A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis.

OBJECTIVE: To investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR). METHODS: Forty-two consented subjects meeting inclusion/exclusion criteria were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily over 2 weeks. The primary endpoint was change in total nasal symptom scores (TNSS) from baseline to end of study. Secondary endpoints included changes in individual symptom scores (ISS) over 2 weeks and average time to first relief. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Rhinitis quality-of-life, rescue medication, and safety endpoints were analyzed. RESULTS: ICX72 versus placebo subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01), had an average time to first relief of 52.6 seconds (P < .01), and improvement in nasal congestion, sinus pain, sinus pressure, and headache at 5, 10, 15, and 30 minutes, persisting at 60 minutes for nasal congestion and sinus pain (P < .05). No difference between groups in adverse events or rescue medication was observed. ICX72 versus placebo subjects experienced no rebound congestion or impaired olfaction at the end of the study. CONCLUSION: This is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component.

Mortality of workers occupationally exposed to refractory ceramic fibers.

This study was prompted by refractory ceramic fibers (RCF) inhalation studies at high dose levels in animals that demonstrated positive effects for lung fibrosis, mesothelioma, and lung cancer. Current and former male workers employed between 1952 and 2000 at two RCF manufacturing facilities were followed to investigate a possible excess in mortality. The mortality analytic methods included: (1) standardized mortality ratios comparing this cohort to the general and state populations, and (2) a proportional hazards model that relates risk of death to the lifetime cumulative fiber-months/cc exposure among the RCF cohort, adjusted for age at hire and for race. There was no excess mortality related to all deaths, all cancers, or malignancies or diseases of the respiratory system including mesothelioma, but there was a statistically significant association with cancers of the urinary organs SMR = 344.8 (95% CL of 111.6, 805.4). The quality of the data for job history, exposure, and smoking history were very high. Although the cohort was relatively small and young with an average age of 51, the mean latency period was over 21 years. Because of these limitations, the preliminary findings warrant the continuation of this mortality registry for future analyses.

Pregnancy hormone metabolite patterns, pregnancy symptoms, and coffee consumption.

Because of contradictory reports of pregnancy outcomes and coffee intake, this study was designed to determine how hormone metabolite levels, symptoms, and coffee consumption patterns are related. Eligible subjects were recruited in Cincinnati, Ohio, from 1996 to 1998, aged 18-40 years, and nonsmokers; drank at least 18 ounces (1 ounce = 29.6 ml) of coffee per week (including decaffeinated) at the last menstrual period; and were enrolled by 9 weeks from the last menstrual period. Beverage consumption and pregnancy symptoms were recorded daily. Weekly, first-morning urine samples were collected to assess human chorionic gonadotropin, estrone-3-glucuronide, and pregnanediol-3-glucuronide. A time-dependent, repeated measures analysis was performed to test several associations. Data from 92 subjects were analyzed with the following results. 1) Coffee consumption was significantly, inversely associated with weekly levels of estrone-3-glucuronide and human chorionic gonadotropin. 2) Weekly hours of nausea were significantly, directly associated with human chorionic gonadotropin and inversely with estrone-3-glucuronide and pregnanediol-3-glucuronide. 3) Weekly coffee consumption was significantly associated with vomiting but not with nausea or appetite loss. 4) Weekly levels of pregnanediol-3-glucuronide were 32.2% lower in subjects who drank at least 8 ounces of coffee/day at the last menstrual period, though above what was necessary to maintain those pregnancies. This study shows the significance of these important variables to be considered in future research.