| 1. Title: Plan B for 17-year olds. Source: Medical Letter On Drugs and Therapeutics. 2009 May 18;51(1312):40. Abstract: The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception. The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred despite use of levonorgestrel-only emergency contraception. (full-text) Language: English Keywords: UNITED STATES OF AMERICA | USFDA | ADOLESCENTS | EMERGENCY CONTRACEPTION | ADMINISTRATION AND DOSAGE | PROGRAM ACCESSIBILITY | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Program Evaluation | Programs | Organization and Administration Document Number: 341625 |
2.  Title: mHealth for development: The opportunity of mobile technology for healthcare in the developing world. Author: Vital Wave Consulting Source: Washington, D.C., United Nations Foundation, 2009. 66 p. Abstract: Mounting interest in the field of mHealth -- the provision of health-related services via mobile communications -- can be traced to the evolution of several interrelated trends. In many parts of the world, epidemics and a shortage of healthcare workers continue to present grave challenges for governments and health providers. Yet in these same places, the explosive growth of mobile communications over the past decade offers a new hope for the promotion of quality healthcare. Among those who had previously been left behind by the 'digital divide,' billions now have access to reliable technology. There is a growing body of evidence that demonstrates the potential of mobile communications to radically improve healthcare services -- even in some of the most remote and resource-poor environments. This report examines issues at the heart of the rapidly evolving intersection of mobile phones and healthcare. It helps the reader to understand mHealth's scope and implementation across developing regions, the health needs to which mHealth can be applied, and the mHealth applications that promise the greatest impact on heath care initiatives. It also examines building blocks required to make mHealth more widely available through sustainable implementations. Finally, it calls for concerted action to help realize mHealth's full potential. (Excerpt) Language: English Keywords: DEVELOPING COUNTRIES | SUMMARY REPORT | PUBLIC HEALTH | TELECOMMUNICATIONS | INFORMATION DISTRIBUTION | EDUCATION | AWARENESS | DATA COLLECTION | PRIMARY HEALTH CARE | TRAINING ACTIVITIES | HEALTH PERSONNEL | DISEASE PREVENTION | TECHNOLOGY | TREATMENT | ADMINISTRATION AND DOSAGE | DRUGS | HIV TESTING | HIV PREVENTION | Health | Broadcast Media | Mass Media | Communication | Knowledge | Sociocultural Factors | Research Methodology | Health Services | Delivery of Health Care | Training Programs | Prevention and Control | Diseases | Economic Factors | Medical Procedures | Medicine | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | HIV Infections | Viral Diseases Document Number: 331450 |
3.  Peer Reviewed Title: Evaluation of mifepristone as a once a month contraceptive pill. Author: Agarwal M; Das V; Agarwal A; Pandey A; Srivastava D Source: American Journal of Obstetrics and Gynecology. 2009 May;200(5):e27-9. Abstract: OBJECTIVE: The purpose of this study was to assess the efficacy and safety of mifepristone as a contraceptive pill. STUDY DESIGN: A prospective case-control study was conducted in a tertiary care center of North India. The study group (n = 86) was given 200-mg mifepristone tablets on the 16th day of the menstrual cycle. The control group (n = 92) received combined oral contraceptive (COC) as per protocol. Subjects were followed for drug compliance, satisfaction, side effects, and failure. RESULTS: Acceptability of mifepristone was significantly higher in educated population (P < .001), with fewer side effects (P = .001), good satisfaction (P < .001), and higher compliance rate (P = .05). The oral contraceptive pill group had higher adverse biochemical parameters. CONCLUSION: Mifepristone can be used as a monthly contraceptive pill effectively. Language: English Keywords: INDIA | RESEARCH REPORT | ORAL CONTRACEPTIVES | RU-486 | TIME FACTORS | ADMINISTRATION AND DOSAGE | Asia, Southern | Asia | Developing Countries | Contraceptive Methods | Contraception | Family Planning | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Population Dynamics | Demographic Factors | Population | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341243 |
| 4. Peer Reviewed Title: Enhanced immunogenicity of an oral inactivated cholera vaccine in infants in Bangladesh obtained by zinc supplementation and by temporary withholding breast-feeding. Author: Ahmed T; Svennerholm AM; Al Tarique A; Sultana GN; Qadri F Source: Vaccine. 2009 Feb 25;27(9):1433-9. Abstract: The killed oral cholera vaccine Dukoral is recommended for adults and only children over 2 years of age, although cholera is seen frequently in younger children and there is an urgent need for a vaccine for them. Since decreased immunogenicity of oral vaccines in children in developing countries is a critical problem, we tested interventions to enhance responses to Dukoral. We evaluated the effect on the immune responses by temporarily withholding breast-feeding or by giving zinc supplementation. Two doses of Dukoral consisting of killed cholera vibrios and cholera B subunit were given to 6-18 months old Bangladeshi children (n=340) and safety and immunogenicity studied. Our results showed that two doses of the vaccine were safe and induced antibacterial (vibriocidal) antibody responses in 57% and antitoxin responses in 85% of the children. Immune responses were comparable after intake of one and two doses. Temporary withholding breast-feeding for 3 h before immunization or supplementation with 20 mg of zinc per day for 42 days resulted in increased magnitude of vibriocidal antibodies (77% and 79% responders, respectively). Administration of vaccines without buffer or in water did not result in reduction of vibriocidal responses. This study demonstrates that the vaccine is safe and immunogenic in children under 2 years of age and that simple interventions can enhance immune responses in young children. Language: English Keywords: BANGLADESH | RESEARCH REPORT | INFANT | CHOLERA | ZINC | HUMAN MILK | VACCINES | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE USE-EFFECTIVENESS | AUTOIMMUNE RESPONSE | SAFETY | Developing Countries | Asia, Southern | Asia | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Bacterial and Fungal Diseases | Infections | Diseases | Metals | Vitamins and Minerals | Physiology | Biology | Lactation | Maternal Physiology | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Contraceptive Effectiveness | Contraception | Family Planning | Antibodies | Immunologic Factors | Immunity | Immune System | Public Health Document Number: 341051 |
| 5. Peer Reviewed Title: Risk factors for virological failure and subtherapeutic antiretroviral drug concentrations in HIV-positive adults treated in rural northwestern Uganda. Author: Ahoua L; Guenther G; Pinoges L; Anguzu P; Chaix ML; Le Tiec C; Balkan S; Olson D; Olaro C; Pujades-Rodriguez M Source: BMC Infectious Diseases. 2009;9:81. Abstract: BACKGROUND: Little is known about immunovirological treatment outcomes and adherence in HIV/AIDS patients on antiretroviral therapy (ART) treated using a simplified management approach in rural areas of developing countries, or about the main factors influencing those outcomes in clinical practice. METHODS: Cross-sectional immunovirological, pharmacological, and adherence outcomes were evaluated in all patients alive and on fixed-dose ART combinations for 24 months, and in a random sample of those treated for 12 months. Risk factors for virological failure (>1,000 copies/ml) and subtherapeutic antiretroviral (ARV) concentrations were investigated with multiple logistic regression. RESULTS: At 12 and 24 months of ART, 72% (n = 701) and 70% (n = 369) of patients, respectively, were alive and in care. About 8% and 38% of patients, respectively, were diagnosed with immunological failure; and 75% and 72% of patients, respectively, had undetectable HIV RNA (<400 copies/ml). Risk factors for virological failure (>1,000 copies/ml) were poor adherence, tuberculosis diagnosed after ART initiation, subtherapeutic NNRTI concentrations, general clinical symptoms, and lower weight than at baseline. About 14% of patients had low ARV plasma concentrations. Digestive symptoms and poor adherence to ART were risk factors for low ARV plasma concentrations. CONCLUSION: Efforts to improve both access to care and patient management to achieve better immunological and virological outcomes on ART are necessary to maximize the duration of first-line therapy. Language: English Keywords: UGANDA | RESEARCH REPORT | RURAL AREAS | CLIENTS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL THERAPY | TREATMENT | ADMINISTRATION AND DOSAGE | PROGRAM ACCESSIBILITY | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Geographic Factors | Population | Program Activities | Programs | Organization and Administration | HIV Infections | Viral Diseases | Diseases | HIV | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Program Evaluation Document Number: 342064 |
| 6. Title: Interventions for pain with intrauterine device insertion. Author: Allen RH; Bartz D; Grimes DA; Hubacher D; O'Brien P Source: Cochrane Database of Systematic Reviews. 2009;(3):CD007373. Abstract: BACKGROUND: Fear of pain during intrauterine device (IUD) insertion is a barrier to use of this contraceptive method. Interventions for pain during IUD insertion include non-steroidal anti-inflammatory drugs (NSAIDs), local cervical anesthetics, and cervical ripening agents such as misoprostol. OBJECTIVES: To review all randomized controlled trials that have evaluated a treatment for IUD insertion-related pain. SEARCH STRATEGY: We searched the computerized databases MEDLINE, POPLINE, CENTRAL, and EMBASE for relevant trials. We also examined reference lists of pertinent articles and wrote to known investigators for information about other published or unpublished trials. SELECTION CRITERIA: We included all randomized controlled trials in any language that evaluated a treatment for IUD insertion-related pain. The intervention could be compared to a placebo or another active intervention. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data from relevant trials and data were entered into RevMan 5.0 for analysis. For dichotomous variables, the Peto odds ratios with 95% confidence intervals was calculated. For continuous variables, the mean differences with 95% confidence interval was computed. MAIN RESULTS: Four trials met the inclusion criteria; the total number of participants was 2204. Nonsteroidal anti-inflammatory drugs of varying types and doses were not effective for reducing pain during IUD insertion. Misoprostol for cervical ripening did not reduce pain with IUD insertion in nulliparous women. Two trials evaluated pain that occurs after IUD insertion using nonsteroidal anti-inflammatory drugs. In one trial, naproxen taken prior to IUD insertion was effective in reducing pain compared with placebo in the first two hours after IUD insertion in mostly nulliparous women. However, this trial utilized the Dalkon Shield, an IUD with a wider diameter than modern IUDs. In another trial, ibuprofen 600 mg taken before IUD insertion did not show evidence of an effect on pain four to six hours after IUD insertion. AUTHORS' CONCLUSIONS: No interventions that have been properly evaluated reduce pain during or after IUD insertion. One poorly controlled trial suggested that topical lidocaine gel may reduce insertion-related pain and warrants further investigation. Language: English Keywords: UNITED STATES OF AMERICA | CHILE | DENMARK | SWEDEN | LITERATURE REVIEW | CLINICAL TRIALS | IUD | INSERTION | PAIN | DRUGS | ADMINISTRATION AND DOSAGE | MISOPROSTOL | Developed Countries | North America | Americas | Developing Countries | South America, Southern | South America | Latin America | Europe, Northern | Europe | Clinical Research | Research Methodology | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Signs and Symptoms | Diseases | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology Document Number: 342475 |
| 7. Peer Reviewed Title: Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Author: Allen RH; Fitzmaurice G; Lifford KL; Lasic M; Goldberg AB Source: Obstetrics and Gynecology. 2009 Feb;113(2 Pt 1):276-83. Abstract: OBJECTIVE: To test the equivalency of oral sedation and intravenous sedation for pain control in first-trimester surgical abortion. METHODS: Women undergoing suction curettage at less than 13 weeks of gestation were randomly assigned to oral sedation, 10 mg of oxycodone and 1 mg of lorazepam, or intravenous sedation, 100 micrograms fentanyl and 2 mg midazolam. All patients received 800 mg of preoperative ibuprofen and a 20-mL paracervical block with 1% lidocaine. The primary outcome was intraoperative pain as measured on a 21-point verbal rating scale that had a range from 0 to 100 (0=no pain and 100=worst pain ever) with an equivalence margin for the treatment group comparison of +/-10. RESULTS: Of 130 women, 65 were randomly assigned to oral sedation and 65 to intravenous sedation. The groups differed at baseline by age and preoperative ratings of depression, stress, and anxiety; however, when adjusted for these differences, the primary results were unaffected. Mean intraoperative pain scores, controlling for age and preoperative depression, stress, and anxiety, were 61.2 for oral sedation and 36.3 for intravenous sedation (mean difference 24.9, 95% confidence interval 15.9-33.9). Other findings included no difference in postoperative adverse effects and less satisfaction with pain control with oral sedation compared with intravenous sedation. CONCLUSION: Oral sedation, as studied, is not equivalent to intravenous sedation for pain control during first-trimester surgical abortion. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00337792 LEVEL OF EVIDENCE: I. Language: English Keywords: MASSACHUSETTS | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | EVALUATION INDEXES | KAP SURVEYS | PREGNANT WOMEN | ANESTHESIA | ABORTION | PREGNANCY, FIRST TRIMESTER | CURETTAGE | ADMINISTRATION AND DOSAGE | PAIN | SIDE EFFECTS | SATISFACTION | Developed Countries | United States of America | North America | Americas | Clinical Research | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Surveys | Sampling Studies | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Pregnancy | Reproduction | Obstetrical Surgery | Surgery | Drugs | Signs and Symptoms | Diseases | Psychological Factors | Behavior Document Number: 330360 Notification |
| 8. Title: Misoprostol for pregnancy termination in grand multiparous women with three cesarean deliveries. Author: Alsibiani SA Source: International Journal of Gynaecology and Obstetrics. 2009 Apr 3; Abstract: In countries in which women have high parity, pregnancy termination is common in women who have had multiple cesarean deliveries. Although a combination of mifepristone and misoprostol is recommended for late abortion, in Saudi Arabia, mifepristone is not approved or available. There is little information about the safety of misoprostol for the termination of pregnancy or induction of labor in women with scarred uteri and multiple cesarean deliveries. Although there is no recommended dose or mode of administration for misoprostol in patients with scarred uteri and high parity, it is advisable to use a low dose. Misoprostol use in women with scarred uteri can lead to uterine rupture, but few incidences have been reported in the literature. However, caution is advisable. Misoprostol administered orally has a rapid onset of action and increases uterine tone, but contractions are not experienced unless repeated doses are administered. In addition, women usually prefer oral administration. Vaginal administration offers prolonged activity, greatest bioavailability, and a lower incidence of adverse effects. Use of misoprostol for termination of pregnancy in 2 grand multiparous (gravidity N10) women each with 3 previous cesarean deliveries is summarized in Table 1. According to the WHO expert dosage guidelines, the maximum dose was not exceeded in either patient. In patient 1 an intracervical Foley catheter with syntocinon infusion was used to ripen the cervix followed by oral administration of 800 µg of misoprostol. Patient 2 received a single dose of 800 µg of misoprostol vaginally. Favorable results were obtained in both women using a single high dose of misoprostol. The safety of using misoprostol in women with high parity and scarred uteri could not be ascertained from this study. A larger study is needed to confirm the effectiveness and safety of this regimen in patients with high parity who have had more than 2 previous cesarean deliveries. (full-text) Language: English Keywords: SAUDI ARABIA | RESEARCH REPORT | SUMMARY REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | CESAREAN SECTION | ABORTION | MULTIPARITY | MISOPROSTOL | UTERUS | RU-486 | ADMINISTRATION AND DOSAGE | Middle East | Developing Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Obstetrical Surgery | Surgery | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Parity | Fertility Measurements | Fertility | Population Dynamics | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Genitalia, Female | Genitalia | Urogenital System | Hormone Antagonists | Hormones | Drugs Document Number: 341466 |
| 9. Peer Reviewed Title: Pregnancy and optimal care of HIV-infected patients. Author: Anderson BL; Cu-Uvin S Source: Clinical Infectious Diseases. 2009 Feb 15;48(4):449-55. Abstract: Human immunodeficiency virus (HIV) infection during pregnancy is a condition that requires multidisciplinary care. Care must be rendered that is appropriate for both the mother and the fetus. Prevention of mother-to-child transmission of HIV is of paramount concern. To prevent transmission, universal testing for HIV infection in pregnant women is ideal. In the United States and other developed countries, great strides have been made toward decreasing the risk of HIV transmission to infants to <2% with use of a combination of highly active antiretroviral therapy during the antepartum period and during labor and delivery, scheduled cesarean section when appropriate, avoidance of breast-feeding, and 6 weeks of zidovudine prophylaxis for infants. The continuation of antiretroviral therapy after delivery depends on the needs of the mother with regard to treatment of her own health. In resource-limited countries, where simplified and shortened courses of antiretroviral regimens have been used, reduction in mother-to-child transmission has also been shown, although not as effectively as that with highly active antiretroviral therapy. In these settings, exclusive breast-feeding for 6 months is recommended to reduce the risk of postnatal transmission. Language: English Keywords: UNITED STATES OF AMERICA | DEVELOPING COUNTRIES | RECOMMENDATIONS | PREGNANT WOMEN | PREVENTION OF MOTHER-TO-CHILD TRANSMISSION | HIV TESTING | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | DRUG RESISTANCE | ANTIRETROVIRAL THERAPY | RISK FACTORS | CESAREAN SECTION | BREASTFEEDING | Developed Countries | North America | Americas | Population Characteristics | Demographic Factors | Population | Disease Transmission Control | Prevention and Control | Diseases | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Treatment | Drugs | HIV | HIV Infections | Viral Diseases | Obstetrical Surgery | Surgery | Infant Nutrition | Nutrition Document Number: 342644 |
| 10. Title: Combined oral contraceptive pills for treatment of acne. Author: Arowojolu AO; Gallo MF; Lopez LM; Grimes DA; Garner SE Source: Cochrane Database of Systematic Reviews. 2009;(3):CD004425. Abstract: BACKGROUND: Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women. OBJECTIVES: To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies. SEARCH STRATEGY: We searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP). We wrote to authors of identified trials to seek any unpublished or published trials that we might have missed. SELECTION CRITERIA: All randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placeboor another active therapy for acne in women were eligible. DATA COLLECTION AND ANALYSIS: We extracted data on total and specific (i.e., open or closed comedones, papules, pustules and nodules) facial lesion counts; acne severity grades; global assessments by the clinician or the participant and discontinuation due to adverse events. Data were entered and analyzed in RevMan. MAIN RESULTS: The search yielded 25 trials: 7 placebo-controlled trials made 4 different comparisons, 17 trials made 13 comparisons between 2 different COC regimens, and 1 additional trial compared a COC to an antibiotic. COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. Differences in the comparative effectiveness of COCs containing varying progestin types and dosages, though, were less clear. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel, although this apparent advantage was based on limited data. A COC with cyproterone acetate might result in better acne outcomes than one with desogestrel; however, the three studies comparing these COCs produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes in one trial, but a second trial found the COC groups were similar. AUTHORS' CONCLUSIONS: The four COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since limited data were available regarding this question. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN | ACNE | TREATMENT | ORAL CONTRACEPTIVES, COMBINED | ADMINISTRATION AND DOSAGE | ANTIBIOTICS | HORMONES | Clinical Research | Research Methodology | Studies | Demographic Factors | Population | Dermatitis | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Drugs | Endocrine System | Physiology | Biology Document Number: 341912 |
| 11. Peer Reviewed Title: Expanding antiretroviral options in resource-limited settings--a cost-effectiveness analysis. Author: Bendavid E; Wood R; Katzenstein DA; Bayoumi AM; Owens DK Source: Journal of Acquired Immune Deficiency Syndromes. 2009 Sep 1;52(1):106-13. Abstract: BACKGROUND: Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown. METHODS: Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses. RESULTS: Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs. CONCLUSIONS: About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | THEORETICAL MODELS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | COST EFFECTIVENESS | MONITORING | WHO | IMMUNOLOGICAL EFFECTS | LIFE EXPECTANCY | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | HIV Infections | Viral Diseases | Diseases | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Evaluation Indexes | Quantitative Evaluation | Evaluation | UN | International Agencies | Organizations | Political Factors | Sociocultural Factors | Immunity | Immune System | Physiology | Biology | Length of Life | Mortality | Population Dynamics | Demographic Factors | Population Document Number: 342908 |
| 12. Title: The association of serotonin transporter genotypes and selective serotonin reuptake inhibitor (SSRI)-associated sexual side effects: possible relationship to oral contraceptives. Author: Bishop JR; Ellingrod VL; Akroush M; Moline J Source: Human Psychopharmacology. 2009 Apr;24(3):207-15. Abstract: OBJECTIVE: To study the relationship between functional variants in the serotonin transporter gene (SLC6A4) and selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction. METHODS: One hundred fifteen subjects aged 18-40 years and currently being treated with an SSRI for depression were assessed for clinical variables known to affect sexual well-being. SSRI-associated sexual difficulties were assessed with the Changes in Sexual Functioning Questionnaire (CSFQ). Subjects were subsequently genotyped for the SLC6A4 promoter region (5HTTLPR) insertion/deletion variant and a variable number of tandem repeats (VNTR) in the second intron. RESULTS: The 5HTTLPR insertion/deletion variant was associated with sexual dysfunction in this study sample [odds ratio (OR) = 2.7; 95% confidence interval (CI) 1.2, 6.4; p = 0.02]. The relationship between promoter genotypes and sexual well-being differed in males and females and was related to whether females were taking an oral contraceptive (OC) medication. Females with the ll genotype were nearly eight times more likely to be categorized as having sexual dysfunction if they were taking OCs, while no relationship was observed in those not taking OCs. CONCLUSIONS: These results suggest that a functional variant in the serotonin transporter gene is associated with sexual difficulties in persons taking an SSRI for depression. This relationship may differ by sex and be dependent on OC status in females. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | SAMPLING STUDIES | CLIENTS | DEPRESSION | DRUGS | ADMINISTRATION AND DOSAGE | SEROTONIN | SIDE EFFECTS | DECREASED LIBIDO | ORAL CONTRACEPTIVES | GENETICS | Developed Countries | North America | Americas | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Mental Disorders | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Sex Behavior | Behavior | Contraceptive Methods | Contraception | Family Planning Document Number: 341959 |
| 13. Peer Reviewed Title: Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: Does it make a difference in the mind and the daily practice of gynaecologists and general practitioners? Author: Bitzer J; Frey B; von Schonau M; Sabler N; Tschudin S Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun 5;:1-10. Abstract: Objectives Currently, evidence-based guidelines concerning the use of oral contraceptives (OCs) containing either 20 or 30 mug ethinyloestradiol (EE) and the same progestogen, are lacking. We wanted to identify whether Swiss gynaecologists and general practitioners (GPs) have specific criteria on which they base their prescribing habit. Methods Two questionnaires were submitted to 158 physicians. The first one contained a list of possible criteria relevant for decision making and a description of specific clinical situations. The second one concerned actual patients who received either a 20 mug (Yasminelle(R)) or a 30 mug (Yasmin(R)) OC containing the same progestogen drospirenone. Results The most relevant criteria for decision making (in hierarchical order) were family history of venous thromboembolic disease (VTE), headache, smoking, age beyond 35, stability of the menstrual cycle, breast tenderness, body mass index, irregular bleeding and acne. The 20 mug dosage was preferred for women older than 35, those smoking more than 15 cigarettes per day, those with a family history of VTE, and those complaining of breast tenderness or headache. The 30 mug dosage was preferred for patients with a history of irregular bleeding, a family history of osteoporosis, expected poor compliance and acne. Conclusion Swiss gynaecologists and GPs do not preferentially prescribe the lowest possible dosage of EE. They use indirect markers they consider relevant for differential prescribing. For some markers, there is inconsistency, indicating that preferences for 20 mug and 30 mug preparations may be influenced by other factors. Language: English Keywords: SWITZERLAND | RESEARCH REPORT | PHYSICIANS | WOMEN | CLIENTS | DECISION MAKING | TOBACCO USE | HEADACHE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, SIDE EFFECTS | THROMBOEMBOLISM | AGE FACTORS | ADMINISTRATION AND DOSAGE | Developed Countries | Europe, Central | Europe | Health Personnel | Delivery of Health Care | Health | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Behavior | Signs and Symptoms | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Embolism | Vascular Diseases | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services Document Number: 341601 |
| 14. Title: [Assessment of adherence to antiretroviral drugs in a municipality in southern Brazil] Avaliacao da adesao aos anti-retrovirais em um municipio no Sul do Brasil. Author: Blatt CR; Citadin CB; Souza FG; Mello RS; Galato D Source: Revista Da Sociedade Brasileira De Medicina Tropical. 2009 Mar-Apr;42(2):131-6. Abstract: The aim of this research is to assess predicting factors and adherence levels to antiretrovirals through self-report and the date of drug retrieval. It is a transversal study in which 67 patients were interviewed. Patients who used more than 90% of doses were considered to have complied with the treatment. Results of adherence were: self-reports (72.7%); calculated using dosage forgotten on the last day (70%); in three (76.1%) days; in seven (80.5%) days; and in fifteen (80.5%) days; calculated using the date of drug retrieval in a period of three (53.7%) months; and in six (47.8%) months. Variables significantly associated with adherence were: educational level, living with the family, refer good adherence, positive assessment of the antiretroviral therapy, a diagnosis of an opportunistic disease, NADIR greater than 200 cells/mm(3) and being in first-time treatment. To improve adherence rates individual and collective strategies should be elaborated taking into account factors which have been identified as negatively effecting adherence. Language: Portuguese Keywords: BRAZIL | RESEARCH REPORT | INTERVIEWS | CLIENTS | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL DRUGS | ANTIRETROVIRAL THERAPY | USER COMPLIANCE | TREATMENT | ADMINISTRATION AND DOSAGE | PROGRAM EFFECTIVENESS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Data Collection | Research Methodology | Program Activities | Programs | Organization and Administration | HIV Infections | Viral Diseases | Diseases | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV | Behavior | Drugs | Program Evaluation Document Number: 342167 |
| 15. Title: Influence of transdermal rotigotine on ovulation suppression by a combined oral contraceptive. Author: Braun M; Elshoff JP; Andreas JO; Muller LI; Horstmann R Source: British Journal of Clinical Pharmacology. 2009 Sep;68(3):386-94. Abstract: AIMS: To assess the influence of the transdermally applied dopamine agonist rotigotine on ovulation suppression by a combined oral contraceptive (0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel) in a randomized, double-blind crossover study in 40 healthy females. METHODS: Treatment A consisted of the combined oral contraceptive for 28 days plus rotigotine for the first 13 days (2 mg (24 h)(-1) on days 1-3, 3 mg (24 h)(-1) maintenance dose thereafter). During treatment B, subjects received matching placebo patches instead of rotigotine. Pharmacodynamic parameters (progesterone, oestradiol, luteinizing hormone, and follicle stimulating hormone serum concentrations), pharmacokinetic parameters for ethinyloestradiol/levonorgestrel and rotigotine, and safety and tolerability of the treatment were assessed. RESULTS: Progesterone serum concentrations remained below 2 ng ml(-1) in all subjects during the luteal phase. Median serum concentrations of all other pharmacodynamic parameters were similar during both treatments. Pharmacokinetic parameters C(max,ss) and AUC(0,24 h)(ss) at steady state were similar with or without co-administration of rotigotine for both ethinyloestradiol and levonorgestrel with geometric mean ratios close to 1 and 90% confidence intervals within the acceptance range of bioequivalence (0.8, 1.25): C(max,ss) 1.05 (0.93, 1.19), AUC(0,24 h)(ss) 1.05 (0.9, 1.22) for ethinyloestradiol; C(max,ss) 1.01 (0.96, 1.06), AUC(0,24 h)(ss) 0.98 (0.95, 1.01) for levonorgestrel. Mean plasma concentrations of unconjugated rotigotine remained stable throughout the patch-on period (day 13). CONCLUSIONS: Concomitant administration of 3 mg (24 h)(-1) transdermal rotigotine had no impact on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive containing 0.03 mg ethinyloestradiol and 0.15 mg levonorgestrel, suggesting that the dopamine agonist does not influence contraception efficacy. Language: English Keywords: SOUTH AFRICA | SUMMARY REPORT | WOMEN | ORAL CONTRACEPTIVES, COMBINED | LEVONORGESTREL | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE SAFETY | TREATMENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Drugs | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Safety | Public Health Document Number: 342711 |
| 16. Peer Reviewed Title: Association between efficacy and body weight or body mass index for two low-dose oral contraceptives. Author: Burkman RT; Fisher AC; Wan GJ; Barnowski CE; LaGuardia KD Source: Contraception. 2009 Jun;79(6):424-7. Abstract: BACKGROUND: This analysis investigated the association of oral contraceptive efficacy with body weight and body mass index (BMI) for hypothesis-generating purposes. STUDY DESIGN: Data were from a randomized, parallel-group trial of 180/215/250 mcg of norgestimate (NGM)/25 mcg of ethinyl estradiol (EE) (given to 1671 women) and 1 mg of norethindrone acetate (NETA)/20 mcg of EE (given to 1139 women). Pregnancies were evaluated across BMI deciles and by BMI and body weight dichotomies. A Pearl index was calculated for each treatment group. The relative risk (RR) of pregnancy was calculated with a Cox proportional hazards model. RESULTS: The Pearl index for women who received NGM/EE was 2.36 [95% confidence interval (CI)=1.33-3.40]; for those who received NETA/EE, the Pearl index was 3.29 (95% CI=1.81-4.77). Consistent, weak positive associations between weight and pregnancy risk were found. Overall, for women with a BMI >or=25 kg/m(2) (compared with women with a BMI <25 kg/m(2)), the RR of pregnancy was 1.84 (95% CI=0.98-3.45); that for women who received NGM/EE was 1.39 (95% CI=0.57-3.40), whereas that for women who received NETA/EE was 2.49 (95% CI=1.01-6.13). For women with a body weight >or=70 kg (compared with women with a body weight <70 kg), the RR was 1.25 (95% CI=0.63-2.46); that for women who received NGM/EE was 1.41 (95% CI=0.56-3.54), whereas that for women who received NETA/EE was 1.12 (95% CI=0.40-3.12). CONCLUSION: Women in the higher body weight or BMI category showed a small increase in the risk of pregnancy with these oral contraceptives, but this increase was not statistically significant overall or for either formulation studied. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL RESEARCH | COMPARATIVE STUDIES | WOMEN | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | NORGESTIMATE | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES, COMBINED | NORETHINDRONE ACETATE | ADMINISTRATION AND DOSAGE | Developed Countries | North America | Americas | Research Methodology | Studies | Demographic Factors | Population | Contraception | Family Planning | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Oral Contraceptives | Contraceptive Methods | Norethindrone | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341104 |
| 17. Peer Reviewed Title: Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. Author: Bussmann H; Wester CW; Thomas A; Novitsky V; Okezie R; Muzenda T; Gaolathe T; Ndwapi N; Mawoko N; Widenfelt E; Moyo S; Musonda R; Mine M; Makhema J; Moffat H; Essex M; Degruttola V; Marlink RG Source: Journal of Acquired Immune Deficiency Syndromes. 2009 May 1;51(1):37-46. Abstract: BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa. METHODS: The Tshepo Study is a completed, open-labeled, randomized study that enrolled 650 ARV-naive adults between December 2002 and 2004. The study is a 3 x 2 x 2 factorial design comparing the efficacy and tolerability among factors: (1) 3 combinations of nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine (ZDV) + lamivudine (3TC), ZDV + didanosine (ddI), and stavudine (d4T) + 3TC; (2) 2 different nonnucleoside reverse transcriptase inhibitors (NNRTIs): nevirapine and efavirenz; and (3) 2 different adherence strategies: the current national "standard of care" versus an "intensified adherence strategy" incorporating a "community-based directly observed therapy." Study patients were stratified into 2 balanced CD4 T-cell count groups: less than 201 versus 201-350 cells per cubic millimeter with viral load greater than 55,000 copies per milliliter. Following Data Safety Monitoring Board recommendations in April 2006, ZDV/ddI-containing arms were discontinued due to inferiority in primary end point, namely, virologic failure with resistance. We report both overall data and pooled data from patients receiving ZDV/ddI- versus ZDV/3TC- and d4T/3TC-containing cART through April 1, 2006. RESULTS: Four hundred fifty-one females (69.4%) and 199 males with a median age of 33.3 years were enrolled into the study. The median follow-up as of April 1, 2006, was 104 weeks, and loss to follow-up rate at 2 years was 4.1%. The median baseline CD4 T-cell count was 199 cells per cubic millimeter [interquartile ratio (IQR) 136-252], and the median plasma HIV-1 RNA level was 193,500 copies per milliliter (IQR 69-250, 472-500). The proportion of participants with virologic failure and genotypic resistance mutations was 11% in those receiving ZDV/ddI-based cART versus 2% in those receiving either ZDV/3TC- or d4T/3TC-based cART (P = 0.002). The median CD4 T-cell count increase at 1 year was 137 cells per cubic millimeter (IQR 74-223) and 199 cells per cubic millimeter (IQR 112-322) at 2 years with significantly lower gain in the ZDV/ddI arm. At 1 and 2 years, respectively, 92.0% and 88.8% of patients had an undetectable plasma HIV-1 RNA level (< or = 400 copies/mL). Kaplan-Meier survival estimates at 1 and 2 years were 96.6% and 95.4%. One hundred twenty patients (18.2%) had treatment-modifying toxicities, of which the most common were lipodystrophy, anemia, neutropenia, and Stevens-Johnson syndrome. There was a trend toward difference in time to treatment-modifying toxicity by pooled dual-NRTI combination and no difference in death rates. CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART. Language: English Keywords: BOTSWANA | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | ADULTS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | USER COMPLIANCE | DRUG RESISTANCE | IMMUNOLOGICAL EFFECTS | SIDE EFFECTS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Studies | HIV Infections | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Behavior | Immunity | Immune System | Physiology | Biology Document Number: 342371 |
| 18. Peer Reviewed Title: Route of administration of contraceptives containing desogestrel/etonorgestrel and insulin sensitivity: a prospective randomized study. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Jul;80(1):34-9. Abstract: BACKGROUND: The study was conducted to investigate whether hormonal contraceptives administered via the oral and vaginal route exert a similar effect on insulin sensitivity (SI). STUDY DESIGN: This is a prospective, randomized study performed in the University Hospital. Subjects were healthy lean young women, needing a hormonal contraceptive, randomly allocated to receive for 6 months (a) an oral contraceptive (OC) containing 30 mcg ethinylestradiol (EE)/150 mcg desogestrel (DSG) (high-estrogen group; n=12), (b) an OC containing 20 mcg EE/150 mcg DSG (low-estrogen group; n=12) and (c) a vaginal ring contraceptive releasing, per day, 15 mcg EE/120 mcg etonorgestrel, the active DSG metabolite (n=12). SI and glucose utilization independent of insulin (Sg) were evaluated by the minimal model method. Modifications of total, high-density lipoprotein (HDL) and low-density lipoprotein cholesterol and triglycerides were also evaluated. RESULTS: Sg did not vary with any treatment. SI decreased during OCs (5.74+/-0.49 vs. 3.86+/-0.44; p=.0005), independently of the high/low-estrogen dose. SI did not decrease during vaginal ring use (4.64+/-1.03 vs. 5.25+/-1.36; p=.57; p=.019 vs. oral). Total cholesterol and HDL cholesterol increased (p=.02) during OCs, independently of the dose. Triglycerides increased during both oral (p=.01) and vaginal (p=.032) contraceptive use. CONCLUSIONS: The present data indicate that in contrast to OC use, vaginal contraception with the ring does not deteriorate SI. The vaginal ring may represent an appropriate choice for long-term contraception in women at risk for developing diabetes mellitus or metabolic syndrome. Language: English Keywords: ITALY | RESEARCH REPORT | PROSPECTIVE STUDIES | WOMEN | VAGINAL RING | CONTRACEPTION | ADMINISTRATION AND DOSAGE | DESOGESTREL | CONTRACEPTIVE EFFECTIVENESS | Developed Countries | Europe, Southern | Europe | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents Document Number: 341584 |
| 19. Peer Reviewed Title: A visual dosing aid for first-line pediatric antiretroviral treatment in resource-poor settings. Author: Callens SF; Westreich D; Kitetele F; Lusiama J; Shabani N; Belhorn T; Colebunders R; Behets F; Van Rie A Source: Journal of Tropical Pediatrics. 2009 Apr;55(2):135-7. Abstract: The visual dosing aid (VDA) was developed to facilitate dosing calculations in response to children's; growth and weight during antiretroviral treatment. The theoretical accuracy of the VDA was assessed using anthropometric data from 55 children receiving care in the USA and 324 children in the Democratic Republic of the Congo. The VDA dose was similar to the WHO recommended dose. A potentially significant relative dosing difference of >or=20% occurred in <3% of children for NVP, AZT and d4T, but was observed in 20% for 3TC, overdosing being more frequent. The VDA compared well with generic pediatric fixed dose combination tablets. Results did not differ between sites. The VDA enables accurate dosing of pediatric ART in distinct populations and could facilitate roll-out of pediatric ART in resource-poor settings. Language: English Keywords: DEMOCRATIC REPUBLIC OF THE CONGO | RESEARCH REPORT | CHILDREN | ANTIRETROVIRAL DRUGS | ANTIRETROVIRAL THERAPY | TREATMENT | ADMINISTRATION AND DOSAGE | BODY WEIGHT | Developing Countries | Africa, Central | Africa, Sub Saharan | Africa | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV | HIV Infections | Viral Diseases | Diseases | Drugs | Physiology | Biology Document Number: 331199 |
| 20. Title: Manual vacuum aspiration for uterine evacuation: pain management. Author: Castleman L; Mann C Source: Chapel Hill, North Carolina, Ipas, 2009. 8 p. Abstract: Reducing the physical pain and anxiety experienced by women undergoing uterine evacuation is an essential part of treatment with MVA. The second edition of this publication addresses the types and origins of discomfort that women may experience, as well as techniques for reducing this discomfort. It includes a table highlighting some common pharmacologic approaches to pain management during MVA. Language: English Keywords: GLOBAL | RECOMMENDATIONS | PROVIDERS WITH CLIENTS | ABORTION | PAIN | PERCEPTION | CERVICAL DILATATION | ANESTHESIA | ANALGESIA | DRUGS | ADMINISTRATION AND DOSAGE | SIDE EFFECTS | POSTOPERATIVE PROCEDURES | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Signs and Symptoms | Diseases | Psychological Factors | Behavior | Treatment | Medical Procedures | Medicine | Surgery Document Number: 342497 Notification |
| 21. Peer Reviewed Title: A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. Author: Chai J; Tang OS; Hong QQ; Chen QF; Cheng LN; Ng E; Ho PC Source: Human Reproduction. 2009 Feb;24(2):320-4. Abstract: BACKGROUND: The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion. METHODS: Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects. RESULTS: There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group. CONCLUSIONS: Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. Language: English Keywords: CHINA | HONG KONG | RESEARCH REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | WOMEN IN DEVELOPMENT | ABORTION | ADMINISTRATION AND DOSAGE | MISOPROSTOL | RU-486 | PREGNANCY, SECOND TRIMESTER | TIME FACTORS | SIDE EFFECTS | Asia, Eastern | Asia | Developing Countries | Developed Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Fertility Control, Postconception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Pregnancy | Reproduction | Population Dynamics Document Number: 331075 Notification |
| 22. Title: Mifepristone plus vaginal misoprostol vs vaginal misoprostol alone for medical abortion in gestation 63 days or less in Nepalese women: a quasi-randomized controlled trial. Author: Chawdhary R; Rana A; Pradhan N Source: Journal of Obstetrics and Gynaecology Research. 2009 Feb;35(1):78-85. Abstract: AIM: To compare the efficacy of mifepristone and vaginal misoprostol with misoprostol alone for pregnancy termination up to 63 days. METHOD: This exploratory study was conducted in the Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal as a part of a thesis study for a period of one year from April 2005-2006. After confirming a pregnancy < or =63 days gestation by transvaginal ultrasound, an equal number of women (50) were randomized into (i) group A, women who received 200 mg oral mifepristone (RU 486) on day 1 and vaginal misoprostol 800 microg on day 3; and (ii) group B, women who received vaginal misoprostol (800 microg) on day 1 and 3 (total dose 1600 microg). The primary study outcome measure was complete abortion without surgical intervention making comparisons between these two groups in terms of complete abortion rate, need for manual vacuum aspiration for incomplete abortion and pregnancy continuation after reconfirming the diagnosis on transvaginal ultrasound, besides comparing the side effects/complications. RESULTS: Fewer side effects and a more complete abortion rate (94%) was observed in group A (mifepristone and vaginal misoprostol) in comparison to vaginal misoprostol alone (total dose 1600 microg) giving a complete abortion rate of 86% along with a significant hematocrit drop on follow-up day 10 (P = 0.03) besides having increased duration of bleeding (P = 0.017). CONCLUSION: Mifepristone oral (200 mg) followed by vaginal misoprostol (800 microg) on day 3 provides a better success rate (94%) with fewer complications than vaginal misoprostol 800 microg used on days 1 and 3 for medical abortion of pregnancies up to 63 days. Language: English Keywords: NEPAL | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | WOMEN IN DEVELOPMENT | PREGNANT WOMEN | RU-486 | MISOPROSTOL | ABORTION | VAGINA | ULTRASONICS | ADMINISTRATION AND DOSAGE | TIME FACTORS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | PREGNANCY, FIRST TRIMESTER | Developing Countries | Asia, Southern | Asia | Clinical Research | Research Methodology | Studies | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Hormone Antagonists | Hormones | Endocrine System | Physiology | Biology | Prostaglandins, Synthetic | Prostaglandins | Fertility Control, Postconception | Family Planning | Genitalia, Female | Genitalia | Urogenital System | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Treatment | Population Dynamics | Contraceptive Agents | Contraception | Pregnancy | Reproduction Document Number: 341125 |
| 23. Title: Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. Author: Chilet-Rosell E; Ruiz-Cantero MT; Horga JF Source: Journal of Public Health. 2009 Sep;31(3):434-45. Abstract: BACKGROUND: The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. METHODS: The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). RESULTS: Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTIVE AGENTS, FEMALE | HORMONE REPLACEMENT THERAPY | SIDE EFFECTS | THROMBOSIS | SEX FACTORS | PREGNANCY | VALIDITY | Clinical Research | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Thromboembolism | Embolism | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Reproduction | Measurement Document Number: 342950 |
| 24. Title: Frequency of Mycobacterium bovis as an etiologic agent in extrapulmonary tuberculosis in HIV-positive and -negative Mexican patients. Author: Cicero R; Olivera H; Hernandez-Solis A; Ramirez-Casanova E; Escobar-Gutierrez A Source: European Journal of Clinical Microbiology and Infectious Diseases. 2009 May;28(5):455-60. Abstract: Mycobacterium bovis can be an important etiological agent for extrapulmonary (EP) manifestations of tuberculosis, especially in HIV-infected persons. From January 2000 to December 2003, M. bovis as a cause of EP tuberculosis was investigated at the Pneumonology Service, Hospital General de Mexico, Mexico City. Eighty HIV-positive (HIV+) patients and 83 HIV-negative (HIV-) with EP involvement (ganglionar, genitourinary, meningeal, cutaneous, peritoneal, and pericardial) were analyzed using clinical, immunological, bacteriological, histopathological, and molecular biology methods. Mycobacterium species were identified by hsp65-RFLP analysis and species of M. tuberculosis complex isolates by spoligotyping. M. bovis was present in 6 HIV- cases (7.2%; 3 with lymphadenitis and 3 genitourinary) vs 11 in HIV+ cases (13.75%; 7 with lymphadenitis, 3 genitourinary, and 1 meningeal). Favorable response to retroviral and specific M. bovis chemotherapy was observed. Spoligotyping showed a unique profile in each isolate, 16 belonging to BOV1 lineage and 1 to BOV2 lineage. M. bovis is an significant re-emerging cause of EPTB in Mexico. Consumption of unpasteurized dairy products is the most likely source of transmission. Successful treatment depends on the adequate and opportune identification of the agent responsible. Language: English Keywords: MEXICO | RESEARCH REPORT | PROSPECTIVE STUDIES | CLIENTS | ADULTS | PERSONS LIVING WITH HIV/AIDS | TUBERCULOSIS | BACTERIAL AND FUNGAL DISEASES | ANTIBIOTICS | ADMINISTRATION AND DOSAGE | DRUG RESISTANCE | North America | Americas | Developing Countries | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Infections | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341794 |
| 25. Peer Reviewed Title: Establishment of drug-resistant HIV-1 in latent reservoirs. Author: Dahl V; Palmer S Source: Journal of Infectious Diseases. 2009 May 1;199(9):1258-60. Abstract: Language: English Keywords: DEVELOPING COUNTRIES | CRITIQUE | PERSONS LIVING WITH HIV/AIDS | MOTHERS | INFANT | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | DRUG RESISTANCE | ANTIRETROVIRAL THERAPY | PREVENTION OF MOTHER-TO-CHILD TRANSMISSION | IMMUNOLOGICAL EFFECTS | HIV Infections | Viral Diseases | Diseases | Parents | Family Relationships | Family Characteristics | Family and Household | Sociocultural Factors | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | HIV | Disease Transmission Control | Prevention and Control | Immunity | Immune System | Physiology | Biology Document Number: 342358 |
| 26. Peer Reviewed Title: Two-months-off, four-months-on antiretroviral regimen increases the risk of resistance, compared with continuous therapy: A randomized trial involving West African adults. Author: Danel C; Moh R; Chaix ML; Gabillard D; Gnokoro J; Diby CJ; Toni T; Dohoun L; Rouzioux C; Bissagnene E; Salamon R; Anglaret X Source: Journal of Infectious Diseases. 2009 Jan 1;199(1):66-76. Abstract: A randomized trial was launched in Côte d'Ivoire in 2002 to compare continuous antiretroviral treatment (hereafter, "C-ART") to an ART regimen of 2 months off and 4 months on therapy (hereafter, "2/4-ART"). We report the final analysis. A total of 435 adults who were receiving successful ART ((median CD4 cell count prior to ART, 272 cells/mm3; 88% were receiving a zidovudine-lamivudine-efavirenz regimen) were randomized to receive C-ART or 2/4-ART. The main primary end point was the percentage of patients with <350 CD4 cells/mm3 at 24 months. The sample size ensured 80% power to demonstrate noninferiority (noninferiority bound, -15%), assuming that 30% of the patients in the C-ART arm would have <350 CD4 cells/mm3. Other end points were mortality, morbidity, cost of care, genotypic resistance, adherence, and toxicity. The percentage of patients with <350 CD4 cells/mm3 at 24 months was 5.6% (6 of 107) in the C-ART arm and 14.6% (46 of 315) in the 2/4-ART arm (lower bound of the 95% CI for the difference, -14%). Cost was 18% higher in the C-ART arm, and resistance to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) was 20% higher in the 2/4-ART arm. Other end points were nonconclusive. Although 2/4-ART met the predetermined criteria for noninferiority, the percentage of patients with <350 CD4 cells/mm3 in the C-ART arm was lower than anticipated, which makes the clinical significance of this noninferiority uncertain. In addition, 2/4-ART led to an unacceptable additional risk of selecting for drug-resistant virus. This new argument against episodic ART strategies is also a caveat against any unplanned ART interruptions in Africa, where most patients receive NNRTIs. Language: English Keywords: COTE D'IVOIRE | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | ADULTS | TIME FACTORS | ADMINISTRATION AND DOSAGE | RISK ASSESSMENT | DRUG RESISTANCE | ANTIRETROVIRAL DRUGS | IMMUNITY, CELLULAR | GENETICS | Developing Countries | Africa, Western | Africa, Sub Saharan | Africa | Clinical Research | Research Methodology | Studies | Age Factors | Population Characteristics | Demographic Factors | Population | Population Dynamics | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Evaluation | Immunity | Immune System | Physiology | Biology Document Number: 328597 |
| 27. Peer Reviewed Title: Determinants of nonadherence to a single-dose nevirapine regimen for the prevention of mother-to-child HIV transmission in Rwanda. Author: Delvaux T; Elul B; Ndagije F; Munyana E; Roberfroid D; Asiimwe A Source: JAIDS. Journal of Acquired Immune Deficiency Syndromes. 2009 Feb 1;50(2):223-30. Abstract: OBJECTIVES: To describe experiences, and identify factors associated with nonadherence to a single-dose nevirapine (SD-NVP) regimen for the prevention of mother-to-child transmission (PMTCT) of HIV in Rwanda. METHODS: In April to May 2006, using a case-control design at 12 PMTCT sites, we interviewed HIV-infected women who did not adhere (n = 111) and who adhered (n = 125) to the PMTCT prophylaxis regimen. Nonadherence was defined as mother and/or infant not ingesting SD-NVP at the recommended time or not at all and adherence as mother-infant pairs who ingested it as recommended. RESULTS: Only 61% of nonadherent women had received SD-NVP during pregnancy or delivery. Among nonadherent women who received SD-NVP, 80% ingested it at the recommended time, representing 49% of all nonadherent women. Only 7% of their newborns ingested SD-NVP. Multivariate logistic regression showed that unmarried women, less educated women, women who made 2 or less antenatal care visits, and those offered HIV testing after their first antenatal care visit were more likely to be nonadherent to PMTCT prophylaxis. Not disclosing one's HIV status to someone aside from a partner was also associated with nonadherence in mother-infant pairs. CONCLUSIONS: Sociodemographic factors, health services delivery factors, and a lack of communication and social support contributed to nonadherence to PMTCT prophylaxis in Rwanda. Language: English Keywords: RWANDA | RESEARCH REPORT | KAP SURVEYS | MULTIVARIATE ANALYSIS | PERSONS LIVING WITH HIV/AIDS | WOMEN IN DEVELOPMENT | PREGNANT WOMEN | USER COMPLIANCE | PREVENTION OF MOTHER-TO-CHILD TRANSMISSION | HIV PREVENTION | ADMINISTRATION AND DOSAGE | PREVALENCE | EDUCATIONAL STATUS | ANTENATAL CARE | PARTNER COMMUNICATION | Africa, Central | Africa, Sub Saharan | Africa | Developing Countries | Surveys | Sampling Studies | Studies | Research Methodology | Data Analysis | HIV Infections | Viral Diseases | Diseases | Economic Development | Economic Factors | Population Characteristics | Demographic Factors | Population | Behavior | Disease Transmission Control | Prevention and Control | Drugs | Treatment | Medical Procedures | |