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Title: Anti-TNF-{alpha} treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial
Authors: Koninckx, Philippe ×
Craessaerts, M
Timmerman, Dirk
Cornillie, F
Kennedy, S #
Issue Date: Sep-2008
Publisher: Published for the European Society of Human Reproduction and Embryology by IRL Press
Series Title: Human Reproduction vol:23 issue:9 pages:2017-2023
Abstract: 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.
URI: 
ISSN: 0268-1161
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gynaecological Imaging Section (-)
Basic Research in Gynaecology Section (-)
× corresponding author
# (joint) last author

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