Mifepristone versus placebo to treat uterine myoma: a double-blind, randomized clinical trial.

OBJECTIVE: To evaluate the efficacy, safety, and quality of life of 5 mg mifepristone per day compared with a placebo in treating uterine fibroids. DESIGN: Randomized, double-blind clinical study. LOCATION: Eusebio Hernández Gynecology and Obstetrics Teaching Hospital, Havana, Cuba. SUBJECTS: One hundred twenty-four subjects with symptomatic uterine fibroids. TREATMENT: One daily capsule of 5 mg mifepristone or a mifepristone placebo over 3 months. VARIABLES IN EVALUATING SAFETY: Changes in fibroid and uterine volumes, changes in symptom prevalence and intensity, and changes in quality of life. RESULTS: Three months into treatment, fibroid volume was reduced by 28.5% in the mifepristone group with an increase of 1.8% in the placebo group (P = 0.031). There were significant differences between the groups with respect to pelvic pain prevalence (P = 0.006), pelvic pressure (P = 0.027), rectal pain (P = 0.013), hypermenorrhea (P < 0.001), and metrorrhagia (P = 0.002) at the end of treatment. Amenorrhea was 93.1% and 4.3% in the mifepristone and placebo groups, respectively (P < 0.001). Treatment side effects were significantly greater in the mifepristone group. Estradiol levels did not differ significantly between the placebo and mifepristone groups at the end of treatment. Improvement in quality of life was significantly greater in the categories of "symptoms" (P = 0.004) and "activity" (P = 0.045) in the mifepristone group. CONCLUSION: The 5 mg dosage of mifepristone presented significantly superior efficacy compared to the placebo.

Mifepristona para tratamiento del fibroma uterino / The use of Mifepristone for treatment of the uterine fibroma

OBJETIVOS: Evaluar la eficacia, seguridad y duración de la mejoría clínica en el tiempo de la administración de 5 vs. 10 mg diarios de mifepristona en el tratamiento del fibroma. MÉTODOS: Fueron aleatorizadas a recibir 5 ó 10 mg diarios de mifepristona oral durante 3 meses y fueron seguidas durante 6 meses después, 100 mujeres con fibromatosis uterina sintomática. Se calcularon los volúmenes del fibroma y del útero por ultrasonografÍa abdominal del útero al inicio, al final del tratamiento, 3 y 6 meses después. RESULTADOS: Al final del tratamiento el fibroma se redujo en 38,3 por ciento, p < 0,001, y 47,5 por ciento, p < 0,001, respecto del valor inicial en los grupos de 5 y 10 mg, respectivamente. El volumen del útero se redujo el 27 por ciento (p = 0,001) y 25,1 por ciento (p = 0,001), con respecto al inicio en los grupos de 5 y 10 mg, respectivamente. La prevalencia de los síntomas fue significativamente menor al final de tratamiento y 6 meses después. Seis meses después del tratamiento el tamaño del fibroma era 21, por ciento y 19, por ciento menor que el valor inicial en los grupos de 5 y 10 mg de mifepristona, respectivamente, y el volumen del útero era 2 por ciento y 0,2, por ciento menor que al inicio en los grupos de 5 y 10 mg, respectivamente. No hubo hiperplasia endometrial en ninguno de los grupos de tratamiento. CONCLUSIONES: La dosis de 5 mg tuvo similar eficacia que la de 10 mg y 6 meses después de concluido el tratamiento los tamaños del fibroma y del útero estaban cercanos a los valores pretratamiento, pero se mantenía una notable mejoría clínica

OBJECTIVES: to evaluate the efficacy, safety and duration improvement obtained over the course of time by administering mifepristone for the treatment of fibroids. METHODS: One hundred women with symptomatic uterine myomas were randomized to receive oral mifepristone 5 or 10 mg daily for 3 months with 6 month post-treatment monitoring. The fibroid and uterus sizes were calculated by means of abdominal ultrasound examination at the beginning and at the end of treatment as well as 3 and 6 months later. RESULTS: At the end of treatment the fibroid decreased in size 38.3 por ciento, p < 0.001, and 47.5 por ciento, p < 0.001, respecting to the initial value in the 5 and 10 mg groups, respectively. The uterine volume decreased 27 por ciento (p = 0.001) and 25.1 por ciento (p = 0.001), regarding to initial values in the 5 and 10 mg groups, respectively. Symptom prevalence was significantly less at the end of treatment and 6 months later. Six months after treatment fibroid size was 21 por ciento and 19 por ciento less than the initial value in the 5 and 10 mg mifepristone groups, respectively, and uterine volume was 2 por ciento and 0.2 por ciento less than initial values in the 5 and 10 mg groups, respectively. There was no endometrial hyperplasia in any of the treatment groups. CONCLUSIONS: The 5 mg dose had an efficacy similar to the 10 mg dosage and 6 months after termination of the treatment fibroid and uterine sizes were close to pre-treatment values but a notable clinical improvement was maintained