Health insurance companies, public bodies and
courts have adopted the view that only randomised
double-blind studies are scientific proof of the
efficacy of a medical procedure. The supposed
‘placebo effect’ is also used as a way of discrediting
as ineffective in principle any methods which
do not involve conventional medicine. This is a
step too far for one of the most prominent lawyers
in the pharmacology industry. He writes in the
German medical journal ärzteblatt:
“A doctor’s opinion is no longer worth anything
… The authorities are increasingly turning
to policy recommendations … Medicine
has been reduced to natural science … The
randomised double-blind study is being used
in an increasingly restrictive manner.”
The focus on randomised double-blind studies is
an inappropriate attempt to apply the laws of inanimate
nature to biological systems. Major pharmacological
scandals go to prove the dubious reliability
of randomised double-blind studies. Such
experiments by their very nature necessitate an
extreme reductionist approach which completely
ignores the idiosyncrasies of biological systems.
From an ethical point of view it is also a very
questionable way of proceeding.
Yet our aim here is not to condemn randomised
double-blind studies in general. Rather, the process
of only accepting this method as scientific evidence
is a very arbitrary and restrictive way of establishing
proof which goes against scientific principles.
From the 260th edition of Pschyrembel onwards
the term ‘evidence’ was included and explained in
detail. The term “evidence” (of a scientific nature)
is at present predominantly used in the English speaking world. In the literature evidence is graduated
in a number of ways.
We commissioned Dr. Volker W. Rahlfs, C. Stat.
(RSS), Head of the Institute for Data Analysis &
Study Planning, founded in 1966, to carry out an
expert analysis of the studies available on BICOM
bioresonance therapy. Dr. Rahlfs has 40 years’
experience as a biometrician/biostatistician in the
area of clinical research and has given expert advice
and opinion to 140 pharmaceutical companies
and university institutes and led more than 400
scientific studies in Germany and overseas.
He has written more than 60 specialist publications.
He is holder of the “Biometry in Medicine” certificate,
is a certified statistician at the Royal Statistical
Society, UK (1993), member of the Gesellschaft
für Medizinische Informatik, Biometrie und
Epidemiologie (GMDS) [German Medical Informatics,
Biometry and Epidemiology Society], the
International Biometric Industry Association
(IBIA), the American Statistical Society (ASA),
the Royal Statistical Society (RSS), the New York
Academy of Sciences, the International Society
for Clinical Biostatistics (ISCB), the Society for
Clinical Trials (SCT), the Drug Information Association
(DIA), the Gesellschaft klinische für Pharmakologie
und Therapie e.V. (GKPharm) [German
Clinical Pharmacology and Therapy Society], the
Fachgesellschaft der ärzte in der pharmazeutischen
Industrie [German Society of Physicians in
Pharmaceutical Industry], the International Association
for Statistical Computing (IASC) and other
professional societies and working groups.
In his report he initially defined eight levels
(levels of evidence used in scientific reports) for
the classification of studies in accordance with
the guidelines for cardiopulmonary resuscitation
(CPR). According to Dr. Rahlfs, levels 1 and 2 are
of greatest significance. They are customary in
major mortality and morbidity studies but are not
required in all cases. For patient case series a level
4 or 5 is sufficient in terms of evidence.
The assessors were given the studies on the application
of BICOM bioresonance therapy to appraise.
In the following I would like to give you a detailed
illustration of the studies with their results and
classification within the 8-level scheme of evidence
(i. e. evidence of a scientific nature).
The Levels of Evidence Used in Scientific Reports
Classification of the levels of evidence according
to the American Heart Association (AHA).
Modified according to W. F. Dick: Evidence based
emergency medicine; (abridged).
Level 1: Statistically significant, randomised,
controlled trials (double-blind studies)
Level 2: Statistically insignificant, randomised,
controlled trials (double-blind studies)
Level 3: Prospective, controlled, but not randomised
Level 4: Historic, nonrandomised cohort or casecontrol
Level 5: Human case series
Level 6: Animal or mechanical model studies
Level 7: Reasonable extrapolations from existing
Level 8: Rationale conjecture
The assessor makes the following concluding remarks
about the studies:
“All previous studies and research work indicate
that the BICOM procedure does not only show
statistically significant (and in the sense of
random statistics, demonstrable) effects. These
are to be interpreted in a clinical context as
demonstrating efficacy. Undesirable side effects,
particularly those that are serious, are not
found in any study.
The work discussed and assessed here corresponds
in principle to the quality standard of university research. Evidence level 1 with
controlled double-blind studies is not the norm
in that area. This quality standard is currently
only required in the area of pharmacological
research. The documents presented correspond
to the requirements of the clinical assessment
of medical products. (cf: R. Prestel, Anforderungen
an die klinische Bewertung von „bekannten“
Medizinprodukten aus der Sicht einer
benannten Stelle [Clinical assessment requirements
of “known” medical products from the
point of view of a Notified Body], Medizintechnik
121 (2001) 9-13.)”
The assessor goes on to sum up his assessment as
“It is standard practice worldwide to publish
your own results, even those with a low level
of evidence and, as demonstrated in the present
report, to derive the level of evidence from the
reproducibility. In practical terms this means
that even studies with a lower level of evidence
are considered as providing proof if other researchers
– who are also carrying out studies
with a lower level of evidence – come to the
This generally recognised technique of external
validation can be seen in the studies appraised
here, carried out by Huang S. et al. (2005),
Yang J. Zhang (2004) and Zhang X. et al. (2005)
in which the named authors each compare their
findings with the results of other authors in
Summary: The studies carried out using the BICOM
method were appraised by experts Dr. Volker W.
Rahlfs, C. Stat. (RSS) and Dr. med. Andreas
Rozehnal from the idv Institute for Data Analysis
& Study Planning as follows.
4 studies were awarded a level of evidence 1
1 study was awarded a level of evidence 1-2
1 study was awarded a level of evidence 2
1 studies were awarded a level of evidence 3
4 studies were awarded a level of evidence 4-5
4 studies were awarded a level of evidence 5
All clinical studies were carried out without our
knowledge, i. e. the studies were not commissioned,
which further increases the evidentiary power
of the studies presented.
Is it now possible to claim that the efficacy of
BICOM bioresonance therapy is scientifically
proven? Clearly YES. Anyone suggesting otherwise
is ignoring these studies and the levels of
evidence they provide.
Brief Presentation of the Studies,
Their Results and Assessments
Study 1(Author: Schumacher, P.)
Single group cohort study (a group of patients - not randomised) with 204 cases of allergy
patients with different strains.
The results of this study should be well known
within our circles. Nevertheless I would like to
reproduce the results in a pie chart.
The biometric/medical assessment: “For this indication
spontaneous healing is extremely rare.
There is no known evidence of healing using
therapeutic measures. Therefore an 83 % recovery
rate is an extremely convincing statistic (15 % recovery
rate would be deemed of clinical significance).
Level of evidence: 4/5”.
Diagram Study 1
Study 2(Yang Jinzh and Zhang Li,
Research Centre of the Jian Paediatric Clinic for
the Prevention and Treatment of Asthma.)
Prospective, controlled but not randomised study
with 2 groups: 213 patients treated with BICOM,
87 patients with corticoids and anti-allergy medication.
Study of patients with asthma.
The results of the treatment were classified after 6
Assessment: “Conventional treatment with medication
is, at least in treating symptoms, extremely effective. It is therefore astonishing that BICOM
treatment achieves the same if not a better level of
efficacy. The study design has a high level of
evidence 3, which means that the results must be
considered as proof of efficacy.”
Study 3(Yuan Ze, Huang Jiali, Wang
Haiyan and Yu Chunyan, Xian Department of
Paediatrics, Central Hospital, Xi’an.)
Single group cohort study with serial observation
of 154 allergy patients from June 2002 to January
2004. Dermatitis, rhinitis, allergic conjunctivitis
and asthma were treated. Immediately before and
during treatment no anti-allergy medication was
Diagram Study 3
Following treatment 120 out of 154 patients (=
78 %) recovered fully (symptom-free for 6 months).
No undesirable effects were reported.
Extract from the assessment: Level of evidence
4/5. This is based on diagnoses which, if using
conventional medical treatment, in practical terms
may only be controlled to a certain extent with
long-term medication (e. g. corticoids) which has
a number of side effects.
The results were looked at and analysed 6 months
after patients received treatment.
Study 4(Authors: Ze Y. und Haiyan W.)
Cohort study with serial observation of 1639 patients
with different allergy diagnoses. These are
patients who had all been unsuccessfully treated
in the past with standard medication.
The study was carried out in the Paediatrics Dept.
of the Central Hospital in Xi’an, China.
Extract from the assessment: The patients had
been treated in the past with various medications
with little success. No recurrence of symptoms 6
months after BICOM therapy meant, for this period
at least, that patients were cured. Spontaneous
healing, placebo effects and similar cannot explain
the percentage of patients who made a recovery in
this allergy area. Level of evidence 4-5.
Results of Study 4:
Study 5(Author: Hennecke, J.)
Single group cohort study of 200 patients from a
total of 248 questionnaires sent out. Patients with
a longer case history (as well as various treatments
prior to this): allergically related skin disorders
(neurodermatitis, eczema, pruritus), allergic conjunctivitis,
allergic intestinal disorders, allergic
respiratory disorders, pollen allergies.
Treatments were carried out without allergen abstinence.
Extract from the assessment:
Despite possible distortion of the result it can be assumed that a substantial
number of patients were symptom-free
(80.6 % return rate from the postal questionnaire).
The number of symptom-free or improved patients
can certainly not be explained by placebo effects
or misdiagnosis. Level of evidence 4/5.
Diagram Study 5
Study 6(Authors: Machowinski, R. und Gerlach, I.)
Prospective randomised parallel 2-group study with 2 x 14
patients with liver cell damage.
The 2 groups were made up of patients with liver cell damage who had been diagnosed at least one year
before. The enzyme values in the control group were almost unchanged around the median value and also
remained largely pathological in individual patients (see the diagrams on following page).
In the group treated with BICOM a considerable improvement can be seen in the median. The individual
values are normalised in most of the patients. The differences between the groups are both substantially
and statistically significant.
Assessment: The study does not only show significant differences from the control group but the effects
are also quite considerable and of medical significance.
The design of the study, awarded a level of
evidence 1, suggests a statistically sound and quite considerable level of efficacy for this indication.
Diagram Study 6a – Liver enzyme GOT
Diagram Study 6b – Liver enzyme GPT
Diagram Study 6c – Liver enzyme Gamma GT
Study 7(Papez, B. J. and Barovic, Maribor Teaching Hospital, Slovenia, Dept. of Medical Rehabilitation.)
Two groups of athletes, not randomised, 12 patients in each group, suffering from overstrain syndromes
associated with high performance athletes.
The control group was treated with ultrasound as well as cryotherapy and electro-stimulation treatment.
The test group only received BICOM bioresonance therapy.
Diagram Study 7a
Diagram Study 7b
Assessment: “Based on the 8-point level of evidence scale, the study is awarded level 2 in terms of
design i. e. providing strong evidence. In this sense the efficacy is shown to be statistically significant.
The extent of the efficacy is also considerable both in terms of length of therapy and pain score.”
Study 8(O. Osadchaya et al.
at the Kavetzky Institute for Experimental Pathology,
Oncology and Radiobiology at the Ukraine
State Academy of Sciences.)
Controlled pre-clinical in-vitro study. Summary
illustration of in-vitro modulation of the phagocyte
activity of human polymorph nuclear leucocytes
through BICOM resonance therapy. A total of
50,000 blood samples were treated and checked
using various program parameters.
Level of evidence 1. The phagocytic activity of human phagocytes in
donor blood was statistically significantly altered
through BICOM treatment. In-vitro study – controlled
The study shows clearly different and reproducible
results using various program parameters. The
phagocytic activity of human phagocytes in donor
blood was altered through BICOM treatment to a
statistically significant extent.
Diagram Study 8
The first bar shows the number of phagocytes in
the donor blood. The blood was placed in 10 test
tubes in the input cup and 10 ampoules with the
same donor blood were also placed in the output
cup. “Treatment” was carried out using different
therapy programs. A and Ai denote the type of
therapy and the additional figures show the amplifications.
The next four bars show the number of
activated phagocytes following each BICOM therapy
Study 9(D. Sakharov et al.)
Controlled pre-clinical in-vitro study: investigation
into the reproduction of the immune system
of radioactively contaminated mice.
Through BICOM treatment it was possible to return
the immune systems of mice weakened by radioactivity
in Chernobyl to a statistically significant
and relevant normal level. Level of evidence 1.
Diagram Study 9
Study 10(Giannazo E., Valenti
S., Puzzo D. from the Physiology Dept, Chair of
Biophysics at the University of Catania.)
Comparative diagnostic study:
BICOM bioresonance therapy versus prick test.
31 subjects were each tested with a prick test
and BICOM test for mites, grasses, olive, wallpellitory.
31 double readings were taken on 4 occasions.
The biometric assessment: The BICOM device is
certainly suitable as an objective procedure for
carrying out allergy testing. It would be desirable
to carry out further investigations in which the
accuracy of both the prick tests and the BICOM
tests could be determined using a “gold” standard
and discussed accordingly. Level of evidence 1.
Diagram Study 10
Study 11(Dr. Du Xia et al.)
Single group cohort study with clearly defined
The study is sufficiently representative with 79
patients taking part. Included in the study are eczema,
ongoing dermatitis, nettle rash and psoriasis.
The efficacy was assessed using a 4-point scale.
The follow-up observation after 1 year is notably
long and increases confidence in the results of the
study in terms of evidence-based medicine.
Result: Recovery in 74.7 % of treated cases and a
visible effect in a total of 89.9 % of cases observed.
Assessment: The study was given a level of evidence
Diagram Study 11
Study 12(Dr. Feng Y. et al.)
Single group cohort study with clearly defined
efficacy criteria. Despite the lack of a comparison
group there appears to be a clear indication of the
efficacy (Diagram 12).
The study comprised 150 patients in total, made
up as follows: 95 patients with asthma and nasal
catarrh, 20 patients with asthma only, 25 patients
with nasal catarrh, 5 patients with skin eczema, 5
patients with other allergies.
Extract from the biometric/medical assessment:
There appears to be a clear indication of the efficacy
despite the lack of a comparison group since
the successful results significantly outweigh the
anticipated random effect. The credibility of the
diagnoses for inclusion is supported by reference
to relevant criteria. Level of evidence 5.
Efficacy was checked using a 3-point scale. In
60.7 % of cases all symptoms had disappeared.
The general efficacy was proven at 94.7 % and a
long-term recovery could also be seen in this study.
Treatment comprised 5 to 8 sessions. It was considered
to be finished if all allergies tested negative
in a renewed check. The observation period
covered 5 to 8 sessions.
Diagram Study 12
Study 13(Dr. Huang S. et al.)
Prospective randomised controlled parallel group
study (Diagram 13).
The patients were distributed into 3 groups.
Group 1: BICOM treatment for children with firsttime
Group 2: BICOM treatment for children who were
previously unsuccessfully treated with
Group 3: Control group, children with first-time
diagnosis, treatment with medication
181 patients with allergy-related colds and allergic
bronchial asthma were included in this study.
The efficacy was assessed using a 3-point scale:
significant effect, effective, ineffective. The success
rate is shown in the following diagrams.
This study is awarded a level of evidence 1-2
based on the comparison groups available.
Diagram Study 13a
Diagram Study 13b
Diagram Study 13c
Study 14(Dr. Xu M. et al.)
Single group cohort study. 56 patients across all
age groups suffering from nettle rash took part in
The results were assessed on a 4-point scale: recovery,
clearly effective, effective (with relapse)
and no effect.
Diagram Study 14a
The success rate for full recovery (35.8 %) and
improvement (25.0 %) is 60.8 %.
It is interesting to note the breakdown into age
groups, where the efficacy rate in the 1 to 15-yearold
patients is the highest at 90 %, followed by
the 16 to 30-year-olds at around 69 %. This study
has a level of evidence 5.
Diagram Study 14b
Study 15(Zhang X. et al.)
Single group cohort study with 54 patients across
all age groups with nettle rash (urticaria).
The success rate for this study is 66.67 % (40.75
+ 25.92), as can be seen in the following diagram.
Extract from the biometric/medical assessment:
Again we have a single group cohort study with
defined efficacy criteria. The design is again
similar to the usual observational studies used in
Germany based on the conclusions described for
the work of Du X. et al. The study is sufficiently
representative with 54 patients taking part. As the
authors themselves concede, the study is not adequate
for long-term assessment.