顺势疗法中强效雌激素治疗子宫内膜异位症相关慢性盆腔疼痛的随机对照试验方案。

Protocol of randomized controlled trial of potentized estrogen in homeopathic treatment of chronic pelvic pain associated with endometriosis.

作者信息

Teixeira Marcus Zulian, Podgaec Sérgio, Baracat Edmund Chada

机构信息

Department of Obstetrics and Gynecology, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.

出版信息

Homeopathy. 2016 Aug;105(3):240-249. doi: 10.1016/j.homp.2016.03.002. Epub 2016 May 13.

DOI:10.1016/j.homp.2016.03.002

PMID:27473545

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/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.

摘要

背景

子宫内膜异位症是一种慢性炎症性疾病，会导致难以治疗的盆腔疼痛。正因如此，许多患者寻求补充和替代医学的帮助，包括顺势疗法。由于文献中缺乏证据，顺势疗法治疗子宫内膜异位症的有效性存在争议。本随机对照试验的目的是评估与安慰剂相比，增效雌激素治疗与子宫内膜异位症相关的慢性盆腔疼痛的疗效。

方法/设计：本研究是一项随机、双盲、安慰剂对照试验，采用根据“新顺势疗法药物：根据相似性原则使用现代药物”计划（http://newhomeopathicmedicines.com）个体化的顺势疗法药物。在圣保罗大学医学院临床医院临床妇科分部的子宫内膜异位症科室（圣保罗大学医学院临床医院 - HCFMUSP）招募患有子宫内膜异位症、慢性盆腔疼痛以及一系列与雌激素引起的不良事件相似的体征和症状的女性。参与者通过分析其病历和应用自我报告结构化问卷进行选择。共有50名符合入选标准的女性将被随机分配接受增效雌激素或安慰剂。主要临床结局指标将是慢性盆腔疼痛的严重程度。在干预24周后，将采用意向性分析和符合方案分析方法对顺势疗法药物与安慰剂的效果进行比较，并进行统计分析。