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Biomedical subjects

D Melchart

Publications and source records attributed to D Melchart.

54 records · Page 3Linked to original sources
PubMed1998

A multicenter survey of amalgam fillings and subjective complaints in non-selected patients in the dental practice.

The aims of this study were to examine whether there is a difference in symptoms between patients with amalgam fillings and patients without such restorations, to investigate the relationship between particular symptoms and the number of amalgam filled surfaces, and the differences in symptoms between patients with and without removal of amalgam fillings. Data from 6744 consecutive patients in 34 dental offices located throughout Germany were documented. Patients completed a questionnaire answering 48 items, and the current oral findings in the patients were registered. The analysis was restricted to 4,787 patients aged 21 to 60 yr because of special dental conditions in children and elderly persons. The study did not show any significant correlation between the intensity of complaints or particular groups of symptoms and the number of amalgam-filled surfaces. A higher number of symptoms as well as a higher intensity of symptoms were found in patients before amalgam removal compared to the remaining patients. The question remains open whether or not there may be a certain kind of relationship between the complaints and amalgam fillings in individual patients.

Adolescent↗
PubMed1998

Randomized controlled trials of individualized homeopathy: a state-of-the-art review.

BACKGROUND AND OBJECTIVE: Individualized homeopathy is the most controversial form of this therapy. This review aims to summarize the actual state of clinical efficacy research on individualized homeopathy. METHODS: Electronic databases as well as other sources were searched for possibly relevant studies. Randomized or quasirandomized controlled clinical trials comparing an individualized homeopathic treatment strategy with placebo, no treatment, or another treatment were eligible. Information on patients, methods, interventions, outcomes, and results was extracted in a standardized manner and quality was assessed using a checklist and two scoring systems. Trials providing sufficient data were pooled in a quantitative meta-analysis. RESULTS: A total of 32 trials (28 placebo-controlled, 2 comparing homeopathy and another treatment, 2 comparing both) involving a total of 1778 patients met the inclusion criteria. The methodological quality of the trials was highly variable. In the 19 placebo-controlled trials providing sufficient data for meta-analysis, individualized homeopathy was significantly more effective than placebo (pooled rate ratio 1.62, 95% confidence interval 1.17 to 2.23), but when the analysis was restricted to the methodologically best trials no significant effect was seen. CONCLUSION: The results of the available randomized trials suggest that individualized homeopathy has an effect over placebo. The evidence, however, is not convincing because of methodological shortcomings and inconsistencies. Future research should focus on replication of existing promising studies. New randomized studies should be preceded by pilot studies.

Confounding Factors, Epidemiologic↗
PubMed1997

Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials.

BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo. METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, "remedy", population, and outcomes. FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05). INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.

Double-Blind Method↗
PubMed1997

Systematic clinical auditing in complementary medicine: rationale, concept, and a pilot study.

A scientific evaluation of complementary medical practices commonly used in healthcare is urgently required. Although randomized clinical trials are the primary tool for such an evaluation, for a number of conceptual and pragmatic reasons, they should not be the only tool. The authors propose systematic clinical auditing as a concept to (1) provide information on the "epidemiology" of complementary medical practices, (2) make the processes used in the daily practice of these complementary methods clearly intelligible, and (3) give a preliminary estimation of outcomes. Systematic clinical auditing uses mainly observational studies of large samples of patients. A pilot study was conducted to investigate the feasibility of using a systematic clinical audit in a hospital for traditional Chinese medicine in Germany. All 1597 patients admitted between February 1, 1992, and August 31, 1993, were included in the study. Patients' characteristics, diagnoses, and preventive and therapeutic interventions were recorded, and patients were asked to rate the intensity of their main complaints (on scale of 1 to 10) at admission; at discharge; and at 2, 6, and 12 months after admission. About two thirds of all patients had chronic pain complaints; the most common diagnosis was migraine (n = 244). Nearly all patients received acupuncture and Chinese herbal therapy; 61% received tuina massages, and 16% received qigong. The mean intensity of main complaints was 7.0 (2.0, SD) at admission, 4.6 (2.4) at discharge, and 5.5 (2.7) 12 months after admission. In the authors' opinion, systematic clinical auditing is a valuable tool for collecting basic information on structural characteristics, processes, and outcomes in complementary medicine and for determining representative and relevant questions for future randomized clinical trials.

Complementary Therapies↗
PubMed1996

St John's wort for depression--an overview and meta-analysis of randomised clinical trials.

OBJECTIVE: To investigate if extracts of Hypericum perforatum (St John's wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs. DESIGN: Systematic review and meta-analysis of trials revealed by searches. TRIALS: 23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment. MAIN OUTCOME MEASURES: A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects. RESULTS: Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants. CONCLUSION: There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed.

Antidepressive Agents↗
PubMed1995

Results of five randomized studies on the immunomodulatory activity of preparations of Echinacea.

This article describes and discusses five placebo-controlled randomized studies investigating the immunomodulatory activity of preparations containing extracts of Echinacea in healthy volunteers. A total of 134 (18 female and 116 male) healthy volunteers between 18 and 40 years of age were studied. Two studies tested intravenous homeopathic complex preparations containing Echinacea angustifolia D1 (study 1) and D4 (study 5). Two studies (2 and 3a) tested oral alcoholic extracts of roots of E. purpurea, one study an extract of E. pallida roots (study 3b), and one study an extract of E. purpurea herb (study 4). Test and placebo preparations were applied for four (study 5) or five (studies 1-4) consecutive days. The primary outcome measure for immunomodulatory activity was the relative phagocytic activity of polymorphonuclear neutrophil granulocytes (PNG), measured in studies 1 and 2 with a microscopic method and in studies 3, 4, and 5 with two different cytometric methods. The secondary outcome measure was the number of leukocytes in peripheral venous blood. Safety was assessed by a screening program of blood and other objective parameters as well as by documentation of all subjective side effects. In studies 1 and 2 the phagocytic activity of PNG was significantly enhanced compared with placebo [maximal stimulation 22.7% (95% confidence interval 17.5-27.9%) and 54.0% (8.4-99.6%), respectively], while in the other studies no significant effects were observed. Analysis of intragroup differences revealed significant changes in phagocytic activity during the observation periods in five test and three control groups. Leukocyte number was not influenced significantly in any study. Side effects due to the test preparations could not be detected. Our studies provide evidence for immunomodulatory activity of the homeopathic combination tested in study 1 and the E. purpureae radix extract tested in study 2. The negative results of the other three studies are difficult to interpret due to the different methods for measuring phagocytosis, the relevant changes in phagocytic activity within most placebo and treatment groups during the observation period, and the small sample sizes. Future studies should be performed on patients rather than healthy volunteers and use standardized or chemically defined monopreparations of Echinacea.

Adjuvants, Immunologic↗
PubMed1995

The integration of natural healing procedures into research and teaching at German universities.

This article describes the activities of the "Münchener Modell," a project for "Integration of Natural Healing Procedures into Research and Teaching" at the Ludwig-Maximilian University in Munich. Its objective is to improve research and teaching of Natural Healing Procedures (NHPs) and to provide the infrastructural and conceptual prerequisites for the establishment of an independent academic institution. In the years 1989 to 1992 the project organized three 1-year pregraduate courses of NHPs for medical students. Parts of the courses have now been integrated in the regular undergraduate education. In 1993 a quality assurance project for postgraduate education was piloted. In a network of clinics using NHPs a comprehensive quality assurance project including observational studies and controlled clinical trials has been implemented and piloted. For evaluating the actual state of knowledge in a transparent way the project performs systematic reviews of published research. Further clinical-experimental research is being done in the area of immunomodulation with natural products.

Complementary Therapies↗
PubMed1994

Critical review and meta-analysis of serial agitated dilutions in experimental toxicology.

1. We conducted an overview and quantitative meta-analysis of all experimental literature on the protective effects of serial agitated dilutions (SADs) of toxin preparations. 2. Articles were systematically collected and evaluated for scientific quality using pre-defined methodological criteria and then independently analysed for validity. 3. We found 105 publications exploring the effects of SAD preparations in toxicological systems. 4. The quality of evidence in these studies was low with only 43% achieving one half of the maximum possible quality score and only 31% reported in a fashion that permitted reevaluation of the data. 5. Very few studies were independently replicated using comparable models. 6. Among the high quality studies, positive effects were reported 50% more often than negative effects. 7. Four of 5 outcomes meeting quality and comparability criteria for meta-analysis showed positive effects from SAD preparations. 8. Average percent protection over controls in these preparations was 19.7 (95%Cl 6.2-33.2). 9. Further research with special attention to methodological detail and independent replication should be done.

Animals↗
PubMed1992

Circadian variation of the phagocytic activity of polymorphonuclear leukocytes and of various other parameters in 13 healthy male adults.

Twenty-four different laboratory parameters including the phagocytic activity (phagocytic index) of polymorphonuclear leukocytes (PMNs) and various hematologic variables were investigated in 13 young healthy men during Spring 1988 in Munich, Germany. Venous blood of these volunteers was obtained under standardized conditions at 4-h intervals over a 24-h span. All parameters were analyzed by the single cosinor method and by a Kruskal-Wallis analysis of variance (ANOVA). Statistically significant circadian rhythms were found for the number of circulating lymphocytes and leukocytes (WBCs), potassium, systolic blood pressure, phagocytic index, Quick test, heart rate, and rectal body temperature (p less than 0.05; single cosinor). For all of these parameters except WBCs, rectal body temperature, and Quick test, a temporal variation was confirmed by the ANOVA (p less than 0.05; phagocytic index: p = 0.05). The circadian acrophases of WBC, number of circulating lymphocytes, and phagocytic index were all found at about 01:00 h. This temporal coincidence of the acrophases of the phagocytic index and the number of circulating lymphocytes may reflect the modulation of phagocytosis by T lymphocytes that release cytokines known to stimulate the phagocytic activity of PMNs.

Adult↗
PubMed1989

Early clinical experience with subcutaneous GR43175 in acute migraine: an overview.

In six European clinics 111 migraine patients were treated in a series of open dose-ranging studies with subcutaneous injections of 1 to 4 mg GR43175, a novel 5-HT 1-like receptor agonist. Response rates after 20-30 min were dose related and rose from 33% with 1 mg to 96% with 4 mg GR43175. Side effects were minor and transient. These promising results warrant confirmation in placebo-controlled double-blind trials. Migraine, treatment, 5-HT agonist, open studies.

Adolescent↗
PubMed1989

Treatment of acute migraine with subcutaneous GR43175 in West Germany.

A subcutaneous preparation of GR43175, a novel antimigraine 5-HT 1-like agonist, was considered to represent a convenient way of administering the drug to patients during an acute migraine attack. In a series of open, uncontrolled dose-ranging studies, 82 patients with migraine were assessed serially for changes in severity of headache and associated symptoms following subcutaneous GR43175 in doses of 1-4 mg. Subcutaneous injection of 3 mg or 4 mg was found to be most effective. Within 60 min, 90% of patients had obtained complete relief of all migraine symptoms. Tolerability was good, 59% of patients reporting no adverse effects. Those reported mainly comprised transient local irritation to the injection. There were no changes attributable to GR43175 in heart rate, blood pressure, ECG readings or laboratory parameters.

Adult↗
PubMed1989

Effective improvement of symptoms in patients with acute migraine by GR43175 administered in dispersible tablets.

GR43175, a selective 5-HT 1-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.

Administration, Oral↗
PubMedDate not supplied

Echinacea root extracts for the prevention of upper respiratory tract infections: a double-blind, placebo-controlled randomized trial.

OBJECTIVE: To investigate the safety and efficacy of 2 extracts of echinacea for preventing upper respiratory tract infections. DESIGN: Three-armed, randomized, double-blind, placebo-controlled trial. SETTING: Four military institutions and 1 industrial plant. PARTICIPANTS: Three hundred two volunteers without acute illness at time of enrollment. INTERVENTIONS: Ethanolic extract from Echinacea purpurea roots, Echinacea angustifolia roots, or placebo, given orally for 12 weeks. MAIN OUTCOME MEASURE: Time until the first upper respiratory tract infection (time to event). Secondary outcome measures were the number of participants with at least 1 infection, global assessment, and adverse effects. RESULTS: The time until occurrence of the first upper respiratory tract infection was 66 days (95% confidence interval [CI], 61-72 days) in the E angustifolia group, 69 days (95% CI, 64-74 days) in the E purpurea group, and 65 days (95% CI, 59-70 days) in the placebo group (P = .49). In the placebo group, 36.7% had an infection. In the treatment groups, 32.0% in the E angustifolia group (relative risk compared with placebo, 0.87; 95% CI, 0.59-1.30) and 29.3% in the E purpurea group (relative risk compared with placebo, 0.80; 95% CI, 0.53-1.31) had an infection. Participants in the treatment groups believed that they had more benefit from the medication than those in the placebo group (P = .04). Adverse effects were reported by 18 subjects in the E angustifolia group, 10 in the E purpurea group, and 11 in the placebo group. CONCLUSION: In this study a prophylactic effect of the investigated echinacea extracts could not be shown. However, based on the results of this and 2 other studies, one could speculate that there might be an effect of echinacea products in the order of magnitude of 10% to 20% relative risk reduction. Future studies with much larger sample sizes would be needed to prove this effect.

Adult↗
PubMedDate not supplied

Acupuncture in patients with osteoarthritis of the knee: a randomised trial.

BACKGROUND: Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee. METHODS: Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat. RESULTS: 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08). INTERPRETATION: After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.

Acupuncture Points↗