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Nutrients Jan 2021Recent systematic reviews and meta-analyses of randomized, double-blind, placebo-controlled trials (double-blind, placebo-controlled RCTs) have reported controversial... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Recent systematic reviews and meta-analyses of randomized, double-blind, placebo-controlled trials (double-blind, placebo-controlled RCTs) have reported controversial findings regarding the associations between calcium supplements on the risk of cardiovascular disease (CVD). This meta-analysis aimed to investigate the association between them.
METHODS
We searched PubMed, EMBASE, the Cochrane Library, and the bibliographies of relevant articles for double-blind, placebo-controlled RCTs in November, 2020. Relative risks (RRs) with 95% confidence intervals (CIs) for the risk of cardiovascular disease were calculated using a random effects model. The main outcomes were CVD, coronary heart disease (CHD), and cerebrovascular disease.
RESULTS
A total of 13 double-blind, placebo-controlled RCTs ( = 28,935 participants in an intervention group and 14,243 in a control group)) were included in the final analysis. Calcium supplements significantly increased the risk of CVD (RR 1.15, 95% CI 1.06-1.25], I2 = 0.0%, = 14) and CHD (RR 1.16, 95% CI 1.05-1.28], I2 = 0.0%, = 9) in double-blind, placebo-controlled RCTs, specifically in healthy postmenopausal women. In the subgroup meta-analysis, dietary calcium intake of 700-1000 mg per day or supplementary calcium intake of 1000 mg per day significantly increased the risk of CVD and CHD.
CONCLUSIONS
The current meta-analysis found that calcium supplements increased a risk of CVD by about 15% in healthy postmenopausal women.
Topics: Calcium; Calcium, Dietary; Cardiovascular Diseases; Clinical Trials as Topic; Coronary Disease; Databases, Factual; Dietary Supplements; Double-Blind Method; Eating; Female; Humans; Randomized Controlled Trials as Topic
PubMed: 33530332
DOI: 10.3390/nu13020368 -
JAMA Network Open Apr 2024Psilocybin has been studied in the treatment of depression and anxiety disorders. Clinical studies have mainly focused on efficacy, with systematic reviews showing... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Psilocybin has been studied in the treatment of depression and anxiety disorders. Clinical studies have mainly focused on efficacy, with systematic reviews showing favorable efficacy; however, none have primarily focused on psilocybin safety.
OBJECTIVE
To evaluate the acute adverse effects of psilocybin at therapeutic doses in the treatment of depression and anxiety.
DATA SOURCES
MEDLINE via PubMed, Web of Science, and ClinicalTrials.gov were searched for publications available between 1966 and November 30, 2023.
STUDY SELECTION
Randomized, double-blind clinical trials that reported adverse effects of psilocybin in patients treated for depression and anxiety were screened.
DATA EXTRACTION AND SYNTHESIS
Data were independently extracted by 2 authors and verified by 2 additional authors following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. The inverse variance method with the Hartung-Knapp adjustment for the random-effects model was used, with a continuity correction of 0.5 for studies with 0 cell frequencies. Sensitivity analysis was conducted by sequentially removing 1 study at a time to assess the robustness of the results.
MAIN OUTCOMES AND MEASURES
The primary outcome was considered as the adverse effects of psilocybin at high and moderate (ie, therapeutic) dose regimens and compared with placebo, low-dose psilocybin, or other comparator in the treatment of depression and/or anxiety.
RESULTS
Six studies met the inclusion criteria with a total sample of 528 participants (approximately 51% female; median age 39.8 years; IQR, 39.8-41.2). Seven adverse effects were reported in multiple studies and included in the analysis. Among these, headache (relative risk [RR], 1.99; 95% CI 1.06-3.74), nausea (RR, 8.85; 95% CI, 5.68-13.79), anxiety (RR, 2.27; 95% CI, 1.11-4.64), dizziness (RR, 5.81; 95% CI, 1.02-33.03), and elevated blood pressure (RR, 2.29; 95% CI, 1.15- 4.53) were statistically significant. Psilocybin use was not associated with risk of paranoia and transient thought disorder.
CONCLUSIONS AND RELEVANCE
In this meta-analysis, the acute adverse effect profile of therapeutic single-dose psilocybin appeared to be tolerable and resolved within 48 hours. However, future studies need to more actively evaluate the appropriate management of adverse effects.
Topics: Humans; Female; Adult; Male; Psilocybin; Drug-Related Side Effects and Adverse Reactions; Anxiety Disorders; Anxiety; Dizziness; Randomized Controlled Trials as Topic
PubMed: 38598236
DOI: 10.1001/jamanetworkopen.2024.5960 -
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 -
Iranian Journal of Nursing and... 2022Blinding is one of the critical criteria of clinical trials that prevents probable bias. Judgment regarding results of an intervention significantly depends on the... (Review)
Review
BACKGROUND
Blinding is one of the critical criteria of clinical trials that prevents probable bias. Judgment regarding results of an intervention significantly depends on the quality of such studies, one of which is blinding. This study aimed to investigate blinding and its quality in clinical trials in patients with breast cancer.
MATERIALS AND METHODS
A systematic review was conducted on the online databases of PubMed, ScienceDirect and ProQuest using keywords, MeSH terms and grey literature. Articles were screened by predefined inclusion and exclusion criteria. They were evaluated based on the checklists introduced by Cochrane database.
RESULTS
From 22519 articles obtained at the initial stage, 20 articles remained after screening for the inclusion and exclusion criteria. Fifteen articles had used single, five: double and none had used triple or quadruple blinding. Seventeen studies had described the details of blinding. Of the 15 single blind articles, the blinded subjects were patients in five, patients and research assistants in three, research assistants in five studies, and two had not given any details.
CONCLUSIONS
The majority of researchers had used the single blind method, though using double, triple or quadruple blinding increases the trustworthiness of results and increases the quality of clinical trials. The details of blinding should be explained to other researchers and for a better understanding of the method if it is to be repeated. Thereafter, nurses can apply new interventions and earn their patients' trust and help those with breast cancer by relieving them of their disease symptoms and its treatment complications.
PubMed: 35280192
DOI: 10.4103/ijnmr.IJNMR_49_20 -
Brazilian Journal of Anesthesiology... 2021Dexmedetomidine (DEX) has been associated with a decrease in postoperative cognitive and behavioral dysfunction in patients submitted to general anesthesia, whether... (Meta-Analysis)
Meta-Analysis Review
Dexmedetomidine reduces postoperative cognitive and behavioral dysfunction in adults submitted to general anesthesia for non-cardiac surgery: meta-analysis of randomized clinical trials.
INTRODUCTION AND OBJECTIVES
Dexmedetomidine (DEX) has been associated with a decrease in postoperative cognitive and behavioral dysfunction in patients submitted to general anesthesia, whether inhalation or total intravenous anesthesia. Consequently, the DEX effects on postoperative agitation and delirium in patients submitted to general anesthesia for non-cardiac surgery have been investigated.
METHOD
A systematic review and meta-analysis of randomized and double-blind clinical trials (RCTs) was undertaken assessing adults submitted to elective procedures under general anesthesia receiving DEX or placebo. The search included articles published in English in the Pubmed and Web of Science databases using keywords such as dexmedetomidine, delirium, and agitation. Duplicate publications, studies involving cardiac surgery or using active control (other than saline solution) were included. A random effects model was adopted using the DerSimonian-Laird method and estimate of Odds Ratio (OR) for dichotomous variables, and weighted mean difference for continuous variables, with their respective 95% Confidence Intervals (95% CI).
RESULTS
Of the 484 articles identified, 15 were selected comprising 2,183 patients (1,079 and 1,104 patients in the DEX and control group, respectively). The administration of DEX was considered a protective factor for postoperative cognitive and behavioral dysfunction (OR=0.36; 95% CI 0.23-0.57 and p<0.001), regardless of the anesthesia technique used.
CONCLUSION
Dexmedetomidine administration reduced by at least 43% the likelihood of postoperative cognitive and behavioral dysfunction in adult patients submitted to general anesthesia for non-cardiac surgery.
Topics: Adult; Anesthesia, General; Cardiac Surgical Procedures; Cognition; Dexmedetomidine; Humans; Hypnotics and Sedatives; Randomized Controlled Trials as Topic
PubMed: 33685760
DOI: 10.1016/j.bjane.2021.02.020 -
Europace : European Pacing,... Jul 2022Vasovagal syncope (VVS) is a common clinical condition that lacks effective medical therapies despite being associated with significant morbidity. Current guidelines... (Meta-Analysis)
Meta-Analysis
AIMS
Vasovagal syncope (VVS) is a common clinical condition that lacks effective medical therapies despite being associated with significant morbidity. Current guidelines suggest that midodrine, a prodrug for an α1-adrenergic receptor agonist, might suppress VVS but supporting studies have utilized heterogeneous methods and yielded inconsistent results. To evaluate the efficacy of midodrine to prevent syncope in patients with recurrent VVS by conducting a systematic review and meta-analysis of published studies.
METHODS AND RESULTS
Relevant randomized controlled trials were identified from the MEDLINE, Embase, CENTRAL, and CINAHL databases without language restriction from inception to June 2021. All studies were conducted in clinical syncope populations and compared the benefit of midodrine vs. placebo or non-pharmacological standard care. Weighted relative risks (RRs) were estimated using random effects meta-analysis techniques. Seven studies (n = 315) met inclusion criteria. Patients were 33 ± 17 years of age and 31% male. Midodrine was found to substantially reduce the likelihood of positive head-up-tilt (HUT) test outcomes [RR = 0.37 (0.23-0.59), P < 0.001]. In contrast, the pooled results of single- and double-blind clinical trials (I2 = 54%) suggested a more modest benefit from midodrine for the prevention of clinical syncope [RR = 0.51 (0.33-0.79), P = 0.003]. The two rigorous double-blind, randomized, placebo-controlled clinical trials included 179 VVS patients with minimal between-study heterogeneity (I2 = 0%) and reported a risk reduction with midodrine [RR = 0.71 (0.53-0.95), P = 0.02].
CONCLUSIONS
Midodrine is effective in preventing syncope induced by HUT testing and less, but still significant, RR reduction in randomized, double-blinded clinical trials.
Topics: Double-Blind Method; Female; Humans; Male; Midodrine; Randomized Controlled Trials as Topic; Syncope; Syncope, Vasovagal; Tilt-Table Test
PubMed: 35025999
DOI: 10.1093/europace/euab323 -
Medicine Aug 2023To assess the efficacy and safety of Tralokinumab in the treatment of moderate-to-severe atopic dermatitis (AD). (Meta-Analysis)
Meta-Analysis
BACKGROUND
To assess the efficacy and safety of Tralokinumab in the treatment of moderate-to-severe atopic dermatitis (AD).
METHODS
PubMed, Embase, Clinical Trials Website, and Cochrane Library were systematically searched for eligible randomized controlled trials which assessed the effects of Tralokinumab on AD. Primary outcomes included Scoring Atopic Dermatitis score, EASI-75%, and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks. Secondary outcomes included the Eczema area and severity index score, the Numeric Rating Scales score, the dermatology life quality index score, and the overall incidence of adverse events. The quality of included studies was evaluated using the Cochrane System and the modified Jadad scale. Analysis was performed using Stata 16 software.
RESULTS
Eight randomized controlled trials involving 2878 patients were included in this meta-analysis. Compared to placebo, Tralokinumab treatment exhibited a significantly higher Scoring Atopic Dermatitis score [SMD = -0.53, 95% confidence intervals [CI]: -0.62 to -0.44, P < .00001], an increased number of patients with EASI-75% [odds ratio (OR) = 2.44, 95% CI: 2.00-2.97, P < .00001] and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks [OR = 2.12, 95% CI: 1.71-2.63, P < .00001]. No significant difference was observed in the incidence of overall adverse events [OR = 1.00, 95% CI: 0.85-1.18, P = 1.00] between the 2 groups.
CONCLUSION
Tralokinumab is effective and safe in treatment of moderate-to-severe AD.
Topics: Humans; Dermatitis, Atopic; Treatment Outcome; Randomized Controlled Trials as Topic; Antibodies, Monoclonal; Severity of Illness Index; Double-Blind Method
PubMed: 37543792
DOI: 10.1097/MD.0000000000034516 -
PloS One 2024To report the first and largest systematic review and meta-analysis of randomized controlled trials (RCT) to evaluate the efficacy and safety of aripiprazole or... (Meta-Analysis)
Meta-Analysis
Efficacy and safety of aripiprazole or bupropion augmentation and switching in patients with treatment-resistant depression or major depressive disorder: A systematic review and meta-analysis of randomized controlled trials.
OBJECTIVES
To report the first and largest systematic review and meta-analysis of randomized controlled trials (RCT) to evaluate the efficacy and safety of aripiprazole or bupropion augmentation and switching in patients with treatment-resistant depression (TRD) or major depressive disorder(MDD).
METHODS
We conducted a systematic literature retrieval via PubMed, Embase, Web of Science, and Cochrane until April 2023 for RCT, which evaluated the efficacy and safety of aripiprazole or bupropion augmentation and switching for patients with TRD or MDD. Outcomes measured were changes in the Montgomery-Asberg Depression Rating Scale (MADRS), response and remission rate, and serious adverse events.
RESULTS
Five RCTs, including 4480 patients, were included for meta-analysis. Among them, two RCTs were rated as "high risk" in three aspects (allocation concealment, blinding of participants and personnel and blinding of outcome assessment) because of the non-blind method, and the quality evaluation of the remaining works of literature was "low risk". Augmentation treatment with Aripiprazole (A-ARI) was associated with a significant higher response rate compared with augmentation treatment with bupropion (A-BUP) (RR: 1.15; 95% CI: 1.05, 1.25; P = 0.0007; I2 = 23%). Besides, A-ARI had a significant higher remission rate compared with switching to bupropion (S-BUP) (RR: 1.22; 95% CI: 1.00, 1.49; P = 0.05; I2 = 59%) and A-BUP had a significant higher remission rate compared with S-BUP (RR: 1.20; 95% CI: 1.06, 1.36; P = 0.0004; I2 = 0%). In addition, there was no significant difference in remission rate(RR: 1.05; 95% CI: 0.94, 1.17; P = 0.42; I2 = 33%), improvement of MADRS(WMD: -2.07; 95% CI: -5.84, 1.70; P = 0.28; I2 = 70%) between A-ARI and A-BUP. No significant difference was observed in adverse events and serious adverse events among the three treatment strategies.
CONCLUSIONS
A-ARI may be a better comprehensive antidepressant treatment strategy than A-BUP or S-BUP for patients with TRD or MDD. More large-scale, multi-center, double-blind RCTs are needed to further evaluated the efficacy and safety of aripiprazole or bupropion augmentation and switching treatment strategies.
Topics: Aripiprazole; Bupropion; Humans; Depressive Disorder, Major; Randomized Controlled Trials as Topic; Depressive Disorder, Treatment-Resistant; Treatment Outcome; Drug Therapy, Combination
PubMed: 38669232
DOI: 10.1371/journal.pone.0299020 -
International Journal of Environmental... Dec 2020Several studies have assessed the effects of milk and dairy product intake on sleep quality and duration. Such investigations have varied in terms of their geographic...
Several studies have assessed the effects of milk and dairy product intake on sleep quality and duration. Such investigations have varied in terms of their geographic locations, amounts of milk and dairy products, study participants (age, sex, race), and study designs. The present study aimed to summarize this literature and provide a unified view on whether the intake of milk and dairy products affects sleep quality. This systematic review was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. The following keywords were chosen as electronic database search items from MeSH (medical subject headings) terms and descriptors in health sciences (DeHS) lists: milk, yogurt, dairy product, cheese, sleep, human, observational study, and interventional study. As a result, a total of 14 studies published between 1972 and 2019 were included in this review, including eight randomized controlled trials, two experimental studies with cross-over designs, one longitudinal study, and three cross-sectional studies. Four studies targeted older adults, three included toddlers, two targeted children, and six enrolled adults inclusive of university students. Overall, these studies indicated that a well-balanced diet that includes milk and dairy products is effective in improving sleep quality, despite mixed results across studies attributable to differences in study populations and methods.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Animals; Child; Child, Preschool; Cross-Sectional Studies; Dairy Products; Diet; Double-Blind Method; Feeding Behavior; Female; Humans; Infant; Longitudinal Studies; Male; Middle Aged; Milk; Nutrition Surveys; Sleep; Young Adult
PubMed: 33339284
DOI: 10.3390/ijerph17249440 -
Epilepsy & Behavior : E&B Jan 2022The efficacy and safety of cenobamate relative to other antiseizure medications (ASMs) has not been evaluated. An indirect treatment comparison (network meta-analysis)... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The efficacy and safety of cenobamate relative to other antiseizure medications (ASMs) has not been evaluated. An indirect treatment comparison (network meta-analysis) was performed to determine if adjunctive cenobamate increases the odds ratio (OR) for ≥50% responder rate or for withdrawals due to treatment-emergent adverse events (TEAEs) leading to ASM discontinuation versus adjunctive therapy with other ASMs.
METHODS
A systematic literature review was conducted to identify randomized, double-blind, placebo-controlled trials (maintenance phase ≥ 12 weeks) assessing adjunctive ASMs in adults with uncontrolled focal seizures. Cenobamate was compared to a group of seven other ASMs, and to subgroups of branded (brivaracetam, eslicarbazepine acetate, lacosamide, and perampanel) and older (lamotrigine, levetiracetam, and topiramate) ASMs at FDA-recommended daily maintenance doses (FDA-RDMD), at all doses, and at maximum and minimum daily doses. Statistical significance was set at p < 0.05.
RESULTS
Twenty-one studies were eligible for analysis. The placebo-adjusted ≥ 50% responder rate for FDA-RDMD of cenobamate was superior (OR 4.200; 95% CI 2.279, 7.742) to FDA-RDMD of all seven assessed (OR 2.202 95% CI 1.915, 2.532; p = 0.044) and branded ASMs (OR 2.148; 95% CI 1.849, 2.494; p = 0.037). There was no significant difference for ≥50% responder rate between FDA-RDMD of cenobamate and FDA-RDMD of older ASMs (OR 2.617; 95% CI 1.767, 3.878; p = 0.202). No significant differences were identified for ≥50% responder rate when comparing all doses and maximum/minimum doses of cenobamate to all seven, branded, and older ASMs. Cenobamate demonstrated comparable TEAE withdrawal rates to all seven ASMs, branded ASMs, and older ASMs across each of the four dose ranges (all p > 0.05).
SIGNIFICANCE
Patients receiving FDA-RDMD of cenobamate were more likely to have ≥50% seizure reduction compared with FDA-RDMD of the seven assessed ASMs and branded ASMs, without an increase in treatment discontinuation due to TEAEs.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Double-Blind Method; Drug Therapy, Combination; Humans; Randomized Controlled Trials as Topic; Seizures; Tetrazoles; Treatment Outcome
PubMed: 34864380
DOI: 10.1016/j.yebeh.2021.108429