CONVENTIONAL MEDICINES VERSUS HOMEOPATHY: THE EPI3 STUDY - BERNARD BÉGAUD, MD, PHD
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Conventional medicines versus homeopathy:
the EPI3 Study
Bernard Bégaud, MD, PhD
Université Bordeaux Segalen, INSERM U657
Bordeaux, FranceDisclosure • The EPI3 Study was entirely funded by the Laboratoires Boiron (France) and conducted by the Contract Research Organization LA- SER Int. (Prof. Lucien Abenhaim Director). • I acted as the Chair of the Scientific Advisory Board of the EPI3 Study at the request of Prof. Lucien Abenhaim (LA-SER). • I (and I did not) have any financial link or contract (research or other) with Laboratoires Boiron. • I currently chair a research unit in pharmacoepidemiology (INSERM U657) working without any support from the pharmaceutical industry.
Does my study told me the truth
?
• Experimental design
– Conditions are artificial
– Conclusions are robust
– Measures the intrinsic effect (efficacy) of the drug
• Observational design
– Based upon real life
– Conclusions may be affected by biases
– Measures the result of interactions between drug(s)
and many factors present in real life.Experimental vs observational
• Randomization • Prescription
• Robustness • Prone to biases
• Not representative • Representative
• Small samples • Large populations
• Standardized
• Real life
• Criteria: robust
but not realistic • Criteria: pragmaticControlling for confounding • Experimental designs (clinical trials): protected from biases by randomisation • Observational designs – Matching – Stratification – Adjustment (e.g. logistic model)
• Molecule
• Cells
• Rats
• Human (Phases I to III)
• Populations
Drugs are developed in order to increase health
and welfare of individuals and populations, not
only to induce publishable effects in rats nor to
win a cup in a clinical trial contest !The golden rule of assessment The results of an experiment are generalizable if, and only if, the conditions of this experiment have not been altered.
Comparing homeopathic to
conventional medicines
• Hard choice:
– Experimental: Robust but often not feasible
– Observational: Feasible but often questionableComparing homeopathic to
conventional medicines
The choice depends upon the purpose of the
assessment:
– To compare a homeopathic remedy with a
conventional medicine ? experimental
design
– To compare 2 practices in a public health
perspective ? observational design.The EPI 3 Programme (1) • Funded by Laboratoires Boiron • Design, coordination, analyses: Pr Lucien Abenhaim and staff (LA-SER, Paris, London) • Scientific Advisory Board (chair: Pr Bernard Bégaud, Bordeaux) • Conducted: March 2007 to July 2008 • Country: France.
EPI 3 Programme (2)
• Observational
• Field
• Actual practice, real life
• Patients recruited in consulting rooms
• Combining cross-sectional (descriptive)
and cohort approaches (explicative).EPI 3 Programme (3).
Cross-sectional study (1)
• Random sample of French community practitioners (850
finally included):
– Allopaths: 196
– Homeopaths: 256
– Mixed practice: 352
• Patients recruited in consulting rooms, during one
random day of practice
• No more than 15 patients/practitionerEPI 3 Programme (4).
Cross-sectional study (2)
• 11809 patients identified in consulting rooms (one
random day)
• 8652 (73.3%) accepted to participate
• 6359 (53.8%) accepted and fulfilled the inclusion
criteria:
– 1501 for homeopathic practice
– 1691 for allopathic practice
– 3187 for mixed practice.EPI 3 Programme (5).
Cross-sectional study (3)
• To describe patients and symptoms and diseases actually
seen in general practice:
– Patients characteristics
– urden of diseases
• Comparing practices and prescriptions of physicians (e.g.
20% of « allopaths » daily prescribed homeopathy what
accounts for 40% of homeopathy remedies prescribed in
France).Distribution of diseases according to practice
•Fréquences en ordonné, en abscisse : A : Maladies de l'appareil respiratoire et ORL-O, B : Maladies du système
musculo-squelettique, C : Troubles névrotiques et troubles du sommeil, D : Maladies cardiovasculaires et du
métabolisme, E : Maladies endocriniennes, F : Maladies de l'appareil digestif, G :Maladies des organes génito-
urinaires, H : Maladies du système nerveux, tête et cou, I : Maladies de la peau et du tissu sous-cutané, J : Maladies
infectieuses et parasitaires systémiques, K : Lésions traumatiques et empoisonnements, L : Grossesse, post-partum,
nouveau-né, enfant, M : Motifs de recours aux services de santé (motifs administratifs et préventifs, vaccinations,
bilans biologiques et radiologiques, symptomes généraux ), N : Autres maladies (cancer et maladies peu communes)Characteristics of physicians according to
practice
Allopaths Mixed Homéopaths
N=196 N=352 N=256
Age (year) median (Q1-Q3) 52 (45-57) 50 (45-56) 52 (47-56)
Frequency (%)
Female 20,4 31,0 48,8
Practicing alone (%) 51,5 56,0 73,1
Salaried 34,5 16,9 14,3
Type of contract with reimbursement system
- Type 1 92,3 90,6 41,8
- Type 2 7,7 6,0 50,4
- None 0 1,1 6,3
Use of non-conventional therapies (daily or often)
Acupuncture 2,0 9,9 34,0
Mesotherapy 7,7 20,4 16,0
Phytotherapy 7,7 41,5 53,1
Other 9,2 10,2 31,6
Having prescribing homeopathy the study day (%)
No 92,4 67,1 6,3
Once 5,6 15,4 5,1
Twice and over 1,0 17,5 88,6Characteristics of patients • Patients referring to homeopathy practice were: – More often women (69.5% vs 57.4%) – Mainly 40 to 59 years – With a higher education level – More often with BMI < 25 – Less often smokers – In better health condition – Presenting more often with affective disorders.
EPI 3 Programme (5) Cohort
studies
• Three cohorts including patients (n = 4899) who presented with:
– SAD (sleep disorders, anxiety, depression) : 1350 patients
included
– DMS (rheumatology): 1905 patients included
– IVAS (upper respiratory tract infections) : 1644 patients included
• Follow-up: 3 days, 1 month, 3 months and 1 year
• Interviews made by the LA-SER team
• Scales and questionaires: SF12, MCS, PCS, CAMBI, and:
– SAD: HAD for anxiety and depression, Berlin CRF and Pittsburg
for sleep disorders.
– DMS: Eifel, Lequesne, Quickdash
– IVAS: clinical assessment (structured questionnaire)Controlling for putative
biases
• Adjustment (logistic model) on:
– Age
– Sex
– Education level
– Number of consultations during the 12 preceding
months
– Number of hospitalisations in the past
– Physical activity
– Comorbidity
– Factors specific to the disease considered (SAD,
DMS, IVAS).Improvement of anxiety
and depression (HADProbabilty of recovering (SAD)
3,6
3,4 Tout médecin Médecin traitant
3,2
3
2,8
2,6
2,4
2,2
OR* (IC 95%)
2
1,92
1,8 1,8
1,6 1,62 1,62
1,4
1,2
1 1 1
0,8
0,6
0,4
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, PCS, antécédent de TS, sévérité du
trouble, traitement prévalentRecovery of sleep disorders
Allopaths Homéopaths Mixed
1 month 30.6% 34.1% 38.6%
3 months 51.6% 37.9% 45.5%Psychotropic users Follow-up Allopaths Homeopaths Mixed practice 1 month 86.0% 45.2% 69.8% 3 months 74.4% 46.0% 62.8% 12 months 68.0% 46.5% 63.5%
Use of psychotropics by SAD patients
Allo (%) Mixed Homeo
SAD patients ++
Antidepressants 69.9 59.0 0.58 (0.42 – 0.80) 35.3 0.23 (0.16 – 0.33)
Anxiolytics and hypnotics 51.4 54.2 1.15 (0.84 – 1.57) 31.3 0.44 (0.31 – 0.63)
Antipsychotics 4.0 5.2 1.22 (0.58 – 2.58) 4.0 1.18 (0.50 – 2.81)
Normothymics 5.5 1.4 0.24 (0.10 – 0.60) 4.7 0.91 (0.42 – 1.99)
Homeopathy for Mood 0 - 7.8 0.10 (0.07 – 0.16) 43.7 Ref.
disorders
* From polytomic regressions adjusted for, employment status (unemployed, retired vs. employed), age ([39-59[, 60+ vs. [18-39[), education level (high school deg
** plus adjusted for severity of anxiety (HAD score >12 versus below)
+ plus adjusted for severity of depression (HAD score >12 versus below)
++ plus adjusted for both severity of anxiety and depression (HAD score >12 versus below)Probability of using a psychotropic
drug during follow-up (SAD)
1,2
Tout médecin Médecin traitant
1 1 1
0,8
OR* (IC 95%)
0,62 0,64
0,6
0,4 0,41
0,36
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, PCS, antécédent de TS, sévérité du
trouble, traitement prévalentProbability of fall during follow-up
(SAD)
1,6
Tout médecin Médecin traitant
1,4
1,2
1 1 1
OR* (IC 95%)
0,8
0,65
0,6
0,55
0,46
0,4 0,4
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, PCS, antécédent de TS, sévérité du
trouble, traitement prévalentTemporal trends of the DMS scales* over 12 months
According to type of practice (N=1153)
Mixed (AH)
Allopaths
Homéopaths
* Tests statistiques par ANCOVA pour mesures répétées ajustés pour sexe, âge, valeur du score à 72hrs, Chronicité à l’inclusion et
score de propension.
Tous les deltas de temps sont significatifs (p0.5).Number of antiinflammatory and analgesic drugs
used by DMS patients during follow-up
Number of drugs declared
per 100 patients
(95% confidence interval)2 Allo Mixed Homeo
Non-Chronic DMS
NSAIDs 102.4 120.5 63.1*
78.7-126.1 95.4–145.6 32.5–93.7
Analgesics 309.7 385.2* 256.4
265.8-353.5 351.8-418.6 209.4–303.4
Chronic DMS
NSAIDs 117.6 113.7 59.0*
89.6-145.6 91.3–136.1 34.5–83.5
Analgesics 335.2 357.0 250.5*
292.9–377.5 322.0-392 211.5–289.5
•Physicians’ prescription preferences: CM = conventional medicine; Mx = mixed practice, conventional and CAMs; Ho = registered homeopathic
•Number of different drugs consumed over twelve months declared by 100 patients; means adjusted for propensity score.
* Comparison with CM category: pProbability of recovering (IVAS)
1,8
Médecin traitant
1,6 Tout médecin
1,4
1,2
OR* (IC 95%)
1 1 1
0,92
0,88
0,8 0,83
0,71
0,6
0,4
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, activité physique, antécédent ORL,
séances de kiné resp., comorbiditésUse of antibiotics (IVAS)
Tout médecin Médecin traitant
1,8
1,6
1,4
1,2 1,2
1,15
OR* (IC 95%)
1 1 1
0,8
0,6
0,54
0,44
0,4
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, activité physique, antécédent ORL,
séances de kiné resp., comorbiditésUse of antipyretics (IVAS)
Tout médecin Médecin traitant
1,8
1,6
1,4
1,2 1,17
1,13
OR* (IC 95%)
1 1 1
0,8
0,6
0,53
0,4 0,42
0,2
0
*Sur cette figure, l’odd ratio associé à la pratique (Allopathique prise comme référence) est représenté grâce à des diagrammes
boursiers en ordonné (l’intervalle de confiance associé est également représenté),
les modèles sont ajustés sur âge, sexe, niveau d’éducation, nombre de visites, hospitalisations, activité physique, antécédent ORL,
séances de kiné resp., comorbiditésScientific publications from EPI3 Study
Manuscript Journal Calendrier
Impact of physician preferences for homeopathic or
conventional medicine on patients with musculoskeletal Pharmacoepi Drug Saf 2012 Cct;21(10):1093-101
disorders : results from the EPI3-MSD cohort
Management of upper respiratory tract infections by
different medical practices, including homeopathy, and
PloS One 2013: In Press
consumption of antibiotics in primary care: the EPI3 cohort
study in France 2007-2008
Homeopathic medical practice for anxiety and depression in
Eur J Gen Pract 2013: Under review
33 the EPI3 cohort study.
primary care:Benchmarking the burden of one hundred diseases:
2011 Nov14;1(2):1(2):e000215
results of a nationwide representative survey within BMJ Open
general practices.
Characteristics of patients consulting their regular
primary care physician according to their prescribing
Homeopathy 2013 e-pub ahead of print
preferences for homeopathy and complementary
medicine.
Benchmarking clinical management of spinal and non-
spinal disorders using quality of life: results from the Eur. Spine Journal 2011 Dec;20(12):2210-6
EPI3-LASER survey in primary care.
Who seeks primary care for musculoskeletal disorders
(MSDs) with physicians prescribing homeopathic and
BMC MSD 2011, Jan 19;12:21
other complementary medicine? Results from the EPI3-
LASER survey in France.
Who seeks primary care for sleep, anxiety and
depressive disorders from physicians prescribing
BMJ Open 2012 Nov22;2(6)
homeopathic and other complementary medicine?
Results from the Epi3 population surveyYou can also read
