Anthroposophic therapies in chronic disease: the Anthroposophic Medicine Outcomes Study (AMOS).

CONTEXT: Anthroposophic medicine (AM) is used worldwide for chronic diseases. OBJECTIVE: To study clinical outcomes and costs in patients treated with AM therapies for chronic conditions. DESIGN: Prospective cohort study. SETTING: 141 medical practices in Germany providing AM treatment. PARTICIPANTS AND INTERVENTIONS: 898 outpatients aged 1-75 years referred to AM therapies (art, eurythmy or rhythmical massage, n = 665) or starting AM medical treatment (counselling, medicines, n = 233). MAIN OUTCOME MEASURES: Disease severity assessed independently by physician (Disease Score) and patient (Symptom Score), and health-related quality of life (SF-36, KINDL, KITA) after 3, 6, 12, 18, and 24 months; health costs in pre-study year and first study year. RESULTS: Most common indications were mental disorders (32.0%), and musculoskeletal disorders (18.9%). Disease duration at baseline was median 3.0 years (interquartile range = i.q.r. 1.0-8.5, mean 6.5 +/- 8.4 years). Median number of AM therapy sessions was 12 (i.q.r. 10-20), median therapy duration was 120 days (i.q.r. 81-195). From baseline to 6-month follow-up, Disease Score (0-10) improved from 6.40 +/- 1.76 to 3.43 +/- 2.23 (p < 0.001), Symptom Score (0-10) improved from 5.89 +/- 1.75 to 3.35 +/- 2.09 (p < 0.001). In adults, SF-36 Physical Component Summary improved from mean 43.34 +/- 10.58 at baseline to 47.44 +/- 10.32 after 6 months (p < 0.001), SF-36 Mental Component Summary improved from 38.83 +/- 12.45 to 44.93 +/- 10.92 (p < 0.001). Similar HRQoL improvements were observed in children (KINDL, KITA). All improvements remained stable until 24-month follow-up. Adverse effects from AM therapies occurred in 2.7% (19/712) of patients. Three (0.5%) patients stopped therapy due to adverse effects. Health costs were 3,637 Euro per patient in the pre-study year and 3,484 Euro in the first study year, a decrease of 152 Euro (4.2%) per patient. CONCLUSION: Anthroposophic therapies were associated with long-term reduction of chronic disease symptoms, improvement of health-related quality of life, and health cost reduction.

Diagnoses and treatment in homeopathic medical practice.

BACKGROUND: Despite increasing interest in complementary medicine worldwide, there has been no systematic large-scale documentation of medical homeopathic care. OBJECTIVE: We therefore conducted a prospective cohort study aimed at characterizing patients seeking homeopathic care and their treatment. PATIENTS AND METHODS: From September 1997 to June 1999, patients of all age groups who were visiting a homeopathic care center for the first time were included consecutively in the study and followed up for 24 months. Diagnostic procedures and prescriptions were documented using specific case report forms. MAIN OUTCOME MEASURES: Diagnoses (ICD-9), medical history, consultations, and prescriptions. RESULTS: A total of 3,981 patients were included in the study, 2,851 adults (29% men, mean age 42.5 +/- 13.1 years; 71% women, 39.9 +/- 12.4 years) and 1,130 children (52% boys, 6.5 +/- 3.9 years; 48% girls, 7.0 +/- 4.3 years). Almost all patients suffered from chronic conditions for 10.3 +/- 9.8 (adults) and 4.3 +/- 3.7 years (children). The most frequent diagnoses were allergic rhinitis in adult males, headache in adult females, and atopic dermatitis in children (both genders). The typical homeopathic initial consultations took 117 +/- 43 minutes for adults and 86 +/- 36 minutes for children, not varying much between primary diagnoses. In the observed 2 years the patients had on average 8.6 +/- 9.3 (adults) and 8.9 +/- 9.6 (children) consultations, approximately 50% each by telephone and face-to-face. Physicians most often prescribed the classical 'great' remedies (like sepia, sulfur, natrium mur., lycopodium), but in total, nearly 600 different homeopathic remedies were used. CONCLUSIONS: Our study provides a wealth of data on the medical practice of classical homeopathy. In terms of treatment, polychrests are used frequently, although it should be noted that a large proportion of patients received 'small remedies' instead. Most patients are treated for chronic diseases. The present results will, in concert with follow-up outcome analysis, aid in determining the effectiveness of medical homeopathic practice.

Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols.

BACKGROUND AND OBJECTIVE: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. DESIGN: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. SETTING: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. PATIENTS: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). INTERVENTIONS: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. MAIN OUTCOME MEASURE: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. OUTLOOK: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Acupuncture Randomized Trials (ART) in patients with chronic low back pain and osteoarthritis of the knee - design and protocols.

BACKGROUND: We report on the study design and protocols of two randomized controlled trials (Acupuncture Randomized Trials = ART) that investigate the efficacy of acupuncture in the treatment of chronic low back pain and osteoarthritis of the knee, respectively. OBJECTIVE: To investigate whether acupuncture is more efficacious than (a) no treatment or (b) minimal acupuncture in the treatment of low back pain and osteoarthritis. DESIGN: Two randomized, controlled, multicenter trials with three treatment arms and a total follow-up time of 52 weeks. SETTING: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. PATIENTS: 300 patients will be included in each study. In the low back pain trial, patients will be included according to clinical diagnosis. In the osteoarthritis pain trial, patients will be included according to the American College of Rheumatology criteria. INTERVENTIONS: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) minimal acupuncture at non-acupuncture points (75 patients), or (3) no treatment for two months followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. MAIN OUTCOME MEASURE: The main outcome measure is the difference between baseline and the end of the 8-week treatment period in the following parameters: pain intensity as measured by a visual analogue scale (VAS; 0-100 mm) in the low back pain trial and by the Western Ontario and McMaster Universities Osteoarthritis Score (WOMAC) in the osteoarthritis trial. OUTLOOK: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

Availability of research results on traditional chinese pharmacotherapy.

INTRODUCTION: The use of Traditional Chinese Medicine (TCM) has been increasing in the Western world over the last few years. Although Traditional Chinese Pharmacotherapy (TCP) plays a central role in TCM treatment in China, acupuncture is a more common form of treatment in the Western world than TCP. OBJECTIVE: The aim of our study was to evaluate the quantity and availability of clinical trials on TCP using Medline. METHODS: Medline searches were performed in PubMed (1966-June 2001) using the MeSH (Medical Subjects Heading) term 'drugs, Chinese herbal.' In a second step we restricted the search to meta-analyses, reviews, randomized controlled trials and clinical trials. Additionally we used the PubMed-Research- Methodology-Filter. Abstracts and information concerning the publication type were used to assess the available information. RESULTS: Using the MeSH term 'drugs, Chinese herbal', 6,504 publications (50% in Chinese) published in 662 journals were identified. The specific search using the PubMed-Research-Methodology-Filter adjusted to 'therapy' and 'specificity' identified 118 studies (11 reviews, 55 randomized controlled trials, 26 controlled trials, 7 longitudinal studies, 12 experiments, and 7 others), 65 of which were written in English. Most studies used western diagnoses for treatment. The most common investigated diagnosis was atopic dermatitis (7 trials) followed by angina pectoris (6 trials). CONCLUSION: Only limited information about TCP research is accessible for physicians using PubMed. Moreover, half of the studies are published in Chinese. The PubMed-Research- Methodology-Filter proved to be an effective tool in restricting the search to relevant publications.