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Forsch Komplementmed 2014;21:239–245 Published online: August 5, 2014 Evidence for the Efficacy of a Bioresonance Method
in Smoking Cessation: A Pilot Study
Aylin Pihtilia Michael Galleb Caglar Cuhadarogluc Zeki Kilicaslana Halim Isseverd Feyza Erkana Tulin Cagataya Ziya Gulbarana a Department of Pulmonary Diseases, Faculty of Medicine, University of Istanbul, Turkeyb Institute for Biophysical Medicine, Idar-Oberstein, Germanyc Department of Pulmonary Diseases, Faculty of Medicine, Acibadem University, Istanbul, Turkeyd Department of Community Health, Faculty of Medicine, University of Istanbul, Turkey Bioresonance therapy · Double-blind · MORA therapy · Bioresonanztherapie · Doppelblind · MORA-Therapie · Placebo therapy · Smoking cessation Placebotherapie · Rauchentwöhnung Background: Since the 1970s, MORA bioresonance ther-
Hintergrund: Seit den 1970er Jahren wurde weltweit im
apy has globally been applied in the context of comple- Rahmen komplementärmedizinischer Interventionen mentary medicine for various indications. In this regard, die MORA-Bioresonanztherapie bei verschiedenen Indi- practitioners also report successful application in smok- kationen angewandt. In diesem Zusammenhang berich- ing cessation. The present study aims to verify these ten Mediziner auch über Behandlungserfolge bei Rauch-
reports in a controlled study setting. Methods: In order
entwöhnung. Die vorliegende Studie verfolgt das Ziel, to achieve the aforementioned objective, we subjected diese Berichte nicht kontrollierter Beobachtungen in der the bioresonance method to a prospective, placebo- Praxis zu prüfen. Methodik: Um das genannte Ziel zu
controlled, double-blind, parallel-group study involving erreichen, haben wir 190 Raucher in eine prospektive, 190 smokers. In both study groups (placebo n = 95; ac- placebokontrollierte doppelblinde Studie eingebunden tive bioresonance group; n = 95) the course of treatment und in 2 Gruppen eingeteilt (Placebogruppe n = 95; Bio- and study conditions were standardized. Results: 1 resonanzgruppe n = 95). In beiden Studiengruppen wur-
week (77.2% vs. 54.8%), 2 weeks (62.4% vs. 34.4%), 1
den der Behandlungsverlauf und Studienbedingungen month (51.1% vs. 28.6%), and 1 year (28.6% vs. 16.1%) standardisiert. Ergebnisse: Eine Woche (77.2% vs.
after treatment, the success rate in the verum group dif- 54.8%), 2 Wochen (62.4% vs. 34.4%), ein Monat (51.1% fered significantly from the results in the placebo group. vs. 28.6%) und ein Jahr (28.6% vs. 16.1%) nach der Be- Also, the subjective health condition after treatment and handlung lag die Erfolgsrate in der Bioresonanzgruppe subjective assessment of efficacy, polled after 1 week, im Vergleich zur Placebogruppe signifikant höher. Zu- were significantly more positive among participants in dem ergaben die Erhebung des subjektiven Gesund- the active bioresonance therapy group than among heitszustands und die Teilnehmereinschätzung bezüg-those in the placebo group. Adverse side effects were lich der Wirksamkeit der Intervention, die nach einer not observed. Conclusion: According to the findings Woche Behandlung erfasst wurden, ebenfalls eine sig-
attained by this pilot study, bioresonance therapy is nifikante Überlegenheit der Bioresonanztherapie ge-
clinically effective in smoking cessation and does not genüber Placebo. Nebenwir kungen wurden nicht beob-
show any adverse side effects.
achtet. Schlussfolgerung: Gemäß den Erkenntnissen
dieser Studie ist die Bio resonanztherapie bei der Rauch-
entwöhnung klinisch wirksam und frei von Nebenwir-
kungen.
2014 S. Karger GmbH, Freiburg Dr. rer. nat. Michael Galle Institute for Biophysical Medicine Fax +49 761 4 52 07 14 Algenrodter Straße 51a, 55743 Idar-Oberstein, Germany Accessible online at: 93.201.0.246 - 10/28/2014 6:17:24 PM fects (see discussion). Various controlled studies [26–29] have shown no effects of alternative therapy concepts, such as acu- MORA bioresonance therapy (traditional bioresonance puncture, acupressure, homeopathy, hypnosis, laser therapy, therapy) was developed by physician Franz Morell and elec- and electrostimulation in smoking cessation. That is why in a trical engineering technician Erich Rasche in the 1970s, as a recently published study on alternative smoking cessation ther- result of medical testing in electroacupuncture [1]. Thereby, apies, Astrid Becerra et al. [30] proposed to seek new paths.
postulated low electromagnetic oscillations of humans (en- In Turkey, Isik [31] has been applying bioresonance for dogenous bioresonance) or of bioactive substances (e.g. aller- smoking cessation in his practice since 2005, reporting high suc- gens, heavy metals, vitamins, exogenous bioresonance) are col- cess rates. In this retrospective, non-controlled, and non-selec- lected by plane electrodes. The oscillations are electronically tive study, 4,733 participants were treated with bioresonance postulated phase-constant or inverted phase-constant ampli- using the MORA device as described in our study (see meth- fied and superimposed on the human electromagnetic oscilla- ods). The main outcome was the smoking rate for 1 week, tion field for therapeutic purposes. This is supposedly achieved 1 month, and 3 months after bioresonance therapy. Smoking within a range of 1–105 Hz, partially deploying frequency fil- anamnesis and basic demographic characteristics of the parti- ters in the respective frequency range. In this pilot study, bi- cipants were similar to our trial. The smoking reduction after oresonance therapy is applied with cigarettes as exogenous 1 week was 80.1%, after 1 month 62.1%, and after 3 months bioactive substance.
48.2%. No side effects were observed.
A number of clinical [2–11], biological [12–17], and physical To date, no controlled bioresonance studies have been pub- [18–19] studies performed by international teams prove the lished verifying Isik's observations regarding smoking cessa- method's efficacy and effectiveness. With respect to clinical tion. Thus, we conducted a placebo-controlled, double-blind issues, successful studies have been performed in relation to study in order to examine whether or not bioresonance holds allergies, rheumatic diseases, respiratory diseases, and various any actual clinical efficacy and effectiveness in smoking cessa- pain syndromes. However, with regard to allergic indication, tion. Prior to the study, none of the performing scientists (AP, there are also 2 studies [20–21] showing negative results. Thus, CC, ZK, HI, FE, TC, ZG) had gathered any experience with the bioresonance method is still subject of controversy within the bioresonance approach or the bioresonance equipment this field [22–23]. As mentioned above, extremely weak, coherent, and low- frequency electromagnetic oscillations are assumed to carry information on a biophysical level. However, present meas- Participants and Methods
urement equipment has so far not been able to produce direct Study Design evidence of their existence. Up to now, there are only a few A prospective, placebo-controlled, double-blind, parallel group study hypothetical explanatory models, such as the temporary work- was carried out at Istanbul University, Turkey. The verum and the pla- ing hypothesis partly formulated above. Nevertheless, this hy- cebo group included each 95 smokers at the age of 18–75 years, who pothesis is supported by various aspects, such as e.g. the elec- wanted to quit smoking. Group allocation of participants was performed tronic storability of substance-specific bioinformation [7, 10, alternately, according to their appearance for treatment. The bioreso-nance treatment was carried out and checked for efficacy after 1 week, 2 weeks, 1 month, and 1 year.
The methodical approach made by Morell and Rasche [1] was typical for empirical medicine, respectively complemen- Inclusion and Exclusion Criteria tary medicine. The method was developed by input-output The test subjects for the study performed were cigarette smokers who studies on the whole (black box) of man. There are only hypo- had decided to quit smoking. Prior to this study, none of the subjects had ever tried to quit smoking. thetical, explanatory models about the physical and physiolog- The following criteria for in- and exclusion were applied: Subjects had ical interactions, much like in homeopathy and acupuncture. to be between 18 and 75 years of age; free from any ischemic heart dis- However, explanatory concepts are not needed to test the re- eases and/or cardiac arrhythmias, and from severe psychiatric disorders, producible effect of an intervention. such as schizophrenia or anxiety attacks. The scale value in accordance Smoking is harmful, especially for the bronchial and cardio- with the nicotine dependence assessment as per Fagerstrom [32] had to be –7. Additionally, the participants' written consent was required (see vascular system. In Europe, about 30% of adult population is smoking. In Turkey, even 44% of adults are smokers. In 85%, smoking leads to lung cancer, chronic bronchitis, and pulmo- Group Allocation nary emphysema and is the most common cause of death in 190 tests subjects who met the aforementioned inclusion criteria were adults beyond 35 years of age [24, 25]. There is a great need for recruited at the Smoking Cessation Center, Pulmonology Department at the Medical Faculty, University of Istanbul. The subjects were allocated simply, reliable, and safe therapy methods, that may help in to a verum group (receiving active bioresonance treatment) and a refer- smoking cessation. ence group (subjected to simulated bioresonance therapy). Allocation Drugs, such as varenicline and bupropion, are effective in was based on the following pattern: The first participant treated received smoking cessation, however with partly considerable side ef- active bioresonance therapy, the second received simulated bioresonance Forsch Komplementmed 2014;21:239–245 93.201.0.246 - 10/28/2014 6:17:24 PM therapy, the third active bioresonance therapy, etc., until all 190 test sub- placebo-controlled double-blind studies and had given their written con- jects had been allocated. As 1 participant in the reference group was per- sent to participate in the study. Subjects were informed about the possi- manently unavailable after treatment, only 189 test subjects were in- bility of receiving ineffective treatment. The study was approved by the cluded in the evaluation (fig. 1). ethical review committee at the Medical Faculty, University of Istanbul. Regarding their age, gender, number of cigarettes smoked per day, number of years smoking, and type of profession, the 95 participants in the verum and 94 subjects in the reference group were statistically equal The essential outcome parameter was smoking behavior. 1 week, 2 (p > 0.05; table 1). 6 subjects in the verum group took antidepressants; in weeks, 1 month, and 1 year after completion of treatment, all subjects the placebo group, 14 subjects were on respective medication. In both test were interviewed by telephone so as to ascertain whether or not they had groups, no medication for smoking cessation was taken during or prior to smoked cigarettes. In addition, 1 week after treatment the participants the test period. Other types of medicines consumed were not checked. were polled by telephone as per questionnaire (fig. 2) in order to evaluate Prior to the study, all subjects had been informed as to the nature of the therapy's immediate effects on the subjects' condition. The inter-viewer was unaware of which treatment the respective participant had been subjected to, i.e. whether the test person had been allocated to verum or reference group. $VVHVVHGIRUHOLJLELOLW Q  Intervention and Blinding ([FOXGHGQ  The bioresonance treatment was carried out only once. Therapeutic procedure and equipment settings (see below) were standardized. Using the bioresonance device MORA-Super (Med-Tronik GmbH, Friesen- heim, Germany), the standard therapy was carried out as described below: Before starting the treatment, the test subjects were requested to smoke 2 half cigarettes and fill the cigarette ash and the remaining halfs of both cigarettes smoked into 2 glass tubes. The glass tubes containing cigarette butts and ash were then separately placed into the bioresonance device's input electrodes MT1 and MT2. In a second step, the bioreso- nance treatment was carried out (approximately 45 min). The test subjects were connected to the hand and foot electrodes of the bioresonance device. An electrode for the head, providing 2 adapters, was positioned on the subjects' forehead and connected to the additional contacts for the left and right hand electrodes, provided at the rear of the device. A round-shaped magnetic electrode was attached 3 cm below the $QDO VHGQ  $QDO VHGQ  test subjects' navel, and an additional external amplifier (amplification = 1,000) was connected to the output. The respective input of the amplifier was connected to the contact for right foot, provided at the rear of the Fig. 1. CONSORT flow diagram.
Table 1. Subjects'
Reference group, demographic charac- active bioresonance (%) simulated bioresonance (%) teristics and smoking history (absolute frequency, relative frequency in brackets; Cigarettes smoked per day, n Workers and employees Evidence for Efficacy of Bioresonance Forsch Komplementmed 2014;21:239–245 Method in Smoking Cessation 93.201.0.246 - 10/28/2014 6:17:24 PM Active bioresonance therapy was performed by applying program 21 The only difference between program no. 22 and program no. 21 was first, followed by program 22, whereas the simulated bioresonance ther- the amplification. Electrode connection in program 21 and 22 was identi- apy deployed programs 11 and 12 (details on programs are provided cal and specified as follows: 1. stage: right hand = input 1, left hand = input 2, below). For both treatment variants, the sounds and indications of biores- right foot = output 2, left foot = output 1, MT-1 = input 1, MT-2 = input 2, onance devices were identical. The participants were thus unable to dif- twin beaker = not connected. 2. stage: right hand = output 2, left hand = ferentiate which of the treatment variants they were exposed to. The per- output 2, right foot = output 2, left foot = output 1, MT-1 = input 1, MT-2 forming party applied the first combination of programs to the first par- = input 2, twin beaker = output 1 and 2. 3. stage: right hand = input 1, left ticipant, the second program combination to the second participant, then hand = input 1, right foot = output 1, left foot = output 2, MT-1 = input 1, again the first combination of programs to the third participant, etc. The MT-2 = input 2, twin beaker = not connected. 4. stage: see stage 2.
performing party recorded which test subject received which treatment, but was unaware of the outcome of the individual program combinations. The performing party had no experience in bioresonance therapy, no training in the operation of the device, and was only able to set the speci- fied programs. He neither knew how to handle the electrode settings nor what they stand for, or what the programming entails. No other party in- volved knew, which programs were being applied in which manner. Nei- ther the performing nor any other involved parties maintained further contact with the test subjects. Test documentation was not revealed until the study has been completed and analyzed. In the process of both the active as well as simulated bioresonance treat- ments, a so-called chip was used as carrier substance. This chip was made of a round-shaped disk of 1 mm thick stainless steel with a diameter of 2.5 cm, and was placed on the bottom of the output electrode twin beaker.
In the course of treatment, a glass bottle containing 92 parts of physi- ologic saline solution and 8 parts of ethanol-water solution were used as ,I RXKDYHVPRNHG RXUILUVWFLJDUHWWH carrier substance, being administered by drops. While the program was executed, the respective glass bottle with the preparation was placed in the same twin beaker mentioned above. At the end of the bioresonance treatment, the respective chip was fixed to a spot 2 fingers below the test subjects' navel using medical tape (meridian: Ren Mai; acupuncture point: Qi Hai) for 1 month. The test persons were asked to instill 5 of the aforementioned therapeutic drops beneath their tongue, whenever they felt the need to smoke. However, the subjects were also informed not to take more than 30 drops a day; otherwise there would be a risk of exacer- bation of withdrawal symptoms, similar to an excessive dose of remedies in homeopathy.
Programs and Electrode Wiring of MORA-Super Device The programs used in the course of therapy were extended MORA programs as described in the following. Programs 21 and 22 (active bioresonance treatment): Program no. 21 was programmed as detailed in table 2. Table 2. Program 21 (active bioresonance treatment). All stages were
conducted in Ai mode, i.e. phase-constant inversion (amplification of program 22 in brackets) Frequency filter :KDWZRXOG RXVD LI RXZHUHDVNHGWRFRPPHQWRQWKHWUHDWPHQW RXUHFHLYHG" *Physiologic amplification, cycle times 3s/7s.
Fig. 2. Questionnaire (carried out 1 week after treatment).
Forsch Komplementmed 2014;21:239–245 93.201.0.246 - 10/28/2014 6:17:24 PM Table 3. Absolute and relative number (in
Time after treatment Active bioresonance Simulated bioresonance brackets) of participants who had quit smoking (chi-squared test) Table 4. Significant
Participants' condition Active bioresonance Simulated bioresonance findings obtained from supplementary interviews, regarding No desire to smoke in the first 3 days the participants' after treatment.
condition 1 week No desire to smoke in the second 3 days after treatment.
(relative number of Smokers who enjoyed smoking after treatment.
chi-squared test) Non-smokers who, after treatment, did not feel any need to smoke, even when being surrounded by smokers. Non-smokers who felt nervous.
Participants believing that the drops had reduced their desire to smoke.
Participants believing in the treatment's being effective.
Programs 11 and 12 (simulated bioresonance treatment): Programs (p = 0.002; p = 0.003); even if surrounded by smokers, they did no. 11 and 12 were set equally to program no. 21, except for the fact that not feel any need to smoke (p = 0.003); they did not feel nerv- amplification was set to 0 in each stage and channel and the in- and out- ous (p = 0.004); believed the therapeutic drops to have reduced put of the MORA device remained unconnected. As a result, the oscilla- their desire to smoke (p = 0.001); and expected the treatment tion could neither get in nor out of the device. For the participants of both groups, however, the treatment seemed identical. The performing parties to be effective (p < 0.001).
were also unable to distinguish if participants received verum or placebo. The bioresonance therapy was well tolerated. 1 participant suffered from contact allergic dermatitis which, however, dis- appeared very soon without any further treatment. No other The test statistics for the findings presented in tables 1, 3, and 4 were adverse reactions and/or side effects were observed. performed by applying the chi-squared test [33]. The respective threshold of significance was p < 0.05.
Regarding the results of this pilot trial, the application of After 1 week, 77.2% of the members in the verum and active bioresonance can be rated as successful. This method 54.8% in the placebo group had quit smoking (p = 0.001); after differs significantly and noticeably from simulated bioreso- 2 weeks, 62.4% vs. 34.4% (p < 0.001); 1 month after treatment nance, 1 week (success rate 77.2% vs. 54.8%), 2 weeks (62.4% 51.1% vs. 28.6% (p = 0.002). Even after 1 year, a significant vs. 34.4%), 1 month (51.1% vs. 28.6%), and 1 year (28.6% vs. difference between the members of verum and placebo group 16.1%) after treatment (table 3). The efficacy of bioresonance was recorded: 28.6% of the participants in the verum and therapy documented in this study was also confirmed by the 16.1% in the placebo group had not smoked (p = 0.04). Table 3 findings obtained from the interview that took place 1 week provides an overview of the results for the main outcome after treatment (fig. 2). The self-rated improvements of health parameter. condition as well as subjective expectation toward treatment The significant findings obtained from supplementary inter- effectiveness were significantly more positive in the bioreso- views, regarding the immediate efficacy 1 week after treat- nance than in the placebo group. ment, are summarized in table 4. Compared to the placebo Comparing bioresonance method (success rate 28.6% after group, the desire to smoke was significantly reduced in the 1 year) with the most effective pharmacological method using verum group over the first 3 and further 3 days after treatment varenicline, the results are similar; yet, they vary in the occur- Evidence for Efficacy of Bioresonance Forsch Komplementmed 2014;21:239–245 Method in Smoking Cessation 93.201.0.246 - 10/28/2014 6:17:24 PM rence of side effects caused by varenicline, such as nausea, in- One participant in the placebo group was unavailable after somnia, and partly even attempted suicides. (In 2009, even a treatment and thus could not be included in the evaluation. warning by the Food and Drug Association was issued). Many Due to the high number of participants, however, this would studies have been conducted on the medication mentioned not substantially influence the significance of the results. above. For example, Oncken et al. 2006 [34] documented the Six participants in the verum and 14 in the placebo group following success rates after 1 year of treatment with vareni- took antidepressants. These group differences may have influ- cline and bupropion: 23.0% for varenicline, 14.6% for bupro- enced the results. pion; and 10.3% for placebo, revealing that the 3 treatments The results of this double-blind pilot study verify the effi- differ significantly. These results are in line with findings from cacy of the bioresonance approach in smoking cessation and a randomized controlled trial by Jorenby et al. [35]. According confirm the practice-related results of Isik [31] that showed a to the trial of Tonstad et al. [36], the carbon monoxide content success rate of 48.2% with the bioresonance method 3 months indicating physical nicotine dependence was significantly low- after treatment. Regarding this time period, Jorenby et al. [35] er in the varenicline group compared to the placebo group in reported a success rate of 43.9% in the varenicline group and weeks 13–24 (70.5% vs. 49.6%) as well as in weeks 13–52 29.8% in the bupropion group. Gonzales et al. [38] document-(43.6% vs. 36.9%). These results correspond with findings ed a success rate of 44.0% for varenicline and 29.5% for bu-from other studies [37–38]. According to the meta-analysis by propion. According to the results of Isik, the success rate of the Eisenberg et al. [39], on a pharmacological level the most suc- bioresonance method is similar to the best pharmacological cessful results were obtained with varenicline.
results, also after a 3-month observation period, only without With regard to complementary therapies in smoking cessa- any side effects. tion, so far no comparable effects are known for any other The results of this study have to be scrutinized by large-scale method. In a recent placebo-controlled study on ear acupunc- randomized placebo-controlled double-blind studies, especial- ture, former positive results from non-controlled studies could ly comparing bioresonance with pharmacological methods. not be confirmed [40]. However, there are also new promising study results in ear acupressure [41] and hypnosis [42].
As the research participants of the bioresonance therapy left the clinic at the end of the intervention and sometimes lived quite far away from the hospital, direct evaluation of the partici- According to the findings obtained from this study, bioreso- pants' health condition after treatment was not possible. There- nance therapy is clinically effective in smoking cessation, with- fore, follow-up data was gathered via telephone and assessed by out involving any adverse side effects. participants' self-rating. In this regard, carbon monoxide con-centration in blood and other smoking-specific parameters could not be determined in this evaluation period. This could limit the validity of the results, since the assessment of the participants AP, CC, ZK, HI, FE, TC, and ZG have no conflict of interest in rela- could not be verified by a fully objective measurement.
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