The purpose of this study was to compare tamoxifen to methotrexate, with respect to effectiveness, when followed by misoprostol to induce abortion. In the first phase, 198 women presenting for medical abortion at < 7 weeks gestation were randomized to receive either 40 mg of tamoxifen, followed 2 to 3 days later by 800 micrograms of misoprostol self-administered vaginally or 50 mg/m2 of methotrexate, followed 5 to 7 days later by the same dose of misoprostol. In the second phase, 200 women were randomized to receive 20 mg tamoxifen twice daily for 4 days, followed by 800 micrograms misoprostol or the same regimen of methotrexate and misoprostol as in phase 1. The main outcome measure was success rate determined by the number of women who aborted without surgery. In phase 1, the success rate was higher in the methotrexate group (93.0%) compared to the tamoxifen group (85.7%) (p = 0.045). In the tamoxifen group, nine of 98 women had incomplete abortions with symptoms requiring a surgical aspiration, compared to one of 100 women in the methotrexate group. In phase 2, the success rates were 90.9% in the methotrexate group compared to 84.7% in the tamoxifen group (p = 0.20). The side effects were less in the tamoxifen group in phase 1 but not in phase 2. When tamoxifen is given as a single dose, it is less effective than methotrexate but when it is given 20 mg twice daily for 4 days, there is no significant difference. Tamoxifen does not appear to have any benefits over methotrexate.
PIP: This study aims to compare the effectiveness of tamoxifen with that of methotrexate when each is used in combination with misoprostol for abortion. In the 1st phase of the study, 198 medical abortion cases at 7 weeks gestation were randomized to receive either 40 mg of tamoxifen followed by 800 mcg of misoprostol after 2-3 days or 50 mg/sq. m of methotrexate followed by the same dose of misoprostol after 5-7 days. In the 2nd phase, 20 mg tamoxifen twice daily for 4 days was administered to 200 women, followed by 800 mcg misoprostol or the same methotrexate and misoprostol regimen as in phase 1. The number of women who experienced abortion without surgery was determined to measure the success rate. The success rate in phase 1 was higher in the methotrexate group (93.0%) than in the tamoxifen group (85.7%) (p = 0.045). About 9 in 98 women in the tamoxifen group and 1 in 100 women in the methotrexate group had incomplete abortions, indicating surgical aspirations. In the 2nd phase, the success rates were 90.9% in the methotrexate group and 84.7% in the tamoxifen group (p = 0.20). There were fewer side effects in the tamoxifen group during the 1st phase but not in the 2nd phase. Tamoxifen was seen to be less effective than methotrexate if given in a single dose. There was no significant difference when tamoxifen was given in 20 mg doses twice daily for 4 days. There were no advantages observed in tamoxifen over methotrexate.