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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 -
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 -
PloS One 2024To evaluate the efficacy and safety of multi-drug therapy based on eszopiclone in the treatment of insomnia after stroke using a network meta-analysis method and to... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the efficacy and safety of multi-drug therapy based on eszopiclone in the treatment of insomnia after stroke using a network meta-analysis method and to provide evidence for clinical practice.
METHOD
Computer searches of PubMed, Excerpt Medica Database (Embase), Cochrane Library Central Register of Controlled Trials, APA PsycInfo, CNKI, WanFang, Sinomed and other databases were performed to search for clinical randomized controlled studies (RCTs) on multi-drug therapy based on eszopiclone in the treatment of insomnia patients after stroke. The search time was from the establishment of each database until July 2023. The bias risk assessment tool recommended by Cochrane was used to evaluate the quality of the included RCTs. Stata 14.0 was applied to perform network meta-analysis using Review Manager 5.3 software for traditional meta-analysis.
RESULT
Eighteen RCTs and 1646 patients were ultimately included, involving 11 treatment options. The results of the network meta-analysis showed that the ranking of Pittsburgh Sleep Quality Index (PSQI) decline was eszopiclone combined with sweet dream oral liquid (ESZ+SDOL)>eszopiclone combined with a shugan jieyu capsule (ESZ+SGJYC)>eszopiclone combined with agomelatine (ESZ+AGO)>eszopiclone combined with flupentixol and melitracen tablets (ESZ+FMT)>eszopiclone combined with yangxue qingnao granules (ESZ+YXQNG)>eszopiclone combined with mirtazapine (ESZ+MIR)>ESZ>FMT; the modified Edinburgh Scandinavia Stroke Scale (MESSS) decline ranking was ESZ+SDOL>ESZ+AGO>ESZ; and the clinical total effective rate ranking was eszopiclone combined with a xuefu zhuyu capsule (ESZ+XFZYC)>ESZ+MIR>ESZ+SGJYC>ESZ+SDOL> ESZ+FMT>ESZ+YXQNG>ESZ>FMT. In terms of clinical adverse reactions, in addition to ESZ therapy, ESZ+ESC had the highest number of adverse reactions, with abdominal pain being the most common. ESZ+YXQNG had the most types of adverse reactions, with 8 types.
CONCLUSION
Multi-drug therapy based on eszopiclone can effectively improve the sleep quality of patients with insomnia after stroke, and ESZ+SDOL has significant efficacy and safety. However, due to the limitations of this study, efficacy ranking cannot fully explain the superiority or inferiority of clinical efficacy. In the future, more multicentre, large sample, double-blind randomized controlled trials are needed to supplement and demonstrate the results of this study.
Topics: Humans; Eszopiclone; Sleep Initiation and Maintenance Disorders; Network Meta-Analysis; Stroke; Double-Blind Method; Randomized Controlled Trials as Topic
PubMed: 38315683
DOI: 10.1371/journal.pone.0297064 -
Cureus Dec 2023With increasing life expectancy, the quest for skin rejuvenation has gained prominence among individuals of diverse age groups. The popularity of nutricosmetics, notably... (Review)
Review
With increasing life expectancy, the quest for skin rejuvenation has gained prominence among individuals of diverse age groups. The popularity of nutricosmetics, notably dietary supplements, has garnered significant attention in recent years. Many scientific investigations have amassed compelling evidence highlighting the positive impact of hydrolyzed collagen supplementation in mitigating the visible signs of skin aging. This study aims to know the powerful effect of hydrolyzed collagen on the skin. This research method is to conduct a systematic review followed by a meta-analysis of the clinical trial focusing on randomized, double-blind, and controlled trials that examined the oral consumption of hydrolyzed collagen and reported outcomes related to skin aging, wrinkles, moisture levels, elasticity, and firmness. The selected articles from CENTRAL, PubMed, Google Scholar, and ScienceDirect databases were published from 2017 to 2023. The subsequent meta-analysis, comprising 14 distinct studies and a collective cohort of 967 participants, revealed encouraging findings favoring hydrolyzed collagen supplementation. It consistently demonstrated substantial enhancements in skin moisture levels and elasticity compared to the placebo group, a trend robustly corroborated by subgroup analysis. These compelling findings underscore the effectiveness of a 12-week regimen of hydrolyzed collagen supplementation in revitalizing the skin by augmenting its hydration and elasticity.
PubMed: 38192916
DOI: 10.7759/cureus.50231 -
Frontiers in Medicine 2023Pudendal nerve block (PNB) is a commonly used anesthesia method that has been widely used in postoperative analgesia for hemorrhoids in recent years. Therefore, we...
BACKGROUND
Pudendal nerve block (PNB) is a commonly used anesthesia method that has been widely used in postoperative analgesia for hemorrhoids in recent years. Therefore, we conducted a systematic review and meta-analysis of double-blind randomized controlled trials (RCTs) to analyze the effectiveness of PNB in postoperative analgesia for hemorrhoids.
METHODS
Relevant data and studies published from inception until August 14, 2023, were retrieved from PubMed, Embase, and Web of Science to evaluate the beneficial effects of PNB for analgesia following hemorrhoidectomy.
RESULTS
This meta-analysis included 6 double-blind RCTs comprising 501 patients. We evaluated the function of PNB in improving outcomes of postoperative analgesia of hemorrhoids. Visual analogue scale (VAS) scores on postoperative within 6 h (MD, -3.04; 95% CI, -4.13 to -1.95; < 0.0001), 12 h (MD, -3.14; 95% CI, -3.87 to -2.40; < 0.0001), and 24 h (MD, -2.25; 95% CI, -2.95 to -1.55; < 0.0001) were enhanced by the application of PNB, but not in 48 h (MD, -2.54; 95% CI, -5.29 to 0.20; = 0.07).
CONCLUSION
Pudendal nerve block (PNB) could effectively relieve postoperative pain of hemorrhoids. However, our results still need to be confirmed by multi-center clinical studies.
PubMed: 38152300
DOI: 10.3389/fmed.2023.1283512 -
The Journal of Headache and Pain Dec 2023Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic migraine can be a profoundly disabling disorder that may be treated with preventive medications. However, uncertainty remains as to which preventive medication is the most effective. We present a network meta-analysis to determine the effectiveness and rank of preventive drugs for chronic migraine in adults.
METHODS
We identified, reviewed, and extracted data from randomised controlled trials (RCTs) of preventive drugs for chronic migraine with at least 200 participants. Data were analysed using network meta-analysis.
FINDINGS
We included 12 RCTs of six medications (Eptinezumab, Erenumab, Fremanezumab, Galcanezumab, Onabotulinumtoxin A, and Topiramate) compared to placebo or each other. All drugs effectively reduced monthly headache and migraine days compared with placebo. The most effective drug for monthly headache days was Eptinezumab 300mg, with a mean difference of -2.46 days, 95% Credible Interval (CrI): -3.23 to -1.69. On the Surface Under the Cumulative Ranking Area (SUCRA) analysis, the probability that Eptinezumab 300mg was ranked highest was 0.82. For monthly migraine days, the most effective medication was Fremanezumab-monthly, with a mean difference: -2.77 days, 95% CrI: -3.36 to -2.17, and 0.98 probability of being ranked the highest. All included drugs, except Topiramate, improved headache-related quality of life. No eligible studies were identified for the other common preventive oral medications such as Amitriptyline, Candesartan, and Propranolol. The main reasons were that the studies did not define chronic migraine, were undertaken before the definition of chronic migraine, or were too small.
INTERPRETATION
All six medications were more effective than the placebo on monthly headache and migraine days. The absolute differences in the number of headache/migraine days are, at best, modest. No evidence was found to determine the relative effectiveness of the six included drugs with other oral preventive medications.
REGISTRATION
PROSPERO (number CRD42021265990).
Topics: Adult; Humans; Topiramate; Network Meta-Analysis; Migraine Disorders; Treatment Outcome; Headache; Double-Blind Method
PubMed: 38057728
DOI: 10.1186/s10194-023-01696-w -
Psychiatry Research Jan 2024Addiction is a substantial health concern; craving-the core symptom of addiction-is strongly associated with relapse. Transcranial direct current stimulation (tDCS) is a... (Meta-Analysis)
Meta-Analysis
Addiction is a substantial health concern; craving-the core symptom of addiction-is strongly associated with relapse. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that reduces cravings by altering cortical excitability and connectivity in brain regions. This systematic review and meta-analysis was conducted (following the PRISMA guidelines) to evaluate the efficacy of tDCS in reducing cravings for substances. Our analysis included 43 randomized, sham-controlled trials involving 1,095 and 913 participants receiving tDCS and sham stimulation, respectively. We analyzed the changes in craving scores and found that tDCS led to a moderate reduction in cravings compared with the sham effects. This effect was particularly pronounced when bilateral stimulation was used, the anodal electrode was placed on the right dorsolateral prefrontal cortex, current intensities ranged from 1.5 to 2 mA, stimulation sessions lasted 20 minutes, and the electrodes size was ≥35 cm². Notably, tDCS effectively reduced cravings for opioids, methamphetamine, cocaine, and tobacco but not for alcohol or cannabis. Our findings indicate tDCS as a promising, noninvasive, and low-risk intervention for reducing cravings for opioids, methamphetamine, cocaine, and tobacco. Additional studies are warranted to refine stimulation parameters and evaluate the long-term efficacy of tDCS in managing substance cravings.
Topics: Humans; Transcranial Direct Current Stimulation; Craving; Prefrontal Cortex; Substance-Related Disorders; Methamphetamine; Cocaine; Double-Blind Method
PubMed: 38043411
DOI: 10.1016/j.psychres.2023.115621 -
The Journal of Clinical Pediatric... Nov 2023Over the last few years, numerous reports have lauded the efficacy of articaine hydrochloride as a local anesthetic (LA) in dental procedures. Numerous studies have... (Meta-Analysis)
Meta-Analysis
Over the last few years, numerous reports have lauded the efficacy of articaine hydrochloride as a local anesthetic (LA) in dental procedures. Numerous studies have shown that articaine outperforms lidocaine in various aspects of dental treatment, leading to its widespread adoption in both adults and children. Despite the publications of comparative studies, there remains a dearth of systematic reviews examining the adverse effects of articaine versus lidocaine in randomized controlled trials. The aim was to assess the available research on the adverse effects of articaine and lidocaine in pediatric dentistry. A comprehensive search was conducted on Cochrane Library, Pubmed, Chinese Biomedical Literature Database (CBM), Embase, Web of Science and China National Knowledge Infrastructure (CNKI). Randomized controlled trials (RCT) that compared articaine with lidocaine in pediatric dentistry were included. Methodological quality assessment and risk of bias were determined for each of the included studies. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to assess the strength of evidence for every research. A total of 333 studies were identified through electronic searches. After conducting primary and secondary assessments, eight studies were included for the final qualitative analysis. We found no difference in the probability of adverse reactions between articaine and lidocaine after treatment in pediatric patients (risk ratio (RR) = 1.08, 95% confidence interval (CI) (0.54-2.15), = 0.83). However, a high heterogeneity was reported among the outcomes in the investigated studies (I = 57%), and the strength of the evidence was classified as "moderate" based on the GRADE approach. Besides, we found no significant difference in the probability of postoperative pain, postoperative soft tissue injury and edema between articaine and lidocaine in pediatric patients following treatment. There was moderate quality evidence suggesting no difference in the occurrence of adverse events between articaine and lidocaine when used for pediatric dental procedures.
Topics: Adult; Humans; Child; Lidocaine; Carticaine; Pediatric Dentistry; Anesthesia, Dental; Systematic Reviews as Topic; Anesthetics, Local; Double-Blind Method; Mandibular Nerve
PubMed: 37997231
DOI: 10.22514/jocpd.2023.078 -
Medicine Oct 2023Zavegepant nasal spray is a novel CGRP receptor antagonist that has been developed for the acute treatment of migraine - a prevalent disease leading to disability and... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Zavegepant nasal spray is a novel CGRP receptor antagonist that has been developed for the acute treatment of migraine - a prevalent disease leading to disability and economic burden. The meta-analysis aims to quantify the efficacy of Zavegepant compared to standard care or placebo in achieving pain freedom, freedom from most bothersome symptoms (MBS), sustained pain freedom, and pain relapse at 2 to 48 hours.
METHODS
Databases and registers were systematically searched to identify relevant clinical trials. Two independent reviewers used a standardized data extraction form to collect relevant data on primary and secondary outcomes. Statistical analysis was performed in RevMan 5.4 software. The efficacy of Zavegepant was compared to placebo using odds ratios (OR) with 95% confidence intervals (CI). Heterogeneity was assessed using the I2 statistic, chi-square test, Z value, and P value. Cochrane ROB-2 and ROBINS-I tools were used to assess the biases (osf.io/b32ne).
RESULTS
Of 36 identified studies, 3 were included in this meta-analysis. Zavegepant was more effective in achieving pain freedom (OR: 1.6, P < .00001), and freedom from MBS at 2 hours (OR = 1.4, P < .00001). The intervention group demonstrated a higher likelihood of sustained pain freedom between 2 and 48 hours (OR = 1.74, P < .00001). Although there was a trend towards reduced pain relapse between 2 and 48 hours in the intervention group, the difference was insignificant (OR = 0.67, P = .11).
CONCLUSION
This meta-analysis confirms the effectiveness of Zavegepant nasal spray in treating acute migraine, with significant improvements in pain and symptom relief. Further research is needed to determine the effect on pain relapse and overall safety.
Topics: Humans; Nasal Sprays; Treatment Outcome; Double-Blind Method; Neoplasm Recurrence, Local; Migraine Disorders; Analgesics; Pain; Recurrence
PubMed: 37904462
DOI: 10.1097/MD.0000000000035632 -
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