Anti-TNF- treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial
Identifieur interne : 001350 ( Main/Exploration ); précédent : 001349; suivant : 001351Anti-TNF- treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial
Auteurs : P. R. Koninckx [Belgique, Royaume-Uni] ; M. Craessaerts [Belgique] ; D. Timmerman [Belgique] ; F. Cornillie [Pays-Bas] ; S. Kennedy [Royaume-Uni]Source :
- Human Reproduction [ 0268-1161 ] ; 2008-09.
Abstract
BACKGROUND Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF- 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.
Url:
DOI: 10.1093/humrep/den177
Affiliations:
- Belgique, Pays-Bas, Royaume-Uni
- Angleterre, Hollande-Méridionale, Oxfordshire
- Leyde, Oxford
- Université d'Oxford
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<front><div type="abstract">BACKGROUND Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF- 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.</div>
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