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Nutrients Oct 2022: Age-related macular degeneration (AMD) is a neurodegenerative ophthalmic disease. The purpose of this systematic review (SR) and meta-analysis was to evaluate if... (Meta-Analysis)
Meta-Analysis Review
: Age-related macular degeneration (AMD) is a neurodegenerative ophthalmic disease. The purpose of this systematic review (SR) and meta-analysis was to evaluate if dietary supplementation alone or in combinations might delay the progression of any of the stages of AMD. A SR and meta-analysis identifying cohort studies and randomized controlled trials (RCTs) evaluating the effect of supplements in patients diagnosed with AMD. PubMed, Scopus, Web of Science, CINAHL, and Cochrane were searched through 8th October 2021. Twenty studies, examining 5634 participants ranging from 55 to 80 years, were included in the SR. Eight studies were selected for meta-analysis (414 and 216 subjects in the intervention and control groups). Lutein and zeaxanthin plus -3 long-chain polyunsaturated fatty acids (-3 LC-PUFA) supplementation showed significant improvements in best-corrected visual acuity (BCVA) (SMD: -1.99, 95% CI: -3.33, -0.65) compared to the control group. Multifocal electroretinogram results (mfERG) were significantly improved overall (SMD: 4.59, 95% CI: 1.75, 7.43) after lutein plus zeaxanthin supplementation. Combinations of lutein and zeaxanthin with -3 LC-PUFA might be beneficial in preventing AMD progression and deterioration of visual function. Our results encourage initiating further studies with combinations of -3 LC-PUFA, lutein, and zeaxanthin especially in early AMD patients.
Topics: Humans; Zeaxanthins; Lutein; Xanthophylls; Visual Acuity; Double-Blind Method; Macular Degeneration; Dietary Supplements; Fatty Acids, Omega-3
PubMed: 36296956
DOI: 10.3390/nu14204273 -
Journal of Neurology Jul 2021This meta-analysis aimed to systematically evaluate the effectiveness and safety of galcanezumab in the prophylactic treatment of adult migraine. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This meta-analysis aimed to systematically evaluate the effectiveness and safety of galcanezumab in the prophylactic treatment of adult migraine.
METHODS
A systematic literature search was performed to identity randomized-controlled trials (RCTs). The primary outcome was the decline in the number of monthly migraine days (MMDs). Secondary outcomes included the reduction of monthly acute migraine‑specific medication days (MSMDs), the number of participants showing a reduction in MMDs from baseline of ≥ 50%, ≥ 75%, and 100%, the incidence of adverse events (AEs), and the number of participants developing anti-drug antibodies (ADAs) to galcanezumab. We calculated the mean difference (MD), relative risk (RR), and 95% confidence intervals (CIs) for these outcomes.
RESULTS
Among the five included trials, galcanezumab given at doses of 120, 150, 240, and 300 mg was superior to placebo for both MMDs and secondary outcomes. The degree of AEs in all group was mild. Notably, no significant differences were found in the occurrence of AEs and ADAs between the galcanezumab and placebo groups.
CONCLUSION
Galcanezumab is a safe and effective treatment for adult patients with episodic and chronic migraine.
Topics: Adult; Antibodies, Monoclonal, Humanized; Double-Blind Method; Humans; Migraine Disorders; Treatment Outcome
PubMed: 32006159
DOI: 10.1007/s00415-020-09707-5 -
Frontiers in Immunology 2021This meta-analysis compared the efficacy and safety of five kinds of COVID-19 vaccines in different age groups (young adults and older adults), aiming to analyze the... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This meta-analysis compared the efficacy and safety of five kinds of COVID-19 vaccines in different age groups (young adults and older adults), aiming to analyze the difference of adverse events (AEs) rate and virus geometric mean titer (GMT) values between young and older people, in order to find a specific trend, and explore the causes of this trend through meta-analysis.
METHOD
Meta-analysis was used to analyze the five eligible articles. The modified Jadad scoring scale was used to evaluate the quality of eligible literature with a scoring system of 1 to 7. The primary endpoint of the effectiveness index was GMT. The primary endpoints of the safety index were the incidence of local AEs and systemic AEs. Stata 12.0 software was used for meta-analysis. Revman 5.0 software was used to map the risk of publication bias, and Egger's test was used to analyze publication bias.
RESULTS
The GMT values of young adults were higher than older adults (SMD = 1.40, 95% CI (0.79, 2.02), P<0.01). There was a higher incidence of local and systemic AEs in young people than in the elderly (OR = 1.10, 95% CI (1.08, 1.12), P<0.01; OR = 1.18, 95% CI (1.14, 1.22), P<0.01).
CONCLUSION
The immune effect of young people after being vaccinated with COVID-19 vaccines was better than that of the elderly, but the safety was worse than that of old people, the most common AEs were fever, rash, and local muscle pain, which were tolerable for young people. As the AEs of the elderly were lower, they can also be vaccinated safely; the reason for the low level of GMT in the elderly was related to Immunosenescence. The vaccine tolerance of people of different ages needs to be studied continuously.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Antibodies, Neutralizing; Antibodies, Viral; COVID-19; COVID-19 Vaccines; Female; Humans; Immunogenicity, Vaccine; Male; Middle Aged; SARS-CoV-2
PubMed: 34938287
DOI: 10.3389/fimmu.2021.758294 -
Journal of Oral & Maxillofacial Research 2020The purpose of this article is to systematically review the use, efficacy, differences between botulinum toxin type A doses and side effects of botulinum toxin type A... (Review)
Review
OBJECTIVES
The purpose of this article is to systematically review the use, efficacy, differences between botulinum toxin type A doses and side effects of botulinum toxin type A therapy in patients with trigeminal neuralgia.
MATERIAL AND METHODS
The search for the performed reviews was done in PubMed and Cochrane library in English language from January 2010 up to February 2020. Inclusion criteria: full-text studies in English language, in which visual assessment scale (VAS) was present, in which patients with trigeminal neuralgia (TN) were participated and the comparison between botulinum toxin type A (BT-A) and saline was done.
RESULTS
The review included 4 randomized, double-blind, placebo-controlled trials with 8 to 12 weeks follow-up to observe changes in VAS and in frequency of TN attacks, differences between dosages of BT-A in therapy and side effects. Mean VAS of BT-A group decreased by approximately 68% and of palcebo group decreased by approximately 21.6% after the therapy. Mean frequency of TN attacks in 3 studies of BT-A group decreased by 85%, while in palcebo by only 15.9%.
CONCLUSIONS
Botulinum toxin type A injection therapy is a safe and effective method in management of trigeminal neuralgia. No differences between dosages of botulinum toxin type A were found. Maximum efficacy was noticed between 6 weeks and 3 months after the procedure. Side effects were mostly facial asymmetry after injection, headaches, haematoma, which disappeared in one week.
PubMed: 32760475
DOI: 10.5037/jomr.2020.11202 -
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 -
Neurocritical Care Aug 2022Vinpocetine as a neuroprotective agent is effective in acute ischemic stroke in some randomized controlled trials (RCTs). Since the last systematic review has been... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vinpocetine as a neuroprotective agent is effective in acute ischemic stroke in some randomized controlled trials (RCTs). Since the last systematic review has been published in 2008, which didn't find conclusive evidence favoring its use, two more RCTs have also been completed.
METHODS
Relevant electronic databases were searched with a suitable combination of Medical Subject Headings terms to detect publications describing RCTs exploring the safety and efficacy of vinpocetine in patients with acute ischemic stroke. The risk of bias was determined by using the Cochrane Collaboration's tool for assessing the risk of bias in RCTs after full-text review and relevant data extraction. Higgins and Thompson's I method was used to assess heterogeneity in studies. The presence of publication bias was assessed by Egger's test. We used a random effect model when I was more than 50% and a fixed-effect model for other parameters.
RESULTS
Four placebo-controlled RCTs enrolling a total of 601 and 236 patients in vinpocetine and placebo groups, respectively, were included. The number of patients with death or significant disability was lower in the vinpocetine group than that in the placebo group at both 1 and 3 months (relative risk 0.80, 95% confidence interval [CI] 0.65-0.99 and relative risk 0.67, CI 0.48-0.92, p = 0.04 and 0.02, respectively). The degree of disability in participants at 1 month and 3 months was also lower in vinpocetine group than that in the placebo group (standardized mean difference (SMD) 0.49, 95% CI 0.03-0.95 and SMD 1.22, CI 0.23-2.24, p = 0.001 and 0.04, respectively). Change in mini-mental state examination score compared with baseline at trial enrolment was also better in the vinpocetine group than in the placebo group (pooled weighted mean difference 0.92, 95% CI 0.02-1.82, p = 0.04).
CONCLUSIONS
Vinpocetine has some promising efficacy in patients with ischemic stroke when used in the acute stage in reducing the disability, but presently there is not enough evidence to suggest that it also reduces case fatality. More double-blind, placebo-controlled RCTs of adequate sample size are needed before making recommendations for the routine administration of vinpocetine for all patients with acute ischemic stroke.
Topics: Humans; Ischemic Stroke; Neuroprotective Agents; Randomized Controlled Trials as Topic; Stroke; Vinca Alkaloids
PubMed: 35488169
DOI: 10.1007/s12028-022-01499-y -
Frontiers in Pharmacology 2022In China, Franch. (Chinese name: Huanglian) prescriptions (HLPs) are prominent hypoglycemic agents used in glycemic control. However, the curative effect of HLPs as...
In China, Franch. (Chinese name: Huanglian) prescriptions (HLPs) are prominent hypoglycemic agents used in glycemic control. However, the curative effect of HLPs as adjunctive therapies for type 2 diabetes mellitus (T2DM) has not been evaluated. Based on a systematic review and a meta-analysis, this study was conducted to assess the effects of HLPs combined with metformin as a reinforcing agent for T2DM. A total of 33 randomized controlled trials (RCTs) reporting on 2,846 cases concerning the use of HLPs in the treatment of T2DM were identified from the China National Knowledge Infrastructure (CNKI), Weipu (VIP), Wanfang, PubMed, Cochrane Library, and EMBASE databases. Primary outcomes included fasting blood glucose (FBG), 2-h postprandial blood glucose (2hPG), glycosylated hemoglobin, type A1c (HbA1c), fasting serum insulin (FINS), and homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes included total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), and gastrointestinal dysfunction (GD). Continuous data were expressed as mean differences (MDs) with 95% confidence intervals (CIs). The methodological quality of the included RCTs was assessed by Cochrane evidence-based medicine systematic evaluation. Statistical analysis was performed using the Review Manager and Stata software. The required information size and treatment benefits were evaluated by trial sequential analysis (TSA). The quality of evidence was rated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The results revealed that HLPs are beneficial to improve the following: FBG (MD = -1.16%, 95% CI: -1.24 to -1.07), 2hPG (MD = -1.64%, 95% CI: -1.84 to -1.43), HbA1c (MD = -0.78%, 95% CI:-0.96 to -0.60), FINS (MD = -1.94%, 95% CI: -2.68 to -1.20), HOMA-IR (MD = -0.77%, 95% CI: -1.28 to -0.27), TC (MD = -0.70%, 95% CI: -1.00 to -0.39), TG (MD = -0.57%, 95% CI: -0.74 to -0.40), LDL-c (MD = -0.70%, 95% CI: -0.97 to -0.43), and HDL-c (MD = -0.21%, 95% CI: -0.32 to -0.10) for patients with T2DM. The funnel plot, Egger's test, and trim-and-fill method indicated a moderate publication bias in the results. The TSA showed that the required sample size of HLPs in improving FBG, 2hPG, HbA1c, FINS, HOMA-IR, TC, TG, LDL-c, and HDL-c could sufficiently draw reliable conclusions. GRADE assessment revealed that the quality of the evidence for the effectiveness of HLPs in improving FBG was moderate, but the quality of evidence for 2hPG, HbA1c, FINS, HOMA-IR, TC, TG, LDL-c, and HDL-c was low, and for GD was very low. The systematic review and meta-analysis suggested that HLPs were beneficial for achieving glycemic control. However, HLPs recommended for T2DM patients have yet to be confirmed because of the poor methodological quality of some trials. Therefore, more RCTs with multicenter and double-blind designs are needed to assess the efficacy of HLPs for patients with T2DM.
PubMed: 36160405
DOI: 10.3389/fphar.2022.956313 -
Journal of Cancer Research and Clinical... Oct 2020Limited treatment options are available in chemotherapy-refractory metastatic colorectal cancer (mCRC). The objective was to conduct a systematic literature review (SLR)... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Limited treatment options are available in chemotherapy-refractory metastatic colorectal cancer (mCRC). The objective was to conduct a systematic literature review (SLR) and exploratory network meta-analysis (NMA) to compare the tolerability and effectiveness of SIRT with Y-90 resin microspheres, regorafenib, TAS-102 (trifluridine/tipiracil), and best supportive care (BSC) as third-line treatment in patients with mCRC.
METHODS
An SLR was conducted to identify studies comparing two or more of the treatments and reporting overall survival (OS), progression-free survival, tumor response, or adverse event (AE) incidence. An exploratory NMA was conducted to compare hazard ratios (HRs) for OS using Markov chain Monte Carlo (MCMC) techniques.
RESULTS
Seven studies were identified in the SLR: two double-blind randomized-controlled trials (RCT) for each drug, one open-label RCT, and two non-randomized comparative studies for SIRT. Patient selection criteria differed between studies, with SIRT studies including patients with liver-dominant colorectal metastases. Nausea and vomiting were more frequent with TAS-102 than regorafenib or SIRT; diarrhea was more common with TAS-102 and regorafenib than SIRT. The exploratory NMA suggested that all active treatments improved OS, with HRs of 0.48 (95% CrI 0.30-0.78) for SIRT with Y-90 resin microspheres, 0.63 (0.38-1.03) for TAS-102, and 0.67 (0.40-1.08) for regorafenib each compared to BSC.
CONCLUSIONS
Regorafenib, TAS-102 and SIRT using Y-90 resin microspheres are more effective than BSC in third-line treatment of mCRC; however, study heterogeneity made comparisons between active treatments challenging. SIRT is a viable treatment for third-line mCRC and its favorable AE profile should be considered in the therapeutic decision-making process.
Topics: Antineoplastic Combined Chemotherapy Protocols; Brachytherapy; Colorectal Neoplasms; Double-Blind Method; Drug Combinations; Humans; Microspheres; Neoplasm Metastasis; Network Meta-Analysis; Palliative Care; Phenylurea Compounds; Progression-Free Survival; Pyridines; Pyrrolidines; Randomized Controlled Trials as Topic; Thymine; Trifluridine; Uracil; Yttrium Radioisotopes
PubMed: 32715436
DOI: 10.1007/s00432-020-03315-6 -
PloS One 2023Immune checkpoint inhibitors (ICIs) have changed the treatment pattern of advanced and metastatic NSCLC. A series of ICI based therapies have emerged in the first-line... (Meta-Analysis)
Meta-Analysis
Identifying optimal first-line immune checkpoint inhibitors based regiments for advanced non-small cell lung cancer without oncogenic driver mutations: A systematic review and network meta-analysis.
BACKGROUND
Immune checkpoint inhibitors (ICIs) have changed the treatment pattern of advanced and metastatic NSCLC. A series of ICI based therapies have emerged in the first-line treatment field, but the comparative efficacy was unclear.
METHOD
We searched multiple databases and abstracts of major conference proceedings up to Apri1, 2022 for phase III randomised trials of advanced driver-gene wild type NSCLC patients receiving first-line therapy. Outcomes analyzed included progression free survival (PFS), overall survival (OS), and et al.
RESULTS
Thirty-two double-blind RCTs were included, involving 18,656 patients assigned to 22 ICI-based first-line regimens. A series of ICI regiments (including ICI plus chemotherapy), ICI monotherapy, doublet ICIs, doublet ICIs plus chemotherapy) emerged, and showed significant PFS and OS benefit than chemotherapy and chemotherapy + bevacizumab (BEV) for advanced wild-type NSCLC. In comprehensive terms of PFS, chemoimmunotherapy (CIT) were significantly more effective than ICI monotherapy and doublet ICIs. In terms of OS for patients with non-squamous NSCLC, pembrolizumab containing CIT was associated with a median rank of the best regimens, and followed by Atezolizumab+BEV based CIT; while for OS in patients with squamous NSCLC, Cemiplimab and sintilimab based CIT were the most effective regimens. For more than 2 years follow-up, the atezolizumab, pembrolizumab, nivolumab and durvalumab containing ICI therapy all provide a durable long-term OS benefit over chemotherapy and BEV + chemotherapy.
CONCLUSIONS
The findings of the present NMA represent the most comprehensive evidence, which might suggest or provide basis for first-line ICI therapy decision for advanced NSCLC patients without oncogenic driver mutations.
Topics: Humans; Carcinoma, Non-Small-Cell Lung; Immune Checkpoint Inhibitors; Network Meta-Analysis; Lung Neoplasms; Bevacizumab; Mutation; Randomized Controlled Trials as Topic
PubMed: 37071610
DOI: 10.1371/journal.pone.0283719 -
JAMA Psychiatry Jan 2022Single-blind placebo run-in (PRI) periods are common in randomized clinical trials (RCTs) of treatment for depression. They aim to increase sensitivity to detect drug... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Single-blind placebo run-in (PRI) periods are common in randomized clinical trials (RCTs) of treatment for depression. They aim to increase sensitivity to detect drug effects; however, the association of PRI periods with study outcomes remains unclear. This is concerning given the costs of PRI periods to patients and investigators.
OBJECTIVE
To examine the association of the use of PRI periods with the placebo response, drug response, and drug-placebo difference among RCTs of antidepressants.
DATA SOURCES
MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO, as well as repositories of unpublished studies, were systematically searched up to July 2021.
STUDY SELECTION
Included studies were double-blind, placebo-controlled RCTs of antidepressant medication among adults with depressive disorders.
DATA EXTRACTION AND SYNTHESIS
Data were extracted into a coding sheet, including the characteristics of studies, the characteristics of PRI periods, and the outcomes of studies.
MAIN OUTCOMES AND MEASURES
Study outcomes were the primary depression symptom measure reported by the RCT. These outcomes were used to calculate effect sizes (Hedges g) of the within-group drug response and placebo response as well as the drug-placebo difference. Random-effects meta-analysis was used to calculate effect sizes, and subgroup analyses were used to compare outcomes depending on use of PRI periods.
RESULTS
A total of 347 trials (representing 89 183 participants) were included; 174 studies (50%) reported using a single-blind PRI period. Response outcome data were available for 189 studies. Studies using PRI periods reported a smaller placebo response (g = 1.05 [95% CI, 0.98-1.11]; I2 = 82%) than studies that did not use a PRI period (g = 1.15 [95% CI, 1.09-1.21]; I2 = 81%; P = .02). Subgroup analysis showed a larger drug response size among studies that did not use a PRI period (g = 1.55 [95% CI, 1.49-1.61]; I2 = 85%) than those that did use a PRI period (g = 1.42 [95% CI, 1.36-1.48]; I2 = 81%; P = .001). The drug-placebo difference did not differ by use of PRI periods (g = 0.33 [95% CI, 0.29-0.38]; I2 = 47% for use of a PRI period vs g = 0.34 [95% CI, 0.30-0.38]; I2 = 54% for no use of PRI periods; P = .92). The likelihood of response to drug vs placebo also did not differ between studies that used a PRI period (odds ratio, 1.89 [95% CI, 1.76-2.03]) and those that did not use a PRI period (odds ratio, 1.77 [95% CI, 1.65-1.89]; P = .18).
CONCLUSIONS AND RELEVANCE
This study suggests that RCTs using PRI periods yield smaller within-group changes across both placebo and drug groups compared with RCTs without PRI periods. The reduction in effect size across groups was equivalent in magnitude. Consequently, PRI studies do not observe larger drug-placebo differences, suggesting that they do not increase trial sensitivity. As such, given the resources and probable deception required and risk to external validity, the practice of using PRI periods in RCTs of antidepressants should be ended.
Topics: Antidepressive Agents; Humans; Placebos; Randomized Controlled Trials as Topic; Single-Blind Method
PubMed: 34757405
DOI: 10.1001/jamapsychiatry.2021.3204