Scientific proof of efficacy for the bioresonance method result of a multicentre study

Introduction

“The effectiveness of the bioresonance method has not been scientifically proven and is therefore not recognised!” We have all heard such statements for decades, however from this year onwards this should be a thing of the past.

This is because a new multi‐centre practical study, has shown that with statistical significance the bioresonance method is effective and harmless in patients with allergic rhinitis and conjunctivitis. This study was carried out according to the currently re-quired and recognized standards and evidence‐based, scientific criteria.

This lecture is about the implementation of the study and the presentation of the re‐ sults, and also about my personal experiences and some of those of my investigator colleagues, with whom I have exchanged information by telephone.

Previous study situation

As we all know, this is not the first study. As early as the beginning of the 1990s, Dr.Schumacher conducted practice studies with children suffering from neurodermatitis and asthma and documented a success rate of over 90%.

At that time, I myself also successfully carried out a practice study on more than 200 allergy patients, as a questionnaire, which is a form of study still carried out today.

Numerous practice and clinic studies followed at home and abroad. Especially in China, clinical studies were conducted at that time with high patient numbers and remarkable success rates. In addition, there were a number of in‐vitro studies on cell cultures that proved the effectiveness of the “bioresonance wave patterns”. Most recently, 2 studies by Prof. Dartsch were published which proved the acceleration of wound healing

in cell cultures. Nevertheless, scientific recognition has so far been lacking. There was criticism of the study design and the non‐European studies were viewed with scepticism.

Need for a current study

This meant that a new study was needed, and was needed for two main reasons. Firstly, for BICOM users and patients who have been waiting for years for scientific confirmation of their positive experiences with the bioresonance method. They want irrefutable arguments and proof to be able to counter the still numerous critics and sceptics. Secondly, there was a very pragmatic argument, which was due to a change in the law.

In order to obtain or keep the certification as a class 2a therapy device, (a new certifi- cation for all medical devices by the TÜV is necessary). For certification, it is necessary, among other things, to present the current state of research and standardised criteria must be applied to assess the studies.

REGUMED has spared no expense and effort to provide this scientific proof. Not only to support the German customers, but above all to be able to continue to compete on the international market. Many bioresonance device manufactures were not able to provide this proof. The BICOM device received this important approval in May 2021 due to a very positive interim result. This was though only a provisional approval, until submittance of the final study results. This was available at the end of May 2022!

The intended use of the BICOM device

According to the new approval guidelines, every medical product (drug or device) must demonstrate proof of efficacy for the intended use applied for. The BICOM device is successfully used for a variety of conditions, it would however not be practical, feasible nor affordable to provide a study for all indications. Fortunately, the authorities were initially satisfied with one “main indication” (“intended use”). After some internal discussions, we agreed on an allergy diagnosis: allergic rhinitis and conjunctivitis.

After successful proof of study, the device will then be approved for this “Intended use”. This means that REGUMED is then only allowed to officially advertise the device for this “intended use”. As a result, the website has also been changed accordingly.

An institute officially independent of REGUMED was also founded: the Academy for Complementary and Information Medicine (AKI). This institute is authorised to provide information on all other indications and to hold corresponding training courses and seminars.

Planning of the study

The study is a prospective, multi-centre, single-arm, open observational study to assess the effectiveness and safety of the BICOM optima in bioresonance therapy in patients with allergic rhino-conjunctivitis.

The study was conducted from 25/01/2021 – 10/02/2022. The plan was to enrol 132 patients in 10 study centres, however at the end, 111 patients (including 28 children between 4 and 11, 14 adolescents between 12 and 17 and 69 adults 18 years and older) could be evaluated.

A recognised institute specialising in clinical trials and research was chosen to conduct the study. The tasks were:

Approval procedure with medical associations/health authorities/ethics commissions.

Preparation of the study design

Preparation of the information/questionnaires

Creation and maintenance of a computer programme specially programmed for this purpose

Guidance / assistance for the participating practices

Control of the correct execution of the study (monitoring)

Statistical evaluation and processing of the study results

Suitable practices had to be found. Only medical practices (no naturopathic practition- ers) were allowed to participate. These practices should have sufficient experience with the method and a large patient population to be able to recruit, if possible, at least 10 – 15 patients during the observation period. I was also selected as the “princi- pal investigator”. Of the 10 practices originally planned for participation, 8 were able to complete the study.

Note: For each federal state in which the study practices were located, the respective medical associations and ethics committees had to be consulted individually. Only the Ethics Committee of Westphalia-Lippe expressed reservations. In their opinion, effec- tiveness could not be proven due to the study design and a placebo effect could not be ruled out. Therefore, the study was “ethically and scientifically” not justifiable. Fortu- nately, this had no influence on the feasibility of the study. Of course, we all know that the placebo effect plays a role in every scientific study. In retrospect, a “placebo effect” of 70% is quite respectable.

Preparation of the investigators and practices

The investigators received a study BICOM device as well as accessories and the two STT basic test kits with allergen ampoules on loan for the study period. The study patients were only allowed to be treated with this device.

The investigators received a thick folder with all relevant study documents and the questionnaires.

The investigators were given online access to the programme, in which all findings had to be entered or transferred from the questionnaires. This could be viewed and checked by the “study company”. For data protection reasons, the patients were only recorded with a number and the patients’ personal information remained in the practice.

Since this was an “observational study”, the practices were in principle supposed to treat the study patients in the same way as they would have done without the study.

Corona

Unfortunately the Corona pandemic made the situation of the participating practices much more difficult than planned. Briefing of the investigators, clarification of questions, examinations and much of the “monitoring” could not take place in person (as planned), but only online. Practice visits by the audit company were not possible for a long time.

The special requirements of the practices in the Corona crisis (testing, ongoing changes in work regulations, hygiene rules, patient fears, implementation of vaccinations) also brought many test practices to their limit, in regards to time and personnel capacities.

Recruitment and implementation of the therapies were difficult and the end of the study had to be postponed several times.

The catastrophic floods of 14 July 2021 also occurred during the study period.

A registered patient from Stolberg could not come to further appointments because her house was washed away!

Recruitment of patients

From my point of view, the result or success is easiest to show with patients who suffer from only one allergen (preferably house dust or animal hair) and who have relatively constant complaints (constant sniffles, blocked nose). Here, significant improvements in the symptoms can usually be achieved after 3 – 4 therapies, and patients can often even be free from symptoms. In my opinion, pollen allergy sufferers are less suitable because the severity of the symptoms depends strongly on the current pollen count (season, weather, etc.). In the case of multi-allergy sufferers, the assessment of the therapy effect is also more difficult because the observed symptoms can also be caused by allergens other than those treated. Cold infections can also cause virtually the same symptoms.

Unfortunately, the desired patients do not always come to the practice at the ideal time, meaning that compromises often have to be made. From a scientific point of view though, this is rather a strength of observational studies in practices, as they provide a more realistic picture of the effectiveness of a treatment under everyday conditions, when compared to studies conducted in clinics.

During the exchange with the other test practices, I learned that many pollen allergy sufferers and “multi-allergy sufferers” were also included in the study.

Clarification and anamnesis

The information sheet comprised 10 pages and included explanations about the study, brief information about bioresonance therapy and the course of treatment, as well as a comprehensive privacy statement. The adult participants signed this on the first day of therapy or brought it with them, which was very practical. It was however more difficult with the children and adolescents, as both parents had to sign and they were rarely present together at the first appointment.

At the first appointment, the inclusion conditions were also clarified and an anamnesis form was filled out: Age, gender, height, weight, size of residence, pets, onset of symptoms, weather dependence. There were also questions about already known allergens: Pollen, house dust, animal dander, moulds, chemicals and food. At the end, questions were asked about symptoms, as well as any allergy tests with conventional medicine and previous treatments.

The criteria for inclusion in the study was as follows: – Symptomatic rhino-conjunctivitis

– Mild to moderate allergy symptoms

– Expectation of treatment to include no more than 8 allergy therapies within 15 weeks – Older than 4 years

– Signed informed consent form

The exclusion criteria was as follows:

– Psychiatric illness/incapacity to consent.

– Device is used in deviation of the instructions for use – Contraindication according to instructions for use

Questionnaires and “scores”

There were three questionnaires to be filled out by the patient (or parent) before the first treatment (“baseline”), before each further treatment (follow-up) and 1-2 weeks after the last treatment (“follow up”). Optimally, a questionnaire would have been filled out daily by the patients – but this would have been too time-consuming.

The data was then transferred online by the therapist into the computer system. The accuracy of the original questionnaires with the online entry was checked at the end of the study within the framework of a “monitoring” and corrected if necessary.

The first questionnaire was about allergy symptoms. The patient was asked to tick the “strongest expression” of the symptoms, as well as the number of symptom days (in the past week). He had the choice between “no, mild, moderate and severe symptoms”. The symptoms “itchy nose”, “sneezing”, “runny nose”, “blocked nose”, “itchy, red eyes” and “watery eyes” were asked about.

The ticked answers were then coded into “scores” for statistical evaluation, i.e. they were given a numerical value indicating the symptom severity: 3 for severe, 2 for moderate, 1 for mild and 0 for no symptoms. In the context of the study, the term “score” refers to a mathematically calculated number that reflects a statistically evaluable quantity.

The symptom score, the “ Mean Weekly Symptom Score” (mean wSS) – represents the mean severity and duration of the subjectively perceived allergy symptoms. The higher the number, the worse the (average) subjectively felt symptoms.

Calculation: Number of severity x number of days / 7 (days of the week)

This medication score – weekly Medication Score (wMS) – represents the number and frequency of allergy medications taken. These medications, of course, also affect allergy symptoms and quality of life. Fortunately, most patients did not need allergy medication. The higher the score, the higher the consumption of allergy medication.

Calculation: number of medications/week : 7 (days of the week)

The second questionnaire was about the intake of allergy medication with the option to answer “yes” or “no”. In the case of “yes”, the number of days on which the medication was taken was also to be indicated. The questionnaire asked about antihistamines, glucocorticoid nasal drops, cortisone tablets or other (also homeopathic) allergy medications.

This medication score, the “Weekly Medication Score” (wMS) represents the number and frequency of allergy medications taken. These medications, of course, also affect allergy symptoms and quality of life. Fortunately, most patients did not need allergy medication. The higher the score, the higher the consumption of allergy medication.

Calculation: Number of medications / 7 (days of the week)

The third questionnaire was about the impairment of quality of life. Here the choice was “not at all”, “a little”, “somewhat”, “significantly” or “strongly/very much”. The questions asked about “wellbeing”, “sleep”, “everyday activities”, “sports activities”, “school/work activities” and “social contacts”. In Corona times, one could not help but smile at the last question. The “Quality of Life Score” (QoLS) represents the impairment of daily life by the allergy symptoms. The higher the number, the worse the subjectively perceived impairment of quality of life.

Calculation: Degree of impairment x number of days / 7 (days of the week)

A further questionnaire was also filled out by the therapist and reflected objectively the symptoms observed by the therapist on the patient before the next therapy session. The questions correspond to the patient questionnaire on symptoms without the indication of days. The results were expressed as the Acute Symptom Score (aSS). The higher the number, the stronger the observed manifestation of allergy symptoms.

Calculation: Acute (current) expression of symptoms (addition)

It was expected that the scores decrease in the course of the treatment and that a statistically significant improvement would occur at the end of the study (Change of Score: “Treatment” compared to “Baseline”). A reduction of at least 2 score points would already indicate a positive therapy effect.

Problems with the questionnaires

The improvement of allergy symptoms in the course of treatment is assumed to be a measure of the effectiveness of the bioresonance method. One would therefore expect the symptom score to improve with each treatment and to be close to “0” at the end of the study, i.e. the patient is largely symptom-free with regard to the treated allergy.

For this reason, I initially tried to include only patients in the study who showed chronic, largely constant symptoms that can be subjectively clearly attributed to a specific allergen. This includes mono-allergy sufferers who subjectively react “only” to their pet, for example, and come to bioresonance in order to not have to give this ani- mal away. Patients who “only” react to house dust, for example with a chronically blocked nose, also fall into the same category. Experience from my practice of more than 30 years has shown that with this group of patients, almost 100% success can be achieved with many patients free from symptoms.

However, not only such patients come to the practice and certainly not when they are needed for a study! Perhaps even fortunate, because it makes the study result seem even more credible “in real everyday practice”. Especially with the far more frequent “multi-allergy patients”, the assessment of the therapy success is often “watered down”. Even a cold infection can imitate allergy symptoms.

Here are some situations that have worsened the “score” regarding allergy symptoms e.g. during the treatment of dog allergy:

– The patient visits a horse stable (and reacts to the horse)

– The patient sleeps in another bed and reacts to house dust/mould

– The patient suffers from the onset of pollen count (partly depending on the weather) – The patient eats an intolerant food

– The patient gets a cold

On the other hand, there are also situations that cause a supposed improvement without the allergen having been sufficiently treated e.g.:

– The pet is temporarily “out of the house”

– Allergy medication has been taken

– The pollen count is decreasing / the weather is getting worse.

This means that in the case of multi-allergy sufferers, the assessment of the success of the therapy is somewhat limited, since even when the treated allergy reaction has ceased, the same symptoms can still persist. In a study with only “mono-allergy sufferers”, the final result of the study would, in my opinion, be even clearer, but this does not correspond to the reality in practice.

The two pre‐treatments

Before treating the actual allergy, it was possible to optionally carry out two “pre- treatments”. After consultation with the investigators, I found out that this option was used very different. Some used it more frequently, and others only in individual cases or not at all.

In my practice, the implementation of the pre-treatment proved to be rather inappropriate.

In the case of mono-allergy patients, this was because patients who come to the prac- tice “only” with an animal hair or house dust allergy expect to be “discharged” largely symptom-free after 3 – 4 therapy sessions. They are not willing to come and pay for 2 preparatory sessions without allergy therapy beforehand. With me, the necessary preparatory programmes (basic therapy, blockades, elimination organs) also usually take place in the same session, as the allergy therapy.

In the case of multi-allergy sufferers, the reason is that two pre-treatment sessions is not enough. According to our therapy systematic, in the case of multi-allergy patients, the treatment of chronic food allergies and intestinal cleansing should take place, in addition to treating the blockages and elimination organs, before a therapy for animal hair or house dust. Two pre-treatments are by far not enough for doing this. Moreover, no allergy therapy should take place during these two pre-treatment sessions.

In order to overcome this, I only included such patients in the study when a series of necessary pre-treatments had been completed. Then, when “house dust” or “animal dander” was to be treated (provided the symptoms persisted), they were recruited for the study. If further therapies were needed, these were then done outside the study.

I never used these (optional) pre-treatments in my study patients.

Type of allergens and number of therapies

A minimum of 3 and a maximum of 8 allergy therapies were prescribed for the study after the optional pre-treatments.

I myself treated 12 patients, 9 of them with single allergens: 2x dog, 3x cat, 3x house dust, 1x early blossom; and in 3 patients I treated two allergens: 1x house dust and dog, 2x house dust and mould. As a rule, 3-4 therapy sessions were sufficient. Only in one case did I need 7 sessions. In the other test practices, between 3 and 8 treatment sessions were needed too.

The treatment in the study was terminated when the patient no longer reacted subjectively to the allergen treated and the kinesiological test or tensor test no longer indicated an allergy. Any further necessary therapies were then no longer carried out as part of the study.

According to telephone conversations with other investigators, in some practices several allergens were treated in different patients and of course more therapy sessions were needed.

Therapy programmes

The basic therapy was selected according to the conductance value, but was usually only on in the first 2-3 therapy sessions. This was followed by “blockage therapy” in the same session, which was selected according to anamnesis and energetic testing.

Examples:

For radiation exposure – programme 700

For scar interference fields – programmes 910 + 900.

This was followed by the “detoxification therapy”: after testing, therapy programmes for the liver, kidneys, lymph, lungs or the general detoxification programme 970 were carried out.

After this the actual allergy therapy was carried out. The original allergens as well as the corresponding STT, CTT or Schumacher ampoules were placed in the input cup.

I exclusively used the proven programme sequence 11310 (which includes pro- grammes 963, 944, 998). In the subsequent processing and counting of the therapy programmes used in all practices, it turned out that these “old” programmes were used most frequently in the test practices, followed in the frequency by use of programme sequences 10325(Ai) and 10326 (Di) according to Riffel. Some practices also used both programme sequences or other existing allergy programmes depending on the energetic testing. The evaluation of the effectiveness of the different therapy programmes cannot be deduced within the scope of the study.

Patient examples

A 55-year-old patient had been suffering from allergic rhinitis for about 4 months, triggered by a new dog. He complained of mild (but annoying!) symptoms such as a runny and blocked nose, as well as sneezing attacks. He also had a long-standing house dust allergy, but this hardly bothered him. The ideal patient for our study!

We discarded the 2 preparatory sessions and started straight away. In the first sessions, we ran basic therapy and integrated some “preliminary programmes”. There were 4 allergy therapy sessions with the original dog hair and the Schumacher and STT ampoules “dogs”.

Afterwards, the patient had the impression that he no longer reacted to his dog, but according to the questionnaire he was not yet free of complaints. We decided to add three more sessions of “house dust”. After that, the nose was completely free with a score “0”! This confirmed my many years of experience with such patients.

Another 59-year-old patient also came to the practice because of a dog hair allergy. As expected, the patient did not react to his dog anymore after 3 therapy sessions, but the information in the questionnaires was very fluctuating and even at the end of the allergy treatment he still showed symptoms. He was also allergic to pollen, mould, house dust and food. Here, the “allowed” 5 more therapy sessions would not have been sufficient. The final score therefore did not represent the effectiveness of the allergy therapy carried out!

Results

The results were largely consistent in all age groups!

Here are the calculated scores (average of all patients) before and after bioresonance therapy:

Symptom score (wSS):

Before 7.0, After 2.1, Difference -4.9 Significant improvement!

Medication score (MS):

Before 0.142, After 0.08, Difference -0.056

Many patients did not take any medication, which is unfavourable from a statistical point of view. Of course, if no medication is taken, no change can be observed in this respect.

Quality of life score (QoLS):

Before 9.4, After 2.5, Difference -6.9 Significant improvement!

Acute symptom score (aSS):

Before 1.2, After 0.4, Difference – 0.8 Significant improvement!

An excellent, statistically significant overall result!!!

Adverse therapy reactions

In order to assess the safety of the bioresonance method, “side effects” – officially known as Adverse Events (AE) – should also be carefully documented. In the entire study, 4 such events were reported that were classified as “mild” to “moderate”. As expected, serious adverse events did not occur. Only female participants were affected

with the following symptoms: transient marked exacerbation of rhino-conjunctivitis, migraine, diarrhoea, skin dryness with fissures of the upper lip and right eyelid. All re-actions disappeared within a few days. From my point of view, these were “initial aggravations”, as they can occur within the framework of any regulative therapy method as a “detoxification reaction”.

Summary

The results showed that a clear, statistically significant improvement of the symptoms of allergic rhinitis and conjunctivitis triggered by pollen, house dust or animal hair could be achieved by bioresonance therapy. On average, the subjectively experienced symptoms, the objectifiable symptoms and the quality of life improved by approx. 70%.

Adverse side effects (mild to moderate) occurred in 5.3% of cases (worsening of the nose- eye symptoms, migraine, diarrhoea, skin dryness).

The study describes the therapeutic efficacy following the therapy sessions. An assessment of a “long-term effect” would be desirable. Here, the treated patients could possibly be interviewed again one year after completion of the treatment.

Outlook

The study on “Allergic Rhinitis and Conjunctivitis” is a first step towards the recognition of BICOM allergy therapy. The next step is to publish it in a recognised medical journal and then also in the general medical and public press.

We all know that there is much more potential in our BICOM devices. Studies on other allergic indications such as Neurodermatitis, food allergies and intestinal diseases would be useful, but also studies for “non-allergic” diseases would be desirable. Theoretically, studies would have to be done for all (over a hundred) indications of the de- vice. If each study takes a year, several more generations of BICOM therapists would be needed, in addition to considering the financial feasibility.

Personal conclusion

Long-time bioresonance therapists know from their own experience the often unbelievable treatment successes with bioresonance, especially in the field of allergy therapy. For patients with few or mild allergies, we can often achieve complete freedom from symptom and with difficult patients and multi-allergy sufferers, we often achieve a significant improvement in symptoms and quality of life, often with a reduction in the necessary medication.

Neither specific allergy therapy (hypo sensitisation) nor long-term drug therapy can achieve comparable results. In addition, bioresonance therapy is faster, less expensive and has fewer side effects. The time has come for orthodox medicine to also address effective “complementary” healing methods such as the bioresonance method.