#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

A two-arm parallel double-blind randomised controlled pilot trial of the efficacy of Omega-3 polyunsaturated fatty acids for the treatment of women with endometriosis-associated pain (PurFECT1)


Autoři: Ibtisam M. Abokhrais aff001;  Fiona C. Denison aff001;  Lucy H. R. Whitaker aff001;  Philippa T. K. Saunders aff002;  Ann Doust aff001;  Linda J. Williams aff003;  Andrew W. Horne aff001
Působiště autorů: MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom aff001;  Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom aff002;  Usher Institute, University of Edinburgh, Edinburgh, United Kingdom aff003
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0227695

Souhrn

Background

Endometriosis is defined by the presence of endometrial-like tissue (lesions) outside the uterus, commonly on the pelvic peritoneum. It affects 6–10% of women and is associated with debilitating pelvic pain. Current management options are often unsatisfactory. Omega-3 polyunsaturated fatty acids (O-PUFA) have the potential to reduce the painful symptoms associated with endometriosis, reduce lesion size, preserve the patient’s ability to conceive, and have minimal side effects. We performed a two-arm, parallel double-blinded randomised controlled trial to inform the planning of a future multicentre randomised controlled trial to evaluate the efficacy of O-PUFA for endometriosis-associated pain.

Objectives

The primary objectives of the trial were to assess recruitment and retention rates. The secondary objectives were to determine the acceptability to women of the proposed methods of recruitment, randomisation, treatments and questionnaires, to estimate the variability in the proposed primary endpoints to inform the sample size calculation and to refine the research methodology for the future definitive trial.

Methods

We recruited women with endometriosis from June 2016 to June 2017 and randomised them to eight weeks of treatment with O-PUFA or olive oil. Pain scores and quality of life questionnaires were collected at baseline and eight weeks. We calculated the proportion of eligible women randomised, and of randomised participants who were followed up to eight weeks. Acceptability questionnaires were used to evaluate women’s experiences of the trial.

Results

The proportion of eligible participants who were randomised was 45.2% (33/73) and 81.8% (27/33) completed the study. The majority of participants described their overall trial experience favourably and there were no adverse events in either group.

Conclusion

Our pilot trial supports the feasibility of a future larger trial to definitively evaluate the efficacy of O-PUFA for endometriosis-associated pain.

Trial registration

The trial was registered on the ISRCTN registry (registration number ISRCTN44202346).

Klíčová slova:

Adverse events – Contraceptives – Drug therapy – Lesions – Olives – Questionnaires – Randomized controlled trials – Vegetable oils


Zdroje

1. Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010;362(25):2389–98. doi: 10.1056/NEJMcp1000274 20573927

2. Hickey M, Ballard K, Farquhar C. Endometriosis. BMJ. 2014;348:g1752. doi: 10.1136/bmj.g1752 24647161

3. Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, et al. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014;29(3):400–12. doi: 10.1093/humrep/det457 24435778

4. Kuznetsov L, Dworzynski K, Davies M, Overton C. Diagnosis and management of endometriosis: summary of NICE guidance. Bmj. 2017;358:j3935. doi: 10.1136/bmj.j3935 28877898

5. Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009;15(4):441–61. doi: 10.1093/humupd/dmp007 19279046

6. Brown J, Farquhar C. Endometriosis: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2014(3):Cd009590. doi: 10.1002/14651858.CD009590.pub2 24610050

7. Calder PC. Marine omega-3 fatty acids and inflammatory processes: Effects, mechanisms and clinical relevance. Biochim Biophys Acta. 2015;1851(4):469–84. doi: 10.1016/j.bbalip.2014.08.010 25149823

8. Wang C, Harris WS, Chung M, Lichtenstein AH, Balk EM, Kupelnick B, et al. n-3 Fatty acids from fish or fish-oil supplements, but not alpha-linolenic acid, benefit cardiovascular disease outcomes in primary- and secondary-prevention studies: a systematic review. Am J Clin Nutr. 2006;84(1):5–17. doi: 10.1093/ajcn/84.1.5 16825676

9. Lousse JC, Defrere S, Colette S, Van Langendonckt A, Donnez J. Expression of eicosanoid biosynthetic and catabolic enzymes in peritoneal endometriosis. Hum Reprod. 2010;25(3):734–41. doi: 10.1093/humrep/dep408 20023295

10. Hino A, Adachi H, Toyomasu K, Yoshida N, Enomoto M, Hiratsuka A, et al. Very long chain N-3 fatty acids intake and carotid atherosclerosis: an epidemiological study evaluated by ultrasonography. Atherosclerosis. 2004;176(1):145–9. doi: 10.1016/j.atherosclerosis.2004.04.020 15306187

11. Gazvani MR, Smith L, Haggarty P, Fowler PA, Templeton A. High omega-3:omega-6 fatty acid ratios in culture medium reduce endometrial-cell survival in combined endometrial gland and stromal cell cultures from women with and without endometriosis. Fertil Steril. 2001;76(4):717–22. doi: 10.1016/s0015-0282(01)01991-4 11591404

12. Attaman JA, Stanic AK, Kim M, Lynch MP, Rueda BR, Styer AK. The anti-inflammatory impact of omega-3 polyunsaturated Fatty acids during the establishment of endometriosis-like lesions. Am J Reprod Immunol. 2014;72(4):392–402. doi: 10.1111/aji.12276 24898804

13. Tomio K, Kawana K, Taguchi A, Isobe Y, Iwamoto R, Yamashita A, et al. Omega-3 polyunsaturated Fatty acids suppress the cystic lesion formation of peritoneal endometriosis in transgenic mouse models. PLoS One. 2013;8(9):e73085. doi: 10.1371/journal.pone.0073085 24039864

14. Dmitrieva N, Suess G, Shirley R. Resolvins RvD1 and 17(R)-RvD1 alleviate signs of inflammation in a rat model of endometriosis. Fertil Steril. 2014;102(4):1191–6. doi: 10.1016/j.fertnstert.2014.06.046 25123641

15. Netsu S, Konno R, Odagiri K, Soma M, Fujiwara H, Suzuki M. Oral eicosapentaenoic acid supplementation as possible therapy for endometriosis. Fertil Steril. 2008;90(4 Suppl):1496–502. doi: 10.1016/j.fertnstert.2007.08.014 18054352

16. Missmer SA, Chavarro JE, Malspeis S, Bertone-Johnson ER, Hornstein MD, Spiegelman D, et al. A prospective study of dietary fat consumption and endometriosis risk. Hum Reprod. 2010;25(6):1528–35. doi: 10.1093/humrep/deq044 20332166

17. Signorile PG, Viceconte R, Baldi A. Novel dietary supplement association reduces symptoms in endometriosis patients. Journal of cellular physiology. 2018;233(8):5920–5. doi: 10.1002/jcp.26401 29243819

18. Deutch B. [Painful menstruation and low intake of n-3 fatty acids]. Ugeskrift for laeger. 1996;158(29):4195–8. 8701537

19. Harel Z, Biro FM, Kottenhahn RK, Rosenthal SL. Supplementation with omega-3 polyunsaturated fatty acids in the management of dysmenorrhea in adolescents. Am J Obstet Gynecol. 1996;174(4):1335–8. doi: 10.1016/s0002-9378(96)70681-6 8623866

20. Abokhrais IM, Saunders PTK, Denison FC, Doust A, Williams L, Horne AW. A pilot randomised double blind controlled trial of the efficacy of purified fatty acids for the treatment of women with endometriosis-associated pain (PurFECT): study protocol. Pilot Feasibility Stud. 2018;4:83. doi: 10.1186/s40814-018-0274-8 29721332

21. Moore SJ, Kennedy SH. The Initial Management of Chronic Pelvic Pain. Royal College of Obstetricians and Gynaecologists Royal College of Obstetricians and Gynaecologists; 2012 2012. Contract No.: 41.

22. Koninckx PR, Martin DC. Deep endometriosis: a consequence of infiltration or retraction or possibly adenomyosis externa? Fertil Steril. 1992;58(5):924–8. doi: 10.1016/s0015-0282(16)55436-3 1426377

23. Walters SJ, Bonacho Dos Anjos Henriques-Cadby I, Bortolami O, Flight L, Hind D, Jacques RM, et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3):e015276. doi: 10.1136/bmjopen-2016-015276 28320800

24. Crocker JC, Ricci-Cabello I, Parker A, Hirst JA, Chant A, Petit-Zeman S, et al. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. Bmj. 2018;363:k4738. doi: 10.1136/bmj.k4738 30487232

25. Beauchamp GK, Keast RS, Morel D, Lin J, Pika J, Han Q, et al. Phytochemistry: ibuprofen-like activity in extra-virgin olive oil. Nature. 2005;437(7055):45–6. doi: 10.1038/437045a 16136122


Článek vyšel v časopise

PLOS One


2020 Číslo 1
Nejčtenější tento týden
Nejčtenější v tomto čísle
Kurzy

Zvyšte si kvalifikaci online z pohodlí domova

KOST
Koncepce osteologické péče pro gynekology a praktické lékaře
nový kurz
Autoři: MUDr. František Šenk

Sekvenční léčba schizofrenie
Autoři: MUDr. Jana Hořínková

Hypertenze a hypercholesterolémie – synergický efekt léčby
Autoři: prof. MUDr. Hana Rosolová, DrSc.

Svět praktické medicíny 5/2023 (znalostní test z časopisu)

Imunopatologie? … a co my s tím???
Autoři: doc. MUDr. Helena Lahoda Brodská, Ph.D.

Všechny kurzy
Kurzy Podcasty Doporučená témata Časopisy
Přihlášení
Zapomenuté heslo

Zadejte e-mailovou adresu, se kterou jste vytvářel(a) účet, budou Vám na ni zaslány informace k nastavení nového hesla.

Přihlášení

Nemáte účet?  Registrujte se

#ADS_BOTTOM_SCRIPTS#