Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT
Cooper, Kevin G. and Bhattacharya, Siladitya and Daniels, Jane P. and Cheed, Versha and Gennard, Laura and Leighton, Lisa and Pirie, Danielle and Meylda, Melyda and Monahan, Mark and Weckesser, Annalise and Roberts, Tracy and Denny, Elaine and Ocansey, Laura and Stubbs, Clive and Cox, Emma and Jones, Georgina and Clark, T Justin and Saridogan, Ertan and Gupta, Janesh K. and Critchely, Hilary O.M. and Horne, Andrew and Middleton, Lee J. (2024) Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT. NIHR Health Technology Assessment, 28 (55). ISSN 2046-4924
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Abstract
Background
Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option.
Objectives
To evaluate the clinical and cost-effectiveness of long-acting progestogen therapy compared with the combined oral contraceptive pill in preventing recurrence of endometriosis-related pain and quality of life.
Design
A multicentre, open, randomised trial with parallel economic evaluation. The final design was informed by a pilot study, qualitative exploration of women’s lived experience of endometriosis and a pretrial economic model.
Setting
Thirty-four United Kingdom hospitals.
Participants
Women of reproductive age undergoing conservative surgery for endometriosis.
Interventions
Long-acting progestogen reversible contraceptive (either 150 mg depot medroxyprogesterone acetate or 52 mg levonorgestrel-releasing intrauterine system) or combined oral contraceptive pill (30 µg ethinylestradiol, 150 µg levonorgestrel).
Main outcome measures
The primary outcome was the pain domain of the Endometriosis Health Profile-30 questionnaire at 36 months post randomisation. The economic evaluation estimated the cost per quality-adjusted life-years gained.
Results
Four hundred and five women were randomised to receive either long-acting reversible contraceptive (N = 205) or combined oral contraceptive pill (N = 200). Pain scores improved in both groups (24 and 23 points on average) compared with preoperative values but there was no difference between the two (adjusted mean difference: −0.8, 95% confidence interval −5.7 to 4.2; p = 0.76). The long-acting reversible contraceptive group underwent fewer surgical procedures or second-line treatments compared with the combined oral contraceptive group (73 vs. 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00).
The mean adjusted quality-adjusted life-year difference between two arms was 0.043 (95% confidence interval −0.069 to 0.152) in favour of the combined oral contraceptive pill, although this cost an additional £533 (95% confidence interval 52 to 983) per woman.
Limitations
Limitations include the absence of a no-treatment group and the fact that many women changed treatments over the 3 years of follow-up. Use of telephone follow-up to collect primary outcome data in those who failed to return questionnaires resulted in missing data for secondary outcomes. The COVID pandemic may have affected rates of further surgical treatment.
Conclusions
At 36 months, women allocated to either intervention had comparable levels of pain, with both groups showing around a 40% improvement from presurgical levels. Although the combined oral contraceptive was cost-effective at a threshold of £20,000 per quality-adjusted life-year, the difference between the two was marginal and lower rates of repeat surgery might make long-acting reversible contraceptives preferable to some women.
Future work
Future research needs to focus on evaluating newer hormonal preparations, a more holistic approach to symptom suppression and identification of biomarkers to diagnose endometriosis and its recurrence.
Trial registration
This trial is registered as ISRCTN97865475. https://doi.org/10.1186/ISRCTN97865475.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/114/01) and is published in full in Health Technology Assessment; Vol. 28, No. 55. See the NIHR Funding and Awards website for further award information.
The NIHR recognises that people have diverse gender identities, and in this report, the word ‘woman’ is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male or non-binary.
Item Type: | Article |
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Identification Number: | 10.3310/SQWY6998 |
Dates: | Date Event 1 September 2024 Accepted 1 September 2024 Published Online |
Subjects: | CAH00 - multidisciplinary > CAH00-00 - multidisciplinary > CAH00-00-00 - multidisciplinary CAH02 - subjects allied to medicine > CAH02-05 - medical sciences > CAH02-05-02 - healthcare science (non-specific) CAH02 - subjects allied to medicine > CAH02-06 - allied health > CAH02-06-01 - health sciences (non-specific) |
Divisions: | Faculty of Health, Education and Life Sciences > College of Nursing and Midwifery |
Depositing User: | Annalise Weckesser |
Date Deposited: | 16 Sep 2024 10:09 |
Last Modified: | 16 Sep 2024 10:14 |
URI: | https://www.open-access.bcu.ac.uk/id/eprint/15832 |
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