Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427386
• Other study ID #: FMUSP
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2015
• Last updated: February 22, 2017
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

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).
• placebo
The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

References & Publications (5)

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 Jan 25;211:48-55. doi: 10.1016/j.ejogrb.2017.01.052. [Epub ahead of print] — View Citation

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):240-9. doi: 10.1016/j.homp.2016.03.002. — View Citation

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.

Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36-Item Short-Form Health Survey (SF-36)		24 weeks (6 months)

External Links

•   New homeopathic medicines: use of modern drugs according to the principle of similitude