Trials in rheumatoid arthritis: choosing the right outcome measure when minimal disease is achievable

Clinical Epidemiology Unit, Boston University School of Medicine, 650 Albany Street, Boston, MA 02118, USA.
Annals of the rheumatic diseases (Impact Factor: 9.27). 06/2008; 67(5):580-3. DOI: 10.1136/ard.2007.079632
Source: PubMed
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    ABSTRACT: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). Secondary outcomes: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers. Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference - 4.497; 95% CI -8.071, -0.923; P = 0.015; ES 0.90). Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. Current controlled trials,, ISRCTN09712705.
    Rheumatology (Oxford, England) 11/2010; 50(6):1070-82. DOI:10.1093/rheumatology/keq234 · 4.44 Impact Factor
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    ABSTRACT: The present longitudinal study of 143 older adults (73-98 years) with serious health problems (arthritis, heart disease, heart attack, stroke) examined the effects of goal engagement, disengagement, and self-protection control strategies on self-rated physical health (condition severity, functional status) and subjective well-being (life satisfaction) at 5 years and survival at 9 years. Main effects and interactions between strategy use and the occurrence of an acute vascular event (no, yes) as well as age (young-old vs. old-old) were assessed. As hypothesized, goal engagement predicted greater survival for individuals with acute conditions but poorer physical health for those with chronic conditions and among old-old adults. In contrast, goal disengagement predicted poorer physical health for those with acute conditions but better health for individuals with chronic conditions and old-old adults. Self-protective strategies (positive reappraisal) predicted greater survival, health, and subjective well-being for those with acute conditions, as well as better physical health for old-old adults.
    Psychology and Aging 06/2010; 25(2):432-45. DOI:10.1037/a0019278 · 2.73 Impact Factor
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    Rheumatology (Oxford, England) 06/2011; DOI:10.1093/rheumatology/ker115 · 4.44 Impact Factor


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