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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The aim of this study was to analyze efficacy, tolerance, and adverse events of reversible contraceptives in women with cardiac disease. The authors studied prospectively, during a period of 24-39 (mean = 29) months, 89 women with heart disease of mean age 25.6 (16-42) years. Rheumatic heart disease was present in 73 cases (82%), congenital heart disease in 11 (11%), coronary artery disease in 2 (2%), and cardiomyopathy in 3 (3%). The patients were divided into three groups: GCO--35 patients taking combined oral contraceptives (30 mcg ethinyl estradiol and 75 mg gestodene); GIT--27 patients using injectable progestagens (depot medroxyprogesterone acetate); and GUID--27 patients with IUDs. In the GCO group were found 4 cases (11.4%) of arterial hypertension, 1 (2.8%) of a transient cerebral ischemic attack, 3 (8.5%) of spotting, 1 (2.8%) of amenorrhea, and 1 (2.8%) of pregnancy. Interruption of this method occurred in 4 cases (11.4%): 2 due to hypertension, 1 due to pregnancy, and 1 due to amenorrhea. In the GIT group there were 2 cases (7.4%) of arterial hypertension, 18 (66.6%) of amenorrhea, and 3 (11.1%) of spotting. Interruption of use occurred in 5 cases (18.5%): 2 due to amenorrhea, 2 due to weight gain, and 1 due to headache. In the GUID group there was 1 case (3.7%) of infection, 1 (3.7%) of pregnancy, and 1 (3.7%) of spontaneous expulsion of the IUD. Interruption of use took place in 3 cases (11.1%): 1 due to infection, 1 due to pregnancy, and 1 due to expulsion. The comparison between the groups demonstrated a difference in the incidence of amenorrhea (p 0.005) and method discontinuation (p 0.025). Use of reversible contraceptives in women with heart disease was associated with an acceptable cardiovascular risk. Efficacy and side effects of the methods were comparable in the groups; however, intolerance was observed more in the GIT group. (author's modified)
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PMID:[Contraceptive use in women with heart disease]. 893 85

The efficacy and safety of a new, low-dose, 21-day combination oral contraceptive containing 100 micrograms of levonorgestrel and 20 micrograms of ethinyl estradiol were evaluated in an open-label, multicenter trial. A total of 1477 subjects were enrolled and had 7870 cycles of exposure as of the data cutoff of this interim report. Of these, 792 subjects had completed six cycles of treatment. A total of five pregnancies occurred during treatment during 7720 efficacy cycles, for a Pearl index of 0.84. To date, 415 (28%) subjects have been withdrawn from the study for any reason, including 131 (9%) due to adverse events. The cumulative life table pregnancy rate was 0.0041 per woman entering the sixth cycle. Breakthrough bleeding alone occurred in 4.3% of the cycles and breakthrough bleeding and spotting occurred together during 11% of the cycles. Of the cycles evaluable, 2.6% were amenorrheic. The most commonly reported adverse events in this trial considered at least possibly drug related were headache (14%) and metrorrhagia (8%). This formulation provides contraceptive efficacy similar to higher-dose oral contraceptives, while maintaining a safety and common OC side effect profile that is consistent with prior years of reported use with levonorgestrel-containing products.
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PMID:A new low-dose monophasic combination oral contraceptive (Alesse) with levonorgestrel 100 micrograms and ethinyl estradiol 20 micrograms. North American Levonorgestrel Study Group (NALSG). 911 1

The side effects of oral contraceptives (OCs) can be minimized by appropriate OC selection. Side effects or perceived side effects that manifest themselves physically--e.g., weight gain, breakthrough bleeding (BTB), nausea, headache, breast tenderness, mood swings, acne, and hirsutism--are the most common causes of premature discontinuation of oral contraception. The relative androgenicity of the progestin component of combination OCs has become an important differential in selecting OC formulations. Several studies have indicated that preparations with less androgenic potential can minimize some of the "physical" side effects and adverse metabolic effects traditionally associated with oral contraception. Acne and hirsutism, common pre-existing conditions that are clearly related to the androgenicity of the progestin component, can be eliminated or improved by use of OCs with low androgenic activity. Many women perceive that OCs cause weight gain; although weight gain is to some extent androgen related, most studies comparing low-androgenic OCs with medium- or high-androgenic preparations have found little or no change in weight regardless of formulation. BTB, which usually subsides within a few months, is related to the dose, potency, and ratio of the estrogen and progestin in the OC formulation. Low-estrogen-dose OCs (< or = 35 micrograms ethinyl estradiol [EE]) containing less androgenic progestins are associated with bleeding patterns as acceptable as older low-estrogen-dose formulations. The same analysis found that smoking cigarettes promotes BTB in women who use OCs. There is no convincing evidence that the use of one progestin or another is less likely to cause or exacerbate headache; however, changing preparations sometimes reduces the incidence. Women with persistent headaches during the pill-free interval may benefit from a longer cycle of OC treatment. Nausea and breast tenderness are primarily estrogen-related effects; if a women experiences persistent nausea, switching to an OC formulation containing 20 micrograms EE may be appropriate as long as the patient is cautioned that BTB is more likely. Mood changes are a common, highly subjective complaint whose relationship to OC use is hard to assess. Concerns about the potentially deleterious effects of combination OCs on lipid/lipoprotein and carbohydrate metabolism have been substantially diminished by new epidemiologic findings relative to cardiovascular disease as well as by the development of low-androgenic progestins. Formulations containing these progestins lower LDL cholesterol and increase HDL cholesterol; they do not affect carbohydrate metabolism as much as older, more androgenic formulations.
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PMID:OC practice guidelines: minimizing side effects. 916 75

Use of vitamin B-6 has been recommended for the treatment of side effects associated with combined oral contraceptive (OC) use. To evaluate this recommendation, a randomized, triple-blinded controlled trial of 124 women recruited from 2 health centers in Zacatecas, Mexico, was conducted. 62 women received 150 mg of vitamin B-6 daily for 30 days, while the remaining 62 received a placebo. All cases and controls were new or continuing users of an OC containing 30 mcg of norgestrel and 30 mcg of ethinyl estradiol. Women rated the severity of 6 common OC side effects (nausea, headache, vomiting, dizziness, depression, and irritability) on a scale from 0 to 3 at baseline and 30 days after admission. There was a decrease in the severity of all 6 symptoms in both groups. Although higher proportions of women in the vitamin B-6 group reported decreases in OC-related side effect severity between admission and the 30-day follow-up visit, these differences were appreciable only for headache and dizziness and none was statistically significant. No evidence of vitamin B-6 toxicity was observed. However, this study failed to substantiate a clinically important pharmacologic effect of vitamin B-6 on OC side effects.
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PMID:Effect of vitamin B6 on the side effects of a low-dose combined oral contraceptive. 917 57

A cross-sectional study involving 60 women from Sydney, Australia, and 99 women from Los Angeles, California (US), evaluated the impact of three different insertion regimens on the transient nausea associated with the contraceptive vaginal ring. The ring released 20 mcg of ethinyl estradiol and 1 mg of norethindrone acetate per day. 128 women completed the 6-month study, providing 831 woman-months of exposure. The one pregnancy recorded during the 6-month study occurred during the 7-day break between cycles 5 and 6. 53% of women experienced nausea in at least one cycle. No significant differences in side effects were noted based on insertion group: 1) early evening (5-7 p.m.); 2) late night (10 p.m. to midnight); and 3) early evening insertion, removal at bedtime, and reinsertion the next morning. In each insertion group, the incidence of nausea was greatly reduced (to 6-9%) in the second cycle of use. 9% of women experienced transient vomiting in the 24 hours after first insertion of a new ring. The remaining side effects--headache, dizziness, uterine cramps, breakthrough bleeding, weight gain, and expulsion--were rare and occurred with equal frequency in all three insertion groups. Women at both study sites expressed a high degree of satisfaction with the vaginal ring, primarily because of its convenience and effectiveness. Overnight soaking of the ring before first use has the potential to reduce the side effect of transient nausea, presumed attributable to the accumulation of ethinyl estradiol on the ring surface during storage.
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PMID:Effect of different insertion regimens on side effects with a combination contraceptive vaginal ring. 940 4

The contraceptive efficacy, cycle control, and safety of a new low-dose oral contraceptive (OC) containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel were investigated in a multicenter clinical study involving 805 German women (average age, 25.6 years) and a total of 4400 treatment cycles. There was one case of method failure, yielding a Pearl index of 0.29. A regular withdrawal bleed occurred in 95.5% of all treatment cycles. Cycle length and the duration and intensity of withdrawal bleeding were not significantly altered by use of the low-dose OC. Spotting alone occurred in 12.4% of treatment cycles and breakthrough bleeding alone was reported in 4.5%; both symptoms occurred in 1.4% of cycles. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of women, respectively. Only 8.4% of women discontinued OC use due to adverse events. Finally, there were no clinically relevant changes in laboratory parameters, blood pressure, or body weight. Overall, these findings suggest that substantial reductions in the estrogen and progestogen doses of OCs do not compromise contraceptive efficacy or cycle control.
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PMID:A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles. 943 56

The contraceptive safety and efficacy of long-term use of the oral contraceptive Belara (30 mcg ethinyl estradiol and 2 mg chlormadinone acetate) were assessed in an open, noncontrolled phase III study. Of particular interest was the effect of the anti-androgenic activity of this formulation on clinical signs of androgenization. Belara was taken by 1655 German women (mean age, 25.9 years), for a total of 22,337 cycles. A total of 12 pregnancies occurred, yielding a theoretical Pearl index of 0.269 (95% confidence interval, 0.109-0.600). No withdrawal bleeding occurred in 1655 cycles (7.4%), while spotting was documented in 2565 (11.5%) and breakthrough bleeding in 786 (3.5%). After 12 cycles of use, acne on the face/neck improved in 64.1% of affected women and completely disappeared in 53.4%. Seborrhea improved after 12 cycles in 67.9% of affected women and was cured in 58.0%. Side effects included headache (37.4%), nausea (23.1%), breast tenderness (21.7%), and vaginal discharge (19.4%). Of the 62 serious adverse events reported by 59 women, only the 2 cases of deep venous thrombosis could be linked to Belara use. Overall, these findings suggest that Belara is a well-tolerated oral contraceptive with minor side effects comparable to those associated with use of other low-dose pills.
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PMID:Efficacy and safety of the new antiandrogenic oral contraceptive Belara. 958 37

The data for this analysis were obtained from the records of the Bulgarian Association for Family Planning (BAFP); the data covered a period of 3 years and were for 593 women with a total menstrual cycle of 3132. The most frequently used monophasic oral contraceptives were Cilest (containing norgestimate and ethinyl estradiol), used by 233 women, Marvelon (containing desogestrel and ethinyl estradiol), used by 154 women, Microgynon FE, used by 117 women, and Nordette (containing levonorgestrel and ethinyl estradiol), used by 89 women. The preparations were used mainly for contraception, but some women used them for menstrual regulation (27 women used Nordette for this purpose and so did 25 women use Marvelon for such a purpose), and a small percentage of the women used them for used dysmenorrhea. 103 (43.2%) women who used Cilest were in the 14-19 age group, while 106 (45.4%) of them were in the 20-25 age group. In the 14-19 age group 20 (17.2%) used Microgynon, 18 (20.2%) used Nordette, and 60 (38.8%) relied on Marvelon. In the 20-25 age group the respective figures were 79 (67.2%) for Microgynon, 40 (44.9%) for Nordette, and 67 (42.5%) for Marvelon. Some of the unfavorable metabolic effects of oral contraceptives included the increase of LDL and the reduction of HDL levels and androgenic effects. The most frequent side effect was intermenstrual bleeding, of which there were 19 cases for Cilest, 7 for Microgynon, 5 for Nordette, and 11 for Marvelon. Menstruation was prolonged in 4 women using Cilest and in 5 using Marvelon. 5 women using Cilest, 2 using Microgynon, and 2 using Nordette had headache. Other adverse effects included episodes of galactorrhea, discomfort, mastopathy, and bloating in the stomach. These effects did not pose a risk to general or reproductive health and did not justify discontinuation of use for these preparations.
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PMID:[Current monophasic hormonal contraception]. 985 26

Menopause and the accompanying reduction in estrogen production may cause a number of symptoms in women which include hot flushes, sweating, mood and sleep disturbances, fatigue and urogenital dysfunction. The effectiveness of estrogen-based hormone replacement therapy (HRT) in ameliorating these symptoms, and in preventing long term sequelae such as osteoporosis, is well established. Comparative trials indicate that oral conjugated estrogens 0.625mg, oral ethinyl estradiol 0.02mg and transdermal estradiol 0.05mg have equivalent efficacy in relief of mild to moderate menopausal symptoms and prevention of bone mineral loss. Concomitant progestogen therapy is usually prescribed for women with intact uteri to protect against endometrial hyperplasia and carcinoma. The addition of progestogen maintains and may even enhance the bone-conserving effects of estrogen, and continuous regimens appear to reduce the incidence of irregular menses. Adverse reactions are predominantly local skin irritation with transdermal preparations (14% of patients) and systemic effects common to most forms of HRT including breast tenderness, flushing, headache and irregular bleeding, occurring in less than or equal to 2% of patients. Data concerning the effect of HRT on quality of life are limited, but most analyses have assigned utility values of 0.99 for mild and 0.95 for severe menopausal symptoms. However, recent clinical data suggest that these utility values may underestimate the impact of menopausal symptoms on quality of life. The cost benefit and cost effectiveness of HRT in the treatment of menopausal symptoms have not been fully researched, although preliminary results suggest that conjugated estrogens and transdermal estradiol compare well with alternative therapies such as veralipride and Chinese medicines. A Swedish study using a prevalence-based approach estimated that estriol treatment in all women with urinary incontinence aged greater than or equal to 65 years resulted in monetary savings compared with treating 20% of women. Cost-utility data indicated that the change in quality-adjusted life years (QALYs) with HRT was always positive, but the degree of change was determined by the baseline assumptions. Estimated changes in QALYs with HRT ranged from 0.006 for 5 years of treatment with unopposed estrogen in women with intact uteri, to 0.5 for 10 years of the same treatment in women with severe menopausal symptoms following hysterectomy. Compliance with HRT is suboptimal as 5 to 50% of women withdraw from therapy, thereby increasing costs per year of life saved.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Hormone replacement therapy: I. A pharmacoeconomic appraisal of its therapeutic use in menopausal symptoms and urogenital estrogen deficiency. 1014 33

This is a multicenter comparative study on the acceptability of levonorgestrel implants (Norplant) and the ethinyl estradiol/gestodene combined pill (Femodene/Minulet) conducted in the UK, which was originally designed to follow 700 subjects for 5 years but was discontinued early. Norplant is a hormonal, long-term method of contraception requiring the subdermal placement of 6 flexible capsules containing levonorgestrel in the inner aspect of the upper nondominant arm. 364 subjects who used the implant and 307 subjects who used a combined pill were included in the final analysis, which showed a significantly greater (p 0.001) continuation rate among the implant users (83.4%) compared to the pill users (64.4%) at 1 year, with a slight decrease in difference at 2 years. The most common reasons for discontinuation were menstrual and mood changes in the implant group and mood changes and headaches in the pill group. A higher proportion of "very satisfied" users was noted in the implant group (28.5%) compared to the combined pill group (14.6%). The high continuation rate for implant users in this study is similar to the rate in the reported literature in other countries.
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PMID:Prospective multicentre study comparing levonorgestrel implants with a combined contraceptive pill: final results. 1045 52


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