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Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcus Zulian Teixeira, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02427386
First received: April 22, 2015
Last updated: February 22, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Endometriosis Pelvic Pain Drug: dynamized estrogen Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis

Resource links provided by NLM:


Further study details as provided by Marcus Zulian Teixeira, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • chronic pelvic pain (measured by visual analog scale (VAS-Pain) [ Time Frame: 24 weeks (6 months) ]
    chronic pelvic pain (dysmenorrhoea, dyspareunia, acyclic pelvic pain depth, cyclic intestinal change and cyclic urinary change) measured by visual analog scale (VAS-Pain)


Secondary Outcome Measures:
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 24 weeks (6 months) ]

Enrollment: 50
Actual Study Start Date: May 2014
Study Completion Date: December 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dynamized estrogen in alcohol solution
Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.
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).
Other Name: dynamized 17-beta estradiol
Placebo Comparator: placebo (alcohol solution)
This arm received alcohol solution during the 24-week study duration.
Drug: placebo
The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.
Other Name: alcohol solution

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02427386

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Marcus Z Teixeira, PhD University of Sao Paulo General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Marcus Zulian Teixeira, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02427386     History of Changes
Other Study ID Numbers: FMUSP
Study First Received: April 22, 2015
Last Updated: February 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marcus Zulian Teixeira, University of Sao Paulo General Hospital:
Endometriosis
Pelvic pain
Homeopathy
RCT

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Ethanol
Estradiol
Estrogens
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on July 26, 2017