title: Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis.
abstract: 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
  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.
  
  
  CONCLUSIONS
  The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02427386.
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: mzulian@usp.br.
authors.forename: Marcus Zulian
authors.initials: MZ
authors.lastname: Teixeira
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Sérgio
authors.initials: S
authors.lastname: Podgaec
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Edmund Chada
authors.initials: EC
authors.lastname: Baracat
mesh_terms: D004311:Double-Blind Method; D004715:Endometriosis / Q000628:therapy*; D004967:Estrogens / Q000627:therapeutic use*; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008419:Materia Medica / Q000627:therapeutic use; D017699:Pelvic Pain / Q000628:therapy*; D012107:Research Design
chemical_list: D004967:Estrogens; D008419:Materia Medica
keywords: Clinical symptoms; Endometriosis; Estrogen; Homeopathy; Pelvic pain; Protocol; Randomized controlled trial