Long-term pharmacotherapy in patients with uterine myoma: assessment of effectiveness

BACKGROUND: Uterine myoma is one of the most prevalent gynecological diseases. Data concerning the effects of the medicinal agents used in patients with uterine leyomyomas, are both scientifically and practically important.

AIM: This study aims to assess the clinical, laboratory, and instrumental effectiveness of 5-year use of micronized oral contraceptive containing estrogen and progestogen, intrauterine levonorgestrel-releasing system and progesterone receptor modulator in patients with uterine myoma.

MATERIAL AND METHODS: Patients aged from 21 to 40 years old were assigned to 3 arms in accordance with the treatment regimen. Group 1 included 42 women with myomas ≤2 cm in diameter. These patients received combined oral contraceptive pills containing ethinylestradiol 20 mcg and desogestrel 150 mg according to the conventional contraceptive regimen, i.e. one pill daily, 21-day courses with following 7-day pauses. Group 2 included 34 women with uterine myoma and concomitant uterine endometriosis. In this group, the intrauterine devices containing levonorgestrel were inserted. Group 3 included 33 patients treated with the progesterone receptor modulator in order to reduce the diameter of uterine myomas. They received oral mifepristone at a dose of 50 mg daily for three months, followed by a 3-month pause and subsequent 3-month course of treatment. During the year, two cycles that included 3-month treatment course and 3-month treatment-free period, were repeated. All patients underwent standard clinical, laboratory and instrumental gynecological examination. Statistical processing was performed in the basis of Statistica 12.0 software.

RESULTS: In Group 1, 80.9% of patients exhibited unchanged mean diameters of uterine myomas all over the course of treatment with contraceptive drugs, 16.7% of patients demonstrated growth of myoma (by 15%), while in 2.4% of patients myoma reduction (by 5%) was observed. In Group 2, the increase in the diameter of leiomyoma ranged from 20 to 30 percent was observed following the insertion of intrauterine levonorgestrel-releasing system in 58.8 percent of patients. In contrast, 35.3 percent of patients exhibited no change in myoma size, while a decrease by 15 percent was observed in only 5.9 percent of patients. In Group 3, 10 intermittent 3-month courses of mifepristone (50 mg) resulted in the reduction of uterine myoma by 40%–50% of the baseline diameter in 97.0% of patients. In general, the study drugs demonstrated beneficial effects and safety in patients with leiomyoma.

CONCLUSION: The long-term use of low-dose oral contraceptives generally leads in the stabilization of the size of uterine myomas, while intrauterine levonergestrel-releasing system prevents their intensive growth. Nevertheless, the use of a drug belonging to the progesterone receptor modulator class, has proven to be the most effective approach to reducing the size of myomas.