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个体化顺势疗法制剂治疗寻常痤疮的疗效:一项双盲、随机、安慰剂对照试验。

Efficacy of Individualized Homeopathic Medicines in Treatment of Acne Vulgaris: A Double-Blind, Randomized, Placebo-Controlled Trial.

机构信息

Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India.

Department of Materia Medica, National Institute of Homoeopathy, Salt Lake, Kolkata, West Bengal, India.

出版信息

Homeopathy. 2022 Nov;111(4):240-251. doi: 10.1055/s-0041-1739397. Epub 2022 Mar 17.

DOI:10.1055/s-0041-1739397
PMID:35299272
Abstract

BACKGROUND

Acne is estimated to affect 9.4% of the global population, making it the 8 most prevalent disease worldwide. Acne vulgaris (AV) is among the diseases that directly affect quality of life. This trial evaluated the efficacy of individualized homeopathic medicines (IHM) against placebo in AV.

METHODS

In this double-blind, randomized, placebo-controlled trial conducted at the National Institute of Homoeopathy, India, 126 patients suffering from AV were randomized in a 1:1 ratio to receive either IHM (verum) in centesimal potencies or identical-looking placebo (control). The primary outcome measure was the Global Acne Grading System score; secondary outcomes were the Cardiff Acne Disability Index and Dermatology Life Quality Index questionnaires - all measured at baseline and 3 months after the intervention. Group differences and effect sizes (Cohen's ) were calculated on the intention-to-treat sample.

RESULTS

Overall, improvements were greater in the IHM group than placebo, with small to medium effect sizes after 3 months of intervention; however, the inter-group differences were statistically non-significant. (17.5%), (15.1%), (14.3%), (10.3%), and (7.1%) were the most frequently prescribed medicines; , and were the most effective of those used. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.

CONCLUSION

There was non-significant direction of effect favoring homeopathy against placebo in the treatment of AV.

TRIAL REGISTRATION

CTRI/2018/11/016248; UTN: U1111-1221-8164.

摘要

背景

痤疮估计影响全球人口的 9.4%,使其成为全球第 8 大最常见疾病。寻常痤疮(AV)是直接影响生活质量的疾病之一。这项试验评估了个体化顺势疗法药物(IHM)与安慰剂在 AV 中的疗效。

方法

在印度国家顺势疗法研究所进行的这项双盲、随机、安慰剂对照试验中,126 名患有 AV 的患者按照 1:1 的比例随机分为接受 IHM(真实药物)或外观相同的安慰剂(对照)。主要结局测量指标是全球痤疮分级系统评分;次要结局测量指标是加的夫痤疮残疾指数和皮肤病生活质量指数问卷-均在基线和干预后 3 个月进行测量。基于意向治疗样本计算组间差异和效应大小(Cohen's )。

结果

总体而言,IHM 组的改善大于安慰剂组,干预 3 个月后具有小到中等的效应大小;然而,组间差异无统计学意义。(17.5%)、(15.1%)、(14.3%)、(10.3%)和(7.1%)是最常开的药物;(13.3%)、(10.3%)和(7.1%)是最有效的药物。两组均未报告任何伤害、意外作用、顺势疗法加重或任何严重不良事件。

结论

在 AV 的治疗中,顺势疗法与安慰剂相比具有非显著的有利作用方向。

试验注册

CTRI/2018/11/016248;UTN:U1111-1221-8164。

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