Transcript Bruges Présentation Epi3 Nov 2015 Gérard Duru

Programme EPI-3
(Etude Phamacoépidémiologique de l’Impact de santé publique de 3 groupes de pathologies)
EPI3 Research Programme
Gérard DURU, PhD
CYKLAD GROUP, Rillieux la Pape, France
Expert of EPI-3 scientific Committee
Bruges, november 2015
Scientific Committee EPI-3
Members
Research TeamEquipe
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 Dr Lamiae Grimaldi, LASER
ANALYTICA
 Mme France Lert, INSERM*
 Pr Jacques Bénichou,
INSERM*
 Pr Michel Rossignol,
Université McGill*
 Pr Lucien Abenhaim, LASER
ANALYTICA
Pr Bernard Bégaud-Président
Pr Frédéric Rouillon
Pr Didier Guillemot
Dr Bernard Avouac
Pr Jacques Massol
Pr Gérard Duru
Pr Anne-Marie Magnier
*LASER Consultants
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Declaration of interest
 Laboratoires Boiron, France, sponsored this independant study
EPI3
 The sponsor had no role in the design, management, data
collection, analyses, interpretation, and writing of the manuscript
or the decision to publish our findings
 10 international publications in peer-reviewed journals have
been published
 Gérard Duru declares that he has no competing interests.
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Publications
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Benchmarking the burden of 100 diseases: results of a nationwide representative survey within general practices. GrimaldiBensouda L, Begaud B, Lert F, Rouillon F, Massol J, Guillemot D, Avouac B, Duru G, Magnier AM, Rossignol M, Abenhaim L; EPI3-LASER Group. BMJ Open. 2011 Nov 14;1(2):e000215.
Characteristics of patients consulting their regular primary care physician according to their prescribing preferences for
homeopathy and complementary medicine. Lert F, Grimaldi-Bensouda L, Rouillon F, Massol J, Guillemot D, Avouac B, Duru G,
Magnier AM, Rossignol M, Abenhaim L, Begaud B; EPI3-LA-SER Group. Homeopathy, 2014 Jan;103(1):51-7.
Benchmarking clinical management of spinal and non-spinal disorders using quality of life: results from the EPI3-LASER
survey in primary care. Rossignol M, Begaud B, Avouac B, Lert F, Rouillon F, Bénichou J, Massol J, Duru G, Magnier AM, Guillemot D,
Grimaldi-Bensouda L, Abenhaim L. Eur Spine J. 2011 Dec;20(12):2210-6. doi: 10.1007/s00586-011-1780-z. Epub 2011 Apr 13.
Who seeks primary care for musculoskeletal disorders (MSDs) with physicians prescribing homeopathic and other
complementary medicine? Results from the EPI3-LASER survey in France. Rossignol M, Bégaud B, Avouac B, Lert F, Rouillon F,
Bénichou J, Massol J, Duru G, Magnier AM, Guillemot D, Grimaldi-Bensouda L, Abenhaim L. BMC Musculoskelet Disord. 2011 Jan
19;12:21.
Impact of physician preferences for homeopathic or conventional medicines on patients with musculoskeletal disorders:
results from the EPI3-MSD cohort. Rossignol M, Begaud B, Engel P, Avouac B, Lert F, Rouillon F, Bénichou J, Massol J, Duru G,
Magnier AM, Guillemot D, Grimaldi-Bensouda L, Abenhaim L; EPI3-LA-SER group. Pharmacoepidemiol Drug Saf. 2012
Oct;21(10):1093-101.
Physician practicing preferences for conventional or homeopathic medicines in elderly subjects with musculoskeletal disorders
in the EPI3-MSD cohort. Danno K, Joubert C, Duru G, Vetel JM. Clin Epidemiol. 2014 Sep 26;6:333-41.
Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of
antibiotics in primary care: the EPI3 cohort study in France 2007-2008.Grimaldi-Bensouda L, Bégaud B, Rossignol M, Avouac B, Lert
F, Rouillon F, Bénichou J, Massol J, Duru G, Magnier AM, Abenhaim L, Guillemot D. PLoS One. 2014 Mar 19;9(3):e89990.
Who seeks primary care for sleep, anxiety and depressive disorders from physicians prescribing homeopathic and other
complementary medicine? Results from the EPI3 population survey. Grimaldi-Bensouda L, Engel P, Massol J, Guillemot D, Avouac
B, Duru G, Lert F, Magnier AM, Rossignol M, Rouillon F, Abenhaim L, Begaud B; EPI3-LA-SER group. BMJ Open. 2012 Nov 22;2(6). pii:
e001498.
Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study. Grimaldi-Bensouda L, Engel P,
Massol J, Guillemot D, Avouac B, Duru G, Lert F, Magnier AM, Rossignol M, Rouillon F, Abenhaim L, Begaud B; EPI3-LA-SER group.
Soumis BMC Family Practice, 2014.
Psychotropic drug utilization by patients consulting for sleep disorders in homeopathic and conventional primary care medical
practice: the EPI3 cohort study. Grimaldi-Bensouda L, Engel P, Massol J, Guillemot D, Avouac B, Duru G, Lert F, Magnier AM,
Rossignol M, Rouillon F, Abenhaim L, Begaud B; EPI3-LA-SER group. En préparation pour Evidence-based complementary and
alternative medicine, 2014.
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Objectives of the EPI3 program
 To assess the role played in France by homeopathy in primary care
and its public health interest,
 To describe and compare patients according to the practices
(allopathic, homeopathic or mixed) selected by their general
practitioners
 CROSS-SECTIONAL STUDY.
 To assess the impact over one year of the various methods of
treatment in three pathology groups representing a very important part
of consultations in primary care:

Musculoskeletal Disorders (MSD).
 Upper Respiratory Tract Infections (URTI),
 Sleep disorders, Anxiety and Depression (SAD),
 THE THREE COHORT STUDIES.
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Evaluated outcomes
Clinical evolution
Drugs
consumption
MSD
URTI
SAD
Reduction 12,5% :
Eifel
Lequesne
Quick Dash
Symptoms (7)
resolved or greatly
improved
HADS < 9
PSQI = 0
NSAID
Analgesics
Antibiotics
Antipyretics
Antidepressants
Psychotropic drugs
Chronicity
The start of a
psychotropic drug
treatment
Otitis media ou
externa, Sinusitis
Tentative suicide
Unintentional
Injuries
(Yes/No)
Complications
(Yes/No)
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Telephone questionnaire and recruitment
of general practitioners
 A representative sample of GPs and their patients in primary
French healthcare
 17 206 GPs were contacted (55 863 GPs in the national registry
of French GPs)
 GPs sampling was stratified according to their declaration of
prescription preferences categorised in three groups. GPs
answered a telephone questionnaire in order to allocate them to
one of these three groups (without the knowledge of objectives).
 804 participating GPs :
 196 GPs who prescribed conventionnal medicines only
(CM)
 352 GPs with a mixed practice (Mx)
 256 homeopathic GPs (Ho)
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The cross-sectional study
 A one-day of consultation for each participating GP randomly
selected
 Collection of data directly at the GP’s office with a trained
interviewer on site
 8 559 included patients of which 6 379 by their gate keeper
GP
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Collection of data directly at the GP’s office
Waiting room :
Consenting patients completed a self-administered
questionnaire:
 Information on socio-demographics, lifestyle, occupation
 History of hospitalization and number of GP consultations
in the past year.
 Quality of life
GP’s office :
Eligible patients were invited to participate for the
cohort study and GP completed a medical
questionnaire for those who accept.
 Diagnostics
 Prescriptions that day
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3 cohort studies
Patients who participated in
the cross-sectional study
N = 8559
Patients who
filled out a MSD
medical
questionnaire
N = 1917
Patients who
filled out a URTI
medical
questionnaire
N = 906
Patients who
filled out a SAD
medical
questionnaire
N = 1694
Patients who
participated in a
MSD interview at
T0
N = 1153
Patients who
participated in a
URTI interview at
T0
N = 518
Patients who
participated in a
SAD interview at
T0
N = 710
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General Scheme of EPI-3 Program
12 months
<72 h 1 month
3 months
12 months
Retrospective data collection
(cross-sectional study )
Inclusion of patients
Prospective follow-up by telephone interview
(3 cohort studies)
Collection of data from February 2007 to August 2009
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EPI-3
The cross-sectional study
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The observed prescription of homeopathic
medicines
Remender : the size of the GPs sample is 804
Homeopathic prescription the day of the consultation (%)
CM
M
Ho
N=196
N=352
N=256
No homeopathic prescription
92,4
67,1
6,3
≥ 1 homeopathic prescription this day
6,6%
32,9% 93,7%
One
More than two
5,6
1,0
15,4
17,5
5,1
88,6
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Characteristics of patients by type of practice
of their treating GP (n=6379 which is the regular GP)
Among patients of homeopathic GPs, we notice :
 More women
 Higher level of education
 Lower tobacco consumption
 Lower body mass index (BMI)
* Differences with GP-CM statistically significant (p< 0,05)
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Prevalence of 14 broad ICD* diagnostics
according to the type of practice
CM
Ho
Mx
Patients attending GP-Ho exhibited more frequently
 Osteoarthritis and joint diseases (B) OR=1.29; IC:(1.07-1.56)
 Anxiety-depressive disorders (C) OR=1.38; IC:(1.15-1.65)
 Dermatological diseases (I) OR=1.40; IC: (1.02-1.92)
 But fewer for acute respiratory diseases (A)
* International classification of diseases: A : Diseases of the respiratory system, B : Diseases of the musculoskeletal
system, C : Anxiety, depression and sleep disorders, D : Cardiovascular diseases, E : Diabetes, thyroid gland & other
endocrine disorders, F : Diseases of the digestive system, G : Diseases of the genitourinary system, H : Diseases of
the nervous system, head & neck, I : Skin and subcutaneous tissue diseases, J : Bacterial, viral and parasitic systemic
diseases, K : Injury and poisoning, L : pregnancy, post-partum, newborn and childcare visit, M : Administrative and
preventive motives, medical results, N: Other diseases (cancer and infrequent diseases)
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Quality of life SF-12
Patients attending GP-Ho are:
 in better physical health (a slightly higher (better)) physical
component score
 more likely to express a psychological malaise (a slightly lower
(worse)) mental component score
CM
Mx
Ho
Physical score
Mean (SD)
45,2 (11,1)
45,2 (11,4)
47,2 (10,6)
OR (CI 95%)*
<1st Quartile
Ref
1,15
(0,98-1,30)
0,81
(0,68-0,95)
Mental score
Mean (SD)
41,6 (10,9)
41,5 (10,8)
40,9 (10,5)
OR (CI 95%)*
<1st Quartile
Ref
1,08
(0,95-1,24)
1,21
(1,04-1,42)
Odds ratios adjusted on gender, age, education and comorbidities.
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The Complementary and Alternative Medicine
Beliefs Inventory (CAMBI)
Patients consulting GP-Ho are:
 More open to natural treatments
 Value further their participation in care
 Have a more holistic approach to health
CM
OR (CI 95%)*
>3rd Quartile
Ref
OR (CI 95%)*
>3rd Quartile
Ref
OR (CI 95%)*
>3rd Quartile
Ref
Mx
Ho
1,22
(1,08-1,37)
0,91
(0,81 – 1,02)
1,13
(1,00-1,28)
2,05
(1,79 – 2,36)
1,52
(1,33 – 1,74)
3,19
(2,77 – 3,66)
Odds ratios adjusted on gender, age and education
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EPI-3
The Logitudinal study
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Results Musculoskeletal pain
and Disorders (MSD)
 Clinical evolution : scales on functional status
 NSAID consumption, Analgesics
 Complications : progress from non-chronic MSD
at inclusion to chronic MSD and the start of
psychotropic drug treatment
N=1 153 (changes slightly depending on missing data in the analyzes)
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Evolution of DMS functional scales
 Ho patients showed better functional scores on average at
baseline (Lequesne et Quickdash)
 Regarding MSD progression, non-chronic patients were
comparable to chronic patients across the three PPP
groups.(ANOVA: p>0,5).
Non-Chronic at inclusion
(N=514)
40
30
CM
Mx
Ho
Chronic at inclusion
(N=615)
40
30
20
CM
Mx
Ho
20
10
10
Inclusion
1 Month
3 Month
12 Month
Inclusion
1 Month
3 Month
12 Month
* Combined standardized over 100: EIFEL, Quick Dash, Lequesne
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NSAID and analgesics consumption
Probability of consuming NSAID or analgesics (12 months of
follow-up) (N=1153)
CM
(N=272)
Mx
Ho
(N=510)
(N=371)
Odds ratios (I.C. 95%)*
Non-chronic MSD
AINS
Ref
Analgesics
0,78
(0,50 – 1,22)
0,53
(0,35 – 1,18)
0,58
(0,35 – 0,95)
0,69
(0,33 – 1,45)
0,81
(0,52 – 1,24)
0,56
(0,35 – 0,90)
0,54
(0,27 – 1,08)
0,40
(0,20 – 0,82)
Chronic MSD
NSAIDs
Ref
Analgesics
* Adjusted for age, gender, functional score at inclusion and propensity score
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Complications
 The rate of progressing from non-chronic MSD at inclusion
to chronic MSD did not differ between the three groups.
 The occurrence of anxiety and depressive disorder during
follow-up, the frequency of use of psychotropic drugs were
comparable across the three groups (For Ho vs CM : OR= 0.96; IC
95% : 0.53-1.75).
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EPI-3
Results Upper Respiratory
Tract Infections (URTI)
 Clinical evolution: symptoms’ resolution
 Antibiotics consumption, antipyretic
 Complications: otitis media/externa and sinusitis
N=518 (changes slightly depending on missing data in the analyzes)
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Probability of URTI resolution
 Probabilities of URTI symptoms’ resolution were comparable
by type of medical practice.
Resolution of the URTI
symptoms resolved or greatly
improved
CM
(N=165)
Mx
(N=203)
Ho
(N=150)
Ref
1.10
[0.63–1.91]
1.16
[0.64-2.10]
Odds ratio (I.C.95%)*
* Adjusted for age, gender, smoking (adults), number of URTI symptoms, diagnosis at inclusion
URTI in previous 12 months and comorbidities.
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Antibiotics and antipyretics consumption
among types of medical practice
Ho
Mx
CM (ref.)
Antibiotics
Antipyretics
0.43
0.54
* Adjusted for age, gender, smoking (adults), number of URTI symptoms, diagnosis at inclusion
URTI in previous 12 months and comorbidities.
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Complications
 Infection rates (sinusitis and otitis media, otitis externa) are
close with an adjusted relative risk slightly higher in the Ho
group compared to the CM group, a difference not statistically
significant.
Potentially associated infections
(At least one declaration of
otitis/sinusitis in 12 months)
CM
(N=165)
Mx
(N=203)
Ho
(N=150)
Ref.
0.88
[0.46–1.71]
1.70¶
[0.90–3.20]
Odds ratio (I.C. 95%) *
* Adjusted for age, gender, smoking (adults), number of URTI symptoms, diagnosis at inclusion
URTI in previous 12 months and comorbidities.
Crude rates for CM:16.9%, Ho:17,7%.
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EPI-3
Results sleep disorders,
anxiety and depression (SAD)
 Clinical evolution : improvement on HADS scale
 Psychotropics drugs consumption
 Complications: injuries and suicide attempts
N=710 (changes slightly depending on missing data in the analyzes)
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Evolution of sleeping disorders
 Evolution of SD (sleep disorders resolution on Pittsburg scale)
did not differ significantly among types of medical practice.
CM
(N=84)
Mx
(N=119)
Ho
(N=143)
Odds ratio (I.C.95%)*
Sleeping disorder persisting at
three months
Ref.
0,94
(0,56 – 1,57)
0,72
(0,42 – 1,22)
* Adjusted for age, gender, education, alcohol consumption, BMI, Smoking, sleeping disorder at inclusion,
the regular treating GP.
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Psychotropic drugs consumption in the
12 month follow-up by type of medical practice
Probability of consuming psychotropic drug for sleep disorders (12 months
of follow-up) was significantly lower in the GP-Ho group compared to the
GP-CM group. This effect was not modified by the severity of SD at
baseline.
CM
(N=84)
Ho
(N=143)
Odds ratios (I.C. 95%)*
0,67
0,25
(0,39 – 1,16)
(0,14 – 0,42)
Psychotropic drug for
sleep disorders
Psychotropic drug for
severe sleep disorders
at inclusion
Mx
(N=119)
Ref
0,67
(0,37 – 1,23)
0,21
(0,12 – 0,37)
* Adjusted for age, gender, education, alcohol consumption, BMI, Smoking, sleeping disorder at
inclusion, the regular treating GP.
Severity of sleeping disorders defined as reporting one or more of the following from the PSQI:
problems staying awake during activities once a week or more or lack of enthusiasm (somewhat or a
very big problem).
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Complications
 Lower rate observed in the GP-Ho group compared to GP-CM
group but not statistically significant.
CM
(N=84)
Mx
(N=119)
Ho
(N=143)
Odds ratio (I.C.95%)*
Traumatics events
(Any injury resulting from a fall,
motor vehicle collision, sport, or
occupation.)
Ref.
0,33
(0,10 – 1,03)
0,57
(0,21 – 1,52)
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Results, anxiety and depression
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Results on anxiety and depression match those of
sleeping disorders.
 Publication under review
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General conclusion
The therapeutic management by homeopathic GPs had a real
interest to public health in studied pathologies in France,
especially:
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Clinical evolution of patients seen by was similar to that of
others patients.
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Patients of homeopathic GPs consume significantly less
targeted conventional medicines . However, this consumption is
not null and seems to follow a consistent distribution in terms of
pathologies.
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The choice of a regular* homeopathic GP is not associated with
a loss of therapeutic opportunity for the patient..
*designated “treating physician” according to French regulation
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Thank you All
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