辣椒（茄科）顺势疗法药物治疗绝经后女性潮热的疗效：一项2期随机对照试验。

Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial.

作者信息

Andrade Débora Cristiane da Silva, Carmona Fabio, Angelucci Mateus Andrea, Martinez Edson Zangiacomi, Pereira Ana Maria Soares

机构信息

Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.

Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo (USP), São Paulo, Brazil.

出版信息

Homeopathy. 2019 May;108(2):102-107. doi: 10.1055/s-0038-1676326. Epub 2019 Feb 8.

DOI:10.1055/s-0038-1676326

PMID:30736083

Abstract

BACKGROUND

Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy .

METHODS

This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group.

RESULTS

The effect of on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with , compared with placebo, also reduced the intensity of the secondary symptoms ( = 0.001) and improved level of activity ( = 0.025) and well-being ( = 0.008).

CONCLUSION

The homeopathic medicine of () was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

摘要

背景

潮热在绝经后女性中很常见，是不适的重要原因，增加了就医次数。激素替代疗法是一种有效的治疗方法，但会带来不良后果。存在替代疗法，但它们并未被普遍接受或有效。食用马拉盖塔辣椒（茄科辣椒属果实的常用名称）会引起类似于女性潮热时的感觉。根据顺势疗法的相似律（以类治类），我们假设由马拉盖塔辣椒制成的顺势疗法药物可有效缓解绝经后潮热。我们将这种药物命名为。

方法

本随机、安慰剂对照、双盲、2期临床试验旨在检验以下假设：在绝经后女性中，与安慰剂相比，顺势疗法药物（30CH）在治疗4周后将显著降低潮热强度。主要结局是潮热强度，通过自我测量医疗结局量表（MYMOP）工具进行测量。共有40名女性参与研究，每组20名。

结果

通过MYMOP评估，在治疗4周期间对主要结局潮热强度的影响优于安慰剂，治疗中断后两组均出现恶化（治疗第4周后，序数逻辑回归中＜0.001）。治疗反应（至少降低三个MYMOP类别）的优势比为2.78（95%置信区间，0.77至10.05）。与安慰剂相比，使用治疗还降低了次要症状的强度（ =0.001），并改善了活动水平（ =0.025）和幸福感（ =0.008）。