scholarly journals Efficacy and safety of cryotherapy, cold cone or thermocoagulation compared to LEEP as a therapy for cervical intraepithelial neoplasia: Systematic review

2020 ◽  
Vol 54 ◽  
pp. 27 ◽  
Author(s):  
Yamilée Hurtado-Roca ◽  
Naysha Becerra-Chauca ◽  
Magaly Malca

OBJECTIVES: To determine the efficacy and safety of the use of cryotherapy, cold knife or thermocoagulation compared to Loop Electrosurgical Excision Procedure (LEEP) for the treatment of cervical intraepithelial neoplasia. METHODS: Systematic review with meta-analysis of randomized controlled trials in women with cervical intraepithelial neoplasia undergoing treatment with cryotherapy, cold knife, or thermo-coagulation compared with LEEP, to estimate its efficacy and safety. The search was conducted on MEDLINE/PUBMED, Cochrane Central Register of Controlled Trials (CENTRAL) and Scopus, until September 2018. RESULTS: The total of 72 studies were identified, of which only 8 studies met the inclusion criteria. The treatment of CIN with cold knife decreases the risk of residual disease compared with LEEP (RR, 0.54, 95%CI, 0.30–0.96, p = 0.04). The management of premalignant lesions with cryotherapy, compared with LEEP, increases the risk of disease recurrence by 86% (RR, 1.86, 95%CI, 1.16–2.97, p = 0.01), increases the risk of infections (RR, 1.17, 95%CI, 1.08–1.28, p < 0.001) and reduces the risk of minor bleeding by 51% (RR, 0.49, 95%CI) %, 0.40–0.59, p ≤ 0.001). CONCLUSIONS: The treatment of premalignant lesions of cervical cancer with cold knife reduces the risk of residual disease. Nevertheless, cryotherapy reduces the risk of minor bleeding in the 24 hours after treatment and increases the risk of recurrence of disease and infections.

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e026975 ◽  
Author(s):  
Caroline Amélia Gonçalves ◽  
Luís Carlos Lopes-Júnior ◽  
Fernando Kenji Nampo ◽  
Adriana Zilly ◽  
Paulo César Morales Mayer ◽  
...  

IntroductionEighty per cent of the sexually active population will get human papillomavirus (HPV) infection, which is the most prevalent sexually transmitted disease worldwide. Persistence of high-grade HPV infection may evolve to a cervical intraepithelial neoplasia (CIN), and these lesions may be precursors of cervical cancer. However, this progression can be prevented by the administration of therapeutic vaccines which use the main oncoproteins responsible for cancer development in an attempt to trigger a more specific and effective immunological response against this disorder. We aim to evaluate the safety, efficacy and immunogenicity of therapeutic vaccines in the treatment of patients with high-grade CIN 2/3 associated with HPV.Methods and analysisA systematic review of clinical trials will be undertaken. Medline, Excerpta Medica Database, Cochrane Central Register of Controlled Trials, Web of Science, Latin American and Caribbean Health Sciences Literature, Scientific Electronic Library Online and Scopus will be searched, with no restriction regarding publication date. Primary outcomes will include measures related to safety, efficacy and the immunogenicity of the therapeutic vaccines used in these patients. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Methodological appraisal of the studies will be assessed by the Cochrane Risk-of-Bias Tool for randomised controlled trials, and the quality evidence of the risk of bias in single studies will be evaluated by Grading of Recommendations Assessment, Development and Evaluation. A narrative synthesis will be done for all included studies. Outcomes will be analysed according to the subgroups of HPV type, CIN grade, route of vaccine administration and vaccine type. Also, if sufficient data are available, a meta-analysis will be conducted. The effect sizes will be generated using Hedges’ g score for both fixed and random effect models. I2statistics will be used to assess heterogeneity and identify their potential sources.Ethics and disseminationEthical approval is not required as primary data will not be collected. Findings will be disseminated widely via peer-reviewed publication and in different media, for example, conferences, congresses or symposia.PROSPERO registration numberCRD42017077428.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042597
Author(s):  
Xinyuan Liu ◽  
Qing Yang ◽  
Zhongning He ◽  
Shukun Yao

IntroductionFunctional constipation (FC) is a common digestive system disease, with an uptrend in morbidity and mortality, resulting in huge social and economic losses. Although the guidelines recommend lifestyle intervention as a first-line treatment, lifestyle intervention is not widely used in clinic. Inulin can be used as the basic material of functional food. Clinical studies have shown that inulin supplementation is associated with increased frequency of bowel movements, but has certain side effects. Therefore, the efficacy and safety of inulin in the treatment of FC need to be further evaluated.Methods and analysisWe will search Medline, Web of Science, Embase, China National Knowledge Infrastructure Database, Wanfang Database and China Biomedical Literature Database. We will also search the China Clinical Trial Registry, the Cochrane Central Register of Controlled Trials and related conference summaries. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RevMan V.5.3.5 will be used for analysis.Ethics and disseminationThis systematic review will evaluate the efficacy and safety of inulin supplementation for the treatment of FC. All included data will be obtained from published articles, there is no need for the ethical approval, and it will be published in a peer-reviewed journal. Due to lack of a new systematic review in this field, this study will combine relevant randomised controlled trials to better explore the evidence of inulin supplementation in the treatment of FC and guide clinical practice and clinical research.PROSPERO registration numberCRD42020189234.


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735


2019 ◽  
Vol 13 (1) ◽  
pp. 32-44
Author(s):  
Nigel Ashworth ◽  
Henry Aidoo ◽  
Alexander Doroshenko ◽  
David Antle ◽  
Charl Els ◽  
...  

Objective:Botulinum Toxin (BTX) has become a widely used treatment in several dystonic conditions, but the evidence for its efficacy has largely come from open trials and expert opinion. This systematic review examined the efficacy and safety of BTX in the treatment of Focal Hand Dystonia (FHD) in Randomized Controlled Trials (RCTs).Methods:We searched Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE), Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, SPORT Discus, SCOPUS, Web of Science, PEDro, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) for randomized, placebo-controlled trials on the use of BTX for FHD.Results:Of 1,116 publications retrieved from the databases searched, three publications were included. The evidence identified pertains to focal task-specific hand dystonias. Sixty-nine participants were involved in the three RCTs with a mean duration of symptoms of 7.5 years. Participants were assessed using a combination of self-reported and functional performance outcome measures following injections of BTX subtype A (BTX-A) or placebo. The Oxford Quality Scale was used to assess the included studies, and the three studies each scored 3/5 or above. The included studies reported no adverse events with BTX-A use, other than muscle weakness and pain at the injection sites.Conclusion:The number of participants included in these three trials is too small to draw dependable conclusions about the efficacy and safety of BTX-A for FHD. There is currently not enough evidence to recommend the routine use of BTX-A for FHD.


Medicina ◽  
2019 ◽  
Vol 55 (12) ◽  
pp. 762 ◽  
Author(s):  
Aikaterini Amaniti ◽  
Chrysanthi Sardeli ◽  
Varvara Fyntanidou ◽  
Panagiota Papakonstantinou ◽  
Ioannis Dalakakis ◽  
...  

Background and Objectives: Among HIV infection symptoms, sensory neuropathy (HIV-SN) remains a main cause of suffering, with incidence varying from 13–50%. So far, numerous pharmacological and non-pharmacological treatments have been tested, although few evidence-based analgesic options are available. We conducted an up-to-date systematic review and meta-analysis of the literature in order to evaluate the efficacy and safety of pharmacologic and non-pharmacologic treatments for pain control, in patients with HIV neuropathy. Materials and Methods: We searched MEDLINE, EMBASE, Scopus/Elsevier, The Cochrane Central Register of Controlled Trials (CENTRAL), USA Clinical Trials registry, and The International Web of Science up to April 2019. All randomized controlled trials evaluating efficacy and safety of non-pharmacologic and pharmacologic therapies were included. Efficacy was defined as pain reduction during the study period. Safety was estimated from adverse events. A meta-analysis was performed whenever possible. Results: 27 randomized controlled trials (RCTs) were included for analysis (7 evaluating non pharmacologic interventions, 20 pharmacologic therapies). Non-pharmacologic studies (n = 742) involved seven different therapeutic modalities. Only Acupuncture/Moxibustion showed pain reduction over placebo, Gracely Pain Scale Mean (SD): Acu/Moxa 0.85 (0.12), placebo 1.10 (0.09), p = 0.05. Pharmacologic studies, involving 2516 patients revealed efficacy for capsaicin 8% over placebo (mean difference −8.04 [95% CI: −14.92 −1.15], smoked cannabis (where pooling data for meta-analysis was not possible) and recombinant Nerve Growth Factor. Conclusion: Despite various modalities for pain control in HIV-SN, strongest evidence exists for capsaicin 8% and smoked cannabis, although of low methodological quality. Among non-pharmacologic modalities, only Acu/Moxa gave a marginal beneficial effect in one study, possibly limited by inherent methodological flaws.


BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029327 ◽  
Author(s):  
Kai Zhang ◽  
Chengyu Li ◽  
Chao Gao ◽  
Chen Zhao ◽  
Qilin Tang ◽  
...  

IntroductionAcupuncture may be effective for acute pancreatitis (AP). This systematic review aims to assess the efficacy and safety of acupuncture as an adjuvant treatment for AP.Methods and analysisWe will search PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, Web of Science, China National Knowledge Infrastructure, Wan Fang Data and Chinese Science Journal Database from inception to 30 June 2019 to identify any eligible study. Only randomised controlled trials will be included. The selection of studies, data extraction and management will be completed by two reviewers independently. The primary outcomes include the overall response rate, mortality during the treatment, the proportion of patients with severe acute pancreatitis transferred to the intensive care unit or scheduled for surgery, gastrointestinal function and the acute physiology and chronic health evaluation II scores. The secondary outcomes include visual analogue scale, the use of analgesics, the recovery time of blood amylase becoming normal, tumour necrosis factor α counts, IL-6 counts, IL-10 counts, length of hospital stay and adverse events related to acupuncture (such as fainting, nausea, haematoma and local infection). Review Manager V.5.3 software will be used for statistical analyses. The risk of bias of included studies will be assessed by the Cochrane ‘risk of bias’ tool.Ethics and disseminationThis study will not involve personal information. The ethical approval will not be required. The results will be published in a peer-reviewed journal.Trial registration numberCRD42018115099


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16067-e16067
Author(s):  
Kenji Omae ◽  
Yasushi Tsujimoto ◽  
Michitaka Honda ◽  
Tsunenori Kondo ◽  
Yasunobu Hashimoto ◽  
...  

e16067 Background: Bone-modifying agents (BMA) have been well-demonstrated to be effective for preventing and inhibiting skeletal-related events (SRE) in patients with bone metastases of breast or prostate cancer. However, the role of BMA treatment has not yet been clearly defined in patients with bone metastases of renal cell carcinoma (RCC). We, therefore, conducted a systematic review and meta-analysis to evaluate the efficacy and safety of BMA in patients with bone metastases of RCC. Methods: Literature search was conducted on MEDLINE, the Cochrane Central Register of Controlled Trials, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov to identify randomized controlled trials of BMA for the treatment of bone metastases in RCC patients. The primary outcomes were SRE and serious adverse events (AEs). Hazard ratios (HRs) were calculated with a random effects model. The Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach was used to assess the certainty of the evidence. This review was prospectively registered on PROSPERO (No. CRD42016032742). Results: Three studies (259 patients) were identified for the systematic review. Two studies that compared zoledronic acid with placebo or non-zoledronic acid showed that zoledronic acid reduced the SRE risk by 68% (HR 0.32; 95% confidence interval (CI) 0.19–0.55; P < 0.0001). The quality of evidence was moderate. No serious osteonecrosis was reported in both studies. The incidence of serious AEs was identical (80%) on both treatment arms in one study and not reported in the other study. In the remaining study, which compared denosumab with zoledronic acid, analyses of the individual patient data shared through Amgen showed a favorable trend for denosumab in terms of SRE (HR 0.71; 95% CI 0.43–1.17) and serious AEs (risk ratio 0.86; 95% CI 0.68–1.08), but this trend did not reach statistical significance. Conclusions: The moderate-quality evidence indicates that zoledronic acid significantly reduces the risk of SRE among patients with bone metastases of RCC.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036960
Author(s):  
Jonathan Sen ◽  
Erin Chung ◽  
Christopher Neil ◽  
Thomas Marwick

BackgroundHypertension confers a poor prognosis in moderate or severe aortic stenosis (AS), however, antihypertensive therapy (AHT) is often not prescribed due to the perceived deleterious effects of vasodilation and negative inotropes.ObjectiveTo assess the efficacy and safety outcomes of AHT in adults with moderate or severe AS.DesignSystematic review and meta-analysis.Data sourcesThe Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and grey literature were searched without language restrictions up to 9 September 2019.Study eligibility criteria, appraisal and synthesis methodsTwo independent reviewers performed screening, data extraction and risk of bias assessments from a systematic search of observational studies and randomised controlled trials comparing AHT with a placebo or no AHT in adults with moderate or severe AS for any parameter of efficacy and safety outcomes. Conflicts were resolved by the third reviewer. Meta-analysis with pooled effect sizes using random-effects model, were estimated in R.Main outcome measuresMortality, Left Ventricular (LV) Mass Index, systolic blood pressure, diastolic blood pressure and LV ejection fractionResultsFrom 3025 publications, 31 studies (26 500 patients) were included in the qualitative synthesis and 24 studies in the meta-analysis. AHT was not associated with mortality when all studies were pooled, but heterogeneity was substantial across studies. The effect size of AHT differed according to drug class. Renin–angiotensin–aldosterone system inhibitors (RAASi) were associated with reduced risk of mortality (Pooled HR 0.58, 95% CI 0.43 to 0.80, p=0.006), The differences in changes of haemodynamic or echocardiographic parameters from baseline with and without AHT did not reach statistical significance.ConclusionAHT appears safe, is well tolerated. RAASi were associated with clinical benefit in patients with moderate or severe AS.


2021 ◽  
Author(s):  
Benny Rashuaman-Conche ◽  
Silvana Loli-Guevara ◽  
Ethel Rodriguez ◽  
Carlos Alva-Diaz

Introduction: Leptospirosis is the most widespread zoonosis in the world. It represents a public health problem especially in tropical and subtropical regions, but it is also presents in temperate regions. Spirochetes from leptospira genus cause the disease, they affect humans as an intermediate host. About pre-exposure prophylaxis for people at risk, antibiotics such as doxycycline or azithromycin were used to prevent the development of leptospirosis and its related adverse outcomes. However, the evidence about the efficacy and safety of this intervention is limited. Objectives: To determine whether pre-exposure antibiotic administration prevents infection, hospitalization, or mortality from leptospirosis, without causing severe adverse effects. Methods: We propose to do a systematic review and meta-analysis. We will search in Pubmed (Medline), Embase.com, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Web of Science, LILACS and ClinicalTrials.gov. Individual randomized controlled trials, non-randomized controlled trials, cohorts, and cases-control studies will be included according to the inclusion and exclusion criteria set. The flow chart for selecting studies to be included will be presented in accordance with the PRISMA guide. The methodological quality of the studies will be evaluated by duplicate. Subsequently, the qualitative analysis of the data will be carried out and the feasibility of a quantitative meta-analysis will be evaluated. Finally, a summary of findings table will be presented according to the feasibility of the meta-analysis. Results: The results will be published in a peer-reviewed journal. Conclusion: This systematic review will sum up-to-date evidence about the efficacy and safety of pre-exposure antibiotic prophylaxis for preventing laboratory-confirmed leptospirosis, hospitalization and mortality.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027376
Author(s):  
Man Yang ◽  
Yuanyuan Yu ◽  
Ping-Guang Lei ◽  
Jinqiu Yuan

IntroductionIrritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder affecting approximately 10% to 25% of the adult population. A large number of clinical trials have been conducted to evaluate the efficacy of probiotics for IBS but the results were inconsistent. Previous meta-analyses have shown that probiotics are effective for IBS, but the comparative efficacy of individual species is unclear. In addition, evidence regarding the superiority of combination over single probiotic is still lacking. We, therefore, perform this study to evaluate the comparative efficacy and safety of various species of probiotics, and combination regimens for the treatment of IBS.Methods and analysisThis study is a systematic review with network meta-analysis. We will search PubMed, Scopus, The Cochrane Central Register of Controlled Trials and CINAHL for randomised controlled trials comparing probiotics with placebo or comparing different probiotics for IBS, with no language restrictions. The primary outcomes will be treatment response and global IBS-symptom score. We will initially combine included studies with traditional pairwise meta-analysis and then with random-effects network meta-analysis. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. We will check the consistency assumption by testing the absolute difference between direct and indirect estimates for comparisons in closed loops. The quality of evidence will be evaluated according to the GRADE framework.Ethics and disseminationEthical approval is not required for literature-based studies. We will disseminate the findings through publications in peer-reviewed journals and relevant conferences.PROSPERO registration numberCRD42018102101


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