Efficacy and safety of a seven-day, transdermal estradiol drug-delivery system: comparison with conjugated estrogens and placebo. The Transdermal Estradiol Patch Study Group.

OBJECTIVE: To evaluate the efficacy and safety of a new, seven-day, transdermal estradiol system in healthy postmenopausal women with hot flushes. METHODS: Two studies are described. In the first study, subjects were randomized to treatment with a 0.05 mg/day estradiol patch, a 0.1 mg/day estradiol patch, or a placebo patch; and in the second study, to treatment with either of the two estradiol patches or oral conjugated estrogens (as Premarin) 0.625 mg/day. Efficacy was evaluated on the basis of diary entries recording hot-flush frequency and severity. Subjects' and investigators' global assessments of treatment efficacy were recorded at follow-up visits. RESULTS: In Study 1, both the 0.05-mg and 0.1-mg estradiol patches were significantly more effective than placebo in reducing hot flushes and were associated with higher global assessments. In Study 2, all three active treatments produced a significant reduction in the number of hot flushes compared with base-line. There were no statistically significant between-group differences, although the response to the 0.1-mg estradiol patch was greater, and to the 0.05-mg estradiol patch less, than the response to conjugated estrogens. The patches were generally well tolerated. Skin irritation from the patch was the most common adverse experience in both studies. CONCLUSIONS: The new, seven-day, transdermal system effectively and safely treats post-menopausal vasomotor symptoms.

Extraperitoneal cesarean section: a new need for old skills. A preliminary report.

Preliminary results of the effect of extraperitoneal cesarean section on operative and postoperative morbidity are presented. The extraperitoneal technique did not prolong delivery time or operative time, as compared to transperitoneal cesarean section. Postoperative febrile morbidity seemed to be less in the patients who had extraperitoneal cesarean section, even when compared to randomly selected transperitoneal cases. Further data will be necessary to conclude that renewed interest in this technique is warranted.