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PloS One 2023Second-generation antipsychotics (SGAs) are frequently prescribed for the treatment of resistant anorexia nervosa. However, few clinical trials have been conducted so...
INTRODUCTION
Second-generation antipsychotics (SGAs) are frequently prescribed for the treatment of resistant anorexia nervosa. However, few clinical trials have been conducted so far and no pharmacological treatment has yet been approved by the Food and Drug Administration. The aim of this paper is to conduct a systematic scoping review exploring the effectiveness and safety of atypical antipsychotics in anorexia nervosa (AN).
METHOD
We conducted a systematic scoping review of the effectiveness and tolerability of SGAs in the management of AN. We included articles published from January 1, 2000, through September 12, 2022 from the PubMed and PsycInfo databases and a complementary manual search. We selected articles about adolescents and adults treated for AN by four SGAs (risperidone, quetiapine, aripiprazole or olanzapine). This work complies with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews (PRIMA-ScR) and was registered in the Open Science Framework (OSF) repository.
RESULTS
This review included 55 articles: 48 assessing the effectiveness of SGAs in AN and 7 focusing only on their tolerability and safety. Olanzapine is the treatment most frequently prescribed and studied with 7 randomized double-blind controlled trials. Other atypical antipsychotics have been evaluated much less often, such as aripiprazole (no randomized trials), quetiapine (two randomized controlled trials), and risperidone (one randomized controlled trial). These treatments are well tolerated with mild and transient adverse effects in this population at particular somatic risk.
DISCUSSION
Limitations prevent the studies both from reaching conclusive, reliable, robust, and reproducible results and from concluding whether or not SGAs are effective in anorexia nervosa. Nonetheless, they continue to be regularly prescribed in clinical practice. International guidelines suggest that olanzapine and aripiprazole can be interesting in severe or first-line resistant clinical situations.
Topics: Adult; Adolescent; Humans; Antipsychotic Agents; Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Anorexia Nervosa; Benzodiazepines; Randomized Controlled Trials as Topic
PubMed: 36928656
DOI: 10.1371/journal.pone.0278189 -
Lower Urinary Tract Symptoms May 2023The aim of this study was to indirectly compare the efficacy and safety of mirabegron and vibegron in patients with overactive bladder. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The aim of this study was to indirectly compare the efficacy and safety of mirabegron and vibegron in patients with overactive bladder.
METHODS
A systematic search was performed on Pubmed, Web of Science, Embase, and the Cochrane Central Register of Controlled Trials databases to identify studies from the date of database inception to January 1, 2022. All randomized controlled trials comparing mirabegron or vibegron with tolterodine, imidafenacin, or placebo were eligible. One reviewer extracted data, and a second reviewer checked. Included trials were assessed for similarity, and networks were developed using Stata 16.0 software. Mean differences for continuous variables and odds ratios for dichotomous variables together with their 95% confidence intervals (CIs) were used to rank treatments and compare the differences, respectively.
RESULTS
A total of 11 randomized controlled trials and 10 806 patients were included. For each outcome, results for all licensed treatment doses were included. Both vibegron and mirabegron were more efficacious than placebo at reducing the frequency of micturition, incontinence, urgency, urgency incontinence, and nocturia. Vibegron was more efficacious than mirabegron in reducing mean voided volume/micturition (95% CI [5.15, 14.98]). Safety outcomes for vibegron and mirabegron were similar to those in the placebo group, except for mirabegron, which had a higher risk of nasopharyngitis and cardiovascular adverse events than placebo.
CONCLUSIONS
Both drugs seem to be comparable and well tolerated, particularly as direct comparisons are not available. However, vibegron may be more effective than mirabegron in reducing mean voided volume.
Topics: Humans; Urinary Bladder, Overactive; Network Meta-Analysis; Treatment Outcome; Double-Blind Method; Acetanilides; Adrenergic beta-3 Receptor Agonists; Randomized Controlled Trials as Topic
PubMed: 36863312
DOI: 10.1111/luts.12475 -
Journal of Attention Disorders Mar 2023A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This meta-analysis was conducted to study the efficacy and safety of PRC-063... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This meta-analysis was conducted to study the efficacy and safety of PRC-063 for ADHD.
METHOD
We searched for published trials to October 2022 in several databases.
RESULTS
A total of 1,215 patients from 5 RCTs were included. We observed significant improvement for PRC-063 in ADHD Rating Scale (ADHD-RS; MD = -6.73, 95% CI [-10.34, -3.12]) compared with placebo. The effect of PRC-063 on the sleep problems due to ADHD was not statistically different from placebo. Six subscales of Pittsburg Sleep Quality Index (PSQI) showed no statistical significance between PRC-063 and placebo. The result showed no significant difference comparing PRC-063 with placebo in serious treatment-emergent adverse events (TEAEs) (RR = 0.80, 95% CI [0.03, 19.34]). In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults.
CONCLUSION
PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents.
Topics: Child; Adult; Adolescent; Humans; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Randomized Controlled Trials as Topic; Methylphenidate; Data Management; Treatment Outcome; Double-Blind Method; Dose-Response Relationship, Drug
PubMed: 36794817
DOI: 10.1177/10870547231153941 -
Cephalalgia : An International Journal... Mar 2023We performed a random-effects network meta-analysis to study the efficacy and safety of newly developed drugs for the acute treatment of migraine attacks. (Meta-Analysis)
Meta-Analysis
Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature.
BACKGROUND
We performed a random-effects network meta-analysis to study the efficacy and safety of newly developed drugs for the acute treatment of migraine attacks.
METHODS
MEDLINE via PubMed, Embase and The Cochrane Register of Controlled Trials were searched from inception to 11 February 2022. Phase 3 randomized controlled trials examining all formulations of lasmiditan, rimegepant and ubrogepant for the acute treatment of adults with migraine, were included. Data were extracted following the PRISMA guidelines.
RESULTS
Seven studies (SAMURAI, SPARTAN, CENTURION, Study 302, Study 303, ACHIEVE I and II) involving = 12,859 patients were included. All treatments were superior in efficacy to placebo. Lasmiditan 200 mg showed the highest two-hour pain freedom, while two-hour freedom from most bothersome symptom was equally achieved by the higher doses of lasmiditan (100 and 200 mg), rimegepant and the higher doses of ubrogepant (50 and 100 mg). The odds of treatment-emergent adverse events were greatest with all doses of lasmiditan.
CONCLUSION
Lasmiditan 200 mg was the most effective intervention in the treatment of migraine attacks, although it was associated with high degrees of dizziness, nausea and somnolence. Rimegepant showed slightly lower, but similar efficacy rates to lasmiditan. Ubrogepant had overall the best tolerability profile. These conclusions are limited by the absence of head-to-head comparisons, limitations of individual trials and of the meta-analysis methodology itself. CRD42022308224.
Topics: Adult; Humans; Network Meta-Analysis; Double-Blind Method; Migraine Disorders; Treatment Outcome
PubMed: 36786357
DOI: 10.1177/03331024231151419 -
Neuromodulation : Journal of the... Dec 2023Transcranial alternating current stimulation (tACS) has been one of numerous investigation methods used for their potential to modulate brain oscillations; however, such... (Review)
Review
BACKGROUND
Transcranial alternating current stimulation (tACS) has been one of numerous investigation methods used for their potential to modulate brain oscillations; however, such investigations have given contradictory results and a lack of standardization.
OBJECTIVES
In this systematic review, we aimed to assess the potential of tACS to modulate alpha spectral power. The secondary outcome was the identification of tACS methodologic key parameters, adverse effects, and sensations.
MATERIALS AND METHODS
Studies in healthy adults who were receiving active and sham tACS intervention or any differential condition were included. The main outcome assessed was the increase/decrease of alpha spectral power through either electroencephalography or magnetoencephalography. Secondary outcomes were methodologic parameters, sensation reporting, and adverse effects. Risks of bias and the study quality were assessed with the Cochrane assessment tool.
RESULTS
We obtained 1429 references, and 20 met the selection criteria. A statistically significant alpha-power increase was observed in nine studies using continuous tACS stimulation and two using intermittent tACS stimulation set at a frequency within the alpha range. A statistically significant alpha-power increase was observed in three more studies using a stimulation frequency outside the alpha range. Heterogeneity among stimulation parameters was recognized. Reported adverse effects were mild. The implementation of double blind was identified as challenging using tACS, in part owing to electrical artifacts generated by stimulation on the recorded signal.
CONCLUSIONS
Most assessed studies reported that tACS has the potential to modulate brain alpha power. The optimization of this noninvasive brain stimulation method is of interest mostly for its potential clinical applications with neurological conditions associated with perturbations in alpha brain activity. However, more research efforts are needed to standardize optimal parameters to achieve lasting modulation effects, develop methodologic alternatives to reduce experimental bias, and improve the quality of studies using tACS to modulate brain activity.
Topics: Adult; Humans; Transcranial Direct Current Stimulation; Alpha Rhythm; Electroencephalography; Brain; Sensation; Randomized Controlled Trials as Topic
PubMed: 36725385
DOI: 10.1016/j.neurom.2022.12.007 -
Journal of Affective Disorders Mar 2023Currently, there is no clear answer to the question of how long antidepressants should be continued or when they can be safely discontinued. (Review)
Review
BACKGROUND
Currently, there is no clear answer to the question of how long antidepressants should be continued or when they can be safely discontinued.
METHODS
Pubmed/Medline was systematically searched from inception to Feb 20, 2021. Double-blind, randomized placebo-controlled trials (RCTs) with maintenance phase were selected to examine the relationship between relapse rate and treatment duration. Among 5351 screened records, 37 RCTs meeting inclusion criteria were selected. Odds ratios were calculated from relapse rates for each study and pooled in random-effect models. Possible predictors of effect sizes, i.e., open-label treatment duration, double-blind phase duration, age, medication type, history of recurrence, were analyzed by meta-regression.
RESULTS
The random-effects model showed the superiority of active medication over placebo for relapse during the follow-up phase (OR = 0.37; 95 % CI, 0.32-0.42). The meta-regression did not show a relationship between treatment duration and the effect sizes. Other clinical variables were not related with effect sizes. Subgroup analysis revealed that, for atypical ADs the effect size increased as the treatment duration increased. Further analysis showed that the relapse rate in the placebo group decreased as function of time, which reduced the absolute benefit of continued treatment.
CONCLUSION
The results may indicate that long term use of antidepressants may not be justified, and this strategy may expose the patients to more adverse effects.
Topics: Humans; Randomized Controlled Trials as Topic; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Recurrence
PubMed: 36623560
DOI: 10.1016/j.jad.2023.01.024 -
Expert Opinion on Drug Safety 2023This study aimed to evaluate the efficacy and safety of dapagliflozin as a monotherapy glucose-lowering drug treatment for older adults with diabetes. (Meta-Analysis)
Meta-Analysis
BACKGROUND
This study aimed to evaluate the efficacy and safety of dapagliflozin as a monotherapy glucose-lowering drug treatment for older adults with diabetes.
RESEARCH DESIGN & METHODS
Randomized controlled trial reports were retrieved from PubMed, Embase Cochrane Library, and Web of Science from database inception to 8 May 2021. Publication bias and heterogeneity were assessed using the Cochrane risk-of-bias tool and the Cochrane Q statistic, respectively.
RESULTS
Compared with placebo, dapagliflozin as a monotherapy glucose-lowering drug did improve the control of glycosylated hemoglobin and fasting plasma glucose levels in older adults. Our analysis also confirmed that the body weight of older adults was well controlled under treatment of dapagliflozin as a monotherapy glucose-lowering drug. Patients in older adults with diabetes took a higher risk of genital infection and renal impairment or failure after treatment of dapagliflozin. In addition, treatment with dapagliflozin reduced the risk of hypoglycemia, and did not reveal increased risk of urinary tract infection and developing fractures compared to placebo in older adults.
CONCLUSIONS
Dapagliflozin as a monotherapy glucose-lowering drug appeared to be an effective treatment for older adults with diabetes, although it might increase risk of genital infection and renal impairment or failure.
Topics: Humans; Aged; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Glucosides; Benzhydryl Compounds; Treatment Outcome; Glucose; Blood Glucose; Double-Blind Method
PubMed: 36608279
DOI: 10.1080/14740338.2023.2166485 -
Journal of the ASEAN Federation of... 2022The weight loss benefit of semaglutide in patients with diabetes is well-documented, but its clinical utility in treating obesity among patients without diabetes is less... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The weight loss benefit of semaglutide in patients with diabetes is well-documented, but its clinical utility in treating obesity among patients without diabetes is less described. We therefore assessed the efficacy and safety of subcutaneous semaglutide as treatment for obesity in patients without diabetes.
METHODOLOGY
A comprehensive search of PubMed/MEDLINE, Cochrane and Google scholar was performed to identify trials on the efficacy and safety of subcutaneous semaglutide on patients with obesity without diabetes. Primary outcome was expressed as percent mean weight difference. Secondary outcomes including risk for gastrointestinal adverse events, discontinuation of treatment and serious adverse events were expressed as risk ratios. These were calculated using the random effects model.
RESULTS
The study included 4 randomized controlled trials having a total of 3,613 individuals with obesity without diabetes. The mean difference for weight reduction was -11.85%, favoring semaglutide [95% confidence interval (CI) (-12.81,-10.90), <0.00001]. Secondary outcomes showed that the risk of developing gastrointestinal adverse events was 1.59 times more likely with semaglutide (RR 1.59, 95%CI [1.34, 1.88], <0.00001). Risk for discontinuation due to adverse events was twice as likely in the semaglutide group (RR 2.19, 95%CI [1.36,3.55], =0.001) and the risk for serious adverse events was 1.6 times more likely for semaglutide (RR1.60, 95%CI [1.24, 2.07], =0.0003). Serious events were mostly of gastrointestinal and hepatobiliary disorders such as acute pancreatitis and cholelithiasis.
CONCLUSION
Among individuals with obesity without type 2 diabetes, subcutaneous semaglutide is effective for weight loss with an 11.85% reduction from baseline compared to placebo. This supports the use of semaglutide for weight management in obesity. However, risk of gastrointestinal adverse events, discontinuation of treatment and serious adverse events were higher in the semaglutide group versus placebo.
Topics: Humans; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Acute Disease; Treatment Outcome; Double-Blind Method; Pancreatitis; Weight Loss; Obesity; Randomized Controlled Trials as Topic
PubMed: 36578889
DOI: 10.15605/jafes.037.02.14 -
International Journal of Molecular... Dec 2022Althoughanti-inflammatory drug therapy has been identified as potentially beneficial for patients suffering from chronic subdural hematoma (cSDH), contemporary... (Meta-Analysis)
Meta-Analysis Review
Althoughanti-inflammatory drug therapy has been identified as potentially beneficial for patients suffering from chronic subdural hematoma (cSDH), contemporary literature presents contradictory results. In this meta-analysis, we aimed to investigate the impact of anti-inflammatory drug therapy on mortality and outcome. We searched for eligible randomized, placebo-controlled prospective trials (RTCs) on PubMed, Embase and Medline until July 2022. From 97 initially identified articles, five RTCs met the criteria and were included in our meta-analysis. Our results illustrate significantly lower rates of recurrent cSDH (OR: 0.35; 95% CI: 0.21-0.58, = 0.0001) in patients undergoing anti-inflammatory therapy. In the subgroup of patients undergoing primary conservative treatment, anti-inflammatory therapy was associated with lower rates of "switch to surgery" cases (OR: 0.30; 95% CI: 0.14-0.63, = 0.002). Despite these findings, anti-inflammatory drugs seemed to be associated with higher mortality rates in patients undergoing surgery (OR: 1.76; 95% CI: 1.03-3.01, = 0.04), although in the case of primary conservative treatment, no effect on mortality has been observed (OR: 2.45; 95% CI: 0.35-17.15, = 0.37). Further multicentric prospective randomized trials are needed to evaluate anti-inflammatory drugs as potentially suitable therapy for asymptomatic patients with cSDH to avoid the necessity of surgical hematoma evacuation on what are predominantly elderly, vulnerable, patients.
Topics: Humans; Aged; Hematoma, Subdural, Chronic; Prospective Studies; Double-Blind Method; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 36555838
DOI: 10.3390/ijms232416198 -
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