Are the Therapeutic Effects of Homeopathy Attributed to the Consultation, the Homeopathic Remedy or Both?  An Exploratory Randomized Controlled Trial in Rheumatoid Arthritis Patients to Assess Feasibility

Principal Investigators: Sarah Brien¹ Msc PhD; Laurie Lachance² MPH, PhD; George Lewith¹ MA, DM, FRCP, MRCGP

Affiliations: ¹Complementary Medicine Research, Community Clinical Sciences, University of Southampton Medical School, UK; ²  School of Public Health, University of Michigan, USA

Background: The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process.  Systematic reviews and a meta-analysis assessing the clinical effects of homeopathy in general suggest that in "good" quality trials, overall homeopathy has a significantly greater effect than placebo and provide support of its efficacy; and contextual effects have been shown to mediate and predict treatment outcome in medicine.

 

This study proposes a conceptual model to identify the effect sizes of both the specific and non-specific aspects of the homeopathic process in rheumatoid arthritis (RA) where there is both evidence and a rationale to employ both classical and complex homeopathic approaches.  The principal question of the study is: "Can the effects of the homeopathic consultation be separated and measured separately from the homeopathic remedy?".

Hypotheses:

            1) Those who receive a homeopathic remedy (be it classical single individualized or complex homeopathy) will experience more benefit in both RA and Quality of Life (QOL) endpoints compared witht the placebo group.

            2) Those who receive homeopathy with consultation will experience more benefit in both RA and QoL end points as compared with those who receive homeopathy with no consultation.

Methods and Materials: One hundred RA patients recruited from outpatient rheumatology clinics at three UK General Hospitals will be evaluated and treated for 10 months each during this two year study.  Patients will remain on their conventional medication throughout the study.  The primary outcome measure will be based on achieving a 20% improvement of symptoms using standardized outcome measures for RA.  Health-related quality of life and analgesic use outcomes will also be measured.

 

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