Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial.

BACKGROUND: Tenofovir-containing antiretroviral therapy regimens may have long-term toxicity-related side effects. This study aimed to compare the virological efficacy of co-formulated darunavir/ritonavir plus lamivudine with darunavir/ritonavir plus tenofovir and emtricitabine or lamivudine. METHODS: The ANDES study was a 48-week, phase 4, randomized, open-label, non-inferiority trial in treatment-naïve adults living with human immunodeficiency virus (HIV). Patients were randomized on a 1:1 basis to receive a daily oral regimen of either dual therapy based on a generic co-formulation of darunavir/ritonavir (800/100 mg) plus a generic lamivudine 300 mg pill, or triple therapy with darunavir/ritonavir plus tenofovir/emtricitabine (300/200 mg) or tenofovir/lamivudine (300/300 mg). The primary endpoint was the proportion of patients with a viral load of <50 copies/mL at week 48 in the intention-to-treat population. The US Food and Drug Administration snapshot algorithm and a non-inferiority margin of -12% were used. The secondary objective was to analyse safety in the per-protocol population. This study has been registered at ClinicalTrials.gov (NCT02770508). RESULTS: Between November 2015 and 31 October 2020, 336 participants were assigned at random to the triple therapy arm (n=165) or the dual therapy arm (n=171). After 48 weeks, 153 patients in the triple therapy group (93%) and 155 patients in the dual therapy group (91%) achieved virological suppression (difference -2.1%, 95% confidence interval -7.0 to 2.9). Drug-related adverse events were more common in the triple therapy group (P=0.04). Two toxicity-related events led to discontinuation in each group. INTERPRETATION: Co-formulated darunavir/ritonavir plus lamivudine showed non-inferiority and a safer toxicity profile compared with the standard-of-care triple therapy regimen including tenofovir in treatment-naïve patients.

Evaluating the implementation of a hypertension program based on mHealth and community pharmacies integration to primary care centers at a municipality level in Argentina during the COVID-19 pandemic.

Introduction: While pharmacists-led interventions in hypertension have proven effective in high-income countries, their implementation and impact in low- and middle-income countries (LMIC) remain limited. This study assessed the implementation and outcomes of the hypertension program FarmaTeCuida (FTC), which integrated community pharmacies into the public primary care level using information and communication technologies. The study took place during the pandemic in General Pueyrredón, Buenos Aires, Argentina, so modifications to the implementation strategy and expected outcomes were also analyzed. Methods: A mixed-methods study was conducted using the non-adoption, abandonment, scaling-up, dissemination, and sustainability (NASSS) conceptual model. Qualitative in-depth interviews were conducted with key stakeholders using snowball sampling until thematic saturation was achieved. The quantitative approach employed a quasi-experimental, prospective, longitudinal design in a cohort of hypertensive patients enrolled in the FTC program since October 2020 to March 2022. Adoption, access, adherence to follow-up, and blood pressure levels were assessed. Clinical outcomes were compared to a cohort of hypertensive patients attending primary health care centers (PHCCs) in 2021 but not enrolled in the FTC program. Routine data from this cohort was obtained from the municipal health information system (HIS). Results: Out of 33 PHCCs, 23 adopted the FTC program, but only four collaborated with community pharmacies. A total of 440 patients were recruited, with 399 (91%) enrolled at PHCCs. Hypertension was detected in 63% (279/440) of cases at the first visit (113 were possible hypertensive patients; 26 new hypertensive patients and 140 already diagnosed). During follow-up, FTC identified 52 new hypertensive patients (12% out of 440). Reduction of systolic blood pressure (SBP) was observed in patients enrolled in both the FTC program and the comparison group over 60 days. In the multivariate analysis that included all hypertensive patient (FTC and HIS) we found strong evidence that for each month of follow up, SBP was reduced by 1.12 mmHg; however, we did not find any significant effect of the FTC program on SBP trend (interaction FTC*months has a p-value = 0.23). The pandemic was identified as the main reason for the program's underperformance; in addition we identified barriers related to technology, patient suitability, implementation team characteristics, and organizational factors. Discussion: Our study, grounded in the NASSS model, highlights the profound complexity of introducing innovative strategies in low- and middle-income settings. Despite substantial challenges posed by the pandemic, these obstacles provided valuable insights, identified areas for improvement, and informed strategies essential for reshaping the care paradigm for conditions like hypertension in resource-constrained environments.

Community cluster of meningococcal disease by Neisseria meningitidis serogroup C in Andalusia, Spain, March to May 2011.

Between March and May of 2011, a cluster of three fatal cases of meningococcal sepsis occurred in Andalusia, Spain, in a municipality with a population of around 20,000 inhabitants. The cases were in their mid-teens to early thirties and were notified to the epidemiological surveillance system of Andalusia (Sistema de Vigilancia Epidemiológica de Andalucía, SVEA) during a 68-day period from March through May 2011. All three were infected with the same strain of Neisseria meningitidis serogroup C genosubtype VR1:5-1;VR2:10-8. None of the cases had been previously vaccinated against N. meningitidis serogroup C. Antibiotic post-exposure chemoprophylaxis was administered to close contacts of every diagnosed case. Once the cluster was confirmed, the local population was informed through the media about the control measures taken by the health authorities. The vaccination history against N. meningitidis serogroup C of the population under 25 years-old in the municipality was checked. Vaccination was offered to unimmunised individuals younger than 25 years of age and an additional dose of vaccine was offered to those who had been vaccinated between 2000 and 2006 with a vaccination schedule of three doses before the first year of age. No further cases occurred since the beginning of these actions.

Myocardial Inflammatory Changes Before and After Antiretroviral Therapy Initiation in People With Advanced Human Immunodeficiency Virus Disease.

Because of the high frequency of late presentation of human immunodeficiency virus (HIV) disease in our population, we decided to explore the presence of myocarditis among people with HIV infection and advanced immunosuppression (less than 200 CD4+ cells/µL) and to describe the inflammatory changes observed after combined antiretroviral therapy initiation in an observational, longitudinal, prospective cohort. We performed both cardiovascular magnetic resonance imaging and doppler transthoracic echocardiogram.

Interethnic differences in the accuracy of anthropometric indicators of obesity in screening for high risk of coronary heart disease.

BACKGROUND: Cut points for defining obesity have been derived from mortality data among Whites from Europe and the United States and their accuracy to screen for high risk of coronary heart disease (CHD) in other ethnic groups has been questioned. OBJECTIVE: To compare the accuracy and to define ethnic and gender-specific optimal cut points for body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) when they are used in screening for high risk of CHD in the Latin-American and the US populations. METHODS: We estimated the accuracy and optimal cut points for BMI, WC and WHR to screen for CHD risk in Latin Americans (n=18 976), non-Hispanic Whites (Whites; n=8956), non-Hispanic Blacks (Blacks; n=5205) and Hispanics (n=5803). High risk of CHD was defined as a 10-year risk > or =20% (Framingham equation). The area under the receiver operator characteristic curve (AUC) and the misclassification-cost term were used to assess accuracy and to identify optimal cut points. RESULTS: WHR had the highest AUC in all ethnic groups (from 0.75 to 0.82) and BMI had the lowest (from 0.50 to 0.59). Optimal cut point for BMI was similar across ethnic/gender groups (27 kg/m(2)). In women, cut points for WC (94 cm) and WHR (0.91) were consistent by ethnicity. In men, cut points for WC and WHR varied significantly with ethnicity: from 91 cm in Latin Americans to 102 cm in Whites, and from 0.94 in Latin Americans to 0.99 in Hispanics, respectively. CONCLUSION: WHR is the most accurate anthropometric indicator to screen for high risk of CHD, whereas BMI is almost uninformative. The same BMI cut point should be used in all men and women. Unique cut points for WC and WHR should be used in all women, but ethnic-specific cut points seem warranted among men.

Rio de La Plata study: a multicenter, cross-sectional study on cardiovascular risk factors and heart failure prevalence in peritoneal dialysis patients in Argentina and Uruguay.

A multicenter cross-sectional study was performed to evaluate the prevalence of heart failure (HF) and the associated cardiovascular (CV) risk factors in 298 peritoneal dialysis (PD) patients from Argentina and Uruguay, representing almost 30% of the total number of PD patients in the two countries. Bidimensional echocardiography, electrocardiography, and biochemical analysis were performed. Systolic HF was defined as an ejection fraction <50%. According to echocardiography, 84.6% showed left ventricular hypertrophy (LVH), 38.3% valvular heart disease, and 35.4% valvular calcification, whereas 20% showed intraventricular conduction disturbances on the electrocardiogram. The prevalence of CV risk factors was of 73% hypertension, 51% sedentarism, 18% diabetes, 16.8% obesity, 12% smokers, 42.3% phosphorus >5.5 mg per 100 ml, 42.3% parathyroid hormone>300 pg ml(-1), and 29.6% calcium phosphate product >55. The prevalence of systolic HF was 9.9%, being significantly associated with diabetes: odds ratio (OR)=4.11 (P<0.006) and hypoalbuminemia: OR=3.45 (P<0.011). Forty percent of patients with a diagnosis of left ventricular dysfunction at the time of the study were asymptomatic. Variables associated with LVH in the multivariate analysis were anemia (OR=4.06; P<0.001) and previous hemodialysis (OR=1.99; P<0.031). The identification of reversible risk factors associated to HF and the diagnosis of asymptomatic ventricular dysfunction in this PD population will lead our efforts to establish guidelines for prevention and early treatment of congestive HF in patients on PD.

Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old.

BACKGROUND: Acute bronchiolitis is the leading cause of medical emergencies during winter in children younger than two years of age. Chest physiotherapy is thought to assist infants in the clearance of secretions and to decrease ventilatory effort. OBJECTIVES: To determine the efficacy and safety of chest physiotherapy in infants aged less than 24 months old with acute bronchiolitis. SEARCH STRATEGY: In June 2006 we updated the searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006); MEDLINE (2004 to May Week 4 2006); EMBASE (July 2004 to December 2005) and CINAHL (1982 to May Week 4 2006). SELECTION CRITERIA: Randomised controlled trials (RCTs) in which chest physiotherapy was compared against no intervention or against another type of physiotherapy in paediatric patients younger than 24 months old. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data. The primary outcome was a severity clinical score. Secondary outcomes were length of hospital stay, duration of oxygen supplementation, and the use of bronchodilators and steroids. MAIN RESULTS: Three clinical trials met the inclusion criteria. All evaluated vibration and percussion techniques with children in postural drainage positions compared to no intervention. The study populations were hospitalised infants with a clinical diagnosis of acute bronchiolitis, although one study included only infants who required nasogastric tube feeding or intravenous fluids. None of the other included trails observed any differences in the severity of the clinical score at day five, during each of the five days of the trial, or until discharge; length of hospital stay; or oxygen requirements between paediatric patients receiving chest physiotherapy and control. AUTHORS' CONCLUSIONS: Based on the results of three RCTs, chest physiotherapy using vibration and percussion techniques does not reduce length of hospital stay, oxygen requirements, or improve the severity clinical score in infants with acute bronchiolitis. These were infants who were not on mechanical ventilation and who did not have any other co-morbidity. Chest physiotherapy using forced expiratory techniques needs to be further evaluated by clinical research.

WITHDRAWN: Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). AUTHORS' CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Cortical blindness as severe neuro-ophthalmological manifestation of tuberous sclerosis complex.

Patients with retinal lesions related to tuberous sclerous complex (TSC) commonly have no impairment of visual acuity. We present a case of a 1-year-old Hispanic girl with TSC in which bilateral cortical blindness is documented.

Radiotherapy for malignant pleural mesothelioma.

BACKGROUND: Malignant pleural mesothelioma is a relatively uncommon disease, but the incidence is increasing and is expected to peak in many developed countries in the next two decades. The management of patients with malignant mesothelioma is controversial. Very few patients are suitable for any potentially curative treatment and the effectiveness of radical therapy with surgery, radiotherapy and/or chemotherapy in curing patients or prolonging survival is uncertain. The role of radiotherapy is controversial although it has been used as part of multimodal therapy. The present review will try to clarify these uncertainties. OBJECTIVES: To assess the effectiveness and safety of radiotherapy on patients with malignant pleural mesothelioma in any stage of the disease. SEARCH STRATEGY: Both electronic and handsearches were conducted. All randomised controlled clinical trials were searched in electronic databases such as: Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE. Handsearching was aimed at the identification of evidence by reviewing journals not indexed in databases, proceedings of conferences and/or scientific meetings. SELECTION CRITERIA: All randomised controlled clinical trials using radiotherapy for malignant pleural mesothelioma in any stage, alone or combined with other therapies in patients of either sex and any age, were included. Studies without a control group were excluded. DATA COLLECTION AND ANALYSIS: There were no studies that fulfilled the inclusion criteria. MAIN RESULTS: To date we have not found any reports of randomised comparisons of radiotherapy alone or combined for patients with malignant pleural mesothelioma. AUTHORS' CONCLUSIONS: As radiotherapy has never been compared to chemotherapy or surgery or to best supportive care (as part of combination therapy) in a prospective, randomised trial, no data exist supporting one or the other treatment as a better option for patients with malignant pleural mesothelioma. There is a need for multicentre controlled randomised trials assessing the role of radiotherapy in the radical treatment of malignant pleural mesothelioma. The studies should be limited to patients with malignant pleural mesothelioma, classified by stage, cytology and type of radiotherapy. The type of radiotherapy should be defined in advance and variables of radiotherapy dose definition and delivery should be carefully controlled.

Mental health, migration stressors and suicidal ideation among Latino immigrants in Spain and the United States.

BACKGROUND: Immigration stress appears to augment the risk for suicide behaviors for Latinos. Yet, specific risk factors that contribute to suicidal ideation (SI) among diverse Latino immigrant populations are not well established. METHODS: Data were collected in Boston, Madrid and Barcelona using a screening battery assessing mental health, substance abuse risk, trauma exposure, demographics, and sociocultural factors. Prevalence rates of lifetime and 30-day SI were compared across sites. Logistic regression modeling was used to identify sociodemographic, clinical, and sociocultural-contextual factors associated with 30-day SI. RESULTS: Five hundred and sixty-seven Latino patients from primary care, behavioral health and HIV clinics and community agencies participated. Rates of lifetime SI ranged from 29-35%; rates for 30-day SI were 21-23%. Rates of SI were not statistically different between sites. Factors associated with SI included exposure to discrimination, lower ethnic identity, elevated family conflict, and low sense of belonging (P<0.01). In the adjusted model, higher scores on depression, posttraumatic stress disorder, and trauma exposure were significantly associated with 30-day SI (OR=1.14, 1.04, and 7.76, respectively). Greater number of years living in the host country was significantly associated with increased odds of having SI (OR=2.22) while having citizenship status was associated with lower odds (OR=0.45). CONCLUSION: Latinos suffering depression, trauma exposure, and immigration stressors are more likely to experience SI. Despite differences in country of origin, education, and other demographic factors between countries, rates of SI did not differ. Recommendations for prevention and clinical practice for addressing suicidal ideation risk among Latino immigrants are discussed.

Megestrol acetate for the treatment of anorexia-cachexia syndrome.

BACKGROUND: Megestrol acetate (MA) is currently used to improve appetite and to increase weight in cancer-associated anorexia. In 1993 MA was approved by the USA's Federal Drug Administration for the treatment of anorexia, cachexia, or unexplained weight loss in patients with AIDS. The mechanism by which MA increases appetite is unknown, and its effectiveness for anorexia and cachexia in neoplastic and AIDS patients is under investigation. OBJECTIVES: To evaluate the efficacy, effectiveness and safety of MA in palliating anorexia-cachexia syndrome in patients with cancer, AIDS and other underlying pathologies. SEARCH STRATEGY: Studies were sought thorough an extensive search of the electronic databases, journals, reference lists, contact with investigators and other search strategies outlined in the methods. The most recent search was carried out on October 2002. SELECTION CRITERIA: Studies were included in the review if they assessed megestrol acetate compared to placebo or other drug treatments in randomized controlled trials of patients with a clinical diagnosis of anorexia-cachexia related to cancer, AIDS or another underlying pathology. DATA COLLECTION AND ANALYSIS: Data extraction was conducted by two independent authors, and methodological quality evaluated. Quantitative analyses were performed using appetite and quality of life as a dichotomous variable, and weight gain was analysed as continuous and dichotomous variables. Studies with more than 50% of patients lost to follow-up were excluded from the analysis. MAIN RESULTS: Thirty trials met the inclusion criteria (4123 patients). Twenty-one trials compared MA at different doses with placebo; four compared different doses of MA versus other drugs; two compared MA with other drugs and placebo; and three compared different doses of MA. For all patient conditions, meta-analysis showed a benefit of MA compared with placebo, particularly with regard to appetite improvement and weight gain in cancer patients. Analysing quality of life, clinical and statistical heterogeneity was found and discussed. There was insufficient information to define the optimal dose of MA. AUTHORS' CONCLUSIONS: This review demonstrates that MA improves appetite and weight gain in patients with cancer. No overall conclusion about quality of life (QOL) could be drawn due to heterogeneity. The small number of patients, methodological shortcomings and poor reporting have not allowed us to recommend megestrol acetate in AIDS patients or with other underlying pathologies.

Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old.

BACKGROUND: Acute bronchiolitis is the leading causes of medical emergencies during winter in children younger than two years of age. Chest physiotherapy is thought to assist infants in the clearance of secretions and decrease ventilatory effort. OBJECTIVES: To determine the efficacy and safety of chest physiotherapy in infants aged less than 24 months old with acute bronchiolitis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2004) which contains the Acute Respiratory Infection Group's specialised register; MEDLINE (January 1966 to June 2004); EMBASE (1990 to June 2004); PASCAL; SCISEARCH; LILACS; and Cumulative Index to the Nursing & Allied Health Literature (CINAHL) (1982 to May 2004). SELECTION CRITERIA: Randomised controlled trails (RCTs) in paediatric patients younger than twenty four months old in which chest physiotherapy was compared against no intervention or against another type of physiotherapy. DATA COLLECTION AND ANALYSIS: Two independent reviewers extracted the data. Primary outcome was a severity clinical score. Secondary outcomes were length of hospital stay, duration of oxygen supplementation, and the use of bronchodilators and steroids. MAIN RESULTS: Three clinical trials met the inclusion criteria. All evaluated vibration and percussion techniques in postural drainage positions compared to no intervention. The study population were hospitalised infants with a clinical diagnosis of acute bronchiolitis, although one study included only infants who required nasogastric tube feeding or intravenous fluids. None of the other included trails observed any differences in the severity of the clinical score at day five or during each of the five days of the trial or until discharge, length of hospital stay, or oxygen requirements between chest physiotherapy group and control. AUTHORS' CONCLUSIONS: Based on the results of three RCTs, chest physiotherapy using vibration and percussion techniques does not reduce length of hospital stay, oxygen requirements, or improve the severity clinical score in infants with acute bronchiolitis that are not under mechanical ventilation, and who do not have any other co-morbidity. Chest physiotherapy using forced expiratory technique needs to be evaluated by clinical research.

The design of clinical trials aimed at assessing the DC-ART properties of new molecules in rheumatoid arthritis.

Considerations in designing clinical trials of novel molecules are not different from those that should be considered in every rheumatoid arthritis clinical trial. This article raises some critical issues that clinicians have to face in the planning and design of clinical trials for new molecules in rheumatoid arthritis. The most frequent problems are related to outcome measures (core set of endpoints, improvement and remission), patient populations, characteristics of the study design, and economic evaluation. Although some of these issues have been resolved by consensus, further research needs to be carried out to support the use of different measurement techniques. Because clinical trials remain the most powerful investigative instrument for deciding about the benefits of new advances in medical therapy, their design should be based on an appropriate methodology.

Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis.

OBJECTIVES: To assess the effects of folic acid and folinic acid in reducing the mucosal and gastrointestinal (GI) and haematologic side effects of low-dose of Methotrexate (MTX) in patients with Rheumatoid Arthritis (RA) and to determine whether or not folate supplementation alters MTX efficacy. SEARCH STRATEGY: We searched the Cochrane Controlled Clinical Trial's Register (CCTR), the Cochrane Musculoskeletal Group Specialized Register and Medline up to and including June 1999, using the search strategy developed by the Cochrane Collaboration (Dickersin 1994). We also handsearched the following: (i) bibliographic references; (ii) current contents of the last 6 months; (iii) abstracts of the rheumatology meetings; and (iv) all issues of four journals; Journal of Rheumatology, Arthritis & Rheumatism, Clinical and Experimental Rheumatology, and British Journal of Rheumatology. All languages were included. Principal investigators were also contacted in order to look for unpublished literature. SELECTION CRITERIA: We selected all double-blind, randomized, placebo-controlled, clinical trials (RCTs), in which adult RA patients were treated with a low dose of MTX (<20 mg / week) concurrently with folate supplementation. DATA COLLECTION AND ANALYSIS: Two observers extracted the data and assessed the quality of the trials. (BS, Z0) The overall treatment effect across trials was calculated using a fixed effect model. Disease activity was evaluated using standardized mean differences to ensure comparability across outcome measures. Results are presented with 95% Confidence Inervals (95% CI). Subgroup analyses were conducted evaluating different doses and sensitivity analysis looking at the quality of the trials. Publication bias was assessed with an inverted funnel plot technique. Heterogeneity of the trials was measured using a standard chi square test. Costs per month in different countries were compared. MAIN RESULTS: Of the 12 trials retrieved, 7 met the inclusion criteria. The total sample included 307 patients, of which 147 were treated with folate supplementation, 80 patients with folinic acid and 67 patients with folic acid. A 79% reduction in mucosal and GI side effects was observed for folic acid [OR = 0.21 (95% CI 0.10 to 0.44)]. For folinic acid, a clinically but non-statistically significant reduction of 43% was found [OR = 0. 57 (95% CI 0.28 to 1.15)]. No major differences were observed between low and high doses of folic or folinic acid. Haematologic side effects could not be analyzed, since details of each haematologic side effect by patients were not provided. No consistent differences in disease activity parameters were observed when comparing placebo and folic or folinic acid at low or high doses, although patients on high dose folinic acid had an increase in the number of tender joints, but not swollen joints. Large differences in costs across countries were found, but folinic acid was more expensive in all. REVIEWER'S CONCLUSIONS: The results support the protective effect of folate supplementation in reducing MTX side effects related to the oral and GI systems. We could not determine if folic was different from folinic acid. Therefore, for folinic acid to be considered cost-effective it must be found more effective than folic acid at reducing MTX side effects.

Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). REVIEWER'S CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Calcium supplementation on bone loss in postmenopausal women.

BACKGROUND: Although calcium is one the simplest and least expensive strategies for preventing osteoporotic fractures calcium supplementation is nevertheless not without controversy (Kanis 1989; Nordin 1990). The Food and Drug Administration in the US has permitted a bone health claim for calcium-rich foods, and the NIH in its Consensus Development Process approved a statement that high calcium intake reduces the risk of osteoporosis. OBJECTIVES: To assess the effects of calcium on bone density and fractures in postmenopausal women. SEARCH STRATEGY: We searched Cochrane Controlled Register, MEDLINE and EMBASE up to 2001, and examined citations of relevant articles and proceedings of international meetings. SELECTION CRITERIA: Trials that randomized postmenopausal women to calcium supplementation or usual calcium intake in the diet and reported bone mineral density of the total body, vertebral spine, hip, or forearm or recorded the number of fractures, and followed patients for at least one year were considered for inclusion. DATA COLLECTION AND ANALYSIS: Three independent reviewers assessed the methodologic quality and extracted data for each trial. For each bone density site (lumbar spine, total body, combined hip and combined forearm), we calculated the weighted mean difference in bone density between treatment and control groups using the percentage change from baseline. We constructed regression models in which the independent variables were year and dose, and the dependent variable was the effect size. This regression was used to determine the years across which pooling was appropriate. Heterogeneity was assessed. For each fracture analysis we calculated a risk ratio. MAIN RESULTS: Fifteen trials, representing 1806 participants, were included. Calcium was more effective than placebo in reducing rates of bone loss after two or more years of treatment. The pooled difference in percentage change from baseline was 2.05% (95% CI 0.24 to 3.86) for total body bone density, 1.66% (95% CI 0.92 to 2.39) for the lumbar spine at 2 years, 1.60% (95% CI 0.78 to 2.41) for the hip, and 1.91% (95% CI 0.33 to 3.50) for the distal radius. The relative risk of fractures of the vertebrae was 0.79 (95% CI 0.54 to 1.09); the relative risk for non-vertebral fractures was 0.86 (95% CI 0.43 to 1.72). REVIEWER'S CONCLUSIONS: Calcium supplementation alone has a small positive effect on bone density. The data show a trend toward reduction in vertebral fractures, but it is unclear if calcium reduces the incidence of non vertebral fractures.

Impacto que genera el diagnóstico de VIH en mujeres trabajadoras de la Región de Antofagasta y Metropolitana / Impact of hiv diagnosis in working women in the Region of Antofagasta and the Metropolitan Region

El propósito del presente artículo expone como el diagnóstico de VIH ha afectado a mujeres chilenas en su rol de trabajadoras, conociéndolo desde su propia perspectiva. Es una investigación cualitativa, donde se entrevistan a 3 mujeres sero positivo de edad entre los 20 y 65 años, que cuentan con experiencia laboral previo al diagnóstico de VIH. Los resultados identifican un antes y después del diagnóstico de VIH, donde para mantener su rol de trabajadoras ocultan su diagnóstico al empleador y a sus compañeros de trabajo por miedo a ser discriminada; dan a conocer abiertamente su diagnóstico al contexto social que se desenvuelven para evitar prejuicios; o cambian su rubro laboral. De esta manera, se reconoce que la ley del SIDA de Chile no logra cubrir una protección real que permita el respeto, fiscalización y responsabilidad de estas normas, siendo vulnerados los derechos de las mujeres que viven con VIH. Las mujeres diagnosticadas sufren apartheid ocupacional e injusticia ocupacional, ya que no logran realizar su rol como trabajadoras debido a la desinformación que existe en la sociedad frente al VIH y a los estigmas que se encuentran en torno a ella, desencadenando prejuicios sociales históricos que han favorecido que mujeres vivan ocultando su realidad...

The purpose of this article is to present how an HIV diagnosis has affected Chilean women in their role as workers, from the perspective of the women themselves. It is qualitative research involving three interviews which HIV positive women between the ages of 20 and 65 who have work experience prior to receiving their HIV diagnosis. The results identify that there is a difference in the women’s experience pre- and post-diagnosis, whereby to maintain their role as workers they hide their diagnosis from their employer and colleagues for fear of discrimination; that the women openly disclose their diagnosis in the social context in which they operate to avoid bias; or that they change their job. Thus, it is clear that the AIDS Chile legislation fails to offer real protection to ensure respect, execution of, and accountability regarding these rules being violated for women living with HIV. The diagnosed women suffer an occupational apartheid and occupational injustice, as they are unable to perform their role as workers due to the misunderstandings that exist in society regarding HIV and to the stigmas that surround it and, moreover, are victims of historical social biases that have favored women live hiding their HIV reality...