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Quality Assessment of Physical Research in Homeopathy - Becker-Witt 2003

Quality Assessment of Physical Research in Homeopathy - Becker-Witt 2003

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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINEVolume 9, Number 1, 2003, pp. 113–132© Mary Ann Liebert, Inc.
Quality Assessment of Physical Research in Homeopathy
CLAUDIA BECKER-WITT, M.D.
1
THOROLF E.R. WEIßHUHN,
1
RAINER LÜDTKE, Dipl.-Stat.,
2
and STEFAN N. WILLICH, M.D., M.P.H.
1
ABSTRACTObjectives:
To assess the evidence of published experiments on homeopathic preparations(potencies) that target physical properties (i.e., assumed structural changes in solvents).
Method:
A suitable instrument (the Score for Assessment of Physical Experiments on Home-opathy [SAPEH]) was developed through consensus procedure: a scale with 8 items covering10 criteria, based on the 3 constructs, methodology, presentation, and experiment standardiza-tion.
Reviewed publications:
Written reports providing at least minimal details on physical ex-periments with methods to identify structural changes in solvents were collected. These reportswere scored when they concerned agitated preparations in a dilution less than 10
2
23
, with noother restrictions. We found 44 publications that included 36 experiments (the identity of 2 wasunclear). They were classified into 6 types (dielectric strength, 6; galvanic effects, 5; light ab-sorption, 4; nuclear magnetic resonance [NMR], 18; Raman spectroscopy, 7; black boxes of undis-closed design, 4).
Results:
Most publications were of low quality (SAPEH
,
6), only 6 were of high quality(SAPEH
.
7, including 2 points for adequate controls). These report 3 experiments (1 NMR, 2black boxes), of which 2 claim specific features for homeopathic remedies, as does the onlymedium-quality experiment with sufficient controls.
Conclusions:
Most physical experiments of homeopathic preparations were performed withinadequate controls or had other serious flaws that prevented any meaningful conclusion. Ex-cept for those of high quality, all experiments should be repeated using stricter methodologyand standardization before they are accepted as indications of special features of homeopathicpotencies.
113
INTRODUCTION
I
n most contexts, homeopathy is regarded asan autonomous medical system. During thetwo centuries of its practice it has not been sat-isfactorily evaluated and nor has it been inte-grated into the medical mainstream. Accordingto Anagnostatos and Viras (1992), homeopathicresearch ultimately reduces to one of three fun-damental problems:1. What properties are specific for homeo-pathic remedies?2. Through which mechanism do they affectthe organism? and3. Can therapeutic effects be demonstrated?
1
Institute for Social Medicine, Epidemiology and Health Economics; Charité Hospital, Humboldt University ofBerlin, D-Berlin, Germany.
2
Karl and Veronica Carstens-Foundation, D-Essen, Germany.
 
Biologic effects of homeopathic treatments havebeen demonstrated in calculatory dilutions* be-yond Avogadro’s number (Endler and Schulte,1994; Harisch and Kretschmer, 1990) and withbiochemically active (lower) dilutions. Meta-analyses of clinical studies repeatedly confirmdifferences from placebo (Cucherat et al., 2000;Kleijnen et al., 1991; Linde et al., 1997). But thespecific properties of homeopathic preparations(“potencies” or “dynamizations.” The results ofalternating steps of diluting and mechanicallyagitating a mother tincture) are still poorly un-derstood, and research quality in physical re-search never has been assessed systematically.Biochemical mechanisms cannot entirely ex-plain homeopathic effects, because cures arestill observed in dilutions far beyond 10
2
23
.Contemporary approaches assume physical(i.e., structural) information storage mecha-nisms: changes in the solvent’s structurethat result from the dynamization process,sometimes popularized as “imprints” or “wa-ter memory” (Resch and Gutman, 1986). Longpolymer chains were postulated first (Barnard,1965), followed by molecular associations up tolarge clusters (clathrates) (Anagnostatos et al.,1993; Boiron and Luu, 1981; Conte et al., 1996;Endler and Schulte, 1994; Zhalko-Tytarenkoet al., 1998a,b,c). In search of solvent structuraldifferences, several well-established tech-niques have been applied, mostly Raman spec-troscopy, light absorption spectroscopy (in-frared [IR] visible, ultraviolet [UV]), nuclearmagnetic resonance (NMR), and setups in-volving galvanic effects or dielectric strength.This research is of mixed quality in designand presentation. We thus developed an ob-jective instrument for quality assessment thatis quick and easy to use when more than facevalue and subjective impression of a researchpaper’s weight is required. The instrumentascalehad to meet several demands: adequacyand open declaration of the underlying notionof quality, reliability, capacity to cover ade-quately the totality of its research field; and in-dependence from experimental methods. Thispaper describes how the scale was developedand demonstrates its use in a systematic reviewof experiments on homeopathic preparations(potencies) that target physical properties.
METHODS
Literature
Our systematic review was focused on ex-periments with Raman spectroscopy, light ab-sorption spectroscopy (IR, visible, UV), NMR,and dielectric strength (also when part of amore complex setup or computed deviceoutput). Methods that we considered too in-sensitive (densitometry, refractometry, mi-crocalorimetry, and measurements of ultra-sound speed, surface tension, or conductivity)were excluded. Also methods producinggestalts as output (e.g., crystalization, precipi-tation, schlieren photographs, Kirlian imag-ing), methods with biologic elements in themeasuring chain, and experiments with dilu-tions that were unsuccussed or more than 10
2
23
only (i.e., potencies
$
D23/C12 had to beamong the samples) were not included. Of ex-periments combining several methods only rel-evant parts were scored. All written reporttypes that gave experimental details were in-cluded (but not short announcements or ab-stracts). All languages were allowed.Reports were collected using the followingsources: (1) Searching medical databases MED-LINE
®
and EMBASE covering 1966 to October2001 for the search string “homeopath* and(NMR or raman or dielectric or absorption).”All citations found were screened. (2) The sameprocedure using general scientific databases(Current Contents
®
). (3) A broader search inthe literature database of the Karl and Veron-ica Carstens-Foundation (KVC). (4) Screening
BECKER-WITT ET AL.114
*We use the words “dilution” or “solvent,” in lieu of aterminology for fluids where the probability approacheszero in which molecules of the originally dissolved sub-stance are present.
King G. Experimental Investigations for the Purposeof Scientifical [sic] Provings of the Efficacy of Homeo-pathic Preparations [inaugural dissertation]. Hannover:Tierärztliche Hochschule; 1988.
Majerus M. Critical Examination of the Scientific Evi-dence in Homeopathic Basic Research [in German] [inau-gural dissertation]. Hannover: Tierärztliche Hochschule;1990.
 
of previously published reviews on similar top-ics (Linde et al., 1994; Endler and Schulte, 1994;Jacobi, 1993).
†,‡
(5) Personal information fromhomeopathic researchers and pharmaceuticalcompanies. (6) Screening of identified publica-tions for further citations (iterated). All identi-fied publications were classified according tomeasuring method. Data extractions and qual-ity assessments were done by the same person(C.B.W.), results were discussed with another(T.W.). The respective author’s opinion (statedor implied) of whether the data supported spe-cific properties of potencies was noted. Forpublications with an experimental basis that isseemingly identical or largely overlapping, theexperiment’s assessment is based on the high-est scored paper.
Score for Assessment of PhysicalExperiments on Homeopathy
The overall notion of quality was based onthree fundamental quality constructs, uponwhich the instrument was then built: method-ology, experiment standardization, and pre-sentation. Developing the quality criteria listwas similar to developing other measurementinstruments. The major task was embracingboth covering capacity and method adequacyfor the complete field of physical research inhomeopathy. By consensus procedure we con-densed different perspectives regarding qual-ity assessment and criteria into a short and yetdiscriminatory set of items. An initial pool of17 items came from 4 sources: (1) Methodolog-ical items from existing quality lists for ran-domized clinical trials (Chalmers et al., 1981;Cho and Bero, 1994; Hornung, 1991a,b; Jadadet al., 1996). (2) Material on homeopathic pe-culiarities in research and publication (Al-brecht and Frühwald, 1995; Hornung andLinde, 1991; Linde et al., 1992; Schulte, 1994).(3) Special quality criteria for physical experi-ments that we developed together with experts.(4) Our own criteria for clear presentation. Theinitial item pool was discussed with a numberof experts (epidemiologists, statisticians, andphysicists) and reduced to the 10 most essen-tial items. One statistician and four epidemiol-ogists further refined the item pool into the fi-nal criteria list. They could dismiss or additems. Two items were excluded: correct han-dling of dropouts (irrelevant for physical ex-periments) and structured text (too trivial).Opinions and arguments on each item werescrutinized until consensus on the final scalewas reached. It was named Score for Assess-ment of Physical Experiments on Homeopathy)(SAPEH).
§
Table 1 lists the final SAPEH score,with 8 items covering 10 criteria. Each affirma-
PHYSICAL RESEARCH IN HOMEOPATHY115
T
ABLE
1. T
HE
SAPEH S
CORE
Item Points Criteria
Objectives
P
1 Explicit statement what problem or hypothesis was investigated.Controls
M
Declared 1 Stated use of controls.Adequate
1
1 Succussed or correspondingly potentized solvent.
a
Inadequate
2
1 Not checking contamination, e.g., unsuccussed.Blinding
M
1 Blinding of experimenter/tester.Randomized
M
1 State of the art samples randomization.Consistency
M
1 Similar results in two or more experiments or test series.Experiment Standardization
S
External factors1 External factors affecting results, controlling strategy.Experiment setup1 Sample preparation and measurement devices.Statistics
M
1 Adequate and correct statistical analysis.Results
P
1 Comprehensible presentation of results.
P
Presentation,
M
Methodology,
S
Standardization: Quality constructs built into SAPEH.
a
See text.SAPEH, Score for Assessment of Physical Experiments on Homeopathy.
§
In an earlier German publication (Witt, 2000), we usedthe BEPEV (Beuteilungs-Score für physikalisch-experi-mentelle Versuchsreihen).

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