RESUMO
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.
Assuntos
Análise Custo-Benefício , Prestação Integrada de Cuidados de Saúde/economia , Homeopatia/economia , Adulto , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e QuestionáriosRESUMO
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.
Assuntos
Antibacterianos/economia , Homeopatia/economia , Sinusite Maxilar/tratamento farmacológico , Sinusite Maxilar/economia , Doença Aguda , Adulto , Antibacterianos/uso terapêutico , Análise Custo-Benefício , Custos de Medicamentos , Homeopatia/métodos , Humanos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
CONTEXT: Economic evaluations of commonly used complementary and alternative medicine (CAM) therapies such as homeopathy are needed to contribute to the evidence base on which policy makers, clinicians, health-care payers, as well as patients base their health-care decisions in an era of constrained resources. OBJECTIVES: To review and assess existing economic evaluations of homeopathy. METHODS: Literature search was made to retrieve relevant publications using AMED, the Cochrane Library, CRD (DARE, NHS EED, HTA), EMBASE, MEDLINE, and the journal Homeopathy (former British Homoeopathic Journal). A hand search of relevant publications was carried out. Homeopathy researchers were contacted. Identified publications were independently assessed by two authors. RESULTS: Fifteen relevant articles reported on 14 economic evaluations of homeopathy. Thirteen studies reported numbers of patients: a total of 3,500 patients received homeopathic treatment (median 97, interquartile range 48-268), and 10 studies reported on control group participants (median 57, IQR 40-362). Eight out of 14 studies found improvements in patients' health together with cost savings. Four studies found that improvements in homeopathy patients were at least as good as in control group patients, at comparable costs. Two studies found improvements similar to conventional treatment, but at higher costs. Studies were highly heterogeneous and had several methodological weaknesses. CONCLUSIONS: Although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy. Recommendations for future research are presented.