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Tissue Fillers for the Nasolabial Fold Area: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

ABSTRACT: Tissue fillers injections remain to be one of the most commonly performed cosmetic procedures. The aim of this meta-analysis was to systematize and present available data on the aesthetic outcomes and safety of treating the nasolabial fold area with tissue fillers. We conducted a systematic review of randomized clinical trials that report outcomes concerning treatment of nasolabial fold area with tissue fillers. We searched the MEDLINE/PubMed, ScienceDirect, EMBASE, BIOSIS, SciELO, Scopus, Cochrane Controlled Register of Trials, CNKI and Web of Science databases. Primary outcomes included aesthetic improvement measured using the Wrinkle Severity Rating Scale score and Global Aesthetic Improvement Scale. Secondary outcomes were incidence rates of complications occurring after the procedure. At baseline, the pooled mean WSRS score was 3.23 (95% CI: 3.20-3.26). One month after the procedure, the pooled WSRS score had reached 1.79 (95% CI: 1.74-1.83). After six months it was 2.02 (95% CI: 1.99-2.05) and after 12 months it was 2.46 (95% CI: 2.4-2.52). One month after the procedure, the pooled GAIS score had reached 2.21 (95% CI: 2.14-2.28). After six months, it was 2.32 (95% CI: 2.26-2.37), and after 12 months, it was 1.27 (95% CI: 1.12-1.42). Overall, the pooled incidence of all complications was 0.58 (95% CI: 0.46-0.7). Most common included lumpiness (43%), tenderness (41%), swelling (34%) and bruising (29%). Tissue fillers used for nasolabial fold area treatment allow achieving a satisfying and sustainable improvement. Most common complications include tenderness, lumpiness, swelling, and bruising. LEVEL OF EVIDENCE II: "This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 ."

SUBMITTER: Stefura T

PROVIDER: S-EPMC8481177 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p?=?0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p?=?0.38).Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.

Project description:ObjectivesThe goal of this systematic review was to analyze, in randomized controlled clinical trials (RCTs), regenerative techniques used to treat peri-implantitis (PI).MethodsThree databases (PubMed/Medline, EMBASE, and On-Line Knowledge Library) were accessed, applying the PICO strategy (Population [P], Intervention [I], Comparison [C], and Outcomes [O]), with the following focused questions: (i) "In patients who received regenerative treatments for peri-implantitis (P), is the regenerative surgical treatment (I) clinically effective and predictable compared to non-regenerative (C) to treat PI (O)?"; and (ii) "In patients who received regenerative treatments for peri-implantitis (P), the regenerative approach (I), compared to non-regenerative (C), significantly increase the prognosis and implant survival rate in the mid- and long-term (O)?" The inclusion criteria were RCTs published in English between 2012 and 2022, with at least a one-year follow-up, which applied regenerative techniques to treat peri-implantitis. Cochrane's collaboration tool for assessing the risk of bias was used.Main resultsNine articles were included with 404 patients (225 females and 179 males; mean age of 60.44 years). One study evaluated patients after 48 months and another after 88 months. The techniques and devices used were: (i) implantoplasty with Er:YAG laser, (ii) blood concentrate (growth factors), and (iii) EMD, with no statistically significant outcome. Two studies considered the use of titanium granules with a significant increase in radiographic bone identification, whereas regenerative techniques with bone graft (autogenous, alloplastic, and xenograft) were the majority chosen, associated or not, with a collagen membrane. Xenograft had better results radiographically when compared to the autogenous bone graft and presented better results for bone level. There was an overall decrease in bleeding on probing, independent of the control or test group, and a reduction in pocket depth in the groups analyzed. Titanium granules, EMD, Er:YAG laser, and CGF had non-significant results; better results were observed when using bone grafts. The RoB showed a low risk in four studies (44.44%), three with moderate (33.33%), and two with high risk (22.23%).ConclusionSurgical regenerative treatment was a predictable option in the management of PI and in improving the clinical parameters of peri-implant tissues in the short term, mainly when using porous titanium granules, alloplastic bone grafts, and xenografts.

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Tissue Fillers for the Nasolabial Fold Area: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

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