Background:
Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic
pain. Thus being, many patients seek help in complementary and alternative medicine,
including homeopathy. The effectiveness of homeopathic treatment for endometriosis
is controversial due to the lack of evidences in the literature. The aim of the present
randomized controlled trial is to assess the efficacy of potentized estrogen compared
to placebo in the treatment of chronic pelvic pain associated with endometriosis.
Methods/design:
The present is a randomized, double-blind, placebo-controlled trial of a homeopathic
medicine individualized according to program ‘New Homeopathic Medicines: use of modern
drugs according to the principle of similitude’ (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar
to the adverse events caused by estrogen were recruited at the Endometriosis Unit
of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University
of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São
Paulo – HCFMUSP). The participants were selected based on the analysis of their medical
records and the application of self-report structured questionnaires. A total of 50
women meeting the eligibility criteria will be randomly allocated to receive potentized
estrogen or placebo. The primary clinical outcome measure will be severity of chronic
pelvic pain. Statistical analysis will be performed on the intention-to-treat and
per-protocol approaches comparing the effect of the homeopathic medicine versus placebo
after 24 weeks of intervention.
Discussion:
The present study was approved by the research ethics committee of HCFMUSP and the
results are expected in 2016.
Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02427386.
Keywords
Endometriosis - Pelvic pain - Estrogen - Protocol - Homeopathy - Clinical symptoms
- Randomized controlled trial