CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI DIAGNOSI … · cpp ed endometriosi: nuove prospettive di...

CPP ED ENDOMETRIOSI: CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI NUOVE PROSPETTIVE DI

DIAGNOSI E TERAPIADIAGNOSI E TERAPIA

DOLORE PELVICO CRONICO DOLORE PELVICO CRONICO –– RIMINI 2011RIMINI 2011

DIAGNOSI E TERAPIADIAGNOSI E TERAPIA

Paolo Vercellini Paolo Vercellini & Maria & Maria PinaPina FrattaruoloFrattaruolo

Department of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

UniversitàUniversità deglidegli StudiStudi di Milanodi Milano

Milan, ItalyMilan, Italy

-- La La laparoscopialaparoscopia èè ilil “gold standard” per la “gold standard” per la diagnosidiagnosi di di endometriosiendometriosi

-- La La laparoscopialaparoscopiaèèun’indagineun’indagineinvasivainvasiva, , checherichiederichiede

CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI DIAGNOSI E TERAPIADIAGNOSI E TERAPIA

-- La La laparoscopialaparoscopiaèèun’indagineun’indagineinvasivainvasiva, , checherichiederichiedeospedalizzazioneospedalizzazione, , anestesiaanestesia generalegenerale, , èè associataassociata a a morbilitàmorbilità eded èè costosacostosa

-- La La diagnosidiagnosi non non invasivainvasiva èè indicataindicata tratra le le prioritàpriorità nellanellaricercaricerca sull’endometriosisull’endometriosi

Rogers Rogers et al., et al., 20092009

EcografiaEcografia transvaginaletransvaginale nellanella diagnosidiagnosi non non invasivainvasiva di di endometriosiendometriosi ovaricaovarica: : datidati delladella letteraturaletteratura, 1993 , 1993 –– 20092009


SENSIBILITA’: 84 SENSIBILITA’: 84 -- 100 %100 %

Moore Moore et al., et al., 20022002Garcia Velasco, 2009Garcia Velasco, 2009

Savelli, 2009 Savelli, 2009

SENSIBILITA’: 84 SENSIBILITA’: 84 -- 100 %100 %

SPECIFICITA’: 90 SPECIFICITA’: 90 -- 100 %100 %

Diagnostic accuracy of Diagnostic accuracy of transvaginaltransvaginal ultrasound for ultrasound for nonnon--invasive diagnosis of bowel endometriosis: invasive diagnosis of bowel endometriosis: a systematic review and metaa systematic review and meta--analysisanalysis


Pooled estimatesPooled estimates

Hudelist et al., Hudelist et al., UltrasoundUltrasound ObstetObstet. . GynecolGynecol. 2011. 2011

SENSITIVITY: 91 %SENSITIVITY: 91 %

SPECIFICITY: 98 %SPECIFICITY: 98 %

PPV: 98 %PPV: 98 %

NPV: 95 %NPV: 95 %

Diagnostic accuracy of Diagnostic accuracy of transvaginaltransvaginal sonographysonographyfor bladder endometriosisfor bladder endometriosis


PPV : 100 %PPV : 100 %

NPV : 98 %NPV : 98 %

LR+ : 75.50LR+ : 75.50

LRLR-- : : 0.750.75

Hudelist et al., Hudelist et al., UltrasoundUltrasound ObstetObstet. . GynecolGynecol. 2011. 2011

GliGli impiantiimpianti peritonealiperitoneali superficialisuperficialisonosonol’unical’unica forma di forma di endometriosiendometriosi


sonosonol’unical’unica forma di forma di endometriosiendometriosinon non identificabileidentificabilecon con modalitàmodalitàdiagnostichediagnostichenon invasive non invasive

Test Test diagnosticodiagnostico::

sisi applicaapplica a a pazientipazienti cheche sisi rivolgonorivolgono al al medico a medico a causacausadeidei sintomisintomi


medico a medico a causacausadeidei sintomisintomi

Test di screening:Test di screening:

sisi applicaapplica ad ad individuiindividui asintomaticiasintomatici a a rischiorischiodi di patologiapatologia

ApplicazioneApplicazionedi un test di un test diagnosticodiagnosticonon non invasivoinvasivoper per endometriosiendometriosi::


-- infertilitàinfertilità

-- doloredolorepelvicopelvicocronicocronico

Overview of Overview of RCTsRCTs comparingcomparing laparoscopiclaparoscopic ablationablation of of lesionslesions with no with no surgerysurgeryin infertile in infertile womenwomen with with minimalminimal or or mildmild endometriosisendometriosis

Source, year Pregnancies/ To tal Experim ental g roup Cont ro l g roup O R (95%, CI)

Marcouxet al., 1997 63/ 172 37/ 169 2.06 (1.28, 3.33)

Parazzin iet al., 1999 12/ 47 13/ 54 0.75 (0.30, 1.85)

N o su rgery bet ter Ab lat ion of lesion bet ter

0.01 0.1 0.5 1 2.0 10.0 100.00.01 0.1 0.5 1 2.0 10.0 100.0

Com m on odds rat io 1.65 (1.06, 2.58)

Odds Rat io

Vercellini et al., Hum. Vercellini et al., Hum. ReprodReprod. 2009. 2009

Diamonds Diamonds representrepresent oddsodds ratio of ratio of conceptionconception and and horizontalhorizontal lineslines 95% 95% CI. CI. BreslowBreslow--DayDay test test for for heterogeneityheterogeneity: : XX22 = = 13.24, 13.24, PP= = 0.42. Data 0.42. Data fromfrom AlAl--InanyInany et al. (2000).et al. (2000).

Effect of surgery for stage IEffect of surgery for stage I--IV endometriosis: IV endometriosis: controlled studiescontrolled studies


Author, year Absolute benefit increase Author, year Absolute benefit increase (pain recurrence rate)(pain recurrence rate)

Sutton Sutton et al., et al., 1997 37%1997 37%

Abbott Abbott et al.,et al.,2004 48%2004 48%

JarrelJarrelet al., et al., 2005 ==2005 ==


In In letteraturaletteratura vi vi èè confusioneconfusione tratra ilil concettoconcetto di di “time“time--toto--diagnosis” e “timediagnosis” e “time--toto--laparoscopy”laparoscopy”“time“time--toto--diagnosis” e “timediagnosis” e “time--toto--laparoscopy”laparoscopy”

La La laparoscopialaparoscopia non non èè indispensabileindispensabile per per diagnosidiagnosi e e trattamentotrattamento

Kennedy S., Kennedy S., FertilFertil. . SterilSteril. 2006. 2006

The availability of a reliable nonThe availability of a reliable non--invasive test to detect invasive test to detect endometriosis would help to avoid worthless diagnostic endometriosis would help to avoid worthless diagnostic laparoscopieslaparoscopies CatenacciCatenacci et al., 2009et al., 2009

HOWEVERHOWEVER


HOWEVERHOWEVER

The availability The availability of a simple test able to detect endometriosis of a simple test able to detect endometriosis is expected to boost the demand for the test, and the ultimate is expected to boost the demand for the test, and the ultimate effect would be to increase the number of women who are effect would be to increase the number of women who are diagnosed with the diseasediagnosed with the disease SomiglianaSomigliana et al., 2010et al., 2010

There is a very real possibility that a There is a very real possibility that a nonnon--invasive diagnostic test aimed at invasive diagnostic test aimed at detecting endometriosis in a very detecting endometriosis in a very


detecting endometriosis in a very detecting endometriosis in a very specific symptomatic population may, specific symptomatic population may, in fact, become a screening testin fact, become a screening test

SomiglianaSomigliana et al., 2010et al., 2010

SomiglianaSomigliana et al., Hum. et al., Hum. ReprodReprod. . 20102010

Disease mongering is the promotion of sickness that Disease mongering is the promotion of sickness that widens the boundary definition of illness in order to widens the boundary definition of illness in order to grow markets for those who sell and deliver grow markets for those who sell and deliver treatmentstreatments


treatmentstreatments

It is a process that turns healthy people into patients, It is a process that turns healthy people into patients, causes iatrogenic harm (both physical and causes iatrogenic harm (both physical and psychological), and wastes precious resources psychological), and wastes precious resources

Moynihan et al., 2008Moynihan et al., 2008

Experimental Experimental drugsdrugs and and proposedproposed future future therapeutictherapeutic schemesschemes for for endometriosisendometriosis((literatureliterature data 1987data 1987--2010)2010)



Aromatase inhibitors: pharmacological extravagance Aromatase inhibitors: pharmacological extravagance


-- During the reproductive period aromatase inhibitors During the reproductive period aromatase inhibitors stimulate ovarian functionstimulate ovarian function

-- In premenopausal women, these compounds must be used In premenopausal women, these compounds must be used together with other drugstogether with other drugs

-- When these combined regimens are used for When these combined regimens are used for endometriosis, it is impossible to assess how much of the endometriosis, it is impossible to assess how much of the effect on pain is related to which of the two medicationseffect on pain is related to which of the two medications

“ The general principles that should guide “ The general principles that should guide medical management of endometriosis are not medical management of endometriosis are not different from those applicable to other chronic different from those applicable to other chronic inflammatory disorders: achievement of long inflammatory disorders: achievement of long


inflammatory disorders: achievement of long inflammatory disorders: achievement of long phases of disease remission is the reasonable phases of disease remission is the reasonable goal, and reappearance of symptoms at drug goal, and reappearance of symptoms at drug discontinuation must not be considered as a discontinuation must not be considered as a demonstration of inefficacy of therapy” demonstration of inefficacy of therapy”

Effect of OCs and Effect of OCs and progestinsprogestins as assessed in controlled trials on the treatment of symptomatic as assessed in controlled trials on the treatment of symptomatic endometriosis (literature data, 1990endometriosis (literature data, 1990--2010)2010)


Main results of individual studies included in systematic review of medical treatments for Main results of individual studies included in systematic review of medical treatments for rectovaginalrectovaginal endometriosisendometriosis


RESULTS OF STUDIES COMPARING CONSERVATIVE SURGERY FOR RESULTS OF STUDIES COMPARING CONSERVATIVE SURGERY FOR OVARIAN ENDOMETRIOMAS WITH OR WITHOUT POSTOPERATIVE OVARIAN ENDOMETRIOMAS WITH OR WITHOUT POSTOPERATIVE LONGLONG--TERM ORAL CONTRACEPTIVE USETERM ORAL CONTRACEPTIVE USE

HorizontalHorizontal lineslines indicateindicate 9595%%CIsCIs;;boxesboxesshowshow thethe studystudy--specificspecific weightweight;; rhombirhombi representrepresent combinedcombined effecteffectsizessizes;;dasheddashed linelineindicatesindicates thethe overalloverall estimateestimate..

Cost of 12 months of continuous medical treatment of Cost of 12 months of continuous medical treatment of rectovaginalrectovaginal endometriosis; Italy, 2009endometriosis; Italy, 2009


Scientific glasnost Scientific glasnost


-- Outcome selectionOutcome selection-- PlaceboPlacebo--controlled designcontrolled design-- PlaceboPlacebo--controlled designcontrolled design-- Monophasic OCs taken continuously or lowMonophasic OCs taken continuously or low--dose NETA dose NETA

as the reference comparator as the reference comparator -- Satisfaction with treatment Satisfaction with treatment vsvs pain relief pain relief -- Duration of studyDuration of study-- IntentionIntention--toto--treat analysistreat analysis

Too soon, too late, too often, to seldom? Too soon, too late, too often, to seldom?


As beneficial as As beneficial as eearly diagnosis may be, without arly diagnosis may be, without careful analysis of the potential many factors careful analysis of the potential many factors careful analysis of the potential many factors careful analysis of the potential many factors that may contribute to her pain, it may also send that may contribute to her pain, it may also send the patient down a trail of endless, the patient down a trail of endless, inappropriate, and irreversible treatmentinappropriate, and irreversible treatment

SteegeSteege J.F., J.F., FertilFertil. . SterilSteril. 2006. 2006

Surgery for EndometriosisSurgery for Endometriosis

Obviously, the skill of the surgeon is relevant to Obviously, the skill of the surgeon is relevant to


the final outcome, but even the most talented the final outcome, but even the most talented

surgeon should think before recommending surgeon should think before recommending

surgery,“surgery,“WhyWhy do I do what I do?”do I do what I do?”

GarciaGarcia--Velasco & Velasco & AriciArici, , FertilFertil. . SterilSteril. . 20042004

SURGICAL PROCEDURES AND THEIR COST ESTIMATES SURGICAL PROCEDURES AND THEIR COST ESTIMATES AMONG WOMEN WITH NEWLY DIAGNOSED AMONG WOMEN WITH NEWLY DIAGNOSED ENDOMETRIOSIS: A US DATABASE STUDYENDOMETRIOSIS: A US DATABASE STUDY


-- Over 65% of Over 65% of patientspatientshadhadendometriosisendometriosis--relatedrelatedsurgicalsurgical-- Over 65% of Over 65% of patientspatientshadhadendometriosisendometriosis--relatedrelatedsurgicalsurgicalproceduresprocedures, , includingincluding hysterectomyhysterectomy, , withinwithin 1 1 yearyear of of beingbeingdiagnoseddiagnosed with with endometriosisendometriosis

-- The The costcost of of surgicalsurgical proceduresprocedures relatedrelated to to endometriosisendometriosisplacesplaces a a significantsignificant financialfinancial burdenburden on the on the healtcarehealtcare systemsystem

FuldeareFuldeare et al., J. Med. Econ. 2011et al., J. Med. Econ. 2011

ORAL CONTRACEPTIVE ORAL CONTRACEPTIVE AND THE “ENDOMETRIOSIS DOMINO EFFECT”AND THE “ENDOMETRIOSIS DOMINO EFFECT”

CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI CPP ED ENDOMETRIOSI: NUOVE PROSPETTIVE DI DIGNOSI E TERAPIADIGNOSI E TERAPIA

ProjectionProjection studiesstudies are are urgentlyurgently neededneeded in in orderorder to to evaluateevaluatethe impact of the impact of twotwo differentdifferenthealthcarehealthcareevaluateevaluatethe impact of the impact of twotwo differentdifferenthealthcarehealthcaremodelsmodels for for womenwomen with with endometriosisendometriosis, , oneone basedbasedmainlymainly on longon long--termtermmanagement with management with OCsOCs and and progestinsprogestins, and the , and the otherother basedbased mainlymainly on on surgicalsurgicalproceduresprocedures targetedtargeted atat lesionlesion eliminationelimination


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