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International Journal of Environmental... Aug 2022The use of herbal products in oral cavity has shown an increased popularity and potential benefits due to their additional anti-inflammatory and antioxidant properties... (Review)
Review
BACKGROUND
The use of herbal products in oral cavity has shown an increased popularity and potential benefits due to their additional anti-inflammatory and antioxidant properties as well as the lack of side effects related to their use.
OBJECTIVE
To assess the clinical effectiveness of herbal dental products (mouthwash, dentifrice, gel) when compared to conventional products or placebo in periodontitis patients.
MATERIAL AND METHODS
A systematic review with 22 studies was carried out using MEDLINE/Pubmed, EMBASE and Web of Science databases in addition to hand searches. Randomized and non-randomized clinical trials that evaluated the effect of any herbal dental product and compared it with conventional products or placebo in periodontitis patients and published up to March 2022, were screened.
RESULTS
Herbal products used as adjuncts to scaling and root planing (SRP) or supragingival debridement (SPD) led to superior clinical outcomes than placebo or no adjuncts (8 studies). In conjunction with SRP, these products showed comparable outcomes with chlorhexidine (6 studies) or better (4 studies). When used as adjuncts to SPD, herbal oral care products demonstrated comparable outcomes with chlorhexidine and conventional products (4 studies).
CONCLUSIONS
Within the limitations of this systematic review, herbal oral care products may play a key role in the management of periodontal disease. Further well-designed studies are needed to establish their efficacy.
Topics: Chlorhexidine; Chronic Periodontitis; Humans; Periodontal Diseases; Periodontitis; Root Planing; Treatment Outcome
PubMed: 36011693
DOI: 10.3390/ijerph191610061 -
Annals of Internal Medicine Sep 2004Even with optimal pharmacotherapy, symptomatic heart failure is associated with substantial morbidity and mortality. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Even with optimal pharmacotherapy, symptomatic heart failure is associated with substantial morbidity and mortality.
PURPOSE
To determine the efficacy and safety of cardiac resynchronization therapy in adults with advanced systolic heart failure.
DATA SOURCES
The Cochrane Central Register of Controlled Trials (2002, volume 4), MEDLINE (1980-2003), EMBASE (1980-2003), other electronic databases, and U.S. Food and Drug Administration reports. We contacted primary study authors and device manufacturers, and we hand searched bibliographies of relevant papers and conference proceedings.
STUDY SELECTION
Randomized, controlled clinical trials for efficacy and controlled trials plus prospective cohort studies for safety.
DATA EXTRACTION
Two reviewers chose studies and extracted data independently; random-effects models were used for analyses.
DATA SYNTHESIS
Nine trials were included in the efficacy review (3216 patients). All trial participants had reduced ejection fraction and prolonged QRS duration, and 85% had New York Heart Association (NYHA) class III or IV symptoms. Cardiac resynchronization therapy improved ejection fraction (weighted mean difference, 0.035 [95% CI, 0.015 to 0.055]), quality of life (weighted mean reduction in score on the Minnesota Living with Heart Failure Questionnaire, 7.6 points [CI, 3.8 to 11.5 points]), and function (58% vs. 37% of patients improved by at least 1 NYHA class). Heart failure hospitalizations were reduced by 32% (relative risk [RR], 0.68 [CI, 0.41 to 1.12]), with benefits most marked in patients with NYHA class III or IV symptoms at baseline (RR, 0.65 [CI, 0.48 to 0.88]; number needed to treat for benefit [NNT(B)], 12). All-cause mortality was reduced by 21% (RR, 0.79 [CI, 0.66 to 0.96]; NNT(B), 24), driven largely by reductions in death from progressive heart failure (RR, 0.60 [CI, 0.36 to 1.01]). Eighteen studies (total of 3701 patients with cardiac resynchronization devices) were included in the safety review. Implant success rate was 90% (CI, 89% to 91%), and 0.4% of patients died during implantation (CI, 0.2% to 0.7%). Over a median 6-month follow-up, leads dislodged in 9% of patients (CI, 7% to 10%) and mechanical malfunctions occurred in 7% (CI, 5% to 8%).
LIMITATIONS
These trials enrolled only patients with heart failure with NYHA class III or IV symptoms despite medical therapy, a prolonged QRS duration, and reduced ejection fraction; in addition, experienced providers implanted the devices. Because all but one of these trials randomly assigned patients after device implantation, their results may overestimate the potential benefits of cardiac resynchronization. Finally, since few patients in these trials had bradyarrhythmias or atrial fibrillation, the role of cardiac resynchronization in such patients is uncertain.
CONCLUSIONS
In selected patients with heart failure, cardiac resynchronization therapy improves functional and hemodynamic status, reduces heart failure hospitalizations, and reduces all-cause mortality.
Topics: Cardiac Pacing, Artificial; Cause of Death; Heart Failure; Hospitalization; Humans; Quality of Life; Ventricular Fibrillation; Walking
PubMed: 15353430
DOI: 10.7326/0003-4819-141-5-200409070-00101 -
The Cochrane Database of Systematic... Aug 2020Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not associated with other systemic or ocular abnormalities. PCG results in considerable morbidity even in high-income countries.
OBJECTIVES
To compare the effectiveness and safety of different surgical techniques for PCG.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue 4); Ovid MEDLINE; Embase.com; PubMed; metaRegister of Controlled Trials (mRCT) (last searched 23 June 2014); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 27 April 2020.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs comparing different surgical interventions in children under five years of age with PCG.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We included 16 trials (13 RCTs and three quasi-RCTs) with 587 eyes in 446 children. Eleven (69%) trials were conducted in Egypt and the Middle East, three in India, and two in the USA. All included trials involved children younger than five years of age, with follow-up ranging from six to 80 months. The interventions compared varied across trials. Three trials (on 68 children) compared combined trabeculotomy and trabeculectomy (CTT) with trabeculotomy. Meta-analysis of these trials suggests there may be little to no evidence of a difference between groups in mean IOP (mean difference (MD) 0.27 mmHg, 95% confidence interval (CI) -0.74 to 1.29; 88 eyes; 2 studies) and surgical success (risk ratio (RR) 1.01, 95% CI 0.90 to 1.14; 102 eyes; 3 studies) at one year postoperatively. We assessed the certainty of evidence as very low for these outcomes, downgrading for risk of bias (-1) and imprecision (-2). Hyphema was the most common adverse outcome in both groups (no meta-analysis due to considerable heterogeneity; I = 83%). Two trials (on 39 children) compared viscotrabeculotomy to conventional trabeculotomy. Meta-analysis of 42 eyes suggests there is no evidence of between groups difference in mean IOP (MD -1.64, 95% CI -5.94 to 2.66) and surgical success (RR 1.11, 95% CI 0.70 to 1.78) at six months postoperatively. We assessed the certainty of evidence as very low, downgrading for risk of bias and imprecision due to small sample size. Hyphema was the most common adverse outcome (38% in viscotrabeculotomy and 28% in conventional trabeculotomy), with no evidence of difference difference (RR 1.33, 95% CI 0.63 to 2.83). Two trials (on 95 children) compared microcatheter-assisted 360-degree circumferential trabeculotomy to conventional trabeculotomy. Meta-analysis of two trials suggests that mean IOP may be lower in the microcatheter group at six months (MD -2.44, 95% CI -3.69 to -1.19; 100 eyes) and at 12 months (MD -1.77, 95% CI -2.92 to -0.63; 99 eyes); and surgical success was more likely to be achieved in the microcatheter group compared to the conventional trabeculotomy group (RR 1.59, 95% CI 1.14 to 2.21; 60 eyes; 1 trial at 6 months; RR 1.54, 95% CI 1.20 to 1.97; 99 eyes; 2 trials at 12 months). We assessed the certainty of evidence for these outcomes as moderate due to small sample size. Hyphema was the most common adverse outcome (40% in the microcatheter group and 17% in the conventional trabeculotomy group), with greater likelihood of occurring in the microcatheter group (RR 2.25, 95% CI 1.25 to 4.04); the evidence was of moderate certainty due to small sample size (-1). Of the nine remaining trials, no two trials compared the same two surgical interventions: one trial compared CTT versus CTT with sclerectomy; three trials compared various suturing techniques and adjuvant use including mitomycin C, collagen implant in CTT; one trial compared CTT versus Ahmed valve implant in previously failed surgeries; one trial compared CTT with trabeculectomy; one trial compared trabeculotomy to goniotomy; and two trials compared different types of goniotomy. No trials reported quality of life or economic data. Many of the included trials had limitations in study design, implementation, and reporting, therefore the reliability and applicability of the evidence remains unclear.
AUTHORS' CONCLUSIONS
The evidence suggests that there may be little to no evidence of difference between CTT and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. A 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy. Considering the rarity of the disease, future research would benefit from a multicenter, possibly international trial, involving parents of children with PCG and with a follow-up of at least one year.
Topics: Child, Preschool; Glaucoma; Glaucoma Drainage Implants; Humans; Hyphema; Infant; Infant, Newborn; Intraocular Pressure; Mitomycin; Postoperative Complications; Randomized Controlled Trials as Topic; Sclera; Trabecular Meshwork; Trabeculectomy; Treatment Outcome
PubMed: 32816311
DOI: 10.1002/14651858.CD008213.pub3 -
Clinical Cardiology Dec 2023Because of the advancement of bioabsorbable polymers and thinner struts, bioabsorbable-polymer sirolimus-eluting stents (BP-SES) with ultrathin struts may be related to... (Meta-Analysis)
Meta-Analysis Review
Long-term safety of ultrathin bioabsorbable-polymer sirolimus-eluting stents versus thin durable-polymer drug-eluting stents in acute coronary syndrome: A systematic review and meta-analysis.
BACKGROUND
Because of the advancement of bioabsorbable polymers and thinner struts, bioabsorbable-polymer sirolimus-eluting stents (BP-SES) with ultrathin struts may be related to superior performance when compared to durable-polymer drug-eluting stents (DP-DES) with thin struts. Nonetheless, the long-term safety of ultrathin BP-SES in acute coronary syndrome (ACS) remains unknown.
METHODS
We sought to assess the long-term safety of ultrathin BP-SES in ACS patients, conducting a thorough meta-analysis of all relevant trials drawing a comparison between ultrathin BP-SES and contemporary thin DP-DES. Target lesion failure (TLF), which includes cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR) was considered the primary endpoint. Multiple databases comprising Embase, MEDLINE, Cochrane Library, and Pubmed were all thoroughly searched.
RESULTS
There were seven randomized controlled trials included in our study with 7522 randomized patients with ACS (BP-SES = 3888, DP-DES = 3634). TLF occurred in 371 (9.5% in BP-SES) and 393 (10.8% in DP-DES) patients, respectively, across a 40.7-month weighted mean follow-up, with no statistically significant group differences (risk ratio [RR]: 0.87; 95% confidence interval [CI]: 0.73-1.04; p = .12). Furthermore, no significant differences in cardiac death (RR: 0.96; 95% CI: 0.68-1.35; p = .81), TV-MI (RR: 0.63; 95% CI: 0.36-1.10; p = .10) and CD-TLR (RR: 0.77; 95% CI: 0.46-1.29; p = .32) were detected between two groups.
CONCLUSION
During a follow-up of 40.7 months, ultrathin BP-SES and thin DP-DES had a comparable risk of TLF and its individual components (CD, TV-MI, and CD-TLR), indicating that ultrathin BP-SES held at least the same safety and efficiency as thin DP-DES presented in patients with ACS.
Topics: Humans; Sirolimus; Drug-Eluting Stents; Everolimus; Acute Coronary Syndrome; Polymers; Coronary Artery Disease; Absorbable Implants; Treatment Outcome; Myocardial Infarction; Stents; Death; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic
PubMed: 37661458
DOI: 10.1002/clc.24139 -
Contraception Sep 2016Postpartum women need effective contraception. Concerns have been raised that use of progestogen-only contraceptives (POCs) may affect breastfeeding performance and... (Review)
Review
BACKGROUND
Postpartum women need effective contraception. Concerns have been raised that use of progestogen-only contraceptives (POCs) may affect breastfeeding performance and infant health outcomes.
OBJECTIVES
We investigated the clinical outcomes of breastfeeding duration, initiation of supplemental feeding and weaning, as well as infant outcomes including infant growth, health and development among breastfeeding women using POCs compared with breastfeeding women not using POCs.
SEARCH STRATEGY
We searched the PubMed database for all articles published from database inception through December 2014.
SELECTION CRITERIA
We included primary research studies of breastfeeding women of any age or parity who received POCs, including progestogen-only pills, injectables, implants or hormonal intrauterine devices (IUDs). The main outcomes were breastfeeding performance (as measured by initiation, continuation, frequency and exclusivity of breastfeeding) and infant health (as measured by growth, development or adverse health effects).
RESULTS
Forty-nine articles reporting on 47 different studies were identified that investigated the use of POCs in breastfeeding women and reported clinically relevant outcomes of infant growth, health or breastfeeding performance. Studies ranged from poor to fair methodological quality and generally failed to show negative effects of the use of POCs on breastfeeding outcomes or on infant growth or development. One randomized controlled trial (RCT) raises concerns that immediate insertion of the levonorgestrel IUD postpartum may be associated with poorer breastfeeding performance when compared with delayed insertion, although two other RCTs evaluating early etonogestrel implants compared with delayed initiation of implants or depot medroxyprogesterone acetate failed to find such an association.
CONCLUSION
The preponderance of evidence fails to demonstrate adverse breastfeeding outcomes or negative health outcomes in infants such as restricted growth, health problems or impaired development. Evidence newly added to this review was largely consistent with previous evidence.
Topics: Breast Feeding; Child Development; Contraception; Contraceptives, Oral, Hormonal; Drug Implants; Female; Humans; Infant; Intrauterine Devices; Levonorgestrel; Medroxyprogesterone Acetate; Progestins; Randomized Controlled Trials as Topic
PubMed: 26410174
DOI: 10.1016/j.contraception.2015.09.010 -
JACC. Cardiovascular Interventions Jan 2017This study sought to compare the 2-year outcomes between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic drug-eluting stent (EES). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This study sought to compare the 2-year outcomes between bioresorbable vascular scaffold (BVS) and everolimus-eluting metallic drug-eluting stent (EES).
BACKGROUND
The occurrence of very late stent/scaffold thrombosis (VLST) of BVS beyond 1 year after implantation is an increasing concern.
METHODS
We conducted a meta-analysis of 24 studies (BVS: n = 2,567 and EES: n = 19,806) reporting the 2-year outcomes of BVS and/or EES to compare the risk of BVS versus EES for stent/scaffold thrombosis (ST) and target lesion failure (TLF) in 7 comparative studies (3 randomized and 4 observational), and to estimate the pooled incidence rates of ST and TLF including additional 17 single-arm studies.
RESULTS
In the 7 comparative studies, the risk for VLST between 1 and 2 years was numerically higher in BVS than in EES (odds ratio [OR]: 2.03 [95% confidence interval (CI): 0.62 to 6.71]). The excess risk of BVS relative to EES for ST through 2 years was significant (OR: 2.08 [95% CI: 1.02 to 4.26]). The risk for TLF was neutral between BVS and EES. In the 24 studies, the pooled estimated incidence rates of VLST, and ST through 2 years were higher in BVS than in EES (0.240 [95% CI: 0.022 to 0.608]% vs. 0.003 [95% CI: 0.000 to 0.028]%, and 1.43 [95% CI: 0.67 to 2.41]% vs. 0.56 [95% CI: 0.43 to 0.70]%, respectively). The corresponding rates for TLF were comparable between BVS and EES (1.88 [95% CI: 1.30 to 2.55]% and 1.78 [95% CI: 1.17 to 2.49]% and 7.90 [95% CI: 6.26 to 9.69]% and 7.49 [95% CI: 5.86 to 9.29]%, respectively).
CONCLUSIONS
In this meta-analysis, BVS as compared with EES was associated with higher risk for VLST between 1 and 2 years and ST through 2 years.
Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Odds Ratio; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 28057284
DOI: 10.1016/j.jcin.2016.10.027 -
Nutrients Jan 2020Several factors affect dental implant osseointegration, including surgical issues, bone quality and quantity, and host-related factors, such as patients' nutritional...
Several factors affect dental implant osseointegration, including surgical issues, bone quality and quantity, and host-related factors, such as patients' nutritional status. Many micronutrients might play a key role in dental implant osseointegration by influencing some alveolar bone parameters, such as healing of the alveolus after tooth extraction. This scoping review aims to summarize the role of dietary supplements in optimizing osseointegration after implant insertion surgery. A technical expert panel (TEP) of 11 medical specialists with expertise in oral surgery, bone metabolism, nutrition, and orthopedic surgery performed the review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) model. The TEP identified micronutrients from the "European Union (EU) Register of nutrition and health claims made on foods" that have a relationship with bone and tooth health, and planned a PubMed search, selecting micronutrients previously identified as MeSH (Medical Subject Headings) terms and adding to each of them the words "dental implants" and "osseointegration". The TEP identified 19 studies concerning vitamin D, magnesium, resveratrol, vitamin C, a mixture of calcium, magnesium, zinc, and vitamin D, and synthetic bone mineral. However, several micronutrients are non-authorized by the "EU Register on nutrition and health claims" for improving bone and/or tooth health. Our scoping review suggests a limited role of nutraceuticals in promoting osseointegration of dental implants, although, in some cases, such as for vitamin D deficiency, there is a clear link among their deficit, reduced osseointegration, and early implant failure, thus requiring an adequate supplementation.
Topics: Animals; Bone-Anchored Prosthesis; Dental Implantation, Endosseous; Dental Implants; Dietary Supplements; Humans; Nutritional Status; Osseointegration; Prosthesis Design; Treatment Outcome
PubMed: 31968626
DOI: 10.3390/nu12010268 -
European Journal of Preventive... Jul 2018Aims The association between progestin-only contraceptive (POC) use and the risk of various cardiometabolic outcomes has rarely been studied. We performed a systematic... (Meta-Analysis)
Meta-Analysis
Aims The association between progestin-only contraceptive (POC) use and the risk of various cardiometabolic outcomes has rarely been studied. We performed a systematic review and meta-analysis to determine the impact of POC use on cardiometabolic outcomes including venous thromboembolism, myocardial infarction, stroke, hypertension and diabetes. Methods and results Nineteen observational studies (seven cohort and 12 case-control) were included in this systematic review. Of those, nine studies reported the risk of venous thromboembolism, six reported the risk of myocardial infarction, six reported the risk of stroke, three reported the risk of hypertension and two studies reported the risk of developing diabetes with POC use. The pooled adjusted relative risks (RRs) for venous thromboembolism, myocardial infarction and stroke for oral POC users versus non-users based on the random effects model were 1.06 (95% confidence interval (CI) 0.70-1.62), 0.98 (95% CI 0.66-1.47) and 1.02 (95% CI 0.72-1.44), respectively. Stratified analysis by route of administration showed that injectable POC with a RR of 2.62 (95% CI 1.74-3.94), but not oral POCs (RR 1.06, 95% CI 0.7-1.62), was associated with an increased risk of venous thromboembolism. A decreased risk of venous thromboembolism in a subgroup of women using an intrauterine levonorgestrel device was observed with a RR of 0.53 (95% CI 0.32-0.89). No effect of POC use on blood pressure was found, but there was an indication for an increased risk of diabetes with injectable POCs, albeit non-significant. Conclusions This systematic review and meta-analysis suggests that oral POC use is not associated with an increased risk of developing various cardiometabolic outcomes, whereas injectable POC use might increase the risk of venous thromboembolism.
Topics: Administration, Oral; Adolescent; Adult; Aged; Cardiovascular Diseases; Contraceptives, Oral, Hormonal; Diabetes Mellitus; Drug Implants; Female; Humans; Injections; Middle Aged; Progestins; Risk Assessment; Risk Factors; Venous Thromboembolism; Young Adult
PubMed: 29745237
DOI: 10.1177/2047487318774847 -
Graefe's Archive For Clinical and... Feb 2023Neovascular glaucoma (NVG) is characterised by neovascularisation of the angle and therefore elevated intraocular pressure (IOP). This results in progressive optic... (Meta-Analysis)
Meta-Analysis
PURPOSE
Neovascular glaucoma (NVG) is characterised by neovascularisation of the angle and therefore elevated intraocular pressure (IOP). This results in progressive optic neuropathy and loss of visual acuity. Treatment aims to reduce IOP in order to prevent optic nerve damage. A systematic review was completed synthesising results from randomised control trials (RCTs) comparing interventions for the management of NVG and their efficacy and safety.
METHODS
Data was sourced from Web of Science, Embase and Medline after 1st January 2000. The primary outcome measures were mean IOP at follow-up and success rate. The secondary outcomes included mean IOP lowering medications and total complications. A meta-analysis was completed on comparative studies using Revman (version 5.4).
RESULTS
For the two studies comparing Ahmed glaucoma valve (AGV) + pan-retinal photocoagulation (PRP) vs AGV + PRP + intra-vitreal bevacizumab (IVB), there was no difference in mean IOP or odds of success from the meta-analysis. From the 4 studies examining the utilisation of anti-vascular endothelial growth factor (anti-VEGF), one study showed lower mean IOP at 1 (p = 0.002) and 3 months (p = 0.033) for IVB vs sham injection. In the 2 studies studying transcleral diode laser (TDL), there were no significant findings. From the 4 studies looking at trabeculectomy (trab), lower mean IOP at 6 (p = 0.001), 9 (p = 0.01), 12 (p = 0.02) and 18 months (p = 0.004) was shown for intra-vitreal ranibizumab (IVR) + PRP + visco-trabeculectomy vs IVR + PRP + trab, and a significantly lower mean IOP was present in the Baerveldt group vs trab at 6 months (p = 0.03). In the 2 studies investigating the AGV, there was a lower mean IOP at 1 month (p = 0.01) in the AGV + triamcinolone (TCA) group. The risk of bias was low for 4 studies, high for 4 studies and 6 studies had some concerns.
CONCLUSION
This is the first meta-analysis of RCTs in the management of neovascular glaucoma. The lack of high-quality evidence contributes to the lack of consensus in managing NVG. Our results highlight modern treatment strategies and the need for better powered RCTs with long-term follow-up in order to establish optimal treatment modalities and true patient outcomes.
Topics: Humans; Glaucoma, Neovascular; Intraocular Pressure; Consensus; Glaucoma; Ranibizumab; Bevacizumab; Glaucoma Drainage Implants; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 35939118
DOI: 10.1007/s00417-022-05785-5 -
BMJ (Clinical Research Ed.) Nov 2011To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants. (Comparative Study)
Comparative Study Review
OBJECTIVE
To determine comparative safety and effectiveness of combinations of bearing surfaces of hip implants.
DESIGN
Systematic review of clinical trials, observational studies, and registries.
DATA SOURCES
Medline, Embase, Cochrane Controlled Trials Register, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the United States Food and Drug Administration.
STUDY SELECTION
Criteria for inclusion were comparative studies in adults reporting information for various combinations of bearings (such as metal on metal and ceramic on ceramic). Data search, abstraction, and analyses were independently performed and confirmed by at least two authors. Qualitative data syntheses were performed.
RESULTS
There were 3139 patients and 3404 hips enrolled in 18 comparative studies and over 830 000 operations in national registries. The mean age range in the trials was 42-71, and 26-88% were women. Disease specific functional outcomes and general quality of life scores were no different or they favoured patients receiving metal on polyethylene rather than metal on metal in the trials. While one clinical study reported fewer dislocations associated with metal on metal implants, in the three largest national registries there was evidence of higher rates of implant revision associated with metal on metal implants compared with metal on polyethylene. One trial reported fewer revisions with ceramic on ceramic compared with metal on polyethylene implants, but data from national registries did not support this finding.
CONCLUSIONS
There is limited evidence regarding comparative effectiveness of various hip implant bearings. Results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.
Topics: Ceramics; Chromium Alloys; Female; Hip Prosthesis; Humans; Joint Diseases; Male; Polyethylene; Prosthesis Design; Recovery of Function; Reoperation; Safety; Treatment Outcome
PubMed: 22127517
DOI: 10.1136/bmj.d7434