Effectiveness of an anti-inflammatory diet intervention and cognitive behavioural therapy in endometriosis: protocol for a randomised controlled clinical trial
Abstract
Introduction: Treatment for women with endometriosis is only partially or temporarily effective. Moreover, medical hormonal treatment is associated with debilitating side effects and interferes with fertility, while surgery has a relatively high risk of complications. Meanwhile, women with endometriosis show increasing interest in implementing lifestyle interventions to alleviate symptoms and improve health-related quality of life (HRQoL). Integrating these lifestyle interventions can provide a holistic approach to the treatment of this debilitating disease. However, scientific evidence supporting the effectiveness of these interventions is limited. This study is designed to investigate the effectiveness of two lifestyle interventions and the combination of both: an anti-inflammatory diet intervention (AIDI) could improve immune cell function and reduce inflammation, resulting in improved HRQoL and alleviating pain. In addition, the integration of cognitive behavioural therapy (CBT) aims to provide insight into pain mechanisms and coping with pain, and to assist in sustaining dietary adjustments.
Methods and analysis: The Pain in Endometriosis And the Relation to Lifestyle (PEARL) study is a five-arm randomised controlled trial with a pre-post factorial design with two factors: an AIDI and CBT. The study population will consist of 250 premenopausal women, of whom 200 are diagnosed with endometriosis and experience pain symptoms and 50 are healthy controls (HC). Women with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.
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