"Evidenz" liefert ein Urteil nur dann und nur insofern, als es sich auf tatsächlich vorhandene Fakten bezieht. Urteile und Schlussfolgerungen, die auf Annahmen beruhen, bieten keine Evi-denz, auch wenn sie klug berechnet sind. Das gilt auch für die Evidenz basierte Medizin, EBM, wie man sehr gut am Beispiel der Lancet-Studie über Homöopathie von SHANG et al. aus dem Berner Institut für Sozial-und Präventivmedizin von Prof. Egger sehen kann [1]. Prof. Egger gilt als prominenter Vertreter von EBM. Seine Arbeitsgruppe kommt auf Grund einer Meta-Regression bekanntlich zum Schluss, dass Homöopathie nicht wirkungsvoller sei als Placebo. Bezieht sich dieses Urteil tatsächlich auf nachgewiesene Fakten? Nein. Die wesentlichen Schlussfolgerung sind Hypostasen, die auf theoretischen Annahmen und darauf aufbauenden probabilistischen Berechnungen beruhen. 1. Es wird angenommen, dass die Effekte der untersuchten Homöopathie-Studien homogen seien, denn nur unter dieser Voraussetzung ist das Herzstück der Studie, die gewählte Funnel Plot Methode sinnvoll. In Wirklichkeit umfassen die Studien jedoch unterschiedlichste Stu-dienmodelle und homöopathische Vorgehensweisen, so dass homogene Effektarten nicht zu erwarten sind. Bei inhomogenen Effektarten kann der Funnel Plot ähnlich schief werden wie in der vorliegenden Arbeit, auch ohne dass ein Publication Bias vorliegt [2]. Das ist bereits im Schlussbericht PEK im Hinblick auf Eggers Arbeit kritisert worden [3]. 2. Es wird von der Egger-Gruppe aus rein theoretischen Gründen angenommen, dass der schiefe Funnel Plot auf einem Publication Bias beruhe, ohne faktischen Nachweis. Dem Publication Bias sind jedoch schon LINDE et al. in ihrer Meta-Analyse von 1997 genauer nachge-gangen, indem sie systematisch nach nicht-publizierten Studien suchten und ihre Berech-nungen auch für einen hypothetischen Publication Bias adjustierten. Dadurch verminderte sich der gepoolte Effekt der Studien, er blieb aber immer noch signifikant positiv zu Gunsten der Homöopathie. Es wären je nach Berechnung 923 oder 4511 (!) "fehlende" Studien mit einem Null-Effekt nötig gewesen, um den Gesamteffekt unter die Signifikanzgrenze zu sen-ken [ 2]. Es gibt aber weltweit nicht genügend Arbeitsgruppen, um so viele Studien zustande zu bringen und sie erst noch zu verstecken. Im übrigen zeigen auch die meisten von LINDE et al. gefundenen nicht-publizierten Studien einen positiven Effekt. 3. Es wird rein theoretisch vorausgesetzt, dass die grossen Studien qualitativ besser seien als die kleineren. Die faktische Evidenz dafür wurde nicht geprüft. Bei der Klassischen Homöo-pathie ist eher das Gegenteil der Fall, nämlich dass ihre individualisierende Vorgehensweise in einer grossen Studie nicht gewährleistet ist oder dass nicht genügend kompetente Thera-peuten zu Verfügung stehen. Falsch negative Ergebnisse sind dann die Folge. Für konventio-nelle Therapien gilt wegen ihrer weitgehenden Standardisierung und der viel weiter gehen-den Unabhängigkeit der Medikamentengabe von der spezifischen Kompetenz der Ärzte nicht dasselbe....
Background: Independent replications of preclinical investigations of homeopathic potencies are rare. However, they are a necessary tool to determine the relevant factors modulating the effects of homeopathic potencies in preclinical systems. Objective: The goal of the present study was to reproduce a trial published in 1997. An Italian group of researchers investigated the effect of Arsenicum album 45x on the growth of wheat which had been previously poisoned with a material dose of Arsenicum album. The homeopathic treatment was associated with increased wheat shoot growth significantly different from the control group (+24%, p < 0.001). Materials and Methods: Wheat poisoned with a sublethal dose of Arsenicum album was cultivated in either Arsenicum album 45x, water 45x, or unpotentized water. After 7 days, shoot length was measured. Reproducibility was assessed in eight independent experiments. Results: Arsenicum album 45x significantly inhibited wheat shoot growth (-3%) compared to treatment with unpotentized water and water 45x (p = 0.011 and p = 0.037). Within the experimental series performed in this reproduction trial, the effects of Arsenicum album 45x proofed to be reproducible. The wheat seed species used did not seem to have a significant impact on the experimental outcome. Conclusion: The result of this replication trial is a reversal of the original study, since Arsenicum album 45x inhibited wheat shoot growth instead of enhancing it. Nevertheless, high homeopathic potencies may induce statistically significant effects in biological systems. However, the magnitude and direction of these effects seem to depend on yet unknown parameters.
Background: Efficacy of higher homeopathic potencies is controversial. Universally accepted specific detection assays for homeopathic dilutions do not exist. Basic research has to develop a spectrum of standardized tools to investigate the mode of action and nature of homeopathic potencies. Objective: Can the shoot growth reaction of dwarf peas (gibberellin- deficient mutants) be regarded as evidence of treatment with homeopathic potencies of plant growth substances? Materials and Methods: Pea seed (Pisum sativum L. cv. Früher Zwerg) is immersed for 24 hours in homeopathic potency or control solutions for soaking. Plants germinate and grow in a standard cultivation substrate under controlled environmental conditions. Shoot length is measured 14 days after planting. Results: A screening of homeopathic potencies (12x-30x) of four different plant growth substances revealed biological activity of certain potency levels of gibberellin and kinetin (p < 0.05). Growth stimulation through gibberellin 17x (5 × 10-18 M) was assessed in six independent replications; results confirmed those of the screening (p < 0.05). The effect of gibberellin 17x seemed to weaken during the course of the experiments. Conclusion: The results back the hypothesis that homeopathic potencies of plant growth substances affect pea shoot growth. Dwarf peas might thus be an interesting system model for studying the action of homeopathic potencies. Further work is required to identify all boundary conditions modulating the reactivity of this system.
BackgroundThe aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.MethodsThe study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.ResultsData of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).ConclusionIn primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.
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