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.

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.

[Einstellung von Ärzten gegenüber Komplementärmedizin in einer ländlichen Region der Schweiz: Ergebnisse einer Umfrage]. / Physicians' Attitude towards Complementary Medicine in a Rural Region of Switzerland: Results of a Survey.

Fragestellung: Im Zusammenhang mit der Einführung ambulanter KM-Sprechstunden am Regionalspital Burgdorf wurde die ärztliche Einstellung zu Komplementärmedizin (KM) untersucht. Weiterhin wurden der Anteil der Ärzte mit KM-Angeboten im Versorgungsgebiet des Regionalspitals, deren KM-Erfahrungen sowie der Einfluss dieser Erfahrungen auf die Einstellung gegenüber KM untersucht. Material und Methoden: Alle Ärzte jeglicher Fachrichtung (n = 170) im Versorgungsgebiet wurden 2011 und 2012 schriftlich zu ihrer Einstellung gegenüber KM (Befürwortung/Ablehnung und Ambivalenz), ihrem KM-Angebot und ihren KM-Erfahrungen befragt (Rücklaufquote 45% bzw. 36%). Ergebnisse: Die Einstellung gegenüber KM war im Durchschnitt neutral (M = 2,47, Standardabweichung (SD) = 0,61; Befürwortung von KM von 1 = «stimme völlig zu¼ bis 4 = «stimme überhaupt nicht zu¼) und klar (M = 1,59, SD = 0,46; Einstellungsambivalenz von 1 = «habe klare Meinung¼ bis 4 = «bin mir sehr unsicher in meiner Meinung¼). Die höchste Zustimmung erhielten die Forderungen nach wissenschaftlicher Untersuchung der KM (M = 2,10, SD = 0,95) und nach zertifizierter ärztlicher KM in der Grundversicherung (M = 2,53, SD = 1,15). Knapp ein Drittel der Ärzte bot KM an, und 77% bzw. 69% überwiesen Patienten zu KM-Behandlungen. Die wichtigsten Prädiktoren der KM-Befürwortung waren eine zertifizierte KM-Ausbildung und unerwartete positive bzw. negative Verläufe unter einer KM-Behandlung (R22011 = 0,44, p < 0,001). 25% der Ärzte hatten Erfahrungen mit der neuen KM-Sprechstunde, die überwiegend positiv waren. Schlussfolgerung: Die teilnehmenden Ärzte aus einer ländlichen Region der Schweiz zeigten im Durchschnitt eine neutrale und klare Einstellung zur KM, die sich im eigenen KM-Angebot bzw. in der Überweisungspraxis spiegelte.

Correction: Usage of Complementary Medicine in Switzerland: Results of the Swiss Health Survey 2012 and Development Since 2007.

[This corrects the article DOI: 10.1371/journal.pone.0141985.].

Use of Complementary and Alternative Medicine in Children with Cancer: A Study at a Swiss University Hospital.

BACKGROUND: Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM. STUDY DESIGN: All childhood cancer patients treated at the University Children's Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM. RESULTS: Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient's general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects. CONCLUSIONS: Since many pediatric oncology patients use CAM, patients' needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.

Usage of Complementary Medicine in Switzerland: Results of the Swiss Health Survey 2012 and Development Since 2007.

BACKGROUND: Complementary medicine (CM) is popular in Switzerland. Several CM methods (traditional Chinese medicine/acupuncture, homeopathy, anthroposophic medicine, neural therapy, and herbal medicine) are currently covered by the mandatory basic health insurance when performed by a certified physician. Treatments by non-medical therapists are partially covered by a supplemental and optional health insurance. In this study, we investigated the frequency of CM use including the evolvement over time, the most popular methods, and the user profile. METHODS: Data of the Swiss Health Surveys 2007 and 2012 were used. In 2007 and 2012, a population of 14,432 and 18,357, respectively, aged 15 years or older answered the written questionnaire. A set of questions queried about the frequency of use of various CM methods within the last 12 months before the survey. Proportions of usage and 95% confidence intervals were calculated for these methods and CM in general. Users and non-users of CM were compared using logistic regression models. RESULTS: The most popular methods in 2012 were homeopathy, naturopathy, osteopathy, herbal medicine, and acupuncture. The average number of treatments within the 12 months preceding the survey ranged from 3 for homeopathy to 6 for acupuncture. 25.0% of the population at the age of 15 and older had used at least one CM method in the previous 12 months. People with a chronic illness or a poor self-perceived health status were more likely to use CM. Similar to other countries, women, people of middle age, and those with higher education were more likely to use CM. 59.9% of the adult population had a supplemental health insurance that partly covered CM treatments. CONCLUSIONS: Usage of CM in Switzerland remained unchanged between 2007 and 2012. The user profile in Switzerland was similar to other countries, such as Germany, United Kingdom, United States or Australia.

Usage of complementary medicine across Switzerland: results of the Swiss Health Survey 2007.

QUESTIONS UNDER STUDY: This study investigated the use among the Swiss adult population and regional dissemination of various methods of complementary medicine (CM) provided by physicians or therapists in Switzerland. METHODS: Data of the Swiss Health Survey 2007 were used, which comprised a telephone interview followed by a written questionnaire (18,760 and 14,432 respondents, respectively) and included questions about people's state of health, health insurance and usage of health services. Users and non-users of CM were compared using logistic regression models. RESULTS: The most popular CM methods were homeopathy, osteopathy, acupuncture and shiatsu/foot reflexology. 30.5% of women and 15.2% of men used at least one CM method in the 12 months preceding the survey. Lake Geneva region and central Switzerland had more CM users than the other regions. Women, people between 25 and 64 years of age and people with higher levels of education were more likely to use CM. 53.5% of the adult population had a supplemental health insurance for CM treatments. 32.9% of people with such an insurance used CM during the 12 months preceding the survey, and so did 12.0% of people without additional insurance. CONCLUSIONS: Almost one fourth of the Swiss adult population had used CM within the past 12 months. User profiles were comparable to those in other countries. Despite a generally lower self-perceived health status, elderly people were less likely to use CM.

Towards a pan-European definition of complementary and alternative medicine--a realistic ambition?

BACKGROUND: The terms used for defining complementary and alternative medicine (CAM) including the methods, procedures and therapies vary greatly. The task of the CAMbrella working group on terminology was to explore the existing CAM terminologies and to develop a pragmatic definition of CAM that is acceptable Europe-wide. This can then be used to systematically research, e.g., its prevalence and legal status and to investigate the citizens' demands on CAM and the perspectives of providers of CAM in Europe. METHODS: Terms and definitions were collected from both scientific and non-scientific sources. The terms and definitions identified were analysed and discussed among the CAMbrella working group participants on several occasions with the aim of arriving at a consensus. RESULTS: We developed a proposal for a pragmatic European definition of CAM: 'Complementary and alternative medicine (CAM) utilised by European citizens represents a variety of different medical systems and therapies based on the knowledge, skills and practices derived from theories, philosophies and experiences used to maintain and improve health, as well as to prevent, diagnose, relieve or treat physical and mental illnesses. CAM has been mainly used outside conventional health care, but in some countries certain treatments are being adopted or adapted by conventional health care.' CONCLUSION: Developing a uniform, pragmatic pan-European definition of CAM was complicated by a number of factors. These included the vast diversity of existing definitions, systems, disciplines, procedures, methods and therapies available within the EU.

Complementary and alternative medicine provision in Europe--first results approaching reality in an unclear field of practices.

BACKGROUND: The demand for complementary and alternative medicine (CAM) treatment in the European Union (EU) has led to an increase in the various CAM interventions available to the public. Our aim was to describe the CAM services available from both registered medical practitioners and registered non-medical practitioners. METHODS: Our literature search comprised a PubMed search of any scientific publications, secondary references and so-called grey literature, a search of government websites and websites of CAM organisations to collect data in a systematic manner, and personal communications, e.g., via e-mail contact. Due to the different reliability of data sources, a classification was developed and implemented. This weighted database was condensed into tables and maps to display the provision of CAM disciplines by country, showing the distribution of CAM providers across countries. RESULTS: Approximately 305,000 registered CAM providers can be identified in the EU (~160,000 non-medical and ~145,000 medical practitioners). Acupuncture (n = 96,380) is the most available therapeutic method for both medical (80,000) and non-medical (16,380) practitioners, followed by homeopathy (45,000 medical and 5,800 non-medical practitioners). Herbal medicine (29,000 practitioners) and reflexology (24,600 practitioners) are mainly provided by non-medical practitioners. Naturopathy (22,300) is dominated by 15,000 (mostly German) doctors. Anthroposophic medicine (4,500) and neural therapy (1,500) are practised by doctors only. CONCLUSION: CAM provision in the EU is maintained by approximately 305,000 registered medical doctors and non-medical practitioners, with a huge variability in its national regulatory management, which makes any direct comparison across the EU almost impossible. Harmonisation of legal status, teaching and certification of expertise for therapists would be of enormous value and should be developed.

Complementary therapy systems and their integrative evaluation.

Complementary and alternative medicine (CAM) is becoming an integral part of modern medicine. Complementary and alternative medicine therapy systems include natural medicinal products, nonpharmacological treatments, and counselling on health and lifestyle issues. Complementary and alternative medicine concepts are often elaborate, transcending biophysical models and employing the principles of salutogenesis. Evaluations of CAM therapy systems need to be integrative and cover the dimensions of: (1) therapeutic professionalism; (2) patient perspective and public demand; (3) conceptuality; (4) safety, effectiveness, and costs. Complex research strategies are required, which reverse the phases of conventional drug assessment. The predominant use of randomized trials would introduce structural bias and create an artificial picture. Important are evaluations of the whole system in real-world conditions, and surveys on component evaluations. Systemic CAM assessments should consist of a broad array of high-quality research methods: well-conducted randomized and nonrandomized studies, cohort studies, qualitative research, high-quality case reports and case series, studies on patient perspective, safety analyses, economic analyses, etc. Good clinical judgement, a core epistemic element of medicine based on nonstochastic principles, should also be integrated and could reflect routine patient care.

Isopathic treatment effects of Arsenicum album 45x on wheat seedling growth--further reproduction trials.

BACKGROUND: Two experimental studies on wheat preintoxicated with Arsenic trioxide yielded a significant shoot growth increase after an isopathic application of Ars-alb 45x. One independent reproduction trial however, yielded an effect inversion: wheat shoot growth was significantly decreased after application of Ars-alb 45x. AIMS: In this study we investigated the role of three potential confounding factors on the experimental outcome: geographical location of the experiments, influence of the main experimenter, and seed sensitivity to Arsenic poisoning. Laboratory-internal reproducibility was assessed by meta-analysis. MATERIAL AND METHODS: Wheat poisoned with Arsenic trioxide was cultivated in vitro in either Ars-alb 45x, water 45x, or unpotentised water. Treatments were blinded and randomised. Shoot length was measured after 7 days. The stability of the experimental set-up was assessed by systematic negative control (SNC) experiments. RESULTS: The SNC experiments did not yield significant differences between the three groups treated with unpotentised water. Thus the experimental set-up seemed to be stable. We did not observe any shoot growth increase after a treatment with Ars-alb 45x in any of the newly performed experiments. In contrast, the meta-analysis of all 17 experiments performed (including earlier experiments already published) yielded a statistically significant shoot growth decrease (-3.2%, p=0.017) with isopathic Ars-alb 45x treatment. This effect was quantitatively similar across all five series of experiments. CONCLUSIONS: Ultramolecular Ars-alb 45x led to statistically significant specific effects in arsenic poisoned wheat when investigated by two independent working groups. Effect size and effect direction differ, however. The investigated factors (geographical location, experimenter, seed sensitivity to Arsenic poisoning) did not seem to be responsible for the effect inversion. Laboratory external reproducibility of basic research into homeopathic potentisation remains a difficult issue.