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: 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


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2020 Číslo 1