scholarly journals Comparing Female Permanent Contraception Options in High Resource Countries: A Systematic Review

2020 ◽  
Author(s):  
Rebecca Gormley ◽  
Brian Vickers ◽  
Brooke Cheng ◽  
Wendy V Norman
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Tubal Ligation ◽  
Risk Of Bias ◽  
High Quality ◽  
Tubal Occlusion ◽  
High Resource ◽  
Intrauterine Contraception ◽  
Permanent Contraception ◽  
Long Acting

Abstract Background: Multiple options for permanent or long-acting contraception are available, each with adverse effects and non-contraceptive benefits. A comprehensive comparison of methods to support decision-making for people seeking to end their fertility and their healthcare providers is needed. We aimed to understand what is known from high quality studies about the comparability of options for permanent contraception. We sought studies comparing these methods of permanent or long-acting contraception: laparoscopic tubal ligation, hysteroscopic tubal occlusion, bilateral salpingectomy, and levonorgestrel-releasing intrauterine contraception (LNG-IUC), for effectiveness, adverse events, tolerability, patient recovery, non-contraceptive benefits and healthcare system costs among females in high resource countries seeking to permanently avoid conception. Methods: We followed PRISMA guidelines, searched EMBASE, Pubmed (Medline), Web of Science, and screened retrieved articles to identify additional relevant studies. We extracted data on population, interventions, outcomes, follow-up, health system costs, and study funding source. We assessed risk of bias using the Newcastle-Ottawa Scale, excluding studies with high risk of bias. Due to considerable heterogeneity, we performed a narrative synthesis. Results: Our search identified 6,612 articles. We reviewed the full text of 154 studies, yielding 35 studies which met inclusion criteria. We excluded 10 studies with high risk of bias, retaining 25 at low or medium risk for bias in our synthesis. Most studies assessed hysteroscopic tubal occlusion and/or laparoscopic tubal ligation. Most comparisons reported on effectiveness and adverse events, with fewer reporting tolerability, patient recovery, non-contraceptive benefits, and healthcare system costs. No comparisons reported accessibility, eligibility, or follow-ups required. We found inconclusive evidence comparing the effectiveness of hysteroscopic tubal occlusion to laparoscopic tubal ligation. All studies reported adverse events. All forms of tubal interruption reported a protective effect against cancers. Tolerability appeared greater among tubal ligation patients compared to hysteroscopic tubal occlusion patients. No medium or high-quality studies compared LNG-IUC to other methods.Conclusions: High-quality studies comparing outcomes relevant for those seeking female permanent contraception are needed to support informed decision-making. Research is needed to directly compare surgical forms of permanent contraception, such as tubal ligation or removal, with alternative options, such as intrauterine contraception.Systematic review registration: PROSPERO [CRD42016038254].

scholarly journals Comparing options for females seeking permanent contraception in high resource countries: a systematic review

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Rebecca Gormley ◽  
Brian Vickers ◽  
Brooke Cheng ◽  
Wendy V. Norman
Keyword(s):  
Adverse Events ◽  
Tubal Ligation ◽  
Risk Of Bias ◽  
High Quality ◽  
Tubal Occlusion ◽  
High Resource ◽  
Intrauterine Contraception ◽  
Permanent Contraception ◽  
Long Acting

Abstract Background Multiple options for permanent or long-acting contraception are available, each with adverse effects and benefits. People seeking to end their fertility, and their healthcare providers, need a comprehensive comparison of methods to support their decision-making. Permanent contraceptive methods should be compared with long-acting methods that have similar effectiveness and lower anticipated adverse effects, such as the levonorgestrel-releasing intrauterine contraception (LNG-IUC). We aimed to understand the comparability of options for people seeking to end their fertility, using high-quality studies. We sought studies comparing laparoscopic tubal ligation, hysteroscopic tubal occlusion, bilateral salpingectomy, and insertion of the LNG-IUC, for effectiveness, adverse events, tolerability, patient recovery, non-contraceptive benefits, and healthcare system costs among females in high resource countries seeking to permanently avoid conception. Methods We followed PRISMA guidelines, searched EMBASE, Pubmed (Medline), Web of Science, and screened retrieved articles to identify additional studies. We extracted data on population, interventions, outcomes, follow-up, health system costs, and study funding source. We used the Newcastle–Ottawa Scale to assess risk of bias and excluded studies with medium–high risk of bias (NOS < 7). Due to considerable heterogeneity, we performed a narrative synthesis. Results Our search identified 6,612 articles. RG, BV, BC independently reviewed titles and abstracts for relevance. We reviewed the full text of 154 studies, yielding 34 studies which met inclusion criteria. We excluded 10 studies with medium–high risk of bias, retaining 24 in our synthesis. Most studies compared hysteroscopic tubal occlusion and/or laparoscopic tubal ligation. Most comparisons reported on effectiveness and adverse events; fewer reported tolerability, patient recovery, non-contraceptive benefits, and/or healthcare system costs. No comparisons reported accessibility, eligibility, or follow-up required. We found inconclusive evidence comparing the effectiveness of hysteroscopic tubal occlusion to laparoscopic tubal ligation. All studies reported adverse events. All forms of tubal interruption reported a protective effect against cancers. Tolerability appeared greater among tubal ligation patients compared to hysteroscopic tubal occlusion patients. No high-quality studies included the LNG-IUC. Conclusions Studies are needed to directly compare surgical forms of permanent contraception, such as tubal ligation or removal, with alternative options, such as intrauterine contraception to support decision-making. Systematic review registration PROSPERO [CRD42016038254].

scholarly journals Beneficial and harmful effects of antidepressants versus placebo, ‘active placebo’, or no intervention for adults with major depressive disorder: a protocol for a systematic review of published and unpublished data with meta-analyses and trial sequential analyses

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Sophie Juul ◽  
Faiza Siddiqui ◽  
Marija Barbateskovic ◽  
Caroline Kamp Jørgensen ◽  
Michael Pascal Hengartner ◽  
...  
Keyword(s):  
Systematic Review ◽  
Major Depressive Disorder ◽  
Depressive Symptoms ◽  
Adverse Events ◽  
Depressive Disorder ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Major Depressive ◽  
Serious Adverse Events ◽  
Harmful Effects

Abstract Background Major depressive disorder is one of the most common, burdensome, and costly psychiatric disorders worldwide. Antidepressants are frequently used to treat major depressive disorder. It has been shown repeatedly that antidepressants seem to reduce depressive symptoms with a statistically significant effect, but the clinical importance of the effect sizes seems questionable. Both beneficial and harmful effects of antidepressants have not previously been sufficiently assessed. The main objective of this review will be to evaluate the beneficial and harmful effects of antidepressants versus placebo, ‘active placebo’, or no intervention for adults with major depressive disorder. Methods/design A systematic review with meta-analysis will be reported as recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), bias will be assessed with the Cochrane Risk of Bias tool-version 2 (ROB2), our eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, Trial Sequential Analysis will be conducted to control for random errors, and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. To identify relevant trials, we will search both for published and unpublished trials in major medical databases from their inception to the present. Clinical study reports will be obtained from regulatory authorities and pharmaceutical companies. Two review authors will independently screen the results of the literature searches, extract data, and perform risk of bias assessment. We will include any published or unpublished randomised clinical trial comparing one or more antidepressants with placebo, ‘active placebo’, or no intervention for adults with major depressive disorder. The following active agents will be included: agomelatine, amineptine, amitriptyline, bupropion, butriptyline, cianopramine, citalopram, clomipramine, dapoxetine, demexiptiline, desipramine, desvenlafaxine, dibenzepin, dosulepin, dothiepin, doxepin, duloxetine, escitalopram, fluoxetine, fluvoxamine, imipramine, iprindole, levomilnacipran, lofepramine, maprotiline, melitracen, metapramine, milnacipran, mirtazapine, nefazodone, nortriptyline, noxiptiline, opipramol, paroxetine, protriptyline, quinupramine, reboxetine, sertraline, trazodone, tianeptine, trimipramine, venlafaxine, vilazodone, and vortioxetine. Primary outcomes will be depressive symptoms, serious adverse events, and quality of life. Secondary outcomes will be suicide or suicide attempt, suicidal ideation, and non-serious adverse events. Discussion As antidepressants are commonly used to treat major depressive disorder in adults, a systematic review evaluating their beneficial and harmful effects is urgently needed. This review will inform best practice in treatment and clinical research of this highly prevalent and burdensome disorder. Systematic review registration PROSPERO CRD42020220279

scholarly journals Prioritising recommendations following analyses of adverse events in healthcare: a systematic review

2020 ◽  
Vol 9 (4) ◽  
pp. e000843
Author(s):  
Kelly Bos ◽  
Maarten J van der Laan ◽  
Dave A Dongelmans
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Data Extraction ◽  
Data Sources ◽  
Cochrane Library ◽  
High Quality ◽  
Data Synthesis ◽  
Study Selection ◽  
Personal Opinion ◽  
User Friendly

PurposeThe purpose of this systematic review was to identify an appropriate method—a user-friendly and validated method—that prioritises recommendations following analyses of adverse events (AEs) based on objective features.Data sourcesThe electronic databases PubMed/MEDLINE, Embase (Ovid), Cochrane Library, PsycINFO (Ovid) and ERIC (Ovid) were searched.Study selectionStudies were considered eligible when reporting on methods to prioritise recommendations.Data extractionTwo teams of reviewers performed the data extraction which was defined prior to this phase.Results of data synthesisEleven methods were identified that are designed to prioritise recommendations. After completing the data extraction, none of the methods met all the predefined criteria. Nine methods were considered user-friendly. One study validated the developed method. Five methods prioritised recommendations based on objective features, not affected by personal opinion or knowledge and expected to be reproducible by different users.ConclusionThere are several methods available to prioritise recommendations following analyses of AEs. All these methods can be used to discuss and select recommendations for implementation. None of the methods is a user-friendly and validated method that prioritises recommendations based on objective features. Although there are possibilities to further improve their features, the ‘Typology of safety functions’ by de Dianous and Fiévez, and the ‘Hierarchy of hazard controls’ by McCaughan have the most potential to select high-quality recommendations as they have only a few clearly defined categories in a well-arranged ordinal sequence.

scholarly journals Racecadotril for acute diarrhoea in children: systematic review and meta-analyses

2015 ◽  
Vol 101 (3) ◽  
pp. 234-240 ◽  
Author(s):  
Morris Gordon ◽  
Anthony Akobeng
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Methodological Quality ◽  
Data Extraction ◽  
Meta Analysis ◽  
Acute Diarrhoea ◽  
Risk Of Bias ◽  
Duration Of Symptoms ◽  
Duration Of Illness ◽  
Significant Difference

ObjectiveRacecadotril is an antisecretory agent that can prevent fluid/electrolyte depletion from the bowel as a result of acute diarrhoea without affecting intestinal motility. An up-to-date systematic review is indicated to summarise the evidence on racecadotril for the treatment of acute diarrhoea in children.DesignA Cochrane format systematic review of randomised controlled trials (RCTs). Data extraction and assessment of methodological quality were performed independently by two reviewers. Methodological quality was assessed using the Cochrane risk of bias tool.PatientsChildren with acute diarrhoea, as defined by the primary studies.InterventionsRCTs comparing racecadotril with placebo or other interventions.Main outcome measursDuration of illness, stool output/volume and adverse events.ResultsSeven RCTs were included, five comparing racecadotril with placebo or no intervention, one with pectin/kaolin and one with loperamide. Moderate to high risk of bias was present in all studies. There was no significant difference in efficacy or adverse events between racecadotril and loperamide. A meta-analysis of three studies with 642 participants showed significantly shorter duration of symptoms with racecadotril compared with placebo (mean difference −53.48 h, 95% CI −65.64 to −41.33). A meta-analysis of five studies with 949 participants showed no significant difference in adverse events between racecadotril and placebo (risk ratio 0.99, 95% CI 0.73 to 1.34).ConclusionsThere is some evidence that racecadotril is more effective than placebo or no intervention in reducing the duration of illness and stool output in children with acute diarrhoea. However, the overall quality of the evidence is limited due to sparse data, heterogeneity and risk of bias. Racecadotril appears to be safe and well tolerated.

scholarly journals Should home-based ovulation predictor kits be offered as an additional approach for fertility management for women and couples desiring pregnancy? A systematic review and meta-analysis

2019 ◽  
Vol 4 (2) ◽  
pp. e001403 ◽  
Author(s):  
Ping Teresa Yeh ◽  
Caitlin E Kennedy ◽  
Sheryl Van der Poel ◽  
Thabo Matsaseng ◽  
Laura Bernard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Observational Study ◽  
Pregnancy Rate ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Time To Pregnancy ◽  
Fertility Management ◽  
Home Based ◽  
Registration Number

IntroductionTo inform the WHO Guideline on self-care interventions, we conducted a systematic review of the impact of ovulation predictor kits (OPKs) on time-to-pregnancy, pregnancy, live birth, stress/anxiety, social harms/adverse events and values/preferences.MethodsIncluded studies had to compare women desiring pregnancy who managed their fertility with and without OPKs, measure an outcome of interest and be published in a peer-reviewed journal. We searched for studies on PubMed, CINAHL, LILACS and EMBASE through November 2018. We assessed risk of bias assessed using the Cochrane tool for randomised controlled trials (RCTs) and the Evidence Project tool for observational studies, and conducted meta-analysis using random effects models to generate pooled estimates of relative risk (RR).ResultsFour studies (three RCTs and one observational study) including 1487 participants, all in high-income countries, were included. Quality of evidence was low. Two RCTs found no difference in time-to-pregnancy. All studies reported pregnancy rate, with mixed results: one RCT from the 1990s among couples with unexplained or male-factor infertility found no difference in clinical pregnancy rate (RR: 1.09, 95% CI 0.51 to 2.32); two more recent RCTs found higher self-reported pregnancy rates among OPK users (pooled RR: 1.40, 95% CI 1.08 to 1.80). A small observational study found higher rates of pregnancy with lab testing versus OPKs among women using donor insemination services. One RCT found no increase in stress/anxiety after two menstrual cycles using OPKs, besides a decline in positive affect. No studies measured live birth or social harms/adverse events. Six studies presented end-users’ values/preferences, with almost all women reporting feeling satisfied, comfortable and confident using OPKs.ConclusionA small evidence base, from high-income countries and with high risk of bias, suggests that home-based use of OPKs may improve fertility management when attempting to become pregnant with no meaningful increase in stress/anxiety and with high user acceptability.Systematic review registration numberPROSPERO registration number CRD42019119402.

scholarly journals Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis

2017 ◽  
Vol 43 (4) ◽  
pp. 302-312 ◽  
Author(s):  
Israel Silva Maia ◽  
Mariângela Pimentel Pincelli ◽  
Victor Figueiredo Leite ◽  
João Amadera ◽  
Anna Maria Buehler
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Therapeutic Effects ◽  
Muscarinic Antagonists ◽  
Serious Adverse Events ◽  
Exacerbation Rate ◽  
Copd Exacerbations ◽  
Long Acting

ABSTRACT Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations. Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. Results: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. Conclusions: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.

scholarly journals Manipulation and Mobilization for Treating Chronic Nonspecific Neck Pain: A Systematic Review and Meta-Analysis for an Appropriateness Panel

2019 ◽  
Vol 2 (22.2) ◽  
pp. E55-E70 ◽  
Author(s):  
Ian D. Coulter
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Neck Pain ◽  
Meta Analysis ◽  
Chronic Neck Pain ◽  
Risk Of Bias ◽  
Current Evidence ◽  
Sample Sizes ◽  
Serious Adverse Events ◽  
Multiple Treatment

Background: Mobilization and manipulation therapies are widely used by patients with chronic nonspecific neck pain; however, questions remain around efficacy, dosing, and safety, as well as how these approaches compare to other therapies. Objectives: Based on published trials, to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic nonspecific neck pain. Study Design: A systematic literature review and meta-analysis. Methods: We identified studies published between January 2000 and September 2017, by searching multiple electronic databases, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation and/or mobilization therapies to sham, no treatment, each other, and other active therapies, or when combined as multimodal therapeutic approaches. We assessed risk of bias by using the Scottish Intercollegiate Guidelines Network criteria. When possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation was applied to determine the confidence in effect estimates. This project was funded by the National Center for Complementary and Integrative Health under award number U19AT007912 and ultimately used to inform an appropriateness panel. Results: A total of 47 randomized trials (47 unique trials in 53 publications) were included in the systematic review. These studies were rated as having low risk of bias and included a total of 4,460 patients with nonspecific chronic neck pain who were being treated by a practitioner using various types of manipulation and/or mobilization interventions. A total of 37 trials were categorized as unimodal approaches and involved thrust or nonthrust compared with sham, no treatment, or other active comparators. Of these, only 6 trials with similar intervention styles, comparators, and outcome measures/timepoints were pooled for meta-analysis at 1, 3, and 6 months, showing a small effect in favor of thrust plus exercise compared to an exercise regimen alone for a reduction in pain and disability. Multimodal approaches appeared to be effective at reducing pain and improving function from the 10 studies evaluated. Health-related quality of life was seldom reported. Some 22/47 studies did not report or mention adverse events. Of the 25 that did, either no or minor events occurred. Limitations: The current evidence is heterogeneous, and sample sizes are generally small. Conclusions: Studies published since January 2000 provide low-moderate quality evidence that various types of manipulation and/or mobilization will reduce pain and improve function for chronic nonspecific neck pain compared to other interventions. It appears that multimodal approaches, in which multiple treatment approaches are integrated, might have the greatest potential impact. The studies comparing to no treatment or sham were mostly testing the effect of a single dose, which may or may not be helpful to inform practice. According to the published trials reviewed, manipulation and mobilization appear safe. However, given the low rate of serious adverse events, other types of studies with much larger sample sizes would be required to fully describe the safety of manipulation and/or mobilization for nonspecific chronic neck pain. Key words: Chronic neck pain, nonspecific, chiropractic, manipulation, mobilization, systematic review, meta-analysis, appropriateness

scholarly journals Acupuncture-Related Therapies for Parkinson's Disease: A Meta-Analysis and Qualitative Review

2021 ◽  
Vol 13 ◽  
Author(s):  
Xiaopeng Wen ◽  
Kunbin Li ◽  
Hao Wen ◽  
Qian Wang ◽  
Zhiyuan Wu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Hamilton Depression Scale ◽  
High Quality ◽  
Conventional Medication

Objective: This systematic review and meta-analysis aimed to assess the effects of the combination of acupuncture-related therapies with conventional medication compared with conventional medication in patients with Parkinson's disease (PD).Methods: A literature search within eight databases [including Medline, Embase, the Cochrane Library, PubMed, China National Knowledge Infrastructure (CNKI), China Biology Medicine (CBM), VIP, and Wanfang Database] was performed covering a time frame from their inception to August 2020. Randomized controlled trials (RCTs) comparing acupuncture-related therapies combined with conventional medication vs. conventional medication in patients with PD were eligible. Two authors independently assessed the risk of bias. Assessments were performed with the total and subscales scores of the Unified Parkinson's Disease Rating Scale (UPDRS), 39-item Parkinson's Disease Questionnaire (PDQ-39), the dosage of Madopar, Mini-Mental State Examination (MMSE), and 17-item Hamilton Depression Scale (HAMD). Data were analyzed by adopting the Cochrane Collaboration's RevMan 5.4 (Review Man, Copenhagen, Denmark); and mean effect sizes and 95% confidence intervals were estimated. Tests for heterogeneity were used to assess differences in treatment effects across different types of acupuncture used.Results: Sixty-six trials met the inclusion criteria, of which 61 trials provided data for the meta-analysis. We defined high-quality articles as those with a low risk of bias in four or more domains; and only 10 (15.15%) articles were of high quality. Compared with the controls, acupuncture-related therapies with conventional medication achieved a benefit in the primary outcomes of UPDRS (motor subscore: −3.90, −4.33 to −3.49, P &lt; 0.01; total score: −7.37 points, −8.91 to −5.82, P &lt; 0.001; activities of daily living subscore: −3.96, −4.96 to −2.95, P &lt; 0.01). For the subgroup difference test among the effects of different acupuncture methods, significant differences existed in outcomes with the UPDRS-III, UPDRS-I, UPDRS-IV, and PDQ-39 scores and Madopar dosage, while non-significant differences existed with the UPDRS-total, UPDRS-II, HAMD, and MMSE scores.Conclusions: Acupuncture-related therapies combined with conventional medication may benefit individuals with PD. Our review findings should be considered with caution because of the methodological weaknesses in the included trials. Future, large randomized trials of acupuncture-related therapies for PD with high methodological quality are warranted.Systematic Review Registration: Identifier CRD42021228110.

scholarly journals Tolerability of duloxetine in the elderly and in adults: a protocol and preliminary results of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

2020 ◽  
Author(s):  
Jean-Charles ROY ◽  
Chloé Rousseau ◽  
Alexis Jutel ◽  
Florian Naudet ◽  
Gabriel Robert
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Elderly Population ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Younger Adults ◽  
Randomized Controlled ◽  
Individual Participant

Abstract Background. Duloxetine is an antidepressant which benefits from a wide range of approval in elderly population while its safety of use in elderly population, compared to younger adults, is not clearly assessed. A comparison of tolerability of duloxetine between elderly and younger adults would help to rule on this issue. Methods and Design. This protocol outlines a systematic review and meta-analysis of individual participant data (IPD) of all double-blind randomized controlled trials comparing the number of serious adverse events among individuals taking duloxetine in comparison to placebo between participants at least 65 years and younger adults in conditions approved by the European Medical Agency (EMA) and the Food Drug Administration (FDA). Secondarily, will be compared the number of any adverse events, clinical efficacy and quality of life between elderly and younger adults under duloxetine, in comparison to placebo. Relevant studies were selected on ClinicalTrials.gov, Clinicaltrialsregister.eu, data sharing platforms, FDA and EMA websites, and from systematic reviews and meta-analyses of duloxetine on PubMed, following Cochrane’s recommendations. Sponsors and authors from eligible studies were invited to share IPD on data sharing platform or directly with our research team. As data cannot be aggregate into a unique database, a two step-approach meta-analysis will be undertaken. Qualitative results from available data. 77 eligible randomized controlled trials were identified, representing 25303 participants. From online available data, 35 trials were assessed as being at an overall low risk of bias, 31 trials at an unclear risk of bias and 1 at high risk of bias. Evaluation of risk of bias was not feasible for 10 studies. Conclusion. This study would represent the first meta-analysis investigating the safety of duloxetine in elderly population across all conditions approved by European and American regulatory authorities with an overall low risk of bias. Registration. PROSPERO: 2019 CRD42019130488.

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