Keywords
homeopathy - public health - review - respiratory tract infections - fibromyalgia
Homeopathy Use in the United States
Homeopathy Use in the United States
Similar to other developed countries, data on the use of homeopathy in the United
States come from large, population-based surveys regarding the use of complementary
and integrative therapies. In the United States, the Centers for Disease Control (CDC)
and National Center for Health Statistics (NCHS) conduct an annual survey known as
the National Health Interview Survey (NHIS) of the civilian, non-institutionalized
population. This rigorous, in-person survey conducted by trained interviewers uses
a complex sampling design to achieve population representation. Survey questions vary
from year to year, include a variety of different health issues, and the data are
used to help inform health policy. Every 5 years since 2002, this survey has included
questions regarding Americans' use of complementary and integrative therapies. The
most recently published data come from the 2012 survey and estimate that 2.2% of U.S.
adults and 1.8% of children used homeopathy within the past year.[1]
[2] Data on the use of homeopathy by adults and children in other developed countries
have been reviewed with estimates ranging from approximately 2% (adults in the UK)
to 27% (children in Germany).[3]
[4]
Recently, we analyzed data from the 2012 NHIS survey of adults to better understand
patterns and use of homeopathy in the United States.[5] We found that U.S. adults who used homeopathy had demographic characteristics similar
to other users of complementary and integrative medicine (CIM), but were even more
likely than such users to be white, female, from 30 to 44 years of age, living in
the western part of the United States, be married, have at least a high school education,
and have a lower body mass index. Homeopathy users were more likely to use more CIM
therapies than other CIM users who didn't use homeopathy and also used more of every
kind of CIM therapy surveyed except for chiropractic and osteopathic manipulation.
Of note, only 19% of homeopathy users surveyed had seen a practitioner for homeopathy.
Thus, the majority of individuals using homeopathy in America are self-prescribing
medicines available over-the-counter (OTC) with little or no professional guidance.
This use likely reflects both individual and combination homeopathic medicines that
are widely available for self-limited conditions (e.g., common cold, allergic rhinitis,
muscle and joint pain). Among those who used homeopathy to address a health condition,
the most common conditions targeted were respiratory and ear, nose, and throat complaints
(18.5%); musculoskeletal complaints (12.3%); fatigue, sleep, stress, or chronic pain
(7.7%); gastrointestinal conditions (5.0%); and neurologic conditions (3.4%). Notably,
many of these diagnostic categories overlap with the top conditions for which U.S.
physicians prescribe homeopathy to patients seeking homeopathic care ([Table 1]).[6]
Table 1
Most frequent conditions for which homeopathy is used in the United States by the
general population and prescribed by physicians
|
General population, Dossett et al[5]
|
Prescribing physicians, Jacobs et al[6]
|
|
Conditions
|
%
|
Conditions
|
%
|
|
Respiratory or ear/nose/throat
|
18.5
|
Asthma, otitis media, allergic rhinitis
|
11.8
|
|
Musculoskeletal
|
12.3
|
Arthritis
|
2.50
|
|
Fatigue, sleep problem, stress, or chronic pain
|
7.70
|
|
|
|
Gastrointestinal
|
5.00
|
|
|
|
Neurologic
|
3.40
|
Headache/migraine
|
3.20
|
|
Mental health
|
2.10
|
Depression and neurotic disorders
|
6.40
|
|
|
Allergy (nonspecific)
|
2.80
|
|
|
Dermatitis, eczema
|
2.60
|
|
|
Hypertension
|
2.40
|
Among those using homeopathy to address a health condition, we also analyzed perceived
helpfulness. Patient-reported outcomes (PROs) are increasingly being used to measure
treatment effectiveness.[7] Though not classical PROs, the NHIS survey collects data on perceived helpfulness
of CIM therapies. We found that individuals who used homeopathy without seeing a practitioner
were more likely to believe that it helped their health condition a great deal and
that it was very important in maintaining health and well-being, than individuals
who used dietary supplements but not homeopathy.[5] Moreover, individuals who saw a practitioner for homeopathic treatment were even
more likely than those who did not see a practitioner to believe that it was helpful.
Although there are many possible reasons for these findings (e.g., selection bias,
therapeutic effect of the clinical relationship,[8] real benefit of the medicines used, and increased effectiveness of individualized
homeopathic prescriptions), the differences in perceived effectiveness between these
three groups of users are nonetheless striking and warrants further study.
Placing these data in the context of recent studies of homeopathy and current health
care policy in the United States, it is worth asking what role, if any, homeopathy
may play in public health, both in the United States and the world at large. The remainder
of this review, though neither an attempt to be exhaustive nor systematic, highlights
studies in four distinct areas relevant to public health that suggest further exploration:
infectious diseases, pain conditions, mental health conditions, and cancer. Finally,
it concludes discussing issues around health care costs, safety, and some current
challenges to the field.
Homeopathy and Infectious Diseases
Homeopathy and Infectious Diseases
A 2011 health technology assessment from Switzerland concluded, based on evidence
from studies evaluating homeopathy in the context of upper respiratory tract infections
(URTIs) and allergic rhinitis, that in terms of “real-world effectiveness,” homeopathy
falls within the category of “effectiveness likely.”[9] Since that time, several additional studies using homeopathic medicines to treat
URTIs have been published. Though perhaps more nuisance than serious threat, URTIs
account for 25 million visits to family physicians and 20 to 22 million days of absence
from work and school in the United States each year.[10] Thus, URTIs pose a significant cost to society. Approximately 28% of all annual
OTC medication expenditures in the United States are for cold and flu treatments.[11] In addition, 55% of antibiotics prescribed in the United States in 1998 were for
infections unlikely to have a bacterial etiology.[12] More recent data suggest this trend has not improved significantly.[13] Antibiotic overprescribing and inappropriate prescribing is a serious issue, contributing
to the development of antibiotic-resistant organisms, reduced clinical effectiveness,
disruption of the gastrointestinal microbiome, and sometimes serious drug-related
side effects.[14]
[15]
[16] The American Institute of Homeopathy recently published an open letter calling for
greater use of homeopathy to help reduce overuse and misuse of antibiotics.[17]
A recent observational study from France supports this possibility. The EPI3 cohort
study analyzed 518 adults who presented to primary care for treatment of rhinopharyngitis
symptoms.[18] The analysis was divided into those individuals who saw conventional general practitioners
(GPs), those who saw GPs who used a combination of conventional medicine and homeopathy,
and those who saw GPs who were certified in homeopathy. Although the patient populations
who saw these three types of physicians were different (those seeing homeopathic GPs
were more likely to be females, had completed high school, and were non-smokers),
after multivariable analysis adjusting for a variety of demographic factors, those
who saw a homeopathic GP were significantly less likely to use an antibiotic or antipyretic
with similar symptom resolution at 1-month follow-up. However, the authors also noted
a nonsignificant trend for an increase in infections in this group, a finding which
needs to be further explored.
A randomized controlled trial from the United States of a commercial homeopathic ear
drop preparation also suggests that homeopathic medicines can reduce antibiotic use.[19] In that study, 210 children aged 6 months to 11 years with acute otitis media in
whom delayed antibiotic therapy was deemed appropriate were randomized to receive
standard therapy or standard therapy plus the homeopathic ear drops. Those receiving
the ear drops were less likely to fill the antibiotic prescription compared with standard
therapy alone (26.9% vs. 41.2%, p = 0.032).
Several randomized controlled trials have examined different combination homeopathic
products for URTIs. One multi-center study conducted in Germany and the Ukraine examined
a combination of Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuana D3, and Phosphorus D5 in 523 adults and children with acute URTIs.[20] Both the homeopathic group and the control group were permitted to use standard
treatment, which consisted of on-demand paracetamol, ambroxol, and/or oxymetazoline.
Their primary outcomes showed a significant increase in the percent of individuals
who were fever free at day 4 (76.8 % in the homeopathic group compared with 56.7%
in the standard treatment group, p < 0.001) and in the percent of subjects with very mild or no symptoms by day 4 (17%
in the homeopathic group compared with 7.5% in the standard treatment group, p = 0.0012). The average time to symptom alleviation was 6.6 days in the homeopathic
group compared with 8.5 days in the standard treatment group. Compared with the homeopathic
treatment group, the standard treatment group had increased symptom severity, increased
use of standard on-demand therapies, slower resolution of fever, and slower resolution
of nasal breathing impairment. A sub-analysis of pediatric subjects yielded similar
findings.[21]
A randomized controlled study of a different combination OTC product in the United
States compared a syrup containing Allium cepa 6×, Hepar sulph 12×, Natrum muriaticum 6×, Phosphorus 12×, Pulsatilla 6×, Sulfur 12×, and Hydrastis 6× to a placebo control syrup in children from 2 to 5 years.[22] A total of 261 children were randomized and treated for 3 days. Although there was
no difference in symptom diaries immediately after taking the product, the investigators
did find significant improvement in a composite cold score at 12 and 24 hours in the
homeopathy group compared with the placebo group; however, thereafter, improvements
were similar in both the groups. Notably, the homeopathy group had a worse cough during
5 to 10 days of follow-up, which the authors speculated may have been rebound symptoms
after stopping therapy.
A RCT from Brazil compared two different homeopathic preparations (a live influenza
nosode 30dH or a complex of Streptococcus, Staphylococcus, and inactivated influenza virus, all 30dH) versus placebo in 600 children followed
in the public health system in a mountainous region of the country.[23] Children were treated with the compounds twice daily for 30 days and then followed
monthly over the course of a year by health agents. Approximately one-quarter of children
were lost to follow-up across the board due to changes in residency or acquisition
of private insurance. Approximately two-thirds of children in all three groups remained
healthy throughout the entire year. However, those children in the placebo group who
became sick tended to have more total infections than the children treated with homeopathy.
Of the children treated with homeopathy, they tended to get sick a month after treatment,
whereas children treated with placebo were more likely to get sick 3 months after
treatment and to have more infections overall.
A study from Spain compared a combination of Agraphis nutans 5CH and Thuya occidentalis
5CH daily plus Kalium muriaticum 9CH and Arsenicum iodatum 9CH twice daily to placebo
in 97 children with otitis media with effusion for 3 months.[24] Children in both groups received aerosolized ambroxol and budesonide in saline for
the first 20 days. There was no significant difference in the percent of patients
cured by 90 days in the two groups (61.9% in the homeopathy group versus 56.6% in
the placebo group, p = 0.63). However, the adverse event analysis was notable for only 3 URTIs in the
homeopathy group versus 13 in the placebo group (p = 0.009).
Finally, an earlier review of homeopathic medicines for children with acute otitis
media or URTIs found evidence that homeopathic treatment resulted in (1) faster resolution
of symptoms than with conventional treatment (including antibiotics), (2) lower fill
rates of watchful waiting antibiotic prescriptions, (3) fewer or less serious side
effects, and (4) less parental sick time leave from work.[25]
While URTIs and otitis media are the most frequently studied infectious conditions
in the modern homeopathic research literature, reports from the nineteenth and early
twentieth centuries suggest that homeopathy may have a role in treating and preventing
more serious infections as well.[26] Dr André Saine reviewed this literature for case reports of mortality rates in pneumonia
and has found that the mortality rate under homeopathic treatment was 3.4% compared
with 24.4% with conventional treatment in the pre-antibiotic era and 13.7% in the
modern era for community-acquired pneumonia.[27] Frass and colleagues have successfully used homeopathy combined with conventional
medical care to treat sepsis in the ICU and found a significant improvement in survival
at 180 days.[28] Work by Bracho and colleagues strongly suggests control of a leptospirosis outbreak
in Cuba using a homeopathically prepared leptospirosis nosode.[29]
[30]
Homeopathy for Pain
According to the National Institutes of Health (NIH), pain affects more Americans
than diabetes, heart disease, and cancer combined.[31] It is the most common reason Americans access the health care system and it is the
leading cause of disability and a major contributor to health care costs. Pain manifests
in a variety of different conditions and can be acute or chronic. Co-occurrence of
depression or other mental health conditions can exacerbate pain and make it more
difficult to treat. Several recent studies have examined the use of homeopathy to
treat painful conditions.
The most studied chronic pain condition in the modern homeopathic research literature
is fibromyalgia, a condition characterized by multiple tender points on exam, fatigue,
sleep difficulties, and cognitive complaints. A recent meta-analysis examined controlled
clinical trials (n = 5 studies; total N = 183 subjects) of homeopathy to treat fibromyalgia and found significant improvements
in tender point count, pain intensity, and fatigue compared with placebo.[32] No improvement was seen in scores on the McGill pain scale or depression (only two
trials for each).
Teixeira and colleagues in Brazil studied the effect of ascending potencies of homeopathically
prepared estrogen on endometriosis-associated pelvic pain in 50 women with deeply
infiltrating lesions on imaging and who had been refractory to conventional therapy
for at least a year.[33] Women received potentized 17-β-estradiol or placebo, three drops twice daily for
24 weeks. In the homeopathy group, a12CH potency was given during the first 8 weeks,
then 18CH was given for the next 8 weeks, and finally 24 CH was given for the last
8 weeks. Potentized estrogen was significantly more effective than placebo for reducing
endometriosis-associated pelvic pain (p < 0.001) as well as depression measured by the Beck Depression Inventory (p < 0.001).
Homeopathy has also shown promise for the treatment of pediatric migraine headaches
with reduced frequency and severity of headaches and less time off from school.[34] An analysis of the EPI3 cohort also demonstrated that homeopathy decreased the use
of non-steroidal anti-inflammatory drugs (NSAIDs) and other analgesics, including
narcotics, in patients with chronic musculoskeletal disorders.[35] Both individualized homeopathy and combination products have shown benefit in reducing
chronic low back pain.[36]
[37]
Homeopathy and Mental Health
Homeopathy and Mental Health
Data from the 2015 National Survey on Drug Use and Health reveal that the prevalence
of any mental illness among U.S. adults is 17.9% (excludes developmental and substance
use disorders).[38] The lifetime prevalence of any mood disorder in the United States is 20.8% and any
anxiety disorder is 28.8%. Poorly treated mental health disorders result in large
costs to society in terms of lost productivity, worsening of physical health issues,
and increased utilization of the health care system.
Observational data from the EPI3 cohort study in France examined outcomes for 710
patients with anxiety or depression and presenting to homeopathic GPs, conventional
GPs, or GPs with a mixed practice.[39] Compared with the other two groups, patients presenting to homeopathic GPs were
less likely to have a Hospital Anxiety and Depression Scale (HADS) score > 12, a history
of suicide attempts, primary insomnia, and were more likely to have fewer co-morbidities
and visits to their GP. After adjusting for baseline differences using multivariable
modeling, patients seeing homeopathic GPs for treatment of an anxiety or depressive
disorder were more likely to have clinical improvement at 1 year (OR: 1.70, 95% CI:
1.00–2.87) and were less likely to be using a psychotropic drug (Odds ratio [OR]:
0.29, 95% confidence interval [CI]: 0.19–0.44) compared with patients seeing a conventional
GP. This clinical improvement despite reduction in the use of psychotropic drugs is
notable given the number of side effects and adverse effects associated with these
medications.
This same group also analyzed patients presenting for the evaluation of sleep complaints
(n = 346) and found a similar rate of symptom improvement in all three groups. However,
those using homeopathy were less likely to be using psychotropic drugs at 1 year (OR:
0.25, 95% CI: 0.14–0.42) compared with those seeing a conventional GP.[40]
Women in the peri-menopause period are at increased risk of developing depression.[41] A recent study from Mexico compared individualized homeopathy to fluoxetine to placebo
in 133 peri- and post-menopausal women with moderate-to-severe depression and who
were not currently taking psychiatric medications or engaged in psychotherapy.[42] After 6 weeks of treatment, individuals in both the homeopathy and fluoxetine groups
had a significant decrease in depression compared with the placebo group (homeopathy
group, number needed to treat [NNT] = 2, fluoxetine group NNT = 3). However, only
individuals in the homeopathy group had an improvement in their menopause symptoms
compared with the placebo group (p = 0.002).
Homeopathy and Cancer
Approximately 40% of men and women in the United States will be diagnosed with cancer
at some point during their lifetime.[43] The most common types are breast cancer, lung and bronchus cancer, prostate cancer,
colon and rectal cancer, bladder cancer, melanoma, non-Hodgkin's lymphoma, and thyroid
cancer. In 2016, an estimated 1.7 million new cases of cancer will be diagnosed and
596,000 people will die in the United States. Total costs of cancer care in the United
States were $125 billion in 2010 and are projected to be $156 billion by 2020. Recent
data suggest that homeopathy may play a role in improving quality of life and symptom
management in patients with cancer and possibly improve survival.
Most cases of breast cancer in post-menopausal women are hormone receptor positive
and these women are typically prescribed an aromatase inhibitor as part of their adjuvant
treatment. However, these medications often cause joint pain, which is a frequent
cause for discontinuation of therapy. Karp and colleagues studied the effect of Ruta graveolens 5CH and Rhus toxicodendron 9CH on joint pain and stiffness in women treated with aromatase inhibitors for breast
cancer.[44] In this observational cohort study conducted at two different centers, women at
one center received both homeopathic medicines twice daily, beginning 7 days prior
to aromatase inhibitor initiation (n = 20), and women at the second center received aromatase inhibitors only (n = 20). After 3 months, women in the homeopathy group had significantly fewer sites
of joint pain (p = 0.03), reduced frequency (p = 0.0004), and intensity (p = 0.0004) of pain, and lower consumption of analgesics (p = 0.0076) compared with the control group.
A pragmatic RCT by Frass and colleagues assessed the effects of individualized homeopathic
treatment on global health status and subjective well-being in 373 patients with a
variety of different stage 3 and stage 4 tumors.[45] They found significant improvements in both parameters after 4 months of follow-up
(mean difference between groups = 7.7, p = 0.005 and 14.7, p < 0.001, respectively). They also noted significant improvements in the group receiving
individualized homeopathy compared with the control group in a variety of other domains,
including physical, cognitive, and emotional functioning, as well as fatigue, pain,
insomnia, and appetite.
Intriguingly, in a retrospective study involving a separate cohort of patients receiving
individualized homeopathy as an adjunctive treatment to their cancer care, this group
found significantly improved survival compared with control patients with similar
diagnoses and who did not receive homeopathic treatment.[46] Although the authors tried to account for bias in their analysis, more prospective
data are needed to confirm these findings.
Homeopathy and Health Care Costs
Homeopathy and Health Care Costs
Of major concern to many governments is the increasing cost of health care and providing
care that is equitable and cost-effective. Among its peer nations, the United States
performs worst in this regard.[47] Could expansion of homeopathy within the United States help to stem the rising tide
of health care 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 6,379 patients seeing 804 physicians
for a variety of different complaints.[49] Compared with 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 compared costs
before and after it started covering visits to homeopathic physicians and showed an
initial increase in costs in those patients using homeopathy compared with 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 were 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
versus initiation of new system may partially explain the differences. Longitudinal
studies that include outcomes will be important to clarify issues around costs.
Safety of Homeopathy
With the recent FDA hearing and alerts about specific products, there has been increased
scrutiny regarding the safety of homeopathic products in the United States. The most
comprehensive analysis of safety to date was recently published, examining 41 RCTs
including over 6,000 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 (five studies) also
showed no difference compared with usual care. Nonetheless, many trials of homeopathy
fail to report on adverse effects and even fewer mention aggravations or proving symptoms.
Regulation of Homeopathy in the United States
Regulation of Homeopathy in the United States
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 both
from 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 OTC. Licensing and certification to practice homeopathy
vary 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 those without a medical
background. The proportion of patients in the United States receiving homeopathic
care from non-medical practitioners is unknown, as is how this affects perceived effectiveness.
Although the total number of homeopathic providers in the United States is unknown,
the total number based on available organizational data is likely less than 1,000.
Summary and Future Directions
Summary and Future Directions
This review highlights several 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 health care 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 are 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]
[55]
[56]
[57] Moreover, adequately powering studies to account for the likelihood of enhanced
placebo effects in homeopathy is also important.[8] Finally, the REDHOT reporting guidelines should be more rigorously followed 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 United States.
What role does homeopathy have in public health in the United States? At present,
it represents a very small fraction of health care in terms of both patients and the
health care workforce with an overall negligible impact. Nonetheless, if it were made
a standard part of the health care offerings in the United States 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 OTC 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 United States. Data also suggest that use of homeopathy can
decrease the 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 health care
financing in the United States. Nonetheless, these questions deserve further exploration.
