ABSTRACT
OBJECTIVE: To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus. METHODS: We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus). RESULTS: From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76). CONCLUSION: Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03665584. FUNDING SOURCE: Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.
Subject(s)
Lasers, Gas/therapeutic use , Vulvar Lichen Sclerosus/pathology , Vulvar Lichen Sclerosus/surgery , Aged , Biopsy , Double-Blind Method , Female , Humans , Intention to Treat Analysis , Lasers, Gas/adverse effects , Middle Aged , Prospective Studies , Severity of Illness Index , Treatment Outcome , Vulva/pathologyABSTRACT
AIMS: This study aims to test the association between the place-provider-matrix (PPM) of bystander cardiopulmonary resuscitation (CPR) and outcomes of out-of-hospital cardiac arrest (OHCA). METHODS: Adult patients with OHCA with a cardiac etiology from 2012 to 2017 in Korea were analyzed, excluding patients who had unknown information on place, type of bystander, or outcome. The PPM was categorized into six groups by two types of places (public versus home) and three types of providers (trained responder (TR), family bystander, and layperson bystander). Outcomes were survival to discharge and good cerebral performance category (CPC) of 1 or 2. Multivariable logistic regression analysis was performed to test the association between PPM group and outcomes with adjustment for potential confounders to calculate adjusted odds ratios (AORs) and 95% confidence intervals (CIs) (reference = Public-TR). RESULTS: A total of 73,057 patients were analyzed and were categorized into Public-TR (0.6%), Home-TR (0.3%), Public-Family (1.8%), Home-Family (79.8%), Public-Layperson (9.9%), and Home-Layperson (7.6%) groups. Compared with the Public-TR group, the AORs (95% CIs) for survival to discharge were 0.61 (0.35-1.05) in the Home-TR group, 0.85 (0.62-1.17) in the Public-Family group, 0.38 (0.29-0.50) in the Home-Family group, 1.12 (0.85-1.49) in the Public-Layperson group, and 0.42 (0.31-0.57) in the Home-Layperson group. The AORs (95% CIs) for good CPC were 0.58 (0.27-1.25) in the Home-TR group, 0.88 (0.61-1.27) in the Public-Family group, 0.38 (0.28-0.52) in the Home-Family group, 1.20 (0.87-1.65) in the Public-Layperson group, and 0.42 (0.30-0.59) in the Home-Layperson group. CONCLUSION: The OHCA outcomes of the Home-Family and Home-Layperson groups were worse than those of the Public-TR group. This finding suggests that OHCA occurring in private places with family or layperson bystanders requires a new strategy, such as dispatching trained responders to the scene to improve CPR outcomes.
