Randomized clinical trial of a handheld cooling device (Menopod®) for relief of menopausal vasomotor symptoms.

OBJECTIVE: Anecdotal reports suggest that application of a cool device to the back of the neck at the onset of a hot flush can afford symptomatic relief. The effects of a novel handheld mechanical cooling device in a population of perimenopausal women with moderate-to-severe vasomotor symptoms were evaluated. METHODS: In this randomized, double-blind, sham-controlled pilot study, 40 perimenopausal women experiencing ≥ 7 moderate-to-severe hot flushes per day were recruited at a single university site. Women were randomized to the active (n = 20) or sham (n = 20) device, which was applied to the back of the neck with each hot flush over the 4-week treatment period. Hot flush scores were calculated based on frequency and severity of symptoms. The Carpenter Hot Flash Related Daily Interference Scale and Zung Anxiety Scale were used to evaluate impact on quality of life. At study end, participants completed an open-ended questionnaire to assess the degree of unblinding and overall subjective improvement in symptoms with use of the device. RESULTS: No statistically significant differences were observed between the effects of the active and sham device. However, thematic analysis of the open-ended questionnaire revealed that 12/17 women (70.6%) in the active group, compared to 4/18 (22.2%) women in the sham group felt the device provided some symptomatic relief. CONCLUSIONS: Although the majority of women using the active device acknowledged that its cooling effect afforded a degree of symptomatic relief, the symptom scores chosen for this pilot study did not reflect a beneficial effect.

The duration of labor in adolescents.

STUDY OBJECTIVES: To determine the lengths of the first and second stages of labor in a group of Canadian adolescents; to compare this timeline to the estimates from a general population, and to a heterogeneous group of adolescents from a previous study. DESIGN: Retrospective chart review. SETTING: Kingston General Hospital, Kingston, Ontario, Canada. PARTICIPANTS: This study included women 19 years old and under at the time of delivery, having had spontaneous labor and a term singleton cephalic vaginal delivery between 2000 and 2005. MAIN OUTCOME MEASURES: The primary outcome is the length of the first and second stages of labor. Impact of epidural use will be determined. RESULTS: In adolescents undergoing spontaneous labor at term (n = 177), the median duration of the first stage was 6.8 and 3.2 hours for nulliparous and multiparous teens respectively, compared to 10.0 and 5.9 hours in a mostly adult population. The duration of the second stage, in term spontaneous vaginal deliveries, was 54 minutes for nulliparous and 10 minutes for multiparous adolescents, similar to the teens in Greenberg's 2007 study. Comparatively, median lengths of second stage for the general population were 92 minutes and 20 minutes for nulliparous and multiparous women respectively. Epidural analgesia had a significant influence on lengthening the second stage in adolescents, however second stages in teens were still shorter, when controlling for regional analgesia, than in a general population. CONCLUSIONS: Adolescents do have shorter both first and second stages when compared to a general group. These differences demonstrate the importance of determining a distinct timeline for evaluating the course of labor in teens.

Development of a national course on research methodology for Canadian residents in obstetrics and gynecology.

OBJECTIVE: To report our experience developing and implementing an introductory course on research methods for Canadian obstetrics and gynecology residents. METHODS: A program entitled "An Introduction to Research," originating at Queen's University, developed into an annual series of regional courses across Canada, under the auspices of the Association of Professors of Obstetrics and Gynaecology of Canada. Didactic lectures, interactive workshops, and online computer demonstrations introduced participants to the basic elements of clinical research. RESULTS: Since its inception, over 1000 participants have attended the program. Nearly all of the 296 respondents to a course evaluation agreed that the program was well organized, presented material at an appropriate level, and was useful. CONCLUSION: This course ensured that residents in obstetrics and gynecology across Canada were given a basic level of research training, as required by the Royal College of Physicians and Surgeons of Canada.

Menopausal-like hot flashes reported in women of reproductive age.

OBJECTIVE: To report the occurrence of menopausal-like hot flashes in women of reproductive age (18-45 years). DESIGN: Observational, prospective cohort study with a retrospective survey component. SETTING: Tertiary care premenstrual syndrome (PMS) clinic and university campus. PATIENT(S): Patients with confirmed PMS (n = 157) were compared with those with chronic menstrual cycle-related symptoms (n = 27). Women without menstrual cycle-related symptoms were solicited as controls (n = 58). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The frequency of episodes of chills and sweats and the magnitude of menstrual cycle-related symptoms were recorded over one cycle using the Prospective Record of the Impact and Severity of Menstrual Symptomatology (PRISM) Calendar. Characteristics of the episodes of chills and sweats were ascertained by a retrospective questionnaire. RESULT(S): In each group, the frequency of episodes of chills and sweats closely patterned the mean daily PRISM Calendar scores. At least one episode of chills and sweats was reported by 83.4% of the PMS group and 81.5% of the chronic group compared with 43.1% of the control group. The mean (+/-SD) number of episodes per cycle was 5.6 +/- 4.9 for the PMS group and 9.5 +/- 9.1 for the chronic group compared with 1.2 +/- 2.0 for the control group (the difference between all means was statistically significant). CONCLUSION(S): Episodes of chills and sweats similar to menopausal hot flashes were commonly reported by women with cyclic and chronic menstrual cycle-related symptoms.

A randomized clinical trial of oxidized regenerated cellulose adhesion barrier (Interceed, TC7) alone or in combination with heparin.

OBJECTIVE: To compare the efficacy of heparin-saturated oxidized regenerated cellulose absorbable adhesion barrier, Interceed (TC7; Johnson and Johnson Medical Inc., New Brunswick, NJ) to oxidized regenerated cellulose alone for the prevention of postoperative adhesions. DESIGN: Clinical trial. By random assignment, one ovary was wrapped in oxidized regenerated cellulose, and the contralateral ovary was wrapped in oxidized regenerated cellulose saturated with a heparin solution (1,000 U/mL). PATIENT(S): Forty women with defects on both ovaries due to adhesiolysis and/or ovarian cystectomy. MAIN OUTCOME MEASURE: Adhesion formation and raw ovarian surface area were assessed at second-look laparoscopy 10 days to 16 weeks later. RESULT(S): At the second-look laparascopy-adhesions were present on 52.5% (21/40) of the ovaries treated with oxidized regenerated cellulose plus heparin and in 65% (26/40) of the contralateral ovaries treated with oxidized regenerated cellulose alone. For ovaries treated with oxidized regenerated cellulose plus heparin, the raw surface area was reduced from 9.41 +/- 1.27 cm2 (mean +/- SE) at laparotomy to 1.33 +/- 0.52 cm2 at second-look laparoscopy. The corresponding figures for ovaries treated with oxidized regenerated cellulose alone were from 10.24 +/- 1.08 to 1.92 +/- 0.54 cm2, respectively. The mean difference between the reductions in raw surface area (85.9% for oxidized regenerated cellulose plus heparin; 81.3% for oxidized regenerated cellulose alone) was not significantly different from zero (difference = - 0.24 cm2; 95% confidence interval = -2.56 to 3.04). CONCLUSION(S): Adding heparin did not enhance significantly the adhesion-reducing capacity of oxidized regenerated cellulose adhesion barrier when applied to ovarian surfaces after cystectomy and/or ovariolysis at laparotomy. This conclusion is subject to the possibility of a type II error.

Vaginal birth after cesarean. Physicians' perceptions and practice.

OBJECTIVE: To determine physician's perceptions about vaginal birth after cesarean section and compare them to the physicians' actual practice experience. STUDY DESIGN: Physicians responded to a questionnaire on their perceptions of vaginal birth after cesarean section. Between July 1, 1991, and June 30, 1992, all attempts at vaginal birth after cesarean section were reviewed. All cesarean deliveries were also reviewed to determine which repeat cesarean sections could have been avoided. RESULTS: One hundred twenty-four patients attempted vaginal birth after cesarean section, and 95 (76.6%) were successful. Physician perceptions revealed a success rate of 73.6%. Those patients whose labor was induced in their attempt at vaginal birth after cesarean section were less successful (41.9%) than those who did not require induction (88.2%) (P < .001). Upon review, 47% of patients who underwent elective repeat cesarean section did not have a contraindication to a trial of labor. CONCLUSION: Physicians had an accurate perception of the success of vaginal birth after cesarean section in their practices. Vaginal birth after cesarean section success rates were consistent with those reported in the literature. Despite a high attempt rate (72.5%) among those eligible for vaginal birth after cesarean section, almost half the patients undergoing a repeat elective cesarean section did not have a contraindication to a trial of labor.

A randomized, placebo-controlled, crossover trial of danazol for the treatment of premenstrual syndrome.

To investigate whether danazol is more effective than placebo for the treatment of premenstrual syndrome (PMS), we conducted a randomized, double-blind, crossover study comparing three successive cycles of danazol (200 mg bid) to three cycles of placebo. Thirty-one women meeting rigorous criteria for a diagnosis of severe PMS over two pretreatment cycles were enrolled; 28 of these subjects completed at least one cycle of treatment with symptom recordings, which were entered into the analysis. A significant period effect confounded the planned within-subject analysis and therefore, the main treatment comparisons were confined to the first period only. Symptom scores on the Premenstrual Tension Self-Rating Scale (PMTS), Beck Depression Inventory (BDI), and a Visual Analogue Scale (VAS) were compared for the premenstrual week in the last cycle of treatment. For the 16 patients on danazol, scores on the PMTS decreased by an average of 14.0 (10.7) (standard deviation) points from a baseline of 25.4 (5.6) points. For the 12 patients on placebo, PMTS scores decreased by an average of 3.6 (9.5) points from a baseline of 23.5 (5.8) points (14.0 vs. 3.6; p = .0133, unpaired t-test). Seven (43.8%) of the subjects on danazol achieved a clinically relevant reduction of symptoms into the asymptomatic range (PMTS scores < or = 5) as compared to one (8.3%) of the subjects on placebo. Thus, danazol (200 mg bid) provided greater relief from severe PMS during the premenstrual week than did placebo.

Photodynamic ablation of early pregnancy in the rat with 5-aminolevulinic acid: a potential new therapy for tubal ectopic pregnancy in the human.

OBJECTIVE: To determine whether systemic 5-aminolevulinic acid (ALA) could produce photosensitization and photodynamic ablation of early pregnancy in the rat. SETTING: A conventional laboratory setting. PATIENTS: Female Sprague-Dawley rats, weighing 220 to 275 g at the time of breeding. INTERVENTIONS: Rats at 10 days of gestation were injected IV with saline, 20 or 200 mg/kg ALA. Three hours later, the abdominal cavity was opened to record the number of fetuses in both uterine horns. One or both uterine horns were exposed to photoactivating light at 630 nm for 0, 5, 15, or 30 minutes. MAIN OUTCOME MEASURES: Mean fetal survival rate was determined 7 days after treatment. RESULTS: The mean +/- SEM fetal survival rates in groups (n = 6) treated with saline, 20 or 200 mg/kg ALA followed by 30-minute light exposure were 90.8% +/- 2.8%, 16.0% +/- 4.9%, and 0%, respectively. The mean +/- SEM fetal survival rates in groups (n = 6) treated with 200 mg/kg ALA followed by 0-, 5-, 15-, or 30-minute light exposure were 71.3% +/- 11.8%, 8.9% +/- 6.2%, 0.9% +/- 1.3%, and 0%, respectively. CONCLUSIONS: We conclude that systemic ALA followed by transmural exposure to photoactivating light (630 nm) results in resorption of early pregnancies in the rat. This approach could potentially be developed as a new treatment for human ectopic pregnancy.

Coping with rheumatoid arthritis: is one problem the same as another?

This study examined how individuals with rheumatoid arthritis (RA) cope with illness-related problems in four different areas: daily activities, leisure activities, work, and social relationships. Eighty-five people with RA took part in the study. They participated in an in-depth interview that focused on the types of changes they had experienced in their lives as a result of their arthritis and how they had coped with these changes. Audiotapes of the interviews were transcribed and content analyzed to assess participants' coping behavior. In addition, standardized measures of psychological and physical functioning were administered shortly following the original interview and at a 4-month follow-up. Three major findings emerged. First, people relied less heavily on behavioral coping strategies when dealing with problems involving social relationships than when dealing with problems involving daily activities, leisure activities, or work. Second, there was little consistency in individuals' use of either cognitive or behavioral strategies across different problem areas. Finally, individuals who exhibited limited flexibility in their coping responses experienced poorer psychological functioning compared with more flexible copers. Implications of these findings for health education practice and future research on coping with RA are discussed.

A randomized, double-blind, placebo-controlled, cross-over trial to assess the side effects of medroxyprogesterone acetate in hormone replacement therapy.

Cyclic progestin therapy has been widely advocated as an adjunct to postmenopausal estrogen replacement therapy to reduce the risk of endometrial carcinoma. Acceptance of this approach, however, appears to have preceded detailed evaluation of possible adverse side effects of progestins that could result in patient noncompliance. We evaluated the nonmenstrual physical and psychological side effects of oral medroxyprogesterone acetate given in conjunction with transdermal estrogen in two groups of women with previous hysterectomy and oophorectomy. Twenty-four women with prospectively documented severe premenstrual syndrome (PMS) before surgery and 24 women with no such history of adverse premenstrual changes received transdermal estrogen 100 micrograms on days 1-25 and either oral medroxyprogesterone acetate 10 mg daily or an identical placebo (days 12-25) in a randomized, double-blind, cross-over design. Mood and physical symptoms were monitored prospectively, using daily self-ratings on the Daily Symptoms Checklist. The Beck Depression Inventory and Premenstrual Tension Self-Rating Scale were completed on day 24. At the study's completion, the patients were asked which treatment period they preferred. Paired comparisons did not reveal any significant differences, and preference for treatment was equally divided between medroxyprogesterone acetate and placebo. We conclude that addition of medroxyprogesterone acetate 10 mg/day for 14 days to cyclic transdermal estrogen therapy (days 1-25) produces no consistent adverse physical or psychological effects on women for one cycle of treatment, regardless of their PMS history.

Effect of menstrual cycle phase and oral contraceptive use on serum lithium levels after a loading dose of lithium in normal women.

Serum lithium levels were analyzed in six healthy, normal women during the midfollicular, midluteal, and premenstrual phases of their menstrual cycles after they had received 300 mg of lithium carbonate orally. An identical protocol was followed for seven women with artificial cycles induced by oral contraceptive steroids. Analysis of variance for repeated measures over time showed no significant differences between groups or between cycle phases. Therefore, hormonal effects of ovarian or contraceptive steroids per se do not appear to alter serum lithium concentrations. Other factors may account for changing lithium requirements during the menstrual cycle in some patients with affective illness.

Lasting response to ovariectomy in severe intractable premenstrual syndrome.

A total of 14 women with severe premenstrual syndrome unresponsive to conservative medical therapy were treated with danazol in doses sufficient to suppress cyclic ovarian steroidogenesis. In each case medical ovarian suppression resulted in complete relief from symptoms. For ongoing symptom relief, each woman elected to undergo bilateral ovariectomy and concomitant hysterectomy. Both medical ovarian suppression and ovariectomy with low-dose conjugated estrogen therapy afforded lasting relief from cyclic symptoms of premenstrual syndrome and a corresponding improvement in overall quality of life. We conclude that cyclic ovarian steroidogenesis is a powerful determinant for the expression of premenstrual symptomatology. Ovariectomy with low-dose estrogen replacement is an effective alternative for the woman with debilitating premenstrual syndrome who does not respond to conventional interventions.

The stability of synthetic gonadotropin-releasing hormone in solution.

The stability of GnRH stored in solution under different conditions was assessed employing both immunoassay and bioassay techniques. No appreciable loss of activity was encountered after 4 weeks of storage at either 4 degrees C or room temperature.

When people die. Cause of death versus time of death.

A sample of 4,920 disease-related deaths from New York City for 1979 (8.7 percent of all relevant data from New York City's files) showed a 60 percent rise in death rate beginning at 2 A.M. and reaching a peak at 8 A.M. A smaller peak was also noted at 6 P.M. The rise in human mortality beginning at 2 A.M. and peaking at 8 A.M. might be explained by: artifact of deaths occurring anytime during the night that are discovered after daybreak, effect of less efficient health care between 2 A.M. and 8 A.M., and disease processes that somehow increase risk of death between 2 A.M. and 8 A.M. An attempt was made to differentiate among these possibilities by comparing time of death for various subsamples. The bimodal pattern appeared only in the temporal distribution of deaths of persons over 65 years of age; deaths of persons under 65 did not show significant temporal concentration. There were also prominent differences in the distribution of deaths for different reported causes of death. Ischemic heart disease, which numerically accounted for over 50 percent of the sample, showed peak mortality at 8 A.M. for both males and females. Hypertensive disease showed a significant peak in mortality at 1 A.M. for females only. Cerebrovascular disease peaked significantly at 6 A.M. with a significant peak only for males. The age and disease specificity of the 2 A.M. to 8 A.M. rise in death is consistent with a disease-related explanation for the bimodal circadian pattern in mortality. The quality and efficiency of health care could be improved with more precise information on peak periods of risk for specific morbid conditions.

Oral glucose tolerance during the menstrual cycle in normal women and women with alleged premenstrual "hypoglycemic" attacks: effects of naloxone.

To resolve existing controversies about the impact of the menstrual cycle on oral glucose tolerance, we examined the glucose, insulin, and glucagon responses to an oral glucose challenge at different phases of the menstrual cycle in five normal women (NW) and six women with premenstrual syndrome and alleged premenstrual hypoglycemic attacks (PMHA). Responses to oral glucose did not differ significantly between follicular and luteal phase studies in either group, nor were significant differences found between the responses of NW and women reporting PMHA. In parallel studies, the possible glucoregulatory effects of endogenous opiates were assessed. Concomitant infusion of naloxone altered neither the basal concentrations of glucose, insulin, and glucagon nor the responses of these measures to the glucose challenge. We conclude that NW and women with premenstrual syndrome and alleged PMHA have no menstrual cycle-related changes in glucose, insulin, or glucagon responses to an oral glucose load. The fact that four of six PMHA subjects had symptoms typical of hypoglycemia at glucose nadirs above 50 mg/dl suggests that an explanation other than hypoglycemia must be sought for such symptomatic episodes. Endogenous opiate peptides appear to exert no glucoregulatory effects at naloxone-sensitive receptor sites.

Obstructive sleep apnea and body weight.

A patient with obstructive sleep apnea was monitored five times during three years while his weight fluctuated within a range of 26 kg. The number of apneas per hour of sleep varied from 59.6 at 111 kg of weight to 3.1 at 85 kg. The relation between apneas per hour of sleep and body weight was a logarithmic function. A modest decrease in weight was thus associated with a disproportionally larger decrease in the rate of apneas. Typical SaO2 levels during the apneic episodes also had a logarithmic relation with body weight. Apnea-related sinus bradycardia and sinus tachycardia were only present at the highest weight. The results suggested that dieting and weight loss lead to an improvement in sleep apnea and related sequelae.

Quantification of penile "buckling" force.

A hand-held transducer was developed for measuring penile rigidity. This instrument gives a quantitative measure of the force at which the penis "buckles." The transducer consists of a cantilever beam with strain gages that is rugged, easy to calibrate, and adaptable to most graphic recorders.