CONTINUOUS VERSUS CYCLICAL TRANSDERMAL ESTROGEN REPLACEMENT THERAPY IN POSTMENOPAUSAL WOMEN - INFLUENCE ON CLIMACTERIC SYMPTOMS, BODY-WEIGHT AND BLEEDING PATTERN

Objectives: To compare continuous and cyclical transdermal estrogen re placement therapy (ERT) with or without an oral progestogen regarding climacteric symptoms, body weight and bleeding pattern. Methods: A tot al of 2459 postmenopausal women were treated for three cycles of 28 da ys in an open, randomized, parallel group multicenter study. Patients received an estrogen matrix patch (50 mu g 17/beta-estradiol/day) twic e weekly, either continuously (eight patches/cycle) or cyclically (six patches/cycle, i.e. 3 weeks on, 1 week off). A total of 1232 patients were treated continuously and 1227 cyclically. In the study group 115 0 patients had an intact uterus (543 in the continuous and 607 in the cyclical treatment arm) and received, in addition to the estrogen patc h, an oral progestogen in a transformation dose for 12 days of each cy cle. Hysterectomized patients totaling 1309 (689 in the continuous ver sus 620 in the cyclical group) did not receive progestogen. Of the 245 9 patients, 771 (31.4%) participated in a follow-up study with two fur ther treatment cycles, which was offered to the patients at the end of the main study. The main outcome measures were climacteric symptoms, measured at the end of cycles 1-3 by a Visual Analogue Scale at baseli ne, and body weight measured at baseline at the end of cycles 3 and 5. In addition, the bleeding time per cycle (days) was evaluated in all patients with an intact uterus. Results: Continuous and cyclical trans dermal ERT reduced, over three treatment cycles, the average climacter ic symptom score by 1.77 and 1.70, respectively. The percentage remiss ion and improvement rates for the ten climacteric symptoms ranged betw een 69.3 and 88.0% and did not differ between the two groups. In patie nts with a higher symptom score at baseline, the continuous treatment was slightly more effective. However, this effect was statistically no t significant. After three treatment cycles body weight increased in b oth treatment groups by between 500 and 700 g. Further treatment durin g the follow-up study induced an additional average weight gain of 200 -400 g. These results were not influenced by the addition of an oral p rogestogen. In patients with an intact uterus, the average bleeding ti me at the end of the first cycle (5.4 days in the continuous versus 5. 3 days in the cyclical group) increased slightly during cycle 2 and re turned to baseline values at the end of cycle 3. Conclusions: Continuo us and cyclical transdermal ERT were equally effective in reducing cli macteric symptoms. The short term use of five cycles transdermal ERT i nduced a slight increase in body weight which was independent of the t reatment regimen. These results were not influenced by the type and mo de of administration of a progestogen. Both ERT regimens were very wel l tolerated and are suitable alternatives for estrogen replacement the rapy of postmenopausal women. (C) 1997 Elsevier Science Ireland Ltd.