Effectiveness and cost-effectiveness of treatment with additional enrollment to a homeopathic integrated care contract in Germany.

BACKGROUND: A number of German statutory health insurance companies are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathic treatment. The effectiveness and cost-effectiveness of these contracts are highly debated. METHODS: To evaluate the effectiveness and cost-effectiveness of treatment after an additional enrollment in an ICCH, a comparative, prospective, observational study was conducted in which participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone. Those insured with either migraine or headache, allergic rhinitis, asthma, atopic dermatitis and depression were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data. RESULTS: Data from 2524 participants (1543 HOM group) were analyzed. The primary effectiveness outcomes after six months were statistically significant in favor of the HOM group for migraine or headache (Δ = difference between groups, days with headache: - 0.9, p = 0.042), asthma (Δ-AQLQ(S): + 0.4, p = 0.014), atopic dermatitis (Δ-DLQI: - 5.6, p ≤ 0.001) and depression (Δ-BDI-II: - 5.6, p ≤ 0.001). BDI-II differences reached the minimal clinically important difference. For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with migraine or headache, atopic dermatitis and depression suggesting cost-effectiveness in terms of additional costs per QALY gained. CONCLUSION: After an additional enrollment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrollment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings. TRIAL REGISTRATION: clinicaltrials.gov , NCT01854580. Registered 15 March 2013 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01854580.

What Future for Hahnemann's Therapeutic System?

This article explores the historical growth patterns in homeopathy, recent shifts in perception, and a likely future of this type of medicine. Homeopathic medicine developed as a contradictory approach to health compared to the orthodox view of mainstream medicine. Over the past two centuries, this form of health care has maintained its heterodox position under continued attacks from the established order. Modern medicine is being pushed by materialism and the drive to generate profits by large pharmaceutical and health care corporations. Whilst homeopathy has also enjoyed economic growth in many markets around the world, rising popularity of this type of treatment has been shown to generate regulatory concerns on some fronts. Recent pressures from regulatory authorities have resulted in both setbacks and improved situations for homeopathic prescribers, varying by country where they are located. Despite widespread attacks in the press and from some governmental authorities, users of homeopathic therapies remain staunchly attached to this form of treatment. The future of homeopathy will likely continue to be as rocky as it has been for the past two centuries.

[Sociodemographic profile of the homeopathy user in Spain]. / Perfil sociodemográfico del usuario de la homeopatía en España.

OBJECTIVE: To identify the sociodemographic profile of the homeopathy user in Spain. DESIGN: Quantitative study. LOCATION: Spain. CORPUS: The Centre for Sociological Research database (Study 3205, February 2018), with a total of 2,486 interviews, and the sub-sample that includes all patients who have claimed to use homeopathy in Spain in the last 12 months (n=124). MAIN MEASUREMENTS: The percentages, means and/or standard deviation of the factors were calculated, as well as the significance of the changes in the different variables analysed in the general population, and the specific users of homeopathy in Spain. This was determined by the variance analysis or Pearson's χ2 test, depending on the nature of the variable in the study. RESULTS: The homeopathy user-type profile in Spain is a woman, of middle/high social status, with higher university studies, and with a progressive political ideology. CONCLUSIONS: The Spanish profile is similar to that in other international studies.

USE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE IN GEORGIA.

In Georgia, like in most countries globally, people commonly resort to complementary and alternative medicine (CAM). However, not much is known about CAM practices there. The aim of the study was to document common practices of CAM in Georgia and related patient attitudes. We collected data from peoples who commonly use CAM at 20 service provision centers in Georgia using cluster sampling from 300 patients. We admininstered a cross-sectional survey and conducted descriptive statistical analyses. People in Georgia use CAM either for prevention to improve general health (33%) or to treat chronic conditions (36%), spending about 25 Euros per month out of pocket. Most (77%) get their knowledge about CAM from family or friends , less than half (44%) from books or media, and 11% from medical providers. A close person's advice or experience was the most common rationale given for CAM use (54%). In our sample, 17% either don't trust or are unsatisfied with conventional medicine, 29% found CAM treatment "very effective" and 61% "quite/partially" effective; only 5% not effective. Conventional treatment was stopped in half of the cases. 35% of respondents informed their physicians of their CAM use, while about half did not. Public mistrust towards conventional medicine, CAM user high satisfaction, relatively low cost of such services in Georgia - are the factors letting us to suggest that CAM use will further increase. Frequent self taking decisions made by patients to stop physician prescribed treatment, not informing physicians on CAM use, as well as other factors put patients health at risk. Further research and capacity building in practice, education and other related aspects are needed to establish evidence-based regulation and standards for CAM in Georgia that ensure informed decision making and patient safety.

Homeopathy in France in 2011-2012 according to reimbursements in the French national health insurance database (SNIIRAM).

BACKGROUND: The use of homeopathic medicine is poorly described and the frequency of combined allopathic and homeopathic prescriptions is unknown. OBJECTIVE: To analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance. METHODS: The French national health insurance databases (SNIIRAM) were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012. RESULTS: A total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period, i.e. 10.2% of the overall population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements. A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Allopathic medicines were coprescribed with 55% of homeopathic prescriptions. CONCLUSION: Many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines.

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis.

The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers' claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

Utilization and costs of conventional and alternative pharmaceuticals in children: results from the German GINIplus and LISAplus birth cohort studies.

PURPOSE: The socioeconomic determinants for drug utilization, especially in children, have not been investigated sufficiently so far. The study's aim was the estimation of prevalences and determinants of conventional, homeopathic and phytotherapeutic drugs and expenditures. METHODS: Population-based data on drug utilization of 3,642 children in two German birth cohorts (GINIplus and LISAplus, 10-year follow-up) were collected using a self-administered questionnaire. For analysis, the reported drugs (use within the last four weeks) were classified into the therapeutic categories of 'conventional medicine', 'homeopathy', 'phytotherapy' and 'others'. Drug costs were estimated using pharmaceutical identification numbers. RESULTS: In all, 42.3% of the children reported drug use; 24.1% of the drugs were homeopathic and 11.5% were phytotherapeutic. The proportion of children who took at least one homeopathic remedy was 14.3%. Drugs prescribed by physicians were dominated by conventional medicine (76.5%), whereas in non-prescribed drugs, both homeopathy and conventional medicine accounted for 37% each. Boys (OR = 0.78) used less homeopathy than girls. Income showed only a weak influence. Education had a strong effect on the use of phytotherapy such that children of mothers with higher school education (>10 years vs. <10 years) used more phytotherapy (OR = 2.01). If out-of-pocket payments arose (n = 613), the mean was €20. On average, total drug expenditures summed up to €39 in 4 weeks for drug users if only clearly identifiable prices for drugs were considered (58% of all data). CONCLUSIONS: Utilization of homeopathy is common in children from the analyzed cohort. User profiles of homeopathy and phytotherapy differ from each other and should be analyzed separately.

Use of complementary and alternative medicine in children with recurrent acute otitis media in Italy.

Controlling environmental factors, chemoprophylaxis, immunoprophylaxis and surgery are considered possible means of preventing recurrent acute otitis media (RAOM), but there are no available data concerning the paediatric use of complementary and alternative medicine (CAM). We evaluated the uses of CAM (homeopathy and/or herbal medicine) as means of preventing AOM in children with a history of RAOM. Eight hundred and forty Italian children with RAOM (≥3 episodes in six months) aged 1-7 years were surveyed in 2009 using a face-to-face questionnaire, filled by parents or caregivers, that explored the prevalence, determinants, reasons, cost, and perceived safety and efficacy of CAM. About one-half (46%) of the children used CAM, significantly more than the number who used immunoprophylaxis (influenza vaccine 15%; p<0.05), PCV-7 34%; p<0.05) or chemoprophylaxis (2%; p<0.001). Use of CAM in the family was the only important factor positively associated with the use of CAM in children (adjusted OR 7.94; 95% CI: 5.26-11.99). The main reasons for using CAM were a fear of the adverse effects of conventional medicine (40%) and to increase host defences (20%). CAM was widely seen as safe (95%) and highly effective (68%). CAM prescribers were paediatricians in 50.7% of cases; self-initiation was reported by 23% of respondents. CAM expenditure was between Euro 25 and Euro 50/month in 27.6% of cases and ≥ Euro 50/month in 16%. Children with RAOM should be considered among the categories of subjects likely to be using CAM. Together with the fact that paediatricians are the main prescribers, this is worrying because of the current lack of evidence regarding the efficacy, safety and cost-effectiveness of CAM in the prevention of RAOM.

The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

OBJECTIVE: To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. METHODS: In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. RESULTS: 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. CONCLUSIONS: A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma.

Do you consider complementary and alternative medicine in your medical history review?

Complementary and alternative medicine (CAM) represents a group of diverse medical and health care systems, practices, and products that are not considered to be part of conventional medicine. Nevertheless, 83 million adults and 8.5 million children used these products and services in 2007 alone, spending almost $34 billion out-of-pocket for many products that have not been proven and, in fact, may be contraindicated. A review is used to raise awareness and concern among dental practitioners as they consider new and current patient medical histories.

Homoeopathic versus conventional therapy for atopic eczema in children: medical and economic results.

BACKGROUND: One of five children visiting a homoeopathic physician is suffering from atopic eczema. OBJECTIVE: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care. METHODS: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs. RESULTS: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 + or - 3.02 [mean + or - SE] vs. conventional 18.20 + or - 2.31, p = 0.290) and 12 months (17.41 + or - 3.01 vs. 17.29 + or - 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups. CONCLUSION: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema.

Economic evaluation of Sinfrontal in the treatment of acute maxillary sinusitis in adults.

Sinfrontal, a complex homeopathic medication, is popular in Germany for the treatment of ear, nose and throat and respiratory tract infections. Unlike many other homeopathic or herbal medications, the efficacy and safety of Sinfrontal has been demonstrated in a number of clinical studies of patients with sinusitis. To assess the cost effectiveness of Sinfrontal versus placebo in the treatment of adults with acute maxillary sinusitis (AMS) in Germany. A secondary objective was to assess the cost effectiveness of Sinfrontal versus standard treatment with antibacterials. Sinfrontal was compared with placebo in a cost-utility analysis based on data from a randomized controlled clinical trial over 3 weeks (Sinfrontal group: n = 57; placebo group: n = 56). Trial data were analysed from a societal perspective; resource use was valued with German unit costs for 2005. In a secondary analysis, the longer-term cost utility of Sinfrontal versus placebo was estimated over a total of 11 weeks based on an 8-week post-treatment observational phase. In addition, the cost effectiveness of Sinfrontal versus antibacterials was determined based on an indirect comparison of placebo-controlled trials. Sinfrontal led to incremental savings of euro 275 (95% CI 433, 103) per patient compared with placebo over 22 days, essentially due to the markedly reduced absenteeism from work (7.83 vs 12.9 workdays). Incremental utility amounted to 0.0087 QALYs (95% CI 0.0052, 0.0123), or 3.2 quality-adjusted life-days (QALDs). Bootstrapping showed that these findings were significant, with Sinfrontal being dominant in 99.9% of simulations. The results were robust to a number of sensitivity analyses. In the secondary analysis, Sinfrontal led to incremental cost savings of euro 511 and utility gains of 0.015 QALYs or 5.4 QALDs compared with placebo. Compared with antibacterials, Sinfrontal had a significantly higher cure rate (11% vs 59%; p < 0.001) at similar or lower costs. The results of this economic evaluation indicate that Sinfrontal may be a cost-effective treatment for AMS in adults.

Cost-benefit evaluation of homeopathic versus conventional therapy in respiratory diseases.

METHODS: A retrospective observational study was conducted on 105 out of 233 patients suffering from chronic respiratory disease attending the Homeopathic Clinic of the Campo di Marte Hospital in Lucca (Tuscany, Italy) between October 1998 and May 2003. We assessed the cost of conventional medicinal products using Anatomic Therapeutic Chemical (ATC) classification, specific for the pathology in question, and the general costs in the year preceding the first appointment at the Homeopathic Clinic vs. the first and second year subsequent to homeopathic treatment. The costs of conventional drugs for a group of patients affected by asthma (8 patients) and recurrent respiratory infections (16 patients) with long term use of conventional medicine treated by homeopathy were compared with the expenses of conventional drugs of a matched group of 16 and 32 patients, respectively. RESULTS: Costs of pharmacological therapy specific for respiratory diseases were reduced by 46.3% (n=105) in the first year (P<0.01); and by 47.5% (n=72) in the second year (P<0.01) of homeopathic treatment. Reduction in general drug costs during homeopathic therapy was 42.4% in the first year (P<0.01); and -49.8 in the second year (N.S.). Costs for patients affected by chronic asthma showed a reduction in expenses of 71.1% for specific medicines relative to the group in homeopathic treatment vs. an increase of 12.3% in the group treated only with conventional drugs after the first year of follow-up and, respectively, a reduction of -54.4% for homeopathic treatment vs. +45.2% after the second year. For patients with recurrent respiratory infections we found a reduction of 35.8% in the homeopathic group in the first year, compared to an increase 8.6% of costs for specific drugs in the control group; in the second year the respective figures were -43.6% versus +7.8% in the control group. CONCLUSIONS: Homeopathic treatment for respiratory diseases (asthma, allergic complaints, Acute Recurrent Respiratory Infections) was associated with a significant reduction in the use and costs of conventional drugs. Costs for homeopathic therapy are significantly lower than those for conventional pharmacological therapy.

Observational study of homeopathic and conventional therapies in patients with diabetic polyneuropathy.

METHODS: The feasibility and outcomes of homeopathic therapy in a group of type-2 diabetes mellitus patients with diabetic neuropathy were studied in a prospective observational study. Patients were followed from baseline (T0) for 6 months (T1) and for 12 months (T2), treatment was adjusted as necessary. Primary outcome was diabetic neuropathy symptom (DNS) score, secondary outcomes were clinical evolution and short-form-36 (SF-36)-evaluated quality of life (QOL). RESULTS: Homeopathy was used in 45 patients, 32 of whom completed the observation study, and in parallel the conventional therapy outcomes were observed in 32 patients, 29 of whom completed the study. DNS improved in both groups during the observation period, but the change with respect to baseline was statistically significant only in Homeopathic group at T1 (P=0.016). Over the course of the observation there was a substantial stability of the electroneurophysiological values, blood pressure and body weight in both groups, a slight decrease of fasting blood glucose and glycated haemoglobin in Homeopathic group. QOL scores showed an improvement in Homeopathic group only. The cost of conventional drugs decreased in Homeopathic group from 114 euro/month to 94 euro/month at T1. CONCLUSION: Complementary homeopathic therapy of diabetic neuropathy was feasible and promising effects in symptom scores and cost savings were observed.

A retrospective cost-analysis of additional homeopathic treatment in Germany: Long-term economic outcomes.

OBJECTIVES: This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months. METHODS: Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache. RESULTS: Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients. CONCLUSION: The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.