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.

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.

Inappropriate and potentially avoidable emergency department visits of Swiss nursing home residents and their resource use: a retrospective chart-review.

BACKGROUND: Emergency department (ED) visits for nursing home residents lead to higher morbidity and mortality. Therefore, inappropriate visits (for conditions treatable elsewhere) or potentially avoidable visits (those avoidable through adequate chronic care management) must be minimized. This study aimed to investigate factors and resource consumption patterns associated with inappropriate and potentially avoidable visits in a Swiss tertiary hospital. METHODS: This is a single-center retrospective chart review in an urban Swiss university hospital ED. A consecutive sample of 1276 visits by nursing home residents (≥ 65 years old), recorded between January 1, 2015 and December 31, 2017 (three calendar years) were included. Case characteristics were extracted from ED electronic documentation. Appropriateness was assessed via a structured Appropriateness Evaluation Protocol; potentially avoidable visits-measured as ambulatory-care sensitive conditions (ACSCs)-were analyzed separately. Inter-group differences concerning ED resource use were tested respectively with chi-square or Wilcoxon rank sum tests. To identify predictors of inappropriate or potentially-avoidable visits, we used multivariable logistic regression analysis. RESULTS: Six percent of visits were rated as inappropriate: they had lower triage levels (OR 0.55 [95%-CI 0.33-0.92], p=0.024) and, compared to ambulance calls, they had higher odds of initiation via either patient-initiated walk-in (OR 3.42 [95%-CI 1.79-6.55], p≤0.001) or GP referrals (OR 2.13 [95%-CI 1.16-3.90], p=0.015). For inappropriate visits, overall ED resource use was significantly lower (median 568 vs. 1403 tax points, p≤0.001). Of all visits included, 29% were due to (often potentially-avoidable) ACSCs. In those cases, compared to ambulance initiation, odds of being potentially-avoidable were considerably lower for walk-in patients (OR 0.46 [95%-CI 0.27-0.77], p=0.004) but higher for GP referrals (OR 1.40 [95%-CI 1.00-1.94], p=0.048). Nurse work (93 tax points vs. 64, p≤0.001) and laboratory resource use (334 tax points vs. 214, p≤0.001) were higher for potentially-avoidable ED visits. CONCLUSIONS: We revealed substantial differences between the investigated groups. While nearly one third of ED visits from nursing homes were potentially avoidable, inappropriate visits were lower in numbers and not resource-intensive. Further research is required to differentiate potentially avoidable visits from inappropriate ones and to determine these findings' public health implications.

Is Homeopathic Arnica Effective for Postoperative Recovery? A Meta-analysis of Placebo-Controlled and Active Comparator Trials.

Background: Homeopathic Arnica montana is used in surgery as prevention or treatment for the reduction of pain and other sequelae of surgery. Our aim was to perform a metaanalysis of clinical trials to assess efficacy of Arnica montana to reduce the inflammatory response after surgery. Method: We conducted a systematic review and metaanalysis, following a predefined protocol, of all studies on the use of homeopathic Arnica montana in surgery. We included all randomized and nonrandomized studies comparing homeopathic Arnica to a placebo or to another active comparator and calculated two quantitative metaanalyses and appropriate sensitivity analyses. We used "Hegde's g," an effect size estimator which is equivalent to a standardized mean difference corrected for small sample bias. The PROSPERO registration number is CRD42020131300. Results: Twenty-three publications reported on 29 different comparisons. One study had to be excluded because no data could be extracted, leaving 28 comparisons. Eighteen comparisons used placebo, nine comparisons an active control, and in one case Arnica was compared to no treatment. The metaanalysis of the placebo-controlled trials yielded an overall effect size of Hedge's g = 0.18 (95% confidence interval -0.007/0.373; p = 0.059). Active comparator trials yielded a highly heterogeneous significant effect size of g = 0.26. This is mainly due to the large effect size of nonrandomized studies, which converges against zero in the randomized trials. Conclusion: Homeopathic Arnica has a small effect size over and against placebo in preventing excessive hematoma and other sequelae of surgeries. The effect is comparable to that of anti-inflammatory substances.

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.

Prevalence and practice of opioid prescription at a Swiss emergency department: 2013-2017.

AIMS OF THE STUDY: Addiction associated with prescription opioids is increasing worldwide, including Switzerland. We aimed (1) to determine whether the prevalence and incidence of opioid therapy at an emergency department (ED) in Switzerland has changed over five years and (2) to characterise consultations with incident opioid prescription. METHODS: In this retrospective chart review, pre-existing opioid treatment and new prescriptions at the ED of Bern University Hospital “Inselspital”, Switzerland, between 2013 and 2017 were identified from the ED documentation system. Patients already taking opioids before presentation (prevalent opioid use) were distinguished from opioid-naïve patients who were prescribed opioids for the first time (incident opioid prescription) and relative numbers in every half year from 2013 to 2017 were calculated. Demographic and consultation characteristics were analysed to determine factors associated with incident opioid prescription. RESULTS: Within the observation period, 199,299 patients consulted the ED. Of those, 4.95% (95% confidence interval [CI] 4.86–5.05, n = 9868) were using opioids on admission. Nearly 7.07% of them (95% CI 6.57–7.58, n = 698), 0.35% of the complete sample, were prescribed additional opioids. Incident opioid prescription for opioid-naïve patients was found in 2.26% of patients (95% 2.19–2.32, n = 4499). The relative number of prevalent opioid users did not show a significant (p = 0.163) association with time (categorised in half years) when adjusted for the potential confounders age group, trauma, the interaction of trauma and age group, other chief complaint, type of admission and time of admission. Incident opioid prescriptions significantly decreased over the study period (slope = −0.041% per half year, standard error = 0.012%, p = 0.007). The trend persisted after adjustment for the abovementioned potential confounders. Consultations resulting in opioid prescription were significantly associated with older age, musculoskeletal disorders and trauma (p <0.05). CONCLUSIONS: Opioid prescriptions in a Swiss ED decreased between 2013 and 2017. Although this might be a sign of awareness of the risks of opioid prescription, the conclusion is derived from a single centre study and the observed trend warrants confirmation by data from other sources.

Individualized Homeopathic Treatment in Women with Recurrent Cystitis: A Retrospective Case Series.

BACKGROUND: Recurrent urinary tract infections are of importance for public health as most clinicians are faced with repeated and long-term administration of broad-spectrum antimicrobial agents leading to an increased risk of resistant bacteria. One encouraging treatment approach may be individualized homeopathy. CASE REPORTS: Here, four female cases with recurrent urinary tract infections are reported. They were treated successfully with the homeopathic strategy after several conventional approaches revealed no improvement. The follow-up period was a minimum of 3 years and the frequency of episodes with urinary tract infection as well as of antibiotic treatment was documented. Additionally, the patients were asked to assess the treatment outcome retrospectively in a validated questionnaire. RESULTS: The treatment resulted in a reduction of urinary tract infections and the need for antibiotics from monthly to less than 3 times a year. Three of the four women had no cystitis and related intake of antibiotics for more than 1.5 years. A relapse of symptoms could be treated efficiently with a repetition of the homeopathic remedy. All subjective outcome assessments resulted positive. CONCLUSION: This case series suggests a possible benefit of individualized homeopathic treatment for female patients with recurrent urinary tract infections. Larger observational studies and controlled investigations are warranted.

A Case Report of Burning Mouth Syndrome Treated with Individualised Homeopathy.

INTRODUCTION: Burning mouth syndrome (BMS) is a rare disease of unknown origin. No efficient treatment is known, and integrative approaches are warranted. So far, individualised homeopathy (iHOM) has not been evaluated or reported in any peer-reviewed journal as a treatment option. METHODS: At the Centre of Complementary Medicine at a university institute in Switzerland, a 38-year-old patient with BMS and various co-morbidities was treated with iHOM between July 2014 and August 2018. The treatment involved prescription of individually selected homeopathic single remedies. During follow-up visits, outcome was assessed with two validated questionnaires concerning patient-reported outcomes. To assess whether the documented changes were likely to be associated with the homeopathic intervention, an assessment using the modified Naranjo criteria was performed. RESULTS: Over an observation period of 4 years, an increasingly beneficial result from iHOM was noted for oral dysaesthesia and pains as well as for the concomitant symptoms. CONCLUSION: Considering the multi-factorial aetiology of BMS, a therapeutic approach such as iHOM that integrates the totality of symptoms and complaints of a patient might be of value in cases where an association of psychological factors and the neuralgic complaints is likely.

Complementary individual homeopathy in paediatric cancer care: A case series from a University Hospital, Switzerland.

The Department of Haematology/Oncology at the University Children's Hospital Bern (HONK), has adopted an integrative approach in addition to state of the art oncological care and implemented a collaboration with the Institute of Complementary Medicine IKOM, University of Bern, over the past 10 years. Stakeholder satisfaction with this service was high. We present descriptive data and report on 4 exemplary patients treated with additional individualized homeopathy (iHOM). Data concerning frequency of consultations, pathologies, follow-ups and clinical results were reviewed and summarized using descriptive statistics. 94 paediatric oncologic patients consulted for iHOM. Indications for the complementary treatment was wide-ranging. No interactions with conventional treatment and no adverse side-effects of iHOM were detected. We present four characteristic patient histories, in which iHOM was used in addition to standard treatment for mucositis, permissive tissue infection, insomnia and affective dysfunctions. All four patients clinically improved in an immediate temporal relationship to the additional treatment. CONCLUSION: The collaboration between HONK and IKOM established iHOM in paediatric oncology in Bern. In this setting, iHOM was a safe and supportive additional treatment for various indications during the conventional cancer care. However, no generalizable results can be deducted from these data. We emphasize future research on this topic.

HRI Malta 2017-Cutting Edge Research in Homeopathy: HRI's Third International Research Conference in Malta.

The third international conference on "Cutting Edge Research in Homeopathy" organised by the Homeopathy Research Institute (HRI) was held on the inspiring and historic island of Malta from 9th to 11th of June, 2017. One hundred and two abstracts underwent peer review by the HRI Scientific Advisory Committee and external experts to produce the programme of 36 oral presentations and 37 posters, presented by researchers from 19 countries. The 2.5-day programme covered a diverse range of topics, including quantitative and qualitative clinical research, basic research, veterinary research, and provings. These intensive plenary and parallel sessions were interspersed with multiple opportunities for delegates to discuss and exchange ideas, in particular through interactive panel discussions and a pre-conference workshop. The continuing commitment of the homeopathy research community to generate high-quality studies in this rapidly evolving field was clear. In this conference report, we present highlights from this memorable event.

Re-analysis of survival data of cancer patients utilizing additive homeopathy.

In this short communication we present a re-analysis of homeopathic patient data in comparison to control patient data from the same Outpatient´s Unit "Homeopathy in malignant diseases" of the Medical University of Vienna. In this analysis we took account of a probable immortal time bias. For patients suffering from advanced stages of cancer and surviving the first 6 or 12 months after diagnosis, respectively, the results show that utilizing homeopathy gives a statistically significant (p<0.001) advantage over control patients regarding survival time. In conclusion, bearing in mind all limitations, the results of this retrospective study suggest that patients with advanced stages of cancer might benefit from additional homeopathic treatment until a survival time of up to 12 months after diagnosis.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

OBJECTIVES: The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. DESIGN: In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. MAIN OUTCOME MEASURES: The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. RESULTS: 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. CONCLUSION: Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.

Additive homeopathy in cancer patients: Retrospective survival data from a homeopathic outpatient unit at the Medical University of Vienna.

BACKGROUND: Current literature suggests a positive influence of additive classical homeopathy on global health and well-being in cancer patients. Besides encouraging case reports, there is little if any research on long-term survival of patients who obtain homeopathic care during cancer treatment. DESIGN: Data from cancer patients who had undergone homeopathic treatment complementary to conventional anti-cancer treatment at the Outpatient Unit for Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria, were collected, described and a retrospective subgroup-analysis with regard to survival time was performed. Patient inclusion criteria were at least three homeopathic consultations, fatal prognosis of disease, quantitative and qualitative description of patient characteristics, and survival time. RESULTS: In four years, a total of 538 patients were recorded to have visited the Outpatient Unit Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria. 62.8% of them were women, and nearly 20% had breast cancer. From the 53.7% (n=287) who had undergone at least three homeopathic consultations within four years, 18.7% (n=54) fulfilled inclusion criteria for survival analysis. The surveyed neoplasms were glioblastoma, lung, cholangiocellular and pancreatic carcinomas, metastasized sarcoma, and renal cell carcinoma. Median overall survival was compared to expert expectations of survival outcomes by specific cancer type and was prolonged across observed cancer entities (p<0.001). CONCLUSION: Extended survival time in this sample of cancer patients with fatal prognosis but additive homeopathic treatment is interesting. However, findings are based on a small sample, and with only limited data available about patient and treatment characteristics. The relationship between homeopathic treatment and survival time requires prospective investigation in larger samples possibly using matched-pair control analysis or randomized trials.