Effective Improvement of Symptoms in Patients with Acute Migraine by GR43175 Administered in Dispersible Tablets

GR43175, a selective 5-HT1-like agonist, was administered as oral dispersible tablets in an open, uncontrolled dose-ranging study to assess its efficacy as an agent for acute migraine. Nine patients, all with well established attacks, were assessed for changes in severity of headache and associated symptoms over 2 h. Drug absorption was compared during and between attacks in five patients. Doses of 140 mg and 280 mg resulted in complete relief of all symptoms within 2 h. Treatment was well tolerated in all patients

Quality profiling at the TCM Hospital Bad Kötzting - examples from an ongoing systematic patient documentation

BACKGROUND Quality profiling is practiced at the TCM hospital Bad Kötzting since its establishment 25 years ago. The profiling comprises assessment of treatment effectiveness andsafety, structural features, staff qualification as well as diagnostic and therapeutic processes. Findings regarding patients, intervention and outcome profiles are presented by appropriate examples. METHODS Data of each in-patient were systematically collected by physicians and via self-reports at admission, discharge and follow-up. Over the years the system was adjusted several times resulting in a data pool of about 19,000 in-patients by end of 2014. RESULTS Patients are 52 years old on average, 70% are female, and suffering from the main complaint since 7 years (median). The diagnostic spectrum changed over the years according to the development towards a psychosomatic focus. For TCM acupuncture therapy 222 different acupoints were used in 7.7 different localisations on average per individual treatment. The mean intensity of the main complaint decreased clinically relevant (Cohen's d = 1.11 at discharge and 0.93 at follow-up). After the hospital stay the number of days of sick leave declined from 51.3 days by 40% per patient and year. Depressive disorders as most common mental illness decreased significantly decreased significantly at discharge (ICD symptom rating; Cohen's d = -1.01). 29.8% of patients met the criteria for a metabolic syndrome diagnosis according to the International Diabetes Federation (IDF). In this group of cases, triglycerides, cholesterol and blood glucose improved markedly at discharge. DISCUSSION The presented quality control measures clearly contribute to an enhanced transparency in terms of a comprehensive quality profile. The findings from various outcome parameters indicate that patients benefit from the treatment

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil IV: Methodische Aspekte, Diskussion und Empfehlungen

Objective: Empirical investigation of the influence of patient self-selection during follow-up in a prospective observational study in 4 in-patient facilities for complementary medicine and discussion of further methodological problems. Methods: 2662 patients treated in the 4 hospitals and included in a prospective observational study had been sent follow-up questionnaires 2, 6, and 12 months after admission. Characteristics and therapeutic success at discharge were compared in patients responding and those not responding. Results: Patients not responding to the follow-up questionnaires tended to be older and to assess the benefit of the treatment less positive than patients who responded (hospital one: 56.2% of patients with a follow-up reported a good or very good response to therapy at discharge compared to 37.7% of the patients without a follow-up: hospital two: 63.7% vs. 54.6%; hospital three: 71.1% vs. 65.8%; hospital four: 78,3% vs. 70,9%). Interpretation: When interpreting the results of the observational study a certain degree of bias induced by selection during follow-up has to be taken into account. Discussion: Other methodological problems discussed narratively include spontaneous improvements, reliability of baseline measures, influence of effective cointerventions, side-effects, outcome measures, feasibility, and efficiency. Finally, recommendations for quality management programs in in-patient facilities for complementary medicine are provided

Systematic reviews of complementary therapies – an annotated bibliography. Part 2: Herbal medicine

Background Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with herbal medicine. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of herbal medicines; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pre-tested form and summarized descriptively. Results From a total of 79 potentially relevant reviews pre-selected in the screening process 58 met the inclusion criteria. Thirty of the reports reviewed ginkgo (for dementia, intermittent claudication, tinnitus, and macular degeneration), hypericum (for depression) or garlic preparations (for cardiovascular risk factors and lower limb atherosclerosis). The quality of primary studies was criticized in the majority of the reviews. Most reviews judged the available evidence as promising but definitive conclusions were rarely possible. Conclusions Systematic reviews are available on a broad range of herbal preparations prescribed for defined conditions. There is very little evidence on the effectiveness of herbalism as practised by specialist herbalists who combine herbs and use unconventional diagnosis

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil III: Zwischenergebnisse der diagnosespezifischen Dokumentation Migräne in der Klinik für TraditionelleChinesische Medizin Kötzting

Objective: To evaluate the course of symtoms and quality of life of migraine patients after treatment with traditional Chinese medicine. Design: Prospective observational study with 12 months follow-up. Patients: 138 consecutive patients diagnosed by a neurologist to have migraine headaches. Intervention: Complex in-patient treatment with traditional Chinese medicine including acupuncture and Chinese drug therapy. Outcomes: Number of days with headaches per month, number, intensity and duration of migraine attacks, concomitant symptoms, quality of life, global assessment and days off work. Results: The number of days with headaches per month decreased from 9 (median) at baseline to 4 at discharge and was 3 at 12 months. Also, for the other outcomes a clear improvement was seen with a slight wash-out tendency in follow-up. Conclusion: The observed patients with long-lasting migraines had a marked benefit from an in-patient treatment with traditional Chinese medicine

Systematic reviews of complementary therapies – an annotated bibliography. Part 3: Homeopathy

Background Complementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with homeopathy. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of homeopathy; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pretested form and summarized descriptively. Results Eighteen out of 22 potentially relevant reviews preselected in the screening process met the inclusion criteria. Six reviews addressed the question whether homeopathy is effective across conditions and interventions. The majority of available trials seem to report positive results but the evidence is not convincing. For isopathic nosodes for allergic conditions, oscillococcinum for influenza-like syndromes and galphimia for pollinosis the evidence is promising while in other areas reviewed the results are equivocal. Interpretation Reviews on homeopathy often address general questions. While the evidence is promising for some topics the findings of the available reviews are unlikely to end the controversy on this 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

Prognos (R) in the diagnosis of amalgam hypersensitivity - A diagnostic case-control study

Objective: We aimed to investigate whether the Prognos (R) device might be a useful tool in the diagnosis of disorders suspected to be due to dental amalgam fillings. Participants and Methods: A diagnostic case-control study was performed in 27 patients who complained about health problems attributed to amalgam ( cases), 27 healthy volunteers with amalgam fillings ( controls I), and 27 healthy amalgam-free volunteers ( controls II). All participants were tested before and after application of 300 mg DMPS (2.3-dimercapto-1-propanesulfonic acid) with Prognos, a diagnostic device for the energetic measurement of Traditional Chinese Medicine meridians. In addition, mercury was measured in blood, urine, and saliva, and a lymphocyte transformation test (LTT) was performed. Results: Diagnoses derived from the first and second Prognos testing did not agree above chance (Cohen's Kappa = -0.11, 95% confidence interval -0.33 to 0.10; p = 0.30). Agreement for secondary outcome measures was poor, too. Prognos measurements did not differ between cases and controls. Correlations with measurements in urine, blood and saliva were low. Conclusion: In this study Prognos could not be shown to be a useful tool in the diagnosis of disorders suspected to be due to dental amalgam fillings

Health technology assessment in Switzerland

OBJECTIVES AND METHODS: To review Switzerland's mixed public and private healthcare system with regard to health technology assessment (HTA). RESULTS: In the past, remarkable work in HTA was done. Accomplishments include the following: (i) Switzerland became an early member of the International Network of Agencies for Health Technology Assessment. (ii) HTA has its legal bases in terms of effectiveness, appropriateness, and efficiency. (iii) The federal law allows the introduction of new technologies for a limited time for evaluation. (iv) A Swiss Network for Health Technology Assessment was established. In 2004, federal HTA activities moved from the Swiss Federal Office "of Social Security" to the one for "Public Health." The Office mainly mandates, manages, and coordinates evaluations attached to its prevention and intervention sections in the fields of AIDS, illegal drugs, and legal drugs. CONCLUSIONS: Because of the absence of a governmental institution assessing and reporting on new health technologies, private and for profit organizations became more important for the decision-making processes. In a regulated market, the implications may be crucial for the public healt

Health technology assessment in Switzerland

OBJECTIVES AND METHODS: To review Switzerland's mixed public and private healthcare system with regard to health technology assessment (HTA). RESULTS: In the past, remarkable work in HTA was done. Accomplishments include the following: (i) Switzerland became an early member of the International Network of Agencies for Health Technology Assessment. (ii) HTA has its legal bases in terms of effectiveness, appropriateness, and efficiency. (iii) The federal law allows the introduction of new technologies for a limited time for evaluation. (iv) A Swiss Network for Health Technology Assessment was established. In 2004, federal HTA activities moved from the Swiss Federal Office "of Social Security" to the one for "Public Health." The Office mainly mandates, manages, and coordinates evaluations attached to its prevention and intervention sections in the fields of AIDS, illegal drugs, and legal drugs. CONCLUSIONS: Because of the absence of a governmental institution assessing and reporting on new health technologies, private and for profit organizations became more important for the decision-making processes. In a regulated market, the implications may be crucial for the public health