Randomized trial of a portable HEPA air cleaner intervention to reduce asthma morbidity among Latino children in an agricultural community.

BACKGROUND: Data on pediatric asthma morbidity and effective environmental interventions in U.S. agricultural settings are few. We evaluated the effectiveness of HEPA air cleaners on asthma morbidity among a cohort of rural Latino children. METHODS: Seventy-five children with poorly controlled asthma and living in non-smoking homes were randomly assigned to asthma education alone or along with HEPA air cleaners placed in their sleeping area and home living room. The Asthma Control Test (ACT) score, asthma symptoms in prior 2 weeks, unplanned clinical utilization, creatinine-adjusted urinary leukotriene E4 (uLTE4 [ng/mg]), and additional secondary outcomes were evaluated at baseline, six, and 12 months. Group differences were assessed using multivariable-adjusted generalized estimating equations. Incident rate ratios of ever experiencing the metrics of poorer asthma health during follow-up (suboptimal asthma management) were estimated using Poisson regression models in secondary analysis. RESULTS: Mean child age was 9.2 and 8.6 years in intervention and control groups, respectively, and two-thirds of participants were male. Primary analysis of repeated measures of ACT score did not differ between groups (HEPA group mean change compared to controls 10% [95% CI: - 12-39%]). A suggestion of greater decrease in uLTE4 (ng/mg creatinine) was observed (- 10% [95% CI: - 20 -1%]). Secondary analysis showed children with HEPAs were less likely to have an ACT score meeting a clinically defined cutoff for poorly controlled asthma using repeated measures (IRR: 0.45 [95% CI: 0.21-0.97]). In Poisson models, intervention participants had reduced risk of ever meeting this cutoff (IRR: 0.43 [95% CI: 0.21-0.89]), ever having symptoms in the past 2 weeks (IRR: 0.71 [95% CI: 0.52-0.98]), and lower risk of any unplanned clinical utilization (IRR: 0.35 [95% CI: 0.13-0.94]) compared to control participants. DISCUSSION: The HAPI study showed generally improved outcomes among children in the HEPA air cleaner group. However, primary analyses did not meet statistical significance and many outcomes were subjective (self-report) in this unblinded study, so findings must be interpreted cautiously. HEPA air cleaners may provide additional benefit for child asthma health where traditional asthmagens (traffic, tobacco smoke) are not prominent factors, but larger studies with more statistical power and blinded designs are needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04919915 . Date of retrospective registration: May 19, 2021.

Long-Term Oral Bisphosphonate Therapy and Fractures in Older Women: The Women's Health Initiative.

OBJECTIVES: To examine the association between long-term bisphosphonate use and fracture in older women at high risk of fracture. DESIGN: Retrospective cohort. SETTING: Women's Health Initiative. PARTICIPANTS: Older women who reported at least 2 years of bisphosphonate use in 2008-09 (N = 5,120). MEASUREMENTS: Exposure data were from a current medications inventory. Outcomes (hip, clinical vertebral, wrist or forearm, any clinical fracture) were ascertained annually. Using multivariate Cox proportional hazards models, the association between duration of bisphosphonate use (3-5, 6-9, 10-13 years) and fracture was estimated, using 2 years as the referent group. RESULTS: On average participants were 80 years old and were followed for 3.7 ± 1.2 years. There were 127 hip, 159 wrist or forearm, 235 clinical vertebral, and 1,313 clinical fractures. In multivariate-adjusted analysis, 10 to 13 years of bisphosphonate use was associated with higher risk of any clinical fracture than 2 years of use (hazard ratio (HR) = 1.29, 95% confidence interval (CI) = 1.07-1.57). This association persisted in analyses limited to women with a prior fracture (HR = 1.30, 95% CI = 1.01-1.67) and women with no history of cancer (HR = 1.36, 95% CI = 1.10-1.68). The association of 10 to 13 years of use, compared with 2 years of use, was not statistically significant for hip (HR = 1.66, 95% CI = 0.81-3.40), clinical vertebral (HR = 1.65, 95% CI = 0.99-2.76), or wrist fracture (HR = 1.16, 95% CI = 0.67-2.00). CONCLUSION: In older women at high risk of fracture, 10 to 13 years of bisphosphonate use was associated with higher risk of any clinical fracture than 2 years of use. These results add to concerns about the benefit of very long-term bisphosphonate use.

Long-term oral bisphosphonate use in relation to fracture risk in postmenopausal women with breast cancer: findings from the Women's Health Initiative.

OBJECTIVE: The aim of the study was to examine the association of long-term oral bisphosphonate use, compared with short-term use, with fracture risk among postmenopausal women with breast cancer. METHODS: We studied 887 postmenopausal women who were enrolled to the Women's Health Initiative from 1993 to 1998, diagnosed with breast cancer after enrollment, and reported current oral bisphosphonate use of 2 years or more on a medication inventory administered in 2008 to 2009. The outcome of any clinical fracture was ascertained by self-report on an annual study form; a subset of fractures was confirmed with medical records. Women were followed from completion of the medication inventory until 2014. The association between duration of bisphosphonate use reported on the medication inventory and fracture was estimated using multivariate Cox proportional hazards survival models that compared 4 to 7 years and 8 or more years of bisphosphonate use with 2 to 3 years of use. RESULTS: On average, women were 76 years of age and were followed for 3.7 (SD 1.1) years. There were 142 clinical fractures. In the multivariate-adjusted analysis for fracture risk factors, 8 or more years of bisphosphonate use was associated with higher risk of fracture compared with 2 to 3 years of use (hazard ratio, 1.67 [95% CI, 1.06-2.62]). There was no significant association of 4 to 7 years of use with fracture. CONCLUSIONS: Bisphosphonate use of 8 or more years was associated with higher risk of any clinical fracture compared with 2 to 3 years of use. Our findings raise concern about potential harm or decreased effectiveness of long-term bisphosphonate use on fracture risk. The findings warrant confirmatory studies.

Validity of Self-Reported Medication Use Compared With Pharmacy Records in a Cohort of Older Women: Findings From the Women's Health Initiative.

Inaccurate self-reported data on medication exposure lead to less reliable study findings. From 2013 to 2015, we assessed the validity of information on medication use collected via a mailed medication inventory among 223 Women's Health Initiative participants who were members of a health-care delivery system. Self-reported information on medication use was compared with pharmacy records for statins, calcium channel blockers, ß-blockers, and bisphosphonates. We assessed sensitivity, specificity, and positive predictive value (PPV) for current medication use. We assessed agreement on duration of use (<2, 2, 3, 4, or ≥5 years) by means of the weighted κ statistic. The mean age of participants was 77 years. Statins, ß-blockers, and calcium channel blockers were each reported by over 15% of women, and bisphosphonates were reported by 4.5%. Compared with pharmacy records, the sensitivity, specificity, and PPV for self-reported use of statins, ß-blockers, and calcium channel blockers were all 95% or greater. The sensitivity and PPV for bisphosphonate use were both 80% (95% confidence interval: 44, 97), and specificity was 99% (95% confidence interval: 97, 100). The κ statistic for duration of use was 0.87 or greater for all 4 medication classes. Compared with pharmacy records, self-reported information on current medication use and duration of use collected via mailed medication inventory among older women had almost perfect agreement for use of statins, ß-blockers, and calcium channel blockers.

An Internet-based osteoporotic fracture risk program: effect on knowledge, attitudes, and behaviors.

OBJECTIVE: The 2004 Surgeon General's Bone Health Report calls for innovative interventions to reduce osteoporotic fracture. We developed an Internet-based risk- and stage-tailored intervention to promote self-management of fracture risk. METHODS: We randomized 121 women to receive 18 personalized Internet-based tutorials with behavior modification strategies for nutrition, exercise, and other behaviors (n=61) or to receive standard information (n=60). Tutorials were tailored for 10-year hip fracture risk, osteoporosis knowledge, attitudes about osteoporosis, nutritional intake, and exercise levels. Participants in both groups completed questionnaires at baseline, 3 months, and 6 months. Qualitative data included tutorial evaluation forms and focus groups. Main outcomes were perceived impact of the intervention, and changes in osteoporosis knowledge and beliefs, calcium and vitamin D intake, and exercise levels. RESULTS: At 6 months, 80% of intervention and 92% of control group participants completed the study. The intervention group significantly increased general osteoporosis knowledge (p=0.03) and calcium knowledge (p=0.02) compared with the control group. At 6 months, intervention participants were not significantly more likely to meet recommendations for calcium (OR: 1.39; 95% CI: 0.64-3.0; p=0.40), vitamin D (OR: 1.27; CI: 0.61-2.66; p=0.53), or aerobic (OR: 1.49; 95% CI: 0.63-3.48; p=0.36) or resistance exercise (OR: 1.36; 95% CI: 0.66-2.79; p=0.40) compared with control group participants. Thematic analyses of two focus groups and 794 tutorial evaluation forms, however, indicated that the intervention improved participant ability to implement and maintain healthy behaviors. Participants suggested program refinements including virtual support groups, applications for portable devices, and tailoring of tutorial length. CONCLUSION: The risk- and stage-tailored intervention was associated with improved knowledge but was not associated with significant behavioral improvements. Qualitative results suggest the intervention improved behavior implementation and maintenance. A refined intervention with additional tailoring capabilities could be used with Internet-based fracture risk assessment tools to confront the growing societal burden of osteoporotic fractures.

Evaluating clinic and community-based lifestyle interventions for obesity reduction in a low-income Latino neighborhood: Vivamos Activos Fair Oaks Program.

BACKGROUND: Obesity exerts an enormous health impact through its effect on coronary heart disease and its risk factors. Primary care-based and community-based intensive lifestyle counseling may effectively promote weight loss. There has been limited implementation and evaluation of these strategies, particularly the added benefit of community-based intervention, in low-income Latino populations. DESIGN: The Vivamos Activos Fair Oaks project is a randomized clinical trial designed to evaluate the clinical and cost-effectiveness of two obesity reduction lifestyle interventions: clinic-based intensive lifestyle counseling, either alone (n = 80) or combined with community health worker support (n = 80), in comparison to usual primary care (n = 40). Clinic-based counseling consists of 15 group and four individual lifestyle counseling sessions provided by health educators targeting behavior change in physical activity and dietary practices. Community health worker support includes seven home visits aimed at practical implementation of weight loss strategies within the person's home and neighborhood. The interventions use a framework based on Social Cognitive Theory, the Transtheoretical Model of behavior change, and techniques from previously tested lifestyle interventions. Application of the framework was culturally tailored based on past interventions in the same community and elsewhere, as well as a community needs and assets assessment. The interventions include a 12-month intensive phase followed by a 12-month maintenance phase. Participants are obese Spanish-speaking adults with at least one cardiovascular risk factor recruited from a community health center in a low-income neighborhood of San Mateo County, California. Follow-up assessments occur at 6, 12, and 24 months for the primary outcome of percent change in body mass index at 24 months. Secondary outcomes include specific cardiovascular risk factors, particularly blood pressure and fasting glucose levels. DISCUSSION AND CONCLUSIONS: If successful, this study will provide evidence for broad implementation of obesity interventions in minority populations and guidance about the selection of strategies involving clinic-based case management and community-based community health worker support. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT01242683.

No beneficial effects of pine bark extract on cardiovascular disease risk factors.

BACKGROUND: Although modifiable cardiovascular disease risk factors are common, some patients eschew conventional drug treatments in favor of natural alternatives. Pine bark extract, a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes, has multiple putative cardiovascular benefits. Studies published to date about the supplement have notable methodological limitations. METHODS: We randomized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark (n = 64; Toyo-FVG, Toyo Bio-Pharma, Torrance, California; Shinyaku Co, Ltd, Saga, Japan; also marketed as Flavagenol in Japan) or placebo (n = 66) once per day. Blood pressure, our primary outcome, and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks. Statistical analyses were conducted using regression models. RESULTS: Baseline characteristics did not differ between the study groups. Over the 12-week intervention, the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg (95% confidence interval, -4.2 to 2.1 mm Hg) in the pine bark extract-treated group and by 1.9 mm Hg (-5.5 to 1.7 mm Hg) in the placebo group (P = .87). Other outcomes were likewise not significantly different, including body mass index, lipid panel measures, liver transaminase test results, lipoprotein cholesterol particle size, and levels of insulin, lipoprotein(a), fasting glucose, and high-sensitivity C-reactive protein. There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors. CONCLUSIONS: This pine bark extract (at a dosage of 200 mg/d) was safe but was not associated with improvement in cardiovascular disease risk factors. Although variations among participants, dosages, and chemical preparations could contribute to different findings compared with past studies, our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00425945.

National patterns of calcium use in osteoporosis in the United States.

OBJECTIVE: Although calcium intake is considered integral to appropriate management of osteoporosis, we hypothesized that the recent therapeutic dominance of bisphosphonates in osteoporosis treatment may have led calcium to be neglected as a component of effective management. STUDY DESIGN: Two national databases were used to assess the adequacy of calcium intake in patients with osteoporosis. Trends in reported supplemental calcium use among physician visits by patients with osteoporosis were assessed using nationally representative 1994-2004 IMS HEALTH National Disease and Therapeutic Index data. Quantity of calcium intake, from both supplements and food, among individuals with osteoporosis (n = 38 men and 376 women) was estimated using the 1999-2002 National Health and Nutrition Examination Survey (NHANES). RESULTS: Physician visits for osteoporosis in the United States increased 4.5-fold between 1994 (1.3 million visits) and 2004 (5.8 million visits). During this time the proportion of osteoporosis visits in which bisphosphonates were prescribed increased from 14% to 81%, while reported calcium use fell from 43% to 23% of visits. Among osteoporosis patients in NHANES, 64% reported using calcium-containing supplements. Reported median calcium intake was 433 (interquartile range: 295, 705) mg/d for calcium supplement nonusers and 1,319 (845, 1,874) mg for calcium supplement users. Overall, only 40% of osteoporosis patients had calcium intake exceeding 1,200 mg/d. CONCLUSION: While osteoporosis is increasingly identified and treated with effective medications, calcium is being neglected as a component of osteoporosis management. Despite the fact that the efficacy of new osteoporosis medications depends on adequate calcium intake, reported calcium intake in osteoporosis patients is far below recommended levels.

National trends in osteoporosis visits and osteoporosis treatment, 1988-2003.

BACKGROUND: Research is limited on physicians' prescribing practices for osteoporosis treatment. We investigated patterns of pharmacotherapy from 1988 to 2003 and the impact of new medications on identification and treatment of patients with osteoporosis. METHODS: We tracked trends from 1988 through 2003 in the frequency of osteoporosis visits and patterns of pharmacotherapy associated with these visits using nationally representative data on prescribing patterns by office-based US physicians from the IMS HEALTH National Disease and Therapeutic Index. RESULTS: The number of physician visits for osteoporosis increased 4-fold between 1994 (1.3 million visits) and 2003 (6.3 million visits), whereas it had remained stable in prior years. This increase coincided with the availability of oral daily bisphosphonates and the selective estrogen receptor modulator raloxifene. The annualized percentage of osteoporosis visits where medications were prescribed increased from 82% in 1988 to 97% by 2003. Prior to 1994, the leading choices for osteoporosis therapy were calcium and estrogens, with lesser roles played by calcitonins and bisphosphonates. Between 1994 and 2003, the percentage of visits where bisphosphonates and raloxifene were prescribed increased from 14% to 73% and from 0% to 12%, respectively, while prescriptions for other medications declined. CONCLUSIONS: New medications for osteoporosis offering improved efficacy and convenient dosing were associated with increased frequency of patient visits and treatment. This finding suggests that new drug therapy contributed to increased disease recognition and treatment.