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)

Autor: Andrew W Horne, Philippa T. K. Saunders, Lucy Whitaker, Ibtisam M. Abokhrais, Ann Doust, Linda Williams, Fiona C. Denison
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Questionnaires
Endometriosis
Pathology and Laboratory Medicine
law.invention
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Plant Products
Medicine and Health Sciences
Medicine
030212 general & internal medicine
Young adult
030219 obstetrics & reproductive medicine
Multidisciplinary
Pharmaceutics
Eukaryota
Olives
Drugs
Agriculture
Contraceptives
Plants
3. Good health
Research Design
Engineering and Technology
medicine.symptom
Research Article
Biotechnology
medicine.medical_specialty
Drug Research and Development
Clinical Research Design
Science
Bioengineering
Research and Analysis Methods
Vegetable Oils
Fruits
03 medical and health sciences
Pharmacotherapy
Signs and Symptoms
Drug Therapy
Diagnostic Medicine
Clinical Trials
Adverse effect
Pharmacology
Survey Research
business.industry
Pelvic pain
Organisms
Biology and Life Sciences
medicine.disease
Agronomy
Randomized Controlled Trials
Sample size determination
Physical therapy
Lesions
Medical Devices and Equipment
Adverse Events
Clinical Medicine
business
Crop Science
Zdroj: PLoS ONE, Vol 15, Iss 1, p e0227695 (2020)
Abokhrais, I, Denison, F, Whitaker, L, Saunders, P, Doust, A, Williams, L & Horne, A 2020, ' 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, vol. 15, no. 1, e0227695 . https://doi.org/10.1371/journal.pone.0227695
PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0227695
Popis: BackgroundEndometriosis 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.ObjectivesThe 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.MethodsWe 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.ResultsThe 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.ConclusionOur pilot trial supports the feasibility of a future larger trial to definitively evaluate the efficacy of O-PUFA for endometriosis-associated pain.Trial registrationThe trial was registered on the ISRCTN registry (registration number ISRCTN44202346).
Databáze: OpenAIRE
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