An Overview and Comprehensive Analysis of Interdisciplinary Clinical Research in Endometriosis Based on Trial Registry

Overview

Journal iScience

Publisher Cell Press

Date 2024 Mar 8

PMID 38455973

Authors

Yicong Xu

Zhengrong Deng

Fan Fei

Shengtao Zhou

Affiliations

Soon will be listed here.

Abstract

Endometriosis is a chronic multisystem disease associated with immunological, genetic, hormonal, psychological, and neuroscientific factors, leading to a significant socioeconomic impact worldwide. Though multidisciplinary management is the ideal approach, there remains a scarcity of published interdisciplinary clinical trials at present. Here, we have conducted a comprehensive analysis of the characteristics and issues of interdisciplinary trials on endometriosis based on the clinical registration database ClinicalTrials.gov. Among all 387 endometriosis trials, 30% (116) were identified as interdisciplinary, mostly conducted in Europe and North America, and fully funded by non-industrial sources. We documented growth in both patient-centered multidisciplinary comprehensive management and collaboration between fundamental biomedical science and applied medicine. However, compared to traditional obstetric-gynecological trials, interdisciplinary studies exhibited negative characteristics such as less likely to be randomized and less likely to report results. Our study provides insights for future trial investigators and may contribute to fostering greater collaboration in medical research.

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References

Farland L, Prescott J, Sasamoto N, Tobias D, Gaskins A, Stuart J . Endometriosis and Risk of Adverse Pregnancy Outcomes. Obstet Gynecol. 2019; 134(3):527-536. PMC: 6922084. DOI: 10.1097/AOG.0000000000003410. View

Roux F, Burns S, Chih H, Hendriks J . Developing and trialling a school-based ovulatory-menstrual health literacy programme for adolescent girls: a quasi-experimental mixed-method protocol. BMJ Open. 2019; 9(3):e023582. PMC: 6528013. DOI: 10.1136/bmjopen-2018-023582. View

Bungum H, Vestergaard C, Breth Knudsen U . Endometriosis and type 1 allergies/immediate type hypersensitivity: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2014; 179:209-15. DOI: 10.1016/j.ejogrb.2014.04.025. View

Gou Y, Li X, Li P, Zhang H, Xu T, Wang H . Estrogen receptor β upregulates CCL2 via NF-κB signaling in endometriotic stromal cells and recruits macrophages to promote the pathogenesis of endometriosis. Hum Reprod. 2019; 34(4):646-658. DOI: 10.1093/humrep/dez019. View

Rahmioglu N, Mortlock S, Ghiasi M, Moller P, Stefansdottir L, Galarneau G . The genetic basis of endometriosis and comorbidity with other pain and inflammatory conditions. Nat Genet. 2023; 55(3):423-436. PMC: 10042257. DOI: 10.1038/s41588-023-01323-z. View

Armour M, Al-Dabbas M, Ee C, Smith C, Ussher J, Arentz S . The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial. Trials. 2021; 22(1):299. PMC: 8058744. DOI: 10.1186/s13063-021-05265-x. View

Li P, Peng X, Niu X, Xu L, Ng E, Wang C . Efficacy of acupuncture for endometriosis-associated pain: a multicenter randomized single-blind placebo-controlled trial. Fertil Steril. 2023; 119(5):815-823. DOI: 10.1016/j.fertnstert.2023.01.034. View

Duffy J, Hirsch M, Vercoe M, Abbott J, Barker C, Collura B . A core outcome set for future endometriosis research: an international consensus development study. BJOG. 2020; 127(8):967-974. DOI: 10.1111/1471-0528.16157. View

Sasamoto N, Ngo L, Vitonis A, Dillon S, Missmer S, Libermann T . Circulating proteomic profiles associated with endometriosis in adolescents and young adults. Hum Reprod. 2022; 37(9):2042-2053. PMC: 9801982. DOI: 10.1093/humrep/deac146. View

10.

Hirsch M, Duffy J, Kusznir J, Davis C, Plana M, Khan K . Variation in outcome reporting in endometriosis trials: a systematic review. Am J Obstet Gynecol. 2016; 214(4):452-464. DOI: 10.1016/j.ajog.2015.12.039. View

11.

Poeta do Couto C, Policiano C, Pinto F, Brito D, Caldeira D . Endometriosis and cardiovascular disease: A systematic review and meta-analysis. Maturitas. 2023; 171:45-52. DOI: 10.1016/j.maturitas.2023.04.001. View

12.

Harada T, Osuga Y, Suzuki Y, Fujisawa M, Fukui M, Kitawaki J . Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study. Fertil Steril. 2021; 117(3):583-592. DOI: 10.1016/j.fertnstert.2021.11.013. View

13.

Pasquini B, Seravalli V, Vannuccini S, La Torre F, Geppetti P, Iannone L . Endometriosis and the diagnosis of different forms of migraine: an association with dysmenorrhoea. Reprod Biomed Online. 2023; 47(1):71-76. DOI: 10.1016/j.rbmo.2023.03.020. View

14.

Peipert B, Spinosa D, Howell E, Weber J, Truong T, Harris B . Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database. Fertil Steril. 2021; 116(5):1381-1390. DOI: 10.1016/j.fertnstert.2021.06.013. View

15.

Zondervan K, Becker C, Koga K, Missmer S, Taylor R, Vigano P . Endometriosis. Nat Rev Dis Primers. 2018; 4(1):9. DOI: 10.1038/s41572-018-0008-5. View

16.

Kvaskoff M, Mahamat-Saleh Y, Farland L, Shigesi N, Terry K, Harris H . Endometriosis and cancer: a systematic review and meta-analysis. Hum Reprod Update. 2020; 27(2):393-420. DOI: 10.1093/humupd/dmaa045. View

17.

Tapmeier T, Rahmioglu N, Lin J, De Leo B, Obendorf M, Raveendran M . Neuropeptide S receptor 1 is a nonhormonal treatment target in endometriosis. Sci Transl Med. 2021; 13(608). DOI: 10.1126/scitranslmed.abd6469. View

18.

Zarin D, Tse T, Williams R, Califf R, Ide N . The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011; 364(9):852-60. PMC: 3066456. DOI: 10.1056/NEJMsa1012065. View

19.

Harris H, Costenbader K, Mu F, Kvaskoff M, Malspeis S, Karlson E . Endometriosis and the risks of systemic lupus erythematosus and rheumatoid arthritis in the Nurses' Health Study II. Ann Rheum Dis. 2015; 75(7):1279-84. PMC: 4740245. DOI: 10.1136/annrheumdis-2015-207704. View

20.

Salmeri N, Li Piani L, Cavoretto P, Somigliana E, Vigano P, Candiani M . Endometriosis increases the risk of gestational diabetes: a meta-analysis stratified by mode of conception, disease localization and severity. Sci Rep. 2023; 13(1):8099. PMC: 10199077. DOI: 10.1038/s41598-023-35236-y. View