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

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis. METHODS: Women 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. RESULTS: A 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). CONCLUSION: Raloxifene 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 REGISTRATION: ClinicalTrials.gov, www.cliicaltrials.gov, NCT00001848

Original languageEnglish (US)
Pages (from-to)88-96
Number of pages9
JournalObstetrics and Gynecology
Volume111
Issue number1
DOIs
StatePublished - Jan 2008
Externally publishedYes

Fingerprint

Pelvic Pain
Endometriosis
Chronic Pain
Randomized Controlled Trials
Pain
Menstrual Cycle
Biopsy
Laparoscopy
Therapeutics
Clinical Trials Data Monitoring Committees
Placebos
Raloxifene Hydrochloride
Bone Density
Quality of Life
Clinical Trials
Safety
Recurrence
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Return of chronic pelvic pain from endometriosis after raloxifene treatment : A randomized controlled trial. / Stratton, Pamela; Sinaii, Ninet; Segars, James; Koziol, Deloris; Wesley, Robert; Zimmer, Carolyn; Winkel, Craig; Nieman, Lynnette K.

In: Obstetrics and Gynecology, Vol. 111, No. 1, 01.2008, p. 88-96.

Research output: Contribution to journalArticle

Stratton, Pamela ; Sinaii, Ninet ; Segars, James ; Koziol, Deloris ; Wesley, Robert ; Zimmer, Carolyn ; Winkel, Craig ; Nieman, Lynnette K. / Return of chronic pelvic pain from endometriosis after raloxifene treatment : A randomized controlled trial. In: Obstetrics and Gynecology. 2008 ; Vol. 111, No. 1. pp. 88-96.
@article{3377e9294d8a4b5fa919668fdca49e71,
title = "Return of chronic pelvic pain from endometriosis after raloxifene treatment: A randomized controlled trial",
abstract = "OBJECTIVE: To evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis. METHODS: Women 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. RESULTS: A 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). CONCLUSION: Raloxifene 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 REGISTRATION: ClinicalTrials.gov, www.cliicaltrials.gov, NCT00001848",
author = "Pamela Stratton and Ninet Sinaii and James Segars and Deloris Koziol and Robert Wesley and Carolyn Zimmer and Craig Winkel and Nieman, {Lynnette K.}",
year = "2008",
month = "1",
doi = "10.1097/01.AOG.0000297307.35024.b5",
language = "English (US)",
volume = "111",
pages = "88--96",
journal = "Obstetrics and Gynecology",
issn = "0029-7844",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Return of chronic pelvic pain from endometriosis after raloxifene treatment

T2 - A randomized controlled trial

AU - Stratton, Pamela

AU - Sinaii, Ninet

AU - Segars, James

AU - Koziol, Deloris

AU - Wesley, Robert

AU - Zimmer, Carolyn

AU - Winkel, Craig

AU - Nieman, Lynnette K.

PY - 2008/1

Y1 - 2008/1

N2 - OBJECTIVE: To evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis. METHODS: Women 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. RESULTS: A 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). CONCLUSION: Raloxifene 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 REGISTRATION: ClinicalTrials.gov, www.cliicaltrials.gov, NCT00001848

AB - OBJECTIVE: To evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis. METHODS: Women 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. RESULTS: A 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). CONCLUSION: Raloxifene 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 REGISTRATION: ClinicalTrials.gov, www.cliicaltrials.gov, NCT00001848

UR - http://www.scopus.com/inward/record.url?scp=37549056548&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=37549056548&partnerID=8YFLogxK

U2 - 10.1097/01.AOG.0000297307.35024.b5

DO - 10.1097/01.AOG.0000297307.35024.b5

M3 - Article

VL - 111

SP - 88

EP - 96

JO - Obstetrics and Gynecology

JF - Obstetrics and Gynecology

SN - 0029-7844

IS - 1

ER -