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随机、双盲、安慰剂对照、个体化顺势疗法药物治疗皮肤疣的初步试验。

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts.

机构信息

Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.

D.N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.

出版信息

Homeopathy. 2021 Aug;110(3):149-159. doi: 10.1055/s-0040-1722232. Epub 2021 Mar 24.

Abstract

BACKGROUND

Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts.

METHODS

A double-blind, randomized, placebo-controlled trial ( = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH ( = 30) or identical-looking placebo ( = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample.

RESULTS

Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all > 0.05, Mann-Whitney tests) with small effect sizes-both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2];  = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7];  = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8];  = 0.935). (28.3%), (10%) and (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported.

CONCLUSION

As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted.

TRIAL REGISTRATION

CTRI/2019/10/021659; UTN: U1111-1241-7340.

摘要

背景

尽管顺势疗法在实践中经常被使用,但研究表明其在治疗疣方面的疗效尚无定论。我们旨在评估未来确定性试验的可行性,并初步评估个体化顺势疗法(IH)药物与安慰剂在治疗皮肤疣方面的差异。

方法

在西孟加拉邦的 D.N. 顺势疗法医学院和医院皮肤科门诊进行了一项双盲、随机、安慰剂对照试验( = 60)。患者被随机分配接受 IH( = 30)或外观相同的安慰剂( = 30)。主要结局指标是疣的数量和大小;次要结局是基线时以及治疗后 3 个月内每月测量的皮肤病生活质量指数(DLQI)问卷。基于意向治疗样本计算组间差异和效应大小。

结果

失访率为 11.6%(IH 组 3 例,安慰剂组 4 例)。IH 组的组内变化明显大于安慰剂组(所有 < 0.05,弗里德曼检验)。组间差异无统计学意义(所有 > 0.05,曼-惠特尼检验),且效应大小较小-主要结局(治疗 3 个月后的疣数:IH 中位数[四分位距;IQR]为 1 [1, 3],安慰剂为 1 [1, 2]; = 0.741;治疗 3 个月后的疣大小:IH 5.6 mm [2.6, 40.2] vs. 安慰剂 6.3 [0.8, 16.7]; = 0.515)和次要结局(治疗 3 个月后的 DLQI 总分:IH 4.5 [2, 6.2] vs. 安慰剂 4.5 [2.5, 8]; = 0.935)。最常开的药物是(28.3%)、(10%)和(8.3%)。未报告任何伤害、顺势疗法恶化或严重不良事件。

结论

就疗效而言,初步研究结果尚无定论,具有统计学意义的效应方向有利于顺势疗法。该试验成功表明,一项充分有力的确定性试验既可行又有必要。

试验注册

CTRI/2019/10/021659;UTN:U1111-1241-7340。

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