Anti-TNF-alpha treatment for pelvic pain associated with endometriosis.

BACKGROUND: Endometriosis is a chronic, recurring condition that can develop during the reproductive years. It is characterized by the development of endometrial tissue outside the uterine cavity. It is the most common cause of pelvic pain in women. This endometrial tissue development is dependent on estrogen produced primarily by the ovaries and, therefore, traditional management has focused on suppression of ovarian function. The mounting evidence shows that altered immune function plays a crucial role in the genesis and development of endometriosis. In this review we considered modulating the inflammation as an alternative approach.

OBJECTIVES: To determine the effectiveness and safety of anti-tumour necrosis factor-alpha (anti-TNF-alpha) drugs in the management of pelvic pain associated with endometriosis.

SEARCH STRATEGY: We searched for trials in the following databases (from their inception to August 2009): Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL, and PsycINFO. In addition, all reference lists of included trials were searched and experts in the field were contacted in an attempt to locate trials.

SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing anti-TNF-alpha drugs with placebo, no treatment, medical treatment, or surgery for pelvic pain associated with endometriosis were included.

DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data using data extraction forms. The domains assessed for risk of bias were sequence generation, allocation concealment, blinding, incomplete outcome data, and selective outcome reporting. Risk ratios (RR) were used for reporting dichotomous data with 95% confidence intervals (CI), whilst mean differences (MD) were expressed for continuous data. Statistical heterogeneity was assessed using the I(2) statistic.

MAIN RESULTS: Only one trial involving 21 participants was included. Results showed no evidence of an effect of infliximab, one of the known anti-TNF-alpha drugs, on pain reduction using the Biberoglu-Behrman (BB) score for patients (MD -0.15, 95% CI -0.51 to 0.21), the BB score for clinicians (MD -0.15, 95% CI -0.45 to 0.15), the visual analogue pain score (VAS) (MD 11.30, 95% CI -3.00 to 25.60) and the use of pain killers (MD -0.10, 95% CI -0.60 to 0.40). There was no evidence of an increase in adverse events in the infliximab group compared with placebo (RR 3.73, 95% CI 0.22 to 63.66). No evidence of clinical benefits of infliximab was found for endometriotic lesions, dysmenorrhoea, dyspareunia or pelvic tenderness. No trial reported the effects of anti-TNF-alpha drugs using economic evaluations and the odds of recurrence.

AUTHORS' CONCLUSIONS: There is no enough evidence to support the use of anti-TNF-alpha drugs in the management of women with endometriosis for the relief of pelvic pain.