A multicenter, placebo-controlled, double-blind clinical trial assessing the effects of a multicomponent nutritional supplement for treating photoaged skin in healthy women

Summary

Background

Dietary or supplementary intake of nutrients and other ingredients positively affects skin appearance.

Aims

Evaluate a multicomponent nutritional supplement on photoaged skin.

Patients/Methods

This multicenter, double-blind, placebo-controlled trial randomized healthy 35- to 65-year-old women with Fitzpatrick skin types I–IV and Glogau classification types II–III to a multicomponent nutritional supplement or placebo for 24 weeks. The primary endpoint was Investigator Global Assessment of overall facial appearance at week 24. Secondary endpoints included investigator- and subject-rated assessments of the face, décolletage, and hands; facial photography assessments (conducted by an independent panel of dermatologists); and instrumental measures. Analysis of variance was used to assess between-group differences (P ≤ 0.05).

Results

Of 194 randomized subjects, 171 completed the study. Subjects had a mean age of 53 years and were primarily white (81%), had Glogau II (58%) and Fitzpatrick III (45%; significantly more supplement subjects had Fitzpatrick III [54%] vs. placebo [35%]; P = 0.039). At week 24, Investigator Global Assessment of overall facial appearance was numerically but not statistically better for supplement over placebo (mean difference: 0.14 [95% confidence interval: −0.16–0.44]; P = 0.358). A significant treatment-by-site interaction (P = 0.073) was observed; by-site analyses revealed a significant difference at one of three geographical sites for supplement vs. placebo (P = 0.001). Differences on secondary endpoints were generally not significant.

Conclusions

In the first multicenter study conducted with this multicomponent nutritional supplement, no significantly greater effects vs. placebo were observed on the primary endpoint, perhaps because of significant between-site variability.

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A text Message Alert System For Trained Volunteers Improves Out-of-Hospital Cardiac Arrest Survival

http://alexsfakianakis.blogspot.com/2016/10/a-text-message-alert-system-for-trained.html

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
2841026182

6948891480

alsfakia@gmail.com

Safety and efficacy of a combination of Paromomycin and Miltefosine for two versus three courses in patients with Post Kala-Azar Dermal Leishmaniasis (PKDL) - an observational pilot Study

PKDL is a dermal form of leishmaniasis caused by protozoal parasite Leishmania donovani. It is characterized by macular, popular and nodular lesions or a mixture of these¹. It is mainly seen in Sudan and India, where it follows treatment of visceral leishmaniasis (VL) in 50% and 5-10% of cases respectively². A phase III study on miltefosine-paromomycin combination for 10 days for treatment of Indian visceral leishmaniasis (n=157) revealed high cure rate (98.7%) with minimal toxicity, good compliance, lesser treatment duration and non-inferiority to standard amphotericin B³. We, therefore, aimed to assess the efficacy and safety of miltefosine plus paromomycin combination in thirty PKDL patients.

This article is protected by copyright. All rights reserved.

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Ultrasonographic Evaluation of Cervical Lymph Nodes in Thyroid Cancer

Objective

To determine what ultrasonographic features can identify metastatic cervical lymph nodes, both preoperatively and in recurrences after complete thyroidectomy.

Study Design

Prospective.

Setting

Outpatient clinic, Department of Head and Neck Surgery, School of Medicine, University of São Paulo, Brazil.

Subjects and Methods

A total of 1976 lymph nodes were evaluated in 118 patients submitted to total thyroidectomy with or without cervical lymph node dissection. All the patients were examined by cervical ultrasonography, preoperatively and/or postoperatively. The following factors were assessed: number, size, shape, margins, presence of fatty hilum, cortex, echotexture, echogenicity, presence of microcalcification, presence of necrosis, and type of vascularity. The specificity, sensitivity, positive predictive value, and negative predictive value of each variable were calculated. Univariate and multivariate logistic regression analyses were conducted. A receiver operator characteristic (ROC) curve was plotted to determine the best cutoff value for the number of variables to discriminate malignant lymph nodes.

Results

Significant differences were found between metastatic and benign lymph nodes with regard to all of the variables evaluated (P < .05). Logistic regression analysis revealed that size and echogenicity were the best combination of altered variables (odds ratio, 40.080 and 7.288, respectively) in discriminating malignancy. The ROC curve analysis showed that 4 was the best cutoff value for the number of altered variables to discriminate malignant lymph nodes, with a combined specificity of 85.7%, sensitivity of 96.4%, and efficiency of 91.0%.

Conclusion

Greater diagnostic accuracy was achieved by associating the ultrasonographic variables assessed rather than by considering them individually.

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Laryngotracheal Stenosis: Risk Factors for Tracheostomy Dependence and Dilation Interval

Objective

Laryngotracheal stenosis (LTS) is a fibrotic process that narrows the upper airway and has a significant impact on breathing and phonation. Iatrogenic injury from endotracheal and/or tracheostomy tubes is the most common etiology. This study investigates differences in LTS etiologies as they relate to tracheostomy dependence and dilation interval.

Study Design

Case series with chart review.

Setting

Single-center tertiary care facility.

Subjects and Methods

Review of adult patients with LTS was performed between 2004 and 2015. The association of patient demographics, comorbidities, disease etiology, and treatment modalities with patient outcomes was assessed. Multiple logistic regression analysis and Kaplan-Meier analysis were performed to determine factors associated with tracheostomy dependence and time to second procedure, respectively.

Results

A total of 262 patients met inclusion criteria. Iatrogenic patients presented with greater stenosis (P = .023), greater length of stenosis (P = .004), and stenosis farther from the vocal folds (P < .001) as compared with other etiologies. Iatrogenic patients were more likely to be African American, use tobacco, and have obstructive sleep apnea, type II diabetes, hypertension, chronic obstructive pulmonary disease, or a history of stroke. Iatrogenic LTS (odds ratio [OR] = 3.1, 95% confidence interval [95% CI] = 1.2-8.2), Cotton-Myer grade 3-4 (OR = 2.6, 95% CI = 1.1-6.4), and lack of intraoperative steroids (OR = 2.9, 95% CI = 1.2-6.9) were associated with tracheostomy dependence. Nonsmokers, patients without tracheostomy, and idiopathic LTS patients had a significantly longer time to second dilation procedure.

Conclusion

Iatrogenic LTS presents with a greater disease burden and higher risk of tracheostomy dependence when compared with other etiologies of LTS. Comorbid conditions promoting microvascular injury—including smoking, COPD, and diabetes—were prevalent in the iatrogenic cohort. Changes in hospital practice patterns to promote earlier tracheostomy in high-risk patients could reduce the incidence of LTS.

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Quality of Life after Sequential Bilateral Cochlear Implantation: An Updated Comprehensive Cochlear Implant Questionnaire

Objective

Assess psychometric properties of the Comprehensive Cochlear Implant Questionnaire (CCIQ) as a tool for assessing changes in health-related quality of life (HRQoL) after receiving a second cochlear implant (CI2).

Study Design

Prospective study.

Setting

Academic cochlear implant center.

Subjects and Methods

The CCIQ is a 29-item questionnaire assessing the physical and psychosocial benefits of a CI2 based on a 5-point Likert scale. The CCIQ was administered with the Nijmegen Cochlear Implant Questionnaire and the Short Form–12 Patient Questionnaire (SF-12) to patients with a CI2. Speech perception was tested with the consonant-nucleus-consonant (CNC) word test and AzBio test.

Results

Of 56 patients, 32 (57.1%) completed the instruments sent by mail. Of the 32 patients, 22 (68.8%) completed retest CCIQs 6 weeks later. CCIQ scores demonstrated significantly increased HRQoL in all domains. Internal consistency was very good overall (Cronbach's α = 0.90), with all subdomains exceeding an alpha value of 0.70. Test-retest reliability was good, with an overall intraclass correlation of 0.62. The CCIQ showed a moderate correlation with the Nijmegen Cochlear Implant Questionnaire and a low correlation with the SF-12. Average CNC and AZBio scores significantly improved by 31% ± 29% and 34% ± 33%, respectively. Audiometric data were not significantly correlated with the CCIQ.

Conclusion

The CCIQ shows (1) good reliability and evidence of construct validity, (2) a significant increase in HRQoL and significantly improved speech perception after CI2, and (3) greater sensitivity at detecting CI2 improvements to HRQoL. This promising measure is quick and easy to administer and provides subjective assessments of HRQoL specifically for those with a CI2.

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Readability Trends of Online Information by the American Academy of Otolaryngology--Head and Neck Surgery Foundation

Objective

Previous studies have shown that patient education materials published by the American Academy of Otolaryngology—Head and Neck Surgery Foundation may be too difficult for the average reader to understand. The purpose of this study was to determine if current educational materials show improvements in readability.

Study Design

Cross-sectional analysis.

Setting

The Patient Health Information section of the American Academy of Otolaryngology—Head and Neck Surgery Foundation website.

Subjects and Methods

All patient education articles were extracted in plain text. Webpage navigation, references, author information, appointment information, acknowledgments, and disclaimers were removed. Follow-up editing was also performed to remove paragraph breaks, colons, semicolons, numbers, percentages, and bullets. Readability grade was calculated with the Flesch-Kincaid Grade Level, Flesch Reading Ease, Gunning-Fog Index, Coleman-Liau Index, Automated Readability Index, and Simple Measure of Gobbledygook. Intra- and interobserver reliability were assessed.

Results

A total of 126 articles from 7 topics were analyzed. Readability levels across all 6 tools showed that the difficulty of patient education materials exceeded the abilities of an average American. As compared with previous studies, current educational materials by the American Academy of Otolaryngology—Head and Neck Surgery Foundation have shown a decrease in difficulty. Intra- and interobserver reliability were both excellent, with intraclass coefficients of 0.99 and 0.96, respectively.

Conclusion

Improvements in readability is an encouraging finding and one that is consistent with recent trends toward improved health literacy. Nevertheless, online patient educational material is still too difficult for the average reader. Revisions may be necessary for current materials to benefit a larger readership.

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