Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis
Overview
- Phase
- Phase 4
- Intervention
- dynamized estrogen
- Conditions
- Endometriosis
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 50
- Primary Endpoint
- chronic pelvic pain (measured by visual analog scale (VAS-Pain)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Marcus Zulian Teixeira
PhD
University of Sao Paulo General Hospital
Eligibility 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
Arms & Interventions
dynamized estrogen in alcohol solution
Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.
Intervention: dynamized estrogen
placebo (alcohol solution)
This arm received alcohol solution during the 24-week study duration.
Intervention: placebo
Outcomes
Primary Outcomes
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
- 36-Item Short-Form Health Survey (SF-36)(24 weeks (6 months))