Anti-TNF-alpha treatment for deep endometriosis-associated pain: a randomized placebo-controlled trial

P R Koninckx, M Craessaerts, D Timmerman, F Cornillie, S Kennedy, P R Koninckx, M Craessaerts, D Timmerman, F Cornillie, S Kennedy

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.

Figures

Figure 1:
Figure 1:
Dysmenorrhea, deep dyspareunia and chronic pelvic pain, as assessed by the clinician (upper graphs) and by the patient in her diary, before treatment, during the 12 week treatment period (shaded area) and after surgery. Baseline versus early treatment: NS, baseline versus late treatment: >0.003 for all. Baseline and late treatment versus post-surgery: P < 0.001 for all. Infliximab: NS for all.
Figure 2:
Figure 2:
Induration, pelvic tenderness and total Biberoglu–Behrman score together with VAS scales as recorded at each visit and weekly by the patient in her diary, before treatment, during the 12 week treatment period (shaded area) and after surgery. Baseline versus early treatment, NS; baseline versus late treatment, >0.003 for all except NS for VAS dysmenorrhea. Baseline and late treatment versus post-surgery: P < 0.001 for all. Infliximab: NS for all.
Figure 3:
Figure 3:
Ibuprofen intake and total pain calculated from the patient dairy.

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