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The role of blood loss and diet in the aetiology of mild iron deficiency in premenopausal adult New Zealand women.

OBJECTIVE: To investigate the role of blood loss and diet in the aetiology of mild iron deficiency (MID) in premenopausal New Zealand women. Mild iron deficiency was defined as low, but not necessarily exhausted, iron stores (i.e. serum ferritin <20 microg/L) in the absence of anaemia (i.e. haemoglobin > or =120 g/L). DESIGN: Cross-sectional study of a volunteer sample of premenopausal adult women. Information on habitual dietary intakes (using a specially designed and validated computerised iron food frequency questionnaire), health and demographic status, sources of blood loss (including menstrual blood loss estimated using a validated menstrual recall method), contraceptive use, height and weight, haemoglobin, serum ferritin and C-reactive protein were collected. SETTING: Dunedin, New Zealand during 1996/1997. PARTICIPANTS: Three hundred and eighty-four women aged 18-40 years. RESULTS: The characteristics that were associated with an increased risk of MID were: low meat/fish/poultry intake, high menstrual blood loss, recent blood donation, nose bleeds, and low body mass index. The protective factors included shorter duration of menstrual bleeding, and multivitamin-mineral supplement use in the past year. CONCLUSIONS: There are a number of potentially modifiable factors that appear to influence risk of MID. Women with low menstrual blood loss may be able to decrease their risk of MID by increasing their meat/fish/poultry intake, while those with a higher menstrual blood loss may be able to decrease their risk by decreasing their menstrual blood loss, perhaps by changing their method of contraception. Women should be encouraged to maintain a healthy body weight, and those who choose to donate blood, or who experience nose bleeds, should have their iron stores monitored.

Adolescent↗

The effect of an injectable progestogen contraceptive on blood coagulation and fibrinolysis.

In 26 women receiving either medroxyprogesterone acetate (Depo-Provera) injections or combined oestrogen-progestogen pills for contraception, tests of coagulation and fibrinolysis were performed before treatment, and after 8, 16 and 24 weeks of therapy. In the medroxyprogesterone group no significant changes were induced in fibrinogen, the vitamin K-dependent factors, or antithrombin III. Plasminogen levels fell during therapy, and were significantly lower than pre-treatment values after 16 and 24 weeks. By contrast, the 13 women receiving oral contraceptives showed raised levels of fibrinogen and plasminogen after 8 weeks of treatment, and of factors VII and X after 24 weeks. These data suggest that medroxyprogesterone acetate injections induce fewer changes in the blood coagulation system than oral contraceptives.

Adult↗

Decline in bone mineral density with stress fractures in a woman on depot medroxyprogesterone acetate. A case report.

BACKGROUND: Depot medroxyprogesterone acetate is a popular contraceptive among young, physically active women. However, its administration has been linked to a relative decrease in estrogen levels. Since bone resorption is accelerated during hypoestrogenic states, there has been growing concern about the potential development of osteoporosis and fractures with the use of this contraceptive method. CASE: A physically active, 33-year-old woman demonstrated a 12.4% drop in femoral neck bone mineral density (BMD), 6.4% drop in lumbar BMD and 0.8% drop in total BMD with the subsequent development of a tibial stress fracture while on depot medroxyprogesterone acetate. Bone mineralization rapidly improved, and the stress fracture resolved with discontinuation of the medication. CONCLUSION: The long-term effects of depot medroxyprogesterone acetate on bone mineralization in physically active women should be evaluated more thoroughly.

Adult↗

Was the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings.

OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.

Case-Control Studies↗

Contraception with levonorgestrel, 0.15 mg, and ethinyl estradiol, 0.03 mg. Clinical studies in Latin America.

Levonorgestrel, 0.15 mg, and ethinyl estradiol, 0.03 mg, an ultra-low-dose oral contraceptive product, was studied in Latin America. In total, 1,206 sexually active, fertile women in their reproductive years were followed through 9,736 cycles. Only one of eight pregnancies was attributed to failure of the medication, resulting in a corrected Pearl index of 0.13. Very good cycle regulation was achieved, with an acceptably low rate of intermenstrual bleeding. The medication was discontinued for medical reasons in only 5% of the patients. Apart from a mild case of thrombophlebitis, there were no major side effects. These studies show that this combination oral contraceptive provides effective contraception with a very low incidence of side effects.

Clinical Trials as Topic↗

Comparison of contraceptive acceptability of levonorgestrel and ethinyl oestradiol administered in one three-phasic (Trionetta) and one monophasic (Neovletta) version.

In a Swedish multicenter study, a total number of 835 women completed a total of 6472 treatment cycles. Half of them were allotted at random to use the monophasic oral contraceptive Neovletta, also known as Microgynon 30 (30 micrograms ethinyl oestradiol + 150 micrograms levonorgestrel in each tablet). The second half was allotted to Trionetta, also known as Triquilar, Trigynon and Logynon (6 tablets with 30 micrograms ethinyl oestradiol + 50 micrograms levonorgestrel, 5 tablets with 40 micrograms ethinyl oestradiol + 75 micrograms levonorgestrel and 10 tablets with 30 micrograms ethinyl oestradiol + 125 micrograms levonorgestrel). The latter version was also present in a 28-day version containing in addition 7 "placebo" tablets to be used in the otherwise tablet-free interval. The contraceptive reliability was excellent although one pregnancy occurred in the three-phase version. It could be attributed to patient failure. In all aspects of bleeding control, the three-phasic pill proved to be superior to the reference monophasic preparation. The extreme low incidence of missed withdrawal bleeding and stability already during the first months of use are noteworthy features. For both preparations, continuation rate was at six months of use about 85% and at 12 months it was a similar figure. The most common reason for withdrawal was bleeding, about 5% each for both preparation. No serious side-effects were reported. The study clearly indicates that the three-phasic version is a major improvement in spite of a considerably decreased total dose of the gestagen.

Clinical Trials as Topic↗

Effects of oral contraceptive combinations containing levonorgestrel or desogestrel on serum proteins and androgen binding.

The effects of the oral contraceptive combinations 0.125 mg Org 2969 (desogestrel) (13-ethyl-11-methylene-18,19-dinor-17alpha-pregn-4-en-20-yn-17-ol) + 0.05 mg ethinyloestradiol (EE) and 0.125 mg levonorgestrel + 0.05 mg EE on serum sex-hormone-binding globulin (SHBG), ceruloplasmin, transcortin and ratio free testosterone over total testosterone (percentage free testosterone) and ratio free 5alpha-dihydrotestosterone over total 5alpha-dihydrotestosterone (percentage free 5alpha-dihydrotestosterone) were compared in healthy female volunteers. Treatment was randomly distributed over the volunteers; 11 women received Org 2969 + EE and 11 women received levonorgestrel + EE. These combinations induced similar increases in transcortin levels (115 and 140%) and ceruloplasmin levels (115 and 123%) after 3 months of treatment. However, the combination Org 2969 + EE induced a substantial increase (213%) in SHBG capacity after 3 months of treatment, whereas a smaller increase (80%) was observed with levonorgestrel + EE. A return to pretreatment values was observed 2 months after termination of treatment for all parameters. The difference in the effects of both preparations oh SHBG was statistically significant and can be best explained by a difference in the androgenicity of the progestogens. A good correlation was free testosterone and the reciprocal value of the percentage free 5 alpha-dihydrotestosterone. These results confirm that SHBG is the major regulator of the biologically active free androgen fraction in women before, during and after combined oral contraceptive treatment.

Adolescent↗

Contraceptive choices for women with endocrine complications.

Previous confusion regarding the interference by oral contraceptives in measurements of endocrine function have been largely eliminated by the advent of improved, more sensitive assays. There are few if any contraindications to oral contraceptive use in patients with thyroid disease. Patients with prolactinoma can be treated with bromocriptine to restore fertility and prevent mineral loss. However, as a less expensive alternative, oral contraceptives can be prescribed to correct mineral loss, because there is no convincing evidence of an adverse effect on prolactinomas by the steroidal content of the pill. Oral contraceptives comprise a near ideal treatment modality for women with polycystic ovary disease because, among other effects, oral contraceptives reduce synthesis of androgen by inhibiting pituitary gonadotropin secretion.

Contraception↗

Action of hormonal contraceptives on the coagulation system and some of its inhibitors.

Changes in the level of inhibitors of the coagulation system, primarily of thrombin neutralizing factors have been studied during the prolonged use of four products of contraceptive preparations containing various amounts of oestrogens and progestogens, two fixed dose pills (Bisecurin, Ovidon), a low dose combination pill (Rigevidon) and a biphasic preparation (Anteovin). Thrombelastographic values referred to hypercoagulability while the results of other examinations indicating activation of the coagulation system did not show definite changes in comparison with the control. The activity and quantity of antithrombin III decreased but never below 80%. Except Anteovin all contraceptives significantly enhanced alpha 1-antitrypsin while alpha 2-macroglobulin levels, remained nearly the same as the control values. Attention is called to that the increased alpha 1-antitrypsin level may be a biochemical risk factor. The results showed that the increased coagulability and disposition to thromboembolic disorders caused by hormonal contraceptives may be attributed not only to the decrease of thrombin inhibitors but also to increased alpha 1-antitrypsin levels which may cause increased inhibition of the fibrinolytic system.

Adolescent↗

Cycle control on low-dose oral contraceptives: a comparative trial.

Cycle control was studied comparing the monophasic oral contraceptive Loestrin with three low-dose phasic preparations (Triphasil, Ortho 10/11 and Ortho 7/7/7) in 391 women of whom 300 completed 6 cycles. Loestrin subjects had a rate of occurrence (31% of cycles) for intermenstrual bleeding (IMB) comparable to the rates for subjects on the phasic preparations (36%, 37% and 37%, respectively). Triphasil subjects had lower rates than the Ortho 10/11 and Ortho 7/7/7 subjects (p less than 0.01) in cycle one when all subjects were analyzed and in pre-study users when continuing menstrual flow (CMF) episodes were not included as IMB. IMB was a cause for dropping out of the study in 7% of subjects who were evenly distributed between groups. There were no differences between groups for BTB when perceived by subjects as a side effect. Spotting was perceived as a side effect more often with Ortho 10/11 and Ortho 7/7/7 use than with Triphasil (p less than 0.01). Loestrin, Ortho 10/11 and Ortho 7/7/7 subjects were more likely to report amenorrhea (p less than 0.001) and less likely to report leg cramps (p less than 0.01) compared to those on Triphasil. Triphasil subjects were less likely to report acne than subjects on Ortho 7/7/7 (p less than 0.01).

Adolescent↗