Anti-TNF-α drugs for women with endometriosis-related pelvic pain

Lu D, Song H, Shi G

Published Online:

November 10, 2010

Endometriosis is a painful condition in which endometrial tissue grows outside the uterus. It potentially affects a woman's ability to conceive. Recent studies support the contributing role of inflammation in endometriosis-related pain. Since anti-TNF-α drugs can inhibit the inflammation process, they may relieve the symptoms of the disease without inhibiting ovulation. However, this systematic review included one randomised controlled trial and found that there was not enough evidence from which to draw conclusions about the effectiveness and safety of anti-TNF-α drugs in relieving pain in women with endometriosis. There was no evidence of an increase in adverse events in the anti-TNF-α drugs group compared with the placebo group.

Abstract (click to read)

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-α (anti-TNF-α) 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-α 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 I2 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-α 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-α drugs using economic evaluations and the odds of recurrence.

Authors' conclusions:

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

This record should be cited as:

Lu D, Song H, Shi G. Anti-TNF-α treatment for pelvic pain associated with endometriosis. Cochrane Database of Systematic Reviews 2010, Issue 3. Art. No.: CD008088. DOI: 10.1002/14651858.CD008088.pub2

Assessed as up to date:

August 10, 2009

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Primary Review Group:

Menstrual Disorders and Subfertility Group

Health topics:

Gynaecology > Pelvic pain > Endometriosis

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Anti-TNF-α drugs for women with endometriosis-related pelvic pain

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