{"title":"个体化顺势疗法药物产品在治疗 COVID-19 后遗症中的应用:双盲、随机、安慰剂对照、可行性试验。","authors":"Abhijit Rana, Pulakendu Bhattacharya, Subhasish Ganguly, Sangita Saha, Satyajit Naskar, Shubhamoy Ghosh, Abdur Rahaman Shaikh, Munmun Koley, Subhranil Saha, Shyamal Kumar Mukherjee","doi":"10.1089/jicm.2024.0102","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Objectives:</i></b> Evidence suggests that post-coronavirus disease 2019 (COVID-19) is associated with reduced health-related quality of life, and up to 80% of those infected with COVID-19 may experience these symptoms. The objective of the present study was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in postCOVID-19 conditions. <b><i>Design:</i></b> Double-blind, randomized (1:1), two parallel arms, placebo-controlled, feasibility trial. <b><i>Setting:</i></b> D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. <b><i>Subjects:</i></b> Sixty participants with post-COVID-19 conditions. <b><i>Interventions:</i></b> Group verum (<i>n</i> = 30; IHMPs plus concomitant care) versus group control (<i>n</i> = 30; placebos plus concomitant care). <b><i>Outcome Measures:</i></b> Feasibility issues; primary-post-COVID-19 symptoms checklist; secondary-Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen's <i>d</i>). <b><i>Results:</i></b> Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: -4.2, 95% CI -4.9 to -3.4, <i>d</i> = 2.854 and MYMOP-2 mean difference after 3 months: -2.2, 95% CI -2.8 to -1.7, <i>d</i> = 2.082, respectively. <i>Natrum muriaticum</i> (11.7%), <i>Pulsatilla nigricans</i> (10%), <i>Rhus toxicodendron</i> (8.3%), and <i>Calcarea carbonica</i> (8.3%) were the most frequently prescribed remedies. <b><i>Conclusions:</i></b> IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.</p>","PeriodicalId":29734,"journal":{"name":"Journal of Integrative and Complementary Medicine","volume":" ","pages":"64-74"},"PeriodicalIF":1.3000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Individualized Homeopathic Medicinal Products in the Treatment of Post-COVID-19 Conditions: A Double-Blind, Randomized, Placebo-Controlled, Feasibility Trial.\",\"authors\":\"Abhijit Rana, Pulakendu Bhattacharya, Subhasish Ganguly, Sangita Saha, Satyajit Naskar, Shubhamoy Ghosh, Abdur Rahaman Shaikh, Munmun Koley, Subhranil Saha, Shyamal Kumar Mukherjee\",\"doi\":\"10.1089/jicm.2024.0102\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Objectives:</i></b> Evidence suggests that post-coronavirus disease 2019 (COVID-19) is associated with reduced health-related quality of life, and up to 80% of those infected with COVID-19 may experience these symptoms. The objective of the present study was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in postCOVID-19 conditions. <b><i>Design:</i></b> Double-blind, randomized (1:1), two parallel arms, placebo-controlled, feasibility trial. <b><i>Setting:</i></b> D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. <b><i>Subjects:</i></b> Sixty participants with post-COVID-19 conditions. <b><i>Interventions:</i></b> Group verum (<i>n</i> = 30; IHMPs plus concomitant care) versus group control (<i>n</i> = 30; placebos plus concomitant care). <b><i>Outcome Measures:</i></b> Feasibility issues; primary-post-COVID-19 symptoms checklist; secondary-Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen's <i>d</i>). <b><i>Results:</i></b> Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: -4.2, 95% CI -4.9 to -3.4, <i>d</i> = 2.854 and MYMOP-2 mean difference after 3 months: -2.2, 95% CI -2.8 to -1.7, <i>d</i> = 2.082, respectively. <i>Natrum muriaticum</i> (11.7%), <i>Pulsatilla nigricans</i> (10%), <i>Rhus toxicodendron</i> (8.3%), and <i>Calcarea carbonica</i> (8.3%) were the most frequently prescribed remedies. <b><i>Conclusions:</i></b> IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.</p>\",\"PeriodicalId\":29734,\"journal\":{\"name\":\"Journal of Integrative and Complementary Medicine\",\"volume\":\" \",\"pages\":\"64-74\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Integrative and Complementary Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1089/jicm.2024.0102\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Integrative and Complementary Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1089/jicm.2024.0102","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/25 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
目的:有证据表明,2019年后冠状病毒病(COVID-19)与健康相关的生活质量下降有关,多达80%的COVID-19感染者可能会出现这些症状。本研究旨在确定个体化顺势疗法药物产品(IHMPs)与安慰剂在COVID-19后症状中的对比效果。设计:双盲、随机(1:1)、两组平行、安慰剂对照、可行性试验。试验地点印度西孟加拉邦加尔各答 D. N. De 顺势疗法医学院和医院。受试者:60名患有COVID-19后遗症的参与者。干预措施:verum组(n = 30;IHMPs加辅助护理)与对照组(n = 30;安慰剂加辅助护理)。结果测量:可行性问题;主要--COVID-19 后症状检查表;次要--Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2);所有测量均在基线和每月间隔期进行,直至 3 个月。对意向治疗样本进行了分析;采用描述性统计方法报告了组间差异:平均值、95% 置信区间(CI)和组间效应大小(Cohen's d)。结果可行性研究结果表明,招募率、保留率和流失率分别为 34.2%、95% 和 5%。与安慰剂相比,IHMPs 在主要结果和次要结果上的组间差异更有利:3 个月后症状检查表得分的平均差异为-4.2,95% C:3个月后症状核对表得分平均差异:-4.2,95% CI -4.9至-3.4,d = 2.854;3个月后MYMOP-2平均差异:-2.2,95% CI -4.9至-3.4,d = 2.854:分别为-2.2,95% CI -2.8至-1.7,d = 2.082。最常使用的处方药是鼠曲草(11.7%)、白头翁(10%)、毒玫瑰(8.3%)和石菖蒲(8.3%)。结论在治疗 COVID-19 后遗症时,IHMP 在降低症状检查表评分和 MYMOP-2 评分方面的效果优于安慰剂。有必要进行最终试验来证实这些发现。
Individualized Homeopathic Medicinal Products in the Treatment of Post-COVID-19 Conditions: A Double-Blind, Randomized, Placebo-Controlled, Feasibility Trial.
Objectives: Evidence suggests that post-coronavirus disease 2019 (COVID-19) is associated with reduced health-related quality of life, and up to 80% of those infected with COVID-19 may experience these symptoms. The objective of the present study was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in postCOVID-19 conditions. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled, feasibility trial. Setting: D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. Subjects: Sixty participants with post-COVID-19 conditions. Interventions: Group verum (n = 30; IHMPs plus concomitant care) versus group control (n = 30; placebos plus concomitant care). Outcome Measures: Feasibility issues; primary-post-COVID-19 symptoms checklist; secondary-Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen's d). Results: Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: -4.2, 95% CI -4.9 to -3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: -2.2, 95% CI -2.8 to -1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies. Conclusions: IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.