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Journal of Prosthodontic Research Jan 2023The efficacy of etch-and-rinse, selective enamel-etching, and self-etching protocols for universal adhesives in follow-ups of over 12 months was compared in a network... (Meta-Analysis)
Meta-Analysis
Efficacy of adhesive strategies for restorative dentistry: A systematic review and network meta-analysis of double-blind randomized controlled trials over 12 months of follow-up.
PURPOSE
The efficacy of etch-and-rinse, selective enamel-etching, and self-etching protocols for universal adhesives in follow-ups of over 12 months was compared in a network meta-analysis.
STUDY SELECTION
Randomized controlled trials (RCTs) published from 1998 to 2022 that compared marginal staining, marginal adaptation, retention and fractures, post-operative sensitivity, or recurrence of caries that took place over 12-months post-restoration were selected. A network meta-analysis determined the performance of each adhesive protocol.
RESULTS
After screening 981 articles, 16 RCTs were subjected to data extraction. Of which, 674 patients with 2816 restorations, were included in the network meta-analysis. The pooled risk of marginal discoloration following self-etching was significantly higher than that following etch-and-rinse at over 12, 24, and 36 months, which was time-dependent. The pooled risks of unfavorable marginal adaptation and unfavorable retention and fractures following self-etching were also significantly higher than that following etch-and-rinse, with the rates of unfavorable retention and fractures in non-carious cervical lesions increasing in a time-dependent manner. The pooled risks of marginal discoloration, unfavorable marginal adaptation, retention and fractures were similar between etch-and-rinse and selective enamel-etching protocols. Post-operative hypersensitivity and recurrence of caries were not significantly different among etch-and-rinse, selective enamel-etching, and self-etching protocols.
CONCLUSIONS
In follow-ups over 12 months, esthetic and functional outcomes of restorations completed with an etch-and-rinse adhesive protocol were superior to the ones achieved with a self-etching strategy without selective enamel-etching. Selective enamel etching is recommended for self-etching systems. Biological responses were similar for all three adhesive strategies.
Topics: Humans; Dental Caries; Dental Marginal Adaptation; Dental Restoration, Permanent; Follow-Up Studies; Network Meta-Analysis; Randomized Controlled Trials as Topic; Treatment Outcome; Adhesives; Denture Retention; Double-Blind Method; Dental Etching
PubMed: 35691823
DOI: 10.2186/jpr.JPR_D_21_00279 -
Advances in Therapy Jul 2023Randomized controlled trials (RCTs) of biologics in patients with severe, uncontrolled asthma have shown differential results by baseline blood eosinophil count (BEC).... (Review)
Review
INTRODUCTION
Randomized controlled trials (RCTs) of biologics in patients with severe, uncontrolled asthma have shown differential results by baseline blood eosinophil count (BEC). In the absence of head-to-head trials, we describe the effects of biologics on annualized asthma exacerbation rate (AAER) by baseline BEC in placebo-controlled RCTs. Exacerbations associated with hospitalization or an emergency room visit, pre-bronchodilator forced expiratory volume in 1 s, Asthma Control Questionnaire score, and Asthma Quality of Life Questionnaire score were also summarized.
METHODS
MEDLINE (via PubMed) was searched for RCTs of biologics in patients with severe, uncontrolled asthma and with AAER reduction as a primary or secondary endpoint. AAER ratios and change from baseline in other outcomes versus placebo were compared across baseline BEC subgroups. Analysis was limited to US Food and Drug Administration-approved biologics.
RESULTS
In patients with baseline BEC ≥ 300 cells/μL, AAER reduction was demonstrated with all biologics, and other outcomes were generally improved. In patients with BEC 0 to < 300 cells/μL, consistent AAER reduction was demonstrated only with tezepelumab; improvements in other outcomes were inconsistent across biologics. In patients with BEC 150 to < 300 cells/μL, consistent AAER reduction was demonstrated with tezepelumab and dupilumab (300 mg dose only), and in those with BEC 0 to < 150 cells/μL, AAER reduction was demonstrated only with tezepelumab.
CONCLUSION
The efficacy of all biologics in reducing AAER in patients with severe asthma increases with higher baseline BEC, with varying profiles across individual biologics likely due to differing mechanisms of action.
Topics: Humans; Eosinophils; Anti-Asthmatic Agents; Biological Products; Asthma; Leukocyte Count; Eosinophilia; Double-Blind Method
PubMed: 37233876
DOI: 10.1007/s12325-023-02514-0 -
Psychiatry Research Jan 2024Major depressive disorder (MDD) and postpartum depression (PPD) are common and burdensome conditions. This study aims to evaluate the efficacy and safety of zuranolone,... (Meta-Analysis)
Meta-Analysis Review
Major depressive disorder (MDD) and postpartum depression (PPD) are common and burdensome conditions. This study aims to evaluate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid type A receptors-positive allosteric modulator, in treating MDD and PPD. A comprehensive literature search was conducted until September 2023, identifying seven randomized controlled trials (RCTs). The results demonstrated that zuranolone significantly decreased Hamilton Rating Scale for Depression (HAM-D) scores in patients with PPD or MDD at day 15 (concluding the 14-day course) and day 42-45 (4 weeks after treatment cessation) compared with the placebo, albeit exhibiting a diminishing trend. Moreover, a higher percentage of patients with PPD or MDD achieved HAM-D response and remission with zuranolone treatment compared with placebo at day 15. However, zuranolone did not significantly increase the proportion of MDD patients achieving HAM-D remission at 42/43 days. Adverse events (AEs) such as somnolence, dizziness, and sedation were linked to zuranolone, with a higher but not statistically significant rate of discontinuation due to AEs in the zuranolone group. Overall, our findings support the rapid antidepressant effects of zuranolone in MDD and PPD, along with a relatively favorable safety and tolerability. Large-scale longitudinal RCTs are needed to evaluate the long-term efficacy of zuranolone.
Topics: Female; Humans; Depression; Antidepressive Agents; Pregnanolone; Depressive Disorder, Major; Treatment Outcome; Double-Blind Method
PubMed: 38029628
DOI: 10.1016/j.psychres.2023.115640 -
Asian Journal of Psychiatry Jul 2023We aimed to systematically evaluate the clinical efficacy and safety of accelerated intermittent theta burst stimulation (aiTBS) for patients with major depressive... (Meta-Analysis)
Meta-Analysis
We aimed to systematically evaluate the clinical efficacy and safety of accelerated intermittent theta burst stimulation (aiTBS) for patients with major depressive disorder (MDD) or bipolar depression (BD). A random-effects model was adopted to analyze the primary and secondary outcomes using the Review Manager, Version 5.3 software. This meta-analysis (MA) identified five double-blind randomized controlled trials (RCTs) comprising 239 MDD or BD patients with a major depressive episode. Active aiTBS overperformed sham stimulation in the study-defined response. This MA found preliminary evidence that active aiTBS resulted in a greater response in treating major depressive episodes in MDD or BD patients than sham stimulation.
Topics: Humans; Depressive Disorder, Major; Bipolar Disorder; Transcranial Magnetic Stimulation; Treatment Outcome; Double-Blind Method; Randomized Controlled Trials as Topic
PubMed: 37201381
DOI: 10.1016/j.ajp.2023.103618 -
Journal of the American Academy of... Jul 2024To evaluate the reporting of race/ethnicity data in randomized controlled trials (RCTs) of attention-deficit/hyperactivity disorder (ADHD) medications. Secondary... (Meta-Analysis)
Meta-Analysis
Systematic Review and Meta-Analysis: Reporting and Representation of Race/Ethnicity in 310 Randomized Controlled Trials of Attention-Deficit/Hyperactivity Disorder Medications.
OBJECTIVE
To evaluate the reporting of race/ethnicity data in randomized controlled trials (RCTs) of attention-deficit/hyperactivity disorder (ADHD) medications. Secondary objectives were to estimate temporal trends in the reporting, and to compare the pooled prevalence of racial/ethnic groups in RCTs conducted in the US to national estimates.
METHOD
We drew on, adapted, and updated the search of a network meta-analysis by Cortese et al. (2018) up to March 2022. We calculated the percentage of RCTs reporting data on race/ethnicity of participants in the published article or in related unpublished material. Temporal trends were estimated with logistic regression. The pooled prevalence of each racial/ethnic group across US RCTs was calculated using random-effects model meta-analyses.
RESULTS
We retained 310 RCTs (including 44,447 participants), of which 231 were conducted in children/adolescents, 78 in adults, and 1 in both. Data on race/ethnicity were reported in 59.3% of the RCTs (75% of which were conducted in children/adolescents and 25% in adults) in the published article, and in unpublished material in an additional 8.7% of the RCTs. Reporting improved over time. In the US RCTs, Asian and White individuals were under- and overrepresented, respectively, compared to national estimates in the most recent time period considered.
CONCLUSION
More than 30% of the RCTs of ADHD medications retained in this review did not include data on race/ethnicity in their published or unpublished reports, and more than 40% in their published articles, even though reporting improved over time. Results should inform investigators, authors, editors, regulators, and study participants in relation to efforts to tackle inequalities in ADHD research.
PLAIN LANGUAGE SUMMARY
A systematic review of 310 randomized controlled trials for attention-deficit/hyperactivity disorder (ADHD) medications found that race/ethnicity were reported in only 30% of trials. Compared to national estimates, Asian individuals were underrepresented and non-Hispanic Whites individuals were overrepresented, drawing attention to the inequities in participation in ADHD research.
DIVERSITY & INCLUSION STATEMENT
One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. We actively worked to promote sex and gender balance in our author group. While citing references scientifically relevant for this work, we also actively worked to promote sex and gender balance in our reference list. While citing references scientifically relevant for this work, we also actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our reference list. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.
STUDY PREREGISTRATION INFORMATION
Reporting and representation of race/ethnicity in double blind randomised controlled trials of medications for ADHD; https://osf.io/; hfgz8.
Topics: Humans; Attention Deficit Disorder with Hyperactivity; Randomized Controlled Trials as Topic; Child; Adolescent; United States; Adult; Ethnicity
PubMed: 37890665
DOI: 10.1016/j.jaac.2023.09.544 -
Psychiatry Research Jan 2022Successful blinding in double-blind RCTs is crucial for minimizing bias, however studies rarely report information about blinding. Among RCTs for depression, the rates... (Meta-Analysis)
Meta-Analysis
Successful blinding in double-blind RCTs is crucial for minimizing bias, however studies rarely report information about blinding. Among RCTs for depression, the rates of testing and success of blinding is unknown. We conducted a systematic review and meta-analysis of the rates of testing, predictors, and success of blinding in RCTs of antidepressants for depression. Following systematic search, further information about blinding assessment was requested from corresponding authors of the included studies. We reported the frequency of blinding assessment across all RCTs, and conducted logistic regression analyses to assess predictors of blinding reporting. Participant and/or investigator guesses about treatment allocation were used to calculate Bang's Blinding Index (BI). The BI between RCT arms was compared using meta-analysis. Across the 295 included trials, only 4.7% of studies assessed blinding. Pharmaceutical company sponsorship predicted blinding assessment; unsponsored trials were more likely to assess blinding. Meta-analysis suggested that blinding was unsuccessful among participants and investigators. Results suggest that blinding is rarely assessed, and often fails, among RCTs of antidepressants. This is concerning considering controversy around the efficacy of antidepressant medication. Blinding should be routinely assessed and reported in RCTs of antidepressants, and trial outcomes should be considered in light of blinding success or failure.
Topics: Antidepressive Agents; Bias; Depression; Double-Blind Method; Humans; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors
PubMed: 34861421
DOI: 10.1016/j.psychres.2021.114297 -
Clinical Rheumatology Oct 2021To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs).
METHODS
A systematic search was conducted in PubMed, Embase, and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at weeks 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events, infections, and serious infections.
RESULTS
Twenty-eight randomized, double-blind, controlled trials including 14,500 patients were included. At both weeks 12 and 24, the pooled analysis suggested effective treatment with jakinibs, represented as an increased clinical response of ACR20, ACR50, and ACR70. Subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients.
CONCLUSIONS
Jakinibs are efficacious and well tolerated in RA patients up to 24 weeks, although they are associated with an increased risk of infectious complications. Key Points • ACR20/50/70 in patients treated with jakinibs was significantly higher than those in patients treated with placebo. • No difference in ACR50/70 was observed in patients with RA treated with peficitinib and placebo. • Jakinibs are beneficial and well tolerated in RA treatment.
Topics: Antirheumatic Agents; Arthritis, Rheumatoid; Double-Blind Method; Humans; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 33990888
DOI: 10.1007/s10067-021-05686-8 -
The Annals of Pharmacotherapy Mar 2021PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of...
OBJECTIVE
PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug.
DATA SOURCES
A systematic literature review was performed using the terms "glabellar lines AND prabotulinumtoxinA" in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies.
STUDY SELECTION AND DATA EXTRACTION
Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated.
DATA SYNTHESIS
By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; < 0.001). PrabotulinumtoxinA was well tolerated across all studies.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians.
CONCLUSION
PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.
Topics: Botulinum Toxins, Type A; Double-Blind Method; Female; Forehead; Humans; Male; Treatment Outcome
PubMed: 32698599
DOI: 10.1177/1060028020943527 -
Integrative Cancer Therapies 2022Remote medical scent detection of cancer and infectious diseases with dogs and rats has been an increasing field of research these last 20 years. If validated, the... (Review)
Review
BACKGROUND
Remote medical scent detection of cancer and infectious diseases with dogs and rats has been an increasing field of research these last 20 years. If validated, the possibility of implementing such a technique in the clinic raises many hopes. This systematic review was performed to determine the evidence and performance of such methods and assess their potential relevance in the clinic.
METHODS
Pubmed and Web of Science databases were independently searched based on PRISMA standards between 01/01/2000 and 01/05/2021. We included studies aiming at detecting cancers and infectious diseases affecting humans with dogs or rats. We excluded studies using other animals, studies aiming to detect agricultural diseases, diseases affecting animals, and others such as diabetes and neurodegenerative diseases. Only original articles were included. Data about patients' selection, samples, animal characteristics, animal training, testing configurations, and performances were recorded.
RESULTS
A total of 62 studies were included. Sensitivity and specificity varied a lot among studies: While some publications report low sensitivities of 0.17 and specificities around 0.29, others achieve rates of 1 sensitivity and specificity. Only 6 studies were evaluated in a double-blind screening-like situation. In general, the risk of performance bias was high in most evaluated studies, and the quality of the evidence found was low.
CONCLUSIONS
Medical detection using animals' sense of smell lacks evidence and performances so far to be applied in the clinic. What odors the animals detect is not well understood. Further research should be conducted, focusing on patient selection, samples (choice of materials, standardization), and testing conditions. Interpolations of such results to free running detection (direct contact with humans) should be taken with extreme caution. Considering this synthesis, we discuss the challenges and highlight the excellent odor detection threshold exhibited by animals which represents a potential opportunity to develop an accessible and non-invasive method for disease detection.
Topics: Humans; Dogs; Animals; Rats; Odorants; Neoplasms; Smell; Communicable Diseases; Randomized Controlled Trials as Topic
PubMed: 36541180
DOI: 10.1177/15347354221140516 -
Clinical Drug Investigation Apr 2022Atogepant is the latest calcitonin gene-related peptide (CGRP) antagonist approved exclusively for prophylaxis of episodic migraine and is administered orally in doses...
BACKGROUND AND OBJECTIVE
Atogepant is the latest calcitonin gene-related peptide (CGRP) antagonist approved exclusively for prophylaxis of episodic migraine and is administered orally in doses of 10-60 mg/day. This article aims to provide a systematic review of the efficacy and safety of atogepant in migraine prevention.
METHODS
The literature was searched in different databases, i.e., the National Institute of Health clinical trials registry, PubMed, and the Cochrane library between 2018 to October 2021 using the keywords atogepant, MK-8031, and migraine. Conference abstracts listed in the Cochrane database (includes Embase) and drug information provided by the US Food and Drug Administration (FDA) label were also reviewed. Only English-language clinical trials were included. The authors retrieved 58 articles. Eventually, two randomized, double-blind, multicenter clinical trials involving 1,727 participants and one open-label trial were analyzed.
RESULTS
The FDA approved atogepant for migraine prevention in September 2021 based on two randomized, double-blind, placebo-controlled trials. Atogepant approved for migraine prevention acts as a CGRP receptor antagonist and is administered orally. Based on the 12-week clinical trials, atogepant was efficacious in prevention of migraine and it was well tolerated. The most common treatment-emergent adverse events were nausea, constipation, and upper respiratory infection.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Atogepant had a statistically significant change from baseline in monthly migraine days, monthly headache days, and acute medication use days.
CONCLUSIONS
Atogepant seems to be beneficial for migraine prevention, and it may be of more benefit in individuals who do not wish to take the drug as an injection or do not require a prolonged duration of drug effect. However, head-to-head trials with other CGRP antagonists are required to ascertain its place in migraine prevention.
Topics: Analgesics; Calcitonin Gene-Related Peptide; Double-Blind Method; Headache; Humans; Migraine Disorders; Multicenter Studies as Topic; Piperidines; Pyridines; Pyrroles; Randomized Controlled Trials as Topic; Spiro Compounds; Treatment Outcome
PubMed: 35230651
DOI: 10.1007/s40261-022-01130-0