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Completed

NCT Number: NCT02427386

Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: dynamized 17-beta estradiol

Placebo

Drug

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

Other names: alcohol solution

Primary outcomes

  1. 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 outcomes

  1. 36-Item Short-Form Health Survey (SF-36)

    Time frame: 24 weeks (6 months)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2015
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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