Adult

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Author/s: 
Cohen, C.R., Wierzbicki, C.R., French, A.L., Morris, S., Newmann, S., Reno, H., Green, L., Miller, S., Powell, J., Parks, T., Hemmerling, S.

Abstract

Background: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.

Methods: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of Lactobacillus crispatus CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.

Results: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, L. crispatus CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.

Conclusions: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).

Copyright © 2020 Massachusetts Medical Society.

N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial

Author/s: 
Radonovich, LJ Jr, Simberkoff, MS, Bessesen, MT, Brown, AC, Cummings, DAT, Gaydos, CA, Los, JG, Krosche, AE, Gibert, CL, Gorse, GJ, Nyquist, AC, Reich, N.G., Rodriguez-Barradas, MC, Price, CS, Perl, TM, ResPECT investigators

IMPORTANCE:

Clinical studies have been inconclusive about the effectiveness of N95 respirators and medical masks in preventing health care personnel (HCP) from acquiring workplace viral respiratory infections.

OBJECTIVE:

To compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP.

DESIGN, SETTING, AND PARTICIPANTS:

A cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 US medical centers between September 2011 and May 2015, with final follow-up in June 2016. Each year for 4 years, during the 12-week period of peak viral respiratory illness, pairs of outpatient sites (clusters) within each center were matched and randomly assigned to the N95 respirator or medical mask groups.

INTERVENTIONS:

Overall, 1993 participants in 189 clusters were randomly assigned to wear N95 respirators (2512 HCP-seasons of observation) and 2058 in 191 clusters were randomly assigned to wear medical masks (2668 HCP-seasons) when near patients with respiratory illness.

MAIN OUTCOMES AND MEASURES:

The primary outcome was the incidence of laboratory-confirmed influenza. Secondary outcomes included incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenzalike illness. Adherence to interventions was assessed.

RESULTS:

Among 2862 randomized participants (mean [SD] age, 43 [11.5] years; 2369 [82.8%]) women), 2371 completed the study and accounted for 5180 HCP-seasons. There were 207 laboratory-confirmed influenza infection events (8.2% of HCP-seasons) in the N95 respirator group and 193 (7.2% of HCP-seasons) in the medical mask group (difference, 1.0%, [95% CI, -0.5% to 2.5%]; P = .18) (adjusted odds ratio [OR], 1.18 [95% CI, 0.95-1.45]). There were 1556 acute respiratory illness events in the respirator group vs 1711 in the mask group (difference, -21.9 per 1000 HCP-seasons [95% CI, -48.2 to 4.4]; P = .10); 679 laboratory-detected respiratory infections in the respirator group vs 745 in the mask group (difference, -8.9 per 1000 HCP-seasons, [95% CI, -33.3 to 15.4]; P = .47); 371 laboratory-confirmed respiratory illness events in the respirator group vs 417 in the mask group (difference, -8.6 per 1000 HCP-seasons [95% CI, -28.2 to 10.9]; P = .39); and 128 influenzalike illness events in the respirator group vs 166 in the mask group (difference, -11.3 per 1000 HCP-seasons [95% CI, -23.8 to 1.3]; P = .08). In the respirator group, 89.4% of participants reported "always" or "sometimes" wearing their assigned devices vs 90.2% in the mask group.

CONCLUSIONS AND RELEVANCE:

Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT01249625.

Tinnitus

Author/s: 
Piccirillo, JF, Rodebaugh, TL, Lenze, EJ

Tinnitus is an auditory perception in the absence of an auditory stimulus. It may be associated with acoustic trauma (eg, exposure to loud noise), chronic hearing loss, emotional stressors, or spontaneous occurrence. The psychopathological reaction to the perceived auditory stimulus is an enormous source of distress and disability for many patients with tinnitus. National health surveys estimate that nearly 10 in 100 adults experience some form of tinnitus. Among workers exposed to occupational noise, the prevalence of tinnitus is 15 per 100. Of these, tinnitus is burdensome and chronic for roughly 20 million and extreme and debilitating tinnitus for 2 million US residents. Many patients with tinnitus report that the auditory perception impairs sleep, concentration, and cognitive function required for day-to-day functioning. Among the nearly 4.5 million US military veterans receiving service-connected compensation, 42% receive compensation for tinnitus, which makes it the most prevalent service-connected disability. The number of veterans who receive compensation due to tinnitus is nearly 60% greater than the number of veterans who receive compensation for hearing loss, which is the condition with the second most disability claims.

Screening for Alcohol Use and Brief Counseling of Adults — 13 States and the District of Columbia, 2017

Author/s: 
McKnight-Eily, LR, Okoro, CA, Turay, K, Acero, C, Hungerford, D

What is already known about this topic?

Binge drinking increases the risk for adverse health conditions and death. Alcohol screening and brief intervention (SBI), recommended by the U.S. Preventive Services Task Force (USPSTF) for all adults in primary care, is effective in reducing binge drinking.

What is added by this report?

In 2017, 81% of survey respondents were asked by their health care provider about alcohol consumption and 38% about binge drinking at a checkup in the past 2 years. Among those asked about alcohol use and who reported current binge drinking, 80% received no advice to reduce their drinking.

What are the implications for public health practice?

Implementation of alcohol SBI as recommended by USPSTF, coupled with population-level evidence-based interventions, can reduce binge drinking among U.S. adults.

Vaccination of Adults in General Medical Practice

Author/s: 
Hunter, P., Fryhofer, S.A., Szilagyi, P.

In vaccinating adults, clinicians face 2 types of challenges: (1) staying current on recommendations for influenza, pneumococcal, hepatitis A and B, zoster, and other vaccines and (2) addressing systemic barriers to implementing practices that increase vaccination rates. Although adult immunization rates remain suboptimal, there has been much good news in adult vaccination recently. New high-dose and adjuvanted influenza vaccines help improve immune response and may reduce influenza complications in older adults. The new recombinant zoster vaccine offers significantly more efficacy against zoster outbreaks and postherpetic neuralgia than zoster vaccine live. Pertussis vaccine given during the third trimester of pregnancy may prevent between 50% and 90% of pertussis infections in infants. Shorter time for completion (1 vs 6 months) of new, adjuvanted hepatitis B vaccine may increase adherence. Clinicians can address systemic barriers to increasing vaccination rates in their clinics and health care systems by following the Centers for Disease Control and Prevention's Standards for Adult Immunization Practice. Clinicians can help increase vaccination rates by writing standing orders and by advocating for nurses or medical assistants to receive training and protected time for assessing and documenting vaccination histories and administration. Strong recommendations that presume acceptance of vaccination are effective with most patients. Communication techniques similar to motivational interviewing can help with vaccine-hesitant patients. Clinicians, as experts on providing preventive services, can educate community leaders about the benefits of immunization and can inform vaccine experts about challenges of implementing vaccination recommendations in clinical practice and strategies that can work to raise vaccination rates. 

Keywords 

Association of household secondhand smoke exposure and mortality risk in patients with heart failure

Author/s: 
He, X, Zhao, J, He, J, Dong, Y, Liu, C

BACKGROUND:

Secondhand smoke (SHS) exposure is a well-established cardiovascular risk factor, yet association between SHS and prognosis of heart failure remains uncertain.

METHOD:

Data were obtained from the US National Health and Nutrition Examination Surveys III from 1988 to 1994. Currently nonsmoking adults with a self-reported history of heart failure were included. Household SHS exposure was assessed by questionnaire. Participants were followed up through December 31, 2011. Cox proportional-hazards models were used to assess the association of household SHS exposure and mortality risk. Potential confounding factors were adjusted.

RESULTS:

Of 572 currently nonsmoking patients with heart failure, 88 were exposed to household SHS while 484 were not. There were totally 475 deaths during follow-up. In univariate analysis, household SHS was not associated with mortality risk (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.76-1.26, p = 0.864). However, after adjustment for demographic variables, socioeconomic variables and medication, heart failure patients in exposed group had a 43% increase of mortality risk compared with those in unexposed group (HR: 1.43, 95% CI: 1.10-1.86, p = 0.007). Analysis with further adjustment for general health status and comorbidities yielded similar result (HR: 1.47, 95% CI: 1.13-1.92, p = 0.005).

CONCLUSION:

Household SHS exposure was associated with increased mortality risk in heart failure patients.

Association of E-Cigarette Use With Respiratory Disease Among Adults: A Longitudinal Analysis

Author/s: 
Bhatta, DN, Glantz, SA

INTRODUCTION:

E-cigarettes deliver an aerosol of nicotine by heating a liquid and are promoted as an alternative to combustible tobacco. This study determines the longitudinal associations between e-cigarette use and respiratory disease controlling for combustible tobacco use.

METHODS:

This was a longitudinal analysis of the adult Population Assessment of Tobacco and Health Waves 1, 2, and 3. Multivariable logistic regression was performed to determine the associations between e-cigarette use and respiratory disease, controlling for combustible tobacco smoking, demographic, and clinical variables. Data were collected in 2013-2016 and analyzed in 2018-2019.

RESULTS:

Among people who did not report respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, or asthma) at Wave 1, the longitudinal analysis revealed statistically significant associations between former e-cigarette use (AOR=1.31, 95% CI=1.07, 1.60) and current e-cigarette use (AOR=1.29, 95% CI=1.03, 1.61) at Wave 1 and having incident respiratory disease at Waves 2 or 3, controlling for combustible tobacco smoking, demographic, and clinical variables. Current combustible tobacco smoking (AOR=2.56, 95% CI=1.92, 3.41) was also significantly associated with having respiratory disease at Waves 2 or 3. Odds of developing respiratory disease for a current dual user (e-cigarette and all combustible tobacco) were 3.30 compared with a never smoker who never used e-cigarettes. Analysis controlling for cigarette smoking alone yielded similar results.

CONCLUSIONS:

Use of e-cigarettes is an independent risk factor for respiratory disease in addition to combustible tobacco smoking. Dual use, the most common use pattern, is riskier than using either product alone.

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