An exploratory double-blind randomised placebo controlled trial in rheumatoid arthritis to evaluate whether the effects of homeopathy are attributable to the consultation process, or the homeopathic remedy

Abstract

Background We evaluated the efficacy of homeopathic intervention as an adjuvant treatment in the management of stable rheumatoid arthritis (RA). An exploratory randomized, double-blind placebo controlled trial using 5 treatment arms was designed to identify if any clinical benefits were due to the homeopathic consultation, the remedy or both. Methods Eighty-three RA patients with active stable disease who were receiving conventional therapy for the preceding 3 months were randomized to homeopathic consultation or no consultation. Those receiving consultation were further randomised to individualised homeopathy, complex homeopathy or placebo. Those having no consultation received a homeopathic complex or placebo (individualised homeopathy can only be prescribed within consultation). Treatment was 24 weeks, with a 12-week follow-up. Co-primary outcomes: A 20% global improvement [American College of Rheumatology, ACR20 criteria] and patient global assessment (PGA). Secondary outcomes: Disease Assessment Score (DAS28), tender and swollen joint count, morning stiffness, Health Assessment Questionnaire (HAQ), visual analogue scales (VAS) of pain, physician and patient global assessment of treatment, and inflammatory markers. Analysis was by intention to treat using longitudinal analytical methods comparing changes from baseline to end of treatment, to identify consultation, treatment and interaction effects. Results Seventy-seven patients were included in the ITT analysis. There was no significant difference for either of the two primary outcomes. Patients receiving consultation demonstrated significant improvement in DAS28 score [mean difference=−0.70 (SE 0.251), 95% CI 0.208, 1.192, p =0.005], swollen joint count [mean difference=−2.47, 95% CI 0.151, 0.719, p =0.003] and functional status [mean HAQ score difference −0.02, 95% CI −0.046, −0.001, p =0.038] as compared to those not receiving a consultation. Patients receiving individualised homeopathy significantly increased positive mood compared to homeopathic complex or placebo [mean score difference 7.45, 95% CI 1.51, 13.38, p =0.015]. Interaction effects confirmed that receiving individualised homeopathy (with consultation) resulted in significant improvement in DAS28, joint swelling, functional status, joint tenderness and mood. Adverse events were minor with no treatment group differences observed. Conclusion The primary outcomes are negative. The secondary outcomes show that the homeopathic consultation mediates moderate clinically relevant benefit in relatively stable RA and that the addition of individualised remedy to consultation provides further clinical benefit for patient's subjective experience of their RA. These findings appear robust and warrant further exploration in a cost-effectiveness study