Intervention Review

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Anti-TNF-α treatment for pelvic pain associated with endometriosis

  1. DongHao Lu1,
  2. Huan Song1,
  3. Gang Shi2,*

Editorial Group: Cochrane Gynaecology and Fertility Group

Published Online: 28 MAR 2013

Assessed as up-to-date: 3 SEP 2012

DOI: 10.1002/14651858.CD008088.pub3


How to Cite

Lu D, Song H, Shi G. Anti-TNF-α treatment for pelvic pain associated with endometriosis. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD008088. DOI: 10.1002/14651858.CD008088.pub3.

Author Information

  1. 1

    Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, Stockholm, Sweden

  2. 2

    West China Second University Hospital, Sichuan University, Department of Obstetrics and Gynecology, Chengdu, Sichuan, China

*Gang Shi, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, No. 20, 3rd Section of Ren Min Nan Road, Chengdu, Sichuan, 610041, China. dr.gangshi@gmail.com. gang-shi@163.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 28 MAR 2013

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Characteristics of included studies [ordered by study ID]
Koninckx 2008

MethodsRCT duration 40 weeks, single centre, 21 participants


Participants21 enrolled: active = 14, placebo = 7

Evaluated: active = 13, placebo = 7

Age (years): active 28.4 ± 4.5, placebo 30.7 ± 5.5

Weight (kg): active 62.5 ± 7.4, placebo 52.7 ± 5.4

Diameters of nodules (mm): active 15.2 ± 4.6, placebo 13.6 ± 3.2

Diagnosis: endometriosis with severe pelvic pain

Inclusion criteria: 20 to 45 years olds with a deep endometriosis nodule of at least 1 cm in diameter, severe pain (at least 1 severe pain score on Biberoglu-Behrman scale), no previous surgery for deep endometriosis, no hormonal medication for at least 3 months prior to enrolment in the study

Exclusion criteria: evidence of infection in the previous 3 months, previous transplant surgery, previous anti-TNF-α treatment


InterventionsActive group: infliximab (5 mg/kg) administered as infusion at weeks 0, 2, and 6. Surgery was performed 3 months later and follow-up continued for a further 6 months

Placebo group: placebo was administered as infusion at weeks 0, 2, and 6. Surgery was performed 3 months later and follow-up continued for a further 6 months


Outcomes1. Reduction of pain based on VAS and Biberoglu-Behrman scale

2. Intake of pain killers

3. Improvement of endometriotic lesions


NotesBelgium
Katholieke Universiteit Leuven
Drug company: Centocor BV


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation

Allocation concealment (selection bias)Low riskSealed envelopes were prepared and opened consecutively by the pharmacist prior to the preparation of the intervention

Blinding (performance bias and detection bias)
All outcomes
Low riskDouble-blind

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo ITT

Selective reporting (reporting bias)Low riskConsistent with protocol

Other biasUnclear riskFunded by the manufacturer

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Lian 2009No evidence that this Chinese herbal medicine, Quyu Jiedu granule, is a specific anti-TNF-α drug

 
Comparison 1. Infliximab versus placebo

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Relief of pelvic pain1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    1.1 BB score by clinician (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)-0.14 [-0.39, 0.11]

    1.2 BB score by participants (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)-0.14 [-0.43, 0.15]

    1.3 VAS (100 mm scale)
121Mean Difference (IV, Fixed, 95% CI)-5.60 [-16.10, 4.90]

    1.4 Use of pain killers (ibuprofen, g/day)
121Mean Difference (IV, Fixed, 95% CI)-0.10 [-0.30, 0.10]

 2 Adverse events1Risk Ratio (IV, Random, 95% CI)Subtotals only

 3 Improvement in endometriotic lesions1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    3.1 Diameter of retrovaginal nodule by transvaginal ultrasound (mm)
120Mean Difference (IV, Fixed, 95% CI)1.90 [-1.63, 5.43]

 4 Improvement of endometriosis-related symptoms - dysmenorrhoea1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    4.1 Dysmenorrhoea: BB score by clinician (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)0.21 [0.03, 0.39]

    4.2 Dysmenorrhoea: BB score by participants (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)-0.20 [-0.55, 0.15]

    4.3 Dysmenorrhoea: VAS by participants (100 mm scale)
121Mean Difference (IV, Fixed, 95% CI)22.88 [12.18, 33.58]

 5 Improvement of endometriosis-related symptoms - dyspareunia142Mean Difference (IV, Fixed, 95% CI)-0.24 [-0.46, -0.01]

    5.1 Dyspareunia: BB score by clinician (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)-0.14 [-0.41, 0.13]

    5.2 Dyspareunia: BB score by participants (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)-0.44 [-0.84, -0.04]

 6 Improvement of endometriosis-related symptoms - pelvic tenderness1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    6.1 Pelvic tenderness: BB score by clinician (0 to 3 scale)
121Mean Difference (IV, Fixed, 95% CI)0.07 [-0.20, 0.34]