Diet and physical activity coaching for well-being and pain reduction in patients with symptomatic endometriosis: a randomized-controlled clinical trial.

Pain is a defining symptom of endometriosis reducing quality of life and increasing the risk of psychological disorders. We conducted an open-label, randomized, controlled trial to investigate whether structured coaching on Mediterranean diet and aerobic exercise recommendation could improve pain-related symptoms in patients with endometriosis (Clinicaltrials.gov: NCT03994432). A total of 140 patients, aged 18-45 years, with symptomatic endometriosis despite hormonal treatment were randomly assigned (1:1) to an intervention or control group. Every 4 months, the intervention group received dietary and physical activity coaching in addition to hormonal therapy, while controls were monitored with no additional lifestyle advice. The primary outcome was the change in endometriosis-related pain symptoms, measured with an 11-point Numerical Rating Scale (NRS) from baseline to 12 months, between groups. Secondary outcomes included quality-of-life, psychological well-being, and patients' perception of health improvement. At 12 months follow-up, under an intention-to-treat (ITT) analysis, the intervention group showed greater improvements than controls in non-menstrual pelvic pain (-1.60 ± 2.52 vs - 0.74 ± 2.19; p = 0.03) and dyschezia (-0.86 ± 2.13 vs -0.04 ± 1.98; p = 0.02). The anxiety component also improved significantly, while depression and quality of life scores did not change significantly. In the ITT analysis, 47 % of patients (95 % CI, 35.9-58.7) in the intervention group, reported an overall improvement in their general health condition, compared with 27 % (95 % CI, 18.1-38.5) in controls (p = 0.01). These results suggest that in endometriosis patient's lifestyle interventions may complement hormonal treatment in improving symptom management and patients' well-being.