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1. 8
Κλινικό Θέμα
Κλινικό Θέμα
Άλγος Δεξιού Υποχονδρίου και
Φυσιολογικό Υπερηχοτομογράφημα
Ελεύθερη μετάφραση και επιμέλεια: Κων/νος Ι. Ζωγράφος
Κλινικό σενάριο ντικός, όπως και στις υπόλοιπες λειτουργικές διαταραχές
του πεπτικού συστήματος.
Γυναίκα 30 ετών προσέρχεται στο ιατρείο σας αναφέ-
ροντας από έτους, διαλείπον, διαξιφιστικό άλγος δεξιού
Η συμπτωματολογία
υποχονδρίου, με ταυτόχρονη εμφάνιση ναυτίας και ενίο-
τε εμέτου. Η διάρκεια του πόνου ποικίλει από 30΄ έως 2 Προεξέχον σύμπτωμα στη δυσκινησία των χοληφόρων εί-
ώρες, αντανακλά στη δεξιά ωμική άρθρωση και δε συνδέ- ναι το εντοπισμένο άλγος στο δεξιό υποχόνδριο. Τα χα-
εται με τις κενώσεις ή τη φυσική άσκηση. Σε επανειλημ- ρακτηριστικά του έχουν καθοριστεί από τα κριτήρια Ρώ-
μένες επισκέψεις της ασθενούς στα επείγοντα περιστατι- μης ΙΙΙ. Ο πόνος είναι διαλείπων, αντανακλά στη δεξιά ωμι-
κά, ο αιματολογικός έλεγχος (ηπατική βιοχημεία, αμυλά- κή άρθρωση ή την πλάτη, συχνά συνοδεύεται από ναυτία
ση κ.λπ.) καθώς και το υπερηχοτομογράφημα άνω κοιλί- ή έμετο και συνήθως είναι μεταγευματικός.
ας ήταν φυσιολογικά. Πρόσφατη ενδοσκόπηση ανωτέρου Ίκτερος ή πυρετός δεν υπάρχουν και η κλινική εξέταση εί-
πεπτικού δεν ανέδειξε παθολογία. ναι συνήθως χωρίς ευρήματα εκτός από κάποια ήπια ευαι-
σθησία κατά την ψηλάφηση του δεξιού υποχονδρίου.
Το πρόβλημα
Φυσιολογικό υπερηχοτομογράφημα και αιματολογικός Διαγνωστική προσπέλαση
έλεγχος. Προέρχεται το άλγος από τα χοληφόρα; Ίσως Διαγνωστικά εργαλεία πρώτης γραμμής, η γαστροσκόπη-
πρόκειται για αλιθιασική χολοκυστοπάθεια αφού αποκλει- ση, η MRCP, και το EUS με τη γνωστή ειδικότητα και ευαι-
σθούν πρώτα το πεπτικό έλκος, η χοληδοχολιθίαση και σθησία που τα διακρίνει.
μικρολιθίαση, οι νεοπλασίες χοληφόρων και παγκρέατος,
Στο πρόσφατο παρελθόν μια σειρά δοκιμασιών μάς έδι-
το ευερέθιστο έντερο και το μυοσκελετικό άλγος.
νε τη δυνατότητα εκτίμησης της συσπαστικής λειτουργί-
Η παθοφυσιολογία της αλιθιασικής χολοκυστοπάθειας ας της χοληδόχου κύστεως. Όπως η αναπαραγωγή πόνου
δεν είναι πλήρως κατανοητή. Πιθανές θεωρίες είναι η πα- μετά από χορήγηση CCK, η χολοκυστογραφία με CCK, η
ρεμπόδιση στη ροή της χολής από τη χοληδόχο κύστη, δι- διενέργεια υπερηχοτομογραφήματος, και η μέτρηση του
αταραχές κινητικότητας αυτής, έλλειψη συντονισμού με- όγκου της χοληδόχου με παράλληλη χορήγηση CCK ή
ταξύ χοληδόχου κύστεως και σφιγκτήρα του Οddi και, τέ- γεύματος. Παρόλα αυτά, η άμεση εξάρτηση του αποτε-
λος, η σπλαγχνική υπερευαισθησία. λέσματος από τον εκτελούντα την εξέταση, καθώς και η
Διαταραχή κινητικότητας της χοληδόχου παρατηρείται χαμηλή ευαισθησία και ειδικότητα που διαθέτουν τις καθι-
μετά από εναπόθεση κρυστάλλων χοληστερόλης επί του στούν πλέον μη αξιόπιστες.
τοιχώματός της, ασθενής ανταπόκριση στη χολοκυστοκι- Η πλέον χρησιμοποιούμενη δοκιμασία για τη διάγνωση της
νίνη (CCK) και, τέλος, συγγενείς ανωμαλίες αυτής. Ο ρό- αλιθιασικής χολοκυστοπάθειας είναι το σπινθηρογράφη-
λος της σπλαγχνικής υπερευαισθησίας είναι εξίσου σημα- μα χοληφόρων (99mtechnetium- labeled hepatoiminodiacetic
endo_no12 c.indd 8 13/5/2009 3:30:07 µµ
2. 9
acid, 99mHIDA). Το iminodiacetic acid προσλαμβάνεται από Ίσως η πιο αξιόπιστη διαδικασία είναι εκείνη την οποία πε-
το ήπαρ και απεκκρίνεται με τη χολή. Το κλάσμα εξώθησης ριγράφουν οι Krishnamurthy και συνεργάτες, κατά τους
της χοληδόχου κύστης εκτιμάται μετά από χορήγηση CCK, οποίους η χορήγηση είναι 3΄ σε διάστημα 30΄και 60΄.
ενώ ο βαθμός κένωσης εξαρτάται από τη δόση και το ρυθ- Η απουσία, λοιπόν, προτύπου τρόπου εκτέλεσης της δο-
μό χορήγησης. Χαμηλό κλάσμα εξώθησης είναι ενδεικτικό κιμασίας έχει σαν αποτέλεσμα τη μη κοινά αποδεκτή και
δυσλειτουργίας. Ορισμένοι ασθενείς εμφανίζουν αναπαρα- ίσως τη λανθασμένη αξιολόγηση του αποτελέσματος. Οι
Κλινικό Θέμα
γωγή των συμπτωμάτων κατά τη διάρκεια της δοκιμασίας, περισσότερες δημοσιεύσεις για την εκτίμηση των αποτε-
και αυτό αποτελεί προγνωστικό στοιχείο για καλή ανταπό- λεσμάτων αναφέρουν παρουσία δυσλειτουργίας όταν το
κριση στην πιθανή χολοκυστεκτομή. Όταν η HIDA επιβε- κλάσμα εξώθησης της χοληδόχου είναι <35-40%. Επίσης
βαιώσει τη δυσλειτουργία της χοληδόχου η χειρουργική υπερσυσταλτικότητα της χοληδόχου (>85%) μπορεί να
αντιμετώπιση είναι πολύ πιθανή. Εκτιμάται, ότι τις δύο τε- προκαλέσει αναπαραγωγή παρόμοιων συμπτωμάτων.
λευταίες δεκαετίες η αύξηση του αριθμού των χολοκυστε-
κτομών ίσως οφείλεται στις αυξανόμε- Η ειδικότητα της χολοκυστογραφίας για τη διάγνωση της
νες θετικές δοκιμασίες. Αρκετές μελέ- δυσλειτουργίας της χοληδόχου δεν εί-
τες προσπάθησαν να αναδείξουν τα ναι 100%. Αρκετές άλλες νοσολογικές
πιθανά οφέλη μιας τέτοιας απόφασης Παρά την ευρεία χρήση οντότητες όπως η παχυσαρκία, ο σακ-
εκ μέρους του θεράποντος ιατρού, της χολοκυστογραφίας χαρώδης διαβήτης, η κύηση, η κοιλιο-
αλλά η αναδρομικότητα των μελετών κάκη, καθώς και λήψη φαρμάκων (ανα-
για τη διάγνωση στολείς διαύλων ασβεστίου, οπιοειδή,
καθώς και ο μικρός αριθμός των συμ-
μετεχόντων ασθενών καθιστά τα απο- της αλιθιασικής αντιχολινεργικά) μπορούν να προκαλέ-
τελέσματά τους χαμηλής αξιοπιστί- χολοκυστοπάθειας σουν παρόμοια εικόνα.
ας. Όμως μια προοπτική μελέτη των υπάρχουν αρκετά
Yap et al ξεκάθαρα υποστηρίζει τη χει- ΜΕΤΑ ΤΗ
ρουργική αντιμετώπιση του προβλή- αδιευκρίνιστα σημεία ΧΟΛΟΚΥΣΤΕΚΤΟΜΗ…
ματος. Ασθενείς με θετική HIDA για για τη διαδικασία Παρά την ΄΄θετικά προσκείμενη΄΄ βι-
αλιθιασική χολοκυστοπάθεια (κλάσμα εκτέλεσης της βλιογραφία ως προς τη θεραπευτι-
εξώθησης < 40%) διακρίθηκαν σε δυο κή αποτελεσματικότητα της χολοκυ-
υποομάδες, χειρουργηθέντες (n =11) δοκιμασίας τα οποία στεκτομής, υπάρχουν ακόμη αρκετά
και μη (n = 10). Χρόνος παρακολού- μειώνουν την αναπάντητα ερωτήματα. Οι ασθενείς
θησης 34 μήνες. Από την πρώτη ομά- αξιοπιστία της με δυσλειτουργία της χοληδόχου
δα 10 είχαν πλήρη ύφεση συμπτωμά- έχουν μερική και όχι πλήρη ύφεση
των, και 1 μερική^ εν αντιθέσει, όλοι οι των συμπτωμάτων μετά το χειρουρ-
ασθενείς της δεύτερης ομάδας παρέ- γείο. Οι λόγοι παραμένουν αδιευκρί-
μειναν συμπτωματικοί, και 2 χειρουργήθηκαν. νιστοι, αλλά πιθανότατα να υπάρχει άλλη γενεσιουρ-
Οι Ponsky και συνεργάτες σε μια μετα-ανάλυση 5 μελε- γός αιτία ή η δυσλειτουργία της χοληδόχου να αποτε-
τών που αφορούσαν 274 ασθενείς με αλιθιασική χολοκυ- λεί στοιχείο ενός πολυπαραγοντικού συνδρόμου. Υπάρ-
στοπάθεια (θετική HIDA) αξιολόγησαν τα οφέλη της χει- χουν ανέκδοτες αναφορές ασθενών με φυσιολογική δο-
ρουργικής θεραπείας. Βελτίωση των συμπτωμάτων εμφά- κιμασία HIDA οι οποίοι είχαν βελτίωση των συμπτωμά-
νισε το 98% των χειρουργηθέντων εν αντιθέσει με το 32% των τους μετά τη χολοκυστεκτομή καθώς και αρκετές
από την ομάδα εκείνων που αντιμετωπίστηκαν συντηρητι- μελέτες οι οποίες αποκαλύπτουν παρόμοια ανταπόκρι-
κά. Πλήρη ύφεση εμφάνισαν το 74% και 8% αντίστοιχα. ση μετά το χειρουργείο σε ασθενείς με ή χωρίς δυσλει-
τουργία της χοληδόχου! Δυστυχώς δεν υπάρχουν ακό-
ΑΜΦΙΒΟΛΙΕΣ… μη ασφαλή προγνωστικά στοιχεία πιθανούς ανταπόκρι-
σης στη χολοκυστεκτομή ατόμων με επιβεβαιωμένη χο-
Παρά την ευρεία χρήση της χολοκυστογραφίας για τη δι-
λοκυστοπάθεια. Τέλος, φαίνεται ότι ο βαθμός μείωσης
άγνωση της αλιθιασικής χολοκυστοπάθειας υπάρχουν αρ-
της συσπαστικής ικανότητας της χοληδόχου, εκτιμώμε-
κετά αδιευκρίνιστα σημεία για τη διαδικασία εκτέλεσης
νος με τη δοκιμασία HIDA, δε συνδέεται απαραίτητα με
της δοκιμασίας τα οποία μειώνουν την αξιοπιστία της. Οι
καλύτερη βελτίωση των συμπτωμάτων μετά το χειρουρ-
μετρήσεις του κλάσματος εξώθησης της χοληδόχου επη-
γείο.
ρεάζονται άμεσα από τη δόση, το ρυθμό και τη διάρκεια
χορήγησης της CCK. Τυποποιημένος τρόπος διενέργειας Η μακροχρόνια διατήρηση της ανταπόκρισης ίσως είναι
της δοκιμασίας, κοινά αποδεκτός, δεν περιγράφεται. Οι ελλιπώς μελετημένη. Το χρονικό διάστημα μελέτης που
κατευθυντήριες γραμμές της Εταιρείας Πυρηνικής Ιατρι- αναφέρεται στις περισσότερες μελέτες, συμπεριλαμβα-
κής δεν αναφέρουν καμία συγκεκριμένη δόση ή διάρκεια νομένης και του Ponsky, ποικίλει από 9-30 μήνες. Μια
χορήγησης της CCK. Στις οδηγίες χρήσης του εμπορικού μελέτη παιδιατρικών ασθενών, με χαμηλό κλάσμα εξώ-
προϊόντος Kinevac (sincalide), μια μορφή συνθετικής CCK, θησης, οι οποίοι υποβλήθηκαν σε χολοκυστεκτομή, 1
αναφέρονται τρεις διαφορετικοί τρόποι χορήγησης!!! μήνα μετά είχαν υψηλά ποσοστά ανταπόκρισης. Όμως
endo_no12 c.indd 9 13/5/2009 3:30:08 µµ
3. μετά από 2ετή παρακολούθηση τα ποσοστά των ασθε- χου γίνεται βάσει του αποτελέσματος της αναίμακτης
νών οι οποίοι παρέμεναν ασυμπτωματικοί ήταν παρόμοια HIDA. Επομένως, σε ασθενή με ακέραια χοληδόχο, η δι-
με εκείνα που αντιμετωπίστηκαν συντηρητικά. Η φυσι- άγνωση της αλιθιασικής χολοκυστοπάθειας προηγείται
κή εξέλιξη της δυσλειτουργίας της χοληδόχου παραμέ- της ΔΣΟ, θέτοντας έτσι την απόφαση διενέργειας ERCP
νει άγνωστη. Παρόλα αυτά σε μια μελέτη αναφέρεται ότι και παράλληλης μανομετρίας (εξετάσεις υψηλής επικιν-
ασθενείς με επιβεβαιωμένη δυσλειτουργία (χαμηλό κλά- δυνότητας) σε δεύτερο χρόνο. Ακόμη και σε κέντρα ανα-
Κλινικό Θέμα
σμα εξώθησης στη δοκιμασία HIDA), εάν υποβληθούν σε φοράς, ο κίνδυνος εμφάνισης επιπλοκών (λοιμώξεις, αι-
εκ νέου δοκιμασία μετά από μήνες ή χρόνια, η δυσλει- μορραγία, διάτρηση, παγκρεατίτιδα) με συνοδό νοση-
τουργία παραμένει. λεία, μετά από διενέργεια ERCP/ μανομετρίας ανέρχε-
ται σε 10-15%. Περιορισμένες αναφορές, αναδρομικού
ΔΥΣΛΕΙΤΟΥΡΓΙΑ ΣΦΙΓΚΤΗΡΑ ΤΟΥ ODDI υλικού, που αφορούν τα αποτελέσματα σφιγκτηροτομής
Η Δυσλειτουργία του Σφιγκτήρα του Οddi (ΔΣΟ) δυνητι- σε ασθενείς με ΔΣΟ, περιγράφουν ύφεση του άλγους σε
κά αποτελεί άλλη μια αιτία εμφάνισης άλγους στην περιο- ποσοστά 40-70%.
χή της άνω κοιλίας. Τυπικά εμφανίζεται μετά από χολοκυ- Σε ασθενή με φυσιολογικό κλάσμα εξώθησης χοληδόχου
στεκτομή, εντοπίζεται στο δεξιό υποχόνδριο, έχοντας συ- κύστης, μετά από δοκιμασία HIDA, η απόφαση της εμπει-
νεχή ή κολικοειδή χαρακτήρα. Αρκετά είναι τα ερωτήματα ρικής χολοκυστεκτομής ή της ERCP, θα πρέπει να λαμβά-
τα οποία παραμένουν αναπάντητα, και αφορούν τη σχέση νεται μετά από λεπτομερή ενημέρωση του ασθενούς για
ΔΣΟ και δυσλειτουργίας της χοληδόχου: (1) εμφανίζεται τους κινδύνους και τα οφέλη αυτών.
η ΔΣΟ σε ασθενείς με άθικτη χοληδόχο κύστη (2) υπάρχει
σχέση μεταξύ ΔΣΟ και δυσλειτουργίας της χοληδόχου και ΔΗΜΟΣΙΕΥΜΕΝΕΣ ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ
(3) ποιος είναι ο ρόλος της ΔΣΟ και της λανθάνουσας δυ- ΓΡΑΜΜΕΣ
σλειτουργίας της χοληδόχου, στην αξιολόγηση και το χει-
Η διάσκεψη Ρώμης ΙΙΙ περιγράφει και αποσαφηνίζει τα δι-
ρισμό ασθενών με άλγος δεξιού υποχονδρίου και φυσιο-
αγνωστικά κριτήρια για τις λειτουργικές διαταραχές της
λογικό υπερηχοτομογράφημα;
χοληδόχου, αλλά δεν προβαίνει σε κατευθυντήριες γραμ-
Υπάρχουν περιορισμένες αναφορές για τη συχνότητα μές για το χειρισμό αυτών των ασθενών. Η Εταιρεία Χει-
εμφάνισης ΔΣΟ σε ασθενείς με άθικτη χοληδόχο. Παρό- ρουργικής Πεπτικού Συστήματος, στις κατευθυντήρι-
λα αυτά ΔΣΟ έχει πιστοποιηθεί στο 10% ασθενών με συ- ες γραμμές που ανακοίνωσε το 2006 για τη θεραπευτι-
μπτωματική χολολιθίαση και στο 50% σε ασθενείς με άλ- κή αντιμετώπιση ασθενών με χολολιθίαση ή χολοκυστοπά-
γος δεξιού υποχονδρίου και φυσιολογικό υπερηχοτομο- θεια, συστήνει χολοκυστεκτομή σε ασθενείς με υποτροπι-
γράφημα. Παραμένει άγνωστο εάν υπάρχει συσχέτιση άζοντα επεισόδια άλγους προέλευσης χοληφόρων, επιβε-
μεταξύ υπερτονίας του Oddi και δυσλειτουργίας της χο- βαιωμένη με χολοκυστογραφία, οριοθετώντας παθολογι-
ληδόχου. Σε μια αναδρομική μελέτη, στην οποία συμμε- κό κλάσμα εξώθησης χοληδόχου <30%. n
τείχαν 81 ασθενείς με άλγος δεξιού υπο-
χονδρίου και φυσιολογική χοληδόχο στο
υπερηχοτομογράφημα υποβλήθηκαν σε Άλγος δεξιού υποχονδρίου και φυσιολογικό U/S
μανομετρία του Oddi και σε δοκιμασία
HIDA. Στους 41 ασθενείς με φυσιολογική Ηπατικά ένζυμα και αμυλάση
HIDA το 57% είχαν ΔΣΟ, ενώ στους 40 με
παθολογική HIDA 50% είχαν ΔΣΟ. Συμπε-
ρασματικά, σε αυτή την ομάδα των ασθε- Παθολογικά Φυσιολογικά Συντηρητική
νών, η ΔΣΟ και η δυσλειτουργία της χο- θεραπεία
ληδόχου μπορεί να εμφανιστούν ταυτό-
χρονα ή ανεξάρτητα η μια από την άλλη. Περαιτέρω διερεύνηση Δοκιμασία HIDA
Ασθενείς με άλγος δεξιού υποχονδρίου,
και, φυσιολογικό υπερηχοτομογράφημα,
Φυσιολογική Παθολογική
ηπατικά ένζυμα, αμυλάση και λιπάση δυ-
νητικά μπορεί να εμφανίσουν ΔΣΟ. Αξιο-
λογώντας έναν ασθενή χωρίς αντικειμενι- ERCP Χολοκυστεκτομή
κά στοιχεία χολοπαγκρεατικής νόσου και &
με ακέραια τη χοληδόχο κύστη, το ερώτη- Μανομετρία
μα που γεννάται είναι κατά πόσον η δια-
γνωστική/ θεραπευτική προσέγγιση θα εί- Επιμονή/υποτροπή Ύφεση συμπτωμάτων
ναι συντηρητική ή θα πρέπει να προχωρή- συμπτωμάτων
σουμε σε περαιτέρω διαγνωστικά και θε-
ραπευτικά μέσα επεμβατικού χαρακτήρα. Αλγόριθμος διαγνωστικής προσπέλασης άλγους δεξιού υποχονδρίου
Η διάγνωση δυσλειτουργίας της χοληδό- (Πηγή: Clin Gastroenterol Hepatol 2008 AGA Institute)
endo_no12 c.indd 10 13/5/2009 3:30:08 µµ
7. Appendix A: Rome III Diagnostic Criteria for FGIDs
A. Functional Esophageal Disorders
A1. Functional Heartburn
Diagnostic criteria* Must include all of the following:
. Burning retrosternal discomfort or pain
. Absence of evidence that gastroesophageal acid reflux is the cause of the
symptom
. Absence of histopathology-based esophageal motility disorders
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
A2. Functional Chest Pain of Presumed Esophageal Origin
Diagnostic criteria* Must include all of the following:
. Midline chest pain or discomfort that is not of burning quality
. Absence of evidence that gastroesophageal reflux is the cause of the symptom
. Absence of histopathology-based esophageal motility disorders
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
A3. Functional Dysphagia
Diagnostic criteria* Must include all of the following:
. Sense of solid and/or liquid foods sticking, lodging, or passing abnormally
through the esophagus
. Absence of evidence that gastroesophageal reflux is the cause of the symptom
. Absence of histopathology-based esophageal motility disorders
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
A4. Globus
Diagnostic criteria* Must include all of the following:
. Persistent or intermittent, nonpainful sensation of a lump or foreign body
in the throat
. Occurrence of the sensation between meals
. Absence of dysphagia or odynophagia
. Absence of evidence that gastroesophageal reflux is the cause of the symptom
. Absence of histopathology-based esophageal motility disorders
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
8. Appendix A: Rome III Diagnostic Criteria for FGIDs
B. Functional Gastroduodenal Disorders
B1. FUNCTIONAL DYSPEPSIA
Diagnostic criteria* Must include:
. One or more of the following:
a. Bothersome postprandial fullness
b. Early satiation
c. Epigastric pain
d. Epigastric burning
AND
. No evidence of structural disease (including at upper endoscopy) that is likely
to explain the symptoms
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
B1a. Postprandial Distress Syndrome
Diagnostic criteria* Must include one or both of the following:
. Bothersome postprandial fullness, occurring after ordinary-sized meals,
at least several times per week
. Early satiation that prevents finishing a regular meal, at least several times
per week
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
Supportive criteria
. Upper abdominal bloating or postprandial nausea or excessive belching
can be present
. Epigastric pain syndrome may coexist
B1b. Epigastric Pain Syndrome
Diagnostic criteria* Must include all of the following:
. Pain or burning localized to the epigastrium of at least moderate severity,
at least once per week
. The pain is intermittent
. Not generalized or localized to other abdominal or chest regions
. Not relieved by defecation or passage of flatus
. Not fulfilling criteria for gallbladder and sphincter of Oddi disorders
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
Supportive criteria
. The pain may be of a burning quality, but without a retrosternal component
. The pain is commonly induced or relieved by ingestion of a meal, but may
occur while fasting
. Postprandial distress syndrome may coexist
9. Appendix A: Rome III Diagnostic Criteria for FGIDs
B2. BELCHING DISORDERS
B2a. Aerophagia
Diagnostic criteria* Must include all of the following:
. Troublesome repetitive belching at least several times a week
. Air swallowing that is objectively observed or measured
* Criteria fulfilled for the last months with symptom
onset at least months prior to diagnosis
B2b. Unspecified Excessive Belching
Diagnostic criteria* Must include all of the following:
. Troublesome repetitive belching at least several times a week
. No evidence that excessive air swallowing underlies the symptom
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
B3. NAUSEA AND VOMITING DISORDERS
B3a. Chronic Idiopathic Nausea
Diagnostic criteria* Must include all of the following:
. Bothersome nausea occurring at least several times per week
. Not usually associated with vomiting
. Absence of abnormalities at upper endoscopy or metabolic disease
that explains the nausea
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
B3b. Functional Vomiting
Diagnostic criteria* Must include all of the following:
. On average one or more episodes of vomiting per week
. Absence of criteria for an eating disorder, rumination, or major
psychiatric disease according to DSM-IV
. Absence of self-induced vomiting and chronic cannabinoid use and
absence of abnormalities in the central nervous system or metabolic
diseases to explain the recurrent vomiting
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
10. Appendix A: Rome III Diagnostic Criteria for FGIDs
B3c. Cyclic Vomiting Syndrome
Diagnostic criteria Must include all of the following:
. Stereotypical episodes of vomiting regarding onset (acute) and duration
(less than one week)
. Three or more discrete episodes in the prior year
. Absence of nausea and vomiting between episodes
Supportive criterion
History or family history of migraine headaches
B4. Rumination Syndrome in Adults
Diagnostic criteria Must include both of the following:
. Persistent or recurrent regurgitation of recently ingested food into the mouth
with subsequent spitting or remastication and swallowing
. Regurgitation is not preceded by retching
Supportive criteria
. Regurgitation events are usually not preceded by nausea
. Cessation of the process when the regurgitated material becomes acidic
. Regurgitant contains recognizable food with a pleasant taste
C. Functional Bowel Disorders
C1. Irritable Bowel Syndrome
Diagnostic criterion*
Recurrent abdominal pain or discomfort** at least days/month in the last
months associated with two or more of the following:
. Improvement with defecation
. Onset associated with a change in frequency of stool
. Onset associated with a change in form (appearance) of stool
* Criterion fulfilled for the last months with symptom onset
at least months prior to diagnosis
** “Discomfort” means an uncomfortable sensation not described as pain.
In pathophysiology research and clinical trials, a pain/discomfort frequency of at least
days a week during screening evaluation is recommended for subject eligibility.
C2. Functional Bloating
Diagnostic criteria* Must include both of the following:
. Recurrent feeling of bloating or visible distension at least days/month in
the last months
. Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel
syndrome, or other functional GI disorder
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
11. Appendix A: Rome III Diagnostic Criteria for FGIDs
C3. Functional Constipation
Diagnostic criteria*
. Must include two or more of the following:
a. Straining during at least % of defecations
b. Lumpy or hard stools in at least % of defecations
c. Sensation of incomplete evacuation for at least % of defecations
d. Sensation of anorectal obstruction/blockage for at least % of defecations
e. Manual maneuvers to facilitate at least % of defecations (e.g., digital
evacuation, support of the pelvic floor)
f. Fewer than three defecations per week
. Loose stools are rarely present without the use of laxatives
. Insufficient criteria for irritable bowel syndrome
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
C4. Functional Diarrhea
Diagnostic criterion*
Loose (mushy) or watery stools without pain occurring in at least % of stools
* Criterion fulfilled for the last months with symptom onset
at least months prior to diagnosis
C5. Unspecified Functional Bowel Disorder
Diagnostic criterion*
Bowel symptoms not attributable to an organic etiology that do not meet criteria
for the previously defined categories
* Criterion fulfilled for the last months with symptom onset
at least months prior to diagnosis
D. Functional Abdominal Pain Syndrome
D. Functional Abdominal Pain Syndrome
Diagnostic criteria* Must include all of the following:
. Continuous or nearly continuous abdominal pain
. No or only occasional relationship of pain with physiological events
(e.g., eating, defecation, or menses)
. Some loss of daily functioning
. The pain is not feigned (e.g., malingering)
. Insufficient symptoms to meet criteria for another functional gastrointestinal
disorder that would explain the pain
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
12. Appendix A: Rome III Diagnostic Criteria for FGIDs
E. Functional Gallbladder and Sphincter of Oddi Disorders
E. Functional Gallbladder and Sphincter of Oddi Disorders
Diagnostic criteria Must include episodes of pain located in the epigastrium
and/or right upper quadrant and all of the following:
. Episodes lasting minutes or longer
. Recurrent symptoms occurring at different intervals (not daily)
. The pain builds up to a steady level
. The pain is moderate to severe enough to interrupt the patient’s daily activities
or lead to an emergency department visit
. The pain is not relieved by bowel movements
. The pain is not relieved by postural change
. The pain is not relieved by antacids
. Exclusion of other structural disease that would explain the symptoms
Supportive criteria
The pain may present with one or more of the following:
. Associated with nausea and vomiting
. Radiates to the back and/or right infra subscapular region
. Awakens from sleep in the middle of the night
E1. Functional Gallbladder Disorder
Diagnostic criteria Must include all of the following:
. Criteria for functional gallbladder and sphincter of Oddi disorder
. Gallbladder is present
. Normal liver enzymes, conjugated bilirubin, and amylase/lipase
E2. Functional Biliary Sphincter of Oddi Disorder
Diagnostic criteria Must include both of the following:
. Criteria for functional gallbladder and sphincter of Oddi disorder
. Normal amylase/lipase
Supportive criterion
Elevated serum transaminases, alkaline phosphatase, or conjugated bilirubin
temporarily related to at least two pain episodes
E3. Functional Pancreatic Sphincter of Oddi Disorder
Diagnostic criteria Must include both of the following:
. Criteria for functional gallbladder and sphincter of Oddi disorder and
. Elevated amylase/lipase
13. Appendix A: Rome III Diagnostic Criteria for FGIDs
F. Functional Anorectal Disorders
F1. Functional Fecal Incontinence
Diagnostic criteria*
. Recurrent uncontrolled passage of fecal material in an individual with a
developmental age of at least years and one or more of the following:
a. Abnormal functioning of normally innervated and structurally
intact muscles
b. Minor abnormalities of sphincter structure and/or innervation
c. Normal or disordered bowel habits, (i.e., fecal retention or diarrhea)
d. Psychological causes
AND
. Exclusion of all the following:
a. Abnormal innervation caused by lesion(s) within the brain (e.g., dementia),
spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple
sclerosis), or as part of a generalized peripheral or autonomic neuropathy
(e.g., due to diabetes)
b. Anal sphincter abnormalities associated with a multisystem disease
(e.g., scleroderma)
c. Structural or neurogenic abnormalities believed to be the major or primary
cause of fecal incontinence
* Criteria fulfilled for the last months
F2. FUNCTIONAL ANORECTAL PAIN
F2a. Chronic Proctalgia
Diagnostic criteria* Must include all of the following:
. Chronic or recurrent rectal pain or aching
. Episodes last minutes or longer
. Exclusion of other causes of rectal pain such as ischemia, inflammatory
bowel disease, cryptitis, intramuscular abscess, anal fissure, hemorrhoids,
prostatitis, and coccygodynia
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
Chronic proctalgia may be further characterized into levator ani syndrome
or unspecified anorectal pain based on digital rectal examination.
F2a.1. Levator Ani Syndrome
Diagnostic criterion
Symptom criteria for chronic proctalgia and tenderness during posterior traction
on the puborectalis
14. Appendix A: Rome III Diagnostic Criteria for FGIDs
F2a.2. Unspecified Functional Anorectal Pain
Diagnostic criterion
Symptom criteria for chronic proctalgia but no tenderness during posterior
traction on the puborectalis
F2b. Proctalgia Fugax
Diagnostic criteria Must include all of the following:
. Recurrent episodes of pain localized to the anus or lower rectum
. Episodes last from seconds to minutes
. There is no anorectal pain between episodes
For research purposes criteria must be fulfilled for months;
however, clinical diagnosis and evaluation may be made prior to months.
F3. Functional Defecation Disorders
Diagnostic criteria*
. The patient must satisfy diagnostic criteria for functional constipation**
. During repeated attempts to defecate must have at least two of the following:
a. Evidence of impaired evacuation, based on balloon expulsion test
or imaging
b. Inappropriate contraction of the pelvic floor muscles (i.e., anal sphincter or
puborectalis) or less than % relaxation of basal resting sphincter pressure
by manometry, imaging, or EMG
c. Inadequate propulsive forces assessed by manometry or imaging
* Criteria fulfilled for the last months with symptom onset
at least months prior to diagnosis
** Diagnostic criteria for functional constipation:
() Must include two or more of the following: (a) Straining during at least % of defeca-
tions, (b) Lumpy or hard stools in at least % of defecations, (c) Sensation of incomplete
evacuation for at least % of defecations, (d) Sensation of anorectal obstruction/blockage
for at least % of defecations, (e) Manual maneuvers to facilitate at least % of defeca-
tions (e.g., digital evacuation, support of the pelvic floor), (f ) Fewer than three defecations
per week.
() Loose stools are rarely present without the use of laxatives.
() Insufficient criteria for irritable bowel syndrome.
F3a. Dyssynergic Defecation
Diagnostic criterion
Inappropriate contraction of the pelvic floor or less than % relaxation of basal
resting sphincter pressure with adequate propulsive forces during attempted
defecation
F3b. Inadequate Defecatory Propulsion
Diagnostic criterion
Inadequate propulsive forces with or without inappropriate contraction or less
than % relaxation of the anal sphincter during attempted defecation
15. Appendix A: Rome III Diagnostic Criteria for FGIDs
G. Childhood Functional GI Disorders: Infant/Toddler
G1. Infant Regurgitation
Diagnostic criteria Must include both of the following in otherwise healthy infants
3 weeks to 12 months of age:
. Regurgitation two or more times per day for or more weeks
. No retching, hematemesis, aspiration, apnea, failure to thrive, feeding or
swallowing difficulties, or abnormal posturing
G2. Infant Rumination Syndrome
Diagnostic criteria Must include all of the following for at least 3 months:
. Repetitive contractions of the abdominal muscles, diaphragm, and tongue
. Regurgitation of gastric content into the mouth, which is either expectorated
or rechewed and reswallowed
. Three or more of the following:
a. Onset between and months
b. Does not respond to management for gastroesophageal reflux disease,
or to anticholinergic drugs, hand restraints, formula changes, and
gavage or gastrostomy feedings
c. Unaccompanied by signs of nausea or distress
d. Does not occur during sleep and when the infant is interacting with
individuals in the environment
G3. Cyclic Vomiting Syndrome
Diagnostic criteria Must include both of the following:
. Two or more periods of intense nausea and unremitting vomiting or retching
lasting hours to days
. Return to usual state of health lasting weeks to months
G4. Infant Colic
Diagnostic criteria Must include all of the following in infants from birth to
4 months of age:
. Paroxysms of irritability, fussing or crying that starts and stops without
obvious cause
. Episodes lasting or more hours/day and occurring at least days/wk for
at least week
. No failure to thrive
G5. Functional Diarrhea
Diagnostic criteria Must include all of the following:
. Daily painless, recurrent passage of three or more large, unformed stools
. Symptoms that last more than weeks
. Onset of symptoms that begins between and months of age
. Passage of stools that occurs during waking hours
. There is no failure-to-thrive if caloric intake is adequate
16. Appendix A: Rome III Diagnostic Criteria for FGIDs
G6. Infant Dyschezia
Diagnostic criteria Must include both of the following in an infant less than 6 months of age
. At least minutes of straining and crying before successful passage of soft stools
. No other health problems
G7. Functional Constipation
Diagnostic criteria Must include one month of at least two of the following
in infants up to 4 years of age:
. Two or fewer defecations per week
. At least one episode/week of incontinence after the acquisition of toileting skills
. History of excessive stool retention
. History of painful or hard bowel movements
. Presence of a large fecal mass in the rectum
. History of large diameter stools which may obstruct the toilet
Accompanying symptoms may include irritability, decreased appetite, and/or early
satiety. The accompanying symptoms disappear immediately following passage of a
large stool.
H. Childhood Functional GI Disorders: Child/Adolescent
H1. VOMITING AND AEROPHAGIA
H1a. Adolescent Rumination Syndrome
Diagnostic criteria* Must include all of the following:
. Repeated painless regurgitation and rechewing or expulsion of food that
a. begin soon after ingestion of a meal
b. do not occur during sleep
c. do not respond to standard treatment for gastroesophageal reflux
. No retching
. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
that explains the subject’s symptoms
* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis
H1b. Cyclic Vomiting Syndrome
Diagnostic criteria Must include both of the following:
. Two or more periods of intense nausea and unremitting vomiting or retching lasting
hours to days
. Return to usual state of health lasting weeks to months
H1c. Aerophagia
Diagnostic criteria* Must include at least two of the following:
. Air swallowing
. Abdominal distention due to intraluminal air
. Repetitive belching and/or increased flatus
* Criteria fulfilled at least once per week for at least months prior to diagnosis
17. Appendix A: Rome III Diagnostic Criteria for FGIDs
H2. ABDOMINAL PAIN-RELATED FUNCTIONAL GI DISORDERS
H2a. Functional Dyspepsia
Diagnostic criteria* Must include all of the following:
. Persistent or recurrent pain or discomfort centered in the upper abdomen
(above the umbilicus)
. Not relieved by defecation or associated with the onset of a change in stool
frequency or stool form (i.e., not irritable bowel syndrome)
. No evidence of an inflammatory, anatomic, metabolic or neoplastic process
that explains the subject’s symptoms
* Criteria fulfilled at least once per week for at least months prior to diagnosis
H2b. Irritable Bowel Syndrome
Diagnostic criteria* Must include both of the following:
. Abdominal discomfort** or pain associated with two or more of the following
at least % of the time:
a. Improvement with defecation
b. Onset associated with a change in frequency of stool
c. Onset associated with a change in form (appearance) of stool
. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
that explains the subject’s symptoms
* Criteria fulfilled at least once per week for at least months prior to diagnosis
** “Discomfort” means an uncomfortable sensation not described as pain.
H2c. Abdominal Migraine
Diagnostic criteria* Must include all of the following:
. Paroxysmal episodes of intense, acute periumbilical pain that lasts for
hour or more
. Intervening periods of usual health lasting weeks to months
. The pain interferes with normal activities
. The pain is associated with of the following:
a. Anorexia
b. Nausea
c. Vomiting
d. Headache
e. Photophobia
f. Pallor
. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
considered that explains the subject’s symptoms
* Criteria fulfilled two or more times in the preceding months
18. Appendix A: Rome III Diagnostic Criteria for FGIDs
H2d. Childhood Functional Abdominal Pain
Diagnostic criteria* Must include all of the following:
. Episodic or continuous abdominal pain
. Insufficient criteria for other FGIDs
. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
that explains the subject’s symptoms
* Criteria fulfilled at least once per week for at least months prior to diagnosis
H2d1. Childhood Functional Abdominal Pain Syndrome
Diagnostic criteria* Must satisfy criteria for childhood functional abdominal pain and
have at least 25% of the time one or more of the following:
. Some loss of daily functioning
. Additional somatic symptoms such as headache, limb pain, or difficulty
sleeping
* Criteria fulfilled at least once per week for at least months prior to diagnosis
H3. CONSTIPATION AND INCONTINENCE
H3a. Functional Constipation
Diagnostic criteria* Must include two or more of the following in a child with a
developmental age of at least 4 years with insufficient criteria
for diagnosis of IBS:
. Two or fewer defecations in the toilet per week
. At least one episode of fecal incontinence per week
. History of retentive posturing or excessive volitional stool retention
. History of painful or hard bowel movements
. Presence of a large fecal mass in the rectum
. History of large diameter stools which may obstruct the toilet
* Criteria fulfilled at least once per week for at least months prior to diagnosis
H3b. Nonretentive Fecal Incontinence
Diagnostic criteria* Must include all of the following in a child with a developmental
age at least 4 years:
. Defecation into places inappropriate to the social context at least once per
month
. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process
that explains the subject’s symptoms
. No evidence of fecal retention
* Criteria fulfilled for at least months prior to diagnosis
21. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
A. Functional Esophageal Disorders A. Functional Esophageal Disorders
A1. Functional Heartburn A4. Functional Heartburn
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: in the preceding 12 months of:
. Burning retrosternal discomfort or pain . Burning retrosternal discomfort or pain;
. Absence of evidence that gastroesophageal and
acid reflux is the cause of the symptom . Absence of pathologic gastroesophageal
. Absence of histopathology-based reflux, achalasia, or other motility disorder
esophageal motility disorders with a recognized pathologic basis.
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
A2. Functional Chest Pain of A3. Functional Chest Pain of
Presumed Esophageal Origin Presumed Esophageal Origin
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: within the preceding 12 months of:
. Midline chest pain or discomfort that is not . Midline chest pain or discomfort that is not
of burning quality of burning quality; and
. Absence of evidence that gastroesophageal . Absence of pathologic gastroesophageal
reflux is the cause of the symptom reflux, achalasia, or other motility disorder
. Absence of histopathology-based with a recognized pathologic basis.
esophageal motility disorders
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
22. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
A3. Functional Dysphagia A5. Functional Dysphagia
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: in the preceding 12 months of:
. Sense of solid and/or liquid foods sticking, . Sense of solid and/or liquid foods sticking,
lodging, or passing abnormally through the lodging, or passing abnormally through the
esophagus esophagus; and
. Absence of evidence that gastroesophageal . Absence of pathologic gastroesophageal
reflux is the cause of the symptom reflux, achalasia, or other motility disorder
. Absence of histopathology-based with a recognized pathologic basis.
esophageal motility disorders
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
A4. Globus A1. Globus
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: in the preceding 12 months of:
. Persistent or intermittent, nonpainful . The persistent or intermittent sensation of a
sensation of a lump or foreign body in lump or foreign body in the throat;
the throat . Occurrence of the sensation between meals;
. Occurrence of the sensation between meals . Absence of dysphagia and odynophagia; and
. Absence of dysphagia or odynophagia . Absence of pathologic gastroesophageal
. Absence of evidence that gastroesophageal reflux, achalasia, or other motility disorder
reflux is the cause of the symptom with a recognized pathologic basis (e.g.,
. Absence of histopathology-based scleroderma of the esophagus).
esophageal motility disorders
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
Rome III criteria do not include unspecified A6. Unspecified Functional
functional esophageal disorder as in Rome II. Esophageal Disorder
At least 12 weeks, which need not be consecutive,
in the preceding 12 months of:
. Unexplained symptoms attributed to the
esophagus that do not fit into the previously
described categories; and
. Absence of pathologic gastroesophageal
reflux, achalasia, or other motility disorder
with a recognized pathologic basis.
23. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
B. Functional Gastroduodenal B. Functional Gastroduodenal
Disorders Disorders
Note major changes in classification for dyspepsia
and nausea and vomiting disorders
B1. Functional Dyspepsia B1. Functional Dyspepsia
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include: in the preceding 12 months of:
. One or more of the following: . Persistent or recurrent symptoms (pain
a. Bothersome postprandial fullness or discomfort centered in the upper
b. Early satiation abdomen);
c. Epigastric pain . No evidence of organic disease (including
d. Epigastric burning at upper endoscopy) that is likely to explain
AND the symptoms; and
. No evidence of structural disease (including . No evidence that dyspepsia is exclusively
at upper endoscopy) that is likely to explain relieved by defecation or associated with the
the symptoms onset of a change in stool frequency or stool
* Criteria fulfilled for the last months with form.
symptom onset at least months prior to
diagnosis B1a. Ulcer-like dyspepsia
Pain centered in the upper abdomen is the
B1a. Postprandial Distress Syndrome predominant (most bothersome) symptom.
Diagnostic criteria*
Must include one or both of the following: B1b. Dysmotility-like dyspepsia
An unpleasant or troublesome nonpainful
. Bothersome postprandial fullness,
sensation (discomfort) centered in the
occurring after ordinary-sized meals, at
upper abdomen is the predominant
least several times per week
symptom; this sensation may be
. Early satiation that prevents finishing a
characterized by or associated with upper
regular meal, at least several times per
abdominal fullness, early satiety, bloating,
week
or nausea.
* Criteria fulfilled for the last months with
symptom onset at least months prior to B1c. Unspecified (nonspecific) dyspepsia
diagnosis Symptomatic patients whose symptoms
Supportive criteria do not fulfill the criteria for ulcer-like or
. Upper abdominal bloating or dysmotility-like dyspepsia.
postprandial nausea or excessive belching
can be present
. Epigastric pain syndrome may coexist
24. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
B1b. Epigastric Pain Syndrome
Diagnostic criteria*
Must include all of the following:
. Pain or burning localized to the
epigastrium of at least moderate severity,
at least once per week
. The pain is intermittent
. Not generalized or localized to other
abdominal or chest regions
. Not relieved by defecation or passage of
flatus
. Not fulfilling criteria for gallbladder and
sphincter of Oddi disorders
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
Supportive criteria
. The pain may be of a burning quality, but
without a retrosternal component
. The pain is commonly induced or
relieved by ingestion of a meal, but may
occur while fasting
. Postprandial distress syndrome may
coexist
25. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
B2. Belching Disorders
B2a. Aerophagia B2. Aerophagia
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: or more in the preceding 12 months of:
. Troublesome repetitive belching at least . Air swallowing that is objectively observed;
several times a week and
. Air swallowing that is objectively . Troublesome repetitive belching.
observed or measured
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
B2b. Unspecified Excessive Belching
Diagnostic criteria*
Must include all of the following:
. Troublesome repetitive belching at least
several times a week
. No evidence that excessive air swallowing
underlies the symptom
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
26. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
B3. Nausea and Vomiting Disorders
B3a. Chronic Idiopathic Nausea
Diagnostic criteria*
Must include all of the following:
. Bothersome nausea occurring at least
several times per week
. Not usually associated with vomiting
. Absence of abnormalities at upper
endoscopy or metabolic disease that
explains the nausea
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
B3b. Functional Vomiting B3. Functional Vomiting
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include all of the following: in the preceding 12 months of:
. On average one or more episodes of . Frequent episodes of vomiting, occurring
vomiting per week on at least three separate days in a week over
. Absence of criteria for an eating disorder, three months;
rumination, or major psychiatric disease . Absence of criteria for an eating disorder,
according to DSM-IV rumination, or major psychiatric disease
. Absence of self-induced vomiting and according to DSM-IV;
chronic cannabinoid use and absence . Absence of self-induced and medication-
of abnormalities in the central nervous induced vomiting; and
system or metabolic diseases to explain . Absence of abnormalities in the gut or
the recurrent vomiting central nervous system, and metabolic
* Criteria fulfilled for the last months with diseases to explain the recurrent vomiting.
symptom onset at least months prior to
diagnosis
27. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
B3c. Cyclic Vomiting Syndrome
Diagnostic criteria
Must include all of the following:
. Stereotypical episodes of vomiting
regarding onset (acute) and duration
(less than one week)
. Three or more discrete episodes in the
prior year
. Absence of nausea and vomiting between
episodes
Supportive criteria
History or family history of migraine
headaches
B4. Rumination Syndrome in Adults A2. Rumination Syndrome
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include both of the following: in the preceding 12 months of:
. Persistent or recurrent regurgitation of . Persistent or recurrent regurgitation of
recently ingested food into the mouth with recently ingested food into the mouth with
subsequent spitting or remastication and subsequent remastication and swallowing;
swallowing . Absence of nausea and vomiting;
. Regurgitation is not preceded by retching . Cessation of the process when the
Supportive criteria regurgitated material becomes acidic; and
. Absence of pathologic gastroesophageal
. Regurgitation events are usually not
reflux, achalasia, or other motility disorder
preceded by nausea
with a recognized pathologic basis as the
. Cessation of the process when the
primary disorder.
regurgitated material becomes acidic
. Regurgitant contains recognizable food
with a pleasant taste
The Rome III criteria classify rumination as a
functional gastroduodenal disorder. In the Rome II
classification, rumination was considered a func-
tional esophageal disorder.
28. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
C. Functional Bowel Disorders C. Functional Bowel Disorders
C1. Irritable Bowel Syndrome C1. Irritable Bowel Syndrome
Diagnostic criterion* At least 12 weeks, which need not be consecutive,
in the preceding 12 months of abdominal discom-
Recurrent abdominal pain or discomfort** at
fort or pain that has two out of three features:
least 3 days/month in last 3 months associated
with two or more of the following: . Relieved with defecation; and/or
. Improvement with defecation . Onset associated with a change in frequency
. Onset associated with a change in frequency of stool; and/or
of stool . Onset associated with a change in form
. Onset associated with a change in form (appearance) of stool.
(appearance) of stool Symptoms that Cumulatively Support the
Diagnosis of Irritable Bowel Syndrome
* Criterion fulfilled for the last months with
symptom onset at least months prior to – Abnormal stool frequency (for research
diagnosis purposes “abnormal” may be defined as
**“Discomfort” means an uncomfortable greater than bowel movements per day
sensation not described as pain. and less than bowel movements per week);
In pathophysiology research and clinical trials, – Abnormal stool form (lumpy/hard or loose/
a pain/discomfort frequency of at least days watery stool);
a week during the screening evaluation is
recommended for subject eligibility. – Abnormal stool passage (straining, urgency,
or feeling of incomplete evacuation);
– Passage of mucus;
– Bloating or feeling of abdominal distension.
C2. Functional Bloating C2. Functional Abdominal Bloating
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
Must include both of the following: in the preceding 12 months of:
. Recurrent feeling of bloating or visible . Feeling of abdominal fullness, bloating, or
distension at least days/month in the last visible distension; and
months . Insufficient criteria for a diagnosis of
. Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel
functional dyspepsia, irritable bowel syndrome, or other functional disorder.
syndrome, or other functional GI disorder
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
29. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
C3. Functional Constipation C3. Functional Constipation
Diagnostic criteria* At least 12 weeks, which need not be consecutive,
in the preceding 12 months of two or more of:
. Must include two or more of the following:
a. Straining during at least % of . Straining > / of defecations;
defecations . Lumpy or hard stools > / of defecations;
b. Lumpy or hard stools in at least % of . Sensation of incomplete evacuation > / of
defecations defecations;
c. Sensation of incomplete evacuation for . Sensation of anorectal obstruction/blockage
at least % of defecations > / of defecations;
d. Sensation of anorectal obstruction/ . Manual maneuvers to facilitate > / of
blockage for at least % of defecations defecations (e.g., digital evacuation, support
e. Manual maneuvers to facilitate at of the pelvic floor); and/or
least % of defecations (e.g., digital . < defecations per week.
evacuation, support of the pelvic floor) Loose stools are not present, and there are
f. Fewer than three defecations per week insufficient criteria for IBS.
. Loose stools are rarely present without the
use of laxatives
. Insufficient criteria for irritable bowel
syndrome
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
C4. Functional Diarrhea C4. Functional Diarrhea
Diagnostic criterion* At least 12 weeks, which need not be consecutive,
in the preceding 12 months of:
Loose (mushy) or watery stools without pain
occurring in at least % of stools . Loose (mushy) or watery stools
* Criterion fulfilled for the last months with . Present > / of the time; and
symptom onset at least months prior to . No abdominal pain.
diagnosis
C.5. Unspecified Functional Bowel C5. Unspecified Functional Bowel
Disorder Disorder
Diagnostic criterion*
Bowel symptoms not attributable to an Bowel symptoms in the absence of organic
organic etiology that do not meet criteria for disease that do not fit into the previously
the previously defined categories defined categories of functional bowel
disorders.
* Criterion fulfilled for the last months with
symptom onset at least months prior to
diagnosis
30. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
D. Functional Abdominal Pain D. Functional Abdominal Pain
Syndrome
D. Functional Abdominal Pain D1. Functional Abdominal
Syndrome Pain Syndrome
Diagnostic criteria* At least 6 months of:
Must include all of the following:
. Continuous or nearly continuous
. Continuous or nearly continuous abdominal pain; and
abdominal pain . No or only occasional relationship of pain
. No or only occasional relationship of pain with physiological events (e.g., eating,
with physiological events (e.g., eating, defecation, or menses); and
defecation, or menses) . Some loss of daily functioning; and
. Some loss of daily functioning . The pain is not feigned (e.g., malingering),
. The pain is not feigned (e.g., malingering) and
. Insufficient symptoms to meet criteria for . Insufficient criteria for other functional
another functional gastrointestinal disorder gastrointestinal disorders that would
that would explain the pain explain the abdominal pain.
* Criteria fulfilled for the last months with
symptom onset at least months prior to
diagnosis
The Rome III Criteria do not include Unspecified D2. Unspecified Functional
Functional Abdominal Pain Abdominal Pain
This is functional abdominal pain that fails to
reach criteria for functional abdominal pain
syndrome.
31. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
E. Functional Gallbladder and E. Functional Disorders of the Biliary
Sphincter of Oddi Disorders Tract and the Pancreas
E. Functional Gallbladder and E1. Gallbladder Dysfunction
Sphincter of Oddi Disorders Episodes of severe steady pain located in the epi-
Diagnostic criteria gastrium and right upper quadrant, and all of the
Must include episodes of pain located in the following:
epigastrium and/or right upper quadrant
. Symptom episodes last minutes or more,
and all of the following:
with pain-free intervals;
. Episodes lasting minutes or longer . Symptoms have occurred on one or more
. Recurrent symptoms occurring at different occasions in the previous months;
intervals (not daily) . The pain is steady and interrupts daily
. The pain builds up to a steady level activities or requires consultation with a
. The pain is moderate to severe enough to physician;
interrupt the patient’s daily activities or lead . There is no evidence of structural
to an emergency department visit abnormalities to explain the symptoms;
. The pain is not relieved by bowel . There is abnormal gallbladder functioning
movements with regard to emptying.
. The pain is not relieved by postural change
. The pain is not relieved by antacids E2. Sphincter of Oddi Dysfunction
. Exclusion of other structural disease that Episodes of severe steady pain located in the epi-
would explain the symptoms gastrium and right upper quadrant, and all of the
Supportive criteria following:
The pain may present with one or more of the . Symptom episodes last minutes or more,
following: with pain-free intervals; and
. Associated with nausea and vomiting . Symptoms have occurred on one or more
. Radiates to the back and/or right infra occasions in the previous months; and
subscapular region . The pain is steady and interrupts daily
. Awakens from sleep in the middle of the activities or requires consultation with a
night physician; and
. There is no evidence of structural
E1. Functional Gallbladder Disorder
abnormalities to explain the symptoms.
Diagnostic criteria
Must include all of the following:
. Criteria for functional gallbladder and
sphincter of Oddi disorder and
. Gallbladder is present
. Normal liver enzymes, conjugated
bilirubin, and amylase/lipase
32. ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
E2. Functional Biliary Sphincter of Oddi
Disorder
Diagnostic criteria
Must include both of the following:
. Criteria for functional sphincter of Oddi
disorder
. Normal amylase/lipase
Supportive criterion
Elevated serum transaminases, alkaline
phosphatase, or conjugated bilirubin
temporarily related to at least two pain
episodes
E3. Functional Pancreatic Sphincter of
Oddi Disorder
Diagnostic criteria
Must include both of the following:
. Criteria for functional gallbladder and
sphincter of Oddi Disorder and
. Elevated amylase/lipase