Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial.

CONTEXT: Pre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75-78 per thousand persons per year. OBJECTIVE: To study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. DESIGN: Six-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. SETTING: Outpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. PATIENTS: Sixty participants with pre-diabetes. INTERVENTIONS: Verum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30). MAIN OUTCOME MEASURES: The primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months. RESULTS: The proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum - 2/30 versus control - 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2022/04/042,026; UTN: U1111-1277-0021.

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis.

The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers' claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

Efficacy of Individualized Homeopathic Medicines in the Treatment of Sciatica Pain: Double-Blind, Randomized, Placebo-Controlled Trial.

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.

Efficacy of Individualized Homeopathic Medicines in the Treatment of Hemorrhoids: Double-Blind, Randomized, Placebo-Controlled Trial.

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I-III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary-the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary-the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann-Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings are promising, but need to be substantiated by further phase 3 trials. Clinical Trial Registration Number: CTRI/2020/03/024342.

Complementary and alternative medicine (CAM) is frequently used by parents for the treatment of functional constipation in children.

OBJECTIVES: Complementary and alternative medicine (CAM) has gained increasing attention as a supportive treatment for chronic diseases such as epilepsy, migraine, autism, and cancer in children. This study aimed to determine the frequency, motivation, and outcomes of CAM in children with functional constipation. METHODS: From January 2018 till September 2019, parents of patients (0-18 years) who were treated for functional constipation (ROME IV-criteria) at our colorectal center were asked to complete a questionnaire on the utilization of CAM. Demographic data and clinical assessments were documented and analyzed for patients with and without CAM treatment. RESULTS: A total of 115 patients were included (mean age: 5.1 years; 49% males), of whom 29 (25%) used CAM as an alternative (4/29,14%) or in addition to conventional therapy (CT), including osteopathy (48%), homeopathy (45%), and natural/herbal remedies (17%). The main reason parents reported for the use of CAM was the urge to leave no treatment option unattempted (76%). Multivariate analysis also identified persistent constipation under CT (72%), adverse effects of CT (24%), and parental use of CAM themselves (83%) as independent variables associated with CAM use. Parents reported positive changes in stool frequency (38%) and fecal incontinence (21%) with CAM. The vast majority (93%) plan to use CAM in the future, and even non-CAM users showed high interest (60%). CONCLUSION: One in four children with functional constipation receives CAM. Significant improvement in stool frequency and continence is missing in the majority. However, parental interest in CAM remains high. Physicians should be aware of CAM when counseling families for functional constipation in children.

Investigations on the morpho-anatomy and histochemistry of Aconitum napellus L.

Aconitum napellus L. is a popular medicinal plant extensively used in homeopathy. This article provides detailed morphology and microscopy, including the anatomical and histochemical features of the herb, to aid authentication and quality control. In cross-section, the root in secondary growth shows the phloem surrounded by pericyclic fibers and a well-developed xylem. The stem is irregular in outline, displaying unicellular trichomes and many free collateral vascular bundles encircling the pith. The leaf is dorsiventral, hypostomatic with anomocytic and anisocytic stomata, and shows non-glandular trichomes. The floral parts are characterized by uniseriate epidermises, homogeneous mesophyll, anomocytic stomata on the abaxial surface, trichomes, and oval pollen grains. The tissue fragments in powdered herbs show these characteristics and have numerous starch grains with thimble-shaped, linear or star-shaped hilum. The detailed macroscopic and microscopic analysis provided in this study can help in the authentication and quality control of A. napellus raw materials. RESEARCH HIGHLIGHTS: Key anatomical, micromorphological, and microchemical features of Aconitum napellus are described. The results of the study can support the taxonomy of the genus Aconitum. Morphological standardization of the species reported here is helpful in the quality control of this herb.

Individualized Homeopathic Medicines in the Treatment of Post-COVID-19 Fatigue in Adults: Single-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults. METHODS: A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences. RESULTS: Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups. CONCLUSION: IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.Die Coronainfektion (COVID-19) zieht unbekannte und ungewöhnliche gesundheitliche Probleme nach sich, deren Management oft eine Herausforderung darstellt. Das gilt unter anderem für Ermüdung nach einer COVID-19-Erkrankung, die mit zunehmender Dauer der Pandemie immer häufiger auftritt und die Lebensqualität der Betroffenen beeinträchtigt. In dieser Studie wird versucht, vorläufige Belege für die Wirksamkeit individualisierter homöopathischer Mittel (IHM) im Vergleich zu Placebo zur Behandlung von Ermüdung nach COVID-19 bei Erwachsenen zu identifizieren.Eine einfach verblindete, randomisierte, placebokontrollierte Parallelgruppenstudie von 3 Monaten Dauer wurde im ambulanten Bereich des Calcutta Homoeopathic Medical College and Hospital in Indien durchgeführt. 60 Teilnehmer erhielten nach Randomisierung im Verhältnis 1:1 entweder IHM (n = 30) oder identisch aussehendes Placebo (n = 30). Die primäre und die sekundäre Zielgröße waren die Fatigue Assessment Scale (FAS) und das Outcome in Relation to Impact on Daily Living (ORIDL) für bis zu 3 Monate, jeweils monatlich gemessen. Vergleichende Analysen wurden an der Intent-to-treat-Population durchgeführt, um Unterschiede zwischen den Gruppen zu erkennen.Gruppenunterschiede bei der primären (FAS gesamt: F1, 58 = 14,356; p < 0.001) sowie der sekundären Zielgröße (ORIDL: F1, 58 = 210,986; p < 0.001) nach 3 Monaten sprachen für die IHM gegenüber Placebo. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%) und Thuja occidentalis (10%) waren die am häufigsten indizierten Mittel. In beiden Gruppen wurden keine Schädigungen, unbeabsichtigten Wirkungen, homöopathischen Verschlechterungen oder jegliche schwerwiegenden unerwünschten Ereignisse beobachtet.Die IHM erzielten signifikant bessere Effekte als Placebo in der Behandlung von Post-COVID-Ermüdung bei Erwachsenen. Definitive, belastbare Studien können eingeleitet werden, um diese Befunde zu bestätigen.

A Fundamental Question for Complementary Medicine: Are There Other Forces in the Natural World Besides the Physical Forces?

BACKGROUND: The integration of conventional and complementary medicine reflects the pluralism in science. Still, a critical issue is the conception of the natural world. Many complementary therapy systems seem to contradict the reductionist-atomistic paradigm that all of natural reality is essentially based on the physical interactions of atoms and molecules. Thus, a fundamental question about the natural world is: Do other than the physical forces exist? SUMMARY: The assumption that no other than physical forces exist and work in the natural world is not tenable. For example, the formation and maintenance of the functional Gestalt of organisms cannot possibly be explained by molecular processes (e.g., from DNA to RNA and further to amino acids and proteins). The processes on each structural level - from molecules, organelles, cells, organs up to the whole organism - are regulated in regard to the formation of the next higher level. Specific Gestalt-forming forces exist and can be systematically investigated. Their existence implies an extended conception of matter. The Gestalt-forming forces and the extended concept of matter may be relevant for the scientific assessment of complementary therapies. KEY MESSAGES: (i) In the natural world, specific Gestalt-forming forces exist in addition to the physical forces, and can be systematically investigated. (ii) The existence of these forces implies an extended conception of matter. (iii) These forces and this extended concept of matter may be relevant for the scientific assessment of complementary therapies, e.g., homeopathy.In der Integration von konventioneller und komplementärer Medizin spiegelt sich der Methodenpluralismus der Wissenschaft. Die Ontologien vieler komplementärmedizinisches Systeme liegen allerdings außerhalb der Erklärbarkeit durch die Kräfte der Physik. Eine zentrale Frage ist deshalb: Gibt es Kräfte in der Natur, die eine materielle Wirkung haben, deren Ursprung aber nicht in Atomen oder Molekülen und in diesem Sinne nicht in der Materie liegt?Die Annahme, dass in der Natur keine anderen als die mit Atomen und Molekülen assoziierten physikalischen Kräfte existent und wirksam seien, ist wissenschaftlich nicht begründet. Beispielsweise ist die Bildung und Erhaltung der funktionsfähigen Gestalt von Organismen nicht durch molekulare Prozesse (z.B. von der DNA zur RNA und weiter zu Aminosäuren und Proteinen) erklärbar. Die Prozesse auf jeder strukturellen Ebene ­ von den Molekülen, Organellen, Zellen, Organen bis hinauf zum Gesamtorganismus ­ sind in Hinblick auf die Bildung der funktionsfähigen Gestalt der jeweils nächsthöheren Ebene gesteuert. Für diese Gestaltbildung gibt es spezifische Kräfte, die systematisch erforscht werden können. Ihre Existenz impliziert eine erweiterte Konzeption von Materie. Diese Gestalt-bildenden Kräfte und dieses erweiterte Konzept von Materie sind relevant für die wissenschaftliche Erfassung komplementärmedizinischer Systeme.(i) In der Natur sind außer den physikalischen Kräften noch weitere spezifische Kräfte wirksam, beispielsweise bei der Bildung und Erhaltung der funktionsfähigen Gestalt von Organismen. Diese Kräfte können systematisch erforscht werden. (ii) Die Existenz dieser Kräfte impliziert eine erweitere Konzeption von Materie. (iii) Diese Kräfte und das erweiterte Materiekonzept sind relevant für die wissenschaftliche Erfassung komplementärmedizinischer Systeme, beispielsweise der Homöopathie.

Overview and quality assessment of health economic evaluations for homeopathic therapy: an updated systematic review.

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.

Migraine in an Adolescent with a Pineal Cyst Treated with Classical Individualized Homeopathy: A Case Report.

BACKGROUND: Migraine is one of the leading causes of morbidity and disability in the world. Its prevalence ranges from 5 to 40% in the pediatric population, with about 50% of these headaches continuing to adulthood. Incidental diagnosis of pineal cysts (PCs) is on the rise with the evolution of imaging techniques; the causal relationship of PC and individuals with headache however remains controversial, and complete resolution is uncommon. Conventional medicine stresses on the importance of tailored therapy in the management of pediatric migraine. CASE REPORT: An 11-year-old female, diagnosed with migraine with an aura and PC, was benefitted by individualized classical homeopathic therapy using the homeopathic preparation Phosphorous and Natrum muriaticum. The symptoms of migraine improved, and the incidentally diagnosed PC completely resolved during the course of treatment. CONCLUSION: Individualized classical homeopathy may have a role in effectively treating migraines and PCs in the pediatric population. There is a need for further scientific investigation with well-designed studies to prove the effectiveness of this therapeutic method, taking care to maintain the individualization principle of classical homeopathy.Migräne ist eine der führenden Ursachen für Krankheitslast und Behinderung weltweit. Ihre Prävalenz bei Kindern und Jugendlichen liegt im Bereich von 5­40%; hiervon sind etwa 50% bis ins Erwachsenenalter von den Kopfschmerzen betroffen. Zufallsdiagnosen von Pinealiszysten (PC) kommen im Zuge des Fortschritts bei den bildgebenden Verfahren immer häufiger vor, jedoch ist ein kausaler Zusammenhang der PC mit Kopfschmerzen umstritten, und ein vollständige Rückbildung kommt nicht häufig vor. Die Schulmedizin betont, wie wichtig eine maßgeschneiderte Therapie bei der Behandlung der Migräne im Kindesalter ist.Ein 11-jähriges Mädchen, bei dem eine Migräne mit Aura und eine Pinealiszyste diagnostiziert wurde, profitierte von einer individualisierten klassisch-homöopathischen Therapie mit den homöopathischen Präparaten Phosphorus und Natrum muriaticum. Die Migränesymptome besserten sich, und die zufällig diagnostizierte Pinealiszyste bildete sich im Laufe der Behandlung vollständig zurück.Die individualisierte klassische Homöopathie kann bei der wirksamen Behandlung von Migräne und Pinealiszysten bei Kindern und Jugendlichen eine Rolle spielen. Es bedarf weiterer wissenschaftlicher Untersuchungen mit gutem Studiendesign, um die Wirksamkeit dieser Behandlungsmethode nachzuweisen, wobei darauf zu achten ist, das Individualisierungsprinzip der klassischen Homöopathie aufrechtzuerhalten.

Effectiveness of Eupatorium perfoliatum 30C in Prevention of Dengue Fever and Acute Febrile Illness during 2017 Dengue Outbreak in Urban Slums of Delhi: A Prospective, Open-Label, Community-Based, Parallel Cohort Study.

OBJECTIVE: This study was undertaken to assess the effectiveness of Eupatorium perfoliatum (EP) 30C on the incidence of dengue fever and acute febrile illness (AFI) during the 2017 dengue outbreak. METHODS: We conducted a prospective, open-label, community-based parallel cohort study involving apparently healthy individuals residing in 06 urban slums (JJ colony) of Delhi. The participants were enrolled in two cohorts - the medicine cohort (MC) and the control cohort (CC). Participants in MC were given weekly one dose of EP 30C for 10 weeks along with Information, Education and Communication (IEC) material regarding dengue. Participants in the CC were provided with the IEC material only. The primary outcome measure was the incidence of dengue fever as per case definitions notified in the national guidelines for clinical management of dengue fever by the Government of India during the 10 weeks follow-up period. The secondary outcome measures were the incidence of AFI and the hospitalization of confirmed dengue cases. RESULTS: The analysis included 40,769 participants residing in 06 slum clusters of Delhi out of which 28,321 participants were in MC and 12,448 participants were in CC. The incidence of laboratory-confirmed dengue in the MC was 2.57 per 10,000 person-weeks (95% confidence interval [CI], 2.02-3.22) in comparison with 7.55 per 10,000 person-weeks (95% CI, 6.12-9.21) in the CC. The incidence of AFI in the MC was 19.66 per 10,000 person-weeks (95% CI, 18.07-21.36) in comparison with 40.96 per 10,000 person-weeks (95% CI, 37.48-44.67) in the CC. The overall protective effect of EP against laboratory-confirmed dengue was 65.77% (95% CI, 53.37-74.87; p = 0.0001) and against AFI was 52.58% (95% CI, 46.37-58.07; p = 0.0001). Hospitalization reported in the MC was nil as against 4.35% in the CC. No dengue-related case fatalities were reported from either cohort. None of the participants from the MC reported any adverse events owing to the prophylactic intervention. CONCLUSION: The study concludes that EP 30C was able to prevent dengue significantly. Randomized controlled trials are needed to confirm or refute our findings.Das Ziel dieser Studie war die Beurteilung der Wirksamkeit von Eupatorium perfoliatum (EP) 30C auf die Inzidenz von Dengue-Fieber und akuter fiebriger Erkrankung (AFE) während des Dengue-Ausbruchs 2017.Wir führten eine prospektive, unverblindete, Bevölkerungs-Parallelgruppen-Kohortenstudie mit augenscheinlich gesunden Bewohnern von 6 städtischen Slums (JJ-Kolonie) in Delhi durch. Die Teilnehmer wurden in 2 Kohorten aufgenommen, einer Medizinkohorte (MK) und einer Kontrollkohorte (KK). Die Teilnehmer in der MK erhielten 10 Wochen lang wöchentlich eine Dosis EP 30C und dazu Aufklärungsmaterialien über Dengue. Die Teilnehmer in der KK erhielten nur die Aufklärungsmaterialien. Die primäre Zielgröße war die Dengue-Fieber-Inzidenz laut der in den nationalen Leitlinien für das klinische Management des Dengue-Fiebers von der indischen Regierung bekannt gegebenen Falldefinition in dem zehnwöchigen Beobachtungszeitraum. Die sekundären Zielgrößen waren die Inzidenz von AFE und die Anzahl hospitalisierter bestätigter Dengue-Fälle.In die Analyse wurden 40,769 Bewohner von 6 Slum-Clustern in Delhi einbezogen, davon wurden 28,321 Teilnehmer in die MK aufgenommen und 12,448 Teilnehmer in die KK. Die Inzidenz von im Labor bestätigter Dengue betrug in der MK 2,57 pro 10,000 Personen/Woche (95%-Konfidenzintervall [KI]: 2,02­3,22), verglichen mit 7,55 pro 10,000 Personen/Woche (95%-KI: 6,12­9,21) in der KK. Die Inzidenz von AFI betrug in der MK 19,66 pro 10,000 Personen/Woche (95%-Konfidenzintervall [KI]: 18,07­21,36), verglichen mit 40,96 pro 10,000 Personen/Woche (95%-KI: 37,48­44,67) in der KK. Der Schutzeffekt (SE) von EP betrug gegen im Labor bestätigte Dengue 65,77% (95%-KI: 53,37­74,87; p = 0,0001) und gegen AFI 52,58% (95%-KI: 46,37­58,07; p = 0,0001). Die Hospitalisierungsrate war in der MK gleich Null versus 4,35% in der KK. In keiner Kohorte waren Dengue-bedingte Todesfälle zu verzeichnen. Bei keinem der Teilnehmer in der MK traten jegliche unerwünschten Ereignisse infolge der prophylaktischen Maßnahme auf.Die Studie gelangt zu dem Schluss, dass Eupatorium perfoliatum 30C in signifikantem Maße Dengue vorbeugen konnte. Randomisierte kontrollierte Studien sind erforderlich, um unsere Ergebnisse zu bestätigen bzw. zu widerlegen.

The Performance and Metabolism of Dairy Cows Receiving an Ultra-Diluted Complex in the Diet during the Transition Period and Early Lactation.

This study evaluated the effects of feeding an ultra-diluted complex to dairy cows during the transition period and early lactation. Thirty multiparous pregnant dairy cows were blocked and randomly assigned to either a placebo control (CON) group or ultra-diluted complex (UD) group. The CON group received a placebo (basal diet + 40 g/cow/day of expanded silicate), while the UD group received the ultra-diluted complex (basal diet + 40 g/cow/day of PeriParto Transição-RealH, composed of ultra-diluted substances + vehicle: expanded silicate). Cows were evaluated from 30 days before the expected calving date until 60 days in milk (DIM) for sample and data collection. Post-partum dry matter intake (DMI) was not affected by the treatment. Cows fed UD had higher DMI relative to BW. Feeding UD increased milk lactose content and decreased milk protein content. Cows fed UD had lower somatic cell counts in the third and fourth week of lactation. Cows fed UD showed a tendency for higher liver health index. Using UD during the transition period and early lactation may benefit liver and udder health of dairy cows with no detrimental effect on milk performance.

Systematic reviews and meta-analyses in Homeopathy: Recommendations for summarising evidence from homeopathic intervention studies (Sum-HomIS recommendations).

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.

A Randomized Three-Arm Double-Blind Placebo-Controlled Study of Homeopathic Treatment of Children and Youth with Attention-Deficit/Hyperactivity Disorder.

Objectives: Approximately 30% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. The objectives of this study were to determine if there (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD; (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD; and (c) are any specific effects of homeopathic medicines in the treatment of ADHD. Design: The design was a randomized double-blind placebo-controlled clinical trial. Setting/Location: Toronto, Canada. Subjects: Children aged 6-16 years diagnosed with ADHD. Interventions: Participants were randomized to one of three arms: Arm 1 (Remedy and Consultation); Arm 2 (Placebo and Consultation); or Arm 3 (Usual Care). Outcome Measures: Primary Outcome was the change of CGI-P T score between baseline and 28 weeks. Results: There was an improvement in ADHD symptoms as measured by the Conner 3 Global Index-Parent T-score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms. Conclusions: In this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6-16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms. Clinical Trial Registration: This trial was registered on ClinicalTrials.gov; NCT02086864.

Homeopathic Treatment of Ramsay Hunt Syndrome: A Case Report.

INTRODUCTION: Ramsay Hunt syndrome (RHS) is an uncommon neurological complication resulting from the reactivation of latent herpes zoster virus. The condition often presents with facial paralysis, palatal ulcers, dysphagia, and altered taste sensation, leading to reduced quality of life. Standard therapeutic options for RHS have limitations, prompting the exploration of alternative treatments with improved prognostic outcomes. This case report aims to present a noteworthy clinical observation of RHS managed with individualized homeopathic treatment, emphasizing its potential therapeutic effect. CASE DESCRIPTION: A 24-year-old female patient exhibited left-sided facial weakness, along with palatal ulcers, dysphagia, and ageusia, prompting the diagnosis of RHS. Following the principles of homeopathy, a personalized therapeutic regimen was formulated, consisting tailored administration of Rhus toxicodendron, Spigelia anthelmia, and Sulfur. The House-Brackmann scale was employed to objectively assess the severity of facial palsy, while photographic documentation tracked the progression of palatal ulcers and facial paralysis. Over a carefully monitored observation period of 14 days, the patient demonstrated notable therapeutic response. There was a significant reduction in the extent of palatal ulceration and left-sided facial palsy exhibited marked improvement. Subsequent days of follow-up witnessed a consistent amelioration of the patient's condition, substantiating the effect of the individualized homeopathic treatment. CONCLUSION: This case report highlights an exceptional instance of RHS recovery within a relatively short timeframe, achieved through the administration of individualized homeopathic therapy. The favorable outcomes observed in this case underscore the potential of homeopathy as a promising intervention for RHS management. Nevertheless, further systematic investigations are imperative to comprehensively evaluate the scope and applicability of homeopathy in the treatment of RHS.Das Ramsay­Hunt­Syndrom (RHS) ist eine seltene neurologische Komplikation, die durch die Reaktivierung einer latenten Herpes­Zoster­Virusinfektion verursacht wird. Die Krankheit manifestiert sich häufig mit Gesichtslähmung, Ulcerationen am Gaumen, Dysphagie und verändertem Geschmacksempfinden und ist mit einer Einschränkung der Lebensqualität verbunden. Die Standardtherapieoptionen für RHS sind begrenzt, weshalb nach alternativen Behandlungsmöglichkeiten mit besseren prognostischen Ergebnissen gesucht wird. Im vorliegenden Fallbericht wird eine interessante klinische Beobachtung bei RHS vorgestellt, das mit individualisierter Homöopathie behandelt wurde, und deren potenzielle therapeutische Wirksamkeit wird hervorgehoben.Eine 24-jährige Patientin zeigte eine linksseitige Gesichtsschwäche in Verbindung mit Ulcerationen am Gaumen, Dysphagie und Ageusie, so dass die Diagnose RHS gestellt wurde. Gemäß den Prinzipien der Homöopathie wurde ein personalisiertes Therapieschema formuliert, das die individuell zugeschnittene Gabe von Rhus toxicodendron, Spigelia anthelmia, und Sulphur umfasste. Die objektive Bewertung des Schweregrads der Gesichtslähmung erfolgte mithilfe der House-Brackmann-Skala, wohingegen das Fortschreiten der Gaumenulcerationen und der Gesichtslähmung fotografisch dokumentiert wurde. Während eines sorgfältig überwachten Beobachtungszeitraums von 14 Tagen zeigte die Patientin ein deutliches therapeutisches Ansprechen. Das Ausmaß der Gaumenulcerationen ging signifikant zurück, und die linksseitige Gesichtslähmung besserte sich deutlich. In den folgenden Tagen besserte sich der Zustand der Patientin kontinuierlich, was die Wirkung der individualisierten homöopathischen Behandlung untermauert.Dieser Fallbericht beleuchtet einen ungewöhnlichen Fall von Genesung nach einem RHS innerhalb relativ kurzer Zeit, die durch Verabreichung einer individualisierten homöopathischen Therapie erreicht wurde. Die im vorliegenden Fall beobachteten günstigen Ergebnisse unterstreichen das Potenzial der Homöopathie als vielversprechende Intervention zur Behandlung von RHS. Allerdings sind weitere systematische Untersuchungen unabdingbar, um den Umfang und die Anwendbarkeit der Homöopathie bei der Behandlung von RHS umfassend zu beurteilen.

Practice, prescription habits, experience and perception of Indian homeopathic practitioners in treatment of diabetes mellitus: An online observational study.

BACKGROUND: Studies have shown homoeopathy to effectively control blood sugar levels and improve quality of life (QOL), though a standard treatment protocol is required. OBJECTIVE: This study intended to assess the homoeopathic practice, prescription habits, experience, and perception of Indian Homeopathic Practitioners (HPs) in treating DM. METHODOLOGY: A web-based cross-sectional with a snowball sampling method was conducted between 30th July 2021 and 18th August 2021. A questionnaire to record clinical attributes of Indian HPs in the management of DM was formed after the consensus of the subject experts and pilot testing for feasibility. RESULTS: Participants were 513 HPs with mean age [Standard Deviation (SD)] of 40.44 years (11.16) and a mean duration of the homoeopathic medical practice of 14.67 years [95% Confidence Interval (CI) = 13.71-15.63]. The majority of HPs made classical homoeopathic prescription (201, 39.2%) though the success in the management of DM was better among HPs who prescribed more than one potentized medicine [vs classical prescription, Odds Ratio (OR) = 2.34, p = 0.032]. As perceived by the HPs, homoeopathic treatment resulted in a major improvement in QOL of the diabetic patients (418, 81.5%) with very few adverse effect (100, 19.5%). The blood sugar level was controlled better when homoeopathy was given alongside conventional medicine (348, 67.8%). CONCLUSION: The clinical experience of HPs in this study has shown that homoeopathic treatment can benefit DM patients in preventing complications and improving QOL. It further reported that homoeopathy can be an important adjuvant to conventional treatment in managing DM.

Treatment seeking behavior among patients with polycystic ovarian syndrome (PCOS)-A cross-sectional study from Northern India.

BACKGROUND: Polycystic ovarian syndrome (PCOS) has now become a common problem among adolescent girls and young women in India. However, little is known about the treatment and satisfaction incurred from it. Our study aimed to assess the treatment-seeking behaviour among patients with PCOS. MATERIALS AND METHODS: The cross-sectional study was carried out in gynecology OPD of PGIMER, Chandigarh. Women with PCOS, 275, visiting the gynecology OPD were included. The treatment-seeking behavior for PCOS was elucidated among cases using a questionnaire. This included parameters like healthcare consulted, preferred system of medicine, referral pattern, treatment efficacy, and expenses incurred. Univariate descriptive analysis was used to present the results. RESULTS: The majority (68%) of the study participants were less than 25 years of age. The average weight was 66.78 (±13.0) Kg. Half of the participants were students. More than 70% belonged to the upper or upper-middle class. The study participants were diagnosed with PCOS at an average age of 21.4 (±4.7) years. The minimum age reported at diagnosis was 11 years, and the maximum age of diagnosis was 36 years. Most respondents preferred Allopathic treatment followed by homeopathy and Ayurveda. Few also opted for other treatment choices like diet therapy, yoga & meditation, weight loss supplements, and home remedies. Treatment efficacy ranged between 17.3%-34.2%. The majority of respondents reported the treatment to be moderately expensive. Most respondents (58.91%) were hardly influenced, while 16% were quite influenced by PCOS medicine or treatment advertisements. CONCLUSION: PCOS patients opt for different treatment options but generally find the treatment less effective and expensive.

Satisfaction with Homeopathic Service and Care for Persons with Spinal Cord Injury.

BACKGROUND: The aim of the study was to investigate the satisfaction of individuals with spinal cord injury (SCI) with a homeopathic service at an SCI rehabilitation center. PATIENTS AND METHODS: A cross-sectional questionnaire study was performed at an SCI rehabilitation center in Switzerland. It included patients with chronic SCI who presented themselves to a homeopathic service offered by the hospital in a 12-months period. The participants filled in standardized questionnaires in German: "Measure Yourself Medical Outcome Profile" (MYMOP), Treatment Satisfaction Questionnaire for Medication (TSQM-9), the European Project on Patient Evaluation of General Practice Care (EUROPEP) questionnaire, and a self-administered questionnaire. RESULTS: The data of 14 patients were analyzed. Symptom severity as well as bother by the symptoms that led to homeopathic treatment decreased under homeopathic treatment (severity: from 4.3 to 3.3; bother: from 4.2 to 2.9) and remained lower over time (severity: 2.6; bother: 2.7), suggesting a sustained effect. Irrespective of the test instrument used, satisfaction rates were higher for homeopathic service than for homeopathic medication, which was rated as successful by 50% of the participants. CONCLUSION: Persons with SCI suffering from secondary complications of SCI who accessed homeopathic care reported high satisfaction rates with the service. Therefore, homeopathic service can be considered as an additive measure in persons with SCI suffering from recurrent symptoms.Evaluierung der Zufriedenheit von Personen mit Querschnittlähmung (QSL) mit einer homöopathischen Betreuung an einem Rehabilitationszentrum für QSL.An einem Rehabilitationszentrum für QSL in der Schweiz wurde eine Querschnittserhebung mittels Fragebögen durchgeführt. Eingeschlossen wurden Personen mit chronischer QSL, die sich in einer von der Klinik angebotenen homöopathischen Sprechstunde in einem 12-Monats-Intervall vorstellten. Die Teilnehmenden füllten standardisierte Fragebogen in deutscher Sprache aus: "Measure Yourself Medical Outcome Profile" (MYMOP), Treatment Satisfaction Questionnaire for Medication (TSQM-9), den "European Project on Patient Evaluation of General Practice Care (EUROPEP)" Fragebogen sowie einen selbst-erstellten Fragebogen.Die Daten von 14 Teilnehmenden wurden ausgewertet. Der Schweregrad der Symptome sowie die Belastung durch die Symptome die zur homöopathischen Behandlung geführt haben, wurden unter der homöopathischen Therapie geringer (Schweregrad: von 4.3 auf 3.3; Belastung: von 4.2 auf 2.9) und blieben über den Untersuchungszeitraum geringer (Schweregrad: 2.6; Belastung 2.7), was einen anhaltenden Effekt nahelegt. Unabhängig von dem verwendeten Testinstrument waren die Zufriedenheitsraten für die homöopathische Betreuung höher als diejenigen für die homöopathische Medikation, die von 50% der Teilnehmenden als erfolgreich bewertet wurde.Personen mit QSL, die wegen Sekundärkomplikationen eine homöopathische Sprechstunde aufsuchten, berichteten eine hohe Zufriedenheit mit dieser Betreuung. Daher kann eine homöopathische Betreuung als zusätzliche Massnahme bei Personen mit QSL mit persistierender Symptomatik in Betracht gezogen werden.

Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine.

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.

The Assessment of the Spectrum of Preventive Measures Taken by Healthcare Providers During the COVID-19 Pandemic in India: A Survey-Based Study.

INTRODUCTION: The first wave of the coronavirus disease 2019 (COVID-19) pandemic created havoc and confusion in choosing appropriate treatment, as well as prophylaxis, due to its rapid surge, disease novelty, and lack of evidence-based literature. It was even more concerning among the healthcare workers (HCWs), who had to take care of patients, themselves, and their own families. OBJECTIVE: This online survey-based study targeted finding the various options for COVID-19 precautionary or prophylactic measures opted for by HCWs. METHODOLOGY: This was an observational study based on a predesigned questionnaire, which was floated online for three months after institutional ethical approval, just after the first wave of COVID-19 in 2021, targeting HCWs of different cadres (doctors, nurses, paramedics/laboratory technicians, etc.), ages, and sexes and HCWs hailing from across the country. Questions were focused on HCW's adopted measures, the order of preference and its reasons, and concerns related to safety and efficacy. Data was collected through Google Forms (Google, Inc., Mountain View, CA) into an Excel spreadsheet (Microsoft® Corp., Redmond, WA) and analyzed by the latest Statistical Package for Social Sciences (SPSS) software (IBM SPSS Statistics, Armonk, NY) using appropriate statistics. RESULTS: The routine practice of standard precautionary measures (face mask, hand hygiene, and social distancing) and wearing a personal protective equipment (PPE) kit during the care of COVID-19-positive or COVID-19-suspected patients was adopted by the majority of HCWs, i.e., 306/312 (>98%) irrespective of cadre (p = 0.001). After the "routine measures," the most adopted measure by participant HCWs irrespective of profession, age, and gender was the consumption of allopathic drugs (n = 188; 60.26%). Anti-COVID-19 measures in the category of drugs used by healthcare providers (HCPs) were prophylactic allopathic drugs (60.26%), homeopathic drugs (11.86%), and other Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (AYUSH)/traditional medical system drugs (11.86%). Vitamin C was the most consumed among all of the drugs for COVID-19 prophylaxis purposes. Non-drug measures espoused by the HCPs were physical exercises (46.47%), increased sleep duration (35.89%), change in dietary habits (42.62%), and spiritual measures (19.23%). CONCLUSION: The fear of COVID-19 imposed on the HCPs the obligation to use all the available preventive measures in spite of the lack of evidence on actual benefits. After the routine infection preventive measures, the most adopted measure by participant HCWs irrespective of profession, age, and gender was the consumption of prophylactic allopathic drugs (>60%), and the most non-drug preventive measures were the initiation of physical exercises and change in dietary habits. Adapting some form of physical exercise was more noted with males than females (p = 0.001), and it significantly increased with HCPs of higher age of >25 and >40 years than younger HCPs (58.6% versus 29.3%; p = 0.016). Females preferred more dietary and nutritional modifications.