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Acute and Sub-acute Oral Toxicity Assessment of Ferrum phosphoricum in Rats. 大鼠口服亚铁的急性和亚急性毒性评估
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-05-01 Epub Date: 2023-08-21 DOI: 10.1055/s-0043-1770338
Mahima Sharma, Sangita Behera, Raj Kumar Regar, Deepika Tripathi, Satvinder Singh, Narasimha G V Kumar, Pankaj Gupta

Background: Ferrum phosphoricum (FP) has been used by traditional medicine practitioners for various ailments since ancient times. However, scientific evidence on the safety of FP is still unavailable. Thus, the current study aimed to investigate the acute and sub-acute oral toxicity of homeopathic FP in experimental rats.

Methods:  In an acute toxicity investigation, a single dose of 2,000 µL/kg of FP 6c, 30c and 200c was administered to female Wistar rats, which were monitored for up to 14 days according to the Organization for Economic Cooperation and Development (OECD) guideline 423. For a sub-acute toxicity study, FP 6c, 30c and 200c (200 µL/kg) were administered to male and female rats for 28 days as per the OECD guideline 407. All the animals were observed for mortality, clinical signs and body weight during the study. At the end of the experiment, hematological, biochemical and histopathological assessments were performed.

Results:  During the acute toxicity study, no mortality was observed in rats administered with FP, and thus the median lethal dose (LD50) was identified as >2,000 µL/kg. In the sub-acute study, no mortality or adverse clinical signs were noticed with FP treatment. Moreover, weekly body weight gain was normal. Hematological and biochemical investigations revealed no abnormalities. Furthermore, histological analysis of FP-treated rats' vital organs revealed no pathological changes.

Conclusion:  Overall, our findings imply that FP 6c, 30c and 200c potencies are safe and do not cause toxicity when given orally to Wistar albino rats for an extended period at a dose of 200 µL/kg.

背景:磷酸亚铁(Ferrum phosphoricum,FP)自古以来就被传统医师用于治疗各种疾病。然而,有关磷铁剂安全性的科学证据仍然缺乏。因此,本研究旨在调查顺势疗法 FP 在实验大鼠中的急性和亚急性口服毒性:在急性毒性研究中,按照经济合作与发展组织(OECD)准则 423,给雌性 Wistar 大鼠口服单剂量 2,000 µL/kg的 FP 6c、30c 和 200c,并对其进行长达 14 天的监测。在亚急性毒性研究中,根据经合组织准则 407,给雄性和雌性大鼠注射 FP 6c、30c 和 200c(200 µL/kg),为期 28 天。研究期间观察了所有动物的死亡率、临床症状和体重。实验结束时,对动物进行血液学、生物化学和组织病理学评估:结果:在急性毒性研究中,使用 FP 的大鼠没有出现死亡现象,因此中位致死剂量(LD50)大于 2,000 µL/kg。在亚急性研究中,使用 FP 治疗的大鼠没有出现死亡或不良临床症状。此外,每周体重增长正常。血液和生化检查未发现异常。此外,对 FP 治疗大鼠重要器官的组织学分析也未发现病理变化:总之,我们的研究结果表明,给 Wistar albino 大鼠长期口服 200 µL/kg 剂量的 FP 6c、30c 和 200c 是安全的,不会引起中毒。
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引用次数: 0
Brief Overview of Clinical Evidence for Homeopathic Interventions in the Management of COVID-19 Patients. 新冠肺炎患者治疗中顺势疗法干预的临床证据概述。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-05-01 Epub Date: 2023-11-02 DOI: 10.1055/s-0043-1771375
Daniel M O Campos, Maria K Silva, Gabriel C F Morais, João F R Neto, Jonas I N Oliveira
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引用次数: 0
Brain Wave Oscillations as an Objective Neurophysiological Biomarker of Homeopathic Subjective Well-Being 脑电波振荡作为顺势主观幸福感的客观神经生理学生物标志物
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-18 DOI: 10.1055/s-0044-1779706
Marcus Zulian Teixeira

Background Homeopathy uses the “similitude principle” to arouse a therapeutic reaction in the body against its own disorders. For this to occur optimally, the medicinal pathogenetic effects must present similarity with the totality of the individual's symptoms. To assess if this similarity has been successfully achieved, Hahnemann states that “improvement in the disposition and mind”—i.e., subjective well-being—is the most important parameter to consider.

Aim Our aim was to perform a narrative review of the literature, exploring what is known about subjective well-being as a marker of therapeutic action, and to formulate ways in which subjective well-being might be quantifiable and applied in future homeopathy research.

Results The concept of subjective well-being has been extensively studied in the complementary and conventional medical literature. Improved well-being has been observed in clinical trials, including those in the fields of positive psychology and meditation. Positive subjective outcomes of this nature are supported by objective evidence through associated changes in brain oscillatory activity using electroencephalography and/or “brain mapping” by functional magnetic resonance imaging. Neurophysiological responses in the brain have been identified in subjects after they ingested a homeopathic medicine.

Conclusions The concept of subjective well-being is supported by a body of literature and is a measurable entity. When viewed from the perspective of electrophysiological changes, brain activity is an objective neurophysiological biomarker with a potential to quantify individual well-being in the context of homeopathy research.

背景 顺势疗法利用 "相似性原理 "来引起人体对自身疾病的治疗反应。为了达到最佳效果,药物的致病作用必须与患者的全部症状相似。哈尼曼指出,"性情和精神的改善"--即主观健康--是评估是否成功实现了这种相似性的最重要参数。目的 我们的目的是对文献进行叙述性综述,探索作为治疗作用标志的主观幸福感的相关知识,并制定可量化主观幸福感的方法,将其应用于未来的顺势疗法研究中。结果 补充医学和传统医学文献对主观幸福感的概念进行了广泛研究。在临床试验中,包括在积极心理学和冥想领域的试验中,都观察到了幸福感的改善。通过脑电图和/或功能性磁共振成像的 "大脑图谱 "观察大脑振荡活动的相关变化,这种性质的积极主观结果得到了客观证据的支持。受试者在摄入顺势疗法药物后,大脑神经生理反应得到了确认。结论 主观幸福感的概念得到了大量文献的支持,是一个可测量的实体。从电生理变化的角度来看,大脑活动是一种客观的神经生理生物标志物,有可能在顺势疗法研究中量化个人的幸福感。
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引用次数: 0
Management of Polycystic Ovarian Syndrome: A Qualitative Inquiry among Complementary and Alternative Medicine Practitioners in South Africa 多囊卵巢综合征的管理:南非补充和替代医学从业者的定性调查
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-18 DOI: 10.1055/s-0044-1779707
Faathimah Khan, Madhueshwaree Maharaj, Nalini Govender, Yasmeen Thandar

Background Polycystic ovarian syndrome (PCOS) is a complex reproductive endocrinopathy affecting 4–20% of females of reproductive age. PCOS and its consequent complications such as infertility, diabetes mellitus and cardiovascular disease significantly impact clinical management. Complementary and alternative medicine (CAM), including homeopathy, is gaining recognition in PCOS management. There remains a paucity of formal protocols for managing PCOS within homeopathy and other CAM systems.

Aims/objectives This study aimed to explore and document existing therapeutic practices in the management of PCOS from diagnosis to treatment used by practitioners within various disciplines of CAM: viz., homeopathy, ayurveda, unani tibb, traditional Chinese medicine (TCM) and naturopathy, in the context of their unique philosophical background.

Methods In this explorative, descriptive study, data were collected from CAM practitioners in eThekwini Municipality, KwaZulu Natal, South Africa, using semi-structured interviews and analysed using Tesch's and Creswell's methods for qualitative analysis.

Results Four themes emerged from the data, namely: CAM philosophical perspectives on PCOS, contributing factors, diagnosis of PCOS, and management of PCOS. Five sub-themes emerged: clinical diagnosis of PCOS, CAM-specific characterisation of PCOS, CAM-specific treatment of PCOS, adjunctive therapies, and lifestyle interventions. Homeopathic management comprised several prescribing methods, the most common ones being miasmatic/constitutional, keynote and clinical, alongside adjunctive therapies and lifestyle interventions. Other CAM modalities adopted similar holistic approaches.

Conclusions This paper offers a comprehensive exploration of the perceptions, clinical investigations and management practices in PCOS by homeopaths and four other CAM modalities – ayurveda, unani tibb, TCM and naturopathy – as documented in the study. Homeopaths and other CAM practitioners employed CAM-specific therapies, along with adjunctive therapies and lifestyle interventions, adopting holistic approaches. Enhancing the quality of life through emotional counselling, stress reduction and lifestyle improvements emerged as shared objectives across modalities. Our findings underscore the need to further explore inter-disciplinary collaboration in PCOS management among registered CAM practitioners, with the potential to expand the scope of comprehensive care for PCOS patients.

背景 多囊卵巢综合征(PCOS)是一种复杂的生殖内分泌疾病,影响 4-20% 的育龄女性。多囊卵巢综合征及其引发的并发症,如不孕症、糖尿病和心血管疾病,对临床治疗产生了重大影响。补充和替代医学(CAM),包括顺势疗法,在多囊卵巢综合症的治疗中正逐渐得到认可。在顺势疗法和其他 CAM 系统中,管理 PCOS 的正式方案仍然很少。目的/目标 本研究旨在探索和记录顺势疗法、阿育吠陀疗法、unani tibb、传统中医(TCM)和自然疗法等不同 CAM 学科的从业人员在管理 PCOS 方面从诊断到治疗的现有治疗方法,并结合其独特的哲学背景。方法 在这项探索性、描述性研究中,采用半结构化访谈法从南非夸祖鲁-纳塔尔省 eThekwini 市的 CAM 从业人员处收集数据,并采用 Tesch 和 Creswell 的定性分析方法对数据进行分析。结果 从数据中发现了四个主题,即CAM 对多囊卵巢综合症的哲学观点、诱因、多囊卵巢综合症的诊断和多囊卵巢综合症的管理。五个次主题分别是:多囊卵巢综合症的临床诊断、多囊卵巢综合症的特定 CAM 特征、多囊卵巢综合症的特定 CAM 治疗、辅助疗法和生活方式干预。顺势疗法包括几种处方方法,最常见的是瘴气/体制、基调和临床,以及辅助疗法和生活方式干预。其他 CAM 方式也采用了类似的整体方法。结论 本文全面探讨了研究中记录的顺势疗法和其他四种 CAM 方式(阿育吠陀、unani tibb、中医和自然疗法)对多囊卵巢综合症的看法、临床调查和管理方法。顺势疗法和其他 CAM 医师采用了 CAM 特定疗法以及辅助疗法和生活方式干预措施,并采用了整体方法。通过情绪咨询、减压和改善生活方式来提高生活质量是各种疗法的共同目标。我们的研究结果表明,有必要进一步探讨注册中医师在多囊卵巢综合症管理方面的跨学科合作,这有可能扩大多囊卵巢综合症患者的综合治疗范围。
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引用次数: 0
Clinical Outcomes in Chronic Conditions: Findings from a Homeopathy Teaching Clinic using the MYCaW Instrument 慢性病的临床疗效:顺势疗法教学诊所使用 MYCaW 工具的研究结果
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-09 DOI: 10.1055/s-0044-1779337
Alastair C. Gray, Christine D. Luketic, Parker Pracjek, Denise Straiges

Background The Academy of Homeopathy Education is a US-based accredited teaching institution offering homeopathy education services to professional and medically licensed homeopathy students. This study reports on clinical outcomes from the teaching clinic from 2020 to 2021.

Methods Data collected using the patient-generated outcome measure, the Measure Yourself Concerns and Wellbeing (MYCaW), were anonymized. Mean MYCaW values for initial and subsequent consultations were analyzed for the degree of change across the intervention period in 38 clients. Each client listed up to two complaints. MYCaW scores between initial and subsequent consultations were analyzed for the degree of change (delta) across the intervention period.

Results A total of 95 body system-related symptoms were analyzed for change in intensity following the homeopathic intervention. Statistically significant improvements in the intensity of main symptoms were observed between initial and subsequent follow-ups. The main symptom scores showed a mean change in intensity (delta MYCaW) of −0.79 points (95% confidence interval (CI), −1.29 to −0.29; p = 0.003) at first follow-up, a mean change of −1.67 points (95% CI, −2.34 to −0.99; p = 0.001) at second follow-up compared with the initial visit, and a mean change of −1.93 points (95% CI, −3.0 to −0.86; p = 0.008) at third follow-up compared with the initial visit. For clients with four or more follow-ups, the mean delta MYCaW was −1.57 points (95% CI, −2.86 to −0.28; p = 0.039).

Conclusion Statistically significant improvements as well as some clinically meaningful changes in symptom intensity were found across a diverse group of individuals with a variety of long-term chronic conditions. The improvement was evident across different body systems and different levels of chronicity. There are limitations to the generalizability of the study due to the research design. Further research and investigation are warranted given the promising results of this work.

背景顺势疗法教育学院是美国一家经认可的教学机构,为专业和持有医疗执照的顺势疗法学生提供顺势疗法教育服务。本研究报告了2020年至2021年教学诊所的临床成果。方法 使用患者生成的结果测量--"测量自己的担忧和幸福感"(MYCaW)--收集的数据已匿名化。我们分析了 38 名患者在初次咨询和后续咨询中的 MYCaW 平均值,以了解他们在整个干预期间的变化程度。每位客户最多列出两项投诉。对初次咨询和后续咨询的 MYCaW 分数进行分析,以确定干预期间的变化程度(delta)。结果 共分析了 95 种身体系统相关症状在顺势疗法干预后的强度变化。在初次随访和随后的随访中,主要症状的强度有了统计学意义上的明显改善。在第一次随访时,主要症状评分的平均强度变化(delta MYCaW)为-0.79分(95%置信区间(CI),-1.29至-0.29;p = 0.003);在第二次随访时,平均强度变化为-1.67分(95%置信区间(CI),-2.34至-0.99;p = 0.001);在第三次随访时,平均强度变化为-1.93分(95%置信区间(CI),-3.0至-0.86;p = 0.008)。对于接受过四次或四次以上随访的受访者,MYCaW 的平均德尔塔值为-1.57 点(95% CI,-2.86 至 -0.28;p = 0.039)。结论 在患有各种长期慢性疾病的不同人群中发现,症状强度有了统计意义上的明显改善和一些有临床意义的变化。这种改善在不同的身体系统和不同的慢性病程度中都很明显。由于研究设计的原因,这项研究的推广性存在局限性。鉴于这项工作取得了可喜的成果,我们有必要开展进一步的研究和调查。
{"title":"Clinical Outcomes in Chronic Conditions: Findings from a Homeopathy Teaching Clinic using the MYCaW Instrument","authors":"Alastair C. Gray, Christine D. Luketic, Parker Pracjek, Denise Straiges","doi":"10.1055/s-0044-1779337","DOIUrl":"https://doi.org/10.1055/s-0044-1779337","url":null,"abstract":"<p>\u0000<b>Background</b> The Academy of Homeopathy Education is a US-based accredited teaching institution offering homeopathy education services to professional and medically licensed homeopathy students. This study reports on clinical outcomes from the teaching clinic from 2020 to 2021.</p> <p>\u0000<b>Methods</b> Data collected using the patient-generated outcome measure, the Measure Yourself Concerns and Wellbeing (MYCaW), were anonymized. Mean MYCaW values for initial and subsequent consultations were analyzed for the degree of change across the intervention period in 38 clients. Each client listed up to two complaints. MYCaW scores between initial and subsequent consultations were analyzed for the degree of change (delta) across the intervention period.</p> <p>\u0000<b>Results</b> A total of 95 body system-related symptoms were analyzed for change in intensity following the homeopathic intervention. Statistically significant improvements in the intensity of main symptoms were observed between initial and subsequent follow-ups. The main symptom scores showed a mean change in intensity (delta MYCaW) of −0.79 points (95% confidence interval (CI), −1.29 to −0.29; <i>p</i> = 0.003) at first follow-up, a mean change of −1.67 points (95% CI, −2.34 to −0.99; <i>p</i> = 0.001) at second follow-up compared with the initial visit, and a mean change of −1.93 points (95% CI, −3.0 to −0.86; <i>p</i> = 0.008) at third follow-up compared with the initial visit. For clients with four or more follow-ups, the mean delta MYCaW was −1.57 points (95% CI, −2.86 to −0.28; <i>p</i> = 0.039).</p> <p>\u0000<b>Conclusion</b> Statistically significant improvements as well as some clinically meaningful changes in symptom intensity were found across a diverse group of individuals with a variety of long-term chronic conditions. The improvement was evident across different body systems and different levels of chronicity. There are limitations to the generalizability of the study due to the research design. Further research and investigation are warranted given the promising results of this work.</p> ","PeriodicalId":13227,"journal":{"name":"Homeopathy","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140589446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing the Feasibility of a Two-Cohort Design to Assess the Potential of Homeopathic Medicinal Products to Reduce Antimicrobial Resistance in Turkeys (The HOMAMR Project)—Study Protocol 评估顺势疗法药用产品降低火鸡抗菌药耐药性的潜力(HOMAMR 项目)--研究方案
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-04 DOI: 10.1055/s-0044-1781448
Silvia Baur-Bernhardt, Annemarie Käsbohrer, Marcus Georg Doherr, Diana Meemken, Lena Sonnenschein-Swanson, Birgit Ursula Stetina, Mary-Ann Sommer, Petra Weiermayer

Background Antimicrobial resistance (AMR) is a serious public health concern worldwide. The European Union requires a reduction in the use of antibiotics by 50% by 2030, with separate regulations on organic production that give preference to homeopathy and phytotherapy in organic farms before the use of conventional medicines (including antibiotics). We have therefore designed a two-phased project whose overarching aim is to investigate the potential role of homeopathic medicinal products (HMPs) in combating AMR in turkeys (the HOMAMR project): a two-cohort feasibility study using turkey-farm data that have been collected and analyzed retrospectively, followed by a prospective two-cohort study in turkey farms that would examine the impact of HMPs on changing antibiotic use.

Objective The objective of this paper is to describe the protocol for the first phase of HOMAMR, which is a study under field conditions to assess the feasibility of collecting data retrospectively about turkeys that have been managed conventionally only or with HMPs.

Methods Surveys performed on farms in Germany and Austria, including interviews with consenting farmers, will determine the feasibility of comparing retrospectively gathered data on antibiotic use and performance/production data in two cohorts of turkeys: (1) homeopathic treatment with conventional care (antibiotics) added if necessary or (2) conventional care (antibiotics) only. Co-primary outcomes to be studied are the amount of antimicrobial use and production period-related mortality. In addition, other production/performance parameters will be compared between the two treated cohorts.

Conclusion To our knowledge, this is the first feasibility study on the treatment of turkeys using homeopathy, and whose retrospectively obtained data will inform a prospective study that would examine the impact of HMPs on antibiotic use in commercial turkey raising, fattening and breeding production.

背景 抗菌药耐药性(AMR)是全球严重的公共卫生问题。欧盟要求到 2030 年将抗生素的使用量减少 50%,并对有机生产制定了单独的法规,规定有机农场在使用常规药物(包括抗生素)之前,优先使用顺势疗法和植物疗法。因此,我们设计了一个分两个阶段进行的项目(HOMAMR 项目),其总体目标是调查顺势疗法药物产品 (HMP) 在对抗火鸡 AMR 方面的潜在作用:利用已收集和分析的火鸡养殖场数据进行两组队列可行性研究,然后在火鸡养殖场进行两组队列前瞻性研究,考察 HMP 对改变抗生素使用的影响。目的 本文旨在介绍 HOMAMR 第一阶段的方案,即在实地条件下开展一项研究,以评估对只采用常规管理或使用 HMP 的火鸡进行回顾性数据收集的可行性。方法 在德国和奥地利的农场进行调查,包括对同意的农场主进行访谈,以确定对回顾性收集的两组火鸡抗生素使用数据和性能/生产数据进行比较的可行性:(1) 采用顺势疗法,必要时添加常规疗法(抗生素),或 (2) 仅采用常规疗法(抗生素)。研究的共同主要结果是抗菌药使用量和生产期相关死亡率。此外,还将比较两个治疗组群的其他生产/性能参数。结论 据我们所知,这是首个使用顺势疗法治疗火鸡的可行性研究,其回顾性数据将为前瞻性研究提供参考,该研究将考察顺势疗法对商业化火鸡饲养、育肥和繁殖生产中抗生素使用的影响。
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引用次数: 0
Homeopathic Pyrogenium Ointment as Adjuvant in Treatment of Traumatic and Infected Myiasis by Cochliomyia Hominivorax (Diptera: Calliphoridae) in Sheep: A Case Series. 顺势疗法火碱软膏作为辅助药物治疗绵羊的外伤性和感染性绵羊蜱螨病(Diptera: Calliphoridae):病例系列。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-03-28 DOI: 10.1055/s-0043-1778066
Giuliano Pereira de Barros, Denise Pereira Leme, Patrizia Ana Bricarello

Background:  The blowfly Cochliomyia hominivorax (Diptera: Calliphoridae) causes traumatic myiasis in farm animals, with deeply embedded larvae that lead to serious tissue damage and sometimes death. Treating this form of myiasis is difficult, often resulting in poor outcomes. As a homeopathic preparation that can mimic traumatic myiasis symptoms, Pyrogenium could potentially supplement treatment. This study aimed to describe the adjuvant effect that a Pyrogenium ointment might have in the treatment of sheep with traumatic myiasis.

Patients:  The study reports a homeopathic adjuvant treatment with Pyrogenium 12cH ointment in six sheep with traumatic and infected myiasis. Daily clinical examinations were performed to monitor the evolution of the health of animals. Pyrogenium 12cH ointment was applied topically on the wounds, after cleaning and mechanical removal of the larvae from the lesion. Blood samples were collected for blood counts, and wound exudate samples were obtained for bacteriological examination before and after wound treatment.

Results:  The ointment of Pyrogenium 12cH limited the development of parasitic larvae and was associated with the repair of tissue losses resulting from the myiases and with subsequent wound healing, together with control of fever and local inflammation.

Conclusion:  Homeopathic Pyrogenium 12cH, formulated as an ointment, may be a useful new and adjuvant therapeutic option for treating traumatic and infected myiasis in animals.

背景:吹蝇(Cochliomyia hominivorax)(双翅目:Calliphoridae)会导致农场动物患上创伤性肌炎,其幼虫会深深地嵌入体内,导致严重的组织损伤,有时甚至死亡。治疗这种形式的绵蛆病很困难,往往效果不佳。作为一种能够模拟创伤性肌炎症状的顺势疗法制剂,Pyrogenium 有可能对治疗起到辅助作用。本研究旨在描述派罗欣软膏在治疗绵羊外伤性肌炎时可能产生的辅助效果:研究报告称,对六只患有外伤性和感染性肌炎的绵羊使用了 12cH Pyrogenium 软膏进行顺势疗法辅助治疗。每天进行临床检查,以监测动物的健康状况。在清洗并用机械方法清除病灶中的幼虫后,在伤口上局部涂抹 12cH Pyrogenium 软膏。在伤口处理前后,采集血液样本进行血细胞计数,并采集伤口渗出液样本进行细菌学检查:结果:12cH Pyrogenium 软膏限制了寄生幼虫的发育,修复了肌瘤造成的组织损失,促进了随后的伤口愈合,并控制了发烧和局部炎症:顺势疗法 Pyrogenium 12cH 软膏可能是治疗动物外伤性和感染性肌炎的一种有用的新辅助疗法。
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引用次数: 0
Homeopathy for Chronic Non-specific Low Back Pain: Study Protocol for a Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (The BIOVERT Trial). 顺势疗法治疗慢性非特异性腰痛:调查生物疗法腰椎疗效的随机、双盲、交叉、安慰剂对照临床试验(BIOVERT 试验)研究方案。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-03-20 DOI: 10.1055/s-0043-1778062
Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Helen Nogueira Carrer, Deise Lilian Costa Dias, José Nelson Martins Diniz, Manoela Gomes Grossi, Neli Aparecida Martins Sugimoto, Edson Zangiacomi Martinez

Background:  Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra, have shown promise in alleviating CNSLBP.

Objectives:  Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration.

Methods:  A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight.

Discussion:  The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP.

Trial registration:  UMIN Clinical Trials Registry - ID: UMIN000051957.

背景:慢性非特异性腰背痛(CNSLBP)缺乏可识别的解剖病理和有效的药物治疗。顺势疗法的替代方法,特别是临床顺势疗法,利用超稀释(增效)生物制品。在巴西,来自绵羊组织的标准化生物疗法,特别是五十毫升(LM)药效的绵羊腰椎,已显示出缓解中枢神经系统脑病的前景:我们的目的是介绍一项临床试验的研究方案,该方案将评估生物疗法绵羊腰椎 LM2 在短期治疗 CNSLBP 方面的有效性和安全性,并估计其治疗持续时间:方法:设计了一项随机、双盲、交叉、安慰剂对照临床试验,每位参与者为期 8 周。参与者包括 120 名经理疗师临床诊断为 CNSLBP 的患者(20 至 60 岁)。排除标准包括根性疼痛、根病迹象、特定腰椎疾病、怀孕或产褥期(产后 60 天内)。医疗干预包括将参与者随机分配到两种治疗顺序中的一种:顺势疗法-安慰剂或安慰剂-顺势疗法。治疗将由腰椎 LM2 口服液、外用药膏和无差别的安慰剂组成。每个疗程为 2 周,中间有 4 周的缓冲期。主要结果是使用数字评分量表(NRS)评分评估自我报告疼痛程度的变化,采用随机效应模型对两个治疗期进行分析。次要结果是使用奥斯韦特里残疾指数(ODI)评估自述残疾程度的变化,采用随机效应模型对两个治疗期进行分析;在第一和第二个治疗期后,分别用 NRS 评分和 ODI 评估疼痛和残疾的变化。不良反应将在第 2 周和第 8 周进行评估。止痛药将同时使用。用药依从性将根据退药重量/标准重量进行评估:BIOVERT(生物活性椎体)试验方案旨在研究顺势疗法对中枢神经系统瘫痪症的短期治疗策略。顺势疗法的有利结果可能会促使后续研究评估腰椎间盘突出症 LM 药效的长期有效性:UMIN 临床试验注册 - ID:UMIN000051957.
{"title":"Homeopathy for Chronic Non-specific Low Back Pain: Study Protocol for a Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (The BIOVERT Trial).","authors":"Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Helen Nogueira Carrer, Deise Lilian Costa Dias, José Nelson Martins Diniz, Manoela Gomes Grossi, Neli Aparecida Martins Sugimoto, Edson Zangiacomi Martinez","doi":"10.1055/s-0043-1778062","DOIUrl":"https://doi.org/10.1055/s-0043-1778062","url":null,"abstract":"<p><strong>Background: </strong> Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep <i>Lumbar Vertebra</i>, have shown promise in alleviating CNSLBP.</p><p><strong>Objectives: </strong> Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic <i>Lumbar Vertebra</i> LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration.</p><p><strong>Methods: </strong> A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of <i>Lumbar Vertebra</i> LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight.</p><p><strong>Discussion: </strong> The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of <i>Lumbar Vertebra</i> for CNSLBP.</p><p><strong>Trial registration: </strong> UMIN Clinical Trials Registry - ID: UMIN000051957.</p>","PeriodicalId":13227,"journal":{"name":"Homeopathy","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Facilitating Healing in Diabetic Foot Ulcers Using Homeopathy in a Multi-Disciplinary Integrative Approach: Two Evidence-Based Case Reports. 在多学科综合疗法中使用顺势疗法促进糖尿病足溃疡的愈合:两例循证病例报告
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-03-05 DOI: 10.1055/s-0044-1779723
Hima Bindu Ponnam

Background:  A rising incidence of diabetic foot ulcers (DFUs) in India has escalated the rate of lower limb amputations in the country. The present study aims to evaluate the potential healing properties of homeopathic medicines as a part of the integrative management of DFUs through two evidence-based case reports.

Methods:  Two patients with DFUs, identified as Wagner grade 2, having had diabetes for 12 years, were treated with individualized homeopathic medicine within a multi-disciplinary approach. Both cases were on oral hypoglycemic agents for managing blood sugar, continued their diabetic medication, and were advised to use regular wound dressings. The DFUs were assessed using the Pressure Ulcer Scale for Healing (PUSH) score at baseline and every 4 weeks until complete wound healing. Neuropathic changes were evaluated by the 10g monofilament tactile test, and the Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory (MONARCH) tool was used to assess the likelihood of there being a causal relationship between clinical improvement and the homeopathic intervention.

Results:  The DFUs showed healing within 12 weeks, with a significant improvement in the PUSH score, though there was no change in tactile sensation as assessed by the monofilament test. The MONARCH tool yielded +9 in both cases, indicating the likelihood of a causal relationship between the clinical outcome and homeopathic intervention. The homeopathic medicines Arsenicum album and Lachesis respectively were found useful by each patient.

Conclusion:  Homeopathy appeared beneficial in facilitating the early healing of DFUs within a multi-disciplinary integrative approach.

背景:印度糖尿病足溃疡(DFUs)发病率不断上升,导致该国下肢截肢率上升。本研究旨在通过两份循证病例报告,评估顺势疗法药物作为综合治疗糖尿病足溃疡的一部分所具有的潜在治疗特性:两名 DFU 患者被确定为 Wagner 2 级,患糖尿病已有 12 年之久,他们在多学科治疗方法中接受了个性化顺势疗法治疗。两例患者均使用口服降糖药控制血糖,继续服用糖尿病药物,并被建议定期使用伤口敷料。在基线和每 4 周对 DFU 进行一次伤口愈合压力溃疡量表(PUSH)评分,直至伤口完全愈合。通过10克单丝触觉测试评估神经病理性变化,并使用顺势疗法因果归因清单(MONARCH)工具评估临床改善与顺势疗法干预之间存在因果关系的可能性:DFU在12周内痊愈,PUSH评分显著提高,但单丝测试评估的触觉没有变化。两个病例的 MONARCH 工具结果均为 +9,表明临床结果与顺势疗法干预之间可能存在因果关系。每位患者都认为顺势疗法药物砒霜和拉奇斯有用:在多学科综合疗法中,顺势疗法似乎有利于促进 DFU 的早期愈合。
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引用次数: 0
Action of Carduus marianus 6cH on Hepatopathy and Gallstone in Ambystoma mexicanum (Axolotl): Case Report. Carduus marianus 6cH 对墨西哥角龙肝病和胆石症的作用:病例报告。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-29 DOI: 10.1055/s-0043-1778686
Jéssica Amâncio Martins, Melina Castilho de Souza Balbueno, Cidéli de Paula Coelho

Background: Carduus marianus is a Mediterranean plant used for treating liver diseases. One of its properties is that it inhibits fat peroxidation, which can contribute toward the prevention of metabolites that are harmful to the liver.

Objective:  The aim of this study was to describe the treatment of fatty liver disease in an axolotl (Ambystoma mexicanum).

Methods:  An approximately 6-year-old female specimen of A. mexicanum, of length 21 cm and weight 153 g, presented edema in the rostral region and inappetence. Ultrasound showed hepatopathy and a gallbladder stone. A globule of C. marianus 6cH was diluted in 30 mL distilled water and administered in spray form over the animal twice a day.

Results:  Twenty days after the beginning of the treatment, improvement of the facial edema and return of appetite were observed. Ultrasound showed improvement in the appearance of the liver and reduction in the size of the gallstone. The Modified Naranjo Criteria for Homeopathy score was +9 in this case, thus suggesting a causal relationship between the use of homeopathic medicine and the clinical outcome.

Conclusion: C. marianus 6cH appeared to be effective in treating fatty liver disease and gallstone in this specimen of A. mexicanum.

背景:红豆杉是一种地中海植物,可用于治疗肝病。它的特性之一是抑制脂肪过氧化,从而有助于预防对肝脏有害的代谢物:本研究的目的是描述治疗斧头鱼(Ambystoma mexicanum)脂肪肝的方法:一只约 6 岁的雌性墨西哥腋螈标本,体长 21 厘米,体重 153 克,喙区水肿,食欲不振。超声波检查显示其患有肝病和胆囊结石。用 30 毫升蒸馏水稀释一粒马钱子 6cH,以喷雾形式喷洒在动物身上,每天两次:治疗开始 20 天后,动物面部水肿有所改善,食欲恢复。超声波检查显示肝脏外观有所改善,胆石体积缩小。该病例的顺势疗法改良纳兰霍标准评分为 +9,这表明使用顺势疗法药物与临床结果之间存在因果关系:结论:C. marianus 6cH 似乎对治疗墨西哥鼠脂肪肝和胆石症有效。
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引用次数: 0
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