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Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception.

The purpose of this study was to provide revised estimates of the effectiveness of the Yuzpe method of emergency contraception. Through a literature search, we identified eight studies that present the number of women treated and outcome of treatment by cycle day of unprotected intercourse relative to expected day of ovulation. Using five sets of external estimates of conception probabilities by cycle day of intercourse among women not using contraception, we assessed the effectiveness of the Yuzpe regimen. The 45 estimates of effectiveness, based on eight separate studies and the eight studies combined and five different sets of conception probabilities by cycle day, ranged from a low of 56.4% to a high of 89.3%. Our preferred point estimate is that the Yuzpe regimen reduces the risk of pregnancy by 74.1%, with a 95% confidence interval extending from 62.9% to 79.2%. True effectiveness is likely to be > 74% because treatment failures (observed pregnancies) include women who were already pregnant when treated and women who became pregnant after being treated.

Contraception↗

Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial.

OBJECTIVE: Emergency contraceptives can prevent unintended pregnancy after unprotected intercourse. The best-studied regimen ("Yuzpe") consists of ordinary combined oral contraceptives containing levonorgestrel and ethinyl estradiol. Women traditionally take one dose within 72 hours after unprotected intercourse, and a second dose 12 hours later. Historically, half experience nausea and a fifth vomit. The purpose of this study was to determine whether 1). women could use combined oral contraceptives other than those containing levonorgestrel and 2). eliminating the second dose improves comfort and convenience. METHODS: Women presenting within 72 hours after unprotected intercourse were randomized to receive 1). standard two-dose Yuzpe, 2). a variant of Yuzpe substituting norethindrone for levonorgestrel, or 3). only the first dose of Yuzpe, followed 12 hours later by a placebo. RESULTS: Perfect-use failure rates were low in all groups and did not differ in a statistically significant way (standard Yuzpe 2.0% [n = 589], norethindrone-ethinyl estradiol 2.7% [n = 547], single dose of Yuzpe 2.9% [n = 546]). Typical-use failure rates were slightly higher but similarly did not differ significantly. Side effects were similar across groups, except that women taking the single dose reported half the vomiting. Taking the pills with food did not seem to reduce nausea or vomiting, and the pills were not more effective when started sooner after unprotected intercourse. CONCLUSION: Oral contraceptives containing norethindrone-ethinyl estradiol work approximately as well for emergency contraception as levonorgestrel-ethinyl estradiol formulations and should be offered when first-line therapies are not available.

Adolescent↗

Herbal and dietary therapies for primary and secondary dysmenorrhoea.

BACKGROUND: Dysmenorrhoea refers to the occurrence of painful menstrual cramps of uterine origin and is a common gynaecological complaint. Common treatment for dysmenorrhoea is medical therapy such as nonsteroidal anti-inflammatories (NSAIDs) or oral contraceptive pills (OCPs) which both work by reducing myometrial activity (contractions of the uterus). The efficacy of conventional treatments such as nonsteroidals is considerable, however the failure rate is still often 20-25%. Many consumers are now seeking alternatives to conventional medicine and research into the menstrual cycle suggests that nutritional intake and metabolism may play an important role in the cause and treatment of menstrual disorders. Herbal and dietary therapies number among the more popular complementary medicines yet there is a lack of taxonomy to assist in classifying them. In the US, herbs and other phytomedicinal products (medicine from plants) have been legally classified as dietary supplements since 1994. Included in this category are vitamins, minerals, herbs or other botanicals, amino acids and other dietary substances. For the purpose of this review we use the wider term herbal and dietary therapies to include the assorted herbal or dietary treatments that are classified in the US as supplements and also the phytomedicines that may be classified as drugs in the European Union. OBJECTIVES: To determine the efficacy and safety of herbal and dietary therapies for the treatment of primary and secondary dysmenorrhoea when compared to each other, placebo, no treatment or other conventional treatments (e.g. NSAIDS). SEARCH STRATEGY: Electronic searches of the Cochrane Menstrual Disorders and Subfertility Group Register of controlled trials, CCTR, MEDLINE, EMBASE, CINAHL, Bio extracts, and PsycLIT were performed to identify relevant randomised controlled trials (RCTs). The Cochrane Complementary Medicine Field's Register of controlled trials (CISCOM) was also searched. Attempts were also made to identify trials from the National Research Register, the Clinical Trial Register and the citation lists of review articles and included trials. In most cases, the first or corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were RCTs of herbal or dietary therapies as treatment for primary or secondary dysmenorrhoea vs each other, placebo, no treatment or conventional treatment. Interventions could include, but were not limited to, the following; vitamins, essential minerals, proteins, herbs, and fatty acids. Exclusion criteria were: mild or infrequent dysmenorrhoea or dysmenorrhoea from an IUD. DATA COLLECTION AND ANALYSIS: Seven trials were included in the review. Quality assessment and data extraction were performed independently by two reviewers. The main outcomes were pain intensity or pain relief and the number of adverse effects. Data on absence from work and the use of additional medication was also collected if available. Data was combined for meta-analysis using Peto odds ratios for dichotomous data or weighted mean difference for continuous data. A fixed effects statistical model was used. If data suitable for meta-analysis could not be extracted, any available data from the trial was extracted and presented as descriptive data. MAIN RESULTS: MAGNESIUM: Three small trials were included that compared magnesium and placebo. Overall magnesium was more effective than placebo for pain relief and the need for additional medication was less. There was no significant difference in the number of adverse effects experienced. VITAMIN B6: One small trial of vitamin B6 showed it was more effective at reducing pain than both placebo and a combination of magnesium and vitamin B6. MAGNESIUM AND VITAMIN B6: Magnesium was shown to be no different in pain outcomes from both vitamin B6 and a combination of vitamin B6 and magnesium by one small trial. The same trial also showed that a combination of magnesium and vitamin B6 was no different from placebo in reducing pain. VITAMIN B1: One large trial showed vitamin B1 to be more effective than placebo in reducing pain. VITAMIN E: One small trial comparing a combination of vitamin E (taken daily) and ibuprofen (taken during menses) versus ibuprofen (taken during menses) alone showed no difference in pain relief between the two treatments. OMEGA-3 FATTY ACIDS: One small trial showed fish oil (omega-3 fatty acids) to be more effective than placebo for pain relief. JAPANESE HERBAL COMBINATION: One small trial showed the herbal combination to be more effective for pain relief than placebo, and less additional pain medication was taken by the treatment group. REVIEWER'S CONCLUSIONS: Vitamin B1 is shown to be an effective treatment for dysmenorrhoea taken at 100 mg daily, although this conclusion is tempered slightly by its basis on only one large RCT. Results suggest that magnesium is a promising treatment for dysmenorrhoea. It is unclear what dose or regime of treatment should be used for magnesium therapy, due to variations in the included trials, therefore no strong recommendation can be made until further evaluation is carried out. Overall there is insufficient evidence to recommend the use of any of the other herbal and dietary therapies considered in this review for the treatment of primary or secondary dysmenorrhoea.

Dietary Supplements↗

Latex rubber condoms: predicting and extending shelf life.

Condoms from five manufacturers were subjected to controlled exposures of heat, humidity, and air and to different natural environments in five countries. Under aerobic conditions (condoms in permeable packages or unpackaged), stress properties declined. The relationship between rate of decline as a function of temperature was quadratic. Under oxygen-restricted conditions (foil-wrapped packages) at average storage temperatures of 30 degrees C and lower, strain properties declined with little or no significant change in stress properties. The effect is to cause condoms to become stiffer; high-breakage rates in use have been correlated with product stiffening. A new rationale for accelerated-aging tests to predict condom shelf stability is suggested, including a test to control the trend of condoms to stiffen. Silicone lubricant, impermeable packaging, and inclusion of antioxidants in the condom formulation can prevent or minimize aerobic breakdown of latex condoms. Specifying low-modulus condoms can prevent excessive stiffening.

Air↗

Family planning in a hospital clinic.

The establishment of a hospital board family planning clinic and the results during its first year of operation are described. Three hundred and fifty-four patients were seen, a third of whom were interested in sterilisation. Only 3 percent presented with infertility and less than 1 percent referred themselves inappropriately. The failure rate in terms of unwanted unplanned pregnancies was 2 percent, and a further 1 percent had socially inconvenient but desired pregnancies. Of those established on contraception 45 percent chose the pill, 34 percent the intra-uterine device and approximately 10 percent each the injection or a barrier method;

Adult↗

The renin-angiotensin-aldosterone system in primary and secondary hypertension.

Important advances have been made in understanding the role of the renin-angiotensin-aldosterone system in the pathogenesis and diagnosis of hypertensive disorders. Measurement of plasma renin activity (PRA) and aldosterone is very important in the assessment of secondary hypertension. Hypertensions with increased PRA include renovascular hypertension, some cases of unilateral and bilateral renal parenchymal disease, malignant hypertension, hypertension associated with oral contraceptive agents, and renin-secreting tumors. Hypertension with decreased PRA is observed in four recognized types of primary aldosteronism: adenoma, bilateral hyperplasia, indeterminate aldosteronism, and glucocorticoid-responsive aldosteronism. Other conditions with hypertension and depressed PRA include ACTH and DOC secreting tumors, primary hyperpituitarism, syndromes of 17-hydroxylase and 11-beta-hydroxylase deficiency. Liddle's syndrome, licorice abuse, exogenous administration of mineralocorticoids, and preeclampsia.

Acute Kidney Injury↗

Use effectiveness of a spermicidal suppository containing benzalkonium chloride.

A multicentric trial in 9 Spanish Clinics of Family Planning was conducted to evaluate the effectiveness of a vaginal contraceptive Ovule (suppository), containing 18.9 mg of benzalkonium chloride. Gynaecological and cytobacteriological examinations were made to evaluate any possible side-effect. Six-hundred-fifty-three women at risk of unwanted pregnancy accepted the method as the only contraception during 9,517 months. The results are expressed in life-tables (Tietze-Lewit). Net cumulative first segment rate at 12 months were: terminations 27.2; pregnancy 3.7; medical reason 2.3; planned pregnancy 2.8; other personal reasons 18.4. At 24 months the rates were: terminations 34.1; pregnancy 3.7; medical reason 2.6; planned pregnancy 6.5; personal reasons 21.3. Error or failure to use the spermicide resulted in 12 of 23 pregnancies (52%), while in another 4 pregnancies (17%) there were reasonable elements of doubt concerning its correct use. There were no gynaecological or cytological changes. We conclude that this product is a safe and very effective contraceptive if used according to the prescribed instructions and before any sexual encounter.

Adult↗

Representing young people's sexuality in the 'youth' media.

This paper reports findings from a content analysis of the main messages about sexuality in media outlets consumed by young people. It examines how sexuality is represented and the level of sexual health information provided in some UK magazines and TV programmes targeted at young people. Our findings show that such outlets included a vast range of useful discussion including information about health concerns and in-depth exploration of issues such as consent and examples of couples exploring whether or not they were 'ready' for sex. In particular, the right of girls to 'say no' was vividly fore-grounded in several teen dramas and magazines. However, coverage was also characterized by certain limitations. A clear pattern was evident whereby contraception and managing 'how far to go' were depicted as women's responsibility. There was a limited range of representations for young men, a lack of positive images of lesbian and gay teenagers, and a failure to represent diversity. There were also no examples of how people might raise concerns such as safer sex. In this context, health educators need to be aware of both the richness and the limitations of current mainstream representations in order to work with and through the media to improve the quality and range of material for young people.

Adolescent↗

Multicenter randomized comparative trial of two low-dose triphasic combined oral contraceptives containing desogestrel or norethindrone.

OBJECTIVE: To compare a new triphasic oral contraceptive (OC) containing desogestrel and ethinyl estradiol (DSG/EE) with triphasic norethindrone/ethinyl estradiol (NE/EE) regarding effects on clinical efficacy, cycle control, and safety indices. METHODS: In an open-label, comparative multicenter study, 407 subjects were randomized to a triphasic preparation containing DSG/EE and 405 subjects to a triphasic preparation containing NE/EE. The women were observed during six cycles of OC use. RESULTS: The contraceptive efficacy of the triphasic DSG/EE OC was at least comparable to that of triphasic NE/EE. No pregnancies were reported with DSG/EE, whereas there were two pregnancies with NE/EE, both user failures. Cycle control with triphasic DSG/EE was statistically superior to that with triphasic NE/EE. Acceptability was excellent with both preparations as measured by the low discontinuation rates (particularly for adverse menstrual experiences). No thromboembolic or other serious drug-related adverse experiences were reported. The incidence of other drug-related adverse experiences was generally low and decreased with time in both groups. No adverse effects were seen in terms of blood pressure, body weight, laboratory indices, cervical cytology, and breast nodularity. CONCLUSION: Triphasic DSG/EE is an effective and safe OC with excellent acceptability and cycle control superior to that of triphasic NE/EE.

Adolescent↗

Efficacy and acceptability of two monophasic oral contraceptives containing ethinylestradiol and either desogestrel or gestodene.

OBJECTIVE: To assess the contraceptive efficacy, cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene. METHODS: In a randomized, open-label, six-cycle, group-comparative, multicenter study performed in Brazil, pregnancies, cycle-control parameters, incidence of side-effects and the presence and severity of acne vulgaris were assessed, and blood pressure and body weight were measured at pretreatment and after one, three and six cycles of oral contraceptive use. RESULTS: Of the 595 women enrolled, 274 (86.7%) in the desogestrel/ethinylestradiol group and 227 (81.4%) in the gestodene/ethinylestradiol group completed the six cycles, providing data for 1753 and 1487 treatment cycles, respectively. Two pregnancies occurred, one of which (in the desogestrel/ethinylestradiol group) was attributed to user failure, whilst the other (in the gestodene/ethinylestradiol group) was thought to result from method failure. Cycle control was observed to be excellent; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle. Pre-existing acne improved in both groups, whereas blood pressure and body weight remained essentially unchanged. CONCLUSIONS: Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability.

Acne Vulgaris↗

Use of placebo controls in an oral contraceptive trial: methodological issues and adverse event incidence.

Two multicenter, double-blind, placebo-controlled studies were conducted to evaluate the effectiveness of triphasic norgestimate/ethinyl estradiol (Ortho Tri-Cyclen) for the treatment of acne vulgaris. To our knowledge, these studies were the first double-blind, placebo-controlled trials to evaluate the efficacy of an oral contraceptive (OC) in the treatment of acne; in fact, they are probably the first placebo-controlled trials ever completed using modern OC. This article examines the conduct and feasibility of these studies including discussions on study planning enrollment, maintenance of the blind, continuation rates, and pregnancy prevention. Subjects were between the ages of 15 and 49 years, with moderate acne vulgaris, no contraindications to oral contraceptive use, and were willing to use a nonsteroidal method of birth control during the 6 months of the trial. More than 500 participants were enrolled in 1 year. Discontinuation rates between groups were similar. To explore the reasons for the similar and low discontinuation rates, OC-related side effects were evaluated in comparison to placebo. This analysis revealed that the OC exhibited a side effect profile that was similar, in many cases, to that of placebo. Although pregnancies occurred in the placebo arm, the incidence was consistent with expected failure rates for users of nonsteroidal methods in the general population.

Acne Vulgaris↗

Impact of the October 1995 pill scare in Grampian.

Over two years have elapsed since the Department of Health issued a press release concerning the safety of some third generation contraceptive pills. Warnings about increased abortion rates followed and recently published national figures for England and Wales have confirmed this. In Grampian we have assessed the impact of the pill scare at a subnational level, which has received much less consideration. Grampian has a stable population with an estimated 116,500 women in the reproductive years. The six month period from November 1995 until April 1996 was chosen to monitor the immediate aftermath of the pill scare. Aberdeen Royal Infirmary provides a regional, dedicated abortion service and has maintained a service specific database since 1994. This is an ideal situation to monitor trends in abortion rates in a specific population. Women attending for abortion counselling were asked to complete a questionnaire regarding their recall of media publicity. Live-births at Aberdeen Maternity Hospital from June to November 1996 were also recorded, reflecting conceptions in the study period. Prescribing patterns for combined pills and emergency contraception for Grampian general practitioners and Grampian Healthcare family planning service were also analysed. There was no increase in the abortion rate in the study period when compared with the same period in the preceding year - a total of 728 women underwent an abortion. Forty six women were identified within the 728 as having conceived as a direct consequence of the scare, but their characteristics were not dissimilar to the other women on the database. Live-birth rates were also stable. Emergency contraception prescribing was slightly increased for the family planning service but not in general practice. Both general practice and the family planning service showed an immediate and sharp fall in prescribing of third generation pills mirrored by an increase in second generation pill prescribing. For family planning particularly, prescriptions for third generation pills have shown an increase again from early 1996, although remaining below original levels. Fifty five per cent of the women who were given the questionnaire about media publicity responded. Seventy nine per cent recalled some publicity, but 17 per cent of these women could not remember any specific details. Unlike national reporting, our figures do not substantiate any increase in abortions or deliveries in the aftermath of the pill scare. The slight increase in emergency contraception prescribing by the family planning service more probably reflects local awareness campaigns rather than any appreciable switch away from regular pill use. On a population level, the scare did not have the predicted negative impact on pill users in Grampian and it would have been incorrect for us to extrapolate from national data in this instance. Failure to demonstrate numerical impact for the population does not deny the devastating effect of a termination for an individual woman. The emotional impact of the scare on women, while more difficult to measure, should not be underestimated. The influence on the next generation of women with regard to their contraceptive choice remains to be seen.

Abortion, Induced↗

Eight years of fertility control with norgestrel-ethinyl estradiol (Ovral): an updated clinical review.

Data on a combination norgestrel-ethinyl estradiol oral contraceptive (Ovral) were obtained from eight large family planning clinics. The safety and efficacy of the drug were evaluated for 6,806 mature, sexually active women who received a total of 127,872 cycles of the medication; this represents 9,836 woman-years of usage. No pregnancy attributable to medication failure occurred, but 19 women who omitted two or more consecutive tablets became pregnant. This produced an overall use-effectiveness pregnancy rate of 0.19/100 woman-years. Cycle control was excellent, and intermenstrual bleeding was rare. Adverse effects were minimal; laboratory values seldom deviated from pretreatment levels. Fertility returned promptly upon withdrawal of the contraceptive, and no infant abnormalities were attributed to its use.

Adrenal Glands↗