Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Drug: dynamized estrogen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary inclusion criteria: aged between 18 and 45; diagnosis of endometriosis (endometrial ectopia) confirmed by imaging test (MRI or TVUS) or laparoscopy (biopsy); chronic pelvic pain refractory to conventional hormone treatments and with intensity ≥ 5 on the visual analog pain scale (VAS-Pain: 0-10 points); secondary inclusion criteria: symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value). Exclusion Criteria: absence of clinical and laboratory diagnosis of menopause or premature ovarian failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dynamized estrogen in alcohol solution<br>Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies. | Drug: dynamized estrogen<br>* 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).<br>* Other names: dynamized 17-beta estradiol;|
| Placebo Comparator: placebo (alcohol solution)<br>This arm received alcohol solution during the 24-week study duration. | Drug: placebo<br>* The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.<br>* Other names: alcohol solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pelvic pain (measured by visual analog scale (VAS-Pain) | chronic pelvic pain (dysmenorrhoea, dyspareunia, acyclic pelvic pain depth, cyclic intestinal change and cyclic urinary change) measured by visual analog scale (VAS-Pain) | 24 weeks (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36-Item Short-Form Health Survey (SF-36) |  | 24 weeks (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Endometriosis, Pelvic pain, Homeopathy