Add-on Psoralea corylifolia mother tincture external application to individualized homeopathic medicines in treatment of vitiligo: Open, randomized, pragmatic, pilot trial
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
{"title":"Add-on Psoralea corylifolia mother tincture external application to individualized homeopathic medicines in treatment of vitiligo: Open, randomized, pragmatic, pilot trial","authors":"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","doi":"10.1016/j.aimed.2021.03.003","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p><span>Vitiligo<span> causes patchy hypo-pigmentation of skin and mucous membrane, with cosmetic and psychological effects. Studies suggest </span></span><span><em>Psoralea corylifolia</em></span><span> (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.</span></p></div><div><h3>Methods</h3><p><span><span>An open, randomized (1:1:1), three parallel arms, pragmatic, pilot trial was conducted on 60 patients at the dermatology and </span>Materia Medica outpatients of National Institute of Homoeopathy (NIH), India. Primary outcome was Vitiligo Area Scoring Index (VASI); and secondary outcomes were Vitiligo </span>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.</p></div><div><h3>Results</h3><p>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 (<em>P</em> < 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 (<em>P</em> = 0.038 and 0.037 respectively) favoring PC and IHPC respectively.</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.aimed.2021.03.003","citationCount":"3","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958821000227","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
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.
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.