NCT02427386

Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. In view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. The absence of evidence in the literature raises controversy about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the treatment of chronic pelvic pain of endometriosis.

Detailed description

This is a randomized, double-blind and placebo controlled trial using individualised homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis. Patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to those of the estrogen adverse events will be recruited in the Sector of Endometriosis of the Clinical Division of Gynaecological of the Hospital das Clínicas of the Faculty of Medicine of the University of Sao Paulo. The selection process was carried out through the analysis of medical charts and self-completing of structured questionnaires. Satisfied the inclusion criteria, fifty patients were randomly and distributed to receive dynamized estrogen or placebo. The primary clinical outcome is the severity of the chronic pelvic pain. Statistical analysis will be by intention-to-treat and per protocol comparing homeopathic drug with placebo after 24 weeks of intervention.

Conditions

• Endometriosis
• Pelvic Pain

Interventions

Type	Name	Description
DRUG	dynamized estrogen	The dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period).
DRUG	placebo	The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-02-01
• Completion: 2016-12-01
• First posted: 2015-04-28
• Last updated: 2017-02-24