Anti-TNF-α treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial
BACKGROUND Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF-α 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 observ...
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Veröffentlicht in: | Human reproduction (Oxford) 2008-09, Vol.23 (9), p.2017-2023 |
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Sprache: | eng |
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Zusammenfassung: | BACKGROUND Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF-α 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. |
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ISSN: | 0268-1161 1460-2350 |
DOI: | 10.1093/humrep/den177 |