The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.

In Western countries, complementary and alternative medicine (CAM) is more and more provided by practitioners and family doctors. To base this reality of health care provision on an evidence-base, academic medicine needs to be included in the development. In the study we aimed to gain information on a structured approach to include CAM in academic health centers. We conducted a semistructured interview study with leading experts of integrative medicine to analyze strategies of existing academic institutions of integrative medicine. The study sample consisted of a purposive sample of ten leaders that have successfully integrated CAM into medical schools in the USA, Great Britain, and Germany and the Director of the National Center for Alternative and Complementary Medicine. Analysis was based on content analysis. The prerequisite to foster change in academic medicine was a strong educational and professional background in academic medicine and research methodologies. With such a skill set, the interviewees identified a series of strategies to align themselves with colleagues from conventional medicine, such as creating common goals, networking, and establishing well-functioning research teams. In addition, there must be a vision of what should be needed to be at the center of all efforts in order to implement successful change.

Background

There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.

Methods

Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.

Results

Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.

Conclusion

The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

Objective

A comprehensive systematic review of economic evaluations of complementary and integrative medicine (CIM) to establish the value of these therapies to health reform efforts.

Data sources

PubMed, CINAHL, AMED, PsychInfo, Web of Science and EMBASE were searched from inception through 2010. In addition, bibliographies of found articles and reviews were searched, and key researchers were contacted.

Eligibility criteria for selecting studies

Studies of CIM were identified using criteria based on those of the Cochrane complementary and alternative medicine group. All studies of CIM reporting economic outcomes were included.

Study appraisal methods

All recent (and likely most cost-relevant) full economic evaluations published 2001–2010 were subjected to several measures of quality. Detailed results of higher-quality studies are reported.

Results

A total of 338 economic evaluations of CIM were identified, of which 204, covering a wide variety of CIM for different populations, were published 2001–2010. A total of 114 of these were full economic evaluations. And 90% of these articles covered studies of single CIM therapies and only one compared usual care to usual care plus access to multiple licensed CIM practitioners. Of the recent full evaluations, 31 (27%) met five study-quality criteria, and 22 of these also met the minimum criterion for study transferability (‘generalisability’). Of the 56 comparisons made in the higher-quality studies, 16 (29%) show a health improvement with cost savings for the CIM therapy versus usual care. Study quality of the cost-utility analyses (CUAs) of CIM was generally comparable to that seen in CUAs across all medicine according to several measures, and the quality of the cost-saving studies was slightly, but not significantly, lower than those showing cost increases (85% vs 88%, p=0.460).

Conclusions

This comprehensive review identified many CIM economic evaluations missed by previous reviews and emerging evidence of cost-effectiveness and possible cost savings in at least a few clinical populations. Recommendations are made for future studies.

Background:

Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture.

Methods:

We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.

Results:

Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.

Interpretation:

Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.

Trial Registration:

Clinicaltrials.gov NCT00599586

Background

For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.

Methods

We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.

Principal Findings

From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02–0.60), which improved after consensus discussions to 0.20–1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.

Conclusion

Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

Background

The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain.

Methodology/Principal Findings

In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0–100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported.

Conclusions/Significance

The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief.

Trial Registration

ClinicalTrials.gov NCT00567736

The Japanese traditional herbal medicine, Kampo, has gradually reemerged and 148 different formulations (mainly herbal extracts) can be prescribed within the national health insurance system. The objective of this article is to introduce Kampo and to present information from previous clinical studies that tested Kampo formulae. In addition, suggestions on the design of future research will be stated. The literature search was based on a summary, up until January 2009, by the Japanese Society of Oriental Medicine and included only those trials which were also available in either Pubmed or ICHUSHI (Japan Medical Abstracts Society). We included 135 studies, half of these studies (n = 68) used a standard control and 28 a placebo control. Thirty-seven trials were published in English [all randomized controlled trials (RCTs)] and the remaining articles were in Japanese only. The sample size for most studies was small (two-third of the studies included less than 100 patients) and the overall methodological quality appeared to be low. None of the studies used Kampo diagnosis as the basis for the treatment. In order to evaluate Kampo as a whole treatment system, certain aspects should be taken into account while designing studies. RCTs are the appropriate study design to test efficacy or effectiveness; however, within the trial the treatment could be individualized according to the Kampo diagnosis. Kampo is a complex and individualized treatment with a long tradition, and it would be appropriate for further research on Kampo medicine to take this into account.

Background:

Anthroposophic treatment for attention deficit hyperactivity disorder (ADHD) includes special artistic and physical therapies and special medications.

Methods:

We studied 61 consecutive children starting anthroposophic treatment for ADHD symptoms under routine outpatient conditions. Primary outcome was FBB-HKS (a parents’ questionnaire for ADHD core symptoms, 0–3), and secondary outcomes were disease and symptom scores (physicians’ and parents’ assessment, 0–10) and quality of life (KINDL® total score, 0–100).

Results:

A total of 67% of patients fulfilled the DSM-IV criteria for ADHD, 15% had an exclusion diagnosis such as pervasive developmental disorders, while 18% did not fulfill ADHD criteria for another reason. Anthroposophic treatment modalities used were eurythmy therapy (in 56% of patients), art therapy (20%), rhythmical massage therapy (8%), and medications (51%). From baseline to six-month follow-up, all outcomes improved significantly; average improvements were FBB-HKS total score 0.30 points (95% confidence interval [CI]: 0.18–0.43; P < 0.001), FBB-HKS inattention 0.36 (95% CI: 0.21–0.50; P < 0.001), FBB-HKS hyperactivity 0.29 (95% CI: 0.14–0.44; P < 0.001), FBB-HKS impulsivity 0.22 (95% CI: 0.03–0.40; P < 0.001), disease score 2.33 (95% CI: 1.84–2.82; P < 0.001), symptom score 1.66 (95% CI: 1.17–2.16; P < 0.001), and KINDL 5.37 (95% CI: 2.27–8.47; P = 0.001). Improvements were similar in patients not using stimulants (90% of patients at months 0–6) and were maintained until last follow-up after 24 months.

Conclusion:

Children with ADHD symptoms receiving anthroposophic treatment had long-term improvement of symptoms and quality of life.

Background

Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases.

Methods

913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to socio-demographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed.

Results

Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39-2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function, general health) remained significant predictors in both analyses, and three further variables (education level, respiratory disorders, therapy goal) were significant in one analysis.

Conclusion

In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies.

Background

This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.

Method

Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 1024), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure.

Discussion

Homeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together.

Trial registration

ClinicalTrials.gov identifier: NCT01061229.

Background

Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care.

Methods

Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions.

Results

In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22).

Conclusion

The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.

Background

Very little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions.

The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment.

Methods

In this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months.

Results

A total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 ± (SD) 3.1 years; 59% women, 74.3 ± 3.8 years).

98.6 percent of all diagnoses were chronic with an average duration of 11.5 ± 11.5 years. 82 percent of the patients were taking medication at baseline.

The most frequent diagnoses were hypertension (20.5%, 11.1 ± 7.5 years) and sleep disturbances (15.7%, 22.1 ± 25.8 years).

The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians' assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change.

Conclusion

The severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.

Background and Methods:

Anthroposophic treatment for migraine is provided by physicians and includes special artistic and physical therapies and special medications. We conducted a prospective cohort study of 45 consecutive adult outpatients (89% women) starting anthroposophic treatment for migraine under routine conditions. Main outcomes were Average Migraine Severity (physician and patient ratings 0-10, primary outcome), Symptom Score (patient rating, 0-10), and quality of life (SF-36); main follow-up time point was after six months.

Results:

The anthroposophic treatment modalities used were medications (67% of patients), eurythmy therapy (38%), art therapy (18%), and rhythmical massage therapy (13%). Median therapy duration was 105 days. In months 0-6, conventional prophylactic antimigraine medications were used by 14% (n=5/36) of evaluable patients.

From baseline to six-month follow-up, physician-rated Average Migraine Severity improved by 3.14 points (95% confidence interval 2.40-3.87, p<0.001); patient-rated Average Migraine Severity improved by 2.82 points (2.05-3.64, p<0.001); and Symptom Score improved by 2.32 points (1.68-2.95, p<0.001). In addition, three SF-36 scales (Social Functioning, Bodily Pain, Vitality), the SF-36 Physical Component summary measure, and the SF-36 Health Change item improved significantly. All improvements were maintained at last follow-up after 24 months. Patients not using conventional prophylactic antimigraine medications had improvements similar to the whole cohort.

Conclusions:

Patients with migraine under anthroposophic treatment had long-term improvement of symptoms and quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that anthroposophic therapies may be useful in the long-term care of patients with migraine.

Background

The management of hypertension is a key challenge in modern health systems. This study aimed to investigate hypertension treatment strategies among physicians specialized in complementary and alternative medicine (CAM) in Germany by analysing prescribing patterns and comparing these to the current treatment guidelines issued by the German Hypertension Society.

Methods

In this prospective, multicentre observational study, which included 25 primary care physicians specialized in CAM treatment, prescriptions and diagnoses were analysed for each consecutive hypertensive patient using routine electronic data. Data analysis was performed using univariate statistical tests (Chi square test, Cochran-Armitage trend test). Multiple logistic regression was used to determine factors associated with antihypertensive medication.

Results

In the year 2005, 1320 patients with 3278 prescriptions were included (mean age = 64.2 years (SD = 14.5), 63.5% women). Most patients were treated with conventional antihypertensive monotherapies (n = 838, 63.5%). Beta-blockers were the most commonly prescribed monotherapy (30.7%), followed by ACE inhibitors (24.0%). Combination treatment usually consisted of two antihypertensive drugs administered either as separate agents or as a coformulation. The most common combination was a diuretic plus an ACE inhibitor (31.2% of dual therapies). Patient gender, age, and comorbidities significantly influenced which treatment was prescribed. 187 patients (14.2%) received one or more CAM remedies, most of which were administered in addition to classic monotherapies (n = 104). Men (OR = 0.66; 95% CI: 0.54-0.80) and patients with diabetes (OR = 0.55; 95% CI: 0.42-0.0.73), hypercholesterolaemia (OR = 0.59; 95% CI: 0.47-0.75), obesity (OR = 0.74; 95% CI: 0.57-0.97), stroke (OR = 0.54; 95% CI: 0.40-0.74), or prior myocardial infarction (OR = 0.37; 95% CI: 0.17-0.81) were less likely to receive CAM treatment.

Conclusions

The large majority of antihypertensive treatments prescribed by CAM physicians in the present study complied with the current German Hypertension Society treatment guidelines. Deviations from the guidelines were observed in one of every seven patients receiving some form of CAM treatment.

Background:

Anthroposophic treatment for asthma includes special artistic and physical therapies and special medications.

Methods:

We studied consecutive outpatients starting anthroposophic treatment for asthma under routine conditions in Germany. Main outcomes were average asthma severity (0–10, primary outcome); symptoms (1–4); and asthma-related quality of life at 12-month follow-up (Asthma Quality of Life Questionnaire [AQLQ] overall score, 1–7, for adults; KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents, asthma module, 0–100, for children) at 12-month follow-up.

Results:

Ninety patients (54 adults, 36 children) were included. Anthroposophic treatment modalities used were medications (88% of patients, n = 79/90); eurythmy therapy (22%); art therapy (10%); and rhythmical massage therapy (1%). Median number of eurythmy/art/massage sessions was 12 (interquartile range 10–20), median therapy duration was 120 days (84–184). From baseline to 12-month follow-up, all outcomes improved significantly (P < 0.001 for all comparisons). Average improvements were: average asthma severity 2.61 points (95% confidence interval CI: 1.90–3.32); cough 0.93 (95% CI: 0.60–1.25); dyspnea 0.92 (95% CI: 0.56–1.28); exertion-induced symptoms 0.95 (95% CI: 0.64–1.25); frequency of asthma attacks 0.78 (95% CI: 0.41–1.14); awakening from asthma 0.90 (95% CI: 0.58–1.21); AQLQ overall score 1.44 (95% CI: 0.97–1.92); and KINDL asthma module 14.74 (95% CI: 9.70–19.78). All improvements were maintained until last follow-up after 24 months.

Conclusions:

Patients with asthma under anthroposophic treatment had long-term improvements of symptoms and quality of life.

We studied costs of healthcare and productivity loss in 487 German outpatients starting anthroposophic treatment: Group 1 was treated for depression, Group 2 had depressive symptoms but were treated for another chronic disorder, while Group 3 did not have depressive symptoms. Costs were adjusted for socio-demographics, comorbidity, and baseline health status. Total costs in groups 1–3 averaged €7,129, €4,371, and €3,532 in the pre-study year (P = 0.008); €6,029, €3,522, and €3,353 in the first year (P = 0.083); and €4,929, €3,792, and €4,031 in the second year (P = 0.460). In the 2nd year, costs were significantly reduced in Group 1. This study underlines the importance of depression for health costs, and suggests that treatment of depression could be associated with long-term cost reductions.

Background

Recent studies have shown that adverse drug reactions (ADRs) are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM). Data on CAM-related ADRs, however, are sparse.

Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting.

Methods

A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results.

To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR) were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI). We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P < 0.05.

Results

A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001) in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P < 0.005) through the first 16 months after the intervention but not significant in the last 4-month period (median: 8.00 (IQR [2.75; 8.75]; P = 0.605). The completeness of the ADR reports increased from 80.3% before to 90.7% after the intervention. The completeness of the item for classifying ADRs as serious or non-serious increased significantly (P < 0.001) after the educational intervention. The quality of ADR reports increased from kappa 0.15 (95% CI: 0.08; 0.29) before to 0.43 (95% CI: 0.23; 0.63) after the intervention.

Conclusion

The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their daily clinical practice. However, the effects of the intervention were temporary.

Background

An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for ≥12 weeks in a usual care situation.

Methods

Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; ≥12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment.

Results

The study included 134 adults (mean age 39.8 ± 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 ± 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00).

Conclusion

This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.

Background

Anthroposophic treatment for chronic low back pain (LBP) includes special artistic and physical therapies and special medications. In a previously published prospective cohort study, anthroposophic treatment for chronic LBP was associated with improvements of pain, back function, and quality of life at 12-month follow-up. These improvements were at least comparable to improvements in a control group receiving conventional care. We conducted a two-year follow-up analysis of the anthroposophic therapy group with a larger sample size.

Methods

Seventy-five consecutive adult outpatients in Germany, starting anthroposophic treatment for discogenic or non-specific LBP of ≥6 weeks’ duration participated in a prospective cohort study. Main outcomes were Hanover Functional Ability Questionnaire (HFAQ; 0–100), LBP Rating Scale Pain Score (LBPRS; 0–100), Symptom Score (0–10), and SF-36 after 24 months.

Results

Eighty-five percent of patients were women. Mean age was 49.0 years. From baseline to 24-month follow-up all outcomes improved significantly; average improvements were: HFAQ 11.1 points (95% confidence interval [CI]: 5.5–16.6; p < 0.001), LBPRS 8.7 (95% CI: 4.4–13.0; p < 0.001), Symptom Score 2.0 (95% CI: 1.3–2.8; p < 0.001), SF-36 Physical Component Summary 6.0 (95% CI: 2.9–9.1; p < 0.001), and SF-36 Mental Component Summary 4.0 (95% CI: 1.1–6.8; p = 0.007).

Conclusion

Patients with chronic LBP receiving anthroposophic treatment had sustained improvements of symptoms, back function, and quality of life, suggesting that larger multicenter rigorous studies may be worthwhile.

Background

Many children with chronic disease use complementary therapies. Anthroposophic treatment for paediatric chronic disease is provided by physicians and differs from conventional treatment in the use of special therapies (art therapy, eurythmy movement exercises, rhythmical massage therapy) and special medications. We studied clinical outcomes in children with chronic diseases under anthroposophic treatment in routine outpatient settings.

Methods

In conjunction with a health benefit program, consecutive outpatients starting anthroposophic treatment for any chronic disease participated in a prospective cohort study. Main outcome was disease severity (Disease and Symptom Scores, physicians' and caregivers' assessment on numerical rating scales 0–10). Disease Score was documented after 0, 6, and 12 months, Symptom Score after 0, 3, 6, 12, 18, and 24 months.

Results

A total of 435 patients were included. Mean age was 8.2 years (standard deviation 3.3, range 1.0–16.9 years). Most common indications were mental disorders (46.2% of patients; primarily hyperkinetic, emotional, and developmental disorders), respiratory disorders (14.0%), and neurological disorders (5.7%). Median disease duration at baseline was 3.0 years (interquartile range 1.0–5.0 years). The anthroposophic treatment modalities used were medications (69.2% of patients), eurythmy therapy (54.7%), art therapy (11.3%), and rhythmical massage therapy (6.7%). Median number of eurythmy/art/massage therapy sessions was 12 (interquartile range 10–20), median therapy duration was 118 days (interquartile range 78–189 days).

From baseline to six-month follow-up, Disease Score improved by average 3.00 points (95% confidence interval 2.76–3.24 points, p < 0.001) and Symptom Score improved by 2.41 points (95% confidence interval 2.16–2.66 points, p < 0.001). These improvements were maintained until the last follow-up. Symptom Score improved similarly in patients not using adjunctive non-anthroposophic therapies within the first six study months.

Conclusion

Children under anthroposophic treatment had long-term improvement of chronic disease symptoms. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that anthroposophic therapies may play a beneficial role in the long-term care of children with chronic illness.

Background

Anthroposophic medications (AMED) are prescribed in 56 countries.

Objective

To study clinical outcomes in patients prescribed AMED for chronic disease.

Design

Prospective cohort study.

Setting

110 medical practices in Germany.

Participants

665 consecutive outpatients aged 1–71 years, prescribed AMED for mental, respiratory, musculoskeletal, neurological, genitourinary, and other chronic diseases.

Main outcomes

Disease and Symptom Scores (physicians’ and patients’ assessment, 0–10) and SF-36.

Results

During the first six months, an average of 1.5 AMED per patient was used, in total 652 different AMED. Origin of AMED was mineral (8.0% of 652 AMED), botanical (39.0%), zoological (7.2%), chemically defined (13.0%), and mixed (33.0%). From baseline to six-month-follow-up, all outcomes improved significantly: Disease Score improved by mean 3.15 points (95% confidence interval 2.97–3.34, p < 0.001), Symptom Score by 2.43 points (2.23–2.63, p < 0.001), SF-36 Physical Component Summary by 3.04 points (2.16–3.91, p < 0.001), and SF-36 Mental Component Summary by 5.75 points (4.59–6.92, p < 0.001). All improvements were maintained at 12-month follow-up. Improvements were similar in adult men and women, in children, and in patients not using adjunctive therapies.

Conclusion

Outpatients using AMED for chronic disease had long-term reduction of disease severity and improvement of quality of life.

Background

Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up.

Methods

In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years.

Results

A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1 ± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success.

Conclusion

Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

Background

The short consultation length in primary care is a source of concern, and the wish for more consultation time is a common reason for patients to seek complementary medicine. Physicians practicing anthroposophic medicine have prolonged consultations with their patients, taking an extended history, addressing constitutional, psychosocial, and biographic aspect of patients' illness, and selecting optimal therapy. In Germany, health benefit programs have included the reimbursement of this additional physician time. The purpose of this study was to describe clinical outcomes in patients with chronic diseases treated by anthroposophic physicians after an initial prolonged consultation.

Methods

In conjunction with a health benefit program in Germany, 233 outpatients aged 1–74 years, treated by 72 anthroposophic physicians after a consultation of at least 30 min participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0–10) and quality of life (adults: SF-36, children aged 8–16: KINDL, children 1–7: KITA). Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (Symptom Score and SF-36) 48 months.

Results

Most common indications were mental disorders (17.6% of patients; primarily depression and fatigue), respiratory diseases (15.5%), and musculoskeletal diseases (11.6%). Median disease duration at baseline was 3.0 years (interquartile range 0.5–9.8 years). The consultation leading to study enrolment lasted 30–60 min in 51.5% (120/233) of patients and > 60 min in 48.5%. During the following year, patients had a median of 3.0 (interquartile range 1.0–7.0) prolonged consultations with their anthroposophic physicians, 86.1% (167/194) of patients used anthroposophic medication.

All outcomes except KITA Daily Life subscale and KINDL showed significant improvement between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: Disease Score from mean (standard deviation) 5.95 (1.74) to 2.31 (2.29) (p < 0.001), Symptom Score from 5.74 (1.81) to 3.04 (2.16) (p < 0.001), SF-36 Physical Component Summary from 44.01 (10.92) to 47.99 (10.43) (p < 0.001), SF-36 Mental Component Summary from 42.34 (11.98) to 46.84 (10.47) (p < 0.001), and KITA Psychosoma subscale from 62.23 (19.76) to 76.44 (13.62) (p = 0.001). All these improvements were maintained until the last follow-up. Improvements were similar in patients not using diagnosis-related adjunctive therapies within the first six study months.

Conclusion

Patients treated by anthroposophic physicians after an initial prolonged consultation had long-term reduction of chronic disease symptoms and improvement of quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that physician-provided anthroposophic therapy may play a beneficial role in the long-term care of patients with chronic diseases.

Background

Many patients with chronic diseases use complementary therapies, often provided by their physicians. In Germany, several physician-provided complementary therapies have been reimbursed by health insurance companies as part of health benefit programs. In most of these therapies, the patient has a predominantly passive role. In eurythmy therapy, however, patients actively exercise specific movements with the hands, the feet or the whole body. The purpose of this study was to describe clinical outcomes in patients practising eurythmy therapy exercises for chronic diseases.

Methods

In conjunction with a health benefit program, 419 outpatients from 94 medical practices in Germany, referred to 118 eurythmy therapists, participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0–10) and quality of life (adults: SF-36, children aged 8–16: KINDL, children 1–7: KITA). Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (SF-36 and Symptom Score) 48 months.

Results

Most common indications were mental disorders (31.7% of patients; primarily depression, fatigue, and childhood emotional disorder) and musculoskeletal diseases (23.4%). Median disease duration at baseline was 3.0 years (interquartile range 1.0–8.5). Median number of eurythmy therapy sessions was 12 (interquartile range 10–19), median therapy duration was 119 days (84–188).

All outcomes improved significantly between baseline and all subsequent follow-ups (exceptions: KITA Psychosoma in first three months and KINDL). Improvements from baseline to 12 months were: Disease Score from mean (standard deviation) 6.65 (1.81) to 3.19 (2.27) (p < 0.001), Symptom Score from 5.95 (1.75) to 3.49 (2.12) (p < 0.001), SF-36 Physical Component Summary from 43.13 (10.25) to 47.10 (9.78) (p < 0.001), SF-36 Mental Component Summary from 38.31 (11.67) to 45.01 (11.76) (p < 0.001), KITA Psychosoma from 69.53 (15.45) to 77.21 (13.60) (p = 0.001), and KITA Daily Life from 59.23 (21.78) to 68.14 (18.52) (p = 0.001). All these improvements were maintained until the last follow-up. Improvements were similar in patients not using diagnosis-related adjunctive therapies within the first six study months.

Adverse reactions to eurythmy therapy occurred in 3.1% (13/419) of patients. No patient stopped eurythmy therapy due to adverse reactions.

Conclusion

Patients practising eurythmy therapy exercises had long-term improvement of chronic disease symptoms and quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that eurythmy therapy can be useful for patients motivated for this therapy.