{"title":"个体化顺势疗法药物治疗成人特应性皮炎的双盲、随机、安慰剂对照试验:一项6个月随访的复制试验。","authors":"Sanjukta Mandal, Shubhamoy Ghosh, Aakash Deep Das, Bikash Biswas, Chithra Palanisamy, Nilanjana Guha, Shukdeb Maiti, Souvik Dutta, Navin Kumar Singh, Munmun Koley, Subhranil Saha","doi":"10.1055/s-0042-1760339","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD.</p><p><strong>Methods: </strong>In this double-blind, randomized, placebo-controlled trial of 6 months' duration (<i>n</i> = 60), adult patients were randomized to receive either IHMs (<i>n</i> = 30) or identical-looking placebos (<i>n</i> = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample.</p><p><strong>Results: </strong>After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (<i>F</i> <sub>1, 52</sub> = 14.735; <i>p</i> <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: <i>F</i> <sub>1, 52</sub> = 0.019; <i>p</i> = 0.891; DLQI: <i>F</i> <sub>1, 52</sub> = 0.692; <i>p</i> = 0.409).</p><p><strong>Conclusion: </strong>IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.</p>","PeriodicalId":13227,"journal":{"name":"Homeopathy","volume":" ","pages":"251-261"},"PeriodicalIF":1.2000,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up.\",\"authors\":\"Sanjukta Mandal, Shubhamoy Ghosh, Aakash Deep Das, Bikash Biswas, Chithra Palanisamy, Nilanjana Guha, Shukdeb Maiti, Souvik Dutta, Navin Kumar Singh, Munmun Koley, Subhranil Saha\",\"doi\":\"10.1055/s-0042-1760339\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD.</p><p><strong>Methods: </strong>In this double-blind, randomized, placebo-controlled trial of 6 months' duration (<i>n</i> = 60), adult patients were randomized to receive either IHMs (<i>n</i> = 30) or identical-looking placebos (<i>n</i> = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample.</p><p><strong>Results: </strong>After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (<i>F</i> <sub>1, 52</sub> = 14.735; <i>p</i> <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: <i>F</i> <sub>1, 52</sub> = 0.019; <i>p</i> = 0.891; DLQI: <i>F</i> <sub>1, 52</sub> = 0.692; <i>p</i> = 0.409).</p><p><strong>Conclusion: </strong>IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.</p>\",\"PeriodicalId\":13227,\"journal\":{\"name\":\"Homeopathy\",\"volume\":\" \",\"pages\":\"251-261\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2023-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Homeopathy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1055/s-0042-1760339\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/3/7 0:00:00\",\"PubModel\":\"Epub\",\"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-0042-1760339","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/7 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up.
Background: Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD.
Methods: In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample.
Results: After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (F1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F1, 52 = 0.019; p = 0.891; DLQI: F1, 52 = 0.692; p = 0.409).
Conclusion: IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.
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.