Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

NCT02427386 | Completed Phase 4 DMC

• 1 other identifier: FMUSP
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Endometriosis; Pelvic Pain

Keywords

Endometriosis; Pelvic pain; Homeopathy; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 36-Item Short-Form Health Survey (SF-36)

  24 weeks (6 months)

Study Arms (2)

dynamized estrogen in alcohol solution

ACTIVE COMPARATOR

Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.

Drug: dynamized estrogen

placebo (alcohol solution)

PLACEBO COMPARATOR

This arm received alcohol solution during the 24-week study duration.

Drug: placebo

Interventions

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).

Also known as: dynamized 17-beta estradiol

dynamized estrogen in alcohol solution

placebo DRUG

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

Also known as: alcohol solution

placebo (alcohol solution)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value).

You may not qualify if:

• absence of clinical and laboratory diagnosis of menopause or
• premature ovarian failure

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (5)

• 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.

  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.

  PMID: 27473545 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.

  PMID: 28187404 BACKGROUND

• 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.

  PMID: 12606247 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.

  PMID: 21962199 RESULT

Related Links

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

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Marcus Z Teixeira, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02