Weight gain in menopause: systematic review of adverse events in women treated with black cohosh.

Weight gain is a frequent problem in perimenopausal and postmenopausal women. Cimicifuga racemosa (CR) is a popular treatment option for menopausal symptoms. The aim of this review was to investigate whether there is scientific evidence that CR causes weight gain. We searched our database for medically confirmed, spontaneous adverse events regarding weight gain, literature for case reports and randomized controlled trials. Thirty cases in total were spontaneously reported in 15 years. The causality was not considered certain/likely in any of the cases. A nurse (consumer) assessed the causality as possible. Only one case was published in the literature. However, no change in body fat composition was reported, and the causality seems unlikely. Of the 31 identified studies, 17 were double-blind placebo-controlled, five were double-blind reference-controlled and nine were open reference-controlled. In total, 1839 women were treated with CR for up to 12 months. Two studies reported weight gain as an adverse event; however, no significant differences in weight changes were observed between the groups. One case of weight gain (about 2 kg) was reported, but the authors did not specify in which treatment group. In conclusion, this study provides no scientific evidence that the use of Cimicifuga racemosa causes weight gain in menopausal women.

Review & meta-analysis: isopropanolic black cohosh extract iCR for menopausal symptoms - an update on the evidence.

A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John's wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCR+HP combination was superior to iCR monotherapy. Efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCR+HP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCR+HP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.

Assessing sequential irregularity of both endocrine and heart rate rhythms.

The quantification of subtle patterns in sequential data, and their changes, has considerable potential utility both in analysis of hormonal secretory dynamics, and of fetal heart rate rhythms. Approximate entropy, a recently developed statistic quantifying serial irregularity, has been applied in both these settings, and has yielded a number of new findings. Among endocrine applications, approximate entropy increases with increasing age for luteinizing hormone and follicle stimulating hormone, for both women and men, indicating greater irregularity (more apparently random dynamics) in the older groups; for the luteinizing hormone-testosterone axis, both irregularity and asynchrony increases accompany advancing age for men. These findings produce a means to potentially predict time until menopause onset, the efficacy of infertility drugs, and also provide firm quantitative support of a partial male menopause. In fetal monitoring, antepartum, and postnatal heart rate studies, approximate entropy consistently detected subtle shifts in heart rate rhythmicity, with greater regularity clinically corresponding to compromised physiology in all settings. Both the capability of approximate entropy to quantify rhythm changes undiscernible by auscultation, and a continuum interpretation linking per-individual antepartum, perinatal, and postnatal heart rate analyses provide considerable potential enhancement to the present clinical utility of fetal monitoring.

Contemporary management of ectopic pregnancy.

Over the five years 1975-79 at Yale-New Haven Hospital, ectopic pregnancy changed from a disease requiring acute emergency are utilizing radical surgery for a ruptured ectopic to a disease requiring chronic, observant care utilizing conservative treatment for the unruptured ectopic. One hundred ninety-five cases of ectopic pregnancy have been retrospectively reviewed to determine how laparoscopy, ultrasound and beta pregnancy testing have affected this change. Over the reviewed period of time, the rate of diagnosed and treated unruptured ectopic pregnancies increased from 8% to 35%. Those patients with ectopic pregnancies having laparoscopy prior to laparotomy rose from 11% to 29.5%. Ultrasound diagnosed intrauterine pregnancy in 13% of those patients suspected of having an ectopic pregnancy by defining an intrauterine gestational sac and demonstrated a mass in 85% of patients diagnosed as having an ectopic pregnancy, although the mass was not always the ectopic pregnancy. Beta pregnancy testing, available only over the past two years, was positive in 99%, with only one false negative. One hundred twenty-eight culdocenteses were done, with 85% positive, and was the most important factor in deciding on emergency versus expectant care. These factors have allowed us to treat ectopic pregnancy expectantly, making the diagnosis sooner and more accurately, leading to an increase in conservative treatment and employing salpingostomy as opposed to salpingectomy as the rate of unruptured ectopic pregnancy increases.

Prophylactic antibiotics in gynecologic surgery.

A 2-year prospective double-blind study of prophylactic antibiotics in 317 patients undergoing elective total abdominal or vaginal hysterectomy was conducted. Patients randomly received placebo, penicillin, or cefazolin 30 minutes prior to surgery and at 6-hour intervals thereafter for 48 hours. Rigid criteria for postoperative morbidity were established. Vaginal hysterectomy patients given either penicillin or cefazolin prophylaxis had fewer postoperative infections (P less than 0.01) compared to those given placebo. A similar trend was noted among women undergoing abdominal hysterectomy; however, this trend was not statistically significant (P greater than 0.05). Despite continuous surveillance, no change in nosocomial flora or antibiotic sensitivity of bacterial isolates was noted. Adverse drug effects and antibiotic-resistant secondary infections were encountered with similar frequency in all treatment groups.

Yale studies of patient care. I. The evaluation of the febrile patient.

Observations are reported on the variation in evaluation and management of 216 episodes of fever in 690 patients on four services of a university hospital. Twenty-two percent of febrile episodes were not commented upon in the medical record. Thirty percent of all fevers and 14% of antibiotic-treated fevers were not evaluated with microbiologic cultures. The extent of evaluation varied with service and varied directly with the height of the fever and the clinical recording of abnormality in temperature.