Trial results for a study investigating an Alternative Healthy Eating Index (AHEI) dietary intervention for Endometriosis were posted on ClinicalTrials.gov on 2026-04-13, with 109 participants enrolled.
Background
Endometriosis is a chronic condition characterized by the growth of endometrial-like tissue outside the uterus, leading to pelvic pain, infertility, and reduced quality of life. Management often involves hormonal therapies, pain medication, and surgery. Exploring non-pharmacological approaches, such as dietary interventions, is important for patients seeking additional ways to manage symptoms and improve their overall well-being. This study aimed to examine if a healthy diet based on the Alternative Healthy Eating Index (AHEI) could influence pain symptoms, quality of life, and inflammatory markers.
Trial design
This completed study, designated as Phase NA, enrolled 109 participants with Endometriosis. The trial investigated whether a healthy diet based on the Alternative Healthy Eating Index (AHEI) could influence pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who were experiencing pain. Participants were assigned to either an intervention group receiving the AHEI diet or a control group.
Key results
The trial reported several key measurements and analyses:
- Pain Measurement - Acyclic Pain (VAS pain score):
- Intervention group: A mean score of 7.1 (95% Confidence Interval 3.0).
- Control group: A mean score of 7.0 (95% Confidence Interval 2.6).
- Intervention group: A mean score of 4.7.
- Control group: A mean score of 6.7.
- Pain Measurement - Pain Catastrophizing (Pain catastrophizing score):
- Intervention group: A mean score of 24.3 (95% Confidence Interval 20.7).
- Control group: A mean score of 25.5 (95% Confidence Interval 22.2).
- Pain Measurement - Pills (Pain pills per week):
- Intervention group: A mean of 16.4.
- Control group: A mean of 17.4.
- Quality of Life EHP-30 (score on a scale):
- Intervention group: A mean score of 58.2.
- Control group: A mean score of 61.8.
- Intervention group: A mean score of 36.7.
- Control group: A mean score of 51.5.
Key analyses using linear mixed models reported p-values of 0.02, 0.0001, and 0.36.
What this means
The posted results suggest that an AHEI dietary intervention may positively impact pain symptoms and quality of life for women with endometriosis. Specifically, the intervention group showed a lower mean acyclic pain score of 4.7 compared to the control group's 6.7 in one measurement, and a lower mean Quality of Life EHP-30 score of 36.7 compared to the control group's 51.5 in another measurement. The reported p-values of 0.02 and 0.0001 from linear mixed models indicate statistically significant differences in some outcomes, supporting the potential benefit of this dietary approach in managing endometriosis symptoms. While other measurements like pain catastrophizing and pain pill usage were also collected, the most pronounced differences and significant p-values align with improvements in acyclic pain and quality of life.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04259788, titled "An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis", were posted on 2026-04-13 on clinicaltrials.gov.