homeopathy and public health: challenges and opportunities · • treated with cantharis 6c 1:100...

Homeopathy and Public Health: Challenges and Opportunities

Michelle Dossett, MD, PhD, [email protected]

Joint American Homeopathic ConferenceApril 1, 2017

Financial Disclosure

• I have no relevant financial interest, arrangement or affiliation related to the content I am about to present.

• Funding: K23 AT009218 (NCCIH/NIH)

Off-label/Experimental Drug Use Disclosure

• All of the homeopathic medicines and products I will be discussing are off-label or investigational use.

Outline

• Homeopathy use in the U.S.• Homeopathy and public health

– Mental health– Infectious disease– Cancer– Pain– Healthcare costs– Safety

• Challenges in homeopathic research

Objectives

• Describe how the American public uses and perceives homeopathy

• List at least 4 ways in which homeopathy can positively impact public health

• Explain challenges inherent in conducting clinical trials of homeopathy

Homeopathy Use and Public Perceptions in the U.S.

National Health Interview Survey (NHIS)

• “People who use homeopathy (ho-mee-AH-puh-thee) to treat health problems take small pills or drops that are often placed under the tongue. They may be labeled as homeopathic remedies or medicine and they may be prescribed by practitioners of homeopathy.”

Percentage of U.S. Adults and Children Using Homeopathy

2002 2007 2012Adults 1.7% 1.8% 2.2%*Children (ages 4-17)

-- 1.2% 1.8%

* p for trend < 0.05

Clarke TC, Natl Health Stat Report, 2015Black LI, Natl Health Stat Report, 2015

Adult Use of Homeopathy in Other Countries

Country% Pop.

EstimateSurvey

Year CitationUK 1.9 2001 Thomas K, J Public Health (Oxf), 2004

Australia 6.0 2005 Xue CC, J Altern Complement Med, 2007

Switzerland 8.2 2012 Klein SD, PLoS One, 2015

Germany 14.8 ? Härtel U, Forsch Komplementarmed KlassNaturheilkd. 2004; cited in Frass M, Ochsner J, 2012

Pediatric Use of Homeopathy in Other Countries

Country% Pop.

Estimate Survey Year First AuthorGermany 27.7 2007 ZutavernNetherlands 14.6 2006 VliegerItaly 7.6 2002 Menniti-IppolitoUK 3.6-6.3 2006, 2008,

2010Crawford; Wye; Thompson

Australia 2.0-5.4 2005, 2006 Lim; Smith

Italia S, Eur J Pediatr, 2014

2016

Adult Homeopathy Users in the U.S.:• More likely than other complementary and integrative

medicine (CIM) users to be white, female, aged 30-44, live in the west, married, highly educated, and have a lower BMI

• Used more of every kind of CIM therapy surveyed than other types of CIM users except for chiropractic & osteopathic manipulation

• More likely to use multiple types of CIM• 19% saw a practitioner for homeopathy

Types of CIM Modalities Assessed

Number of CIM Modalities Used by Type of User

Total Number of CIM Modalities Used

ConditionSupplement

UsersHomeopathy

UsersRespiratory or ENT* 1.5 18.5Musculoskeletal 13.6 12.3Fatigue, sleep problem, stress, or chronic pain

2.9 7.7

Gastrointestinal 3.6 5.0Neurologic 0.9 3.4Mental health 0.9 2.1Cardiac and vascular 10.9 --*ENT = ears, nose, throat complaints-- unable to accurately estimate due to small number and large standard error

Most Common Health Conditions Addressed

Jacobs J, Arch Fam Med, 1998

0

10

20

30

40

50

60

70

Supplements withouthomeopathy

Homeopathy - nopractitioner

Homeopathy -practitioner

Chiropractic/OsteopathicManipulation

Acupuncture

p < 0.0001

p = 0.03

p = 0.001

p = 0.009

Perc

ent o

f Use

rsPerceived Helpfulness of Therapy

Helped condition a great deal Very important in maintaining health & well-being

Supplements Homeopathyno practitioner

AcupunctureHomeopathywith practitioner

Chiropractic/Osteopathic

Outline




Homeopathy and Mental Health

Prevalence of Any Mental Illness Among US Adults (2015)

https://www.nimh.nih.gov/health/statistics/prevalence/any-mental-illness-ami-among-us-adults.shtml

More U.S. Statistics

• Any mood disorder– lifetime prevalence 20.8%– 12 month prevalence 9.5%– 12 month prevalence of major depressive disorder

6.7%• Any anxiety disorder

– lifetime prevalence 28.8%– 12 month prevalence 18.1%

https://www.nimh.nih.gov/health/statistics/index.shtml

Depression Scores Menopause Symptoms

Baseline Characteristics

% With Clinical Improvement

% Using at Least 1 Psychotropic Medication

Multivariable Modeling

GP-Mx vs GP-CMOR [95% CI]

p value

GP-Ho vs GP-CMOR [95% CI]

p valueClinical Improvement(HADS score)

1.49 [0.89-2.50]0.13

1.70 [1.00-2.87]0.05

Psychotropic Drug Use 0.62 [0.41-0.94]0.02

0.29 [0.19-0.44]<0.001

Sleep Disorders

• 50-70 million US adults have a sleep disorder• Drowsy driving is responsible for 1,550 fatalities and 40,000

nonfatal injuries annually in the United States• Each year, sleep disorders, sleep deprivation, and sleepiness

add an estimated $15.9 billion to the national health care bill• Insomnia is the most common specific sleep disorder, with

short term issues reported by about 30% of adults and chronic insomnia by 10%

• The benefit of sedative hypnotics is small and their use is associated with adverse effects such as falls and cognitive impairment

https://www.sleepassociation.org/sleep/sleep-statistics/https://www.nhlbi.nih.gov/about/org/ncsdr/Glass J, BMJ, 2005

Results

• Gelsemium 2C, 3C, 4C, 5C, 9C, and 30C• Results verified in 2 different cell lines with replications and

compared to control solutions• Gelsemium 2C: 49 genes were down-regulated, 7 genes were up-

regulated. Similar expression trends were observed up to 30C.

Families of Affected Genes

Homeopathy & Infectious Diseases

2011

“Final conclusion after analysis of the reviews on homeopathy: in a three-tier evaluation scale of the ‘real-world effectiveness’ (effectiveness likely, questionable or unlikely), homeopathy falls within the category: ‘effectiveness likely’.”

Treatment of Pneumonia

Treatment # Patients Mortality RatePre-antibiotic Homeopathy 25,216 3.4%Pre-antibiotic Conventional medicine 146,237 24.4%Modern Day Conventional medicine (community acquired pneumonia only) 33,148 13.7%

http://homeopathy.ca/debates_2013-03-22Q1ns.shtml

Data culled by Dr. André Saine

https://homeopathyusa.org/about-aih-2/position-statements-letters-2/letter-regarding-antibiotic-resistance.html

Upper Respiratory Infection Statistics

• Uncomplicated URIs account for 25 million visits to family physicians and about 20 to 22 million days of absence from work or school each year in the United States

• ~28% of all annual over-the-counter medication expenditures are for cold and flu treatments

• ~55% of antibiotics prescribed in 1998 were for infections unlikely to have a bacterial etiology.

Zoorob R, Am Fam Physician. 2012 Klemas N, Med Econ. 2015Gonzales R, Clin Infect Dis. 2001

Results

Inclusion criteria (within 24 hours):1. Age 1-652. Axillary temperature > 37.5 C3. At least 1 URTI symptom (cough, sore throat, nasal symptoms)4. 1 “general” symptom (malaise, body aches, irritability (child))Exclusion criteria:Complicated URTI, lower respiratory disease, + rapid strep, pregnant, or recent treatment with antibiotics, steroids, antihistamines.

Study Design

• 10 centers in Germany, 12 in the Ukraine• Received on-demand standard treatment (ST = paracetamol,

ambroxol, and/or oxymetazoline as needed) or ST + a combination homeopathic product (IFC)

• IFC = Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuana D3, and Phosphorus D5.

• First 72 hours, adults 12 tablets daily (1/hr), children 8 (1/2 hr)• Next 96 hours, adults 2 tablets 3x/day, children 1 tablet 3x/day• Patients filled out a study dairy and were assessed by the study

team on days 1, 4, 8, and 15.

Results – Primary Outcomes

• % of subjects fever free at day 4– 76.8% if the IFC group vs. 56.7% in the ST group

(p < 0.001)

• % of subjects with very mild or no symptom by day 4 (measured by the WURSS-21)– 17% in the IFC group vs. 7.5% in the ST group

(p = 0.0012)

Results

Secondary Outcomes

* p < 0.05

Complex = Streptococcus, Staphylococcus, + inactivated influenza virus, 30 dH InfluBio = live influenza virus (H3N2) 30 dH

p < 0.01p < 0.001

p = 0.99

• 97 patients enrolled

• 61.9% cured by the 3rd visit in the homeopathy group vs. 56.8% in the placebo group (p=0.63)

• Adverse event analysis notable for 3 URTIs in the homeopathy group vs. 13 in the placebo group (p=0.009)

• Contains Sulfur 4x, 10x and Vincetoxicum hirundinaria 6x, 10x, 30x• Issues – no mention of blinding protocol or funding. Vaccine

challenged mice had previously been exposed to the homeopathic compound for 28 days followed by a 14 day washout period.

Tablet Analysis

• Treated with Cantharis 6C 1:100 dilution in drinking water x 24 hrs• Cantharis treated mice had increased production of inflammatory

cytokines IL-12p40 & IFN-g, decreased production of IL-10, in bladder fluid; also increased number of B cells in the bladder

• Issues – unclear blinding protocol, volumes of bladder fluid washes, funding?

Homeopathy & Cancer

Cancer Statistics

• In 2016, an estimated 1,685,210 new cases of cancer will be diagnosed and 595,690 people will die in the U.S.

• Approximately 39.6 percent of men and women will be diagnosed with cancer at some point during their lifetimes

• The most common cancers are breast cancer, lung and bronchus cancer, prostate cancer, colon and rectum cancer, bladder cancer, melanoma of the skin, non-Hodgkin lymphoma, and thyroid cancer

• Costs of cancer care in the US totaled nearly $125 billion in 2010 and could reach $156 billion in 2020.

https://www.cancer.gov/about-cancer/understanding/statistics

Patient Characteristics

All patients had stage III or IV tumors.

b improvement = positive change; c improvement = negative change; * significant after adjusting for multiple comparisons; LCL & UCL are upper and lower confidence limits (95%)

Relevance

• 464,000 cases of breast cancer and 131,000 deaths in Europe in 2012 (200,000 new cases in US).

• Most cases are in post-menopausal women and are hormone receptor positive

• Most of these women will receive aromatase inhibitor therapy as adjuvant treatment

• The most common reason for discontinuation of aromatase inhibitors is because of new or worsening joint pain.

Study Protocol

Subject Characteristics

p=0.0315

p=0.0004

p=0.0004p=0.0076

Relevance

• Bleeding and seroma formation are major complications of breast surgery resulting in physical discomfort, need for transfusion, repeat surgery, and delay in adjuvant therapy.

• If only 2.5% of hospitalizations in the US had bleeding complications, globally this extends length of stay by 1.3 days and increases costs by $5495 per admission

Population & Intervention

• Women age 20-75 receiving unilateral total mastectomy with or without reconstruction.

• Exclusion criteria – complex reconstruction, needing axillary dissection, taking anti-platelets/anti-coagulants, bleeding disorder, liver disease or other severe systemic disease, history of stroke or heart attack < 24 months before, other non-breast tumors, lab abnormalities in PT or PTT.

• Received “Arnica montana 1000 K” or placebo three times a day from 1 day prior to surgery until 4 days after (6 days total).

Changes in Volume of Drainage

Homeopathy for Painful Conditions

Pain Statistics• Pain affects more Americans than diabetes, heart disease and

cancer combined.

• Pain is cited as the most common reason Americans access the health care system. It is a leading cause of disability and it is a major contributor to health care costs.

• Approximately 76.2 million, 1 in every 4 Americans, have suffered from pain that lasts longer than 24 hours and millions more suffer from acute pain.

• Chronic pain is the most common cause of long-term disability.

https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=57

Inclusion criteria:1. men & woman age 50-862. Clinically diagnosed knee osteoarthritis per ACR criteria3. Had to stop all oral or topical analgesicsExclusion critieria:1. Severe degeneration of the knee joint2. Non-ambulatory patients3. Recent joint injection, knee surgery, knee transplant4. Uncontrolled comorbid disease (e.g., diabetes, hypertension)5. Homeopathic treatment within 6 months

Change in Outcomes

Inclusion criteria:1. Age 18-452. Deeply infiltrating endometriosis based on history & imaging

(MRI or TVU)3. Absence of menopause or premature ovarian failure4. Chronic pelvic pain refractory to conventional therapy > 1 year

18% dropout rate

Baseline Subject Characteristics

Study Flow

• Participants were randomized to receive potentized 17-beta-estradiol or placebo, 3 drops twice daily (every 12 hours) for 24 weeks.

• Participants were evaluated at weeks 0, 8, 16, and 24 and potency was changed every 8 weeks.

0 8 16 24

12cH 18cH 24cH

weeks

Change in Endometriosis-Associated Pelvic Pain Global Score

p < 0.001

placebo

potentizedestrogen

Dysmenorrhea Score Acyclical Pelvic Pain

Cyclical Bowel Pain

p < 0.001 p = 0.009

p < 0.001

Change in Depression

p < 0.001

Menstrual Pain Intensity

p=0.021

p=0.648

Between group comparison p=0.371

SF-36 Physical Health SF-36 Mental Health

p=0.02

p=0.20


p=0.01

p=0.01


Homeopathy & Healthcare Costs

http://www.pbs.org/newshour/rundown/health-costs-how-the-us-compares-with-other-countries/

http://www.commonwealthfund.org/publications/fund-reports/2014/jun/mirror-mirror

• 8/14 studies found health improvements and reduced costs with homeopathy

• 4/14 studies found health improvements at least as good as controls for comparable costs

• 2/14 studies found health improvements equal to conventional care at higher costs

A = respiratory; B = musculoskeletal; C = neurotic & sleep disorders; D = cardiovascular & metabolic; E = endocrine; F = digestive; G = genitourinary; H = nervous system; I = skin; J = infectious disease; K = injury & poisoning; L = pregnancy & peripartum; M = patterns of use of health services; N = other. CM = conventional med; Mx = mixed; Ho = homeopathy

CM (N=1691)

Mx(N=3187)

Ho (N=1501) p

Consult cost 22.7 (2.5) 22.5 (2.2) 27.1* (5.0) <0.0001Prescriptioncost

63.7 (106) 59.0 (167) 41.7* (80) <0.0001

Total cost 86.6 (107) 81.6 (170) 68.9* (82) 0.0034Mean costs in euros (standard deviation); * = significant difference between Ho and CM groups

Comparison of Costs

Most prescribed homeopathic medicines:Arnica montanaInfluenzinumIgnatia amaraGelsemium sempervirensHamamelis virginianaPassifloraNux vomicaThuja occidentalisLachesis mutus

Monthly Distribution of Homeopathic Prescriptions

Rates of Use by Age and Gender

Safety of Homeopathy

• 41 RCTs from 1995-Jan 2011• 6055 patients• 28 trials (68%) reported adverse effects; 12 trials reported none

68% were grade 1, 25% were grade 2, 6% were grade 3• 5 trials (12%) reported on homeopathic aggravations

98% were grade 1, 2% were grade 3

Meta-analysis of Homeopathy vs. Placebo

OR 1.03 [0.89, 1.20]

Overall OR 0.99 [0.86, 1.14]

vs. conventionalcare

vs. herbal therapy

vs. usual care

vs. conventional+ placebo

total

Meta-analysis of Homeopathy…

Outline




Challenges in Homeopathic Research

• Lack of funding• Regulatory burdens

– NCCIH– FDA

• Incomplete reporting & nonsensical studies

• High “placebo effect”

Reporting Clinical Studies of Homeopathy

Study/Report Type Guideline Extension*

Randomized controlled trial CONSORT RedHot

Observational study STROBE --

Case report CARE HOM-CASE

*Reporting guidelines will likely be revised in the near future.

1. Is the condition amenable to homeopathic intervention?2. Is the intervention used consistent with homeopathic principles?3. Would the rationale be supported by homeopathic practitioners?4. Does the main outcome measure reflect key effects expected?5. Is the main outcome measure capable of detecting change?6. Is the length of follow-up appropriate?

Components of the Placebo Effect

Enck P, Nat Rev Drug Discov. 2013

Finniss DG, Lancet, 2010

Receptor Pathways Activated by Both Psychosocial Context and Drugs

Enck P, Nat Rev Drug Discov. 2013

Mechanisms of Placebo Responses

Therapeutic Effects of the Clinical Relationship

• The patient-provider relationship affects health outcomes across a range of health conditions1.

• The homeopathic consultation itself has a therapeutic effect2.

1. Del Canale S, Acad Med, 2012; Hojat M, Acad Med, 2011; Kaptchuk TJ, BMJ, 2008; Kelley JM, PLoS One, 2014; Rakel D, Patient Educ Couns. 2011.

2. Jacobs J, J Altern Complement Med. 2005; Brien SB, Rheumatology, 2011; Dossett ML, PLoS One 2015.

• The homeopathic consultation includes elements of humanistic therapy and narrative medicine as well as taking signs and symptoms into account in treatment selection.

• The homeopathic consultation is structured to take maximum advantage of the placebo effect.

Topics Covered




Continuing Education

• The continuing education code for this session is ______________. Please record this code on the Continuing Education Record form in the back of your conference program. This code must be included in your post-conference session evaluation, in order to verify your attendance at and receive CE credit for your participation in this session.

homeopathy and public health: challenges and opportunities · • treated with cantharis 6c 1:100...

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