Positive Health Online

Abstract

ABOKHRAIS and COLLEAGUES,   1 MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom; 2 Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom; 3 Usher Institute, University of Edinburgh, Edinburgh, United Kingdom conducted a two-arm parallel double-blind randomized controlled pilot trial of the efficacy of Omega-3 polyunsaturated fatty acids for the treatment of women with endometriosis-associated pain (PurFECT1).

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. The authors 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.

Methodology

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, randomization, 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. The authors recruited women with endometriosis from June 2016 to June 2017 and randomized 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. The authors calculated the proportion of eligible women randomized, and of randomized 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 randomized 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 Omega-3 polyunsaturated fatty acids O-PUFA for endometriosis-associated pain. Trial registration: The trial was registered on the ISRCTN registry (registration number ISRCTN44202346).

References

Ibtisam M Abokhrais  1 , Fiona C Denison  1 , Lucy H R Whitaker  1 , Philippa T K Saunders  2 , Ann Doust  1 , Linda J Williams  3 , Andrew W Horne  1.  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). PLoS One; 15(1):e0227695. doi: 10.1371/journal.pone.0227695. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227695  eCollection 2020. Jan 17 2020.

Erratum: Correction: 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).

Abokhrais IM, Denison FC, Whitaker LHR, Saunders PTK, Doust A, Williams LJ, Horne AW. PLoS One. Feb 27 2020 ;15(2):e0230055. doi: 10.1371/journal.pone.0230055. https://www.research.ed.ac.uk/en/publications/correction-a-two-arm-parallel-double-blind-randomised-controlled-  eCollection 2020.