Abstract | OBJECTIVES: The aim of this study was to evaluate the safety and improvement in quality of life using 10 mg and 5 mg daily doses of mifepristone for the treatment of uterine fibroids. DESIGN: The research was a randomized double-blind clinical study undertaken at the Eusebio Hernández Hospital in Havana, Cuba. SUBJECTS AND METHODS: RESULTS: There were 30/49 (61.2%) and 13/24 (54.2%) diagnoses of endometrial changes associated with mifepristone in the 10 mg and 5 mg groups, respectively (P = 0.282). At every evaluation visit the average endometrial thickness was significantly greater in the 10 mg group than in the 5 mg group (P = 0.013, P = 0.002, and P = 0.013, respectively). Only five subjects had slight elevations in their hepatic transaminases after 9 months' treatment. Sixteen of 35 (45.7%) and eight of 33 (24.2%) subjects had the occasional hot flush in the 10 mg and 5 mg groups, respectively (P = 0.032). In total, there were 12.9 ± 4.6 (n = 21) and 9.1 ± 3.9 (n = 18) days of irregular bleeding in the 10 mg and 5 mg groups, respectively (P = 0.009). CONCLUSION: According to the study findings, a 5 mg daily dose over 9 months has a relatively better safety profile than the 10 mg dose.
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Authors | Josep Ll Carbonell, Rita Acosta, Yasmiriam Pérez, Ana G Marrero, Edilia Trellez, Carlos Sánchez, Giuseppe Tomasi |
Journal | International journal of women's health
(Int J Womens Health)
Vol. 5
Pg. 115-24
( 2013)
ISSN: 1179-1411 [Print] New Zealand |
PMID | 23658500
(Publication Type: Journal Article)
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