Although an estimated 40-54% of postmenopausal women report vulvovaginal symptoms, more than half of symptomatic women do not use any medications for their symptoms. There have been few studies on the efficacy of recommended treatments. In this randomized controlled trial, 302 postmenopausal women with moderate-to-severe vulvovaginal symptoms were randomized to receive a vaginal 10-µcg estradiol tablet plus placebo gel, vaginal moisturizer plus placebo tablet, or dual placebo in order to study the effects of vaginal estradiol tablets and vaginal moisturizer on the treatment of vulvovaginal symptoms. The primary outcome was the severity of the most bothersome symptom (MBS) as defined by the participant at time of enrollment. The most commonly reported MBS was pain with vaginal penetration (60%) followed by vulvovaginal dryness (21%). Researchers found that neither treatment reduced MBS severity at 4 or 12 weeks of follow-up when compared to placebo. A decrease of 2 points in MBS is considered a clinically meaningful change, and all groups had a mean of 1.2 to 1.4 point reduction from baseline MBS score by 12 weeks. There was no difference between the groups in the proportion of women with a decrease of at least 2 points in MBS severity (estradiol 49%, placebo tablet 45%, p=0.61; moisturizer 35%; placebo gel 47%, p=0.16). In terms of secondary outcomes, the change in the Female Sexual Function Index (FSFI) score did not differ significantly between the groups, and mean treatment satisfaction was similar between groups. Overall, results suggest that although vaginal estrogen therapy and vaginal moisturizers are currently recommended for the treatment of vulvovaginal symptoms, these treatments are no more effective than placebo. This study is limited in that it enrolled a relatively homogenous population of women, impacting its generalizability.
Bronchiolitis is the most common reason for non-selective hospital admission in infants. However, there are few interventions for this condition. High-flow oxygen therapy through a nasal cannula has been proposed as a new method to provide respiratory support for infants. In this randomized controlled trial, 1638 infants with bronchiolitis were randomized to receive either heated and humidified high-flow oxygen (2 L/kg/min) or standard therapy with supplemental oxygen in order to study the effect on treatment failure requiring escalation of care. Based on the data obtained on 1472 participants, treatment failure with escalation of care occurred in 12% of the high-flow group in comparison to 23% in the standard-therapy group (risk difference -11%, 95% CI -15% to -7%, p<0.001). The effect of high-flow oxygen differed significantly between hospitals with an on-site ICU and those without one (p<0.001). In hospitals without an on-site ICU, treatment failure and escalation of care occurred in 7% of the high-flow group and 28% in the standard therapy group (risk difference -21%, 95% CI -27% to -14%). In hospitals with an on-site ICU, the difference was smaller as 14% of the high-flow group and 20% of the standard-therapy group required escalation of care (risk difference -6%, 95% CI -11% to -1%). There were no significant differences between the groups for duration of hospital stay, duration of ICU stay, or duration of oxygen therapy. Taken together, results suggest that high-flow oxygen can reduce the need for escalation of care in infants. This trial was limited in that it was difficult to blind due to the oxygen-delivery methods used, although prespecified clinical criteria was used for escalation of care in order to minimize bias.
Testing for human immunodeficiency virus (HIV) in patients’ homes rather than clinics has been a strategy used to increase diagnosis and treatment of individuals affected by HIV. However, less than half of patients who are found to be HIV positive through home-based testing are linked to care to receive antiretroviral therapy (ART). Same-day ART initiation as a test-and-treat approach has been put forth as a recommendation by the World Health Organization (WHO), but evidence on this approach has been limited. In this randomized controlled trial, 278 adults in rural Lesotho were offered home-based HIV testing and randomized to either immediate ART initiation or usual care with standard clinic referral in order to study the effect on the co-primary end points of 3-month linkage to care and 12-month viral suppression. Researchers found that linkage to care within 90 days after enrollment was 68.6% in the same-day ART group and 43.1% in the usual care group (absolute difference 25.6%, 95% CI 13.8% to 36.3%, p<0.001). For viral suppression, 42.3% of participants in the same-day ART group achieved viral suppression at 11-14 months after enrollment in comparison to 34.3% of the usual care group (absolute difference 16%, 95% CI 4.4% to 27.2%, p=0.007). Taken together, results from this study support the WHO recommendation of same-day initiation of ART. It is important to note, however, that this study was limited in that it only enrolled individuals consenting to home-based HIV testing and was therefore unable to study whether participants in the same-day group who did not subsequently link to care developed any resistance to therapy.
There is growing concern that survivors of preterm birth are at an increased risk of developing premature chronic obstructive pulmonary disease (COPD). In this cohort study, investigators followed 126 very preterm children with bronchopulmonary dysplasia, 74 very preterm children without bronchopulmonary dysplasia, and 67 healthy term control children between age 4 and 12 years in order to study the effect of very preterm birth on lung function. Results for spirometry showed that in very preterm children with bronchopulmonary dysplasia, forced expiratory volume in 1 second (FEV1), forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75), and FEV1/forced vital capacity (FVC) all declined by at least -0.1 z-score per year in comparison to controls (all p<0.001). Very preterm children without bronchopulmonary dysplasia also had declining z-scores per year for FEV1/FVC (β=-0.07, 95% CI -0.11 to -0.03, p<0.001) and FEF25-75 (β=-0.06, 95% CI -0.10 to -0.02, p=0.002). In their analysis, investigators found that each additional week of gestation was associated with an improvement in FEV1 trajectory between early and mid-childhood by 0.1 z-score (β=0.10, 95% CI 0.04 to 0.15, p=0.001). Preterm children showed decreasing trajectories for respiratory system reactance 8 Hz over time with a decrease of -0.05 z-scores per year (95% CI -0.08 to -0.01, p=0.006 and increased area under the reactance curve by 0.04 (95% CI 0.01 to 0.07, p=0.023) z-scores per year). A decline of-0.03 z-score per year was observed in the preterm group (95% CI -0.06 to -0.01, p=0.048) in the diffusing capacity of the lungs for carbon monoxide (DLCO). Chest computed tomography (CT) was done on 133 preterm children at a mean age of 10.9 (SD 0.6) years, and analysis showed that bronchial wall thickening on chest CT was associated with an FEV1 z-score decline of -0.61 (95% CI -1.03 to -0.19, p=0.005) in comparison to lungs without thickening. Overall, results indicate that survivors of very preterm birth are more likely to have long-term lung health issues, especially children with bronchopulmonary dysplasia. Bronchial wall thickening is also associated with a steeper decrease in lung function trajectory. This study, however, is limited in that it could not collect reliable data of other predictors of lung function decline such as the number and severity of early-life respiratory infections. Further studies on the natural history of lung disease following preterm birth are needed.
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