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Can we really treat endometriosis?

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Can we really treat endometriosis? Johannes L.H. Evers, Maastricht, Netherlands Belek, Turkey, 6 October 2011, Annual Congress of the Turkish Society of Reproductive ... – PowerPoint PPT presentation

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Title: Can we really treat endometriosis?


1
Can we really treat endometriosis?
  • Johannes L.H. Evers, Maastricht, Netherlands
  • Belek, Turkey, 6 October 2011,
  • Annual Congress of the Turkish Society of
    Reproductive Medicine

2
Objectives
Belek, Turkey, 6 October 2011
  • To investigate the following hypotheses
  • We understand endometriosis
  • Endometriosis is a progressive disease
  • We can treat endometriosis
  • We have good evidence for all of this

3
Belek, Turkey, 6 October 2011
Evidence-based medicine is the integration
of (patho)physiological mechanisms and
the outcome of top-quality clinical research
David Sackett
4
Belek, Turkey, 6 October 2011
Preface
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Hypothesis 1
Belek, Turkey, 6 October 2011
  • Measles is the disease
  • The spots are the symptoms

Endometriosis
8
Belek, Turkey, 6 October 2011
Hypothesis 2
You cannot cure the disease by removing the
symptoms
9
2 important pitfalls
  • When to perform Second Look Laparoscopy?
  • How to deal with spontaneous progression/regressi
    on?

10
6 months drug treatment
Belek, Turkey, 6 October 2011
Number of implants
FLL
SLL2
SLL
Danazol x 6 months
Evers, Fertil Steril,1985
11
Placebo group - better 5/17 (29) - same 4/17
(24) - worse 8/17 (47)
Br Med J. 1987 January 31 294(6567) 272274.
E J Thomas and I D Cooke
12
Preamble
Belek, Turkey, 6 October 2011
  • Endometriosis is a dynamic process

13
Preamble
Belek, Turkey, 6 October 2011
  • Endometriosis is a dynamic process
  • Lesions come and lesions go

14
Preamble
Belek, Turkey, 6 October 2011
  • Endometriosis is a dynamic process
  • Lesions come and lesions go
  • This depends on
  • Aggression reflux menstruation
  • Defense peritoneal immune system

15
Preamble
Belek, Turkey, 6 October 2011
  • Endometriosis is a dynamic process
  • Lesions come and lesions go
  • This depends on
  • Aggression reflux menstruation
  • Defense peritoneal immune system
  • How can we modulate this process?

16
Belek, Turkey, 6 October 2011
Surgery Drugs
17
Belek, Turkey, 6 October 2011
Surgery
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Belek, Turkey, 6 October 2011
Drugs
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surgery
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drugs
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Hypothesis
Belek, Turkey, 6 October 2011
  • Endometriosis is a dynamic process
  • You can remove the implants by surgery
  • Occult implants will remain, and grow
  • You can inactivate (hide) implants by drugs
  • They will regrow after the end of therapy

43
Belek, Turkey, 6 October 2011
Back to the title
44
Pain
1
45
Belek, Turkey, 6 October 2011
Surgery Drugs
46
Belek, Turkey, 6 October 2011
Hierarchy of major study designs
interventional
RCT
cohort
observational
cross-sectional
case control
validity
case reports / case series
47
Belek, Turkey, 6 October 2011
Drugs
48
Endometriosis pelvic paindrug - placebo
Belek, Turkey, 6 October 2011
Medical treatment
49
Belek, Turkey, 6 October 2011
Surgery
50
Endometriosis pelvic painLUNA ablation
Belek, Turkey, 6 October 2011
Sutton, 1997
51
Endometriosis pelvic painLUNA ablation
Belek, Turkey, 6 October 2011
Sutton, 1997
52
Improvement pain
Belek, Turkey, 6 October 2011
Abbott et al, 2004 FS 82 878-84
53
Long term follow-up of pain surgery
Belek, Turkey, 6 October 2011
VAS score
Abbott et al. 2003
54
Number Needed to Treat
Belek, Turkey, 6 October 2011
Pain relief surgery 36/52 69
Pain relief controls 13/50 26
ARI 43
NNT 3
95 Confidence Interval 2 6
Sutton, 1997 Abbott, 2004
55
Belek, Turkey, 6 October 2011
Jacobson et al. I
Jacobson TZ, Barlow DH, Garry R, Koninckx P.
Laparoscopic surgery for pelvic pain associated
with endometriosis (Cochrane Review). In The
Cochrane Library, Issue 2, 2003. Oxford Update
Software.
56
Pain conclusion
Belek, Turkey, 6 October 2011
  • Medical treatment works
  • Surgical treatment works
  • Medical treatment will only suppress
    endometriosis temporarily
  • Surgical treatment will only remove visible
    lesions

57
Infertility
2
58
Belek, Turkey, 6 October 2011
Surgery Drugs
59
Belek, Turkey, 6 October 2011
Drugs
60
Ovulation suppression for endometriosis
Belek, Turkey, 6 October 2011
24 trials Drugs vs OR 95 CI
OR pregnancy drugs versus placebo or no treatment Placebo 0.79 0.54-1.14
No treatment 0.80 0.51-1.24
Hughes et al, Cochrane 2007
61
Ovulation suppression for endometriosis
Belek, Turkey, 6 October 2011
24 trials Drugs vs OR 95 CI
OR pregnancy drugs versus placebo or no treatment Placebo 0.79 0.54-1.14
No treatment 0.80 0.51-1.24
Hughes et al, Cochrane 2007
AUTHORS' CONCLUSIONS There is no evidence of
benefit in the use of ovulation suppression in
subfertile women with endometriosis who wish to
conceive.
62
Belek, Turkey, 6 October 2011
Surgery
63
Grading endometriosis
Belek, Turkey, 6 October 2011
Type Clinical findings
Complicated Implants Adhesions Cysts
Simple Implants
Occult ---
64
Grading endometriosis
Belek, Turkey, 6 October 2011
Type Clinical findings
Complicated Implants Adhesions Cysts
Simple Implants
Occult ---
65
Grading endometriosis
Belek, Turkey, 6 October 2011
Type Clinical findings
Complicated Implants Adhesions Cysts
Simple Implants
Occult ---
66
Grading endometriosis
Belek, Turkey, 6 October 2011
Type Clinical findings
Complicated Implants Adhesions Cysts
Simple Implants
Occult ---
67
Belek, Turkey, 6 October 2011
2
2 questions
Does endometriosis affect fertility?
68
Belek, Turkey, 6 October 2011
2
2 questions
Does endometriosis affect fertility?
If so, will treatment restore fertility?
69
Belek, Turkey, 6 October 2011
Hierarchy of major study designs
interventional
RCT
cohort
observational
cross-sectional
case control
validity
case reports / case series
70
The best option RCT
Belek, Turkey, 6 October 2011
  • Sow - at random - endometrium in peritoneal
    cavity of one group of healthy female volunteers
    and not in the other, and
    compare fertility

(cf. Ridley JH, Edwards IK Experimental
endometriosis in the human Am J Obstet Gynecol
76 783-790, 1958)
71
Belek, Turkey, 6 October 2011
Hierarchy of major study designs
interventional
RCT
cohort
observational
cross-sectional
case control
validity
case reports / case series
72
Belek, Turkey, 6 October 2011
Prospective cohort study
unselected young women
20 years follow-up live birth rates
73
Belek, Turkey, 6 October 2011
Prospective cohort study
?
?
?
?
women with unexplained subfertility
10 years untreated follow-up live birth rates
74
The second best option, rephrased
Belek, Turkey, 6 October 2011
  • Study spontaneous PR in untreated controls of
    RCTs
  • Compare to PR in women with unexplained
    subfertility

75
Spontaneous PR in RCT Controls
Belek, Turkey, 6 October 2011
RCTs medical treatment
76
Spontaneous PR in RCT Controls
Belek, Turkey, 6 October 2011
RCTs surgical treatment
77
Spontaneous PR in RCT Controls
2 RCTs surgical treatment 6 RCTs medical
treatment
78
Spontaneous PR in RCT Controls
2 RCTs surgical treatment 6 RCTs medical
treatment
79
Spontaneous PR in RCT Controls
2 RCTs surgical treatment 6 RCTs medical
treatment
80
Spontaneous pregnancy rates
Adamson, WCE Yokohama, 1996 Taylor Collins,
Unexplained Infertility, 1992
81
Belek, Turkey, 6 October 2011
surgery
82
Belek, Turkey, 6 October 2011
  • ENDOCAN 1997 Canada
  • 172 surgery
  • 169 controls
  • 29 PR surgery
  • 17 PR controls
  • Removal of lesions lysis of adhesions
  • GISE 1999 Italy
  • 51 surgery
  • 49 controls
  • 20 PR surgery
  • 22 PR controls
  • Removal of lesions lysis of adhesions

83
Belek, Turkey, 6 October 2011
Jacobson et al. 2003
Jacobson TZ, Barlow DH, Koninckx PR, Olive D,
Farquhar C. Laparoscopic surgery for subfertility
associated with endometriosis (Cochrane Review).
In The Cochrane Library, Issue 2, 2003. Oxford
Update Software.
84
Number Needed to Treat
Belek, Turkey, 6 October 2011
PR surgery 60/223 26.9
PR controls 39/214 18.2
ARI 8.7
NNT 12
95 Confidence Interval 6 - 111
85
Can we treat Endometriosis?
  • Evidence for drug effect
  • Pain ovulation suppression works
  • Subfertility no effect
  • Evidence for surgery effect
  • Pain NNT 3 (95 CI 2 6)
  • Subfertility NNT 12 (95 CI 6 111)

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88
Control treated pats
Belek, Turkey, 6 October 2011
E
C
Untreated controls, 7 RCTs
Endocan
89
Control treated pats
Belek, Turkey, 6 October 2011
E
C
Untreated controls, 7 RCTs
Endocan
90
Control treated pats
Belek, Turkey, 6 October 2011
E
C
Untreated controls, 7 RCTs
Endocan
91
Hummelshoj 01/2006
  • www.endometriosis.ca

92
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