Treatment of health complaints attributed to amalgam.

The aim of the present study was to compare the reduction of subjective complaints by 3 treatment strategies in 90 "amalgam patients" whose complaints could not be explained by a medical or psychological disorder. The individuals were randomly assigned either to removal of dental amalgam only (removal group), or removal in combination with a "biological detoxification" therapy with high doses of vitamins and trace elements (removal-plus group), or participation in a health promotion program without removal of dental amalgam (no-removal group). Between baseline and month 12, the sum score of main complaints decreased by 3.5 (SD=2.2) points on average in the removal group as well as in the removal-plus group, and by 2.5 (SD=2.4) points in the no-removal group (p=0.152). Both removal groups showed a significant decrease in steady-state levels of inorganic mercury compared with the no-removal group. Thus, all 3 interventions were associated with clinically relevant improvements.

Acupuncture for chronic pain within the research program of 10 German Health Insurance Funds--basic results from an observational study.

OBJECTIVES: To investigate which patients receive acupuncture in the framework of statutory health insurance in Germany, how treatment was carried out, and what results were achieved. DESIGN: Basic documentation (carried out by physician) within a prospective observational study. SETTING: 454,920 patients with at least one of the three chronic pain conditions including headache, low back pain and osteoarthritis treated by 8727 medical acupuncturists (panel doctors) within the scope of a reimbursement program. RESULTS: Fifty-three percent of the patients were treated by general practitioners, 19% by orthopaedists and 9% by internists. Eighty percent of patients were female, mean age was 53.6 (S.D.=15.7) years. Primary indication for acupuncture was low back pain (45%), headache (36%), and osteoarthritis (12%). Median time since the initial diagnosis was 3 years. 8.4 (S.D.=3.0) acupuncture sessions (body acupuncture) were administered on average. In 28% a concomitant treatment was reported. Effectiveness of acupuncture was rated by physicians in 22% of the patients as marked, in 54% as moderate, in 16% as minimal and in 4% as poor (unchanged). In 8% of the patients mild adverse reactions were reported, severe side effects occurred in 13 patients (0.003%). Orthopaedists rated the effectiveness of acupuncture lower, showing shortest time for face-to-face contact with the patient. More acupuncture training did not correspond to better therapeutic effect assessed by physicians. CONCLUSIONS: Acupuncture proved a highly demanded treatment option for chronic pain conditions within the German research program. Results indicate that acupuncture provided by qualified therapists is safe, and patients benefited from the treatment.

Physician and treatment characteristics in a randomised multicentre trial of acupuncture in patients with osteoarthritis of the knee.

OBJECTIVE: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee. DESIGN: Three-armed, randomised, controlled multicentre trial with 1-year follow-up. SETTING: Twenty-eight outpatient centres in Germany. INTERVENTIONS: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture). OUTCOME: Participating trial physicians and interventions. RESULTS: Forty-seven physicians specialised in acupuncture (mean age 43+/-8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140-2508). The total number of needles used was 17.4+/-4.8 in the acupuncture group compared to 12.9+/-3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing). CONCLUSIONS: Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

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.

Echinacea for preventing and treating the common cold.

BACKGROUND: Preparations of the plant Echinacea (family Compositae) are widely used in some European countries and in North America for common colds. Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and addition of other components. OBJECTIVES: The objective of this review was to assess whether there is evidence that Echinacea preparations are 1) more effective than no treatment; 2) more effective than placebo; 3) similarly effective to other treatments in A) the prevention and B) the treatment of the common cold. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005); PubMed (1997 to April 2005), EMBASE (1998 to June 2005), AMED (to August 2005), Centre for Complementary Medicine Research (in Munich) (1988 to May 2005), contacted experts, and screened references of reviews. SELECTION CRITERIA: We included randomized controlled trials that compared mono-preparations of Echinacea with a placebo, no treatment, or another treatment for the prevention or treatment of common colds. Trials on combinations of Echinacea and other herbs were excluded. DATA COLLECTION AND ANALYSIS: For all studies, at least two authors independently assessed eligibility and trial quality, and extracted data. Outcomes of interest in prevention trials were: numbers of individuals with one or more colds, and severity and duration of colds; and in treatment trials: total symptom scores, nasal symptoms, and duration of colds. MAIN RESULTS: Sixteen trials including a total of 22 comparisons of an Echinacea preparation and a control group (19 with placebo, 2 with no treatment, 1 with another herbal preparation) met the inclusion criteria. All trials except one were described as double-blind. The majority had reasonable to good methodological quality. Three comparisons investigated prevention of colds and 19 comparisons tested treatment of colds. A variety of different Echinacea preparations were used. None of the three comparisons in the prevention trials showed an effect over placebo. Comparing an Echinacea preparation with placebo as treatment, a significant effect was reported in nine comparisons, a trend in one, and no difference in six. More than one trial was available only for preparations based on the aerial parts from Echinacea purpurea (E. purpurea). AUTHORS' CONCLUSIONS: Echinacea preparations tested in clinical trials differ greatly. There is some evidence that preparations based on the aerial parts of Echinacea purpurea might be effective for the early treatment of colds in adults but results are not fully consistent. Beneficial effects of other Echinacea preparations, and for preventative purposes might exist but have not been shown in independently replicated, rigorous randomized trials.

Impact of study quality on outcome in placebo-controlled trials of homeopathy.

We investigated the influence of indicators of methodological quality on study outcome in a set of 89 placebo-controlled clinical trials of homoeopathy in three different ways: (1) The results of studies meeting single criteria (explicit statement of random allocation, allocation concealment, double-blinding, completeness of follow-up) of methodological quality were compared with those of studies not meeting the criteria in univariate and multivariate analyses; (2) The results of studies scoring above and below predefined scores in two quality assessment scales were compared; (3) Primary studies were consecutively entered into a cumulative meta-analysis according to the summary scores derived from the quality assessment scales. All analyses were performed using meta-regression methods. Studies that were explicitly randomized and were double-blind as well as studies scoring above the cut-points yielded significantly less positive results than studies not meeting the criteria. In the cumulative meta-analyses, there was a trend for increasing effect sizes when more studies with lower-quality scores were added. However, there was no linear relationship between quality scores and study outcome. We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results. Because summarizing disparate study features into a single score is problematic, meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.

The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture.

BACKGROUND: To investigate the methodological quality of randomized controlled trials in three areas of complementary medicine. METHODS: The methodological quality of 207 randomized trials collected for five previously published systematic reviews on homeopathy, herbal medicine (Hypericum for depression, Echinacea for common cold), and acupuncture (for asthma and chronic headache) was assessed using a validated scale (the Jadad scale) and single quality items. RESULTS: While the methodological quality of the trials was highly variable, the majority had important shortcomings in reporting and/or methodology. Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals. There were relevant differences in single quality components between the different complementary therapies: For example, acupuncture trials reported adequate allocation concealment less often (6% versus 32% of homeopathy and 26% of herb trials), and trials on herbal extracts had better summary scores (mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials). Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria. CONCLUSION: Trials of complementary therapies often have relevant methodological weaknesses. The type of weaknesses varies considerably across interventions.

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.

Echinacea for preventing and treating the common cold.

BACKGROUND: Extracts of the plant Echinacea (family Compositae) are widely used in some European countries and the USA for upper respiratory tract infections. OBJECTIVES: The objective of this review was to assess the effects of preparations containing extracts of Echinacea in the prevention and treatment of the common cold. SEARCH STRATEGY: We searched the Cochrane Acute Respiratory Infections Group and Complementary Medicine Field's trials registers, MEDLINE, EMBASE, Phytodok and reference lists of articles. We also contacted researchers and manufacturers. Date of last search: Spring 1998. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing preparations containing an extract of Echinacea compared with a placebo, no treatment, or another treatment for common colds. DATA COLLECTION AND ANALYSIS: At least two independent reviewers assessed trial quality and extracted data. MAIN RESULTS: Sixteen trials (eight prevention trials, and eight trials on treatment of upper respiratory tract infections) with a total of 3396 participants were included. Variation in preparations investigated and methodological quality of trials precluded quantitative meta-analysis. Overall, the results suggested that some Echinacea preparations may be better than placebo. REVIEWER'S CONCLUSIONS: The majority of the available studies report positive results. However there is not enough evidence to recommend a specific Echinacea product, or Echinacea preparations for the treatment or prevention of common colds.

Acupuncture for idiopathic headache.

BACKGROUND: Acupuncture is widely used for the treatment of headache, but its effectiveness is controversial. OBJECTIVES: To determine whether acupuncture is: - more effective than no treatment - more effective than 'sham' (placebo) acupuncture - as effective as other interventions used to treat idiopathic (primary) headaches. SEARCH STRATEGY: Electronic searches were performed in MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and the database of the Cochrane Field for Complementary Medicine. We also contacted researchers in the field and checked the bibliographies of all articles obtained. SELECTION CRITERIA: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of idiopathic (primary) headaches were included. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, methods, and results was extracted by at least two independent reviewers using a pre-tested standard form. Results on headache frequency and intensity were summarized descriptively. Responder rate ratios (responder rate in treatment group/responder rate in control group) were calculated as a crude indicator of results for sham-acupuncture-controlled trials. Quantitative meta-analysis was not possible due to trial heterogeneity and insufficient reporting. MAIN RESULTS: Twenty-six trials including a total of 1151 patients (median, 37; range, 10-150) met the inclusion criteria. Sixteen trials were conducted among patients with migraine, six among patients with tension-type headache, and four among patients with various types of headaches. The majority of trials had methodological and/or reporting shortcomings. In eight of the 16 trials comparing true and sham (placebo) acupuncture in migraine and tension-type headache patients, true acupuncture was reported to be significantly superior; in four trials there was a trend in favor of true acupuncture; and in two trials there was no difference between the two interventions. (Two trials were uninterpretable.) The 10 trials comparing acupuncture with other forms of treatment yielded contradictory results. REVIEWER'S CONCLUSIONS: Overall, the existing evidence supports the value of acupuncture for the treatment of idiopathic headaches. However, the quality and amount of evidence are not fully convincing. There is an urgent need for well-planned, large-scale studies to assess the effectiveness and cost-effectiveness of acupuncture under real-life conditions.

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.

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.

Monitoring of liver enzymes in patients treated with traditional Chinese drugs.

BACKGROUND: Use of traditional Chinese drug treatment is widespread. While cases of hepatotoxic effects have been reported, little is known about the frequency of such effects. OBJECTIVES: To investigate the frequency, magnitude and course of liver enzyme elevations in patients treated with traditional Chinese drugs. DESIGN: Retrospective study. SETTING: Hospital for traditional Chinese medicine in Germany. PATIENTS: All 1507 patients admitted for inpatient treatment between February 1994 and July 1995. MAIN OUTCOME MEASURE: Number of patients who presented at discharge with a more than 2-fold elevation of alanine amino transferase (ALT) levels (over maximum normal values or elevated admission values). RESULTS: A more than 2-fold elevation of ALT values was observed in 14 patients (0.9%). In 13 cases a causal relationship with Chinese drug therapy seemed possible and, for one patient, likely. However, all patients were also on non-Chinese drug treatment. Follow-up values of ALT within 8 weeks after discharge were normal in 11 patients (six of them had continued to take traditional Chinese drugs) and close to normal in the remaining three. In five patients there were indications for previous liver damage. CONCLUSIONS: In the population and setting studied, clinically relevant liver enzyme elevations occurred in about 1/100 patients treated with traditional Chinese drugs.

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.

Systematic reviews of complementary therapies - an annotated bibliography. Part 1: acupuncture.

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 acupuncture. 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 acupuncture; 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: From a total of 48 potentially relevant reviews preselected in a screening process 39 met the inclusion criteria. 22 were on various pain syndromes or rheumatic diseases. Other topics addressed by more than one review were addiction, nausea, asthma and tinnitus. Almost unanimously the reviews state that acupuncture trials include too few patients. Often included trials are heterogeneous regarding patients, interventions and outcome measures, are considered to have insufficient quality and contradictory results. Convincing evidence is available only for postoperative nausea, for which acupuncture appears to be of benefit, and smoking cessation, where acupuncture is no more effective than sham acupuncture. CONCLUSIONS: A large number of systematic reviews on acupuncture exists. What is most obvious from these reviews is the need for (the funding of) well-designed, larger clinical trials.

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.

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.

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.

Why do patients seek treatment in hospitals of complementary medicine?

OBJECTIVE: This exploratory study evaluated patients' reasons for entering a complementary (alternative) medicine hospital by ranking 15 medical and psychosocial factors that were thought to influence this choice. SUBJECTS AND OUTCOME MEASURES: Two hundred patients (200) from two complementary hospitals, one focusing on Traditional Chinese Medicine and one on the Western type of complementary medicine, completed an extensive questionnaire at the beginning of their inpatient treatment. The questionnaire covered personal background; disease parameters; attitude towards conventional medicine; previous experience with, and knowledge of, complementary therapies; expectations concerning the forthcoming treatment; health-related habits; personality traits; and social support. RESULTS: Optimistic attitudes towards treatment and a positive appraisal of alternative doctors were frequently stated reasons (80%), as was the disease severity (long duration: 86%; acute progression or imminent surgery: 70%). Previous successes with complementary therapies, however, ranked relatively low (53%). Negative opinions concerning conventional therapies and conventional doctors' treatments were mentioned by 68% of the patients. Many patients felt themselves to be under considerable psychologic stress (74%). A majority (73%) was well informed about complementary therapies, and 65% were curious about the forthcoming therapies. Sixty-eight percent (68%) indicated good health behaviors. Fewer patients mentioned contemplative and/or religious attitudes (44%) or lack of social support (25%). Age primarily accounted for variations in the ranking weights of the two subgroups. The specific type of complementary medicine was of minor influence. In 14 out of 21 personality dimensions, the current patient group showed significant deviations from the healthy reference, which is in good agreement with findings from conventionally treated patients.

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.