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Hum. Reprod. Advance Access originally published online on June 12, 2008
Human Reproduction 2008 23(9):2017-2023; doi:10.1093/humrep/den177
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© The Author 2008. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
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Anti-TNF-{alpha} treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial

P.R. Koninckx1,2,4, M. Craessaerts1, D. Timmerman1, F. Cornillie3 and S. Kennedy2

1 Department of Obstetrics and Gynaecology, UZ Gasthuisberg, Katholieke Universiteit Leuven, B3000 Leuven, Belgium 2 Nuffield Department of Obstetrics and Gynaecology, John Radcliffe Hospital, University of Oxford, Oxford, UK 3 Centocor BV, Medical Affairs Europe, Leiden, The Netherlands

4 Correspondence address. E-mail: pkoninckx{at}gmail.com

BACKGROUND: Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF-{alpha} monoclonal antibody, might relieve pain.

METHODS: A randomized placebo-controlled trial was designed with 21 women with severe pain and a rectovaginal nodule of at least 1 cm. After 1 month of observation, three infusions of infliximab (5 mg/kg) or placebo were given. Surgery was performed 3 months later and follow-up continued for 6 months. The primary end-point was pain (dysmenorrhea, deep dyspareunia and non-menstrual pain) rated at each visit by the clinician and on a daily basis by the patient who in addition scored pain by visual analog pain scale and analgesia intake. Secondary end-points included the volume of the endometriotic nodule, pelvic tenderness and the visual appearance of endometriotic lesions at laparoscopy.

RESULTS: Pain severity decreased during the treatment by 30% in both the placebo (P < 0.001) and infliximab groups (P < 0.001). However, no effect of infliximab was observed for any of the outcome measures. After surgery, pain scores decreased in both groups to less than 20% of the initial value.

CONCLUSIONS: Infliximab appears not to affect pain associated with deep endometriosis. Treatment is associated with an important placebo effect. After surgery, pain decreases to less than 20%. Trials registration number ClinicalTrials.gov: NCT00604864 [ClinicalTrials.gov] .

Submitted on January 18, 2008; resubmitted on March 15, 2008; accepted on April 11, 2008.


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