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| Info Symposion |
An interim statement after a meeting of placebo specialists at
Eggeland-Hospital Bad Driburg, Germany; Friday 13.6 - Sunday 15.6.1997 "The Problem of Placebo and therapeutic effectiveness" or the "Hunger for healing enigma"10 Hypotheses MOMBURG, M. (Eggeland-hospital Bad Driburg);
G.FISCHER (Department of Primary care at the University of Hannover; Germany)
Chapter 1: Introduction The terms placebo, nocebo, placebo effect, placebo phenomenon, placebo medicine have a
considerable role to play in the present discussion about reduction of costs in Health
Care. In spite of their very high practical importance placebo phenomena do not play a part in the education of medical students and are no systematic subject of discussion in medical science. In order to achieve a better understanding of the phenomenology of placebo effects in
therapeutic relationships and to maximalise the outcome of student´s education in general
practice, we (the Director of the Eggeland-Hospital and the Department of Primary Care,
University of Hannover, Germany) organized a project "Placebo and Nocebo: effects and
phenomena in general practice". Chapter 2: Methods The methods used to produce the following results were:
The specialist interviews were carried using the method of
"qualitative-empirical-social investigation" and a modified
"Delphi-technique". From September 1996 till March 1997 19 specialists of placebo (see appendix) in Germany, Austria and Switzerland were visited by the author and conversations based on a structured interview with standardized questions were carried out.
These specialists were identified by publications, letters and papers in medical science. They have worked on the therapeutic effectiveness and the efficacy of therapeutic methods in conventional, complementary medicine and psychotherapy from different standpoints (see appendix). The interview time ranged from 1 ½ to 10 hr per conversation. Every interview was then evaluated sentence by sentence according to statements about definitions, theories, opinions on the subject "specific or nonspecific effects, scientific works for solving the placebo problem in future, opinions on the role of placebo effects in the different medical methods, training for understanding the placebo-effects in the education of medical students. The statements in these subsections were arranged into comparison groups of medical fields such as internal medicine, psychiatry, molecular biochemistry, methodology of outcome etc. to establish whether there may be a connection between theory and specific medical professions. In this manner, material resulted for evaluation from approximately 800 typewritten
pages. Chapter 3: Results First results of this project will be shown in this article.The opinions, statements and presumptions were matched with references found via the specialists, throug Medline, in medical journals and tested for plausibility. 3.1) During the systematical check and classification of publications about the placebo subject we have found two emotionally split fractions.:
Summarized the following Synopsis of different or similar theories for the placebo
phenomena were found: 3.2) From the specialist interviews, unambiguous, valid and distinct statements for the definitions of placebo terms were not derived, even though the phrases most frequently used were similar to the classical definitions of Shapiro or Brody [1].
However, the ambiguous definitions are understandable in connection with the used theories. The position of the specialist in the field of medicine apparently seemed to determine his point of view. The definition of placebo terms can also result from further clarification in the sense of an inductive philosophical procedure. Many misunderstandings, which are a result of the placebo problem, derived from determined definitions of the terms according to the principle: "What can not be, must not be"
3.3) Evaluation of the dimension of the placebo effects in different
medical fields. Chapter 4: Consequences 1.Hypothesis An arrangement system then results from the idea that specific aspects in papers, determine connected"spaces", in which placebo phenomena occur:
These limiting conditions implied the existence of the placebo effects and were scrutinized in concrete scientific papers [2]. 2.Hypothesis: My idea was to extract phenomena of placebo and nocebo independently from the definition of the placebo terms and to use an optimized overall view, which may be possible in a healing environment with the aim:
And in almost exactly the same way to look for extremely negative points in medical situations with the aim:
As for routine reality in therapeutic relationships, parts of both effects, placebo and nocebo principles are always present. The therapeutic effectiveness and the efficiency result is like the integral calculation of the positive and negative effects on an individual base of both, the patient and the therapist! In the diagrams " Placebophenomena and therapeutic effects A-D" the terms given are divided into the fields explained above (or below!): What is accumulated under the term Placebophenomena:
3.Hypothesis: The nocebo effects become clear by giving the terms of placebo-phenomena a negative
sign indicating the opposite: ( e.g.: inaccurate information instead of precise
information or illness profit instead of compensation for illness)
4. Hypothesis
Therefore "spontaneous healing" can not be seen as a part of the placebo effect. The emergent potential of the placebo principle becomes reality in the case of symptoms, which indicate a feared illness.
5. Hypothesis:
Consequences: These unidentifiable effects may only be evaluated by comparison with
an untreated group. From the view of an individual, sick feeling person these medical science results are
without any relevance, because he feels that very different methods could be effective, if
the therapist, the relationship and the surroundings are optimized. 6.Hypothesis That would be more essential for the progress of medicine than pseudo-scientific trials
on the level of nominalism with psychological, reductionist, introjectionist
materialisation, which hides itself frequently behind the name "natural scientific
orientated medicine" (Schmitz; Neue Phänomenologie)
Diagram 3: Inner world and reduced body 7. Hypothesis This is an expression of an evolutionary developed and constantly functionable
possibility for repairing and protection to effect 1) language information, (possibly one word = the "Flash" of Balint as a
positive result at that moment),
They all use the concealed placebo principle. On each level, from the cell to the social communities, the complexity and the possibilities of healing processes increase, but also the risk of negative effects. So on the one hand we can understand healing effects and on the other it is an aid for understanding an unsuccessful attempt of healing, which results in a new illness. This instead is an alarm signal in the sense of the need for early diagnosis for the social community.
Diagram 4: An example: Nocebo phenomenon in the therapeutic situation All conditions for therapeutic effectiveness look optimized, but anxiety inducing information e.g.a. misleading description about side-effects leads to NON-compliance. 8.Hypothesis Then the phenomenology of the placebo principle, e.g. the positive thinking self-deception or the belief in the therapeutic myth can induce the "healing effect" by autosuggestion using unknown psychophysical ways. We can call this a structural gain, which increases the self-effectiveness. That could be similar to the breathlessness of an allergic asthma patient, who cannot understand, that his damaged biological system tries to protect him against further intoxication by an allergic substance. After a few years the result is, that the allergic substance is no longer necessary, because the asthma illness has become fixed. A positive protecting system changes into an autoaggressive, uncontrolled system, which we diagnose as a disease. (The connection of these mechanisms with the process of homeostasis in biological systems can be seen in the very strong emotional conflicts between mainstream medicine and complementary medicine.) 9. Hypothesis Interestingly this explanation of the placebo phenomena might be confirmed through the similarity of the theories for understanding phenomena such as "hunger and thirst", "pain and lust (desire)", which concern the mechanisms of expectancy, learning, conditioning and biochemical neurotransmitters. 10. Hypothesis The "good-enough" mother gives the first chance for development, when she begins to separate herself for a short time. The infant who, up to this point, has been living in a so called "primary complex," needs a substitute mother in order to bear this separation. This takes the form of an object e.g.a. soft toy like a teddy-bear, a blanket, or some other objects of comfort. Winnicott called such an object "transitional object". The "transitional object" remains as a stable principle and is necessary for regression, which is the requirement for the possibility of the so-called "Integrated placebo/nocebo principle" entering into a therapeutic relationship. So the prescription, the remedies or the emotions or the attitude of the therapist are
symbols for the transitional object. This means: The therapeutic relationship uses the
"motherliness" of the therapists. The fatherliness of the therapists can be
engaged, when guidance and careful detailed information is given.
MOMBURG M.: Eggeland-hospital, 33014 Bad Driburg, Germany, Bahnhofstraße 1 Specialist interviews:
Literature of the placebo-specialists: Caspar, F.: Im Streit um die richtige Sicht in der Wirksamkeitsforschung; Psychotherapie Forum 1 (1993) 96-99 Caspar, F.; Th. Rothenflush; Z. Segal: The Appeal of Connectionism for Clinical Psychology; Clinical Psychology Review 12 (1992) 719-762 Engelhardt, K.: Plazebos, Alternative Medizin und die Arzt-Patient-Beziehung; in Feiereis, H.; R. Saller (ed.): Psychosomatische Medizin und Psychotherapie, Hans Marseille Verlag München (1995) 199-209 Ernst, E.; K.L.Resch: The science and art of the placebo-effect; Current therapeutics (1994) 619-621 Ernst, E.; K.L.Resch: Concept of true and perceived placebo effects; BMJ 311 (1995) 551-553 Fahrländer, H.; P. Truog: Plazebowirkung und Alternativmedizin. Internistische Praxis 4 (1990) 763-772 Fahrländer, H.: Die Placebowirkung; Therapiewoche Schweiz 9 (1993) 569-572 Flick, U.: Qualitative Forschung - Theorie, Methoden, Anwendung in Psychologie und Sozialwissenschaften; rowohlts enzyklopädie (1995) 109-110 Habermann, E.: Wappen schlägt Zahl: Die biologische Grundlage des Placebo und Nocebo; Futura 3 (1996) 179-188 Kiene,H.: Komplementärmedizin - Schulmedizin. Der Wissenschaftsstreit am Ende des 20.Jahrhunderts. (2.,durchgesehene und erweiterte Auflage). Schattauer Stuttgart Kiene, H. : Kritik der klinischen Doppelblindstudie. (1993) MMV Medizin Verlag München Kiene, H.; M.Kalisch: Wissenschaftliche Dogmen bei der Nachzulassung von Arzneimitteln. Deutsche Apotheker Zeitung 136 Jahrg. Nr 28 (1996) 17-22 Kienle, G.S.: Der sogenannte Placeboeffekt - Illusion, Fakten, Realität, (1995) Schattauer Stuttgart Kienle, G.; H. Kienle: Placeboeffekt und Placebokonzept - eine kritische methodologische konzeptionelle Analyse von Angaben zum Ausmaß des Placeboeffekts. Forschende Komplementärmedizin 3 (1996) 121-138 Kofler, W: Toxikopie: Placebo im Umweltbereich - Wissenschaftstheoretische Konsequenzen aus erfahrungswissenschaftIichen Tatsachen in : Stacher, A.: Placebo und Placebophänomen Facultas Wien (1995) 100-148 Langer, G.: Placebo, Placebophänomen und Aura curae: Eine kritische Erörterung. in Stacher, A.: Placebo und Placebophänomen. Facultas Wien (1995) 21-31 Langer, G.: Principia Medica humana unter besonderer Berücksichtigung von Placebo, Arzt-Patient-Beziehung und Compliance; Vortrag am 9.3.1997 an der Wiener Akademie für Ganzheitsmedizin Meißel, Th.: Die Bedeutung und Funktion des Placebo aus psychoanalytischer Sicht. in Stacher, A.: Placebo und Placebophänomen. Facultas (1995) 71-99 Meißel, Th.: Placebo, Compliance und der Traum von Irmas Injektion; Edition pro mente Linz (1996) Oepen, I.: Zur rechtlichen Beurteilung paramedizinischer Heilverfahren. Versicherungsmedizin 44 (1992) (23-29) Oepen, I.:Besondere Therapierichtungen, Gleichberechtigung neben der Schulmedizin?. Deutsche Apotheker Zeitung 134.Jg. 32 ( 1994) 42-53 Oepen, I.; O. Prokop: Außenseitermethoden in der Medizin. Wissenschaftliche Buchgesellschaft (1994) Oepen, I.: Das Problem der unkonventionellen medizinischen Methoden - dargestellt am Beispiel der "besonderen Therapierichtungen". Z.f.Gesundheitswiss. 3 (1995) 111-129 Pirlet, K.: Die Heilkraft der Natur - Ein Ausleseprozeß auf protein-molekularer Ebene; Erfahrungsheilkunde 11 (1996) 848-858 Pletscher, A.: Alternativmedizin: Glaube oder Wissenschaft? Internistische Praxis 1 (1991) 149-161 Schaefer, H.: Was heißt Heilen? Die Bedeutung der spezifischen und der unspezifische Therapie. in Oepen, I. (ed.): An den Grenzen der Schulmedizin. Dtsch.Ärzte-Verlag (1985) 363-375 Schaefer, H.: Das Prinzip Psychosomatik. Verlag für Medizin Dr. Ewald Fischer (1990) Schaefer, H.: Die wissenschaftliche Medizin zwischen Mystik und Materialismus. In Köbberling, J.: (ed.) Die Wissenschaft in der Medizin. Schattauer Stuttgart (1993) 15-26 Schaefer, H.: Altern und Sterben - Gedanken zu statistischen Zahlen. Z Gerontol Geriat 28 (1995) 285-292 Schaefer, H.: Schwache Wirkungen als Cofaktoren bei der Entstehung von Krankheiten. Springer Verlag Berlin (1996) Schmitz, H.: Thesen zur phänomenologisch-philosophischen Fundierung der Psychotherapie in: Kühn, R.; H. Petzold: Psychotherapie & Philosophie - Philosophie als Psychotherapie?; Junfermann Verlag Paderborn (1992) Schmitz, H.: Leib und Gefühl - Materialien zu einer philosophischen Therapeutik Junfermann Verlag Paderborn (1989) Schmitz, H.: Der gespürte Leib und der vorgestellte Körper; in: Großheim M.(ed.): Wege zu einer volleren Realität - Neue Phänomenologie in der Diskussion; Akademie Verlag Berlin (1994) 75-91 Schmitz, H.: Der Placebo-Effekt im Licht der Neuen Phänomenologie, Veröffentlichung in Vorbereitung Schonauer, K.: Das Plazebo-Problem; in Bühring, M.; F.H. Kemper (ed): Naturheilkunde; Springer Berlin (1994) Loseblattsammlung, unveröffentliches Manuskript Schonauer, K.: Semiotic Foundations of Drug Therapy-The Placeboproblem in a New Perspective, Mounton de Gruyter, Berlin (1994) Uexküll von, T.: Das Placebo-Phänomen. In: Adler, R. H.; J. M. Herrmann, K. Köhle, O. W. Schonecke, Th. von Uexküll, W. Wesiak: Psychosomatische Medizin. Urban und Schwarzenberg, München-Wien-Baltimore (1996) 363-369 Walach, H.: Homöopathie - Heilung mit Nichts? Psychologie heute (9/1993) 40-49 Walach, H.: Which Placebo to Use? The Problem of Using a Proper Placebo for High Dilution and succussion Studies. The Berlin Journal on Research in Homoeopathy 1, Vol. 1, No. 3 (1991) 174 Walach, H.: Wissenschaftliche homöopathische Arzneimittelprüfung-Doppelblinde Crossover-Studie einer homöopathischen Hochpotenz gegen Placebo; Haug (1993)Wirsching, M.; L. Frölich; W. Georg; B. Haas; F. Hoffmann; J. Riehl; G. Schmidt; P. Schmidt; H. Stierlin; B. Wirsching: Krebs im Kontext. Patient, Familie und Behandlungssystem. Klett-Cotta Stuttgart (1988) Wirsching,M.: Psychosomatische Medizin. Konzepte- Krankheitsbilder- Therapien.
Verlag C.H. Beck München (1996) |
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| [1] SHAPIRO et al.
1978: "1) A placebo is defined as any therapy or component of therapy that is
deliberately used for its nonspecific, psychological, or psychophysiological effect, or
that is used for its presumed specific effect, but is without specific activity for the
condition being treated. 2) A placebo, when used as a control in experimental studies, is defined as a substance or procedure that is without specific activity for the condition being studied. 3) A placebo effect is defined as the psychological or psychophysiological effect produced by placebos". BRODY 1980: " A placebo is: 1) a form of medical therapy, or an intervention designed to simulate medical therapy, that at the time of use is believed not to be a specific therapy for the condition, for which it is offered and that is used either for its psychological effect or to eliminate observer bias in an experimental setting. 2) (by extension from 1) a form of medical therapy now believed to be inefficacious, though believed efficacious at the time of use." [2] Roberts A.H. et al: The power of
nonspecific effects in healing: Implications for psychosocial and biological treatments;
Clinical Psychology Review 13 (1993) 375-391
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