Evidence map›Paper›PMID 18165396›Full record

Trial reportObstetrics and gynecology2008

Return of chronic pelvic pain from endometriosis after raloxifene treatment: a randomized controlled trial.

Pamela Stratton, Ninet Sinaii, James Segars, Deloris Koziol, Robert Wesley, Carolyn Zimmer, Craig Winkel, Lynnette K Nieman

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
11.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00001848 phase2completednot on this map

The Safety and Effectiveness of Surgery With or Without Raloxifene (Evista (Trademark), Lilly) for the Treatment of Pelvic Pain Caused by Endometriosis

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran1998 to 2006Enrolled612ConditionsEndometriosis, Pelvic PainArmsRaloxifene
NCT03991520 early_phase1unknown statusnot on this mapstarted 2020, after this paper: background citation

Pilot Study of the IL-1 Antagonist Anakinra for the Treatment of Endometriosis Related Symptoms

TypeinterventionalSponsorUniversity of California, San DiegoRan2020 to 2022Enrolled20ConditionsEndometriosis, Anakinra, Markers of InflammationArmsAnakinra 100Mg/0.67Ml Inj Syringe, Placebo
NCT05175248 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis

TypeinterventionalSponsorPhysicians Committee for Responsible MedicineRan2022 to 2029Enrolled120ConditionsEndometriosisArmsPlant-based Intervention Group
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
  2. Selective oestrogen receptor modulators (SERMs) for endometriosis.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Hormonal treatments for endometriosis: The endocrine background.Reviews in endocrine & metabolic disorders · 2022
    Review
  14. Review
  15. Estrogen Receptors and Endometriosis.International journal of molecular sciences · 2020
    Review
  16. Review
  17. Molecular Targets for Endometriosis Therapy: Where We Are and Where We Are Going?International journal of fertility & sterility · 2019
    Article
  18. Endometriosis and nuclear receptors.Human reproduction update · 2019
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Pamela StrattonReproductive Biology and Medicine Branch, National Institutes of Health, Bethesda, Maryland, USA. ps79c@nih.gov
Ninet Sinaii
James Segars
Deloris Koziol
Robert Wesley
Carolyn Zimmer
Craig Winkel
Lynnette K Nieman
National Institutes of Health Clinical Center · USGeorgetown University · US

Funding

Reproductive Endocrinology And Infertility Clinical Training ProgramZIAHD008737 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI SEGARS, JAMES H. · 2009 to 2010
$3.2M
Reproductive Endocrinology And Infertility TrainingZ01HD008737 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI SEGARS, JAMES H. · 2001 to 2008
$2.7M
Neural Immune and Genetic Influences on Chronic Pelvic Pain and EndometriosisZIAHD008769 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI STRATTON, PAMELA · 2009 to 2016
$2.1M
Treatment Of EndometriosisZ01HD008728 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI STRATTON, PAMELA · 2001 to 2008
$559k
Intramural NIH HHS Z01 HD008737
6 · The paper itself

Abstract

objectiveTo evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis.

methodsWomen with chronic pelvic pain and no endometriosis treatment for 6 months underwent laparoscopy for excision of all lesions. Those with biopsy-proven endometriosis were randomly allocated to raloxifene (180 mg) or placebo daily. A second laparoscopy was performed at 2 years, or earlier, if pain returned. Return of pain was defined as 2 months of pain equal to or more severe than that at study entry. Menstrual cycles and adverse events were recorded. The log rank test was used to compare the time to return of pain by drug group. Analyses were done as intent-to-treat.

resultsA total of 127 of 158 women underwent surgery. Of these, 93 had biopsy-confirmed endometriosis and were randomly assigned to study treatment. Menstrual cycle length, pelvic pain severity, quality of life, bone mineral density, and adverse events did not differ between treatment groups. The Data Safety Monitoring Committee terminated the study early when the raloxifene group experienced pain (P=.03) and had second surgery (P=.016) significantly sooner than the placebo group. Interestingly, biopsy-proven endometriosis was not associated with return of pain (P=.6).

conclusionRaloxifene significantly shortened the time to return of chronic pelvic pain. Because recurrence of endometriosis lesions did not correlate with return of pain, other factors are implicated in pelvic pain. CLINICAL

trial registrationClinicalTrials.gov, www.cliicaltrials.gov, NCT00001848 LEVEL OF EVIDENCE: I.

Indexed as

AdultChronic DiseaseEndometriosisFemaleHumansLaparoscopyPelvic PainQuality of LifeRaloxifene HydrochlorideRecurrenceSelective Estrogen Receptor ModulatorsTreatment OutcomeRaloxifene HydrochlorideSelective Estrogen Receptor Modulators

Identifiers

PMID18165396
PMCPMC2755201
OpenAlexW2003063828

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.