Recommendations for Designing, Conducting and Reporting Clinical Observational Studies in Homeopathic Veterinary Medicine.

BACKGROUND: Clinical observational studies are an important methodological approach in human and veterinary research, examining and describing treatment experience with good external validity. There are currently few observational studies in the field of homeopathic veterinary medicine. AIM: The aim of the study was to develop recommendations for designing, conducting and reporting observational studies in homeopathic veterinary medicine. MATERIALS AND METHODS: A literature review was performed using various search strategies for identifying guidelines and checklist tools relevant for observational studies, veterinary research and homeopathy. Useful guidelines were selected. Prior recommendations for designing and conducting observational studies in human homeopathic medicine were supplemented with recommendations for homeopathic veterinary medicine that were evaluated by an expert panel. RESULTS: The veterinary extension of the Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary (STROBE-Vet) statement was identified as a useful tool to improve the reporting quality of observational studies, and it has been supplemented here with additional recommendations that are applicable to homeopathy. STROBE-Vet is complemented in the literature by several reports, checklists and guidelines on veterinary medicine in general, such as the Checklist for One Health Epidemiological Reporting of Evidence (COHERE) and the Animal Health Surveillance Reporting Guidelines (AHSURED). Identified items that related to laboratory animal research were excluded as non-relevant to our study. CONCLUSION: Clinical observational studies are an important methodological approach, having currently unrealized potential in the field of homeopathic veterinary medicine. With relatively minor adjustments, the practical guidelines and checklists available to researchers in designing, conducting and reporting observational studies in human homeopathic medicine have been adapted for homeopathic veterinary medicine, for which high quality can be assured by implementing recommendations such as those in STROBE-Vet. With the emergence of the One Health concept, the COHERE checklist can be viewed with growing significance.

Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study.

LESSONS LEARNED: Conventional medicine and homeopathy work well together. Quality of life improves with additive homeopathy in patients with non-small cell lung cancer (NSCLC). Survival improves with additive homeopathy in patients with NSCLC. BACKGROUND: Patients with advanced non-small cell lung cancer (NSCLC) have limited treatment options. Alongside conventional anticancer treatment, additive homeopathy might help to alleviate side effects of conventional therapy. The aim of the present study was to investigate whether additive homeopathy might influence quality of life (QoL) and survival in patients with NSCLC. METHODS: In this prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter, phase III study, we evaluated the possible effects of additive homeopathic treatment compared with placebo in patients with stage IV NSCLC, with respect to QoL in the two randomized groups and survival time in all three groups. Treated patients visited the outpatients' centers every 9 weeks: 150 patients with stage IV NSCLC were included in the study; 98 received either individualized homeopathic remedies (n = 51) or placebo (n = 47) in a double-blinded fashion; and 52 control patients without any homeopathic treatment were observed for survival only. The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. The remedies were manufactured by stepwise dilution and succussion, thereby preparing stable Good Manufacturing Practice grade formulations. RESULTS: QoL as well as functional and symptom scales showed significant improvement in the homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment (p < .001). Median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as versus control (228 days; p < .001). Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001). CONCLUSION: QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumor entities are warranted.

Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial.

BACKGROUND: Incidence of difficult endotracheal intubation ranges between 3 and 10%. Bougies have been recommended as an airway adjunct for difficult intubation, but reported success rates are variable. A new generation flexible tip bougie appears promising but was not investigated so far. We therefore compared the new flexible tip with a standard bougie in simulated normal and difficult airway scenarios, and used by experienced anesthesiologists. METHODS: We conducted a observational, randomized, cross-over simulation study. Following standardized training, experienced anesthesiologists performed endotracheal intubation using a Macintosh blade and one of the bougies in six different airway scenarios in a randomized sequence: normal airway, tongue edema, pharyngeal obstruction, manual cervical inline stabilization, cervical collar stabilization, cervical collar stabilization and pharyngeal obstruction. Overall success rate with a maximum of 3 intubation attempts was the primary endpoint. Secondary endpoints included number of intubation attempts, time to intubation and dental compression. RESULTS: Thirty-two anesthesiologist participated in this study between January 2019 and May 2019. Overall success rate was similar for the flexible tip bougie and the standard bougie. The flexible tip bougie tended to need less intubation attempts in more difficult airway scenarios. Time to intubation was less if using the flexible tip bougie compared to the standard bougie. Reduced severity of dental compression was noted for the flexible tip bougie in difficult airway scenarios except cervical collar stabilization. CONCLUSION: In this simulation study of normal and difficult airways scenarios, overall success rate was similar for the flexible tip and standard bougie. Especially in more difficult airway scenarios, less intubation attempts, and less optimization maneuvers were needed if using the flexible tip bougie. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03733158. 7th November 2018.

The Hydra-Headed Coronaviruses: Implications of COVID-19 for Homeopathy.

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

Performance and skill retention of five supraglottic airway devices for the pediatric difficult airway in a manikin.

Supraglottic airway devices (SADs) have been introduced to assist medical professionals in emergency situations with limited experience in securing airways via conventional endotracheal intubation (ETI). Literature on the use of SADs for securing an airway during pediatric critical settings is scarce, and there is a lack of studies comparing different SADs to each other and to conventional ETI. We conducted a study comparing five different SADs to ETI with regard to success rate, time to first ventilation, and personal rating in a pediatric manikin under simulated physiologic and pathologic airway conditions in 41 pediatricians of varying clinical experience and training. Only the AirQ, AuraG, and laryngeal tube (LT) were inserted within 30 s correctly by all participants under physiologic conditions. In tongue edema (TE), AirQ and LT had the highest success rate. In limited mobility of the cervical spine (CS), AirQ, AuraG, and LT again all were inserted within 30 s. In a multivariate analysis, factors influencing the success were experience with the respective device and level of medical education. Under TE conditions, there were significantly longer insertion times for the ETI, laryngeal mask airway (LMA), and EzT. Under CS conditions, there were significantly longer insertion times for the ETI, LMA, LT, and EzT. A multivariate analysis showed experience with the respective device to be the only factor of influence on time to first ventilation. CONCLUSION: LT, AuraG, and AirQ were superior in providing fast and effective ventilation during simulated difficult airway situations in pediatricians. What is Known: • Supraglottic airway devices have been introduced for medical professionals who lack experience for managing difficult airway situations. • A variety of these devices have been developed so far, but not compared to each other yet. What is New: • We compared five different supraglottic airway devices with regard to success rate, time to first ventilation, and personal rating in a pediatric manikin under simulated physiologic and pathologic airway conditions. • Laryngeal tube, AuraG, and AirQ were superior in providing fast and effective ventilation during simulated difficult airway situations in pediatricians with varying clinical experience.

Case Reports of Five Cancer Patients with Unusual Course.

INTRODUCTION: The analysis of the periodic table of elements by Jan Scholten opened the way for a new kind of classification and repertorisation of homeopathic remedies. Thereby, group analysis (resorting to series and stages) makes precise prescriptions possible. This approach appears to yield striking results, even in severe cases. Whereas Hahnemann stressed the emotional state ('Gemüthssymptome', Organon § 210) when choosing a remedy, Scholten 200 years later investigated the mental picture that represents a life conflict or even a life theme that may maintain the disease process. The person's environment, emotional traumas or a conflict drives him or her to suppress and dissect painful emotions. Such compensations can become subconscious and so strong that they can no longer be controlled; they then influence the patient with a highly destructive energy. METHODS: We present five case reports, each dealing with an unusual clinical course of severe cancer associated with homeopathic treatment using the Scholten method. RESULTS: By presenting these cases, we consider how the constitution (lifelong signs and symptoms of the patient) and the mental state are interwoven and, as a complex mechanism, might provoke disease. CONCLUSION: The appropriate homeopathic remedy, reflecting the Scholten approach, seemed to have beneficial impact on the disease process of the five individuals presented.

CPR using the lifeline ARM mechanical chest compression device: a randomized, crossover, manikin trial.

INTRODUCTION: European Resuscitation Council as well as American Heart Association guidelines for cardiopulmonary resuscitation (CPR) stress the importance of uninterrupted and effective chest compressions (CCs). Manual CPR decreases in quality of CCs over time because of fatigue which impacts outcome. We report the first study with the Lifeline ARM automated CC device for providing uninterrupted CCs. METHODS: Seventy-eight paramedics participated in this randomized, crossover, manikin trial. We compared the fraction of effective CCs between manual CPR and automated CPR using the ARM. RESULTS: Using the ARM during resuscitation resulted in a higher percentage of effective CCs (100/min [interquartile range, 99-100]) compared with manual CCs (43/min [interquartile range, 39-46]; P<.001). The number of effective CCs decreased less over time with the ARM (P<.001), more often reached the required depth of 5 cm (97% vs 63%, P<.001), and more often reached the recommended CC rate (P<.001). The median tidal volume was higher and hands-off time was lower when using the ARM. CONCLUSION: Mechanical CCs in our study adhere more closely to current guidelines than manual CCs. The Lifeline ARM provides more effective CCs, more ventilation time and minute volume, less hands-off time, and less decrease in effective CCs over time compared with manual Basic Life Support and might therefore impact outcome.

Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for Intubation With C-spine immobilization: A Randomized, crossover, manikin trial.

INTRODUCTION: Endotracheal intubation (ETI) using a Macintosh laryngoscope (MAC) requires the head to be positioned in a modified Jackson position, slightly reclined and elevated. Intubation of trauma patients with an injured neck or spine is therefore difficult, since the neck usually cannot be turned or is already immobilized in order to prevent further injury. The iGEL supraglottic airway seems optimal for such conditions due to its blind insertion without the need of a modified Jackson position. METHODS: Prospective, randomized, crossover study in 46 paramedics. Participants performing standard intubation and blind intubation via iGEL supraglottic airway device in three airway scenarios: Scenario A - normal airway; Scenario B - manual inline cervical immobilization, performed by an independent instructor; scenario C: cervical immobilization using a standard Patriot cervical extraction collar. RESULTS: In Scenario A, nearly all participants performed ETI successfully both with MAC and iGEL (100% vs. 95.7%). The time to intubation (TTI) using the MAC and iGEL amounted to 19 [IQR, 18-21]s vs. 12 [IQR, 11-13]s (P<0.001). Head extension angle as well as tooth compression were significantly better with the iGEL compared to the MAC (P<0.001). In scenario B and C, the results with the iGEL were significantly better than with MAC for all analyzed variables (TTI, success of first intubation attempt, head extension angle, tooth compression and VAS scores). CONCLUSION: We showed that blind intubation with the iGEL supraglottic airway was superior to ETI performed by paramedics in a simulated cervical immobilization scenario in a manikin in terms of success rate, time to definite tube placement, head extension angle, tooth compression, and rating.

Human Cytomegalovirus Infection in Nonimmunocompromised Patients: A Retrospective Analysis and Review of the Literature.

In a retrospective analysis of patients visiting the Outpatient Department of the Division of Infectious Diseases and Tropical Medicine over a period of 3 years, we found a high incidence of symptomatic nonsevere human cytomegalovirus (HCMV) infection in nonimmunocompromised patients. We present 11 symptomatic cases of HCMV infection in nonimmunocompromised patients with non-life-threatening symptoms like long-lasting depletion, fatigue, and subfebrile fever with or without muscular pain and arthralgia. Although the symptoms were not life-threatening, all of the patients suffered a prolonged duration of the disease until improvement. These cases reinforce the important fact that HCMV infections in nonimmunocompromised patients are not always asymptomatic. Therefore, HCMV infection should always be included in the differential diagnosis of patients with unspecific signs of disease like depletion, subfebrile fever, and arthralgia.

First evidence of Beauvais' hypothesis in a plant model.

INTRODUCTION: Beauvais presented the application of a so-called 'quantum-like model of homeopathy' by introducing the idea of a type of randomization/unblinding which he called 'in situ'. He predicted that randomized studies based on this type of randomization/unblinding lead to more pronounced effects in placebo controlled randomized homeopathic trials. We designed an experiment regarding wheat germination and stalk length to investigate Beauvais' idea of 'in situ randomization/unblinding' using a homeopathic dilution of sulphur (LM VI) as compared to placebo as well as to water. AIM AND METHOD: The primary aim of this double-blind randomized controlled experiment was to investigate whether there are differences of 'in situ randomization/unblinding' vs 'central randomization/unblinding' with respect to the effect of a homeopathic substance compared to placebo. The secondary aim of our study was to examine possible differences between the sulphur and the placebo group in the 'in situ' arm regarding germination and/or stalk growth of wheat seedlings measured after a seven days exposure. Wheat was treated either with sulphur LM VI, placebo, or water. The wheat grains were placed on glass lids and treatment was performed following the 'in situ randomization/unblinding' as well as 'central randomization/unblinding' method. Germination was measured and classified into three categories. RESULTS: Under 'in situ' randomization/unblinding the odds of a seed not to germinate is 40% lower if treated with sulphur compared to placebo (p=0.004). In contrast, these odds are practically equal in the 'central' meta-group (OR=1.01, p=0.954). Under 'in situ' randomization/unblinding the odds of a seed to germinate with a length ≥1mm is practically equal if treated with sulphur or with placebo (OR=0.96, p=0.717). In contrast, these odds are 21% higher under sulphur compared to placebo in the 'central' meta-group (OR=1.21, p=0.062). In summary, we found a sulphur effect that is significantly different between 'in situ' and 'central' randomization/unblinding relating to all three stages of germination.

Comparison of 4 supraglotttic devices used by paramedics during simulated CPR : a randomized controlled crossover trial.

BACKGROUND: Ensuring an open airway during cardiopulmonary resuscitation is fundamental. The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel. METHODS: Four devices were compared in a simulated resuscitation scenario: ILMA (Intavent Direct Ltd, Buckinghamshire, United Kingdom), Cobra PLA (Engineered Medical Systems Inc, Indianapolis, IN), Supraglottic Airway Laryngopharyngeal Tube (SALT) (ECOLAB, St. Paul, MN), and Air-Q (Mercury Medical, Clearwater, FL). A group of 210 paramedics intubated a manikin with continuous chest compressions. RESULTS: The mean times to intubation were 40.46 ± 4.64, 33.96 ± 6.23, 17.2 ± 4.63, and 49.23 ± 13.19 seconds (SALT vs ILMA, Cobra PLA, and Air-Q; P < .05). The success ratios of blind intubation for the devices were 86.7%, 85.7%, 100%, and 71.4% (SALT vs ILMA, Cobra PLA, and Air-Q; P < .05). CONCLUSION: The study showed that the most efficient device with the shortest blind intubation time was the SALT device.

Unequal brothers : are homeopathy and hormesis linked?

The debate between those who believe homeopathy and hormesis derive from the same root and those who believe the two are different phenomena is as old as hormesis. It is an emotionally loaded discussion, with both sides fielding arguments which are far from scientific. Careful analysis of the basic paradigms of the two systems questions the claim of the homeopaths, who find similarities between them. The authors discuss these paradigms, indicating the differences between the claims of homeopathy and hormesis. It is time for thorough and serious research to lay this question to rest. One possible approach is to compare the activity of a hormetic agent, prepared in the usual way, with that of the same agent in the same concentration prepared homeopathically by serial dilution and succussion.

Retrospective evaluation of antibody index of human parvovirus B19 as a prognostic factor in patients with dilated and ischemic cardiomyopathy.

Cardiotropic viral infections are important causative factors in dilated cardiomyopathy. This retrospective study examined the antibody index for human parvovirus B19 in patients suffering from dilated or ischemic cardiomyopathy as a prognostic factor for stable left ventricular function. Blood specimens from 43 patients with the diagnosis of dilated or ischemic cardiomyopathy were analyzed for human parvovirus B19 by polymerase chain reaction (PCR) and enzyme immunoassay kit for qualitative determination of IgG and IgM antibodies. To exclude patients with acute myocarditis, only patients with onset of symptoms more than 4 months previously were included. Patients with dilated cardiomyopathy and a high antibody index showed a significantly better clinical outcome when compared to patients with a low IgG antibody index (8.5 ± 2.4 vs. 3.1 ± 2.6; P = 0.006). There was no significant difference in left ventricular ejection fraction between patients with a high antibody index and patients with a lower antibody index (P = 0.59). The presence of human parvovirus B19 antibodies is associated with protective immunity. A high antibody index seems to be a good prognostic factor for the disease correlating to a relatively stable left ventricular ejection fraction.

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.

Bibliography of Homeopathic Intervention Studies (HOMIS) in Human Diseases.

Objectives: Homeopathy (HOM) is a therapeutic method, which is widely used by patients and medical professionals. The medical conditions as well as the homeopathic medical products investigated vary strongly. There is an extensive amount of research, and this necessitates a bibliography that comprehensively presents the entire body of clinical evidence grouped according to medical conditions. Design: Thirty-seven online sources as well as print libraries were searched for HOM and related terms in eight languages (1980 to March 2021). We included studies that compared a homeopathic medicine or intervention with a control regarding the therapeutic or preventive outcome of a disease (classified according to International Classification of Diseases-10). The data were extracted independently by two reviewers and analyzed descriptively. Results: A total of 636 investigations met the inclusion criteria, of which 541 had a therapeutic and 95 a preventive purpose. Seventy-three percent were randomized controlled trials (n = 463), whereas the rest were non-randomized studies (n = 173). The leading comparator was placebo (n = 400). The type of homeopathic intervention was classified as multi-constituent or complex (n = 272), classical or individualized (n = 176), routine or clinical (n = 161) and isopathic (n = 19), or various (n = 8). The potencies ranged from 1X (dilution of -10,000) to 10 M (100-10.000). The included studies explored the effect of HOM in 223 medical indications. We present the evidence in an online database. Conclusions: This bibliography maps the status quo of clinical research in HOM. The data will serve for future targeted reviews, which may focus on the most studied conditions and/or homeopathic medicines, clinical impact, and the risk of bias of the included studies.

Ventilation with the esophageal-tracheal Combitube during general anaesthesia: assessing complications in 540 patients.

Background: The esophageal-tracheal Combitube (ETC) was developed for the management of difficult airways but can also be used for general anaesthesia. Methods: This clinical study collected data from patients undergoing anaesthesia with the ETC in order to assess the rate of complications. Results: Five hundred forty patients were ventilated with the ETC. In 94.8% (512/540), insertion was performed for the first time by the respective physician. The following minor complications were observed: 38.7% sore throat, 30.9% blood on tube as sign of mucosal lesions and 17.0% cyanotic tongue. Experience decreased the risk of mucosal lesions (odds ratio [OR]: 2.3, 95% confidence interval [CI]: 1.5-3.5). A higher than recommended volume of the oropharyngeal cuff was associated with blood on the ETC (OR: 1.5, 95% CI: 1.0-2.3) and tongue cyanosis (OR: 2.3, 95% CI: 1.4-3.7). Ventilation for more than 2 h was associated with tongue cyanosis (OR: 2.2, 95% CI: 1.6-3.1) and tongue protrusion (OR: 1.4, 95% CI: 1.1-1.9). Conclusion: We conclude that the Combitube may be used for short procedures requiring general anaesthesia, but the high rate of minor complications limits its value when other alternatives such as a laryngeal mask airway are available. The tested method appears safe regarding major complications, but minor complications are common. Adherence to recommended cuff volumes, experience with the ETC and limiting its use to surgeries lasting less than 2 h might reduce the rate of complications.

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.