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.

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.

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 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.

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.

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: "Miscellaneous Therapies". Animals 2021, 11, 3356.

(1) Background: Classical (=individualized) homeopathic therapy is based on the individual and not on the indication. (2) Methods: The prerequisite for conducting methodologically high-quality studies on indvidualized homeopathy is that the principles of homeopathy are considered, since the selection of the simile (the individually appropriate homeopathic medicinal product) is decisive for the effectiveness of the homeopathic treatment, because only an application lege artis can be effective for the respective patient. Apart from this, criteria for evidence-based medicine must be considered for design, conduction, documentation, and rating of studies in homeopathy. (3) Results: When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in the methodologically high-quality studies. (4) Conclusions: Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle (Similia similibus curentur, or 'Let like be cured by like') is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine and the integration of complementary medicine including homeopathy at universities seems a necessary consequence and requirement in the interests of the patient, which is already expressed in the American consensus guidelines for an integrative veterinary medicine curriculum and is legally anchored in Switzerland by the Medical Professions Act for university teaching and research.

Adjunctive homeopathic treatment of hospitalized COVID-19 patients (COVIHOM): A retrospective case series.

BACKGROUND: and purpose. COVID-19 is a novel viral disease causing worldwide pandemia. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection. PATIENT PRESENTATION: Thirteen patients with COVID-19 were admitted. Mean age was 73.4 ± 15.0 (SD) years. Twelve (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). Mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19. CONCLUSION: The observations suggest that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high - risk patients especially since there is no conventional treatment of COVID-19 available at present.