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EuroIntervention : Journal of EuroPCR... Jun 2016Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional... (Comparative Study)
Comparative Study Meta-Analysis Review
AIMS
Several studies have suggested good procedural and similar clinical outcomes between everolimus-eluting Absorb bioresorbable stents (BRS) versus conventional drug-eluting stents (DES), but the evidence is not definitive. Our aim was to perform a systematic review and meta-analysis to investigate the effects of BRS versus conventional drug-eluting and bare metallic stents on the cardiovascular endpoints and all-cause mortality.
METHODS AND RESULTS
The follow-up in the included studies was up to 13 months. The following endpoints were evaluated: all-cause mortality, cardiac death, patient-oriented major adverse cardiac events (POCE), device-oriented major adverse cardiac events (DOCE), any-cause myocardial infarction (MI), target vessel MI (TVMI), target vessel revascularisation (TVR) and target lesion revascularisation (TLR). The results of 10 studies with 5,773 subjects showed a statistically significant increase in the risk of TVMI between BRS and conventional stents (odds ratio [OR]: 1.45, 95% confidence interval [CI]: 1.03-2.05, p=0.032). None of the other differences reached statistical significance: all-cause mortality (OR: 0.67, 95% CI: 0.30-1.49, p=0.333), cardiac death (OR: 1.00, 95% CI: 0.47-2.12, p=0.996), POCE (OR: 0.91, 95% CI: 0.68-1.22, p=0.546), DOCE (OR: 1.12, 95% CI: 0.86-1.46, p=0.387), any-cause MI (OR: 1.34, 95% CI: 0.98-1.82, p=0.064), TVR (OR: 0.99, 95% CI: 0.73-1.33, p=0.934) and TLR (OR: 0.92, 95% CI: 0.66-1.29, p=0.641). Similar results were observed after restricting the meta-analysis to the comparison of BRS vs. EES.
CONCLUSIONS
Our meta-analysis suggests a significantly higher risk of TVMI with BRS compared with conventional stents and no significant differences in the rates of occurrence of the other outcomes during one-year follow-up. Further studies with larger samples sizes, longer follow-up, different clinical scenarios and more complex lesions are required to confirm or refute our findings.
Topics: Absorbable Implants; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome
PubMed: 27290677
DOI: 10.4244/EIJY16M06_02 -
Journal of Taibah University Medical... Feb 2023Dental implants are prosthetic devices that are surgically placed in direct contact with the jawbone to support intra-oral functions and esthetics. Diabetes mellitus may... (Review)
Review
Dental implants are prosthetic devices that are surgically placed in direct contact with the jawbone to support intra-oral functions and esthetics. Diabetes mellitus may contribute to peri-implant bone loss. During the last few years, there have been attempts to reduce this bone loss and improve the survival rate of implants. Metformin, an anti-diabetic drug known for its osteogenic properties, is thought to prevent peri-implant bone loss in diabetic patients. Although several studies have been conducted to study metformin's effect on diabetic and non-diabetic study models, no systematic review has analyzed and summarized these studies critically. Therefore, the objectives of this systematic review were to summarize the outcomes of these studies and critically appraise them. Seven studies were included in this systematic review. Four studies used only animal models, two used both animal and cell culture models, and one used only cell culture studies. The general characteristics and outcomes of the included studies were summarized, and Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were used to assess the quality of the animal studies. In vitro studies indicate that metformin may induce stem cells to undergo osteoblastic differentiation to produce a higher amount of bone and may also improve osseointegration. Nevertheless, several studies had potential sources of bias. Therefore, it is recommended that emphasis be placed on increasing the quality of future animal studies and human trials to determine the effects of metformin on the osseointegration of dental implants. Future studies are needed with adequate follow-up to evaluate the efficacy of metformin in improving the osseointegration of dental implants.
PubMed: 36398019
DOI: 10.1016/j.jtumed.2022.07.003 -
European Archives of... May 2017The majority of tinnitus patients are affected by chronic idiopathic tinnitus, and almost 60 different treatment modalities have been reported. The present study is a... (Review)
Review
The majority of tinnitus patients are affected by chronic idiopathic tinnitus, and almost 60 different treatment modalities have been reported. The present study is a multidisciplinary systematic analysis of the evidence for the different forms of treatment for chronic tinnitus. The results are used to form the basis of an S3 guideline. A systematic search was carried out in PubMed and the Cochrane Library. The basis for presenting the level of evidence was the evidence classification of the Oxford Centre of Evidence-based Medicine. Whenever available, randomised controlled trials were given preference for discussing therapeutic issues. All systematic reviews and meta-analyses were assessed for their methodological quality, and effect size was taken into account. As the need for patient counselling is self-evident, specific tinnitus counselling should be performed. Due to the high level of evidence, validated tinnitus-specific, cognitive behavioural therapy is strongly recommended. In addition, auditory therapeutic measures can be recommended for the treatment of concomitant hearing loss and comorbidities; those should also be treated with drugs whenever appropriate. In particular, depression should be treated, with pharmacological support if necessary. If needed, psychiatric treatment should also be given on a case-by-case basis. With simultaneous deafness or hearing loss bordering on deafness, a CI can also be indicated. For auditory therapeutic measures, transcranial magnetic or direct current stimulation and specific forms of acoustic stimulation (noiser/masker, retraining therapy, music, and coordinated reset) for the treatment of chronic tinnitus the currently available evidence is not yet sufficient for supporting their recommendation.
Topics: Acoustic Stimulation; Cognitive Behavioral Therapy; Diagnosis, Differential; Disease Management; Electric Stimulation Therapy; Hearing Loss; Humans; Tinnitus
PubMed: 27995315
DOI: 10.1007/s00405-016-4401-y -
Clinical Ophthalmology (Auckland, N.Z.) 2021This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and... (Review)
Review
PURPOSE
This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and dexamethasone implant for the treatment of diabetic macular edema (DME) and to identify factors affecting treatment response using evidence generated from meta-regression.
METHODS
A systematic review of electronic databases was conducted to identify randomized controlled trials (RCTs) and real-life/observational studies that reported 12-month changes in BCVA in patients with DME on anti-VEGF or dexamethasone implant treatment in monotherapy. Study factors that were analyzed are baseline patient characteristics, study type, drug employed, number of injections and 12-month change in BCVA. Data were pooled in a random-effects meta-analysis with BCVA change as the main outcome. Meta-regression was conducted to assess the impact of multiple covariates.
RESULTS
One-hundred-five heterogeneous study populations (45,032 eyes) were identified and included in the analysis. The use of anti-VEGFs and dexamethasone implant induced an overall increase of +8.13 ETDRS letters in BCVA at 12 months of follow-up. Meta-regression provided evidence that mean BCVA change using anti-VEGFs was not statistically higher for RCTs (p=0.35) compared to observational studies. Dexamethasone implant showed a trend for better results in observational studies over RCTs. Populations following a fixed aflibercept regimen performed better than those following a reactive treatment regimen. Mean BCVA gain was higher in younger populations (p<0.001), with lower baseline BCVA (p<0.0001) and longer diabetes duration (p<0.0001), receiving a higher number of injections (p<0.0001).
CONCLUSION
Intravitreal therapy with anti-VEGFs or dexamethasone implant produces a significant improvement in BCVA at 12 months in patients with DME. Meta-regression identified the modifiable covariates that can be targeted in order to maximize functional results.
PubMed: 33551641
DOI: 10.2147/OPTH.S236423 -
European Cells & Materials Oct 2021Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis...
Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis directly in patients, animal models allow researchers to investigate the pathogenesis of the infection and the development of novel prophylactic, anti-inflammatory and antimicrobial treatment strategies. This review is specifically focused on the in vivo mouse osteomyelitis studies available in literature. Thus, a systematic search on Web of Science and PubMed was conducted using the query "(infection) AND (mice OR mouse OR murine) AND (model OR models) AND (arthroplasty OR fracture OR (internal fixator) OR (internal fixation OR prosthesis OR implant OR osteomyelitis)". After critical assessment of the studies according to the inclusion and exclusion criteria, 135 studies were included in the detailed analysis. Based on the model characteristics, the studies were classified into five subject groups: haematogenous osteomyelitis, post-traumatic osteomyelitis, bone-implant-related infection, peri-prosthetic joint infection, fracture-related infection. In addition, the characteristics of the mice used, such as inbred strain, age or gender, the characteristics of the pathogens used, the inoculation methods, the type of anaesthesia and analgesia used during surgery and the procedures for evaluating the pathogenicity of the infecting micro-organism were described. Overall, the mouse is an excellent first step in vivo model to study the pathogenesis, inflammation and healing process of osteomyelitis and to evaluate novel prophylaxis and treatment strategies.
Topics: Animals; Anti-Bacterial Agents; Disease Models, Animal; Humans; Inflammation; Mice; Osteomyelitis; Staphylococcal Infections
PubMed: 34672359
DOI: 10.22203/eCM.v042a22 -
Preventive Medicine Nov 2015To systematically review the literature on contraceptive use by women with opioid and other substance use disorders in order to estimate overall contraceptive use and to... (Review)
Review
AIM
To systematically review the literature on contraceptive use by women with opioid and other substance use disorders in order to estimate overall contraceptive use and to examine method choice given the alarmingly high rate of unintended pregnancy in this population.
METHOD
Pubmed (1948-2014) and PsycINFO (1806-2014) databases were searched for peer-reviewed journal articles using a systematic search strategy. Only articles published in English and reporting contraceptive use within samples of women with opioid and other substance use disorders were eligible for inclusion.
RESULTS
Out of 580 abstracts reviewed, 105 articles were given a full-text review, and 24 studies met the inclusion criteria. The majority (51%) of women in these studies reported using opioids, with much smaller percentages reporting alcohol and cocaine use. Across studies, contraceptive prevalence ranged widely, from 6%-77%, with a median of 55%. Results from a small subset of studies (N=6) suggest that women with opioid and other substance use disorders used contraception less often than non-drug-using comparison populations (56% vs. 81%, respectively). Regarding method choice, condoms were the most prevalent method, accounting for a median of 62% of contraceptives used, while use of more effective methods, especially implants and intrauterine devices (IUDs), was far less prevalent 8%.
CONCLUSIONS
Women with opioid and other substance use disorders have an unmet need for contraception, especially for the most effective methods. Offering contraception services in conjunction with substance use treatment and promoting use of more effective methods could help meet this need and reduce unintended pregnancy in this population.
Topics: Adult; Analgesics, Opioid; Choice Behavior; Contraceptive Agents; Family Planning Services; Female; Humans; Opioid-Related Disorders; Pregnancy; Substance-Related Disorders
PubMed: 25900803
DOI: 10.1016/j.ypmed.2015.04.008 -
World Neurosurgery Nov 2022Neuromodulatory implants provide promising alternatives for patients with drug-resistant epilepsy (DRE) in whom resective or ablative surgery is not an option.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Neuromodulatory implants provide promising alternatives for patients with drug-resistant epilepsy (DRE) in whom resective or ablative surgery is not an option. Responsive neurostimulation (RNS) operates a unique "closed-loop" system of electrocorticography-triggered stimulation for seizure control. A comprehensive review of the current literature would be valuable to guide clinical decision-making regarding RNS.
METHODS
Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols, a systematic PubMed literature review was performed to identify appropriate studies involving patients undergoing RNS for DRE. Full texts of included studies were analyzed and extracted data regarding demographics, seizure reduction rate, responder rate (defined as patients with >50% seizure reduction), and complications were compiled for comprehensive statistical analysis.
RESULTS
A total of 313 studies were screened, and 17 studies were included in the final review, representative of 541 patients. Mean seizure reduction rate was 68% (95% confidence interval 61%-76%), and the mean responder rate was 68% (95% confidence interval 60%-75%). Complications occurred in 102 of 541 patients, for a complication rate of 18.9%. A strong publication bias toward greater seizure reduction rate and increased responder rate was demonstrated among included literature.
CONCLUSIONS
A meta-analysis of recent RNS for DRE literature demonstrates seizure reduction and responder rates comparable with other neuromodulatory implants for epilepsy, demonstrating both the value of this intervention and the need for further research to delineate the optimal patient populations. This analysis also demonstrates a strong publication bias toward positive primary outcomes, highlighting the limitations of current literature. Currently, RNS data are optimistic for the treatment of DRE but should be interpreted cautiously.
Topics: Humans; Deep Brain Stimulation; Treatment Outcome; Epilepsy; Drug Resistant Epilepsy; Seizures
PubMed: 35948217
DOI: 10.1016/j.wneu.2022.07.147 -
Clinical Oral Implants Research Sep 2015The objective of this review was to analyze research with regard to the effect of zirconia or titanium as abutment material on soft peri-implant tissues. (Meta-Analysis)
Meta-Analysis Review
AIM
The objective of this review was to analyze research with regard to the effect of zirconia or titanium as abutment material on soft peri-implant tissues.
METHODS
Clinical studies were selected via electronic and hand searches in English language journals until December 1, 2014. Only randomized clinical trials (RCTs) and prospective controlled clinical trials (CCTs) showing direct comparison between zirconia (Zr) and titanium (Ti) abutments in the same patient were considered. The outcome measures were (1) soft tissue color, (2) soft tissue recession, (3) peri-implant probing, (4) bleeding on probing, (5) esthetic indexes, (6) patient-reported outcome, (7) marginal bone level, and (8) biological complications.
RESULTS
Nine relevant studies (11 papers) were identified: 4 RCTs and 5 CCTs. Due to heterogeneity in the study design, statistical methods, and reported results, a meta-analysis of the data was feasible only for soft tissue color. The outcome was found to be significantly superior for Zr abutments. For the other outcome measures, a qualitative analysis of the selected articles was performed. The studies did not show any statistically significant differences between Zr and Ti abutments on soft tissue recession, probing depths, bleeding on probing, marginal bone level, and patient-reported outcome. One study reported significantly higher pink esthetic score (PES) scores at Zr implants with Zr abutments, compared to metal implants and Ti abutments.
CONCLUSION
Overall, the research does not support any obvious advantage of Ti or Zr abutments over each other. However, there is a significant tendency in Zr abutments evoking better color response of peri-implant mucosa and superior esthetic outcome measured by PES score.
Topics: Dental Abutments; Dental Implants; Esthetics, Dental; Gingiva; Gingival Diseases; Humans; Titanium; Zirconium
PubMed: 26073346
DOI: 10.1111/clr.12631 -
JAMA Surgery Apr 2016Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown. (Review)
Review
IMPORTANCE
Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown.
OBJECTIVES
To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices.
EVIDENCE ACQUISITION
Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis, and collagen. The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools.
EVIDENCE SYNTHESIS
Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly.
CONCLUSIONS AND RELEVANCE
There is insufficient evidence to determine the extra costs associated with or the clinical efficacy of biological mesh materials for the repair of abdominal wall hernia.
Topics: Bioprosthesis; Hernia, Abdominal; Herniorrhaphy; Humans; Prosthesis Design; Surgical Mesh; United States; United States Food and Drug Administration; Wound Healing
PubMed: 26819222
DOI: 10.1001/jamasurg.2015.5234 -
Journal of Plastic, Reconstructive &... Jul 2023The impact of chemotherapy on complications following breast reconstruction surgery (BRS) is currently inconclusive. This meta-analysis investigates the impact of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of chemotherapy on complications following breast reconstruction surgery (BRS) is currently inconclusive. This meta-analysis investigates the impact of chemotherapy on complication rates in BRS.
METHODS
Preferred Reporting in Systematic Review and Meta-Analysis (PRISMA) guidelines was used to search relevant studies published from January 2006 to March 2022. The complication rates of neoadjuvant systemic therapy (NST) and adjuvant systemic therapy (AST) were analyzed via RevMan software 5.4, and a P value of< 0.05 was considered significant. The quality of selected studies was performed using the Newcastle-Ottawa scale for quality assessment.
RESULTS
A total of 18 studies comprising 49,217 patients were included. There was no significant difference in the total complications rate, major complications, or minor complications between NST and BRS or control. The rate of wound dehiscence was higher in the NST group compared with the BRS only group [RR= 1.54, 95% CI, (1.08, 2.18), P = 0.02], and the rate of infection was lower in the NST group compared with the BRS only group, [RR= 0.75, 95% CI, (0.61, 0.94), P = 0.01]. No significant difference in the rates of hematoma, seroma, skin necrosis, and implant loss was detected between NST and AST, or NST with BRS only. No statistically significant differences in total complication rates were observed between flap and implant BRS types (P = 0.88).
CONCLUSION
No significant differences between AST and NST were detected for complications. Significantly, NST had more wound dehiscence and less infection rates compared with BRS only groups, possibly reflecting selection bias or issues in the design of reported studies.
LEVEL OF EVIDENCE
I.
Topics: Humans; Female; Postoperative Complications; Mammaplasty; Surgical Flaps; Combined Modality Therapy; Neoadjuvant Therapy; Breast Neoplasms
PubMed: 37182249
DOI: 10.1016/j.bjps.2023.04.007