Cost-effectiveness analysis for SilAtro-5-90 adjuvant treatment in the management of recurrent tonsillitis, compared with usual care only.

PURPOSE: Antibiotics are one possible treatment for patients with recurrent acute throat infections (ATI), but effectiveness can be modest. In view of worries over antibiotic resistance, treatment pathways that reduce recurrence of ATI are essential from a public health perspective. Integrative treatment strategies can be an option but there is still a high demand to provide evidence of their cost effectiveness. METHODS: We constructed a 4-state Markov model to compare the cost-effectiveness of SilAtro-5-90 as adjuvant homeopathic therapy to care as usual with care as usual alone in reducing the recurrence of ATI for children and adults with suspected moderate recurrent tonsillitis. The analysis was performed from a societal perspective in Germany over a 2-year period. Results are reported separately for children < 12 and for individuals aged 12 and over. The model draws on evidence from a multi-centre randomised clinical trial that found this strategy effective in reducing recurrence of ATI. Costs in 2019 € and outcomes after 1 year are discounted at a rate of 3% per annum. RESULTS: For adults and adolescents aged 12 years and over, incremental cost per ATI averted in the adjuvant therapy group was €156.64. If individuals enter the model on average with a history of 3.33 previous ATIs, adjuvant therapy has both lower costs and better outcomes than care as usual. For children (< 12 years) adjuvant therapy had both lower costs and ATI than care as usual. The economic case is stronger if adjuvant treatment reduces surgical referral. At a hypothetical cost per ATI averted threshold of €1000 probabilistic sensitivity analysis suggests Silatro-5-90 has a 65% (adults) and 71% (children) chance of being cost-effective. CONCLUSION: Our results indicate the importance of considering homeopathy as adjuvant therapy in the treatment of ATIs in individuals with recurrent tonsillitis from a socio-economic perspective. Further evaluation should assess how differences in uptake and sustained use of homeopathic adjuvant therapy, as well as changing patterns of antibiotic prescribing, impact on cost effectiveness.

Survey on hand gestures relevance in patient practitioner communication: a homeopathic example.

BACKGROUND: Gestures play an important role in medical communication. METHODS: 94 homeopaths (Mean age 49.6 years, 20% male) completed a 20-item questionnaire on utilization and relevance of gestures in patients' symptom description. RESULTS: After excluding nine items due to low validity (n = 4) or low item total correlation (n = 5), factor analysis of the questionnaire resulted in the following three dimensions explaining 66.6% of variance: 'Hand gestures in relation to verbal expressions' (5 items; Cronbach's α = 0.81), 'Hand Gestures describing the experience of bodily and mental symptoms' (4 items; Cronbach's α = 0.74) and 'practitioners' behavior and active attitude in observing hand gestures' (2 items; Cronbach's α = 0.86). CONCLUSION: The survey shows how homeopathic therapists view patients' hand gestures, whether they use these diagnostically and how this relates to their homeopathic practice. Practitioners with only homeopathic influence on this topic are highly congruent to findings on hand gestures from other domains.

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.

Complementary and alternative medicine in the (symptomatic) treatment of acute tonsillitis in children: A systematic review.

BACKGROUND: Acute tonsillitis (including tonsillopharyngitis) in childhood is a common disease with a peak of illness in school-age. Most of these cases have a viral origin and antibiotic therapy is not indicated, therefore, effective symptomatic therapy is required. For this reason, complementary, alternative and integrative medicine therapies might be a solution. OBJECTIVE: The aim of this review is to demonstrate study status of such therapies. METHODS: The databases PubMed, Cochrane Library, OVID, CAMbase, CAM-QUEST® and Anthromedics were systematically screened for studies investigating complementary, alternative and integrative therapy approaches in paediatric cohorts. Studies were analyzed by therapy approach, study design, cohort and outcome, using the PRISMA 2020 checklist. RESULTS: The systematic literature search resulted in 321 articles. Five publications corresponded to the search criteria and were assigned to the following specific therapeutic categories: herbal medicine (3), homeopathy (1) and ayurvedic medicine (1). Clinical trials were found for the herbal compounds BNO 1030 (Impupret®) and EPs® 7630 (Umckaloabo), the homeopathic complex Tonzolyt® and the ayurvedic medicine Kanchnara-Guggulu and Pratisarana of Tankana­Madhu. Antimicrobial effects of essential oils and carvacrol as single agents as well as in combination with erythromycin were analysed in an in vitro study. CONCLUSION: Clinical studies indicate an improvement of symptoms and a good tolerability of all investigated remedies of complementary, alternative and integrative medicine in the treatment of tonsillitis in childhood. Nevertheless, quality and quantity of the studies were insufficient to make a reliable conclusion regarding effectiveness. Therefore, more clinical trials are urgently needed to achieve a meaningful result.

Usage and appraisal of educational media by homeopathic therapists - a cross sectional survey.

BACKGROUND: During recent years the market for homeopathic education media has increasingly diversified with old (books, seminars) and new media (video-seminars, pc-programs, homeo-wiki and internet-courses). However, little is known about homeopaths' preferences in using educational media and their requirements of this topic. AIM: This survey was designed to gain a better understanding of the usage and appraisal of educational media by homeopaths. METHODS: 192 homeopathic practitioners (GPs and health practitioners) at a educational conference were asked to answer a standardized questionnaire covering the topics "formal education and context of work" (9 items), "homeopathic practise and usage (24 items), "utilization of educational media" (9 items) and "favoured attributes for educational media" (11 items). RESULTS: Out of 192 homeopaths who attended the conference, 118 completed the questionnaire (response rate 61.5%). For their continuing homeopathic education they predominantly indicated to use books (scale value from 0 = never to 2 = always: 1.72) and seminars (1.54) whereas journals (0.98) and the internet (0.65) were used less often. The most favoured attributes concerning medical education media were reliability (1.76), relevance for clinical practice (1.74) and user friendliness (1.6). Less favoured attributes were inexpensiveness (1.1), graphical material (0.92) and interactivity (0.88). CONCLUSIONS: The survey illustrates the current situation of medical education media in homeopathy. Although there are parallels to earlier research conducted in conventional GPs, homeopaths are more likely to refer to classical media. New education tools should be designed according to these preferences.

A systematic review and meta-analysis on the use of Hypericum perforatum (St. John's Wort) for pain conditions in dental practice.

BACKGROUND: Hypericum perforatum (St. John's Wort) has been used for a variety of medicinal indications. Most recent research has focussed on its use in herbal form for depression, but its claimed analgesic and anti-inflammatory properties in homeopathic form have also led to a number of studies in patients with acute pain conditions. This systematic review overviews the literature on the use of St. John's Wort for pain conditions in homeopathic dental practice. MATERIAL AND METHODS: PubMed, EMBASE, AMED, CAMbase and the electronic archives of Thieme Publishers were searched with the search terms "(Hypericum OR St. Johns Wort) AND pain". We reviewed and meta-analysed the evidence on Hypericum in pain after tooth extraction was carried out. RESULTS: Twenty one relevant articles were found: four described general recommendations, three basic research, six reported studies in dental care and eight were expert opinions or case reports. Four studies were eligible for the meta-analysis. There was marked high heterogeneity in the effects pain (Chi-Squared = 26.46; I(2) = 0.89). The overall effect of 0.24 (95% CI: [0.06; 1.03]) favours Hypericum but is not statistically significant. CONCLUSION: Although case reports suggest therapeutic potential of Hypericum for pain conditions in dental care, this effect is not currently supported by clinical studies. All studies included in this meta-analysis used Arnica montana as well as Hypericum the results are more influenced by Arnica than Hypericum. Further clinical controlled trials of Hypericum alone in dental practice should be performed.

Hypericum perforatum to Improve Postoperative Pain Outcome After Monosegmental Spinal Sequestrectomy (HYPOS): Results of a Randomized, Double-Blind, Placebo-Controlled Trial.

Introduction: Patients undergoing lumbar spine surgery often suffer from severe radicular postoperative pain leading to the prescription of high-dose opioids. In Integrative Medicine, Hypericum perforatum is known as a remedy to relieve pain caused by nerve damage. Objectives: This trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo. Design: Randomized double blind, monocentric, placebo controlled clinical trial. Settings/Location: Department of Neurosurgery, Community Hospital Herdecke. Subjects: Inpatients undergoing lumbar sequestrectomy surgery. Interventions: Homeopathic treatment versus placebo in addition to usual pain management. Outcomes Measures: Primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception. Results: Baseline characteristics were comparable between the groups. Pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed. Conclusion: This is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction. Clinical Trial Registration Number: German Clinical Trials Register No: DRKS00007913.

Usage of alternative medical systems, acupuncture, homeopathy and anthroposophic medicine, by older German adults.

OBJECTIVE: The manifold studies on the usage of complementary and alternative medicine (CAM) indicate that its utilization differs with respect to socio-cultural background, gender, age and underlying disease. This study intended to analyze the usage of specific CAM practices among a population of older German adults with health insurance coverage. METHODS: Data of 5 830 older individuals who participated in an anonymous cross sectional survey among German insurance beneficiaries were analyzed with respect to usage of CAM treatments applied by medical doctors or non-medical practitioners within the last 5 years. RESULTS: The most frequently used approaches were acupuncture/traditional Chinese medicine (21%), homeopathy (21%), movement therapies/physical exercises (19%), osteopathy/chiropractic (12%), herbs/phytotherapy (7%), diets/specific food recommendations (6%) and foot reflexology (5%). Anthroposophic medicine was used only to a minor degree. Acupuncture and homeopathy users were likely to choose more than one CAM treatment simultaneously, particularly the combination of homeopathy and acupuncture. Moreover, this study can confirm significant differences between women and men in the use of the main relevant CAM interventions. CONCLUSION: The relative proportion of acupuncture usage was similar to homeopathy, which is an alternative whole medical system originating from Western Europe. This means that an Eastern alternative system is established also in Germany. In several cases not only one CAM treatment was used but distinct combinations existed (particularly homeopathy and acupuncture); thus one should be cautious to draw predictive conclusions from studies with broad and unspecific CAM categories, for among them there are several therapies which should not be regarded as CAM.

[Immunologische Ex-vivo-Untersuchung zur Wirkung potenzierter Substanzen bei parodontaler Entzündung unter Verwendung der Durchflusszytometrie]. / Immunological ex vivo Study on the Effects of Potentiated Substances in Periodontal Inflammation Using Flow Cytometry.

Hintergrund: Bei der Behandlung parodontaler Entzündungen werden in der Versorgungspraxis auch homöopathische Mittel eingesetzt. Noch ist weniger über deren grundlegende Wirkprinzipien bekannt. Ziel dieser Arbeit war es daher, die Auswirkungen potenzierter Substanzen bei parodonta-ler Entzündung mittels Durchflusszytometrie zu untersuchen. Material und Methoden: Lymphozyten aus Blutproben von drei Parodontitis-Patienten und drei gematchten gesunden Probanden wurden extrahiert und mit stark verdünnten wässrigen Extrakten (D12 und C200) aus Mercurius solubilis, Silicea, Sulphur, Tuberculinum oder Placebo inkubiert. Um die Lymphozytenexpression zu untersuchen, wurde die Durchflusszytometrie für CD45R0- und CD25-Antikörper angewandt. Die statistische Analyse wurde unter Verwendung von Histogramm- und bivariaten Dot-Plot-Analysen durchgeführt. Ergebnisse: Veränderungen der Expression von CD25 und CD45R0 wurden bei Mercurius C200, Mercurius D12, Silicea D12 und Sulphur D12 beobachtet. Mit 36,47% zeigte Sulphur D12 die höchsten Veränderungen in der CD45R0-Expression zwischen Verum und Placebo bei den Parodontitis-Patienten. Die CD25-Expression war in Mercurius D12 mit 18,68% am höchsten. Aufgrund der hohen Variabilität konnten die Ergebnisse jedoch nicht durch statistische Analysen untermauert werden. Diskussion: Diese Studie konnte zeigen, wie Effekte hoch verdünnter Substanzen mit modernen immunologischen Methoden analysiert werden können. Obwohl die Schlussfolgerungen aufgrund der hohen Variabilität der Lymphozytenexpression begrenzt sind, könnten die Ergebnisse dieser Pilotstu-die weitere Untersuchungen anregen. BACKGROUND: Several homeopathic remedies are applied in the treatment of periodontal inflammation. Still, little is known about their basic working principles. We therefore aimed at investigating the effects of homeopathic drugs in periodontal inflammation by flow cytometry. MATERIAL AND METHODS: Lymphocytes from blood samples of three periodontitis patients and three matched healthy volunteers were extracted and incubated with highly diluted (D12 and C200) aqueous extracts from Mercurius solubilis, Silicea, Sulphur, Tuberculinum, or placebo. To investigate lymphocyte expression, flow cytometry was applied for CD45R0 and CD25 antibodies. Statistical analysis was performed using histogram and bivariate dot-plot analysis. RESULTS: Changes in CD25 and CD45R0 expression were observed in Mercurius C200, Mercurius D12, Silicea D12, and Sulfur D12. With 36.47%, Sulfur D12 showed the highest differences in CD45R0 expression in periodontitis patients between verum and placebo. CD25 expression was highest in Mercurius D12 with 18.68%. Due to high variability, the results could, however, not be underpinned by statistical analyses. CONCLUSION: This study demonstrated how effects of highly diluted substances can be analyzed using modern immunological methods. Although conclusions are limited due to high variability in lymphocyte expression, results from our pilot study might encourage further investigations.

Effectiveness of a homeopathic complex medicine in infantile colic: A randomized multicenter study.

OBJECTIVES: Infantile colic is a common benign disease occurring in early infancy that may have a great impact on family life. In the present study, the effectiveness and safety of the complex homeopathic medicine Enterokind was compared with Simethicone for treating infantile colic. DESIGN AND SETTING: Current data were drawn from a prospective, multicenter, randomized, open-label, controlled clinical trial that was conducted in 2009 in 3 Russian outpatient clinics. Children received either Enterokind (Chamomilla D6, Cina D6, Colocynthis D6, Lac defloratum D6 and Magnesium chloratum D6) or Simethicone. Data from infants ≤ 6 months with infantile colic are presented here. MAIN OUTCOME MEASURES: The main outcomes assessments were the change of total complaints score (maximum 17 points) and total objective symptoms score (maximum 22 points) after 10 days of treatment. RESULTS: Data from 125 infants ≤ 6 months with infantile colic were analyzed. The differences in total complaints and objective symptoms scores between baseline and day 10, estimated from the ANCOVA model, were found to be highly significant (p < 0.0001; ITT) in favor of Enterokind, both for complaints (Δ=-2.38; 95% confidence interval (CI): [-2.87; -1.89]) and for objective symptoms (Δ=-2.07; 95% CI: [-2.65; -1.49]). 1 adverse event (AE), vomiting, occurred under Enterokind and was rated to be unlikely related to it; 4 AEs occurred under Simethicone. All AEs were non-serious. CONCLUSIONS: The current study indicates that Enterokind is an effective and safe homeopathic treatment for functional intestinal colic in infants ≤ 6 months.

[Management of Acute Gastroenteritis in Children: A Systematic Review of Anthroposophic Therapies].

BACKGROUND: Acute gastroenteritis in children accounts for about 10% of hospital admissions and is still one of the major causes of death worldwide. As many children are treated with complementary and alternative medicine (CAM) and anthroposophic medicine, respectively, especially in Europe, the aim of this review was to descriptively present published anthroposophic therapies applied for the treatment of acute gastroenteritis in childhood. METHODS: A complex search strategy recording a broad spectrum of CAM therapies was developed to identify anthroposophic therapy options for the treatment of gastroenteritis in children. The search was conducted in 4 general scientific as well as 3 CAM-specific databases. RESULTS: In total, 3,086 articles were identified and screened for anthroposophic related content. The majority of hits deal with nutritional/dietary therapies. Articles considering anthroposophic approaches constitute only 3.1% (7/227) of all CAM-related articles. Among these articles 2 observational studies, 3 experience reports and 2 reviews were identified. In the experience reports, a variety of anthroposophic remedies was recommended but mostly unsupported by scientific evidence. However, observational studies for the anthroposophic medications, Bolus alba comp. and Gentiana comp., were detected. Additionally, studies investigating the efficacy and safety of Chamomilla, Ipecacuanha, Podophyllum or Tormentilla preparations in homeopathy and phytomedicine, respectively, were presented. CONCLUSIONS: Most CAM-associated therapies for gastroenteritis in childhood comprise dietary recommendations. Studies concerning anthroposophic approaches and medications, respectively, are deficient. The results of this study underline that effort is needed to evaluate anthroposophic therapies in a clinical setting.

Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Spinal disc herniation is a frequently occurring degenerative disease of the spine. Many patients undergoing surgery suffer from radicular pain, known as memory pain, beginning from the third post-operative day. This results in the prescription of high-dose opioid medications. In homeopathy, Hypericum perforatum is known as a remedy for unbearable, shooting or jabbing pain especially when neural damage is involved. Reduction of pain after application of H. perforatum has been observed in previous studies. This study is aimed to investigate whether homeopathic H. perforatum in a potentisation of C200 leads to the reduction of post-operative pain and a decrease of pain medication compared to placebo. METHODS/DESIGN: This is a monocentric, double-blind, randomised placebo-controlled trial conducted at the Department of Neurosurgery at the Community Hospital Herdecke, Germany. One hundred study participants are being recruited from inpatients undergoing elective, monosegmental, lumbar microdiscectomy surgery. Patients are randomly allocated to receive homeopathic treatment or placebo in addition to usual pain management after surgery. The primary clinical outcome is pain reduction after 3 days of inpatient care as measured by pain reduction of subjective pain on a 100-mm Visual Analogue Scale (VAS) at the third post-operative day. Statistical analysis will be carried out by means of a covariance model with adjustment for baseline values and patient expectation for all randomised patients. DISCUSSION: This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic H. perforatum after monosegmental spinal microdiscectomy. We intend to clarify the potential of homoeopathic H. perforatum to reduce surgery-associated pain. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00007913 . Registered on 17 October 2014. EudraCT - Nr: 2013-001383-31. Data sets from the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) are updated every 4 weeks automatically to the International Clinical Trials Registry Platform of World Health Organisation: http://apps.who.int/trialsearch/ . Responsibilities Sponsor: Witten/Herdecke University Alfred-Herrhausen-Straße 50 58,448 Witten Deputy of the sponsor: Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke) Alfred-Herrhausen-Straße 50 58,448 Witten E-mail: wolfgang.eglmeier@uni-wh.de Principal investigator: Prof. Dr. med. Wolfram Scharbrodt Community Hospital Herdecke Department for Neurosurgery Gerhard-Kienle-Weg 4 58,313 Herdecke w.scharbrodt@gemeinschaftskrankenhaus.de Project coordination: Christa Raak Faculty for Health (Department for Integrative and Anthroposophic Medicine) University Witten/Herdecke gGmbh Gerhard-Kienle-Weg 4 58,313 Herdecke christa.raak@uni-wh.de Project manager/data analysis/biometry: Prof. Dr. Thomas Ostermann Faculty for Health (Department for Psychology and Psychotherapy) University Witten/Herdecke gGmbh Alfred-Herrhausen-Straße 50 58,448 Witten thomas.ostermann@uni-wh.de.

[Lymphocyte migration under exposure of homeopathic remedies for periodontal inflammation - a controlled pilot study]. / Lymphozytenmigration unter Exposition homöopathischer Arzneimittel bei parodontaler Entzündung - eine kontrollierte Pilotstudie.

BACKGROUND: Several homeopathic remedies are applied in the treatment of periodontal inflammation. However, little is known about their basic active principles. Therefore, we aimed at investigating the effects of homeopathic drugs in periodontal inflammation by observing lymphocyte migration activity in vitro. MATERIAL AND METHODS: Lymphocytes from blood samples of 3 periodontitis patients and 3 matched healthy volunteers were extracted and embedded in collagen matrix migration assays together with highly diluted (D12 and C200) aqueous extracts from Mercurius solubilis, Silicea, Sulphur, Tuberculinum, or placebo. Lymphocyte migration and lymphocyte speed were observed in a 60-min time frame. Statistical analysis was performed using univariate statistics and SiZer time series analysis. RESULTS: While C-dilutions did not reveal clear differences between placebo and substances, strong effects were observed in D-dilutions compared to placebo. The strongest effects were achieved in lymphocytes exposed to Sulfur D12. While most specific effects were observed in Sulphur D12 showing an activating effect on periodontitis patient lymphocytes (mean activity: 11,1% (placebo) vs. 23,8% (verum)), there was no effect in healthy volunteers (25,8% (placebo) vs. 25,6% (verum)). SiZer analysis confirmed this effect to be significant. CONCLUSION: The basic active principles of highly diluted substances are still a matter of controversial debate. Although conclusions are limited due to low sample size, results from our pilot study might encourage further investigations on the role of highly diluted Sulphur in the treatment of periodontitis. Apart from a reproduction study with Sulphur, other immunological experiments, i.e. the investigation of cell limes via flow cytometry, should be performed to underpin these results.

Homeopathy in the treatment of fibromyalgia--a comprehensive literature-review and meta-analysis.

BACKGROUND: Coping with the complex nature of fibromyalgia symptoms (FMS) still remains a challenge for patients. Taking into account the possible adverse events of pharmacological treatments patients often seek additional treatments for the management of fibromyalgia and turn towards complementary and alternative medicine (CAM). OBJECTIVE: In this review, we aimed to investigate the current state of literature of homeopathy in the treatment of FMS. METHODS: We searched Medline, the Cochrane Register of Controlled Trials, Embase, AMED, PsycInfo and CAMbase for the terms "fibromyalgia AND homeopath$" through February 2013. In addition we searched Google Scholar, the library of the Carstens Foundation and that of the Deutsche Homöopathische Union (DHU). Standardized mean differences (SMD) with 95% confidence intervals (CI) were calculated and meta-analyzed using the generic inverse variance method. RESULTS: We found 10 case-reports, 3 observational studies, 1 non-randomized and 4 randomized controlled trials (RCTs) on homeopathy for fibromyalgia. Both case reports and observational studies are naturally predominated by the use of qualitative and not validated outcome measures. Meta-analyses of CCTs revealed effects of homeopathy on tender point count (SMD=-0.42; 95%CI -0.78, -0.05; P=0.03), pain intensity (SMD=-0.54; 95%CI -0.97, -0.10; P=0.02), and fatigue (SMD=-0.47; 95%CI -0.90, -0.05; P=0.03) compared to placebo. CONCLUSION: The results of the studies as well as the case reports define a sufficient basis for discussing the possible benefits of homeopathy for patients suffering from fibromyalgia syndrome although any conclusions based on the results of this review have to be regarded as preliminary.

Are the effects of homeopathy attributable to a statistical artefact? A reanalysis of an observational study.

Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM). Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects. Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua's modified t-test. Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06-0.19, P < 0.001) in the mental and 0.25 (0.22-0.28, P < 0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses. Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.

Adaptive coping strategies and attitudes toward health and healing in German homeopathy and acupuncture users.

CONTEXT: Although acupuncture and homeopathy both have a theoretical background that refers to immaterial forces difficult to verify, they are nevertheless used and accepted as effective treatments by many individuals. OBJECTIVE: We intended to investigate whether and how users of acupuncture and homeopathy differ with respect to sociodemographic data, adaptive coping strategies, and attitudes toward complementary and alternative medicine (CAM). DESIGN AND PATIENTS: In an anonymous questionnaire survey among 5,830 elderly German health insurants, we identified individuals who used CAM within the last five years. RESULTS: Acupuncture was used by 10% of the population, homeopathy by 7%, and both by 5%. More men than women used acupuncture, whereas homeopathy was used equally by women and men. Acupuncture users had a reduced physical health status compared to homeopathy users. In most cases, it was not a disappointment with conventional medicine that accounted for CAM usage. Stepwise regression analyses revealed that the best predictors of acupuncture and homeopathy usage were the conviction that CAM is more profound and expends more time, fear of the side effects of conventional medicine, and high scores in the measure of search for information and alternative help. Negative predictors were physical health, male gender, age, and trust in a scientific rationale of treatments. CONCLUSION: We found that usage of distinct CAM approaches might depend on particular psychosocial profiles, attitudes, and convictions. In contrast to homeopathy users, acupuncture users seemed to be much more pragmatic and referred more often to an expected scientific background of chosen treatment. Our findings fill a gap of knowledge that needs further attention.

Remedies containing Asteraceae extracts: a prospective observational study of prescribing patterns and adverse drug reactions in German primary care.

BACKGROUND: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety. OBJECTIVE: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany. METHODS: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated. RESULTS: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and nonserious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class 'skin and subcutaneous tissue disorders' (six ADRs) and 1.0 (95% CI 0.3, 3.6) for 'gastrointestinal disorders' (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al. CONCLUSION: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.