2016•Journal of Evidence Based Medicine and HealthcareOpen access

EFFECT OF LOW DOSE MIFEPRISTONE IN SYMPTOMATIC UTERINE LEIOMYOMA

Balla Sudha Rani, Durga Kumari P, Prasad Usha

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Abstract

BACKGROUND \nLeiomyoma is the common benign tumour of uterus occurring in up to 20% of women with maximum incidence between 35-45 \nyears of age leading to menorrhagia, pain and lump in abdomen. Medical treatment of leiomyoma are many with high cost and \nsignificant side effects. Mifepristone is a synthetic steroid with both anti-progesterone and anti-glucocorticoid activities. \n \nAIM \nThe aim of the study was to evaluate the effect of 25 mg Mifepristone on uterine and myoma volume, haemoglobin and \nsymptomatic improvement in cases of symptomatic leiomyoma. \n \nMATERIALS AND METHODS \nThe present clinical study was conducted at a tertiary care centre at Visakhapatnam. This study was a prospective randomized \ndouble blind clinical trial. A total of 40 patients with symptomatic leiomyoma and normal endometrial histology were included \nin this study. After the written informed consent, symptoms like menorrhagia, dysmenorrhoea, pelvic pressure, low back ache \nwas obtained. Severity of pain was graded according to visual analogue scale while quantification of blood loss was done using \npictorial blood loss assessment chart (PBAC). \n \nRESULTS \nThe mean age, parity and number of patients with symptoms was comparable in both the groups. After treatment, all the \npatients in group M had complete resolution of symptoms where as those patients in group C still continued to have the \nsymptoms. After treatment, mean uterine volume in group M was 130.95±96.89 compared to that of 212.52±146.56 before \ntreatment. The mean leiomyoma volume in group M, before treatment was 139.15±113.15 and after treatment was \n78.15±71.18, a reduction of 43.84% was noted. In group C, the mean leiomyoma volume before treatment was 170.38±169.97 \nand after treatment was 177.78±171.56, an increase in volume of 4.34% was noted. The mean haemoglobin concentration in \nmifepristone group before treatment was 8.57±0.79 and after treatment was 10.09±0.99. \n \nCONCLUSION \nLow dose mifepristone is useful in case of symptomatic moderate sized leiomyoma, perimenopausal age group with symptomatic \nleiomyoma and high risk cases with uterine leiomyoma where surgery has been postponed. The clinical safety of the drug has \nyet to be determined by larger sample size with longer periods of treatment because of the associated risk of endometrial \nhyperplasia.

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BACKGROUND \nLeiomyoma is the common benign tumour of uterus occurring in up to 20% of women with maximum incidence between 35-45 \nyears of age leading to menorrhagia, pain and lump in abdomen. Medical treatment of leiomyoma are many with high cost and \nsignificant side effects. Mifepristone is a synthetic steroid with both anti-progesterone and anti-glucocorticoid activities. \n \nAIM \nThe aim of the study was to evaluate the effect of 25 mg Mifepristone on uterine and myoma volume, haemoglobin and \nsymptomatic improvement in cases of symptomatic leiomyoma. \n \nMATERIALS AND METHODS \nThe present clinical study was conducted at a tertiary care centre at Visakhapatnam. This study was a prospective randomized \ndouble blind clinical trial. A total of 40 patients with symptomatic leiomyoma and normal endometrial histology were included \nin this study. After the written informed consent, symptoms like menorrhagia, dysmenorrhoea, pelvic pressure, low back ache \nwas obtained. Severity of pain was graded according to visual analogue scale while quantification of blood loss was done using \npictorial blood loss assessment chart (PBAC). \n \nRESULTS \nThe mean age, parity and number of patients with symptoms was comparable in both the groups. After treatment, all the \npatients in group M had complete resolution of symptoms where as those patients in group C still continued to have the \nsymptoms. After treatment, mean uterine volume in group M was 130.95±96.89 compared to that of 212.52±146.56 before \ntreatment. The mean leiomyoma volume in group M, before treatment was 139.15±113.15 and after treatment was \n78.15±71.18, a reduction of 43.84% was noted. In group C, the mean leiomyoma volume before treatment was 170.38±169.97 \nand after treatment was 177.78±171.56, an increase in volume of 4.34% was noted. The mean haemoglobin concentration in \nmifepristone group before treatment was 8.57±0.79 and after treatment was 10.09±0.99. \n \nCONCLUSION \nLow dose mifepristone is useful in case of symptomatic moderate sized leiomyoma, perimenopausal age group with symptomatic \nleiomyoma and high risk cases with uterine leiomyoma where surgery has been postponed. The clinical safety of the drug has \nyet to be determined by larger sample size with longer periods of treatment because of the associated risk of endometrial \nhyperplasia.

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Available abstract

BACKGROUND \nLeiomyoma is the common benign tumour of uterus occurring in up to 20% of women with maximum incidence between 35-45 \nyears of age leading to menorrhagia, pain and lump in abdomen. Medical treatment of leiomyoma are many with high cost and \nsignificant side effects. Mifepristone is a synthetic steroid with both anti-progesterone and anti-glucocorticoid activities. \n \nAIM \nThe aim of the study was to evaluate the effect of 25 mg Mifepristone on uterine and myoma volume, haemoglobin and \nsymptomatic improvement in cases of symptomatic leiomyoma. \n \nMATERIALS AND METHODS \nThe present clinical study was conducted at a tertiary care centre at Visakhapatnam. This study was a prospective randomized \ndouble blind clinical trial. A total of 40 patients with symptomatic leiomyoma and normal endometrial histology were included \nin this study. After the written informed consent, symptoms like menorrhagia, dysmenorrhoea, pelvic pressure, low back ache \nwas obtained. Severity of pain was graded according to visual analogue scale while quantification of blood loss was done using \npictorial blood loss assessment chart (PBAC). \n \nRESULTS \nThe mean age, parity and number of patients with symptoms was comparable in both the groups. After treatment, all the \npatients in group M had complete resolution of symptoms where as those patients in group C still continued to have the \nsymptoms. After treatment, mean uterine volume in group M was 130.95±96.89 compared to that of 212.52±146.56 before \ntreatment. The mean leiomyoma volume in group M, before treatment was 139.15±113.15 and after treatment was \n78.15±71.18, a reduction of 43.84% was noted. In group C, the mean leiomyoma volume before treatment was 170.38±169.97 \nand after treatment was 177.78±171.56, an increase in volume of 4.34% was noted. The mean haemoglobin concentration in \nmifepristone group before treatment was 8.57±0.79 and after treatment was 10.09±0.99. \n \nCONCLUSION \nLow dose mifepristone is useful in case of symptomatic moderate sized leiomyoma, perimenopausal age group with symptomatic \nleiomyoma and high risk cases with uterine leiomyoma where surgery has been postponed. The clinical safety of the drug has \nyet to be determined by larger sample size with longer periods of treatment because of the associated risk of endometrial \nhyperplasia.

Key concepts: Mifepristone, Medicine, Uterine leiomyoma, Leiomyoma, Gynecology, Surgery, Pregnancy, Biology

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