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2.
Homeopathy ; 113(3): 131, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39059411
3.
Altern Ther Health Med ; 30(6): 16-25, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38843420

ABSTRACT

Background: Camphora officinarum (CO) is a commonly used homeopathic remedy for treating colds, collapse, and recurrent eruptive illnesses. Objective: Due to the non-availability of safety data on CO, the current study intended to determine the oral toxicity of CO in its ethanol-potentized dilutions 6C, 30C, and 200C in Wistar albino rats as per OECD guidelines. Materials and methods: A single oral dose of CO-6C, 30C, and 200C (2000 µl/kg) was administered, and the animals were monitored for behavior and mortality for up to 14 days in an acute toxicity study. In the subacute study, the effects of daily oral administration of CO-6C, 30C, and 200C (200 µl/kg) for 28 days were observed for clinical signs, change in body weight, and mortality. Hematological, biochemical, and histopathological analyses were assessed and organ weights were determined. Results: Results indicate no mortality of CO in its potencies in the acute toxicity study and was found to be safe at 2000 µl/kg dosage in the subacute toxicity study. CO (200 µl/kg/day) did not show any signs of toxicity in the hematological, biochemical, and histopathological analyses, along with organ weights. Conclusion: In conclusion, the findings suggest that CO in potencies of 6C, 30C, and 200C is safe up to a single oral dose of 2000 µl/kg body weight, and the No Observed Adverse Effect Level (NOAEL) was determined to be greater than 200 µl/kg/day.


Subject(s)
Plant Extracts , Rats, Wistar , Animals , Rats , Plant Extracts/pharmacology , Plant Extracts/toxicity , Male , Toxicity Tests, Acute , Female , Homeopathy/methods , Dose-Response Relationship, Drug
4.
Altern Ther Health Med ; 30(5): 58-61, 2024 May.
Article in English | MEDLINE | ID: mdl-38819187

ABSTRACT

Background: Adenoid is a mass of lymphoid tissue seen in the posterior nasopharyngeal wall, generally seen in the pediatric age group, and it disappears as age advances till puberty. Patients with recurrent allergic rhinitis, otitis media, or persistent nasopharyngeal obstruction is associated with adenoid hypertrophy can be considered for adenoidectomy. Objective: To evaluate the potential role of Individualised Homeopathic medicine in managing allergic rhinitis and troublesome symptoms of upper respiratory tract in case of Enlarged adenoid. Method: An 8-year-old boy came with complaints of Allergic rhinitis, snoring, and recurrent upper respiratory tract infection. He had taken treatment for the same from modern medicine, but still, a recurrence of symptoms occurred. His radiological investigations showed grade II Adenoid Hypertrophy. The patient was advised surgical intervention, but their parents were unwilling to the same so the patient came for Homoeopathic Management. Individualized Homeopathic Medicine Calcarea carbonicum 200 C was prescribed to the patient. The patient's condition significantly improved during the course of his five years of treatment; his snoring has decreased, his allergic manifestations have diminished, and monthly check-ups have revealed that the patient's general and particular condition are improving. indicating the positive result of homeopathic medicine in the treatment of enlarged adenoid. Assessment of outcome is based on Radiological reports and modified Naranjo criteria. Result: Homoeopathic medicine Calcarea Carb 200 C is given to the patient based on the totality of symptoms. The incidence of allergic rhinitis has also declined following treatment. Furthermore, there has been a decrease in the grade of adenoid hypertrophy and a noticeable improvement in symptoms. Conclusion: This is a single case where evidence shows that complete patient recovery occurs with individualized Homoeopathic Medicine. this is single case study and more researches, observational studies and randomized control trials are required to ascertain homeopathy's efficacy in managing enlarged Adenoids.


Subject(s)
Adenoids , Homeopathy , Hypertrophy , Humans , Male , Adenoids/pathology , Child , Homeopathy/methods , Evidence-Based Medicine , Treatment Outcome , Rhinitis, Allergic/drug therapy , Rhinitis, Allergic/therapy
5.
Integr Cancer Ther ; 23: 15347354241233302, 2024.
Article in English | MEDLINE | ID: mdl-38721830

ABSTRACT

INTRODUCTION: Homeopathy is one of most widely used non-conventional supportive care methods used by women with breast cancer. This article aims to describe the routines and practices related to homeopathy as supportive care used by women with non-metastatic breast cancer in France. METHODS: This qualitative study used Grounded Theory. Participants were women with early breast cancer and healthcare professionals (General Practitioner homeopaths & oncologists). Inclusion depended on specific criteria and the aim of theoretical sampling until data saturation. Data were collected through individual semi-structured interviews and focus groups following evolving topic guides. Transcribed interviews underwent in-depth thematic analysis. Inclusion, interviewing, transcription and coding occurred iteratively. Data was reported according to COREQ guidelines. RESULTS: The therapeutic agency of homeopathy was distributed to different actors and ritualized material activities highly involving the patient. The choice of remedy was mostly delegated by patients to General Practitioner homeopaths (GPH) during consultations. Individualization, that is to say adaptation to the patient, differed from other modes of access to homeopathy (self-medication and oncologists). Self-medication was mostly limited to known products in a limited time frame. However, we identified a supported self-medication using trusted homeopathic protocols. Following homeopathic prescriptions involves a high level of commitment on behalf of the patient and follows different rules for homeopathy intake. This knowledge was either acquired earlier for users or discovered along breast cancer treatment for non-users. Taking homeopathy involved small daily actions for intake of different products at different times of the day. New users used strategies to ease the integration of homeopathy into their daily life. The stance toward such rules differed among patients. Some followed rules to optimize their effects while others simplified the rules and took those rituals as part of homeopathy benefits. CONCLUSION: Homeopathy as supportive care in breast cancer is distributed toward different actors and ritualized activities. Homeopathy is a supported practice where GPH played a role in the prescription. Health Literacy in homeopathy played a role to ease its integration into daily life and identify the potential benefits. The high involvement of patients in their homeopathic treatment is a form of treatment reappropriation and empowerment.


Subject(s)
Breast Neoplasms , Homeopathy , Qualitative Research , Humans , Homeopathy/methods , Female , Breast Neoplasms/therapy , Breast Neoplasms/psychology , Middle Aged , Adult , Aged , France , Focus Groups , Grounded Theory
6.
Altern Ther Health Med ; 30(4): 144-147, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38702160

ABSTRACT

Context: Lichen planus (LP) is a chronic lichenoid inflammatory disease of the skin, mucosa and appendages. The classic LP symptom is a dense infiltration of inflammatory T cells moving in the upper dermis and arranged in a band-like pattern. Lichen planus has an undetermined aetiology; however, it is known to have immune-mediated pathogenesis. Lichen planus cannot be cured, although treatment can lessen symptoms and shield against further problems. Antihistamines, PUVA (psoralen plus ultraviolet) treatment, retinoic acid, tacrolimus ointment, pimecrolimus cream, as well as corticosteroids are among the most often used therapies. To treat Lichen planus, individualized homeopathic medicine (iHOM) has shown excellent success. Methods: The case was documented at the dermatology OPD (Outpatient Department) of Dr. DY Patil Homoeopathic Medical College and Research Centre. A 32-year-old male patient with lichen planus was treated with individualized homeopathic medicine (iHOM) from March 25, 2021, to August 12, 2021. The results were evaluated at the follow-up visits. An evaluation based on the modified Naranjo criteria was carried out to determine if the alterations were brought on by homeopathic medication. Results: Over a five-month observation period, iHOM medicine produced positive results that physicians may utilize as an additional form of treatment for lichen planus. Conclusion: Individualized homeopathic medicine (iHOM) Nitric acid 30C was prescribed based on the totality of symptoms. Within 5 months, the disease's progression was halted, the itching was controlled, and the lesions flattened.


Subject(s)
Homeopathy , Lichen Planus , Humans , Lichen Planus/drug therapy , Male , Adult , Homeopathy/methods , Precision Medicine
7.
J Integr Complement Med ; 30(7): 671-681, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38301139

ABSTRACT

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary-Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary-Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings. Clinical Trial Registration Number: CTRI/2020/10/028617.


Subject(s)
Materia Medica , Sciatica , Humans , Sciatica/drug therapy , Double-Blind Method , Adult , Male , Female , Middle Aged , Materia Medica/therapeutic use , Materia Medica/administration & dosage , Homeopathy/methods , Treatment Outcome , Pain Measurement , India
8.
Homeopathy ; 113(3): 176-185, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38286416

ABSTRACT

By means of a historical, classical philological and philosophical approach, this paper attempts to demonstrate that homeopathy is based on three powerful traditions of thinking, which can be traced back to Ancient Greece's pre-Socratic era. Actually, it seems to be constituted by what may be termed lógos-, hómoion- and iásthai-thinking: that is, thinking in terms of rationality, similarity and healing. By contrast, modern medicine tends to be aligned with just one of these traditions, at the expense of the others, this being not without risk and adverse effects. It is mainly determined by the first type of rationality that genealogically derives from, and is therefore compatible with, the logic of economics whose predominance in the health care systems of modern societies is progressively rising. Homeopathy, however, may not be sufficiently and fairly understood without taking into account the complementary forms of thinking on which it also rests, such as the principle of similarity in an all-encompassing sense, and ancient healing knowledge in the tradition of catharsis. As a corollary of being essentially constituted by the three, homeopathy may persistently be in need of a dynamic equilibrium of its three constituent bases. Attempts to approach homeopathy from only one of the indicated modes of thinking fail to grasp its essence and result in figments or caricatures of what homeopathy was originally meant to be.


Subject(s)
Homeopathy , Homeopathy/methods , Homeopathy/history , Humans , History, Ancient , Thinking
9.
Wien Klin Wochenschr ; 136(5-6): 177-184, 2024 Mar.
Article in English | MEDLINE | ID: mdl-36961535

ABSTRACT

Homeopathy was first postulated by the German physician Samuel Hahnemann in 1796 and 220 years later homeopathy is the most popular and widespread alternative medicine. Partly, it is also part of the national healthcare and insurance systems but homeopathy is not without controversy within the medical and healthcare community. Its implausible basic assumptions, some of which contradict natural laws, do not lead us to expect that its remedies have any specific effect. In fact, there is no study or systematic review to date that reliably certifies homeopathy to have an effect beyond the placebo effect and other context effects. In this respect it must be disconcerting how widely homeopathy is applied and represented in therapeutic practice. It indeed claims a role within scientific (evidence-based) medicine but cannot substantiate this claim. It displays clear characteristics of pseudoscience [1]. This implies a lot of problems, such as misleading people and tackling medical ethics up to scientific publication practices. Furthermore, it turns out that quite a few people do not know exactly what homeopathy is, which may lead them to make wrong decisions for their personal health. This article summarizes the information about homeopathy and its problematic implications and serves as a general introduction to this topic and its unacceptable role in today's medicine.The medical irrelevance of the sham method of homeopathy has been proven with more than sufficient probability [2]. As a major testimonial, the statement "Homeopathic products and practices" of the European (EASAC 2017) can be regarded. The primary aim of this brief report is therefore not to take another look at homeopathy from a medical scientific perspective, but rather focus attention on the implications of the still continuous and largely uncritically accepted existence of this method in medical practice, in the medical scientific sphere and in the judgement of the general public.


Subject(s)
Homeopathy , Physicians , Humans , Homeopathy/methods , Evidence-Based Medicine
10.
Homeopathy ; 113(2): 67-79, 2024 May.
Article in English | MEDLINE | ID: mdl-37364594

ABSTRACT

BACKGROUND: Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus. OBJECTIVE: In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD. METHODS: A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's d) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data. RESULTS: Between-group differences for FBS were statistically significant, favoring IHMs against placebos (F 1,58 = 7.798, p = 0.007), but not for OGTT (F 1,58 = 1.691, p = 0.199). The secondary outcome, DSC-R total score, favoring IHMs significantly compared with placebos (F 1,58 = 15.752, p < 0.001). Calcarea Carbonicum, Thuja occidentalis and Sulphur were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups. CONCLUSION: IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings. TRIAL REGISTRATION: CTRI/2019/10/021711.


Subject(s)
Diabetes Mellitus, Type 2 , Homeopathy , Materia Medica , Prediabetic State , Humans , Homeopathy/methods , Double-Blind Method , Treatment Outcome
11.
Expert Rev Pharmacoecon Outcomes Res ; 24(1): 117-142, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37795998

ABSTRACT

INTRODUCTION: Likewise other medical interventions, economic evaluations of homeopathy contribute to the evidence base of therapeutic concepts and are needed for socioeconomic decision-making. A 2013 review was updated and extended to gain a current overview. METHODS: A systematic literature search of the terms 'cost' and 'homeopathy' from January 2012 to July 2022 was performed in electronic databases. Two independent reviewers checked records, extracted data, and assessed study quality using the Consensus on Health Economic Criteria (CHEC) list. RESULTS: Six studies were added to 15 from the previous review. Synthesizing both health outcomes and costs showed homeopathic treatment being at least equally effective for less or similar costs than control in 14 of 21 studies. Three found improved outcomes at higher costs, two of which showed cost-effectiveness for homeopathy by incremental analysis. One found similar results and three similar outcomes at higher costs for homeopathy. CHEC values ranged between two and 16, with studies before 2009 having lower values (Mean ± SD: 6.7 ± 3.4) than newer studies (9.4 ± 4.3). CONCLUSION: Although results of the CHEC assessment show a positive chronological development, the favorable cost-effectiveness of homeopathic treatments seen in a small number of high-quality studies is undercut by too many examples of methodologically poor research.


To help make decisions about homeopathy in healthcare, it is important, as with other medical treatments, to look at whether this treatment is effective in relation to its costs; in other words, to see if it is cost-effective. The aim of the current work was to update the picture of scientific studies available on this topic until 2012. To this purpose, two different researchers screened electronic literature databases for studies between January 2012 and July 2022 which assessed both the costs and the effects of a homeopathic treatment. They did this according to strict rules to make sure that no important study was missed. They reviewed the search results, gathered information from the studies, and assessed the quality of the studies using a set of criteria. They detected six additional new studies to the 15 already known from the previous work. Overall, they found that in 14 out of 21 studies, homeopathic treatment was at least equally effective for less or similar costs. For the remaining seven studies, costs were equal or higher for homeopathy. Of these seven, two were shown to be advantageous for homeopathy: indeed, specific economic analyses demonstrated that the benefit of the homeopathic treatment compensated for the higher costs. For the remaining five studies, the higher or equal costs of homeopathic treatment were not compensated by a better effect. The quality of the studies varied, with older studies generally being of lower quality compared to newer ones. The authors concluded that although the quality of research on homeopathy's cost-effectiveness has improved over time, and some high-quality studies show that it can be a cost-effective option, there are still many poorly conducted studies which make it difficult to offer a definitive statement. In other words, while there is some evidence that homeopathy can be effective in relation to its costs, there are still many studies that are not very reliable, which means that interested parties need to be cautious about drawing conclusions.


Subject(s)
Homeopathy , Humans , Cost-Benefit Analysis , Homeopathy/methods , Economics, Medical
12.
Complement Ther Med ; 79: 102999, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37898390

ABSTRACT

BACKGROUND: Mainly due to the use of different inclusion criteria and quality assessments, systematic reviews (SRs) and meta-analyses (MAs) with homeopathic intervention studies (HOMIS) have shown inconsistent results. We aimed to build recommendations for "Summarizing evidence from Homeopathic Intervention Studies" (Sum-HomIS recommendations) in order to approach standardization. METHODS: Against the background of a framework-project to update the evidence from homeopathic intervention studies, we launched an expert panel on how to assess the quality of HOMIS and how to summarize evidence from HOMIS. The results of a literature review and the expert communications in advance of the panel as well as the consensus from the discussions are presented here. We added specific considerations for homeopathic veterinary research. RESULTS: On top of the general guidelines when planning a review we report five basic Sum-HomIS recommendations. These are: 1) A broad literature search including special archives and consideration of so-called grey-literature; 2) The inclusion of controlled observational studies alongside randomized controlled trials; 3) The choice of a clear clinical research question in the terms that, if possible, the review project includes studies with predominantly homogeneous populations, interventions, comparators and outcomes (PICOs); 4) The use of a global quality assessment including the assessment of external, model and internal validity; 5) A summary of evidence using the GRADE-approach if the body of evidence is sufficiently large and homogenous or a descriptive summary if it is not so. CONCLUSIONS: We present recommendations for designing, conducting, and reporting SRs and MAs with HOMIS.


Subject(s)
Homeopathy , Humans , Homeopathy/methods , Research Design
13.
Homeopathy ; 112(4): 280-285, 2023 11.
Article in English | MEDLINE | ID: mdl-37673082

ABSTRACT

The controversial claim that homeopathic medicines actively stimulate the innate capacity of body and mind for healing and repair demands continuing and energetic investigation. But regardless of the outcome of this scientific controversy, the reported changes associated with applying the homeopathic method are matters of clinical fact. There is thus a case to be made that the homeopathic approach, the way that it studies and construes the experience of illness in individual patients, enriches our understanding of health, illness and healing; and is itself an essential contribution that homeopathy can make to the advancement of medicine. Practitioners and researchers involved in homeopathy can, and should, be more energetic and forceful in making that case.


Subject(s)
Homeopathy , Medicine , Humans , Homeopathy/methods
14.
Complement Ther Med ; 76: 102961, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37393961

ABSTRACT

BACKGROUND: Randomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking. OBJECTIVES: This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy. METHODS: Identification of the homeopathy-specific requirements for RCTs by reviewing literature and experts' communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy. RESULTS: Recommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented. CONCLUSIONS: The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.


Subject(s)
Homeopathy , Randomized Controlled Trials as Topic , Homeopathy/methods , Homeopathy/veterinary , Materia Medica , Research Design , Animals
15.
Schmerz ; 37(3): 215-227, 2023 Jun.
Article in German | MEDLINE | ID: mdl-37154977

ABSTRACT

The interest of patients with chronic pain in complementary and alternative medicine (CAM) is high. The aim of an accompanying complementary therapy is to strengthen the patient's self-efficacy, the ability to make decisions and the autonomy. The best evidence exists for physical activity and a balanced diet. Exercise combinations of strength and endurance as well as targeted strengthening of the muscles in the area of the pain are particularly suitable. When choosing the form of exercise, low-threshold training options are recommended. There is no reliable evidence for kinesio taping, homeopathy, neural therapy and draining procedures. The extensive data on acupuncture must be interpreted taking methodological limitations into account. Heat applications can support multimodal pain therapy. In the case of anti-inflammatory phytotherapeutic agents, there are good rationales from basic research and reliable empirical knowledge regarding the dosage. The evidence on cannabis is low.


Subject(s)
Acupuncture Therapy , Chronic Pain , Complementary Therapies , Homeopathy , Humans , Chronic Pain/therapy , Complementary Therapies/methods , Homeopathy/methods , Acupuncture Therapy/methods
16.
Complement Med Res ; 30(4): 332-339, 2023.
Article in English | MEDLINE | ID: mdl-37231828

ABSTRACT

BACKGROUND: N-of-1 studies allow the formal assessment of a patient's treatment. A single participant receives different interventions the same number of times in a crossover, double-blind, randomized design. Using this methodology, we will investigate the effectiveness and safety of a standardized homeopathy protocol in treating 10 cases of major depression. METHODS: The method is described below: Design: crossover double-blind placebo-controlled randomized N-of-1 studies, with at most 28 weeks of duration per participant. PARTICIPANTS: women and men at age over 18 years with a diagnosis of a major depressive episode given by a psychiatrist, who have presented a therapeutic response, i.e., a reduction ≥50% of the baseline depressive symptoms, self-assessed by the Beck Depression Inventory - Second Edition (BDI-II), and sustained for at least 4 weeks during an open homeopathic treatment following the protocol of the sixth edition of the Organon, with or without concomitant use of psychotropic drugs. INTERVENTIONS: individualized homeopathy following the same protocol, one globule of the fifty-millesimal potency diluted in 20 mL of 30% alcohol; placebo - 20 mL of 30% alcohol, in the same posology as homeopathy. Crossover study: the participant will go through three consecutive treatment blocks, with two random and masked treatment periods (A or B), corresponding to homeopathy or placebo. Treatment periods will have 2, 4, and 8 weeks in the first, second, and third blocks, respectively. A clinically significant worsening (characterized by an augmentation in BDI-II inclusion score ≥30%) will result in the termination of study participation and resumption of the open treatment. PRIMARY MEASURE: progression of the depressive symptoms, self-assessed by the participant using the BDI-II scale at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28 and analyzed throughout the study concerning homeopathy and placebo partitions. Secondary measures: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey; participant's blind preference for treatment A or B at each block; clinical worsening; and adverse events. DATA ANALYSIS: the participant, assistant physician, evaluator, and statistician will remain blinded for the study treatments until the completion of data analysis of each study. We will follow a 10-step procedure for analyzing N-of-1 observational data of each participant and conduct a meta-analysis of the combined results. DISCUSSION: We understand that each N-de-1 study will be a chapter with its teachings in a book of ten, allowing a broader view of the effectiveness of the homeopathy protocol of the sixth edition of the Organon in treating depression.HintergrundEinzelpatienten- oder "n = 1"-Studien ermöglichen die formelle Beurteilung der Behandlung eines Patienten. Bei einem einzigen Teilnehmer werden verschiedene Maßnahmen in gleicher Zahl in einem doppelblinden, randomisierten Crossover-Design angewendet. Mit dieser Methode untersuchen wir die Wirksamkeit und Sicherheit eines standardisierten Homöopathie-Protokolls zur Behandlung von Major Depression in zehn Fällen.MethodenAufbau der Studie: Doppelblinde, placebokontrollierte, randomisierte Einzelpatienten- oder "n = 1"-Studie von maximal 28 Wochen Dauer pro Teilnehmer. Teilnehmer: Frauen und Männer ab 18 Jahren mit durch einen Psychiater diagnostizierter Episode einer Major Depression und mit mindestens vier Wochen lang anhaltendem therapeutischem Ansprechen (in Form einer Reduktion der depressiven Symptome um ≥50% gegenüber Baseline laut Selbstbeurteilung mit dem Beck Depression Inventar, zweite Ausgabe [BDI-II]) unter einer offenen homöopathischen Behandlung gemäß dem Protokoll der sechsten Auflage des Organon, mit oder ohne gleichzeitige Anwendung von Psychopharmaka. Interventionen: Individualisierte Homöopathie gemäß demselben Protokoll, ein Globulus der Quinquaginta-Millesimal-Potenz, verdünnt in 20 mL 30%igem Alkohol; Placebo in Form von 20 mL 30%igem Alkohol, nach demselben Dosierungsschema wie die Homöopathie. Crossover-Studie: Der Teilnehmer durchläuft in zwei randomisierten und maskierten Behandlungszeiträumen (A oder B), die Homöopathie oder Placebo enstprechen, je drei aufeinanderfolgende Behandlungsblöcke. Innerhalb der Behandlungszeiträume umfassen der erste, zweite und dritte Block je zwei, vier beziehungsweise acht Wochen. Eine klinisch bedeutsame Verschlechterung (gekennzeichnet durch einen Anstieg des BDI-II-Scores um ≥30% gegenüber der Aufnahme) führt zum Abbruch der Studienteilnahme und zur Wiederaufnahme der offenen Behandlung. Primäre Messgröße: Verlauf der depressiven Symptome laut Selbstbeurteilung des Teilnehmers mit der BDI-II-Skala in Woche 0, 2, 4, 8, 12, 16, 20, 24, 28 und Auswertung im Verlauf der Studie nach Homöopathie-und Placebo-Abschnitten. Sekundäre Messgrößen: Score auf der Clinical Global Impression Scale; Scores für psychische und physische Gesundheit laut 12-Item Short-Form Health Survey; verblindete Teilnehmerpräferenz für Behandlung A oder B in jedem Block; klinische Ver-schlechterung und unerwünschte Ereignisse. Datenauswertung: Der Teilnehmer, behandelnde Arzt, Auswertende und Statistiker bleiben im Hinblick auf die Stu-dienbehandlungen verblindet, bis die Datenauswertung jeder Studie abgeschlossen ist. Wir werden in einem 10-schrittigen Vorgehen die "n = 1"-Beobachtungsdaten der einzelnen Teilnehmer auswerten und eine Metaanalyse der zusammengeführten Ergebnissee durchführen.DiskussionUnserer Auffassung nach wird jede einzelne "n = 1"-Studie ein Kapitel mit eigenen Lehren innerhalb eines zehnteiligen Buches sein, welches eine umfassende Darstellung der Wirksamkeit des Homöopathie-Protokolls der sechsten Ausgabe des Organon zur Behandlung von Depressionen ermöglicht.


Subject(s)
Depressive Disorder, Major , Homeopathy , Female , Humans , Male , Cross-Over Studies , Depressive Disorder, Major/therapy , Depressive Disorder, Major/etiology , Double-Blind Method , Homeopathy/methods , Meta-Analysis as Topic , Randomized Controlled Trials as Topic , Adult
17.
Homeopathy ; 112(3): 205-212, 2023 08.
Article in English | MEDLINE | ID: mdl-36724815

ABSTRACT

INTRODUCTION: A 32-year-old patient with colon cancer consulted for homeopathic supportive care (HSC). She had also suffered from recurrent urinary tract infections (RUTIs) for 20 years. Could homeopathy treat these two very different issues with the same medicine? THE PATIENT'S MAIN CONCERNS: Though the main reason for the consultation was a fear of the side effects of chemotherapy, the presence of Escherichia coli-induced RUTIs affected the patient's quality of life. INTERVENTIONS AND OUTCOMES: The repertory listing highlighted Pulsatilla as the patient's homeopathic constitutional medicine. It was prescribed both for HSC and also for RUTI. In association with Arsenicum album and Nerves, Pulsatilla enabled a good tolerance to chemotherapy, with rapid recovery from peripheral neuropathies. In combination with Colibacillinum, Pulsatilla provided relapse-free curing of the RUTIs. The MOdified NARanjo Criteria for Homeopathy (MONARCH) Inventory score was +9. CONCLUSION: The one individual's two different clinical complaints were treated with a constitutional homeopathic medicine, Pulsatilla, which covered the whole case. However, in HSC, the use of the constitutional remedy alone is rarely sufficient: it was reinforced by individualised symptomatic medication, organotherapy and isotherapy. For RUTI, isopathic and tubercular miasmatic treatments were each helpful. For both complaints, individualised homeopathy gave rapid, long-lasting and effective results.


Subject(s)
Homeopathy , Materia Medica , Peripheral Nervous System Diseases , Pulsatilla , Urinary Tract Infections , Female , Humans , Adult , Homeopathy/methods , Quality of Life , Peripheral Nervous System Diseases/etiology , Materia Medica/therapeutic use , Urinary Tract Infections/drug therapy
18.
Hepatol Commun ; 7(3): e0064, 2023 03 01.
Article in English | MEDLINE | ID: mdl-36757412

ABSTRACT

INTRODUCTION: Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non-liver-related systemic side effects. We present the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center. METHODS: A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy. RESULTS: Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute on chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in 'supposed' ultra-dilute formulations. CONCLUSION: Homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not 'gentle placebos.'


Subject(s)
COVID-19 , Chemical and Drug Induced Liver Injury , Homeopathy , Materia Medica , Male , Humans , Middle Aged , Materia Medica/adverse effects , Homeopathy/adverse effects , Homeopathy/methods , Chemical and Drug Induced Liver Injury/diagnosis , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , India/epidemiology
19.
J Clin Epidemiol ; 155: 64-72, 2023 03.
Article in English | MEDLINE | ID: mdl-36736709

ABSTRACT

OBJECTIVES: A "null field" is a scientific field where there is nothing to discover and where observed associations are thus expected to simply reflect the magnitude of bias. We aimed to characterize a null field using a known example, homeopathy (a pseudoscientific medical approach based on using highly diluted substances), as a prototype. STUDY DESIGN AND SETTING: We identified 50 randomized placebo-controlled trials of homeopathy interventions from highly cited meta-analyses. The primary outcome variable was the observed effect size in the studies. Variables related to study quality or impact were also extracted. RESULTS: The mean effect size for homeopathy was 0.36 standard deviations (Hedges' g; 95% confidence interval: 0.21, 0.51) better than placebo, which corresponds to an odds ratio of 1.94 (95% CI: 1.69, 2.23) in favor of homeopathy. 80% of studies had positive effect sizes (favoring homeopathy). Effect size was significantly correlated with citation counts from journals in the directory of open-access journals and CiteWatch. We identified common statistical errors in 25 studies. CONCLUSION: A null field like homeopathy can exhibit large effect sizes, high rates of favorable results, and high citation impact in the published scientific literature. Null fields may represent a useful negative control for the scientific process.


Subject(s)
Homeopathy , Humans , Homeopathy/methods , Bias , Odds Ratio
20.
Homeopathy ; 112(3): 144-151, 2023 08.
Article in English | MEDLINE | ID: mdl-36623825

ABSTRACT

BACKGROUND: The healing effects of homeopathic ultra-high potencies (UHPs) have always been a puzzle for material science, though recent research papers have now characterised the nanomaterial nature of several such UHPs. This study aimed to analyse the material content of clinically used potencies of the homeopathic medicine Platina (platinum) compared with alcohol control samples. METHODS: Potencies of Platina were analysed under dynamic light scattering (DLS), high resolution transmission electron microscopy (HRTEM) with energy dispersive spectroscopy (EDS) and selected area electron diffraction (SAED) to identify the nanomaterial content. As control samples, both unsuccussed and potencies of alcohol were analysed by using DLS and HRTEM. RESULTS: Platina 30c to CM: Nanoparticles were identified under DLS (mean particle size varying from 1.3 nm in 30c to 6.5 nm in CM) and HRTEM (particle size varying from 3.31 to 12.7 nm in 30c to 1.94 to 8.54 nm in CM). EDS confirmed the presence of platinum in all the samples of Platina. SAED analysis of Platina 30c, 200c, 1M and 10M confirmed also the presence of platinum dioxide (PtO2). For control samples, DLS and the HRTEM analyses of pharmaceutical grade unsuccussed alcohol and potentized Alcohol (6c, 12c and 30c) did not show any particles. CONCLUSION: Homeopathic potentization generated NPs of platinum in ultra-dilutions. NPs in potencies of Platina showed platinum in EDS and PtO2 in SAED. Importantly, control samples of alcohol did not show the presence of particles under DLS or HRTEM.


Subject(s)
Homeopathy , Materia Medica , Nanoparticles , Homeopathy/methods , Platinum , Materia Medica/pharmacology , Plant Extracts/chemistry , Nanoparticles/chemistry , Ethanol
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