James L Nodler1,2, Amy D DiVasta3,4,5, Allison F Vitonis2,3, Sarah Karevicius3, Maggie Malsch6, Vishnudas Sarda4, Ayotunde Fadayomi2,3, Holly R Harris7,8, Stacey A Missmer3,4,9,10. 1. Department of Obstetrics and Gynecology, Colorado Center for Reproductive Medicine-Houston, Houston, TX, USA. 2. Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. 3. Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA. 4. Division of Adolescent and Young Adult Medicine, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA. 5. Division of Gynecology, Department of Surgery, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA. 6. Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA, USA. 7. Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. 8. Department of Epidemiology, University of Washington, Seattle, WA, USA. 9. Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. 10. Department of Obstetrics, Gynecology, and Reproductive Biology, College of Human Medicine, Michigan State University, Grand Rapids, MI, USA.
Abstract
BACKGROUND:Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects of vitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents. OBJECTIVES: We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis. METHODS:Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo. RESULTS:A total of 147 women were screened and 69 were randomly assigned as follows: 27 tovitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P = 0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P = 0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P = 0.39]. Neither of the intervention arms were statistically different from placebo. CONCLUSIONS: In young women with endometriosis, supplementation withvitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.
RCT Entities:
BACKGROUND: Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects of vitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents. OBJECTIVES: We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis. METHODS:Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo. RESULTS: A total of 147 women were screened and 69 were randomly assigned as follows: 27 to vitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P = 0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P = 0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P = 0.39]. Neither of the intervention arms were statistically different from placebo. CONCLUSIONS: In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.
Authors: Holly R Harris; Jorge E Chavarro; Susan Malspeis; Walter C Willett; Stacey A Missmer Journal: Am J Epidemiol Date: 2013-02-03 Impact factor: 4.897
Authors: Stacey A Missmer; Susan E Hankinson; Donna Spiegelman; Robert L Barbieri; Lynn M Marshall; David J Hunter Journal: Am J Epidemiol Date: 2004-10-15 Impact factor: 4.897
Authors: Allison F Vitonis; Katy Vincent; Nilufer Rahmioglu; Amelie Fassbender; Germaine M Buck Louis; Lone Hummelshoj; Linda C Giudice; Pamela Stratton; G David Adamson; Christian M Becker; Krina T Zondervan; Stacey A Missmer Journal: Fertil Steril Date: 2014-09-22 Impact factor: 7.329