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Development of ‚Ordnungstherapie‚ due to Bircher-Benner in the Naturopathy of the 20th Century Background: The German term ‚Ordnungstherapie‚ is one of the five therapeutics which defines naturopathy in German-speaking countries. Objective: Who formed the term Ordnungstherapie in naturopathy and what does it mean? Material and Methods: Heuristics and criticism of literature of the 20th century as well as database research. Results: Nowadays in German-language medical books Ordnungstherpie belongs to the five therapeutics which define European naturopathy. Yet, the interpretation ranges from health education to body-orientated forms of psychotherapy. The term Ordnungstherapie is often related with the German priest and hydropath Sebastian Kneipp, however, term and definition have been founded by the Swiss physician Maximillian Bircher-Benner. In 1937 he defined Ordnungstherapie as a complex concept of natural healing. It is based upon the rather nosological idea that health is order/harmony in the human body (physically, psychologically), the environment and the daily course. Illness occurs if disorder appears in one of these fields. The therapeutic setting of Ordnungstherapy is defined by 9 rules of conduct to maintain order, which include nutrition, the skin as an organ (exposure to light, air, water), breathing, movement, rhythm of life, and psyche. For all these aspects Bircher-Benner himself uses the terms somatotherapy (dietotherapy, sun and light therapy, hydrotherapy, exercise therapy, breathing technique, order of the rhythm of live) and psychotherapy. He chose these complementary methods subjectively after learning them from 1897 onwards in an eclectic manner and after gaining therapeutic empiricism. Nevertheless his ideas of the Ordnungstherapie correlate with the socio-political context of the 1940ies. Conclusions: The term Ordnungstherapie was introduced by Bircher-Benner as an umbrella term in 1937 to describe a complex concept of naturopathic therapies. It comprises, with certain limitations for phytotherapy, the therapies which nowadays define European naturopathy. Yet, in European naturopathy today Ordnungstherapie is mostly considered as one out of 5 constituents of naturopathy (dietotherapy, hydrotherapy, exercise therapy, phytotherapy, Ordnungstherapie). The classification of Ordnungstherapie as one of the 5 pillars of the Kneipp therapy was only done by Kneipp physicians in the middle of the 20th century and needs to be thought over.

Background: In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. Questions: Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? Methods: The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. Patients: 426 patients with the main diagnosis ‘Migraine’ and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 ± 11.7 years (range 14–73 yrs). Results: 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. Conclusions: Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later.

dients of Chinese medicinal drugs used for inpatient treatment. Responsible for this area of interest are Hildebert Wagner of the Center for Drug Research of the Ludwig-Maximilians-Universitat Munich and Rudolf Bauer of the Institute of Pharmaceutical Science, Department of Pharmacognosists of the Karl-Franzens-Universitat Graz. Especially in Germany, there is a long tradition of classifying active herbs and their chemical constituents. For this reason, the monographs on TCM drugs resulting from this work are important features of the scientific activities, as indicated in the cover of this issue and the article by Wagner et al. [3]. TCM is under increasing pressure to show therapeutic efficacy and lack of side effects as well as to improve clinical quality continuously. Therefore, a ‘complication screening program’ with an effective adverse event reporting system for all used methods in the clinic has been established. We especially stress the absence of toxins, contamination and adulteration in order to avoid risks for the patients. The article by Melchart et al. [4] describes a model of safety monitoring and risk management in TCM drugs, so that risks can be identified early. Both Eastern and Western medical systems will benefit from additional TCM approaches, modified according to modern scientific requirements – these objectives are shared by all members of the scientific board.

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.

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.

Einleitung: Es werden erste Zwischenergebnisse aus der Basisdokumentation einer Beobachtungsstudie zur Akupunktur bei chronischem Kopfschmerz, chronischen LWS-Beschwerden und chronischem Osteoarthroseschmerz berichtet. Die Studie ist eine Teilkomponente des wissenschaftlichen Begleitprogramms des Modellvorhabens der Ersatzkassen zur Akupunktur. Zielsetzung: Beschreibung der Versorgungspraxis mit Akupunktur bei den definierten Indikationen, durchgefuhrt von qualifizierten arztlichen Akupunkteuren im niedergelassenen Bereich; Abschatzung der Inzidenz von unerwunschten Ereignissen und Beschreibung der Behandlungseffekte der Akupunktur. Methodik: Offene, prospektive, multizentrische Beobachtungsstudie mit einer fur alle Patienten des Modellvorhabens verbindlichen Basisdokumentation durch den Arzt. Neben den allgemeinen Rahmenbedingungen des Modellvorhabens gibt es keine weiteren Vorgaben hinsichtlich der durchgefuhrten Akupunktur. Ergebnisse: Zum Stichtag 25.3.2002 steht die Basisdokumentation von 97 733 Fallen (80,5 % weiblich, Alter 55,1 ± 15,5 Jahre), behandelt von 7050 Akupunkteuren, zur Verfugung. Haufigste Indikation fur die Akupunktur sind LWS-Beschwerden (45,7 %). 35,2 % der Falle werden wegen chronischer Kopfschmerzen und 12,1 % wegen Arthroseschmerz behandelt. In 7 % liegen mehrere Indikationen gleichzeitig vor. Die Diagnose ist im Median seit 3 Jahren bekannt und meist facharztlich gesichert. 70,8 % der Patienten erhielten bislang noch keine Akupunktur. Pro Patient wurden durchschnittlich 7,9 Akupunktursitzungen dokumentiert. 34,3 % erhielten eine Begleitbehandlung. Die therapeutische Wirksamkeit wird von den Arzten abschliesend in 21,6 % der Falle als sehr gut, in 55,1 % als gut und in 16,8 % als gering beurteilt. 3,6 % der Falle werden als unverandert oder verschlechtert eingestuft. Eine unerwunschte Wirkung wurde in 7,1 % der Falle berichtet. Schwerwiegende Ereignisse wurden in 6 Fallen mitgeteilt, ihre Haufigkeit liegt unter 0,01 %. Ausblick: Fur die laufende Studie werden bis etwa 500 000 Behandlungsfalle erwartet. Derzeit werden die an einer Patientenstichprobe zusatzlich eingesetzten Patientenfragebogen ausgewertet. Eine elektronische Form der Dokumentation wird derzeit erprobt. Introduction: The German Social Law allows the health insurance companies to perform so called „Modellvorhaben” (trial phases) in order to investigate effectiveness and efficiency of health care interventions under real life conditions. We report preliminary results of a study representing one component of the concomitant research strategy of a Modellvorhaben on acupuncture by a group of German social health insurance companies. Objective: Description of the usage of acupuncture in routine care of out-patients, estimation of the incidence of adverse effects, description of the therapeutic effects of acupuncture. Methods: Open prospective multicenter observational study of patients suffering from chronic headache, low back pain and osteoarthritic pain. Acupuncture is performed by registered medical acupuncturists with at least 140 hours of acupuncture training. Results: By March, 25, 2002 data from 97 733 patients (80.5 % female; mean age 55.1 ± 15.5 yrs) treated by 7050 acupuncturists were available for analysis. The most frequent indication for acupuncture was low back pain (45.7 %). The relative frequency of chronic headache was 35.2 % and 12.1 % for osteoarthritic pain, respectively. Multiple indications were reported in 7 % of the patients. The median duration of complaints was 3 years. 70.8 % of the patients were treated with acupuncture for the first time. 7.9 acupuncture sessions were reported per patient on average. 34.3 % of the patients received concomitant treatment. The therapeutic effectiveness was judged by the physicians as very good in 21.6 % of the patients, as good in 55.1 %, and as minimal in 16.8 %. In 3.6 % complaints were rated as unchanged or worse. Adverse effects were reported in 7.1 % of all patients, whereas severe adverse effects were documented in 6 cases meaning a frequency of below 0.01 %. Outlook: About 500 000 patients are expected for this ongoing study. An electronic version of the documentation is currently being tested. At present, more detailed patient-based data obtained in a random sample of patients are analyzed.

In an open prospective study with matched historical controls we aimed to evaluate whether a polysaccharide fraction isolated from the herb Echinacea purpurea could counteract the undesired effects of chemotherapy. Fifteen patients with advanced gastric cancer undergoing palliative chemotherapy with etoposide, leucovorin and 5-fluorouracil (ELF) received for 10 days (beginning 3 days before chemotherapy) daily i.v. injections of 2 mg of a polysaccharide fraction isolated from Echinacea purpurea herb cell cultures (EPS-EPO VIIa). The median number of leukocytes 14-16 days after chemotherapy was 3630/microL (range 1470-5770) in the patients receiving EPS-EPO VIIa compared with 2370/microL (870-3950) in the patients of the historical control group (p = 0.015). EPS-EPO VIIa had no clinically relevant effects on phagocytic activity of granulocytes or on lymphocyte subpopulations. Sixty-eight adverse events including two deaths were observed, most likely due to chemotherapy and the general condition of the patients. However, an association with the test intervention cannot be ruled out completely. The results of this pilot study suggest that EPS-EPO VIIa might be effective in reducing chemotherapy-induced leukopenia. The efficacy and safety should be investigated in further studies.

We aimed to investigate: (1) whether patient and intervention characteristics, design-independent quality aspects, and response rates differ between randomized and non-randomized trials of acupuncture for chronic headache; (2) whether non-randomized studies provide useful additional information (regarding long-term effects, prognostic factors, adverse effects, and generalizability); (3) reasons for potential differences in response rates. Studies including at least five patients and reporting clinical outcome data were identified through searches in Medline, Embase, the Cochrane Controlled Trials Register, other databases and checking of bibliographies. Twenty-four randomized trials and 35 non-randomized studies (five non-randomized controlled cohort studies, 10 prospective uncontrolled studies, 10 case series, and 10 cross-sectional surveys) met the inclusion criteria. Studies were heterogeneous regarding patients, interventions, outcome measurements and results. On average, randomized trials had smaller sample sizes, met more quality criteria, and had lower response rates (0.59 [95% confidence interval 0.48-0.69] vs. 0.78 [0.72-0.83]). Whether randomized or not, studies meeting more quality criteria had lower response rates. Non-randomized studies did not have significantly longer follow-up periods, three included an analysis of prognostic variables, only one reported on adverse effects, and the degree of generalizability was unclear. In the case of acupuncture for chronic headache, non-randomized studies confirmed the finding of a systematic review of randomized trials that the treatment is likely to be effective but provided little relevant additional information on long-term effects, prognostic factors, and adverse effects.

Description of the drug: Compressed-cylindrical, somewhat curved, varying in length, 0.5–2 cm in diameter. Externally greyish-yellow or dark grey, with longitudinal wrinkles and transverse cracks, some bark transversely broken and wood exposed. Texture tough, fracture bark thick, purple or yellowish-brown or yellowish-white, 1–5 mm in diameter. Odour, slight; taste, sweetish and slightly astringent.

Description of the drug : Slender cylindrical, straight or slightly curved, 15–70 cm, 0.4–1 cm in diameter. Externally grayish-yellow or pale brown, with slightly twisted and fine longitudinal wrinkles, transverse lenticel-like protrudings and sparse rootlet scars. Texture hard and fragile, easily broken, softened when moistened, fracture even, pale brown, slightly horny and oily. Xylem of vascular bundles arranged in 2–4 whorls. Odour, slight; taste, slightly sweet, somewhat bitter and astringent.

Description of the drug: Occuring in masses formed by numerous rolled irregular slivers, or in long slat-shaped shavings, varying in width and thickness, greenish or yellowish-green. Texture light, loose, flexible and elastic. Odour, slight; taste, weak.

Description of the drug: Ovoid, elliptical or spherical, 4.5–8.5 cm long, 3.5–6 cm in diameter. Externally brown, yellowish-brown or greenish-brown, marked with dark-coloured patches and covered with yellow fine hairs, some exhibiting 6–11 longitudinal lines. Apex with a style scar, and base with a fruit stalk scar. Texture light, fragile, pericarp thin, easily broken. Sarcocarp spongiform, pale brown. Seeds oblate, abundant, about 1.5 cm long and 1.2 cm wide, pale red to brownish-red, slightly dented between two surfaces, surrounded by radial furrows, and channelled at the edge. Odour, slight; taste, sweet.

Description of the drug: Capitulum hemispherical, 4–5 mm in diameter. Bracts densely arranged in numerous layers at the base, pale yellowish-green, lustrous, densely pubescent at the upper margin. The top of the capitulum greyish-white. After rubbing, numerous black anthers and fine yellowish-green unripe fruits visible. Peduncles slender, varying in length, less than 1 mm in diameter, pale yellowish-green, bearing numerous twisted ridges. Texture pliable. Odour, slight; taste, weak.

Description of the drug: Interwined into a loose mass; grayish-green or grayish brown; 1 axial root; rootlets fine. Stem fine and curled; marked with longitudinal ridges. Leaves opposite (borne in pairs at each node), mostly in fragments, extremely shriveled, fall off easily; when intact, blades linear (long and narrow); with stupiles, 1–2 mm long, membranous, lower part accrete (grown or joined together), top end serrulate (finely notched). Flowers usually solitary (occurring singly) and axillary (grown at axil); mostly pedicellate (with a pedicel). Capsules flattened and spherical; top end with 4-toothed persistent calyx. Odour: faint; taste: mild.

Description of the drug: Mostly crumpled and rolled, some broken, when whole, elliptical-lanceolate or ovate-lanceolate, 2–5 cm long, 0.5–2 cm wide, pale green or greyish-green, apex obtuse and mucronate, base obtuse or cuneate, margin serrulate, usually recurved, glabrous on both surfaces, veins on lower surface prominent; petioles thin, about 4 mm long. Texture fragile. Odour, slight; taste, weak.

Description of the drug: Interweaved silvery vascular bundles, mostly prolate cylindrical, somewhat curved, 30–70 cm long, 7–10 cm in diameter. Externally pale yellowish-white. Texture light, tenacious and springy, uneasily broken. 3 loculi visible, transverse section hollowed. Odour, slight; taste, weak.

Description of the drug: Elliptical, oblong or irregular oblique slices, 0.3–1 cm thick. Cork greyish-brown, sometimes greyish-white patches visible and appearing reddish-brown when the cork exfoliated. Texture compact and hard. In the transversely cut surface, xylem reddish-brown or brown, showing numerous pores of vessels; phloem with resinous secretion reddish-brown to blackish-brown, arranged alternately with xylem, forming several concentric elliptical or eccentric semi-circular ring; pith inclined to one side. Odour, slight; taste, astringent.

Description of the drug: Stems cylindrical, up to 1 m long, densely covered with yellow spreading pubescens; texture slightly fragile, fracture medullated in the centre. Leaves alternate, leaflets 1–3, rounded or oblong, 2–4 cm in diameter; retuse at the apex, cordate or obtusely rounded at the base, margin entire; the upper surface yellowish-green or grayish-green, glabrous, the lower surface densely covered with grayish-white tomenta, lateral veins pinnate; petiole 1–2 cm long; stipules 2, lanceolate, about 8 mm long. Odour, slightly aromatic; taste, slightly sweet.

Description of the drug: Frequently twisted into masses, glabrous or sparsely pubescent. Stems twisted, externally brown or dark brownish-red, striated longitudinally, stem nodes of the lower part sometimes with rootlets, fracture solid. Leaves opposite, mostly crumpled, when whole, broadly ovate or cordate, 1–4 cm long, 1–5 cm wide, base slightly concave, margin entire; the upper surface grayish-green or dark brown, the lower surface pale in colour, midrib distinctly prominent, after soaking in water, the black or brown stripes visible under the light; petioles 1–4 cm long. Some with flowers, yellow, solitary and axillary, longpetioled. Capsules globose. Odour, slight; taste, weak.

Description of the drug: Irregular cylindrical, conical or fusiform, slightly twisted, the lower part frequently branched, 3–15 cm long, 1–2 cm in diameter. Externally blackish-brown or greyish-yellow, frequently with stem scars and fibrous remains of pericladia at the root stock, with numerous fine annular striations at the upper end, and longitudinal furrows or wrinkles and transverse lenticel-like cicatrices at the lower part. Texture relatively flexible, hard when dried, easily broken, fracture uneven, pale yellowish-white, numerous brownish-yellow oily spots scattered in bark, cambium ring brown, rays radiated. Odour, aromatic; taste, slightly bitter and pungent.

Description of the drug: Stolons slender cylindrical, slightly curved, up to 2 m long, 1–3 mm in diameter, with yellow-white rootlets underneath. Erect stems bifurcated. Leaves densely growing on the stems, spirally arranged, crumpled and curved, linear or needle-shaped, 3–5 mm long, yellowish-green to pale yellowish-brown, glabrous, aristate at the apex, margin entire, easily broken. Texture soft, fracture pale yellow in bark and whitish in wood. Odour, slight; taste, weak.

Description of the drug: Ovoid, elliptical or reniform, 6–8.5 mm long, 3.5–5.5 mm in diameter. Externally blackish-purple or greyish-black, shrunken and uneven, with a fruit stalk scar or persistent calyx and a short fruit stalk at the base. Texture light. Epicarp thin, mesocarp relatively lax and soft, easily stripped off, endocarp woody, yellowish-brown, with longitudinal ribs. Seed 1 reniform, purplish-black, oily. Odour, slight; taste, sweet but slightly bitter and astringent.

Description of the fresh drug: The plant G. pentaphyllum consists of slender stems of thin, soft leaves arranged like fingers on a hand, bearing 3–9 (mainly 5–7) leaves. The leaflets are long and pliable, broadest below the middle and tapering to a point like a lance.

Descriptions of the drug: Frequently fusiform, some slightly curved, 2–3.5 cm long, 0.5–1 cm in diameter. Externally dark brown or blackish-brown, longitudinally wrinkled and with 6–10 slightly prominent annular nodes with brown fibrous roots and broken roots; or slightly smooth and exhibiting indistinct annular nodes on the ones of fibrous roots completely removed. Texture hard, fracture of steamed rhizomes appearing yellowish-brown or reddish-brown, horny: fracture of the unsteamed ones white and starchy, an endodermis ring obvious, stele darkened in colour, with scattered dotted vascular bundles. Odour, aromatic; taste, slightly bitter.

Description of the drug : 50–120 cm long. Rhizomes relatively large, with numerous rootlets. Stems cylindrical, frequently branched, 0.3–1.3 cm in diameter; externally dark green to dark brown, with distinct fine longitudinal striations, longitudinal lenticels scattered, nodes swollen; texture fragile, easily broken, fracture medullated or hollowed. Leaves opposite, lamina ovate-lanceolate to ovate-elliptical, 5–15 cm long, 3–6 cm wide; externally green, greenish-brown to dark brown or brownish-red, glabrous, margin roughly serrate, the tips of serrations with blackish-brown glandular bodies, petiole about 1 cm long; texture nearly leathery. Spikes terminal, frequently branched. Odour, slightly aromatic; taste, slightly pungent.

Description of the drugs: Liandanpi: Quilled or semiquilled, with longitudinal cut fissures, somewhat involute or opened. 5–20 cm long, 5–12 mm in diameter, 1–4 mm thick. Outer surface greyish-brown or yellowish-brown, showing numerous transverse lenticel-like prominences and rootlet scras, the exposed surface where cork fallen off appearing pink; inner surface pale greyish-yellow or pale bron, with obvious fine longitudinal striations, usually showing bright crystals. Texture hard and fragile, easily broken, fracture relatively even, mealy, pale pink. Odour, aromatic; taste, slightly bitter and astringent.

Description of the drugs: Folium Crataegi: Mostly broken, when whole, broadly ovate, 6–12 cm long, 5–8 cm wide. Green to brownish-yellow, apex acuminate, base broadly cuneate, 2–6 pinnate-lobed margin acutely biserrate; petiole 2–6 cm long, stipule ovate to ovate-lanceolate. Odour, slight; taste, astringent, slightly bitter.

Description of the drugs: Root of Glycyrrhiza uralensis: Roots cylindrical, 25–100 cm long, 0.6–3.5 cm in diameter. The outer bark loose or tight. Externally reddish-brown or grayish-brown, obviously longitudinally wrinkled, furrowed, lenticel-like protruded and with sparse rootlet scars. Texture compact, structure slightly fibrous, yellowish-white, starchy, cambium ring distinct, rays radiate, some with clefts. Rhizomes cylindrical, externally with bud scars, pith present in the center of fracture. Odour, slight; taste, sweet and characteristic.

Description of the drug: Long conical or long cylindrical, gradually tapering towards the lower part, some slightly tortuous, 15–30 cm long, 0.5–2 cm in diameter. Externally greyish-brown, rugged, with longitudinal wrinkles, numerous transverse-elongated lenticel-like protrudings and dotted raised rootlet scars. Root stock with obvious dense annulations, some annulations marked by brown hair-like remains of leaf bases. Texture light, easily broken, fracture uneven, bark brownish and cracked, wood yellowish. Odour, characteristic; taste, sweetish.

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.

SummaryWhile the effectiveness of Hypericum extracts in the treatment of mild and moderately severe depressive disorders seems to be well-established, the mechanism of action is still unl

Summary Background: Measures of heart rate variability (HRV) are widely recognized as being an important indicator method for autonomical function an

SummaryDie Akupunktur scheint derzeit dabei zu sein, sich aus dem Reigen der alternativen bzw. komplementaren Verfahren zu verabschieden. Eine «offizielle» Konsensuskonferenz gibt fur def

SummaryGrossen Staub wirbelte in Italien der Streit um das «Wunderheilmittel» eines pensionierten Physiologen gegen alle moglichen Formen von Krebs auf, selbst grosse internationale Zeits

Die Prufung einzelner Bausteine in randomisierten Studien ware wunschenswert, ist aber bei den meist sehr individualisierten und klinikund praxisspezifischen Vorgehensweisen oft nicht reprasentativ und nur von begrenzter Aussagefahigkeit. Ein wissenschaftlicher Wirksamkeitsnachweis im engeren Sinne ist deshalb fur die in der Naturheilkunde und Komplementarmedizin sehr unterschiedlichen und im zeitlichen Verlauf variablen «Therapiecocktails» kaum zu erbringen. Meist fehlt die fur eine Verallgemeinerung notwendige Reprasentativitat und Reproduzierbarkeit der Methode: Pflanzenextrakte enthalten haufig keine standardisierten Inhalte, Akupunkturbehandlungen werden in Form verschiedenster Techniken, Schulmeinungen und personlicher Therapeutenqualifikation ausgeubt und als Erganzung oder Alternative zur konventionellen Therapie durchgefuhrt. Die randomisierte Vergleichsstudie kann deshalb im Bereich von Naturheilverfahren/ Komplementarmedizin nicht immer der erste Schritt einer klinischen Forschungsaktivitat sein, da haufig andere Fragen als die Wirksamkeit eines einzelnen Behandlungsverfahrens im Vordergrund der Gesamtproblematik stehen oder das methodische Design fur die Fragestellung nicht geeignet ist. Dies liegt an den zum Teil prinzipiellen Unterschieden, die zwischen der an der Arzneimittelforschung orientierten Forschungsstrategie und der naturheilkundlichen Wirksamkeitsprufung bestehen. Bis ein Arzneimittel fur die medizinische Versorgung empfohlen und zugelassen werden kann, sind die bekannten Phasen der klinischen Prufung zu durchlaufen. Die Innovation gelangt also nur in die Versorgung, wenn ausreichende Evidenz durch Studienergebnisse vorliegt. Insbesondere in der komplementarmedizinischen Onkologie besteht bereits eine hohe Migration des «Produktes» Naturheilverfahren in die medizinische Versorgung, aber eine niedrige bis fehlende Studienevidenz. Die Tatsache, dass Naturheilverfahren und andere traditionelle Heilsysteme bereits vor einem potenziellen EvidenzDie gesamte Medizin ist seit Jahren mit steigenden Forderungen nach mehr Evidenz und Qualitatssicherung konfrontiert. Von dieser Entwicklung wird die sogenannte Komplementarmedizin in der Onkologie in besonderer Weise beruhrt. Nur: Wer soll diese Aufgabe losen, und wie? Die Komplementarmedizin hat ein erhebliches Defizit an kontrollierten klinischen Studien, und es existieren derzeit kaum Fachgesellschaften und Lehrstuhlstrukturen, die fur dieses Anwendungsgebiet eine ausreichende Koordinationsund Leitkompetenz besitzen. Daher sind die einzelnen Arbeitsgruppen fur Komplementarmedizin in der Onkologie aufgefordert, einen eigenen Weg fur eine systematische und kritische Evaluation wie Qualitatssicherung zu finden. Dabei ist die vermehrte Durchfuhrung von evidenzgenerierenden klinischen Studien als auch eine alltagsnahe und anwenderorientierte Dokumentation der Versorgungswirklichkeit zu berucksichtigen. Es ware wunschenswert, wenn sich neben der Deutschen Krebshilfe mit ihrer vorbildlichen Projektforderung des Kompetenznetzes Komplementarmedizin in der Onkologie (KOKON) [1] auch staatliche Fordereinrichtungen mit neuen Forschungsprogrammen an dieser Aufgabe beteiligen wurden. Das Interesse an dieser Art von Forschung ist jedoch in unserer Gesellschaft sehr unterschiedlich verteilt: Universitare Vertreter der Komplementarmedizin sind vorwiegend an den Fragen der wissenschaftlichen Evidenz interessiert, Krankenkassen orientieren sich an Wirtschaftlichkeit und Versichertenwettbewerb und Praxisarzte sowie Kliniken an Patientenanbindung und positiver Ausendarstellung. Patienten und zuweisende Arzte benotigen Informationen fur die Inanspruchnahme komplementarer Behandlungsmethoden – normative Instanzen wie z.B. das Bundesamt fur Gesundheit entscheiden vorwiegend auf der Grundlage von Wirksamkeitsnachweisen im Sinne der evidenzbasierten Medizin. Published online: February 12, 2015

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.