scholarly journals Efficacy and Safety of Laser Therapy for the Treatment of Genitourinary Syndrome of Menopause: A Protocol for Systematic Review and Meta-Analysis of Clinical Trials

2021 ◽  
Vol 3 ◽  
Author(s):  
Lisieux de Lourdes Martins Nóbrega Pessoa ◽  
Ayane Cristine Alves Sarmento ◽  
Kleyton Santos Medeiros ◽  
Ana Paula Ferreira Costa ◽  
Ana Katherine Gonçalves ◽  
...  

Laser therapy has been proposed to improve the symptoms of genitourinary syndrome of menopause (GSM), especially in women who do not accept hormonal therapy or are at a high risk of complications if they undergo hormonal therapy. However, studies evaluating the effectiveness and safety of laser treatment for GSM have shown controversial results. Thus, we aimed to determine the efficacy and safety of laser therapy in post-menopausal women with GSM. We have developed a protocol according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol using the population, intervention, comparison, outcome, and study design (PICOS) framework for post-menopausal women who have received no treatment, laser therapy, placebo, or vaginal estrogen for GSM. As per our protocol, randomized controlled trials and quasi-randomized trials, regardless of language of publication, will be searched in PubMed, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, and clinicaltrials.gov. Gray literature will be searched in Open Gray and Google Scholar. The reference lists will be scanned for additional trials, and the authors will be contacted if necessary. Outcome data reported in a trial registry, even when no published results were available, will be analyzed. The search will be performed using key terms, such as “post-menopausal women,” “menopausal genitourinary syndrome,” “vulvovaginal atrophy,” and “laser therapy.” Two review authors will independently screen the titles and abstracts, while three others will independently evaluate the full text of each study to determine its eligibility for this systematic review (SR). Any disagreement will be resolved through discussion and consensus. Data extraction will be performed independently using a standardized data collection form. Clinical outcomes, including vaginal atrophy, vaginal pH, dryness, dyspareunia, itching, burning, dysuria, urinary frequency, urinary urgency, and urinary incontinence, will be systematically evaluated. We will not perform a separate search for adverse effects; instead, we will consider the adverse effects described in the included studies. Furthermore, we will summarize the effects of dichotomous outcomes as risk ratios with 95% confidence intervals. On the other hand, continuous outcomes will be summarized by expressing treatment effects as a mean difference with standard deviation or as a standardized mean difference when different scales were used to measure the same outcome. We will use the Cochrane Risk of Bias 2 tool for bias assessment and the Grading of Recommendations Assessment, Development and Evaluation approach to rate the overall certainty of evidence. Review Manager 5.3.5 will be used for quantitative data synthesis, subgroup analysis, sensitivity analysis, meta-regression, and risk of bias assessment. The SR findings will provide highly relevant evidence through the synthesis of well-designed and robust clinical trials on the effectiveness and safety of laser therapy in GSM. The Prospective Register of Systematic Reviews (PROSPERO) registration number (2021) of the SR is CRD42021253605.

Maturitas ◽  
2017 ◽  
Vol 103 ◽  
pp. 78-88 ◽  
Author(s):  
Eleni Pitsouni ◽  
Themos Grigoriadis ◽  
Matthew E. Falagas ◽  
Stefano Salvatore ◽  
Stavros Athanasiou

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.


Maturitas ◽  
2021 ◽  
Author(s):  
Eduard Mension ◽  
Inmaculada Alonso ◽  
Marta Tortajada ◽  
Isabel Matas ◽  
Sílvia Gómez ◽  
...  

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ana Carolina de Figueiredo Costa ◽  
Thays Allane Cordeiro Maia ◽  
Paulo Goberlânio de Barros Silva ◽  
Lucas Guimarães Abreu ◽  
Delane Viana Gondim ◽  
...  

Abstract Objectives The aim of this systematic review and meta-analysis was to assess the effects of low-level laser therapy (LLLT) on the orthodontic mini-implants (OMI) stability. Materials and methods An unrestricted electronic database search in PubMed, Science Direct, Embase, Scopus, Web of Science, Cochrane Library, LILACS, Google Scholar, and ClinicalTrials.gov and a hand search were performed up to December 2020. Randomized clinical trials (RCTs) or non-randomized clinical trials (Non-RCTs) that assessed the effects of LLLT on the OMI stability were included. Data regarding the general information, LLLT characteristics, and outcomes were extracted. The authors performed risk of bias assessment with Cochrane Collaboration’s or ROBINS-I tool. Meta-analysis was also conducted. Results Five RCTs and one Non-RCT were included and 108 patients were evaluated. The LLLT characteristics presented different wavelength, power, energy density, irradiation time, and protocol duration. Five RCTs had a low risk of selection bias. Two RCTs had a low risk of performance and detection bias. All RCTs had a low risk of attrition bias, reporting bias and other bias. The Non-RCT presented a low risk of bias for all criteria, except for the bias in selection of participants. The meta-analysis revealed that LLLT significantly increased the OMI stability (p < 0.001, Cohen’s d = 0.67) and the highest clinical benefit was showed after 1 (p < 0.001, Cohen’s d = 0.75), 2 (p < 0.001, Cohen’s d = 1.21), and 3 (p < 0.001, Cohen’s d = 1.51) months of OMI placement. Conclusions LLLT shows positive effects on the OMI stability.


2021 ◽  
Vol 12 ◽  
Author(s):  
Bethany D. Skinner ◽  
Rebecca J. Davies ◽  
Samuel R. Weaver ◽  
N. Tim Cable ◽  
Samuel J. E. Lucas ◽  
...  

Sex differences in cerebrovascular disease rates indicate a possible role for ovarian sex steroid hormones in cerebrovascular function. To synthesise and identify knowledge gaps, a systematic review and meta-analysis was conducted to assess how ovarian sex steroid hormone changes across the lifespan affect cerebrovascular function in women. Three databases (EMBASE, MEDLINE and Web of Science) were systematically searched for studies on adult cerebrovascular function and ovarian sex steroid hormones. Forty-five studies met pre-defined inclusion criteria. Studied hormone groups included hormone replacement therapy (HRT; n = 17), pregnancy (n = 12), menstrual cycle (n = 7), menopause (n = 5), oral contraception (n = 2), and ovarian hyperstimulation (n = 2). Outcome measures included pulsatility index (PI), cerebral blood flow/velocity (CBF), resistance index (RI), cerebral autoregulation, and cerebrovascular reactivity. Meta-analysis was carried out on HRT studies. PI significantly decreased [−0.05, 95% CI: (−0.10, −0.01); p = 0.01] in post-menopausal women undergoing HRT compared to post-menopausal women who were not, though there was considerable heterogeneity (I2 = 96.8%). No effects of HRT were seen in CBF (p = 0.24) or RI (p = 0.77). This review indicates that HRT improves PI in post-menopausal women. However, there remains insufficient evidence to determine how changing ovarian sex steroid hormone levels affects cerebrovascular function in women during other hormonal phases (e.g., pregnancy, oral contraception).


2021 ◽  
Vol 15 ◽  
Author(s):  
Xinglin Ruan ◽  
Fabin Lin ◽  
Dihang Wu ◽  
Lina Chen ◽  
Huidan Weng ◽  
...  

Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Helen Koechlin ◽  
Ben Whalley ◽  
Nicky J. Welton ◽  
Cosima Locher

Abstract Background Chronic primary musculoskeletal pain (CPMP) is one subcategory of the new classification of chronic primary pain for the upcoming ICD-11, defined as chronic pain in the muscles, bones, joints, or tendons that persists or recurs for more than 3 months and is associated with significant emotional distress or functional disability. An array of pharmacological, psychological, physical, complementary, and rehabilitative interventions is available for CPMP, for which previous research has demonstrated varying effect sizes with regard to effectiveness in pain reduction and other main outcomes. This highlights the need for the synthesis of all available evidence. The proposed network meta-analysis will compare all available interventions for CPMP to determine the best treatment option(s) with a focus on efficacy and safety of interventions. Methods We are interested in comparing interventions of the following types: psychological, pharmacological, physical, complementary, and rehabilitative interventions. We will include all randomized controlled trials that compare one intervention with another, or with a control group, in the treatment of CPMP. Primary efficacy outcomes will be pain intensity, emotional distress, and functional disability. Safety outcomes extracted will include proportion of patients with treatment-emergent adverse events, unwanted events, or drop-out rates due to side effects. Published and unpublished trials will be sought through the search of all relevant databases and trial registries. At least two independent reviewers of the team will select the references and extract data independently. We will assess the risk of bias of each individual study using the Cochrane risk of bias assessment tool. We will conduct a network meta-analysis to synthesize all evidence for each outcome. We will fit our model primarily within a Bayesian framework. Discussion CPMP is a disabling condition for which several interventions exist. To our knowledge, this is the first network meta-analysis to systematically compare all available evidence. This is required by national health institutions to inform their decisions about the best available treatment option(s) with regard to efficacy and safety outcomes. Systematic review registration PROSPERO CRD42018096114


BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e023206 ◽  
Author(s):  
Humaira Hussein ◽  
Francesco Zaccardi ◽  
Nafeesa N Dhalwani ◽  
Melanie J Davies ◽  
Kamlesh Khunti ◽  
...  

IntroductionSodium-glucose cotransporter 2 inhibitors (SGLT-2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) are two classes of glucose-lowering drugs gaining popularity in the treatment of type 2 diabetes mellitus (T2DM). Current guidelines suggest patient-centred approaches when deciding between available hyperglycaemia drugs with no indication to which specific drug should be administered. Despite systematic reviews and meta-analyses being conducted within SGLT-2is and GLP-1RAs, differences across these classes of drugs have not been investigated. Therefore, this systematic review and network meta-analysis (NMA) will aim to compare the efficacy and safety profiles across and within SGLT-2is and GLP-1RAs.MethodsPubMed, the Cochrane Central Register of Controlled Trials and ISI Web of Science will be searched from inception for published randomised controlled trials conducted in patients with T2DM, with at least two arms consisting of SGLT-2is, GLP-1RAs or control/placebo. Title and abstracts will be screened by two independent reviewers with conflicts resolved by a third. Data will be extracted by the primary researcher, a random sample will be checked by an independent reviewer. Risk of bias will be assessed using the Cochrane Risk of Bias Tool and overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Study characteristics, participants baseline characteristics, mean change in cardiometabolic outcomes and number of adverse events will be extracted for each study. Primary outcome will be the mean change in glycated haemoglobin (HbA1c) (%, mmol/mol). Initial random-effects pairwise meta-analysis will be conducted for each unique treatment comparison where heterogeneity will be assessed. A Bayesian NMA approach will be adopted where random-effects generalised linear models will be fitted in WinBUGS. Sensitivity analysis will be conducted to assess choices of prior distributions and length of burn-in and sample.Ethics and disseminationEthics approval is not required for this study. Results from this study will be published in a peer-review journal.PROSPERO registration numberCRD42018091306.


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