P Eiken1, N Kolthoff. 1. Department of Clinical Physiology, Hillerød Hospital, Denmark.
Abstract
OBJECTIVE: To study long-term compliance with oral hormonal replacement therapy (HRT). METHODS: A total of 151 early postmenopausal women were initially randomly allocated to three groups in a double-blind, placebo controlled trial. Fifty women receivedcontinuous combined therapy, another 50 were placed on sequential therapy, while the remaining 51 women were given placebo for 2 years with no subsequent therapy. After 2 years of the trial, the women were followed in an open investigation for a total of 8 years. RESULTS:After 8 years, 112 (85%) women were interviewed. None of the women in the combined group had changed to other therapies (46% were still in treatment), 32% were still being treated with sequential therapy and 18% had changed to other HRTs (mainly because the women disliked the monthly bleeding induced). Of the placebo group, 18% had started HRT while 53% still did not receive any therapy. Of the women who had taken combined therapy for 5 years, 95% were still in therapy at the 8-year stage. Of the 25 women who had taken sequential therapy for 5 years, 52% continued until the 8-year stage and a further 16% received other types of HRT. The women who changed HRT switched to continuous combined therapy. CONCLUSION: The continuous combined treatment might provide an alternative to sequential treatment in postmenopausal women to achieve high long-term compliance.
RCT Entities:
OBJECTIVE: To study long-term compliance with oral hormonal replacement therapy (HRT). METHODS: A total of 151 early postmenopausal women were initially randomly allocated to three groups in a double-blind, placebo controlled trial. Fifty women received continuous combined therapy, another 50 were placed on sequential therapy, while the remaining 51 women were given placebo for 2 years with no subsequent therapy. After 2 years of the trial, the women were followed in an open investigation for a total of 8 years. RESULTS: After 8 years, 112 (85%) women were interviewed. None of the women in the combined group had changed to other therapies (46% were still in treatment), 32% were still being treated with sequential therapy and 18% had changed to other HRTs (mainly because the women disliked the monthly bleeding induced). Of the placebo group, 18% had started HRT while 53% still did not receive any therapy. Of the women who had taken combined therapy for 5 years, 95% were still in therapy at the 8-year stage. Of the 25 women who had taken sequential therapy for 5 years, 52% continued until the 8-year stage and a further 16% received other types of HRT. The women who changed HRT switched to continuous combined therapy. CONCLUSION: The continuous combined treatment might provide an alternative to sequential treatment in postmenopausal women to achieve high long-term compliance.