A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PURPOSE: This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. METHODS: Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. RESULTS: In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Exogenous Lipoid Pneumonia in Laryngectomy Patients: Radiological Findings.

Exogenous lipoid pneumonia (ELP) is a rare (incidence 1.0%-2.5%), often under-diagnosed disease, caused by the aspiration and accumulation of exogenous lipids within the pulmonary alveoli. Various cases have been described due to inhalation of lubricants via the nasal passages and oropharynx, aspiration of mineral oils in laxatives in patients with eating disorders, application of lip gloss, occupational exposure to liquid paraffin or mineral oils ("fire-eaters", industrial use in washing of machinery, automobile workshops, plastic paints, etc.) and application of Vaseline during the insertion of nasogastric tubes and in the care of tracheotomy patients. ELP usually presents radiologically as areas of low-attenuation peribronchial consolidation and ground glass opacities, with a predominantly bibasal distribution. We present 5 cases of long-standing laryngectomy patients diagnosed with ELP who admitted using Vaseline in their tracheal stoma care.

Effect of vaginal lubricants on natural fertility.

PURPOSE OF REVIEW: Vaginal lubricants are commonly utilized to facilitate more comfortable and enjoyable intercourse. The impact of these lubricants on fertility is unclear. The aim of this review is to summarize the current in-vitro and clinical data pertaining to lubricants' effect on natural conception. RECENT FINDINGS: In-vitro studies suggest lubricants can be toxic to sperm in the artificial laboratory environment. Lubricants formulated to be nontoxic to sperm have no effect on sperm motility or viability in vitro compared to controls. However, a recent longitudinal cohort study suggests lubricant use and choice has no effect of fecundity. SUMMARY: As a result of the conflicting in-vitro and clinical data, the effect of vaginal lubricants on fertility is still unresolved. A randomized controlled trial is needed to determine the effects of vaginal lubricants on fertility.

The acceptability, feasibility, and efficacy (phase I/II study) of the OVERcome (Olive Oil, Vaginal Exercise, and MoisturizeR) intervention to improve dyspareunia and alleviate sexual problems in women with breast cancer.

INTRODUCTION: Almost half of breast cancer survivors experience chronic sexual problems. Despite the negative effects of dyspareunia on physical and overall quality of life, sexual dysfunction remains underreported and undertreated in clinical practice. This is likely due to the paucity of evidence-based interventions to improve sexual functioning. AIM: The study aims to prospectively evaluate the acceptability, feasibility, and efficacy of a novel intervention (Olive Oil, Vaginal Exercise, and MoisturizeR [OVERcome]) to improve sexual problems following breast cancer treatment. MAIN OUTCOME MEASURES: Dyspareunia, sexual functioning, quality of life, distress, and pelvic floor muscles (PFMs) functioning were evaluated. METHODS: Twenty-five women with dyspareunia were instructed to perform pelvic floor muscle (PFM) relaxation exercises twice/day to prevent/manage PFM overactivity, apply a polycarbophil-based vaginal moisturizer three times/week to alleviate vaginal dryness, use olive oil as a lubricant during intercourse, and complete a weekly compliance diary. PFM relaxation training was administered by a physiotherapist at weeks 0 and 4, with follow-up at weeks 12 and 26. At each visit, women completed validated self-report questionnaires and the physiotherapist recorded objective measures of PFM functioning. RESULTS: OVERcome resulted in significant improvements in dyspareunia, sexual function, and quality of life over time (all P<0.001). PFM relaxation training was reported to be effective (P≤0.001). Maximum benefits were observed at week 12. Most women rated PFM relaxation exercises (92%), vaginal moisturizer (88%), and olive oil (73%) as helpful, indicating that the intervention was acceptable. Unexpectedly, six cases (11%) of vaginal stenosis were noted during initial screening. CONCLUSIONS: This novel intervention is acceptable to patients with demonstrated efficacy in improving dyspareunia and sexual function following breast cancer. Delivery of the OVERcome intervention appears feasible in a clinical setting, providing a potential treatment for this important clinical issue. The unexpected number of observed cases of stenosis further highlights the underreporting of sexual problems in this population, deserving further exploration.

Acceptability of potential rectal microbicide delivery systems for HIV prevention: a randomized crossover trial.

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use.

Sperm toxicity of "nonspermicidal" lubricant and ultrasound gels used in reproductive medicine.

Three commercial, nonspermicidal gels used in fertility practice were found to be toxic to sperm in a 24-hr sperm survival assay; these included Felis, Replens, and Aquasonic Gel, which is used for transvaginal ultrasound during ovulation monitoring. In contrast, Pre-Seed did not cause any sperm toxicity, suggesting its appropriate use by patients who are trying to conceive, as well as clinicians during fertility procedures.