Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- chronic pelvic pain (measured by visual analog scale (VAS-Pain)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •absence of clinical and laboratory diagnosis of menopause or
- •premature ovarian failure
研究组 & 干预措施
dynamized estrogen in alcohol solution
Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.
干预措施: dynamized estrogen (Drug)
placebo (alcohol solution)
This arm received alcohol solution during the 24-week study duration.
干预措施: placebo (Drug)
结局指标
主要结局
chronic pelvic pain (measured by visual analog scale (VAS-Pain)
时间窗: 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)
次要结局
- 36-Item Short-Form Health Survey (SF-36)(24 weeks (6 months))
研究者
Marcus Zulian Teixeira
PhD
University of Sao Paulo General Hospital