Harald Walach
University of Freiburg
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Complementary Medicine Research | 2003
Harald Walach
Homeopathy is scientifically banned, both for lack of consistent empirical findings, but more so for lack of a sound theoretical model to explain its purported effects. This paper makes an attempt to introduce an explanatory idea based on a generalized version of quantum mechanics (QM), the weak quantum theory (WQT). WQT uses the algebraic formalism of QM proper, but drops some restrictions and definitions typical for QM. This results in a general axiomatic framework similar to QM, but more generalized and applicable to all possible systems. Most notably, WQT predicts entanglement, which in QM is known as Einstein-Podolsky-Rosen (EPR) correlatedness within quantum systems. According to WQT, this entanglement is not only tied to quantum systems, but is to be expected whenever a global and a local variable describing a system are complementary. This idea is used here to reconstruct homeopathy as an exemplification of generalized entanglement as predicted by WQT. It transpires that homeopathy uses two instances of generalized entanglement: one between the remedy and the original substance (potentiation principle) and one between the individual symptoms of a patient and the general symptoms of a remedy picture (similarity principle). By bringing these two elements together, double entanglement ensues, which is reminiscent of cryptographic and teleportation applications of entanglement in QM proper. Homeopathy could be a macroscopic analogue to quantum teleportation. This model is exemplified and some predictions are derived, which make it possible to test the model.
BMC Medical Research Methodology | 2005
Harald Walach; Catarina Sadaghiani; Cornelia Dehm; Dick J. Bierman
Background and purposePlacebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability.MethodsWe analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks) to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out.ResultsWe found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p < .001). A multiple regression model explained 79% of the variance in placebo variability (F = 59.7; p < 0.0001). Significant predictors are, among others, the duration of the study (beta = .31), the quality of the study (beta = .18), the fact whether a study is a prevention trial (beta = .44), whether dropouts have been documented (beta = -.20), or whether additional treatments have been documented (beta = -.17). Healing rates with placebo are lower in the following diagnoses; neoplasms (beta = -.21), nervous diseases (beta = -.10), substance abuse (beta = -.14). Without prevention trials the amount of variance explained is 42%.ConclusionMedication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.
Journal of Psychosomatic Research | 1993
Harald Walach
A basic tenet of homoeopathy is that remedies which do not contain active molecules can have effects on the healthy human organism, by virtue of the specific preparation process of stepwise dilution and succussion, called potentization. The claim that a so called high potency of a homoepathic remedy, Belladonna C30, could produce effects different from placebo, was investigated in a pilot study. In a double-blind crossover trial, 4 weeks of Belladonna C30 were compared to 4 weeks of placebo in 47 healthy volunteers. Data were collected daily. The number and types of changes were recorded into a predefined category system. Single-case evaluation showed differences between the two experimental phases for 21 subjects. Group evaluation showed no clearcut differences. The claim that homoeopathic potencies can produce symptoms other than placebo in healthy subjects should be put to further scrutiny.
European Psychologist | 2001
Harald Walach; Stefan Schmidt; Yvonne-Michelle Bihr; Susanne Wiesch
We studied the effect of experimenter expectations and different instructions in a balanced placebo design. 157 subjects were randomized into a 2 × 4 factorial design. Two experimenters were led to expect placebos either to produce physiological effects or not (pro- vs. antiplacebo). All subjects except a control group received a caffeine placebo. They were either made to expect coffee, no coffee, or were in a double-blind condition. Dependent measures were blood pressure, heart rate, well-being, and a cognitive task. There was one main effect on the instruction factor (p = 0.03) with the group “told no caffeine” reporting significantly better well-being. There was one main effect on the experimenter factor with subjects instructed by experimenter “proplacebo” having higher systolic blood pressure (p = 0.008). There was one interaction with subjects instructed by experimenter “proplacebo” to receive coffee doing worse in the cognitive task than the rest. Subjects instructed by experimenter “antiplacebo” w...
Complementary Medicine Research | 2005
Harald Walach
Dieser Tage ist mir ein Erlebnis aus meiner Jugend in den Sinn gekommen: Wir hatten mit Schlauchbooten eine Flussfahrt auf dem Lech organisiert, einem Fluss, der durch unzahlige Wehre gestaut und gebremst wird. Manche Wehre mussten wir, die Boote tragend, umgehen. Bei einigen kleineren versuchten wir durchzufahren. Es gelang uns auch bis auf ein einziges Mal. Da war die Ruckstromwalze am Fuss des Wehres so stark, dass sie das Boot gefangen hielt und wir nicht mehr freikamen. Langsam drehte sich das Boot parallel zur Wasserwalze, wurde dann vom fallenden Wasser erfasst und kenterte. Einen Moment nur versuchte ich, gegen den machtigen Strom anzukampfen, gab aber rasch auf. Ich liess mich vom Wasser hinunterziehen bis auf den Grund und konnte unten mit dem stromenden Wasser abtauchen. Etwa 20 m von der Walze entfernt wurde ich wieder ausgespuckt. Diese Episode hat mir eine wichtige Lehre erteilt: gegen machtige Stromungen anzukampfen ist Irrsinn. Man kann nur ihre Kraft nutzen, ihnen so lange folgen, bis sich eine Moglichkeit bietet freizukommen. Eine solche machtige Stromung, gegen die sich zu stellen sinnlos ware, ist die globale Okonomisierung, die auch vor der Gesundheit nicht Halt macht. In Deutschland hat diese Tendenz ihre Maximen langsam, fast unmerklich auch ins Gesundheitswesen sickern lassen. In der Schweiz ist ein fulminanter Auftakt bereits durch die Presse gegangen: Bundesrat Pascal Couchepin, der liberale Innenminister und als solcher in der Schweiz auch fur das Gesundheitswesen zustandig, hat beschlossen, alle komplementarmedizinischen Verfahren aus der Grundversorgung zu streichen. Damit ist das mit viel Spannung erwartete Ergebnis des so genannten «Programmes Evaluation Komplementarmedizin», kurz PEK, eines 7-jahrigen, einmaligen Feldversuchs zur Nutzlichkeit der Komplementarmedizin in der niedergelassenen Versorgung, durch eine politische Entscheidung bagatellisiert worden. Couchepins Agenda ist an sich lobenswert und verstandlich: Die Kosten im Schweizer Gesundheitswesen sind hoch und mussen gesenkt werden. Dies kann nur durch drei mogliche Prozesse geschehen: (1) Die Anbieter senken ihre Preise und arbeiten kostengunstiger; dies wurde zu einer Einkommensreduktion im Gesundheitswesen fuhren und ist wohl kaum realistisch. (2) Die Konsumenten senken ihre Anspruche; angesichts der wachsenden Anspruchshaltung wohl kaum zu erwarten. (3) Leistungen, die nicht absolut notwendig sind, mussen privat bezahlt werden.
Complementary Medicine Research | 1996
Harald Walach; A. Brednich; S. Heinrich; P. Eßer
Auf Initiative der Innungskrankenkassen (IKK) wurde im Januar 1995 in Sachsen-Anhalt mit der Durchfuhrung eines Erprobungsverfahrens zu den Heilverfahren Akupunktur und Homoopathie begonnen. Erprobung
Schmerz | 1992
W. Gaus; Harald Walach; G. Haag
The efficacy of classic homeopathic therapy is scientifically not well proven. Few of the studies available are acceptable from a scientific point of view. In this paper we will describe a study protocol for a trial of classic homeopathy in chronic headache, which not only is in accordance with currently accepted scientific research standards but also accounts for the special needs of homeopathic therapy. The prescribing practioners are allowed to use any homeopathic drug at any potency or dosage, this enables them to ful fill the homeopathic principle of individuality. At the same time, the study is strictly controlled, randomized and double blind. The prescribing physician sends the homeopathic medication selected for a patient to a notary public, who either forwards it to the patient or substitute placebo, according to the randomization plan. Hence, the trial is not testing a specific drug, but the rationale of individual homeopathic drug selection and the efficacy of the selected drugs in headache patients in general. Patients suffering from chronic headaches for at least 1 year and with headaches at least once a week on average are eligible for the study. Exclusion criteria follow the generally accepted standards and account for the special needs of homeopathic therapy. Data are to be recorded in a patients diary containing the outcome variables occurrence, duration, intensity of headaches and use of analgesic drugs. After a baseline period of at least 6 weeks the first consultation will take place, with the proper remedy selected and sent to the patient via the notary. After 6 weeks a first follow-up will allow the physician to modify the treatment if necessary. After another 6 weeks the final examination will take place. The duration of the homeopathic treatment, then, is 12 weeks. A total of 100 patients in two groups of 50 are to be treated in the study. The study started in the later part of 1991, and is scheduled to last for 2 1/2 years. We expect a critical discussion of the results from conventional medicine or from homeopathy, depending on the outcome of the study. The study protocol is being published in advance to enable the reviewers of the study to check the original study design and the a priori hypotheses adopted.The efficacy of classic homeopathic therapy is scientifically not well proven. Few of the studies available are acceptable from a scientific point of view. In this paper we will describe a study protocol for a trial of classic homeopathy in chronic headache, which not only is in accordance with currently accepted scientific research standards but also accounts for the special needs of homeopathic therapy. The prescribing practioners are allowed to use any homeopathic drug at any potency or dosage, this enables them to ful fill the homeopathic principle of individuality. At the same time, the study is strictly controlled, randomized and double blind. The prescribing physician sends the homeopathic medication selected for a patient to a notary public, who either forwards it to the patient or substitute placebo, according to the randomization plan. Hence, the trial is not testing a specific drug, but the rationale of individual homeopathic drug selection and the efficacy of the selected drugs in headache patients in general. Patients suffering from chronic headaches for at least 1 year and with headaches at least once a week on average are eligible for the study. Exclusion criteria follow the generally accepted standards and account for the special needs of homeopathic therapy. Data are to be recorded in a patients diary containing the outcome variables occurrence, duration, intensity of headaches and use of analgesic drugs. After a baseline period of at least 6 weeks the first consultation will take place, with the proper remedy selected and sent to the patient via the notary. After 6 weeks a first follow-up will allow the physician to modify the treatment if necessary. After another 6 weeks the final examination will take place. The duration of the homeopathic treatment, then, is 12 weeks. A total of 100 patients in two groups of 50 are to be treated in the study. The study started in the later part of 1991, and is scheduled to last for 2 1/2 years. We expect a critical discussion of the results from conventional medicine or from homeopathy, depending on the outcome of the study. The study protocol is being published in advance to enable the reviewers of the study to check the original study design and the a priori hypotheses adopted.ZusammenfassungAus medizinisch-wissenschaftlicher Sicht gibt es bisher keinen methodisch befriedigenden Beweis für die Wirksamkeit der mit Hochpotenzen arbeitenden klassischen Homöopathie. Hochpotenzen enthalten nach naturwissenschaftlichem Verständnis von der Urtinktur und der “Wirksubstanz” kein Molekül mehr. Die Homöopathie beansprucht jedoch eine Arzneimittelwirkung gerade der Hochpotenzen. Im folgenden wird ein Studienprotokoll zum Wirkungsnachweis der klassischen Homöopathie bei chronischen Kopfschmerzen vorgelegt, das einerseits der klassischen Homöopathie mit ihrer auf den einzelnen Patienten “mageschneiderten” Mittelfindung gerecht wird, gleichzeitig aber auch strenge methodische und biostatistische Anforderungen erfüllt. Die Studie hat im Herbst 1991 mit der Rekrutierung der Patienten begonnen und wird voraussichtlich 21/2 Jahre dauern. Bei der Publikation der Ergebnisse erwarten wir auf jeden Fall überaus kritische Stimmen; zeigt die Studie die Wirksamkeit der klassischen Homöopathie bei chronischen Kopfschmerzen auf, so wird uns die naturwissenschaftliche Medizin argwöhnish betrachten, andernfalls wird die Homöopathie versucht sein, Gründe für die mangelnde Wirksamkeit im nichthomöopathiegerechten Prozedere darzulegen. Für die statistische Beurteilung der Aussagekraft einer Studie ist es entscheidend, ob die getestete Hypothese a priori formuliert oder nachgeschoben wurde (nachgeschobene Hypothesen sind Fragestellungen, die erst nach teilweiser Einsicht in vorläufige Ergebnisse formuliert werden). Auch Abweichungen vom Studienprotokoll können das Ergebnis beeinflussen. Um dabei “mit offenen Karten zu spielen” publizieren wir das Studienprotokoll jetzt bei Studienbeginn.
Complementary Medicine Research | 1994
Harald Walach; E. Linsenmann; I. Reisenegger
Fragestellung: Untersucht wurde die Langzeitwirksamkeit einer kombinierten komplementarmedizinischen Therapie der atopischen Dermatitis (AD). Untersuchungsdesign:
Schmerz | 1992
W. Gaus; Harald Walach; G. Haag
The efficacy of classic homeopathic therapy is scientifically not well proven. Few of the studies available are acceptable from a scientific point of view. In this paper we will describe a study protocol for a trial of classic homeopathy in chronic headache, which not only is in accordance with currently accepted scientific research standards but also accounts for the special needs of homeopathic therapy. The prescribing practioners are allowed to use any homeopathic drug at any potency or dosage, this enables them to ful fill the homeopathic principle of individuality. At the same time, the study is strictly controlled, randomized and double blind. The prescribing physician sends the homeopathic medication selected for a patient to a notary public, who either forwards it to the patient or substitute placebo, according to the randomization plan. Hence, the trial is not testing a specific drug, but the rationale of individual homeopathic drug selection and the efficacy of the selected drugs in headache patients in general. Patients suffering from chronic headaches for at least 1 year and with headaches at least once a week on average are eligible for the study. Exclusion criteria follow the generally accepted standards and account for the special needs of homeopathic therapy. Data are to be recorded in a patients diary containing the outcome variables occurrence, duration, intensity of headaches and use of analgesic drugs. After a baseline period of at least 6 weeks the first consultation will take place, with the proper remedy selected and sent to the patient via the notary. After 6 weeks a first follow-up will allow the physician to modify the treatment if necessary. After another 6 weeks the final examination will take place. The duration of the homeopathic treatment, then, is 12 weeks. A total of 100 patients in two groups of 50 are to be treated in the study. The study started in the later part of 1991, and is scheduled to last for 2 1/2 years. We expect a critical discussion of the results from conventional medicine or from homeopathy, depending on the outcome of the study. The study protocol is being published in advance to enable the reviewers of the study to check the original study design and the a priori hypotheses adopted.The efficacy of classic homeopathic therapy is scientifically not well proven. Few of the studies available are acceptable from a scientific point of view. In this paper we will describe a study protocol for a trial of classic homeopathy in chronic headache, which not only is in accordance with currently accepted scientific research standards but also accounts for the special needs of homeopathic therapy. The prescribing practioners are allowed to use any homeopathic drug at any potency or dosage, this enables them to ful fill the homeopathic principle of individuality. At the same time, the study is strictly controlled, randomized and double blind. The prescribing physician sends the homeopathic medication selected for a patient to a notary public, who either forwards it to the patient or substitute placebo, according to the randomization plan. Hence, the trial is not testing a specific drug, but the rationale of individual homeopathic drug selection and the efficacy of the selected drugs in headache patients in general. Patients suffering from chronic headaches for at least 1 year and with headaches at least once a week on average are eligible for the study. Exclusion criteria follow the generally accepted standards and account for the special needs of homeopathic therapy. Data are to be recorded in a patients diary containing the outcome variables occurrence, duration, intensity of headaches and use of analgesic drugs. After a baseline period of at least 6 weeks the first consultation will take place, with the proper remedy selected and sent to the patient via the notary. After 6 weeks a first follow-up will allow the physician to modify the treatment if necessary. After another 6 weeks the final examination will take place. The duration of the homeopathic treatment, then, is 12 weeks. A total of 100 patients in two groups of 50 are to be treated in the study. The study started in the later part of 1991, and is scheduled to last for 2 1/2 years. We expect a critical discussion of the results from conventional medicine or from homeopathy, depending on the outcome of the study. The study protocol is being published in advance to enable the reviewers of the study to check the original study design and the a priori hypotheses adopted.ZusammenfassungAus medizinisch-wissenschaftlicher Sicht gibt es bisher keinen methodisch befriedigenden Beweis für die Wirksamkeit der mit Hochpotenzen arbeitenden klassischen Homöopathie. Hochpotenzen enthalten nach naturwissenschaftlichem Verständnis von der Urtinktur und der “Wirksubstanz” kein Molekül mehr. Die Homöopathie beansprucht jedoch eine Arzneimittelwirkung gerade der Hochpotenzen. Im folgenden wird ein Studienprotokoll zum Wirkungsnachweis der klassischen Homöopathie bei chronischen Kopfschmerzen vorgelegt, das einerseits der klassischen Homöopathie mit ihrer auf den einzelnen Patienten “mageschneiderten” Mittelfindung gerecht wird, gleichzeitig aber auch strenge methodische und biostatistische Anforderungen erfüllt. Die Studie hat im Herbst 1991 mit der Rekrutierung der Patienten begonnen und wird voraussichtlich 21/2 Jahre dauern. Bei der Publikation der Ergebnisse erwarten wir auf jeden Fall überaus kritische Stimmen; zeigt die Studie die Wirksamkeit der klassischen Homöopathie bei chronischen Kopfschmerzen auf, so wird uns die naturwissenschaftliche Medizin argwöhnish betrachten, andernfalls wird die Homöopathie versucht sein, Gründe für die mangelnde Wirksamkeit im nichthomöopathiegerechten Prozedere darzulegen. Für die statistische Beurteilung der Aussagekraft einer Studie ist es entscheidend, ob die getestete Hypothese a priori formuliert oder nachgeschoben wurde (nachgeschobene Hypothesen sind Fragestellungen, die erst nach teilweiser Einsicht in vorläufige Ergebnisse formuliert werden). Auch Abweichungen vom Studienprotokoll können das Ergebnis beeinflussen. Um dabei “mit offenen Karten zu spielen” publizieren wir das Studienprotokoll jetzt bei Studienbeginn.
Schmerz | 1996
Harald Walach; G. Haag
ZusammenfassungHomöopathie wird in der Bevölkerung auch und gerade zur Behandlung von Kopfschmerzen immer populärer. Im Gegensatz hierzu steht die mangelnde wissenschaftliche Durchdringung. Wir diskutieren 3 Studien, die zur Effektivität von homöopathischer Therapie bei Migräne und Kopfschmerzen durchgeführt wurden: die italienische und die Londoner Migränestudie und die Münchener Kopfschmerzstudie. Während die erste von geradezu sensationellen Heilungsraten berichtet, konnten die beiden anderen Studien diese Ergebnisse nicht replizieren. Weder die Londoner noch die Münchener Studie fanden Hinweise für einen Unterschied zwischen Homöopathie und Plazebotherapie. Allerdings können beachtenswerte klinische Erfolge auftreten, über deren Zustandekommen wir derzeit wenig wissen. Auch fehlen uns Daten darüber, wie effektiv homöopathische Therapie in der normalen, unkontrollierten Praxis ist.AbstractHomeopathy as an alternative to conventional therapy is becoming increasingly popular. Although interest is rising, little is known about the real effectiveness of homeopathic therapy in headaches. Three studies addressing this question are discussed: an Italian migraine study, the London migraine study and our own, the Munich headache trial. While the first one reported very high effects, the best ones known in the literature, the results of the other two trials do not endorse this first finding. The London trial did not show any effect other than placebo, although a different time trend was reported. The Munich study failed to show any difference between homeopathy and placebo whatsoever. The merits and shortcomings of these studies are discussed. At present, we do not have any evidence that homeopathic therapy has any effect other than a placebo effect. However, this can be very impressive sometimes. We do not know which variables are correlated with placebo effectiveness, and we do not have any data on real-type homeopathy outside a trial setting, as there are no data available.