To evaluate the effect of tamoxifen on vaginal epithelial maturation and on oestrogen-related hepatic synthesis, we prospectively studied the karyopyknotic index (KPI), the maturation index (MI), expressed as a percentage of parabasal (MI-1), intermediate (MI-2) and superficial (MI-3) cells, as well as the serum levels of the oestrogen-dependent sex hormone binding globulin (SHBG). Tests were performed at baseline, after 1, 3, 6 and 12 months of therapy in 64 post-menopausal breast cancer patients. Basal KPI ranged from 0 to 9 (mean 1.5 +/- 0.3) and rose 13.5-fold to 21 +/- 2.5 (P = 0.000) after the first 30 days of tamoxifen. Absence of KPI rise was observed in 23% of patients. Pretreatment MI figures 1, 2 and 3 were 56.9 +/- 5.6, 41.7 +/- 5.4 and 1.4 +/- 0.3, respectively, and sharply shifted to the right (P = 0.000) after 1 month of therapy, indicating an increase of vaginal epithelial maturation. At baselines the SHBG mean value was 62.1 +/- 3.3 nmol/l and underwent an increase of 44% (P = 0.000) after 30 days of tamoxifen. All of these observed 1-month modifications remained stable up to the studied 12 months of therapy. Present findings indicate an early and persistent oestrogenic effect of tamoxifen on the vaginal epithelium and the hepatic synthesis of SHBG.
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