Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque.

BACKGROUND: Standard recommendations for oral hygiene practices have focused on mechanical methods (toothbrushing and interdental cleaning). Published evidence indicates antimicrobial mouthrinses provide oral health benefits beyond mechanical methods alone. The purpose of this meta-analysis was to evaluate the combined effectiveness of mechanical methods with essential oil-containing mouthrinses (MMEO) versus mechanical methods (MM) alone in achieving site-specific, healthy gingival tissue and reducing plaque and gingivitis. TYPES OF STUDIES REVIEWED: All industry-sponsored clinical trials investigating the antigingivitis and antiplaque effects of essential oil (EO)-containing mouthrinses conducted from 1980 to 2012 were reviewed; 29 of 32 studies met the inclusion criteria of 6 months or longer duration, randomized, observer-masked, placebo-controlled, and with individual-level site-specific data. By-study treatment effects were estimated through generalized linear models for binary data and analysis of covariance for continuous data, and then combined using standard meta-analysis techniques; heterogeneity was also assessed. RESULTS: Summary odds ratios for a healthy gingival site and for a plaque-free site were, respectively, 5.0 (95% confidence interval [CI], 3.3-7.5) and 7.8 (95% CI, 5.4-11.2) for MMEO participants versus MM participants at 6 months. The summary percentage reductions in whole-mouth mean gingivitis and plaque at 6 months were 16.0 (95% CI, 11.3-20.7) and 27.7 (95% CI, 22.4-32.9), respectively. Responder analyses using aggregate individual-level data showed 44.8% of MMEO participants and 14.4% of MM participants achieved at least 50% healthy sites in their mouths at 6 months. Similarly, 36.9% of MMEO participants and 5.5% of MM participants achieved at least 50% plaque-free sites in their mouths at 6 months. CONCLUSIONS AND PRACTICAL IMPLICATIONS: This is the first meta-analysis to demonstrate the clinically significant, site-specific benefit of adjunctive EO treatment in people within a 6-month period (that is, between dental visits).

Benefit-risk assessment of rivaroxaban versus enoxaparin for the prevention of venous thromboembolism after total hip or knee arthroplasty.

PURPOSE: Venous thromboembolism is a common complication after major orthopedic surgery. When prescribing anticoagulant prophylaxis, clinicians weigh the benefits of thromboprophylaxis against bleeding risk and other adverse events. Previous benefit-risk analyses of the REgulation of Coagulation in ORthopaedic surgery to prevent Deep vein thrombosis and pulmonary embolism (RECORD) randomized clinical studies of rivaroxaban versus enoxaparin after total hip (THA) or knee (TKA) arthroplasty generally used pooled THA and TKA results, counted fatal bleeding as both an efficacy and a safety event, and included the active and placebo-controlled portions of RECORD2, which might confound benefit-risk assessments. We conducted a post hoc analysis without these constraints to assess benefit-risk for rivaroxaban versus enoxaparin in the RECORD studies. PATIENTS AND METHODS: Data from the safety population of the two THA and two TKA studies were pooled separately. The primary analysis compared the temporal course of event rates and rate differences between rivaroxaban and enoxaparin prophylaxis for symptomatic venous thromboembolism plus all-cause mortality (efficacy events) versus nonfatal major bleeding (safety events). Additionally, these rates were used to derive measures of net clinical benefit, number needed to treat (NNT), and number needed to harm (NNH) for these two end points. RESULTS: After THA or TKA, and compared with enoxaparin, rivaroxaban therapy resulted in more efficacy events prevented than safety events caused, with benefits exceeding harms early and throughout treatment and follow-up. Relative to enoxaparin, rivaroxaban treatment prevented six efficacy events per harm event caused for THA, with NNT =262/NNH =1,711. For TKA, rivaroxaban treatment prevented four to five efficacy events per harm event caused, with NNT =102/NNH =442. Sensitivity analysis that included surgical-site bleeding resulted in NNH =345 for THA and NNH =208 for TKA. CONCLUSION: In the RECORD studies, considering death, symptomatic venous thromboembolism, and major bleeding, rivaroxaban resulted in greater benefits than harms compared with enoxaparin. When incorporating surgical-site bleeding, rivaroxaban also results in greater benefit than harm for TKA and is balanced with enoxaparin for THA.

Effects of L-carnitine on dialysis-related hypotension and muscle cramps: a meta-analysis.

BACKGROUND: L-Carnitine is an endogenous compound thought to be helpful in treating patients with dialysis-related hypotension and muscle cramps; however, sufficient evidence for these indications is lacking. STUDY DESIGN: Systematic review and meta-analysis. SETTING & POPULATION: Adult patients with end-stage renal disease receiving long-term hemodialysis. SELECTION CRITERIA FOR STUDIES: All published English-language reports of randomized placebo-controlled trials of L-carnitine supplementation in adult long-term hemodialysis patients. INTERVENTION: Supplemental L-carnitine (or placebo) for at least 8 weeks. OUTCOME: Random-effects pooled odds ratio for intradialytic cramping or hypotension in L-carnitine-treated participants. RESULTS: Of 317 potentially relevant articles, 7 (total enrollment of 193 patients) met criteria for inclusion. Four articles reported results for both hypotension and cramps, 1 had results for only hypotension, and 2 reported results for only cramps. Using data from all 6 relevant trials, the pooled odds ratio for cramping after L-carnitine supplementation was 0.30 (95% confidence interval, 0.09 to 1.00; P = 0.05). Analysis of the 5 studies examining the response of intradialytic hypotension to l-carnitine supplementation yielded a pooled odds ratio of 0.28 (95% confidence interval, 0.04 to 2.23; P = 0.2). LIMITATIONS: The small number of available studies yielded limited statistical power. In addition, there was considerable interstudy heterogeneity. CONCLUSIONS: Although suggestive in the case of muscle cramping, the available evidence does not confirm a beneficial effect of L-carnitine supplementation on dialysis-related muscle cramping or intradialytic hypotension. Additional study in the form of large rigorous randomized trials is needed in both cases.

Choice of exposure scores for categorical regression in meta-analysis: a case study of a common problem.

OBJECTIVE: Reporting categorical relative risk estimates for a series of exposure levels versus a common reference category is a widespread practice. In meta-analysis, categorical regression estimates a dose-response trend from such results. This method requires the assignment of a single score to each exposure category. We examined how closely meta-analytical categorical regression approximates the results of analysis based on the individual-level continuous exposure. METHODS: The analysis included five studies on tea intake and outcomes related to colorectal cancer. In addition, we derived categorical mean and median values from published distributions of tea consumption in similar populations to assign scores to the categories of tea intake when possible. We examined whether these derived mean and median values well approximate the individual-level results. RESULTS: In meta-analytical categorical regression, using the midrange scores approximated the individual-level continuous analyses reasonably well, if the value assigned to the uppermost, open-ended category was at least as high as the lower bound plus the width of the second-highest category. Categorical mean values derived from the published distributions of regular tea (in the US) and green tea (in Japan) well approximated the slope obtained from individual-level analysis. CONCLUSION: Publication of both the categorical and the continuous estimates of effect in primary studies, with their standard errors, can enhance the quality of meta-analysis, as well as providing intrinsically valuable information on dose-response.

Factors affecting decisions to seek treatment for sick children in Kerala, India.

The purpose of this study was to measure the effects of social and economic variables, disease-related variables, and child gender on the decisions of parents in Kerala, India, to seek care for their children and on their choice of providers in the allopathic vs. the alternative system. A case-control analysis was done using data from the Kerala section of the 1996 Indian National Family Health Survey, a cross-sectional survey of a probability sample of households conducted by trained interviewers with a close-ended questionnaire. Of the 469 children who were eligible for this study because they had at least one common symptom suggestive of acute respiratory illness or diarrhea during the 2 weeks before the interview, 78 (17%) did not receive medical care, while the remaining 391 (83%) received medical care. Of the 391 children who received medical care, 342 (88%) received allopathic medical care, and 48 (12%) received alternative medical care. In multivariable analyses, parents chose not to seek medical care for their children significantly more often when the illness was mild, the child had a specific diagnosis, the mother had previously made fewer antenatal visits, and the family had a higher economic status. When parents sought medical care for their children, care was sought significantly more often in the alternative provider system when the child was a boy, the family lived in a rural area, and the family had a lower social class. We conclude that, in Kerala, disease severity and economic status predict whether children with acute respiratory infection or diarrhea are taken to medical providers. In contrast, most studies of this issue carried out in other populations have identified economic status as the primary predictor of medical system utilization. Also in Kerala, the gender of the child did not influence whether or not the child was taken for treatment but did influence whether care was sought in the alternative or the allopathic system.