Transcript SF-36 means scores: Response in Time

DRINKING HABITS - Self-rating Scale (1)
I use to drink:
1. When I meet someone
2. When I have some trouble, to forget them
3. Out of habit
4. For the taste
5. For the taste which became a habit
6. It's a family habit
7. To pep up
8. In the company of my spouse
9. Because I like to drink
10. When I feel lonely
11. To raise my morale
12. To avoid trembling the day after a bout of heavy drinking
13. For professional reasons
14. When I feel abandoned
Each item is rated as:
0 = never
1 = seldom
2 = sometimes
3 = frequently
according to the global situation during the last 6 months
DRINKING HABITS - Self-rating Scale (2)
I use to drink:
15. When I have problems which I can't tolerate
16. With a meal
17. When I find myself with a group of drinkers
18. To feel better
19. Before doing something
20. To kill time
21. In the evening to relax
22. To pick me up
23. When I am offered a drink
24. When I feel isolated
25. To be in a good mood when I am with other people
26. When I am bored
27. When I am busy with something
28. When I feel tense, anxious
29. Before meeting someone
Each item is rated as:
0 = never
1 = seldom
2 = sometimes
3 = frequently
according to the global situation during the last 6 months
DRINKING HABITS - Self-rating Scale (3)
I use to drink:
30. When I feel down
31. When I am in a particular surrounding
32. I enjoy drinking
33. To show that I can drink as much or more than anyone
34. To be less anxious, the day after a bout heavy drinking
35. When I am influenced by others to drink
36. When I have to do something unusual
37. To be different from my everyday self
38. Before speaking to certain persons
39. To avoid feeling lousy, the day after a bout of heavy drinking
40. As an escape, to avoid reality
41. To feel more selfassured in certain situations
42. To isolate myself
43. When I feel tired, exhausted
44. After the first drink I can't stop
45. To help me fall asleep at night
Each item is rated as:
0 = never
1 = seldom
2 = sometimes
3 = frequently
according to the global situation during the last 6 months
MODES OF DRINKING: ALCOHOLISM
1. SOCIAL:
in a social setting
2. HABIT:
from habit, for the taste
3. STRESS:
to escape psychological difficulties
4. PHYSICAL DEPENDENCE:
to avoid withdrawal symptoms
5. STIMULUS:
as a stimulus for activity, for assertiveness
Each mode is rating on a 4 level scale, validated for time
and interrater reliability:
0 = never
2 = sometimes
1 = seldom
3 = frequently
ANGER 70 %
This person feels anger
Not at all
1 2 3 4 5 6 7
Very intensively
INTENSITY SCORES AS FUNCTION OF
GROUP AND FACIAL EXPRESSION
I
n
t
e
n
s
i
t
y
4
3,5
Normal Controls
Abstinent Alcoholics
**
**
Recently detoxified Alcoholics
**
**
3
2,5
*
2
1,5
s
c
o
r
e
s
1
0,5
0
Happiness
Anger
Sadness
Disgust
Emotional Facial Expressions
Note. * p<.05; ** p<.01
Kornreich et al. (2001) Journal of Studies on Alcohol
Fear
COMPARISONS BETWEEN PERFORMANCES
ON THE SERIAL AND THE ALPHABETICAL
RECALL SCORES ON THE ALPHA-SPAN TEST
10
9,47(0,53)
9,33 (0,71)
8,93 (1,14)
9
8
7
S
c
o
r
e
*
6
5,13 (1,62)
5
Controls
Alcoholics
4
3
2
1
0
Serial recall
Condition
Alphabetical Recall
Effect of group: F1,58=43.6, p<.001; Effect of condition: F1,58=90.9, p<.001 Interaction between group and
condition: F1,58=54.6, p<.001
* Post-hoc analysis indicated that ALC performed lower only in alphabetic recall (p<.01)
AVERAGE NUMBER OF ERRORS MADE BY
ALCOHOLICS AND CONTROLS
ON THE HAYLING TEST
P
o
i
n
t
s
9
8
8
7
6
o
f
p
e
n
a
l
t
y
5
***
Controls
4,2
Alcoholics
4
3
2
1
0,2
0,23
0
Initiation (Section A)
Note. *** p<.001
Condition
Inhibition (Section B)
RELATIONSHIP BETWEEN POSITIVE AND
NEGATIVE REINFORCEMENT
drug
adapt
drug
drug
adapt
adaptation
drug
POSITIVE REINFORCEMENT
chemical drug reward
Glu, GABA, DA/endorphins
adapt
adapt
CHRONIC DRUG TOLERANCE
neurochemical adaptation
Glu RS, GABAA Rs, ? DA/Es
NEGATIVE REINFORCEMENT
exposure of neuronal adaptation
early minor signs of withdrawal
WITHDRAWAL SIGNS
until adaptation is removed
DETOXIFICATION IS RELATIVELY EASY
MAJOR THERAPEUTIC PROBLEMS BEGIN HERE
CONDITIONING OF REINFORCEMENTS =
CRAVING?
D
D
D
+ CUE
+ CUE
+ CUE
CUE
D
POSITIVE ASPECTS OF CRAVING
Conditioned stimulus (cue) elicits anticipation of drug reward
e.g. relaxation, euphoria, excitement
A
D
+ CUE
A
CUE
Repeated pairing
"conditions"
associated
stimulus ("cue")
A
+ CUE
D
A
+ CUE
Cue becomes
conditioned
stimulus for
adaptation
NEGATIVE ASPECTS OF CRAVING
Conditioned stimulus (cue) elicits "pseudo-withdrawal"
e.g. anxiety, dysphoria, depression, tremor, etc.
THE MECHANISMS OF ALCOHOL
DEPENDENCE
Adaptation to alcohol as the basis for the Withdrawal Syndrome
Excitation
Littleton JM.
Addiction, 1995
Withdrawal
syndrome
Acute effect
Development of tolerance
Inhibition
Alcohol administration
Immediate CNS depressant effects of ethanol
become limited by neurochemical adaptation
Withdrawal
Exposure of adaptation
causes hyperexcitation
Campral®: A NOVEL ACTION IN
ALCOHOL DEPENDENCE
NORMAL
CHRONIC ALCOHOLISM
BAR
Inh
Exc
Inh
WITHDRAWAL
BAR Alc
Exc
BRAIN
Inh
+
Exc
Campral® + CRAVING
Inh
Alc
+
Exc
Exc
+
BRAIN
BALANCE
Exc
CRAVING
Inh
Exc
+
Exc
BRAIN
(learned
association)
BRAIN
(learned association)
HYPER
EXCITATION
BALANCE
EFFECT OF Campral® ON DISRUPTED
NEUROTRANSMISSION
GABA
GABA
GABA +
Acute
alcohol
intake
Chronic
exposure
to alcohol
Campral®
Adaptation
EAA EAA*
*Excitatory Amino Acids
Glutamate in particular
EAA
META-ANALYSIS
Method of Hedges & Olkin, 1985
 Included 15 randomized placebo-controlled, doubleblind studies


performed in 11 European countries
involved over 4,400 alcohol-dependent outpatients
 Confirmed the significant effect of acamprosate versus
placebo on abstinence parameters
 Supports the generalizability of acamprosate data
W
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II
R
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B
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B
A
R
R
LC
II
LE
LC
PE
PE
PA
IL
STUDY SIZE
700
600
500
400
300
200
100
0
CUMULATIVE ABSTINENCE
DURATION PROPORTION
0,7
0,6
0,5
0,4
*
*
*
0,3
*
*
*
*
*
0,2
*
*
Placebo
*
0,1
UA
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CH
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LC
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LC
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RR
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GO
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M
PE
ST
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A
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RL
IN
G
S
LA
DE
W
IG
0
*p < 0.05
Campral
ACAMPROSATE EUROPEAN DOUBLEBLIND, PLACEBO-CONTROLLED TRIALS
Days to First Drink
180
Acamprosate
Placebo
160
140
120
100
80
60
40
20
0
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ACAMPROSATE EUROPEAN DOUBLE-BLIND,
PLACEBO-CONTROLLED TRIALS
Rate of Total Abstinence (%)
Placebo
50%
D = 13.8%
40%
Acamprosate
Overall Mean %:
Acamprosate = 35.7%
Placebo = 21.9%
60%
30%
20%
10%
0%
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RESULTS: % ABSTAINERS IN PATIENTS ON
TREATMENT
5 TRIALS (TREATMENT DURATION: 12 MONTHS)
acamprosate
%
100
90
80
70
60
50
40
30
20
10
0
placebo
*: p<0,001
*
*
*
*
*
Days
0
30
90
180
270
360
ABSTINENCE RATES FOR PATIENTS WHO
REMAINED IN THE TRIALS
Percentage of patients abstinent
(treatment duration 3-12 months)
Acamprosate
%
Placebo
100
90
*: p<0,001
80
*
70
*
60
*
*
*
270
360
50
40
0
30
90
N = 3,338
N = 2,876
N = 2,262
Days
180
N = 1,679
N = 958
N = 866
FOLLOW-UP PERIOD
(Sass et al.)
% Patients
Continuous abstinence: time to first drink
100
90
80
70
60
50
40
30
20
10
0
Acamprosate
Never
had a
drink
Placebo
0
60
120 180 240 300
Treatment Period
360 420 480
540 600
660 720
Follow-up Period
EFFECT OF CAMPRAL ON ABSTINENCE
RATE, CUMULATIVE ABSTINENCE
DURATION, COMPLIANCE TO TREATMENT
AND CLINICAL GLOBAL IMPRESSION
Pelc I
BELGIUM
Results after 180 treatment days
Acamprosate
Placebo
* p<0.05
** p<0.005
**
60
50
*
40
*
30
*
20
10
0
Abstinence rate
CAD
Compliance
Days
CGI
NEW EUROPEAN ALCOHOLISM TREATMENT
(NEAT) ACAMPROSATE PROGRAM




Open label, multicenter, multinational (5)
1 281 alcohol-dependent patients
6-month study duration
Concurrent group, individual, relapse prevention or
brief intervention therapy
 Comparisons of acamprosate efficacy across therapy
conditions found

significant improvement in all groups in maintaining
abstinence and reducing relapse duration

no difference between behavioral therapy groups
THERE IS NO DIFFERENCE IN CAD
BETWEEN DIFFERENT TYPES
OF PSYCHOTHERAPY IN PATIENTS ON
Campral®
Cumulative Abstinence Duration in days
by intervention type (per protocol)
Total
Brief intervention + CAMPRAL
Cognitive therapy + CAMPRAL
Individual therapy +CAMPRAL
Group therapy + CAMPRAL
0
50
100
150
200
250
CONCLUSIONS (1)
Of all patients included
1. HRQoL in markedly reduced in alcoholic patients
2. The greater deficit is related to mental and social
functioning
3. QoL at baseline is influenced by severity of alcoholism,
health, employment status, age and gender
Of compliant patients
4. Treatment normalised QoL in three months
5. Abstinence and compliance are the best predictor of
QoL at study end
CONCLUSIONS (2)
Acamprosate Treatment Outcomes
CAD values in the NEAT were similar to those
in randomised controlled studies
Acamprosate increases QoL in enhancing
abstinence.
Abstinence
Acamprosate
QOL
•
FURTHER QUESTIONS
1. The Role of the Environment
2. The Role of Cognitive Functioning
3. The Time Factor
CAPRISO STUDY
Role of Social Support - Brief Intervention
and Motivational contact on the efficacy of
Acamprosate during the follow-up of
detoxified alcoholic patients
Pr I. PELC and coll
University Hospital Brugmann
Université Libre de Bruxelles
BELGIUM
CAPRISO STUDY
Introduction (1)
 Importance of "Supportive Treatment" (Social support
Brief intervention-motivational Contact) in the follow-up of
alcoholic patients is well documented
 Studies combining pharmacotherapy
psychosocial intervention are more seldom
and
various
 Differential outcome regarding allocation of patients
according to "clinical based experience" (Ansoms and coll,
Belgium, 2000) or to "Patient - Treatment matching"
(Project Match, USA, 1993) is not conclusive
CAPRISO STUDY
Introduction (2)
 Success in implementing a "General helping process"
and providing a "General well-being feeling " to the
patients during follow-up, seems to be key factors
throughout the various psychotherapeutic procedures
during follow-up (I. Pelc, 1977 and 1985)
 "Although social support has been repeatedly identified
as a strong correlate of recovery from alcohol problems,
enhancing social support has seldom been a focus of
treatment research" (M.B. Sobell and coll., 2000)
CAPRISO STUDY
Efficacy Variables
 Cumulative
abstinence duration
(CAD) in per cent
 Clinical
Global Impression
 Medication
compliance
CAPRISO STUDY
Cumulative abstinence days (%)
p < 0.23
60
50
55
40
30
39
No Fu
Fu
20
10
0
ITT
CAPRISO STUDY
Influence of baseline variables on CAD %
%
60
Age
p = 0.33 (interaction test)
40
20
58
53
49
Fu
No Fu
30
0
25-45 years 49-55 years
60
Gender
p = 0.21 (interaction test)
60
40
20
34 35
41
0
Female
Male
Fu
No Fu
CAPRISO STUDY
Influence of baseline variables on CAD %
%
60
54
40
Marital status
Fu
No Fu
33
20
p = 0.20 (interaction test)
62 65
0
Non
married
Married
%
67
60
58
Education
40
58
49
Fu
No Fu
p = 0.09 (interaction test)
20
28
33
0
None
Secondary
University
CAPRISO STUDY
Influence of baseline variables on CAD %
%
60
Family history
40
p = 0.14 (interaction test)
20
56 52
55
Fu
No Fu
30
0
FH +
FH -
%
60
72
52
Employment
status
40
53
45
35
37
37
34
29
p = ns (interaction test)
20
19
0
Work
Sick
Disability Jobless
Retired
Fu
No Fu
CAPRISO STUDY
Influence of baseline variables on CAD % Cont’d
Attendance to Self Help Group
p = 0.008 (interaction test)
60
65
51
40
20
35
41
0
No SHG
SHG
Fu
No Fu
CAPRISO STUDY
Structural modelling representation of
regression analysis on CAD
Education
0.12
Marital status
F.U.
0.19
0.29
-0.24
Female
-0.22
SHG +
Regression analysis: R2 = .49
CAD
CAPRISO STUDY
%
Medication Compliance
100
90
80
70
No Fu
Fu
60
*
50
40
30
visit
V1
V2
V3
V4
V5
V6
V7
V8
*: P<0.01
CAPRISO STUDY
Rate of Complete Abstinence throughout a 6 month
Period Evaluation after Detoxification
Randomized
Psycho-social follow-up
Study **
Randomized
Placebo-controlled
Study *
N = 104
N = 100
Acamprosate
Placebo
Acamprosate
No Fu
4%
24%
* Acamprosate in the treatment of alcohol
dependence: a 6 months postdetoxification study - I. Pelc and coll, 1992
14%
Fu
32%
* * Capriso Study
I. Pelc and coll, 2001