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个体化顺势疗法药物治疗更年期综合征的疗效:双盲、随机、安慰剂对照试验。

Efficacy of Individualized Homeopathic Medicines in the Treatment of Menopausal Syndrome: Double-Blind, Randomized, Placebo-Controlled Trial.

机构信息

Department of Pathology & Microbiology, D.N. De Homoeopathic Medical College and Hospital, The West Bengal University of Health Sciences, Government of West Bengal, Kolkata, West Bengal, India.

Department of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, The West Bengal University of Health Sciences, Government of West Bengal, Howrah, West Bengal, India.

出版信息

J Integr Complement Med. 2023 Oct;29(10):649-664. doi: 10.1089/jicm.2022.0760. Epub 2023 May 24.

Abstract

Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this trial against placebos in the treatment of the menopausal syndrome. Double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Sixty women with menopausal syndrome. Group 1 ( = 30; IHMs plus concomitant care; verum) versus group 2 ( = 30; placebos plus concomitant care; control). Primary-the Greene climacteric scale (GCS) total score and menopause rating scale (MRS) total score, and secondary-the Utian quality of life (UQOL) total score; all of them were measured at baseline and every month up to 3 months. Intention-to-treat sample ( = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired tests comparing the estimates obtained individually every month. The level of significance was set at  < 0.025 two-tailed. Between-group differences were nonsignificant statistically-GCS total score ( = 1.372,  = 0.246), MRS total score ( = 0.720,  = 0.4), and UQOL total scores ( = 2.903,  = 0.094). Some of the subscales preferred IHMs significantly against placebos-for example, MRS somatic subscale ( = 0.466,  < 0.001), UQOL occupational subscale ( = 4.865,  = 0.031), and UQOL health subscale ( = 4.971,  = 0.030). and were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group. Although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis. CTRI/2019/10/021634.

摘要

绝经症状是与绝经后雌激素缺乏相关的全身症状。尽管顺势疗法被广泛应用,但在绝经综合征方面,其质量证据,特别是随机试验中的证据仍然不足。本试验评估了个体化顺势疗法药物 (IHM) 治疗绝经综合征的疗效与安慰剂相比。 双盲、随机(1:1)、两平行臂、安慰剂对照试验。 Mahesh Bhattacharyya 顺势疗法医学院和医院,印度西孟加拉邦豪拉。 60 名绝经综合征妇女。 第 1 组( = 30;IHM 加伴随护理;真)与第 2 组( = 30;安慰剂加伴随护理;对照)。 主要指标-格林绝经量表(GCS)总分和绝经评分量表(MRS)总分,次要指标-乌蒂安生活质量量表(UQOL)总分;所有这些指标均在基线和 3 个月内每月测量一次。 采用意向治疗样本( = 60)进行分析。通过双向(对半)重复测量方差分析检查组间差异,主要考虑所有按月间隔测量的估计值,其次通过比较每月单独获得的估计值的未配对检验进行比较。显著性水平设定为双侧  < 0.025。组间差异无统计学意义-GCS 总分( = 1.372,  = 0.246)、MRS 总分( = 0.720,  = 0.4)和 UQOL 总分( = 2.903,  = 0.094)。一些亚量表显示 IHMs 明显优于安慰剂,例如 MRS 躯体亚量表( = 0.466,  < 0.001)、UQOL 职业亚量表( = 4.865,  = 0.031)和 UQOL 健康亚量表( = 4.971,  = 0.030)。 和 是最常开的药物。两组均未报告任何伤害或严重不良事件。 尽管主要分析未能明确表明该治疗效果优于安慰剂,但在次要分析中仍能在一些亚量表中检测到 IHMs 相对于安慰剂的一些显著益处。 CTRI/2019/10/021634.

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