Work and productivity loss in the rizatriptan multiple attack study.

The objective of this study was to measure the self-reported effect of acute migraine and its treatment on paid work and productivity loss. Patients self-administered a questionnaire in which the impact of a recent migraine on paid work and productivity activities was assessed. We included the questionnaire in a randomized, double-blind, placebo-controlled, crossover, out-patient study designed to examine the safety and efficacy of rizatriptan (5-HT1B/1D receptor agonist) 10 mg p.o. in patients treating four separate migraine attacks. A total of 407 patients, aged 18-65 years, suffering from moderate to severe migrainous headaches was studied. Patients receiving rizatriptan compared with placebo reported 0.7 fewer hours (P < 0.01) of paid worked missed due to absenteeism, 0.4 fewer hours (P < 0.05) of productive time lost on the job, and 1.1 fewer total hours (P < 0.01) of work loss per migraine attack. Rizatriptan compared with placebo significantly reduced migraine-related work loss associated with absenteeism and decreased effectiveness on the job.

Duration of protection from clinical hepatitis A disease after vaccination with VAQTA.

Recent papers examining the expected persistence of anti-hepatitis A virus antibody following vaccination with inactivated hepatitis A vaccine have estimated that geometric mean antibody levels will remain above cut-off levels for 10-30 years. However, the methodology used in these papers did not take into account any estimates of variability between subjects. In this paper data from the persistence of antibody after the administration of another vaccine, VAQTA (hepatitis A vaccine, inactivated; MSD), were used to develop further models of antibody decay. Using individual subject estimates instead of group means allowed the estimation of time to negativity for various percentiles of the population (including the median), and the construction of confidence intervals on estimates of time to negativity. Data from studies of subjects who seroreverted to negativity, and subsequently received a booster dose, were also considered to show that subjects who lose detectable antibody are likely to remain protected from hepatitis A disease by persistent immune memory and rapid anamnestic response soon after exposure to hepatitis A virus. The estimates of duration of protection suggest that VAQTA will provide protection for many years, first through presence of antibody and further through an anamnestic response based on persistent immune memory.

Evaluation of a dressing to reduce nipple pain and improve nipple skin condition in breast-feeding women.

This study was designed to evaluate whether maintenance of a moist environment on the nipple skin during the first week of breast-feeding would improve damaged nipple skin condition, as indicated by the presence of eschar, erythema, and fissures, and reduce pain. Fifty White women applied a polyethylene film dressing with a perimeter adhesive system to a randomly determined nipple. The dressing was present at all times except during feeding. Subjects were assessed every 48 hours (four times) over 7 days. Serial photographic slides were obtained and assessed for skin characteristics. Nipple pain was self-rated with a verbal descriptor scale. Use of an occlusive film dressing on nipple skin during the first week of breast-feeding appeared to have limited influence on improvement in damaged skin condition. Summary scores indicated significant reduction in the amount of eschar on the surface of the nipple. There were no differences in erythema intensity or fissure severity. Use of a dressing significantly reduced nipple pain during the study period.

Skin changes and pain in the nipple during the 1st week of lactation.

OBJECTIVE: To document skin changes in the nipple during the 1st week of breastfeeding and to explore the relationship of such changes to pain. DESIGN: Longitudinal descriptive study. Subjects were visited four times during the 1st week of breastfeeding. SAMPLE: Convenience sample of 20 Caucasian women. SETTING: Hospital and home. MAIN OUTCOME MEASURES: Observed skin characteristics of the nipple included erythema, edema, fissures, blisters, inflamed areas, eschar, white patches, dark patches, yellow patches, peeling, pus, and ecchymosis. Subject-rated nipple pain. RESULTS: Skin changes were identified and quantified. Changes were visible in 100% (20) of the sample, and 65% (13) had severe skin damage; 90% (18) of the subjects reported pain. Some correlations between skin characteristics and pain were statistically significant, but not clinically meaningful. Skin damage was concentrated on the tip of the nipple. CONCLUSIONS: The data chronicle skin changes and their relationship to nipple pain during the 1st week of breastfeeding. Normal neonatal sucking appears to induce a suction wound on the skin of the nipples of many breastfeeding women that may account for pain experienced at the onset of lactation.

A method of designing clinical trials for combination drugs.

Many pharmaceutical companies are now exploring combination drug therapies as an alternative to monotherapy. Consequently, it is of interest to investigate the simultaneous dose response relationship of two active drugs to select the lowest effective combination. In this paper, we propose a method for designing clinical trials for drug combinations that seems to offer several advantages over the 4 x 3 or even larger factorial studies that have been used to date. In addition, our proposed method provides a convenient formula for calculating the required sample size.

Changes in dyspnea-fatigue ratings as indicators of quality of life in the treatment of congestive heart failure.

A new clinical index of dyspnea and fatigue has been applied to rate the condition of patients with congestive heart failure. The index has 3 components, each rated on a scale from 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component are added to form an aggregated score, which can range from 0, for the worst condition, to 12, for the best. Because dyspnea and fatigue are prime symptoms and sources of clinical distress, the index helps reflect the quality of life in patients with congestive heart failure. In double-blind trials of therapy, changes in the index showed good correlations with patients' self-selected ratings of improvement. The posttherapeutic changes in the index ratings were significantly higher with a new active agent (lisinopril) than with placebo or another active agent (captopril).