Periostin levels in children without respiratory disease.

BACKGROUND: Periostin is a protein that serves as a downstream marker of the T-helper type 2 (Th2) cell response. It may serve to identify drug-responsive inflammatory phenotypes, particularly in children with asthma and possibly bronchiolitis. There are no published levels of periostin in healthy children <2 years of age, limiting interpretation of periostin levels in disease. We sought to explore the range of periostin levels of children <2 years without significant confounding illnesses. METHODS: Children undergoing clinically indicated phlebotomy or having a peripheral intravenous catheter inserted prior to general anesthesia or procedural sedation were enrolled. A 0.5 mL sample of blood was collected and frozen at -70°C. After thawing, periostin was measured with a Luminex assay (R&D Systems, Minneapolis, MN). Medical record review and/or parental interview elicited potential variables associated with periostin. Association was evaluated using Mann-Whitney rank sum test, Kruskal-Wallis ANOVA, and Spearman correlation as appropriate. RESULTS: Among 43 children (23 male, 20 female, age range 9-15.7 months), periostin levels were inversely correlated to age (r = -0.438, P = 0.003). Periostin levels also differed significantly between children <12mo (734.0 [576.6-906.5] ng/mL), 12-18mo (645.1 [363.8-538.2] ng/mL) and >18mo (416.4 [363.8-538.15] ng/mL) (P < 0.001). CONCLUSION: In our sample of relatively healthy patients <2 years old, periostin levels were inversely correlated with age and not dependent on other studied variables. However, further work is needed to establish normal periostin values in young children.

Bivalved Versus Circumferential Cast Immobilization for Displaced Forearm Fractures: A Randomized Clinical Trial to Assess Efficacy and Safety.

BACKGROUND: The purpose of this study was to determine the effects of bivalved versus circumferential cast immobilization on maintenance of reduction and associated complications after closed reduction (CR) of radius and/or ulna fractures in children. METHODS: Two hundred two children with displaced radius and/or ulna fractures were randomized to either circumferential (n=101) or bivalved (n=101) long-arm casts after CR. The mean age was 10±3 years. There were no significant differences between groups in terms of age, sex, or initial fracture displacement or angulation. Clinical and radiographic evaluations were performed at 1, 2, 4, and 6 weeks postreduction. Radiographic loss of reduction (LOR), need for remanipulation or surgery, and associated complications of compartment syndrome, cast saw injury, and neurovascular compromise were recorded. RESULTS: Overall, the median angulation of the radius and ulna fractures improved from 20 and 18 degrees to 3 and 2 degrees after CR, respectively. The median cast index after reduction was 0.78 in the bivalved group and 0.80 in the circumferential group. The median angulation of the radius and ulna was 8 and 1 degrees at 4 weeks, with no significant difference between groups. By the fourth week of follow-up, 70 patients (34%)-35 bivalved and 35 circumferential-had radiographic LOR. Forty-seven patients (23%)-23 bivalved and 24 circumferential-underwent remanipulation or surgical reduction and fixation. There were no significant differences between groups with respect to LOR rate or need for surgical treatment. One bivalved patient sustained a cast saw injury, and 3 bivalved patients had transient neurological abnormalities. No patients developed compartment syndrome. CONCLUSIONS: Cast immobilization is effective in the majority of patients after CR of displaced forearm fractures. There were no significant differences in maintenance of reduction, need for surgery, or complications between bivalved or circumferential long-arm casts. LEVEL OF EVIDENCE: Level I-therapeutic.

The Pediatric International Knee Documentation Committee (Pedi-IKDC) Subjective Knee Evaluation Form: Normative Data.

BACKGROUND: Children are participating in sports at an increasingly younger age, which has contributed to an increased incidence of knee injuries among this population. Because of increased interest in the application of patient-reported outcome measures in orthopaedic surgery to evaluate treatment results, numerous knee outcome scores, including the International Knee Documentation Committee Subjective Form (IKDC), have been used to evaluate the knee. Although the IKDC has been validated only in adults, it is also being used for children because of a lack of appropriate outcome scores in the pediatric population. To address this concern, a pediatric version of the IKDC (Pedi-IKDC) was developed and evaluated for reliability, validity, and responsiveness. However, normative data for the Pedi-IKDC have not been established. PURPOSE: We aimed to aid the interpretation of Pedi-IKDC scores by characterizing normative data in children and adolescents and to validate the Pedi-IKDC by examining differences in scores among children who had a history of knee surgery or limited activity compared with those who did not. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: We conducted a cross-sectional survey of 2000 children and adolescents aged 10 to 18 years living in the United States, who were recruited by ORC International to obtain equal numbers of participants by sex and by integer age group. Participants were asked to complete the Pedi-IKDC for 1 study-designated "index" knee (right or left) and to provide demographic data and information on their knee surgery history and recent (4-week) activity limitations. Raw Pedi-IKDC total scores were rescaled to a 0 to 100 scale. We used nonparametric Wilcoxon or Kruskal-Wallis tests to compare subgroup scores, and we used the van Elteren test to adjust for age. Unadjusted and adjusted P values were similar, and only unadjusted values are reported. RESULTS: The number of respondents (N = 2000) was uniform with respect to age and sex, with 11% in each age represented (10-18 years). Fifty percent of respondents were female. Forty-nine states plus Washington, DC, were represented. In addition, 68% and 86% of respondents identified themselves as white and non-Hispanic, respectively. Seven percent of respondents (n = 136) respondents reported having prior surgery in 1 or both knees; 4% of these surgeries (n = 79) were in the index knee. The Pedi-IKDC score distribution was skewed left (mean ± SD score, 86.7 ± 16.8; median, 94.6) and 34% of scores reached the ceiling value of 100. Participants who reported prior surgery or limited activity in the index knee had median Pedi-IKDC scores that were approximately 25 points lower than participants without these histories ( P < .0001 for both comparisons). In contrast, although it was statistically significant, the variation by age ( P = .02), race ( P = .02), ethnicity ( P = .01), and level of sports/exercise participation ( P = .04) was much smaller (all ranges of median scores <4.5). There were no significant differences in scores in terms of respondent sex or geographic region. CONCLUSION: Normative Pedi-IKDC scores were determined in this study. The strong association between Pedi-IKDC scores and prior knee surgery as well as recent activity limitations in the index knee can be used to evaluate clinical outcomes and supports the construct validity of the Pedi-IKDC. There was a large ceiling effect, with 34% of scores at the maximum value of 100. The lack of a sex-based effect and the minor variation with age both simplify the interpretation and use of the Pedi-IKDC. Therefore, Pedi-IKDC score distributions can provide assumptions for use in sample size or power calculations for research.

Does periacetabular osteotomy for hip dysplasia modulate cartilage biochemistry?

BACKGROUND: The aim of periacetabular osteotomy is to improve joint mechanics in patients with developmental dysplasia of the hip. In our study, we tried to determine whether the proteoglycan content, as measured with delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC), can be modulated with the alteration of the hip joint biomechanics. METHODS: In this prospective cohort study, thirty-seven patients (thirty-seven hips) with no or minimal osteoarthritis were treated with periacetabular osteotomy for symptomatic acetabular dysplasia. All patients had preoperative and one-year follow-up dGEMRIC scans. Twenty-eight of the thirty-seven also had two-year scans. The changes in dGEMRIC findings and hip morphology between the preoperative visit and the examinations at one and two years following the periacetabular osteotomy were assessed. RESULTS: The mean preoperative dGEMRIC index (and standard deviation) was 561.6 ± 117.6 ms; this decreased to 515.2 ± 118.4 ms at one year after periacetabular osteotomy but subsequently recovered to 529.2 ± 99.1 ms at two years postoperatively. The decrease in the dGEMRIC index of the acetabular cartilage after surgery appears to be most pronounced at the superior aspect of the acetabulum, where the decrease in mechanical loading after periacetabular osteotomy would be most pronounced. All domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) demonstrated significant improvement from the preoperative to the postoperative visits (all p < 0.001). CONCLUSIONS: Periacetabular osteotomy for developmental dysplasia of the hip appears to alter the mechanical loading of articular cartilage in the hip, which in turn alters the cartilage matrix composition, as demonstrated by dGEMRIC.

PedsQL correlates to PODCI in pediatric orthopaedic outpatient clinic.

PURPOSE: Quality-of-life (QOL) measures can be a valuable tool to assess the general welfare across a spectrum of patients in a pediatric orthopaedic outpatient clinic and can be a simple way to assess patient-based outcomes particularly for quality initiatives. The Pediatric Outcomes Data Collection Instrument (PODCI) is validated for many orthopaedic conditions but typically takes around 20 minutes to complete (86 questions). The Pediatric Quality of Life Inventory (PedsQL) takes <4 minutes to complete (23 questions) but has not been assessed in an orthopaedic setting. We initiated this study to find the best method for assessing QOL in our outpatient clinic. A short pediatric QOL measure that is correlated to an established orthopaedic-specific QOL measure is needed; therefore, we compared the PedsQL to the PODCI in the outpatient orthopaedic clinic. METHODS: This was a quality initiative project and as such did not require a priori IRB approval. Families of patients 2 to 18 years old who presented for follow-up after upper or lower extremity fractures or brachial plexus injuries in the orthopaedic clinic from October 2010 through August 2011 were asked to fill out both the PODCI and the PedsQL. Patients aged 5 years and older filled out a patient-report PedsQL; patients aged 11 years and older filled out the patient-report PODCI. Parents/guardians completed questionnaires for children of all ages. Most fracture patients (and/or their parent/guardian) repeated the questionnaires after 6 to 12 weeks. Data were then assessed for correlation between the PODCI and PedsQL. RESULTS: A total of 428 parent/guardian reports for 283 patients and 172 self-reports for 104 patients were included. The correlation between the PODCI Global score and the PedsQL Total score for the parent/guardian-reported questionnaires for all injuries was 0.77 (95% confidence interval, 0.72-0.82). When categorized within domains and injuries, parent/guardian-reported correlations ranged from 0.23 to 0.79. In patients aged 11 years and older, the correlation between the PODCI and PedsQL for the patient-reported questionnaire for all injuries was 0.85 (95% confidence interval, 0.80-0.89). When categorized within domains and injuries, patient-reported correlations ranged from 0.30 to 0.99. CONCLUSIONS: Utilizing the substantially shorter PedsQL in a high volume orthopaedic clinic as a substitute for the PODCI for quality improvement measures seems reasonable. Correlation between the PedsQL Global score and the PODCI Total score for orthopaedic patients is strong. Utilizing the patient-reported questionnaires when age appropriate is best. In this era of increased outcome reporting, PedsQL may be a valuable tool.

Effect of early membrane removal on the treatment of mandibular class II furcation defects--a controlled clinical trial with re-entry after 12 months.

In a previous study in dogs, the early removal of expanded polytetrafluoroethylene (ePTFE) membrane (2 weeks after placement) showed histomorphometric results (of new bone, cementum and periodontal ligament) similar to that obtained with membrane removal at 4 weeks after placement. This study evaluated the influence of early removal of an ePTFE membrane on the treatment of Class II furcation defects. Twelve patients who provided 12 pairs of mandibular furcation defects were recruited for the study. Baseline clinical measurements were recorded: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival margin position (GMP) and relative clinical attachment level (RCAL). Full flaps were elevated and hard tissue measurements were performed during the surgery: relative vertical (RVBL) and horizontal (RHBL) bone level. The ePTFE membranes were adapted and sutured to their correspondent tooth and removed at 2 weeks in the test group (TGr) and at 4 weeks in the control group (CGr). After 1 year all sites were re-entered, and soft and hard tissue measurements were recorded. There were no statistically significant differences between TGr and CGr for any baseline measurement. After 12 months, there were no statistically significant differences between TGr and CGr in the PD (p=0.74), GMP (p=0.76) and RCAL (p=0.44) values. However, the RHBL resolution was significant for both groups (CGr p=0.01 and TGr p=0.02), without difference between groups (p=0.39). Early removal of membranes did not affect the outcome on the treatment of Class II furcation defects.

Effect of Early Membrane Removal on the Treatment of Mandibular Class II Furcation Defects - A Controlled Clinical Trial with Re-entry after 12 Months

In a previous study in dogs, the early removal of expanded polytetrafluoroethylene (ePTFE) membrane (2 weeks after placement) showed histomorphometric results (of new bone, cementum and periodontal ligament) similar to that obtained with membrane removal at 4 weeks after placement. This study evaluated the influence of early removal of an ePTFE membrane on the treatment of Class II furcation defects. Twelve patients who provided 12 pairs of mandibular furcation defects were recruited for the study. Baseline clinical measurements were recorded: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), gingival margin position (GMP) and relative clinical attachment level (RCAL). Full flaps were elevated and hard tissue measurements were performed during the surgery: relative vertical (RVBL) and horizontal (RHBL) bone level. The ePTFE membranes were adapted and sutured to their correspondent tooth and removed at 2 weeks in the test group (TGr) and at 4 weeks in the control group (CGr). After 1 year all sites were re-entered, and soft and hard tissue measurements were recorded. There were no statistically significant differences between TGr and CGr for any baseline measurement. After 12 months, there were no statistically significant differences between TGr and CGr in the PD (p=0.74), GMP (p=0.76) and RCAL (p=0.44) values. However, the RHBL resolution was significant for both groups (CGr p=0.01 and TGr p=0.02), without difference between groups (p=0.39). Early removal of membranes did not affect the outcome on the treatment of Class II furcation defects.

Em estudo prévio, em cães, a remoção precoce da membrana de politetrafluoretileno expandido (PTFE-e), 2 semanas após a colocação, mostrou resultados histomorfométricos (formação de novo osso, cemento e ligamento periodontal) similares aos de remoção da membrana 4 semanas após a sua colocação. Este estudo avaliou a influência da remoção precoce de uma membrana de PTFE-e no tratamento de defeitos de bifurcação classe II. Foram selecionados para o estudo 12 pacientes, com 12 pares de defeitos de bifurcação mandibulares. Foram feitas as seguintes medidas clínicas iniciais: índice de placa (IP), índice gingival (IG), sangramento à sondagem (SAS), profundidade de sondagem (PS), posição da margem gingival (PMG) e nível relativo da inserção clínica (NRIC). Foram elevados retalhos totais e as medidas do tecido ósseo foram tomadas transcirurgicamente: níveis ósseos vertical (NOV) e horizontal (NOH). Membranas de PTFE-e foram adaptadas e suturadas aos dentes correspondentes e removidas após 2 semanas no grupos teste (GT) ou quatro semanas no grupo controle (GC). Após 1 ano, em todos os sites foi realizada reentrada cirúrgica e medidas clínicas e ósseas foram novamente feitas. Não houve diferenças estatisticamente significantes entre GT e GC para nenhuma das medidas iniciais avaliadas. Após 12 meses, não houve diferenças estatisticamente significantes entre GT e GC para os valores de PS (p=0,74), PMG (p=0,76) e NRIC (p=0,44). Entretanto, a resolução do nível ósseo horizontal foi significante para ambos os grupos (GC: p=0,01 e GT: p=0,02), sem diferenças entre grupos (p=0,39). A remoção precoce da membrana não afetou os resultados do tratamento de defeitos de bifurcação Classe II.

Inflammation markers in healthy and periodontitis patients: a preliminary data screening.

Advances in diagnostic research are moving towards methods whereby the periodontal risk can be identified and quantified by objective measures using biomarkers. Patients with periodontitis may have elevated circulating levels of specific inflammatory markers that can be correlated to the severity of the disease. The purpose of this study was to evaluate whether differences in the serum levels of inflammatory biomarkers are differentially expressed in healthy and periodontitis patients. Twenty-five patients (8 healthy patients and 17 chronic periodontitis patients) were enrolled in the study. A 15 mL blood sample was used for identification of the inflammatory markers, with a human inflammatory flow cytometry multiplex assay. Among 24 assessed cytokines, only 3 (RANTES, MIG and Eotaxin) were statistically different between groups (p<0.05). In conclusion, some of the selected markers of inflammation are differentially expressed in healthy and periodontitis patients. Cytokine profile analysis may be further explored to distinguish the periodontitis patients from the ones free of disease and also to be used as a measure of risk. The present data, however, are limited and larger sample size studies are required to validate the findings of the specific biomarkers.

Effects of periodontal therapy on glycemic control and inflammatory markers.

BACKGROUND: Periodontitis, a complication of diabetes mellitus (DM), can induce or perpetuate systemic conditions. This double-masked, placebo-controlled study evaluated the effects of periodontal therapy (scaling and root planing [SRP]) on the serum levels of glycated hemoglobin (HbA1c) and on inflammatory biomarkers. METHODS: Thirty subjects with type 2 DM and periodontitis were treated with SRP + placebo (SRP; N = 15) or with SRP + doxycycline (SRP+Doxy; N = 15), 100 mg/day, for 14 days. Clinical and laboratory data were recorded at baseline and at 3 months after treatment. RESULTS: After 3 months, the reduction in probing depth was 0.8 mm for the SRP group (P <0.01) and 1.1 mm for the SRP+Doxy group (P <0.01) followed by a 0.9% (SRP; P = 0.17) and 1.5% (SRP+Doxy; P <0.01) reduction in HbA1c levels. A significant reduction in interleukin (IL)-6; interferon-inducible protein 10; soluble fas ligand; granulocyte colony-stimulating factor; RANTES; and IL-12 p70 serum levels were also verified (N = 30). To our knowledge, this is the first report on the effects of periodontal therapy on multiple systemic inflammatory markers in DM. CONCLUSIONS: Periodontal therapy may influence the systemic conditions of patients with type 2 DM, but no statistical difference was observed with the adjunctive systemic doxycycline therapy. Moreover, it is possible that the observed improvement in glycemic control and in the reduction of inflammatory markers could also be due to diet, which was not controlled in our study. Therefore, a confirmatory study with a larger sample size and controlled diet is necessary.

Preventing stroke: a narrative review of community interventions for improving hypertension control in black adults.

Incidence rates for stroke and hypertension are higher in black ethnic groups of African descent in the USA and UK than in white groups, suggesting a need for targeted intervention. We conduct a narrative review of published research evidence on community interventions to manage hypertension among black ethnic groups, and explore the concept of cultural sensitivity in these interventions. Data sources comprised computer-aided searches of published studies over the years 1981 to March 2006, on community strategies for improving hypertension control targeting black groups, and further references from these articles. Twenty-seven relevant studies were identified. Health education was associated with improvements in knowledge about hypertension, while education combined with individualised support for patients to self-manage hypertension, including goal setting and monitoring to enhance patient self-management of hypertension, and family support in managing hypertension were associated with reductions in blood pressure levels and improvements in blood pressure control. Collaboration with black communities, using local or minority ethnic staff, conducting preliminary research with target groups to investigate perceptions and canvass ideas for the intervention design were common methods assumed to achieve cultural sensitivity. Studies, however, provided insufficient robust evidence of the effectiveness of these strategies in terms of quantifiable outcomes, although this criterion is contested, with social justice arguments being offered instead. Implicit assumptions about homogeneity and shared interests within the 'community', and representation of 'community' views have implications for the effectiveness of interventions. These findings highlight areas for the future development of interventions to reduce hypertension rates in black groups, and factors that need to be robustly investigated and explicitly addressed in intervention design.

Inflammation markers in healthy and periodontitis patients: a preliminary data screening

Advances in diagnostic research are moving towards methods whereby the periodontal risk can be identified and quantified by objective measures using biomarkers. Patients with periodontitis may have elevated circulating levels of specific inflammatory markers that can be correlated to the severity of the disease. The purpose of this study was to evaluate whether differences in the serum levels of inflammatory biomarkers are differentially expressed in healthy and periodontitis patients. Twenty-five patients (8 healthy patients and 17 chronic periodontitis patients) were enrolled in the study. A 15 mL blood sample was used for identification of the inflammatory markers, with a human inflammatory flow cytometry multiplex assay. Among 24 assessed cytokines, only 3 (RANTES, MIG and Eotaxin) were statistically different between groups (p<0.05). In conclusion, some of the selected markers of inflammation are differentially expressed in healthy and periodontitis patients. Cytokine profile analysis may be further explored to distinguish the periodontitis patients from the ones free of disease and also to be used as a measure of risk. The present data, however, are limited and larger sample size studies are required to validate the findings of the specific biomarkers.

Avanços no diagnóstico da doença periodontal levam a métodos nos quais o risco e atividade da doença periodontal podem ser identificados e quantificados por biomarcadores. Pacientes com periodontite podem apresentar elevados níveis circulatórios de marcadores inflamatórios específicos que podem ser correlacionados com a severidade da doença. Portanto, o objetivo desse estudo foi avaliar as diferenças nos níveis séricos de biomarcadores inflamatórios em pacientes saudáveis e com doença periodontal. Foram incluídos no estudo 25 pacientes (8 saudáveis e 17 com periodontite crônica). Uma amostra de 15 mL de sangue foi obtida para identificar os marcadores inflamatórios simultaneamente utilizando Array de proteínas através de citometria de fluxo. De 24 citocinas inflamatórias analisadas, apenas 3 (RANTES, MIG e Eotaxina) apresentaram diferenças estatisticamente significantes (p<0,05) entre os dois grupos. Conclui-se que alguns marcadores inflamatórios selecionados apresentam diferença de concentração em pacientes com periodontite e saudáveis. A análise do perfil de citocinas pode ser utilizada tanto para distinguir pacientes periodontais de pacientes saudáveis, como para medir o risco à doença. Contudo, mais estudos com número maior de amostras são necessários para validar os achados sobre os biomarcadores específicos.

Strategies to manage hypertension: a qualitative study with black Caribbean patients.

BACKGROUND: The detection of hypertension in black Caribbean populations is good, but its control is thought to be inadequate. AIM: To explore how black Caribbean patients with hypertension understand their condition, and the strategies they use in managing hypertension. DESIGN OF STUDY: Qualitative study using in-depth interviews. SETTING: One general practice in inner-city London. METHOD: Practice records were searched to identify black Caribbean patients with known and treated hypertension. Audiotaped in-depth interviews were conducted with all identified patients and transcripts of the interviews were analysed for thematic content. RESULTS: We interviewed 19 black Caribbean patients with hypertension. Participants reported physical symptoms for elevated blood pressure; a minority relied on symptoms to determine their medicine use. A majority of participants equated 'normal' blood pressure readings with being cured and with no need for prescribed medicine. All participants had been prescribed antihypertension medication, and seven reported taking medication as prescribed. Those who did not, reported diverse and dynamic patterns of medication consumption. Some who had achieved normal blood pressure equated this with being cured and stopped medication, resuming when diagnosed with high blood pressure. Some modified their use of tablets according to bodily symptoms that they felt indicated higher or lower blood pressure. Some stopped or reduced medication because of unwanted effects and almost half of the participants used Caribbean 'bush' remedies. CONCLUSION: These findings suggest that some patients are making reasoned decisions about blood pressure management, drawing on medical information, their own bodily experiences of illness and sociocultural notions and practices. However, this may lead to medication use that diverges from that which is recommended. This study indicates a continued need to address these patients' perspectives and develop and evaluate new strategies to achieve hypertension control in this group.

Stop Hypertension with the Acupuncture Research Program (SHARP): clinical trial design and screening results.

Hypertension is a major public health problem with serious medical and financial consequences. Barriers to successful conventional pharmacological treatment include side effects, out-of-pocket expenses, patient noncompliance and insufficient dosages. Acupuncture has been studied as an alternative therapy for controlling blood pressure (BP) but previous studies have serious methodological limitations. This paper describes the design of the Stop Hypertension with the Acupuncture Research Program (SHARP) trial, a pilot randomized clinical trial designed to gather preliminary data regarding the efficacy of traditional Chinese medicine (TCM)-based acupuncture for control of essential hypertension. The design of the SHARP trial balanced rigorous clinical trial methodology with principles of TCM. Eligible participants had systolic BP (SBP) 140-179 mm Hg and diastolic BP (DBP) 90-109 mm Hg in the absence of antihypertensive therapy. Following screening, participants were randomized to one of three groups: individualized, standardized or control acupuncture. Treatments were designed according to principles of TCM; nonspecific effects associated with the interventions were standardized across the randomized groups. For individualized acupuncture, points were tailored to each participant. Standardized acupuncture used a prespecified set of points. The invasive sham control acupuncture regimen was designed to be non-active. Each participant received a "prescription" for individualized acupuncture from an acupuncturist who was masked to treatment assignment, and was subsequently treated by an independent acupuncturist. Patients and those assessing BP were masked to treatment group. Acupuncture was delivered twice a week for 6 weeks. Follow-up visits were every 2 weeks to week 10 and then at months 4, 6, 9 and 12. The primary endpoint will be change in SBP from baseline to 10 weeks. DBP, BP trajectories over the 12-month follow-up and antihypertensive medication requirements will also be examined. Initial contact was documented for 1442 prospective participants from March 2001 to April 2002; 424 provided informed consent and 192 were ultimately randomized.