It Takes Two: Homeopathy and Rheumatoid Arthritis
Abstract & Commentary
By Russell H. Greenfield, MD, Editor
Source: Brien S, Lachance L, Prescott P, et al. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: A randomized controlled clinical trial. Rheumatology November 2010. Doi:10.1093/rheumatology/keq234
Synopsis: Results of this unique randomized controlled trial of homeopathy for people with active rheumatoid arthritis (RA) suggest that any therapeutic benefits that might occur are due not to the specific remedy employed but to the empathetic and healing nature of the homeopathic process of consultation. The question begging to be asked is, what can any practitioner take away from this conclusion?
The majority of conventional medical practitioners look askance at the practice of homeopathy. They are also, however, challenged by the existence of a small but significant number of methodologically sounds studies reporting therapeutic benefits with homeopathy in select clinical settings. One of those settings is RA. The authors of this exploratory multicenter, double-blind, randomized, placebo-controlled clinical trial sought to tease out which aspects of homeopathy could be of adjunctive benefit to patients with active RA who also were receiving conventional medical therapy.
Adult subjects with active RA were recruited from three British outpatient rheumatology clinics. Patients were screened at baseline and then randomized. The researchers used a 5-arm design where patients receiving a consultation randomly were prescribed individualized (classical) homeopathy, a fixed combination of remedies (also called complex homeopathy, where remedies for specific maladies are offered without homeopathic consultation), or placebo. Those not receiving the consultation received either complex homeopathy or placebo. The study authors posit that their design permits comparisons between consultation and non-consultative treatment, and the effects of complex treatment, individualized treatment or placebo.
Subjects who were randomized to consultation had a meeting with one of two experienced and classically trained homeopaths from visits 2-6 inclusive (initial consultation lasted for one hour; all follow-ups were 30 minutes long). Individualized homeopathic treatment was prescribed at each visit as would normally occur in the practitioners' practices. Subjects received their trial medications via mail from an off-site homeopathic pharmacist. Remedies were either individualized homeopathic remedies in the form of tablets, prescribed from the entire homeopathic repertoire and all at ultra-molecular doses as determined at post-analysis review; or a standardized commercial homeopathic complex previously reported as efficacious for RA. Patients and study staff were aware of consultation allocation but blinded to treatment allocation.
The content of the consultation process was partially standardizedspecific topics were always covered (detailed clinical history, current symptoms and medication, assessment of emotional and mental states, etc.). In between clinic visits, patients completed weekly diaries recording pain, global assessment, and adverse events.
Primary outcome measures of interest were: 1) the proportion of subjects meeting the ACR (American College of Rheumatology) 20 improvement criteria, and 2) improvement in the subjects' global assessment of health. Secondary outcomes included DAS (Disease Activity Score)-28 measures of change in disease activity over time and changes in mood as assessed by an affect scale, among others. Participants also completed questionnaires regarding expectations of outcome, a sense of coherence scale to assess the degree to which subjects felt their lives made sense, and tools measuring degree of spirituality and beliefs about integrative therapies.
Participants were withdrawn from the study if their disease-modifying antirheumatic drugs (DMARDs) were changed or if they received > 80 mg steroids total during the treatment period. Intention-to-treat analysis was employed.
A total of 83 subjects were randomized, 6 of whom dropped out before treatment, leaving data from 77 subjects for final analysis. No significant differences were identified between the effects of consultation or treatment allocation for the primary outcomes of ACR20 and improvement in global assessment. Adverse effects did not differ significantly between the groups, and measures of treatment expectations, coping style, spirituality, sense of coherence, and other like variables did not predict outcome for the primary variables.
Regarding secondary outcomes, however, receiving a homeopathic consultation was associated with a significant improvement over time in DAS-28 compared with no consultation (mean group difference of 0.623, 95% confidence interval [CI] 0.186-1.06, P = 0.005). Receiving homeopathic consultation also was associated with a significant reduction in the number of swollen joints (group difference of 3.04, 95% CI 1.055-5.030, P = 0.0030) and current pain (group difference 9.12, 95% CI 0.521-17.718, P = 0.038) compared with those not experiencing homeopathic consultation. Further analyses showed that receiving a homeopathic consultation significantly reduced weekly pain compared with no consultation, and that subjects receiving placebo compared with individualized homeopathic remedies reported significantly improved patient global health assessment. No significant differences were detected regarding homeopathic treatment allocation.
The authors conclude that homeopathic intervention in people with active but relatively stable RA offers significant clinical benefits attributable primarily to the homeopathic consultation process, and not to the homeopathic remedies themselves.
RA is a chronic inflammatory disease that can significantly impair quality of life and overall health status. While DMARDs are commonly used to treat the disorder, they are not always effective and carry the potential for significant side effects. As is the case with many chronic ailments, the medical community's search for safe and effective measures to slow, if not altogether stop, underlying pathophysiologic processes continues with great hope for future treatments, while present-day patients often turn to CAM therapies in an attempt to gain added control over their health circumstances. Homeopathy is one therapy that many people, especially Europeans, turn to in confidence. That rosy outlook is not often shared by conventional health practitioners, in large part because explanations for the activity of homeopathic remedies run counter to widely accepted science.
The current study suggests that when therapeutic benefit can be ascribed to a homeopathic approach to RA treatment its source is not the remedy, regardless of how it was chosen, but the relationship engendered between practitioner and patient by the homeopathic consultation, a whole person evaluation that is necessarily individualized, in-depth, and collaborative. This is deemed a mere placebo effect.
The authors review the published data supporting a role for homeopathic remedies in the context of RA, be they individualized or complex in nature, and are to be congratulated for their creative and pragmatic use of a multicenter randomized clinical trial to assess qualitative issues over an extended period of time. Yes, the sample size was relatively small, but methodologically the study is strong. It is not methodology that weakens the results of this paper. It is their interpretation.
To restate, the author's conclude that the benefits of homeopathy, when present, are primarily due to the development of a healing relationship between patient and practitioner that involves trust, empathy, and hopefulness. Rather than an indictment of homeopathic remedies, this statement could more correctly be taken as an indictment of the conventional medical consultation process that often lacks these same interpersonal characteristics. Nowhere is the contrast between approaches mentioned, only the conclusion that homeopathic remedies are likely inactive in the setting of RA.
Regardless of one's bias regarding the potential for clinical benefit from homeopathy, and bias seems inherent in any discussion of homeopathy, almost all health care practitioners believe in the power of relationship. To point out that the empathic nature of a homeopathic consultation may be the source of clinical improvement, without acknowledging that the harried nature of conventional medical practice today does not allow for the consistent development of healing relationships, misses the forest for the trees. Do homeopathic remedies work for people with RA? These results suggest no. Is a healing relationship the foundation of an effective medical encounter? Yes. If it takes a "negative" homeopathic trial to reinforce that belief, Alternative Medicine Alert will review more such studies.