Showing posts with label placebos. Show all posts
Showing posts with label placebos. Show all posts

Tuesday, May 14, 2013

Homeopathic dilutions - Homöopathische Lösungen

Homeopathy involves a process known by practitioners as "dynamisation" or "potentisation" whereby a substance is diluted with alcohol or distilled water and then vigorously shaken in a process called "succussion". Insoluble solids, such as quartz and oyster shell, are diluted by grinding them with lactose (trituration). The founder of homeopathy, Samuel Hahnemann (1755 — 1843) believed that the process of succussion activated the "vital energy" of the diluted substance,[1] and that successive dilutions increased the "potency" of the remedy.
The idea is considered a pseudoscience, because at common dilutions, no atoms of the original material are likely to remain. It is illogical that a process of dilution would arrive at a higher potency. There is not enough water on earth to produce the highest homeopathic dilutions from one molecule.

Contents

Potency scales

Several potency scales are in use in homeopathy. Hahnemann created the centesimal or "C scale", diluting a substance by a factor of 100 at each stage. The centesimal scale was favored by Hahnemann for most of his life. A 2C dilution requires a substance to be diluted to one part in one hundred, and then some of that diluted solution diluted by a further factor of one hundred. This works out to one part of the original substance in 10,000 parts of the solution.[2] A 6C dilution repeats this process six times, ending up with the original material diluted by a factor of 100−6=10−12. Higher dilutions follow the same pattern. In homeopathy, a solution that is more dilute is described as having a higher potency, and more dilute substances are considered by homeopaths to be stronger and deeper-acting remedies.[3] The end product is often so diluted that it is indistinguishable from the dilutant (pure water, sugar or alcohol).[4][5][6]
Hahnemann advocated 30C dilutions for most purposes (that is, dilution by a factor of 1060).[7] In Hahnemann's time it was reasonable to assume that remedies could be diluted indefinitely, as the concept of the atom or molecule as the smallest possible unit of a chemical substance was just beginning to be recognized. We now know that the greatest dilution that is reasonably likely to contain one molecule of the original substance is 12C, if starting from 1 mole of original substance.
This bottle contains arnica montana (wolf's bane) D6, i.e. the nominal dilution is one part in a million (106).
Some homeopaths developed a decimal scale (D or X), diluting the substance to ten times its original volume each stage. The D or X scale dilution is therefore half that of the same value of the C scale; for example, "12X" is the same level of dilution as "6C". Hahnemann never used this scale but it was very popular throughout the 19th century and still is in Europe. This potency scale appears to have been introduced in the 1830s by the American homeopath, Constantine Hering.[8] In the last ten years of his life, Hahnemann also developed a quintamillesimal (Q) or LM scale diluting the drug 1 part in 50,000 parts of diluent.[9] A given dilution on the Q scale is roughly 2.35 times its designation on the C scale. For example a remedy described as "20Q" has about the same concentration as a "47C" remedy.[10]
Potencies of 1000c and above are usually labelled with Roman numeral M and with the centesimal 'c' indicator implied (since all such high potencies are centesimal dilutions): 1M = 1000c; 10M = 10,000c; CM = 100,000c; LM (which would indicate 50,000c) is typically not used due to confusion with the LM potency scale.
The following table is a synopsis comparing the X and C dilution scales and equating them by equivalent dilution. However, the homeopathic understanding of its principles is not explained by dilution but by "potentisation", hence one can not assume that the different potencies can be equated based on equivalence of dilution factors.
X Scale C Scale Ratio Note
1X 1:10 described as low potency
2X 1C 1:100 called higher potency than 1X by homeopaths
6X 3C 10−6
8X 4C 10−8 allowable concentration of arsenic in U.S. drinking water[11]
12X 6C 10−12
24X 12C 10−24 Has a 60% probability of containing one molecule of original material if one mole of the original substance was used.
26X 13C 10−26 If pure water was used as the diluent, no molecules of the original solution remain in the water.
60X 30C 10−60 Dilution advocated by Hahnemann for most purposes: on average, this would require giving two billion doses per second to six billion people for 4 billion years to deliver a single molecule of the original material to any patient.
400X 200C 10−400 Dilution of popular homeopathic flu remedy Oscillococcinum
Note: the "X scale" is also called "D scale". 1X = 1D, 2X = 2D, etc.

The problem of homeopathic dilution

Serial dilution of a solution results, after each dilution step, in fewer molecules of the original substance per litre of solution. Eventually, a solution will be diluted beyond any likelihood of finding a single molecule of the original substance in a litre of the total dilution product.

The molar limit

If one begins with a solution of 1 mol/L of a substance, the 10-fold dilution required to reduce the number of molecules to less than one per litre is 1 part in 1×1024 (24X or 12C) since:
6.02×1023/1×1024 = 0.6 molecules per litre
Homeopathic dilutions beyond this limit (equivalent to approximately 12C) are unlikely to contain a single molecule of the original substance and lower dilutions contain no detectable amount. ISO 3696 (Water for analytical laboratory use) specifies a purity of ten parts per billion, or 10×10−9 - this water cannot be kept in glass or plastic containers as they leach impurities into the water, and glassware must be washed with hydrofluoric acid before use. Ten parts per billion is equivalent to a homeopathic dilution of 4C.

Analogies

Critics and advocates of homeopathy alike commonly attempt to illustrate the dilutions involved in homeopathy with analogies. The high dilutions characteristically used are often considered to be the most controversial and implausible aspect of homeopathy.

1 bottle of poison in Lake Geneva

Hahnemann is reported[by whom?] to have joked that a suitable procedure to deal with an epidemic would be to empty a bottle of poison into Lake Geneva, if it could be shaken 60 times.[citation needed]

1 Pinch of salt in the Atlantic Ocean

One example given is that 12C solution is equivalent to a "pinch of salt in both the North and South Atlantic Oceans", which is approximately correct.[12]

1/3 of a drop in all the waters of the Earth

One third of a drop of some original substance diluted into all the water on earth would produce a remedy with a concentration of about 13C.[13][14]

Duck liver 200C in the entire observable Universe

A popular homeopathic treatment for the flu is a 200C dilution of duck liver, marketed under the name Oscillococcinum. As there are only about 1080 atoms in the entire observable universe, a dilution of one molecule in the observable universe would be about 40C. Oscillococcinum would thus require 10320 more universes to simply have one molecule in the final substance.[15]

Swimming pool

Another illustration of dilutions used in common homeopathic remedies involves comparing a homeopathic dilution to dissolving the therapeutic substance in a swimming pool.[16][17]
One example, inspired by a problem found in a set of popular algebra textbooks, states that there are on the order of 1032 molecules of water in an Olympic-size swimming pool[18] and if such a pool were filled with a 15C homeopathic remedy, to have a 63% chance of consuming at least one molecule of the original substance, one would need to swallow 1% of the volume of such a pool, or roughly 25 metric tons of water.[19][20][21]

30C: 1 ml in 1,191,016 cubic light years

Yet another illustration: 1 ml of a solution which has gone through a 30C dilution is mathematically equivalent to 1 ml diluted into 1054 m3 - a cube of water measuring 1,000,000,000,000,000,000  (1018) metres per side, which is about 106 light years. When spherical, then it would be a ball of 131.1 light years in diameter. Thus, homeopathic remedies of standard potencies contain, almost certainly, only water (or alcohol, as well as sugar and other nontherapeutic ingredients).

Proposed explanations

Homeopaths maintain that this water retains some "essential property" of the original material, because the preparation has been shaken after each dilution.[22] Hahnemann believed that the dynamisation or shaking of the solution caused a "spirit-like" healing force to be released from within the substance. Even though the homeopathic remedies are often extremely diluted, homeopaths maintain that a healing force is retained by these homeopathic preparations.[21]

Dilution debate

Not all homeopaths advocate extremely high dilutions. Many of the early homeopaths were originally doctors and generally used lower dilutions such as "3X" or "6X", rarely going beyond "12X". The split between lower and higher dilutions followed ideological lines. Those favoring low dilutions stressed pathology and a strong link to conventional medicine, while those favoring high dilutions emphasised vital force, miasms and a spiritual interpretation of disease.[23][24] Some products with both low and high dilutions continue to be sold, but like their counterparts, they have not been conclusively demonstrated to have any effect beyond the placebo effect.[25][26]

See also

References
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http://curanderomatasanos.blogspot.com/2013/05/homoopathie-die-irrlehre.html
Potenzierung
Hauptartikel: Potenzieren (Homöopathie) Ein weiterer Grundsatz der Homöopathie ist die Verwendung „potenzierter“ Mittel. Unter Potenzierung ist die starke Verdünnung bei gleichzeitiger „Dynamisierung“ (Verschüttelung oder Verreibung siehe unten) zu verstehen. Die Mittel werden durch stufenweise durchgeführtes Potenzieren aus „Urtinkturen“ (pflanzlichen und tierischen Ursprungs: Symbol: Ø oder mineralischen und chemischen Ursprungs: Symbol O) und aus Verdünnungsmitteln wie Ethanol, destilliertem Wasser, Glycerin und Milchzucker hergestellt. Homöopathische Mittel werden flüssig (Dilution) oder als Globuli, in tiefen Potenzen auch in Form von Tabletten angewendet.[19]
Hahnemann führte die Potenzierung um 1798 ein.[44] Nach seinen Anweisungen wurden Homöopathika in Hunderterschritten potenziert („C-Potenzen“). Das heute gebräuchlichere Dezimalsystem zur Potenzierung und Bezeichnung der Potenzen, z. B. D10, wurde vom Heilpraktiker und späteren Arzt Arthur Lutze entwickelt und von Constantin Hering in die Behandlung eingeführt.[45][46]
Aus der Sicht der Homöopathen ist die Wirkung einer bloßen Verdünnung nicht mit der eines potenzierten, also verschüttelten oder verriebenen Mittels vergleichbar. Schon im Organon der Heilkunst (Anmerkung zu § 11) wurde die Wirkung eines potenzierten Mittels nicht der körperlichen Substanz oder physischen Wirkung eines Arzneistoffes, sondern einer immateriellen, daraus freigewordenen „spezifischen Arzneikraft“ zugeschrieben.[47] Homöopathen, die sogenannte Hochpotenzen anwenden, nehmen an, bei der Potenzierung, auch Dynamisierung genannt, werde durch die Energiezufuhr beim Verschütteln oder Verreiben eine Information an das Lösungsmittel abgegeben und bei jedem Potenzierungsschritt verstärkt, auch wenn keine Moleküle des Arzneimittels mehr in der Lösung vorhanden sind.[48][49] Es existieren keine Belege für die Existenz der postulierten immateriellen Energiezufuhr durch die rituellen mechanischen Prozeduren. Die mit dieser Methode hergestellten Lösungen unterscheiden sich nicht von einfach nur verdünnten Lösungen.[27]
Die Verdünnung unter die chemische Auflösungsgrenze (ab D23 – siehe auch Avogadro-Konstante) ist kein zwingendes Element der Homöopathie. Viele Heilpraktiker und einige Ärzte arbeiten in Deutschland auch mit den Verdünnungen 1:10.000 und 1:1.000.000 (D4 und D6), in denen die Stoffe noch in nennenswerter Konzentration vorliegen. Bei diesen nur schwach verdünnten Mitteln sind die regulären Dosis-Wirkungs-Beziehungen des verwendeten Stoffes zu beachten und diverse Wirkungen möglich. Neben der bekanntesten D-Potenzierungsreihe (1:10) gibt es noch die C-Reihe (1:100), die M (1:1000) und die LM- oder Q-Reihe (1:50.000).
Die Fluxionspotenzierung nach Dellmour ist eine Sonderform der flüssigen Potenzierung, die ohne Verschütteln erfolgt. Durch Turbulenzen der zuzufügenden Flüssigkeit bei der Zugabe ins Potenzierungsgefäß soll das Verschütteln unnötig sein. Jedoch sei der Dynamisierungseffekt geringer, so dass sehr hohe Potenzgrade hergestellt werden müssten.[46]
Bei der K-Potenzierung nach Semjon Nikolajewitsch Korsakow, einem russischen Homöopathen, erfolgt die Potenzierung vereinfacht in nur einem Glas. Die Methode wurde zwar nicht in das Homöopathische Arzneimittelbuch (HAB) aufgenommen, dennoch stellen einige Firmen aus Zeit- und Kostengründen Hochpotenzen nach dieser Methode her.[46]
Aus Sicht einiger heutiger Homöopathen müsse man eine „Schwache Quantentheorie“ zur Erklärung der Homöopathie heranziehen.[50][51] Dabei wird das Phänomen der Verschränkung jedoch ohne klare mathematische Definition auf grundlegend verschiedene Systeme wie ein homöopathisches Mittel und Krankheitssymptome angewandt; die extrem leichte Zerstörbarkeit verschränkter Zustände wird nicht berücksichtigt.[52]
Als Versuch der Erklärung eines „Gedächtniseffekts von Wasser“ werden von einigen Homöopathen strukturelle Veränderung am Wasser als Lösungsmittel angeführt.[53] Diese Gedächtnisfunktion ist jedoch, selbst nach Ansicht von anderen Vertretern der Homöopathie, nicht mit den Kenntnissen über Wasser vereinbar.[54]
D Skala C Skala Verdünnung / Mischung Bemerkungen
Ø/O Ø/O 1:1
  • Urtinktur, unverdünnt
  • Ungiftige Urtinkturen, etwa von Calendula officinalis, sind apothekenpflichtig, aber frei erhältlich.[55]
D1 1:10
1:101
  • Niedrigpotenzen von Giften wie Quecksilber (Mercurius solubilis), Tollkirsche (Belladonna), Salzsäure (Muriaticum acidum) usw. sind toxisch. So kann beispielsweise das vor allem in der Laienhomöopathie als D6 oder D12 verwendete Arsen(III)-oxid (Arsenicum album) in der Dosierung von 1 g der D1-Lösung tödlich sein.[56]
D2 C1 1:100
1:102

D4 C2 1:10.000
1:104
  • Entspricht im Volumen ca. einem Tropfen auf einen halben Liter Lösungsmittel.
  • Bei auf D4 verdünnten Giften können Vergiftungserscheinungen auftreten. Beispielsweise führt Arsenicum album D4, 3 mal täglich 5 Tropfen über Wochen aufgenommen, zu chronischen Vergiftungserscheinungen.[57]
D6 C3 1:1.000.000
1:106
D8 C4 1:100.000.000
1:108
  • Entspricht etwa einem Tropfen auf 50 m3 Lösungsmittel
  • Grenzwert beispielsweise von Arsen im Trinkwasser. Ab dieser Konzentration sind auch bei langfristigem Konsum keine Gesundheitsrisiken zu erwarten.[61]
D24 C12 1:1024
  • Entspräche etwa einem Tropfen im Volumen des Atlantiks
  • Bei dieser Potenz enthalten in einem idealisierenden Gedankenexperiment nur etwa 50 % aller Lösungen ein Molekül einer einmolarigen Urtinktur; dementsprechend wird ab hier kaum mehr verdünnt, sondern nur noch Lösungsmittel mit Lösungsmittel gemischt.
D60 C30 1:1060
  • Hier wäre weniger als ein Tropfen in mehreren Erdvolumina vorhanden.[62]
  • Von Hahnemann bevorzugte und für die Arzneimittelprüfungen empfohlene Potenz. Hochpotenzen von Belladonna haben bei homöopathischen Arzneimittelprüfungen keinen Unterschied zu Placebos ergeben.[63]
D1000 C500 1:101.000
  • Höchste üblicherweise lieferbare D-Potenz[64]
C1000 1:102.000
  • Höchste üblicherweise lieferbare C-Potenz[64]
Legende: grün = Niedrigpotenzen die eine toxikologische oder pharmakologische Wirkung besitzen können; gelb = Die Potenzierung und chemische Wirksamkeit stößt an die chemisch-physikalischen Grenzen; rosa = Hochpotenzen. Potenzierungen in diesem Bereich überschreiten die chemischen und physikalischen Möglichkeiten.

Oscillococcinum, para la influenza de tontos


One dose (one gram) of Oscillococcinum
Oscillococcinum (commonly shortened to Oscillo[1]) is a homeopathic alternative medicine marketed to relieve influenza-like symptoms. It is a popular homeopathic preparation, particularly in France. Oscillococcinum is manufactured by a French company, Boiron, its sole manufacturer. There are, however, other manufacturers who make similar preparations. Oscillococcinum is used in more than 50 countries. In France, it has been in production for over 65 years.
The preparation is derived from duck liver and heart, diluted to 200C—a ratio of one part duck offal to 10400 parts water.[2] This is such a high dilution that the final product likely contains not a single molecule of the original liver. Homeopaths claim that the molecules leave an "imprint" in the dilution that causes a healing effect on the body, although there is no evidence that supports this mechanism or efficacy beyond placebo.[3][4][5]
A class action lawsuit on behalf of customers who purchased Oscillococcinum was filed against Boiron in the United States, alleging that Boiron falsely advertises that Oscillo has the ability to cure the flu; Boiron settled the case for $2million.[6][7]

Contents

Origin and history

The word Oscillococcinum was coined in 1925 by the French physician Joseph Roy (1891–1978) who saw military duty during the Spanish Flu epidemic of 1917.[2] Roy wrote that on examining the blood of flu victims, he had observed an oscillating bacterium which he named Oscillococcus.[8]
Roy claimed he had detected it in the blood of patients that had several viral diseases like herpes, chicken pox and shingles.[8] He thought that this bacterium was the causative agent of diseases as varied as eczema, rheumatism, tuberculosis, measles, and cancer. Believing he had detected it in the blood of cancer patients, he tried a vaccine-like therapy on them, which was unsuccessful.[8] Medical science has since disproved Roy's theory: rheumatism, for example, is not caused by bacteria, and measles is caused by a virus far too small for Roy to have observed in his optical microscope.[2]
The oscillococcus bacterium has never been independently observed.[9]
He searched for the "bacterium" in several animals until he felt that he had found it on the liver of the Long Island duckling.[8] The modern preparation is created from the heart and liver of Muscovy Duck (see the preparation section for the details).
In France the selling of all products manufactured according to the Korsakovian principle of dilution was forbidden until 1992, with the exception of Oscillo, thanks to a special measure made for it.[8] As of 2000 Oscillococcinum was one of the top ten selling drugs in France, was publicised widely in the media, and was being prescribed for both flu and cold.[8] As of 2008 it sells US$15 million per year in the U.S., and it also sells widely in Europe.[10]

Preparation

The ingredients of a one gram tube of Oscillococcinum are listed as:
  • Active ingredient: Anas Barbariae Hepatis et Cordis Extractum (extract of Muscovy Duck liver and heart) 200CK HPUS 1×10−400 g[10]
  • Inactive ingredient: 0.85 g sucrose, 0.15 g lactose (100% sugar.[11])
The 200CK indicates that the preparation entails a series of 200 dilutions of the starting ingredient, an extract from the heart and liver of a Muscovy Duck.[10] Each step entails a 1:100 dilution, where the first mixture contains 1% of the extract, the second contains 1% of the first mixture, etc.[10] The K indicates that it is prepared by the Korsakovian method, in which rather than 1% of the preparation being measured out at each stage and then diluted, a single vessel is repeatedly emptied, refilled, and vigorously shaken (in homeopathic terminology "succussed"), and it is assumed that 1% remains in the vessel each time.[12] The 200C dilution is so extreme that the final pill contains none of the original material.[10][13] Mathematically, in order to have a reasonable chance to obtain one molecule of the original extract, the patient would have to consume an amount of the remedy roughly 10321 times the number of atoms in the observable universe.
In the United States, under the 1938 Federal Food, Drug, and Cosmetic Act, only those substances listed in the Homeopathic Pharmacopeia of the United States (HPUS) and prepared according to the guidelines therein may be marketed as homeopathic. Only preparations of Oscillococcinum made according to those guidelines may be thus labeled. "A product's compliance with the requirements of the HPUS, USP, or NF does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."[14]
Oscillococcinum is generally considered harmless. When Boiron's spokeswoman Gina Casey was asked if a product made from the heart and liver of a duck was safe, she replied: "Of course it is safe. There's nothing in it."[11]

Efficacy

There is no scientific evidence that Oscillococcinum has any effect beyond placebo. None of its active ingredient is present in a dose of the final product, nor is there any credible evidence that duck liver is effective in relieving flu symptoms in the first place. Homeopaths claim the diluted molecules leave an "imprint" in the remedy, but there is no known mechanism for how this could occur.[10][15] Homeopathy as a whole is considered to be pseudoscience.[16]
Since it is used for the relief of symptoms of flu, a disease that goes away on its own in a variable number of days, the best it could do is shorten the duration of those symptoms. If one takes any medication and one's flu goes away, then it is easy to attribute this to the medication; however, the infection would have resolved anyway.[10] Someone who gets over a mild strain of flu will attribute the mildness to the efficacy of the homeopathic preparation and not to the fact that it was a mild strain, and will recommend it to other people, spreading its popularity.[10] Also, the most likely explanation for its effectiveness with flu symptoms is that patients are misdiagnosing the symptoms of several rhinovirus diseases or of allergies to several hundred substances, and attributing them to a flu infection that they do not have.[10]
A 2002 review says that the evidence for Oscillococcinum's effectiveness concludes that no homeopathic preparation is relevantly different from placebo or superior to other treatments.[3] A 2003 review from the U.S.'s National Institutes of Health found that, in general, systematic reviews of homeopathic preparations have not found homeopathy to be a definitively proven treatment for any medical condition.[5] A 2005 review of flu treatments (vaccine, medicine, homeopathy) has concluded that the popularity of Oscillococcinum in France was unsupported by the current evidence as to its efficacy.[17] In a 2007 review, the effectiveness of non-mainstream remedies against seasonal flu could not be established beyond reasonable doubt, and the evidence is found to be sparse and limited by "small sample sizes, low methodological quality, or clinically irrelevant effect sizes", and that the results strengthen using conventional approaches for flu.[4]
A Cochrane review published in December 2012 found that there was insufficient evidence to make a robust conclusion about whether Oscillococcinum is effective for the prevention or treatment of influenza.[18]

Criticisms of marketing

The non-profit, educational organizations Center for Inquiry (CFI) and the associated Committee for Skeptical Inquiry (CSI) have petitioned the U.S. Food and Drug Administration (FDA), criticizing Boiron for misleading labeling and advertising of Oscillococcinum. "One petition complains that Boiron’s packaging for Oscillococcinum lists the alleged active ingredient – duck liver and heart – in Latin only. Another petition complains that Boiron’s web ad for this product implies that it has received FDA approval." Ronald Lindsay, CFI and CSI president and chief executive officer, contends, "If Boiron is going to sell snake oil, the least they can do is use English on their labels.[19]
A class action lawsuit has been filed against Boiron on behalf of "all California residents who purchased Oscillo at any time within the past four years." The lawsuit charges that Boiron "falsely advertises that Oscillo has the ability to cure the flu because it contains an active ingredient it claims is proven to get rid of flu symptoms in 48 hours." The lawsuit also states that the listed active ingredient in Oscillococcinum (Oscillo) "is actually Muscovy Duck Liver and Heart...and has no known medicinal quality."[20] A settlement was reached, with Boiron denying any wrongdoing. As part of the settlement, Boiron has agreed to make specific changes to its marketing.[21] These changes include adding to their packaging notices like "These ‘Uses’ have not been evaluated by the Food and Drug Administration" and "C, K, CK, and X are homeopathic dilutions."[22]

References