Safety
With the recent FDA hearing and alerts regarding specific products, there has been increased scrutiny regarding the safety of homeopathic products in the U.S. The most comprehensive analysis of safety to date was recently published, examining 41 RCTs including over 6000 patients. 51 In a meta-analysis, the authors found that homeopathy had no more side effects than placebos (OR 1.03, 95% CI 0.89 – 1.20). A smaller sub-analysis (5 studies) also showed no difference compared to usual care. Nonetheless, many trials of homeopathy fail to report on adverse effects and even fewer mention aggravations or proving symptoms.
Summary
This review highlights a number of recent studies published in peer-reviewed journals on the use of homeopathy to target health concerns that have the potential to significantly impact public health and possibly reduce healthcare costs. In URTIs and fibromyalgia there is a small but significant evidence base. In other conditions, there is the suggestion of a possible health benefit, but much work still remains to be done. In particular, more independent replications of published positive studies using well-validated measures is needed. Investigators seeking to explore new avenues for research should particularly try to adhere to model validity in homeopathy research as many published trials in homeopathy do not represent standard treatment approaches used in clinical practice. 54 – 57 Moreover, adequately powering studies to account for the likelihood of enhanced placebo effects in homeopathy is also important. 8 Finally, use of the REDHOT reporting guidelines should be more rigorously adhered to to reduce the potential for bias in reporting. 58 This also includes better reporting of adverse effects and aggravations. Of course, all of these recommendations presuppose adequate funding for research in this field, a challenge worldwide and particularly difficult in the U.S.
What role does homeopathy have in public health in the U.S.? At present, it represents a very small fraction of healthcare in terms of both patients and the healthcare workforce with an overall negligible impact. Nonetheless, if it were made a standard part of the healthcare offerings in the U.S. for URTIs and fibromyalgia alone, there is the potential for significant public health benefit in terms of symptom reduction and improvement in quality of life. While there are over-the-counter combination products that target URTI symptoms that the public can access, use of homeopathy to treat fibromyalgia or other chronic health conditions would require an evaluation by trained homeopathic providers. Data suggest this approach may be more effective; however, there is a dearth of such providers in the U.S. Data also suggest that use of homeopathy can decrease use of pharmaceuticals that have known adverse effects. How potential cost-savings in terms of reduced costs for lost productivity, medications, and adverse medication effects would be counter-balanced by longer consultation times is unknown. Measuring these costs would be challenging given the complex landscape of healthcare financing in the U.S. Nonetheless, these questions deserve further exploration.
Homeopathy
Of major concern to many governments is the increasing cost of healthcare and providing care that is equitable and cost-effective. Among its peer nations, the U.S. performs worst in this regard. 47 Could expansion of homeopathy within the U.S. help to stem the rising tide of healthcare costs? A 2014 review examined economic evaluations of homeopathy and found that of 14 published studies 8 found health improvements and reduced costs with homeopathy, 4 studies found health improvements at least as good as controls for comparable costs, and 2 studies found health improvement equal to conventional care at higher costs. 48 Since that time, several additional studies have been published.
The EPI3 study from France analyzed costs for 6379 patients seeing 804 physicians for a variety of different complaints. 49 Compared to those seeing a conventional GP, those seeing a homeopathic GP incurred significantly higher costs for the consult, significantly lower costs for prescriptions, and overall a significantly lower cost for medical care.
A retrospective analysis of claims from a private German health insurer comparing costs before and after it initially started covering visits to homeopathic physicians showed an initial increase in costs in those patients using homeopathy compared to those who were not using it. 50 Whether these costs represented new use of homeopathic treatment, a shift away from prior out-of-pocket expenses, or some combination of both is unclear. Costs incurred by those using homeopathy gradually decreased over time, eventually approaching costs in those not using it by 1.5 years after initiation of coverage. There was no data on costs after 1.5 years and no data on outcomes. Though costs were increased across multiple categories, the major drivers were calculated lost productivity, outpatient care costs, and treatment of depression.
It is unclear why the results from France and Germany are so different, but a steady-state vs. initiation of new system may partially explain the differences. Longitudinal studies that include outcomes will be important to clarify issues around costs.
Regulation
Homeopathic medicines are regulated by the U.S. FDA according to the 1938 Food, Drug, and Cosmetic Act and more recent compliance guidelines. These regulations differ from both those governing supplements and those governing conventional pharmaceutical drugs, placing homeopathic medicines in a unique category unto themselves. 52 With the exception of certain potencies and nosodes, many homeopathic medicines are available for purchase over-the-counter. Licensing and certification to practice homeopathy varies based on state and the provider's qualifications. 53 Providers recommending homeopathy differ widely in their backgrounds from those with medical training of varying degrees (e.g., medical doctors, osteopathic doctors, naturopathic doctors, chiropractors, nurses, acupuncturists) to lay practitioners without a medical background. The proportion of patients in the U.S. receiving homeopathic care from lay practitioners is unknown, as is how this affects perceived effectiveness. Although the total number of homeopathic providers in the U.S. is unknown, the total number based on available organizational data are likely less than 1000.
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