{"title":"个体化顺势疗法药物治疗体癣:双盲、随机、安慰剂对照试验。","authors":"Bakibillah Laskar, Swapan Paul, Abhijit Chattopadhyay, Avaranjika Karuppusamy, Dharshna Balamurugan, Puja Bhakta, Sourav Das, Siddhartha Pal, Navin Kumar Singh, Munmun Koley, Subhranil Saha","doi":"10.1055/s-0042-1750799","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by <i>Microsporum</i>, <i>Epidermophyton</i> and <i>Trichophyton</i> genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC.</p><p><strong>Methods: </strong>A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales - degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences.</p><p><strong>Results: </strong>The primary outcome revealed no improvement in either of the groups (<i>χ</i> <sup>2</sup> = 0.012, <i>p</i> = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo - itching NRS (mean group difference after 3 months: -0.7 (95% confidence interval [CI], -1.1 to -0.4; <i>p</i> = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, -0.6 to 7.0; <i>p</i> = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, -0.2 to 1.9; <i>p</i> = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0-3.4; <i>p</i> = 0.002]).</p><p><strong>Conclusion: </strong>Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months.</p><p><strong>Trial registration: </strong>CTRI/2019/11/021999; UTN: U1111-1242-0070.</p>","PeriodicalId":13227,"journal":{"name":"Homeopathy","volume":"112 2","pages":"74-84"},"PeriodicalIF":1.2000,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Individualized Homeopathic Medicines in the Treatment of Tinea Corporis: Double-Blind, Randomized, Placebo-Controlled Trial.\",\"authors\":\"Bakibillah Laskar, Swapan Paul, Abhijit Chattopadhyay, Avaranjika Karuppusamy, Dharshna Balamurugan, Puja Bhakta, Sourav Das, Siddhartha Pal, Navin Kumar Singh, Munmun Koley, Subhranil Saha\",\"doi\":\"10.1055/s-0042-1750799\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by <i>Microsporum</i>, <i>Epidermophyton</i> and <i>Trichophyton</i> genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC.</p><p><strong>Methods: </strong>A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales - degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences.</p><p><strong>Results: </strong>The primary outcome revealed no improvement in either of the groups (<i>χ</i> <sup>2</sup> = 0.012, <i>p</i> = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo - itching NRS (mean group difference after 3 months: -0.7 (95% confidence interval [CI], -1.1 to -0.4; <i>p</i> = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, -0.6 to 7.0; <i>p</i> = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, -0.2 to 1.9; <i>p</i> = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0-3.4; <i>p</i> = 0.002]).</p><p><strong>Conclusion: </strong>Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months.</p><p><strong>Trial registration: </strong>CTRI/2019/11/021999; UTN: U1111-1242-0070.</p>\",\"PeriodicalId\":13227,\"journal\":{\"name\":\"Homeopathy\",\"volume\":\"112 2\",\"pages\":\"74-84\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2023-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Homeopathy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1055/s-0042-1750799\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Homeopathy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1055/s-0042-1750799","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
Individualized Homeopathic Medicines in the Treatment of Tinea Corporis: Double-Blind, Randomized, Placebo-Controlled Trial.
Introduction: Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by Microsporum, Epidermophyton and Trichophyton genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC.
Methods: A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales - degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences.
Results: The primary outcome revealed no improvement in either of the groups (χ2 = 0.012, p = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo - itching NRS (mean group difference after 3 months: -0.7 (95% confidence interval [CI], -1.1 to -0.4; p = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, -0.6 to 7.0; p = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, -0.2 to 1.9; p = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0-3.4; p = 0.002]).
Conclusion: Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months.
期刊介绍：
Homeopathy is an international peer-reviewed journal aimed at improving the fundamental understanding and clinical practice of homeopathy by publishing relevant high-quality original research articles, reviews, and case reports. It also promotes commentary and debate on matters of topical interest in homeopathy.
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