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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.
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 ClÃnicas 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dynamized estrogen in alcohol solution | Active Comparator | Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies. |
|
| placebo (alcohol solution) | Placebo Comparator | This arm received alcohol solution during the 24-week study duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dynamized estrogen | Drug | 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). |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 36-Item Short-Form Health Survey (SF-36) | 24 weeks (6 months) |
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Inclusion Criteria:
primary inclusion criteria:
secondary inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Z Teixeira, PhD | University of Sao Paulo General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Teixeira MZ. 'New Homeopathic Medicines' database: A project to employ conventional drugs according to the homeopathic method of treatment. European Journal of Integrative Medicine 5(3): 270-278, 2013. | ||
| 27473545 | Background | Teixeira MZ, Podgaec S, Baracat EC. Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis. Homeopathy. 2016 Aug;105(3):240-249. doi: 10.1016/j.homp.2016.03.002. Epub 2016 May 13. | |
| 28187404 |
| Label | URL |
|---|---|
| New homeopathic medicines: use of modern drugs according to the principle of similitude | View source |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| placebo | Drug | The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study. |
|
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| Background |
| Teixeira MZ, Podgaec S, Baracat EC. Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:48-55. doi: 10.1016/j.ejogrb.2017.01.052. Epub 2017 Jan 25. |
| 12606247 | Result | Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. doi: 10.1016/s0306-9877(02)00386-9. |
| 21962199 | Result | Teixeira MZ. New homeopathic medicines: use of modern drugs according to the principle of similitude. Homeopathy. 2011 Oct;100(4):244-52. doi: 10.1016/j.homp.2011.01.002. |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |