Add-on Psoralea corylifolia mother tincture external application to individualized homeopathic medicines in treatment of vitiligo: Open, randomized, pragmatic, pilot trial

IF 1.7 Q2 Medicine Advances in integrative medicine Pub Date : 2022-03-01 DOI:10.1016/j.aimed.2021.03.003
Anaitulah Ahmad Mir , Ghulam Nabi Wani , Ramkripal Prajapati , Nitin Saklani , Avaranjika Karuppusamy , Pankaj Kanti Jha , Abhijit Chattopadhyay , Chintamani Nayak , Swapan Paul , Sk. Swaif Ali , Munmun Koley , Subhranil Saha
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引用次数: 3

Abstract

Background

Vitiligo causes patchy hypo-pigmentation of skin and mucous membrane, with cosmetic and psychological effects. Studies suggest Psoralea corylifolia (PC) has pigmentor properties and that individualized homeopathic medicines (IH) are a promising treatment option in vitiligo. This pilot trial was aimed at testing the feasibility of a future definitive trial comparing the effects of three treatment regimens – 1. IH, 2. PC mother tincture (MT) external application, and 3. IH and PC (IHPC) in the treatment of vitiligo.

Methods

An open, randomized (1:1:1), three parallel arms, pragmatic, pilot trial was conducted on 60 patients at the dermatology and Materia Medica outpatients of National Institute of Homoeopathy (NIH), India. Primary outcome was Vitiligo Area Scoring Index (VASI); and secondary outcomes were Vitiligo Quality of Life (VitiQoL) and Dermatological Life Quality Index (DLQI); assessed at baseline, 3rd month and 6th month. Intention-to-treat analysis was performed; intra-group and inter-group comparisons were made by Friedman and Kruskal-Wallis tests respectively.

Results

Five patients dropped out (IH: 2, PC: 2, IHPC: 1). Intra-group changes over 3 and 6 months were mostly statistically significant in all 3 outcomes (P < 0.001). No significant differences were observed in VASI and DLQI total scores among the three groups over either 3 or 6 months. Differences among groups after 3 and 6 months showed statistical significances in VitiQoL total scores (P = 0.038 and 0.037 respectively) favoring PC and IHPC respectively.

Conclusion

A definitive trial appears feasible. All three regimens appeared equally effective and safe, though a small positive direction of effect towards PC and IHPC was observed. As a pilot trial, no definite conclusions could be drawn. Trial registration: CTRI/2018/04/013446.

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补骨脂母酊剂外敷个体化顺势疗法药物治疗白癜风:开放、随机、务实、试点试验
背景白癜风引起皮肤和粘膜色素沉着斑片状,具有美容和心理影响。研究表明,银屑病(PC)具有色素特性,个体化顺势疗法药物(IH)是白癜风治疗的一个有希望的选择。该试点试验旨在测试未来确定试验的可行性,比较三种治疗方案的效果。IH 2。PC母酊剂(MT)外用;IH和PC (IHPC)在白癜风治疗中的应用。方法采用开放、随机(1:1:1)、三平行臂、务实的方法,对印度国立顺势疗法研究所皮肤科和本草科门诊60例患者进行临床试验。主要终点为白癜风区域评分指数(VASI);次要结局为白癜风生活质量(VitiQoL)和皮肤病生活质量指数(DLQI);在基线、第3个月和第6个月进行评估。进行意向治疗分析;组内比较采用Friedman检验,组间比较采用Kruskal-Wallis检验。结果5例患者退出(IH: 2例,PC: 2例,IHPC: 1例),3个月和6个月组内变化均有统计学意义(P <0.001)。在3个月或6个月期间,三组患者VASI和DLQI总分均无显著差异。治疗后3、6个月各组间VitiQoL总分分别以PC组和IHPC组为优,差异有统计学意义(P = 0.038、0.037)。结论一项明确的试验是可行的。所有三种方案似乎同样有效和安全,尽管观察到对PC和IHPC的小的积极方向的影响。作为一项试点试验,不能得出明确的结论。试验报名:CTRI/2018/04/013446。
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来源期刊
Advances in integrative medicine
Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
3.20
自引率
11.80%
发文量
0
审稿时长
15 weeks
期刊介绍: Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.
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