Efficacy of ipriflavone in preventing adverse effects of leuprolide

The purpose of this study was to evaluate the efficacy of ipriflavone in pr eventing bone loss, decreasing in serum cholesterol and decreasing the rate of appearance of vasomotor symptoms, as well as the effects of ipriflavone on reduction of myoma volume by estrogen deficiency during treatment with the GnRH analog leuprolide. One hundred two women (mean age, 44.3 +/- . 0.53 yr) receiving leuprolide t herapy for uterine leiomyoma were randomly allocated to two groups (group A , leuprolide only; group B, leuprolide with ipriflavone). Bone mineral density of the lumbar spine was measured by dual-energy x-ray absorptiometry before and after treatment for 6 months. Levels of serum tot al cholesterol (TC), triglyceride (TG), high-density lipoprotein cholestero l, and low-density lipoprotein cholesterol (LDL-C) were measured before tre atment and after 3 and 6 months of treatment. Subjects were asked to report the appearance of vasomotor symptoms throughout treatment. Myoma node volu mes were measured before treatment and after treatment for 6 months. Bone m ineral density was reduced in both groups, with reduction rates of -5.26% i n group A and -3.70% in group B (P < 0.01 vs. group A). Changes in bone mar kers were not significant in either group. TC was significantly increased i n both groups, and TG levels were increased significantly after 3 and 6 mon ths of treatment in group Abut not in group B. There was no significant dif ference between these two groups in amount of increase of either TC or TG. LDL-C levels were increased significantly after 3 and 6 months of treatment in both groups, and the differences between the groups (11.7% in group A v s. 7.5% ingroup B at 3 month and 22.6% in group A us. 8.4% in group B at 6 month) were significant. Severe vasomotor symptoms were reduced in group B. The rates of reduction of myoma volume were 49.8% in group A and 52.9% in group B; this difference between groups was not significant. Ipriflavone efficaciously alleviated the adverse effects of estrogen defici ency such as bone loss and increase in LDL-C level, and the ability of leup rolide therapy to reduce myoma volume was not decreased by ipriflavone admi nistration.