OBJECTIVES: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS: 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. RESULTS: 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). CONCLUSION: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION: Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.
RCT Entities:
OBJECTIVES: To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS: 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. RESULTS: 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). CONCLUSION: Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION: Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.
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