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Geneva, Switzerland, WHO, 1981. 76 p. (WHO Technical Report Series No. 657)This report on the effect of female sex hormones on fetal health and development aimed to evaluate research on the specific types of sex hormones and their uses, to determine their safety with respect to fetal development and infant health, and to recommend further research in these areas. Theoretically, sex hormones can affect any stage of fetal development. Sex hormones appear to act by promoting synthesis of messenger ribonucleic acid (mRNA) in target tissues, so that research should focus on the specific proteins formed under the direction of newly synthesized mRNA to elucidate potential morphological and physiological effects of exogenous hormones. Following are some research avenues: cytogenetic research, microscopic and macroscopic examination, observations on births and later life, animal teratology, and epidemiological studies. Epidemiological studies not only help elucidate causal associations but also provide public health data. Studies of sex hormones and fetal development and infant health must be free of bias and often suffer from problems of defining pregnancy outcome. Also sex steroids are frequently administered at the same time as other drugs, leading to confounding effects of drug interactions. In order to assess existing data, it is necessary to disaggregate the data from different reports and then to regroup them according to the indications for use, i.e., infertility, contraception, pregnancy testing, supportive therapy during pregnancy, contraception during pregnancy, contraception during breast feeding. Likewise data must be disaggregated according to different types of exposure, i.e., preconception or postconception. The bulk of this monograph is spent disaggregating study data based on the above-stated rationales. The following recommendations are made for indications for use of sex hormones: 1) they should not be used as pregnancy tests; 2) diethylstilbestrol should not be prescribed to a suspected pregnant woman; 3) benefits of progestin therapies must first be proven before they can be recommended for use in supporting pregnancy; 4) oral contraceptives given before pregnancy seem to have no effect on subsequent pregnancy; and during lactation combined therapy should not be given.
Geneva, Switzerland, WHO, 1978. (World Health Organization Technical Report Series No. 619) 54 pStudies on steroid contraception (SC) and risk of neoplasia are reviewed. Methodological issues in neoplasia etiology studies include: 1) possibility of a latent period between exposure to cause and disease development; 2) cumulative effects of prolonged or repeated SC exposure; 3) discontinued drugs or dosage schedules; 4) time of exposure (adolescence or prenatal, e.g.); 5) isolation of specific causes among multiple risks; and 6) variations in neoplasma diagnoses. The 4 epidemiological approaches to SC-associated neoplasia studies have inherent shortcomings, but cohorts yield significant associations. Relative risk (ratio of disease incidence among exposed vs. nonexposed persons) is an index of association only, not evidence of cause and effect. Benign breast neoplasia risk was reduced by current SC use of >2 years, and weak evidence points to a residual protective effect, apparently associated with progestogen dose. Aggregated breast cancer data show no clear adverse or beneficial effect of SC use; however, evidence suggests SCs may increase breast cancer risk in population subgroups (e.g., young women). Only short-term evidence is available; hence, no inference of long-term SC breast cancer effects is possible. No beneficial effect of SCs on uterine fibroids is evident, but sequential SCs, no longer marketed, may have increased risk to endometrial carcinoma. Inconclusive data suggest SCs may decrease ovarian cancer risk. Increased risk of cervical dysplasia and carcinoma in situ is associated with SC use, especially long-term use by women with predisposing factors. Risk of hepatocellular adenoma of the liver increases with prolonged SC exposure, especially high dose. Relevance of existing data from more developed countries to disease risk in less developed ones is discussed, and recommendations made.
LAKARTIDNINGEN. 1979 Apr 25; 76(17):1625-7.An overview of the risk of developing cancer related to oral contraceptive (o.c.) use is presented. A committee of experts affiliated with WHO studied the problem of developing cancer related to o.c. use. O.c. use for more than 2 years prevents the formation of benign breast tumors, even after discontinuing o.c. use. The effect is due to the progestin component. There is no clear indication that o.c. use increases the risk of breast cancer. A higher risk of endometrial cancer is associated with sequential preparation use, but not with the use of combination preparations. Cervical neoplasms and pituitary adenoma may be more frequent among predisposed women who use o.c.s. Studies show a reduced risk of ovarian cancer with o.c. use, but more studies are necessary. There is a marked increase in the relative risk of developing hepatocellular adenoma among women who use o.c.s for longer than 3 years. The risk increases with the hormone dosage, the duration of treatment, and the age of the patient. There is no reliable data to indicate that the risk of malignant melanoma increases with o.c. use. More study is needed to determine the possible cancer risks of injection preparations. Combination preparations can cause an increased risk of vaginal epithelial metaplasia. Diethylstilbestrol taken during early pregnancy can cause vaginal neoplasms in the offspring. More epidemiological studies and clinical and laboratory studies on the carcinogenic effects of o.c.s and the endocrinological effects of o.c.s on younger women should be undertaken. It is recommended that o.c.s with the lowest possible hormone dosages be used. O.c.s should not be prescribed to women with vaginal adenosis. (Summary in ENG)