated with risk of these cancers. The primary limitations of this analysis include the modest statistical power for analyses of drug targets in relation to some less common histological subtypes of cancers examined and the restriction of the majority of analyses to participants of European ancestry. CONCLUSIONS: In this study, we observed that genetically proxied long-term ACE inhibition was associated with an increased risk of colorectal cancer, warranting comprehensive evaluation of the safety profiles of ACE inhibitors in clinical trials with adequate follow-up. There was little evidence to support associations across other drug target-cancer risk analyses, consistent with findings from short-term randomized controlled trials for these medications.
Zhu P, Guan JZ, Hai QC
… +3 more, Jin J, Shi L, Hua L
Medicine (Baltimore)
· 2022 Jan · PMID 35089214
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BACKGROUND: Polycystic ovary syndrome (PCOS) is the main cause of infertility in women, the essence of which is an endocrine disorder syndrome with abnormal sugar metabolism and reproductive dysfunction, and the incidenc...BACKGROUND: Polycystic ovary syndrome (PCOS) is the main cause of infertility in women, the essence of which is an endocrine disorder syndrome with abnormal sugar metabolism and reproductive dysfunction, and the incidence rate of about 6% of women. Traditional Chinese medicine (TCM) Jinfeng pill has achieved very good clinical results in the treatment of infertility with PCOS, but there is currently a lack of strong evidence-based medical evidence. This study uses meta-analysis method to analyze the clinical effectiveness and safety of TCM Jinfeng pill in the treatment of infertility with PCOS, hoping to provide help for the clinical treatment of infertility with PCOS. METHODS: Using the computer to retrieve SinoMed, CNKI, VIP, WANFANG Database, as well as Public, The Cochrane library, Medline (Ovid SP), Embase and other foreign language databases, while manually retrieving the relevant magazine supplements, special issues, professional materials, network information, and so on. The retrieval time is from the beginning of each database to June 2021. The selected literature is evaluated using the Cochrane System Rating Manual Bias Risk Tool. Statistical analysis and graphics of the inclusion literature are performed using Review Manager 5.3 statistical software. RESULTS: All the results of this study on the clinical effectiveness and safety of TCM Jinfeng pill in adjuvant treatment of infertility with PCOS will be published in a peer-reviewed academic journal of medicine. ETHICS AND DISSEMINATION: The type of study is systematic evaluation, the whole process of research does not involve human trials, the data used in the institute are obtained through published literature, so ethical review is not suitable for this study. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/JEP2D. (https://osf.io/jep2d). CONCLUSION: Our research will provide evidence-based medical evidence on whether the TCM Jinfeng pill is effective and safe in the treatment of infertility with PCOS.
Bian Z, Yu J, Tu M
… +4 more, Liao B, Huang J, Jiang Y, Fang J
Medicine (Baltimore)
· 2021 Dec · PMID 34918706
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BACKGROUND: Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression syndrome of the upper limb. Plenty of studies showed the effects of acupuncture therapy on relieving pain and improving functional...BACKGROUND: Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression syndrome of the upper limb. Plenty of studies showed the effects of acupuncture therapy on relieving pain and improving functional status for CTS patients. Diverse types of acupuncture therapies have been used in the treatment for CTS, but their relative treatment effects are poorly understood. This study will evaluate the effects of different acupuncture and related therapies for CTS by conducting a systematic review and Bayesian network meta-analysis (NMA). METHODS: We will search randomized controlled trials (RCTs) of acupuncture and related therapies for CTS in MEDLINE (via PubMed), EMBASE, Web of Science, Cochrane Library, Chinese Biomedical Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database, WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, Chinese Clinical Trial Register, and OpenGrey from inception to November 2021. Then, we will select eligible studies, extract data, and conduct risk of bias assessment using the Cochrane tool. Pairwise meta-analysis and Bayesian NMA will be performed in Stata 15.1 software and Aggregate Data Drug Information System 1.16.8 software. We will assess the quality of the evidence using the Confidence in Network Meta-Analysis application. RESULTS: In this study, the treatment effects and safety of different acupuncture and related therapies for CTS will be evaluated. CONCLUSION: This study will provide evidence for choosing the optimal acupuncture and related therapies in the treatment for CTS.
Medicine (Baltimore)
· 2021 Dec · PMID 34918656
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BACKGROUND: Ultrafiltration plays an indispensable role in relieving congestion and fluid retention in patients with acute decompensated heart failure (ADHF) in recent years. So far, there is no consistent agreement abou...BACKGROUND: Ultrafiltration plays an indispensable role in relieving congestion and fluid retention in patients with acute decompensated heart failure (ADHF) in recent years. So far, there is no consistent agreement about whether early ultrafiltration (UF) is a first-line treatment for patients with ADHF. We, therefore, conducted a meta-analysis to assess the efficacy and safety of UF. METHODS: PubMed, Embase, and Cochrane Library databases were searched for randomized controlled trials (RCTs) that compared UF with diuretics in patients with ADHF and included our interested outcomes. The primary outcomes are heart failure rehospitalization, all-cause rehospitalization, and mortality. The second outcomes are fluid loss, weight loss, and adverse events. RevMan Version 5.4.1 was used to analyze the data of included studies. RESULTS: A total of 12 studies with 1197 patients were included. Our results showed a reduction in heart failure rehospitalization (risk ratio [RR] 0.67, 95% confidence interval [CI]: 0.52-0.87, P = .003) and all-cause rehospitalization (RR 0.62, 95% CI: 0.42-0.92; P = .02), an increase in fluid loss (1.47 L, 95% CI: 0.95-1.99 L, P < .001) and weight loss (1.65 kg, 95% CI: 0.90-2.41 kg; P < .001). There was no difference in mortality (RR 1.09, 95% CI: 0.78-1.51; P = .62). There were inconsistent agreements about which group have more total adverse events. Subgroup analysis showed that UF with larger mean fluid-remove rate (≥200 mL/h) could significantly remove more fluid, lose more weight, and decrease heart failure rehospitalization. Less weight loss for patients with ADHF may correlated to higher percent of ischemic etiology (ischemic etiology ≥50%). CONCLUSION: Although UF is more effective in removing fluid than diuretics and decrease rehospitalization of heart failure and all causes, there is not enough evidence to prove that UF is superior because of adverse events and mortality in the UF group. The mean fluid-removal rates should be set to ≥200 mL/h. Patient with different etiology may have different effects when treated with UF and it is a weak conclusion.Trial registration: The systematic review was registered with the International Prospective Registry of Systematic Reviews. (https://www.crd.york.ac.uk/prospero/, registration number CRD42021245049).
BACKGROUND: Although randomized controlled trials (RCTs) have suggested a non-significant increased risk of stroke among proton pump inhibitor (PPI) users, the association has not been confirmed. We evaluated the associa...BACKGROUND: Although randomized controlled trials (RCTs) have suggested a non-significant increased risk of stroke among proton pump inhibitor (PPI) users, the association has not been confirmed. We evaluated the association between regular use of PPIs and incident stroke and identified population groups at high net risk. METHODS: This is a prospective analysis of 492,479 participants free of stroke from the UK biobank. Incident stroke was identified through linkage to hospital admission and death registries using the International Classification of Diseases (ICD)-10 codes (I60, I61, I63, and I64). We evaluated hazard ratios (HRs) adjusting for demographic factors, lifestyle habits, prevalent comorbidities, concomitant use of medications, and indications of PPIs. We assessed the risk differences (RDs) according to the baseline Framingham Stroke Risk Score. In the meta-analysis, we searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (from 1988 to 1 June 2020) for randomized trials comparing PPIs with other interventions, placebo, or no treatment on stroke risk. Results were combined using a fix-effect meta-analysis (Mantel-Haenszel method). RESULTS: We documented 5182 incident strokes over 3,935,030 person-years of follow-up. Regular PPI users had a 16% higher risk of stroke than non-users (HR 1.16, 95% CI 1.06 to 1.27). The estimated effect was similar to our meta-analysis of nine RCTs (case/participants 371/26,642; RR 1.22, 95% CI 1.00 to 1.50; quality of evidence: moderate). The absolute effect of PPI use on stroke increased with the baseline Framingham Stroke Risk Score, with an RD of 1.34‰, 3.32‰, 4.83‰, and 6.28‰ over 5 years for the lowest, quartile 2, quartile 3, and the highest quartile, respectively. CONCLUSIONS: Regular use of PPIs was associated with an increased risk of stroke, with a higher absolute risk observed in individuals with high baseline stroke risk. Physicians should therefore exercise caution when prescribing PPIs. An assessment of the underlying stoke risk is recommended for individualized use of PPIs.
Wang F, Li Q, Yu Q
… +3 more, Liang J, Xu Y, Chen G
Medicine (Baltimore)
· 2021 Nov · PMID 34797292
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BACKGROUND: Peripheral facial paralysis (PFP) is a consequence of the peripheral neuronal lesion of the facial nerve. It can be either primary (Bell palsy) or secondary. The incidence of PFP is 11.5 to 40.2 per 100,000 p...BACKGROUND: Peripheral facial paralysis (PFP) is a consequence of the peripheral neuronal lesion of the facial nerve. It can be either primary (Bell palsy) or secondary. The incidence of PFP is 11.5 to 40.2 per 100,000 people a year. Nearly 70% of patients with PFP recover completely, but almost 30% of patients leave multiple sequelae which caused impacts on the patient's quality of life, both physically and psychologically. The conventional treatments of PFP are limited for some person because of side-effects. Previous studies have suggested that using acupoint catgut embedding (ACE) alone or combined with other therapeutic methods is effective for PFP. However, whether ACE is effective for PFP is still unknown. The purpose of this systematic review (SR) and meta-analysis will summarize the present evidence of ACE used as an intervention for PFP. METHOD/DESIGN: Randomized controlled clinical trials that use ACE for PFP will be searched from four international electronic databases (PubMed, Cochrane Library, EMBASE, and Web of Science) and 4 Chinese electronic databases (China National Knowledge Infrastructure, VIP, Wanfang, and China Biology Medicine) to search for relevant literature. We only include studies that were published from the initiation to May 2021. The primary outcomes include effectiveness rate based on House-Brackmann Facial Nerve Grading System. Secondary outcomes will include Sunnybrook facial nerve grading system, Portmann score, facial nerve conduction velocity, Facial Disability Index Scale, adverse events. Two reviewers will perform study selection, data extraction, data synthesis, and quality assessment independently. Assessment of risk of bias and data synthesis will be conducted by using Review Manager 5.3 software. Grade system will be used to evaluate the quality of evidence. DISCUSSION: This systematic review will help establish clinical evidence regarding the efficacy and safety of acupoint catgut embedding for peripheral facial paralysis. TRIAL REGISTRATION NUMBER: CRD42021243212 (PROSPERO).
Hanley-Cook GT, Huybrechts I, Biessy C
… +43 more, Remans R, Kennedy G, Deschasaux-Tanguy M, Murray KA, Touvier M, Skeie G, Kesse-Guyot E, Argaw A, Casagrande C, Nicolas G, Vineis P, Millett CJ, Weiderpass E, Ferrari P, Dahm CC, Bueno-de-Mesquita HB, Sandanger TM, Ibsen DB, Freisling H, Ramne S, Jannasch F, van der Schouw YT, Schulze MB, Tsilidis KK, Tjønneland A, Ardanaz E, Bodén S, Cirera L, Gargano G, Halkjær J, Jakszyn P, Johansson I, Katzke V, Masala G, Panico S, Rodriguez-Barranco M, Sacerdote C, Srour B, Tumino R, Riboli E, Gunter MJ, Jones AD, Lachat C
BACKGROUND: Food biodiversity, encompassing the variety of plants, animals, and other organisms consumed as food and drink, has intrinsic potential to underpin diverse, nutritious diets and improve Earth system resilienc...BACKGROUND: Food biodiversity, encompassing the variety of plants, animals, and other organisms consumed as food and drink, has intrinsic potential to underpin diverse, nutritious diets and improve Earth system resilience. Dietary species richness (DSR), which is recommended as a crosscutting measure of food biodiversity, has been positively associated with the micronutrient adequacy of diets in women and young children in low- and middle-income countries (LMICs). However, the relationships between DSR and major health outcomes have yet to be assessed in any population. METHODS AND FINDINGS: We examined the associations between DSR and subsequent total and cause-specific mortality among 451,390 adults enrolled in the European Prospective Investigation into Cancer and Nutrition (EPIC) study (1992 to 2014, median follow-up: 17 years), free of cancer, diabetes, heart attack, or stroke at baseline. Usual dietary intakes were assessed at recruitment with country-specific dietary questionnaires (DQs). DSR of an individual's yearly diet was calculated based on the absolute number of unique biological species in each (composite) food and drink. Associations were assessed by fitting multivariable-adjusted Cox proportional hazards regression models. In the EPIC cohort, 2 crops (common wheat and potato) and 2 animal species (cow and pig) accounted for approximately 45% of self-reported total dietary energy intake [median (P10-P90): 68 (40 to 83) species consumed per year]. Overall, higher DSR was inversely associated with all-cause mortality rate. Hazard ratios (HRs) and 95% confidence intervals (CIs) comparing total mortality in the second, third, fourth, and fifth (highest) quintiles (Qs) of DSR to the first (lowest) Q indicate significant inverse associations, after stratification by sex, age, and study center and adjustment for smoking status, educational level, marital status, physical activity, alcohol intake, and total energy intake, Mediterranean diet score, red and processed meat intake, and fiber intake [HR (95% CI): 0.91 (0.88 to 0.94), 0.80 (0.76 to 0.83), 0.69 (0.66 to 0.72), and 0.63 (0.59 to 0.66), respectively; PWald < 0.001 for trend]. Absolute death rates among participants in the highest and lowest fifth of DSR were 65.4 and 69.3 cases/10,000 person-years, respectively. Significant inverse associations were also observed between DSR and deaths due to cancer, heart disease, digestive disease, and respiratory disease. An important study limitation is that our findings were based on an observational cohort using self-reported dietary data obtained through single baseline food frequency questionnaires (FFQs); thus, exposure misclassification and residual confounding cannot be ruled out. CONCLUSIONS: In this large Pan-European cohort, higher DSR was inversely associated with total and cause-specific mortality, independent of sociodemographic, lifestyle, and other known dietary risk factors. Our findings support the potential of food (species) biodiversity as a guiding principle of sustainable dietary recommendations and food-based dietary guidelines.