Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Pelvic Pain; Endometriosis

Treatments: Drug: placebo; Drug: dynamized estrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT02427386

FMUSP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

dynamized estrogen in alcohol solution

Active Comparator group

Description:

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

Treatment:

Drug: dynamized estrogen

placebo (alcohol solution)

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo