土耳其大學針對Mora 戒煙療效的研究

土耳其伊斯坦布爾大學( University of Istanbul)研究團隊研究MORA生物能共振在戒煙上的療效。針對190位吸煙者,分為兩組進行測試(生物共振組N = 95;安慰劑組 N= 95)。

結果顯示,生物共振組的戒煙效果比安慰劑組更為顯注,一周後為77.2%對54.8%、二週(62.4%對34.4%),一個月(51.1%對28.6%),和一年(28.6%對16.1%)。使用mora生物共振療法戒煙,不但在臨床上達到有效的戒菸效果,而且並未顯示有任何不良副作用。

Original Article · Originalarbeit

Forsch Komplementmed 2014;21:239–245 Published online: August 5, 2014 DOI: 10.1159/000365742

Evidence for the Efficacy of a Bioresonance Method in Smoking Cessation: A Pilot Study  Article · Originalarbeit

Community Health, Faculty of Medicine, University of Istanbul, Turkey Keywords Bioresonance therapy · Double-blind · MORA therapy · Placebo therapy · Smoking cessation Summary Background: Since the 1970s, MORA bioresonance ther- apy has globally been applied in the context of comple- mentary medicine for various indications. In this regard, practitioners also report successful application in smok- ing cessation. The present study aims to verify these reports in a controlled study setting. Methods: In order to achieve the aforementioned objective, we subjected the bioresonance method to a prospective, placebo- controlled, double-blind, parallel-group study involving 190 smokers. In both study groups (placebo n = 95; ac- tive bioresonance group; n = 95) the course of treatment and study conditions were standardized. Results: 1 week (77.2% vs. 54.8%), 2 weeks (62.4% vs. 34.4%), 1 month (51.1% vs. 28.6%), and 1 year (28.6% vs. 16.1%) after treatment, the success rate in the verum group dif- fered significantly from the results in the placebo group. Also, the subjective health condition after treatment and subjective assessment of efficacy, polled after 1 week, were significantly more positive among participants in the active bioresonance therapy group than among those in the placebo group. Adverse side effects were not observed. Conclusion: According to the findings attained by this pilot study, bioresonance therapy is clinically effective in smoking cessation and does not show any adverse side effects.

Introduction MORA bioresonance therapy (traditional bioresonance therapy) was developed by physician Franz Morell and elec- trical engineering technician Erich Rasche in the 1970s, as a result of medical testing in electroacupuncture [1]. Thereby, postulated low electromagnetic oscillations of humans (en- dogenous bioresonance) or of bioactive substances (e.g. aller- gens, heavy metals, vitamins, exogenous bioresonance) are col- lected by plane electrodes. The oscillations are electronically postulated phase-constant or inverted phase-constant ampli- fied and superimposed on the human electromagnetic oscilla- tion field for therapeutic purposes. This is supposedly achieved within a range of 1–105 Hz, partially deploying frequency fil- ters in the respective frequency range. In this pilot study, bi- oresonance therapy is applied with cigarettes as exogenous bioactive substance. A number of clinical [2–11], biological [12–17], and physical [18–19] studies performed by international teams prove the method’s efficacy and effectiveness. With respect to clinical issues, successful studies have been performed in relation to allergies, rheumatic diseases, respiratory diseases, and various pain syndromes. However, with regard to allergic indication, there are also 2 studies [20–21] showing negative results. Thus, the bioresonance method is still subject of controversy within 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- urement equipment has so far not been able to produce direct evidence of their existence. Up to now, there are only a few hypothetical explanatory models, such as the temporary work- ing hypothesis partly formulated above. Nevertheless, this hy- pothesis is supported by various aspects, such as e.g. the elec- tronic storability of substance-specific bioinformation [7, 10, 11, 13, 14]. The methodical approach made by Morell and Rasche [1] was typical for empirical medicine, respectively complemen- tary medicine. The method was developed by input-output studies on the whole (black box) of man. There are only hypo- thetical, explanatory models about the physical and physiolog- ical interactions, much like in homeopathy and acupuncture. However, explanatory concepts are not needed to test the re- producible effect of an intervention. Smoking is harmful, especially for the bronchial and cardio- 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- nary emphysema and is the most common cause of death in adults beyond 35 years of age [24, 25]. There is a great need for simply, reliable, and safe therapy methods, that may help in smoking cessation. Drugs, such as varenicline and bupropion, are effective in smoking cessation, however with partly considerable side effects (see discussion). Various controlled studies [26–29] have shown no effects of alternative therapy concepts, such as acu- puncture, acupressure, homeopathy, hypnosis, laser therapy, and electrostimulation in smoking cessation. That is why in a recently published study on alternative smoking cessation ther- apies, Astrid Becerra et al. [30] proposed to seek new paths.

In Turkey, Isik [31] has been applying bioresonance for smoking cessation in his practice since 2005, reporting high suc- cess rates. In this retrospective, non-controlled, and non-selec- tive study, 4,733 participants were treated with bioresonance using the MORA device as described in our study (see meth- ods). The main outcome was the smoking rate for 1 week, 1 month, and 3 months after bioresonance therapy. Smoking anamnesis and basic demographic characteristics of the parti- cipants were similar to our trial. The smoking reduction after 1 week was 80.1%, after 1 month 62.1%, and after 3 months 48.2%. No side effects were observed.

To date, no controlled bioresonance studies have been pub- lished verifying Isik’s observations regarding smoking cessa- tion. Thus, we conducted a placebo-controlled, double-blind study in order to examine whether or not bioresonance holds any actual clinical efficacy and effectiveness in smoking cessa- tion. Prior to the study, none of the performing scientists (AP, CC, ZK, HI, FE, TC, ZG) had gathered any experience with the bioresonance approach or the bioresonance equipment used.

Participants and Methods

Study Design

A prospective, placebo-controlled, double-blind, parallel group study was carried out at Istanbul University, Turkey. The verum and the pla- cebo group included each 95 smokers at the age of 18–75 years, who wanted to quit smoking. Group allocation of participants was performed 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.

Inclusion and Exclusion Criteria

The test subjects for the study performed were cigarette smokers who had decided to quit smoking. Prior to this study, none of the subjects had ever tried to quit smoking.

The following criteria for in- and exclusion were applied: Subjects had to be between 18 and 75 years of age; free from any ischemic heart dis- eases and/or cardiac arrhythmias, and from severe psychiatric disorders, such as schizophrenia or anxiety attacks. The scale value in accordance with the nicotine dependence assessment as per Fagerstrom [32] had to be 7. Additionally, the participants’ written consent was required (see below).

Group Allocation

190 tests subjects who met the aforementioned inclusion criteria were recruited at the Smoking Cessation Center, Pulmonology Department at the Medical Faculty, University of Istanbul. The subjects were allocated to a verum group (receiving active bioresonance treatment) and a refer- ence group (subjected to simulated bioresonance therapy). Allocation was based on the following pattern: The first participant treated received active bioresonance therapy, the second received simulated bioresonance

herapy, the third active bioresonance therapy, etc., until all 190 test sub- jects had been allocated. As 1 participant in the reference group was per- manently unavailable after treatment, only 189 test subjects were in- cluded in the evaluation (fig. 1). 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 (p > 0.05; table 1). 6 subjects in the verum group took antidepressants; in the placebo group, 14 subjects were on respective medication. In both test groups, no medication for smoking cessation was taken during or prior to the test period. Other types of medicines consumed were not checked. Prior to the study, all subjects had been informed as to the nature of

placebo-controlled double-blind studies and had given their written con- sent to participate in the study. Subjects were informed about the possi- bility of receiving ineffective treatment. The study was approved by the ethical review committee at the Medical Faculty, University of Istanbul.

Outcome

The essential outcome parameter was smoking behavior. 1 week, 2 weeks, 1 month, and 1 year after completion of treatment, all subjects were interviewed by telephone so as to ascertain whether or not they had smoked cigarettes. In addition, 1 week after treatment the participants were polled by telephone as per questionnaire (fig. 2) in order to evaluate 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.

Intervention and Blinding

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 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 device.

 

Active bioresonance therapy was performed by applying program 21 first, followed by program 22, whereas the simulated bioresonance ther- apy deployed programs 11 and 12 (details on programs are provided below). For both treatment variants, the sounds and indications of biores- onance devices were identical. The participants were thus unable to dif- ferentiate which of the treatment variants they were exposed to. The per- forming party applied the first combination of programs to the first par- ticipant, the second program combination to the second participant, then again the first combination of programs to the third participant, etc. The 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 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.

The only difference between program no. 22 and program no. 21 was the amplification. Electrode connection in program 21 and 22 was identi- cal and specified as follows: 1. stage: right hand = input 1, left hand = input 2, right foot = output 2, left foot = output 1, MT-1 = input 1, MT-2 = input 2, twin beaker = not connected. 2. stage: right hand = output 2, left hand = output 2, right foot = output 2, left foot = output 1, MT-1 = input 1, MT-2 = input 2, twin beaker = output 1 and 2. 3. stage: right hand = input 1, left hand = input 1, right foot = output 1, left foot = output 2, MT-1 = input 1, MT-2 = input 2, twin beaker = not connected. 4. stage: see stage 2.

Program 21

Frequency filter

Amplification

Cycles

Stage 1

24

Channel 1

low pass 1 kHz

90* (80*)

Channel 2

high pass 1 kHz

70* (60*)

Stage 2

30

Channel 1

low pass 1 kHz

100* (90*)

Channel 2

high pass 1 kHz

80* (70*)

Stage 3

24

Channel 1

low pass 1 kHz

50* (40*)

Channel 2

high pass 1 kHz

70* (60*)

Stage 4

30

Channel 1

low pass 1 kHz

60* (50*)

Channel 2

high pass 1 kHz

80* (70*)

*Physiologic amplification, cycle times 3s/7s.

page4image71264 page4image71424 page4image71584

242 Forsch Komplementmed 2014;21:239–245

Fig. 2. Questionnaire (carried out 1 week after treatment).

Table 3. Absolute and relative number (in brackets) of participants who had quit smoking (chi-squared test)

Table 4. Significant findings obtained from supplementary interviews, regarding the participants’ condition 1 week after treatment (relative number of participants, chi-squared test)

Programs 11 and 12 (simulated bioresonance treatment): Programs no. 11 and 12 were set equally to program no. 21, except for the fact that amplification was set to 0 in each stage and channel and the in- and out- put of the MORA device remained unconnected. As a result, the oscilla- tion could neither get in nor out of the device. For the participants of both groups, however, the treatment seemed identical. The performing parties were also unable to distinguish if participants received verum or placebo.

Statistics

The test statistics for the findings presented in tables 1, 3, and 4 were performed by applying the chi-squared test [33]. The respective threshold of significance was p < 0.05.

Results

After 1 week, 77.2% of the members in the verum and 54.8% in the placebo group had quit smoking (p = 0.001); after 2 weeks, 62.4% vs. 34.4% (p < 0.001); 1 month after treatment 51.1% vs. 28.6% (p = 0.002). Even after 1 year, a significant difference between the members of verum and placebo group was recorded: 28.6% of the participants in the verum and 16.1% in the placebo group had not smoked (p = 0.04). Table 3 provides an overview of the results for the main outcome parameter.

The significant findings obtained from supplementary inter- views, regarding the immediate efficacy 1 week after treat- ment, are summarized in table 4. Compared to the placebo group, the desire to smoke was significantly reduced in the verum group over the first 3 and further 3 days after treatment

(p = 0.002; p = 0.003); even if surrounded by smokers, they did not feel any need to smoke (p = 0.003); they did not feel nerv- ous (p = 0.004); believed the therapeutic drops to have reduced their desire to smoke (p = 0.001); and expected the treatment to be effective (p < 0.001).

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 adverse reactions and/or side effects were observed.

Discussion

Regarding the results of this pilot trial, the application of active bioresonance can be rated as successful. This method differs significantly and noticeably from simulated bioreso- nance, 1 week (success rate 77.2% vs. 54.8%), 2 weeks (62.4% vs. 34.4%), 1 month (51.1% vs. 28.6%), and 1 year (28.6% vs. 16.1%) after treatment (table 3). The efficacy of bioresonance therapy documented in this study was also confirmed by the findings obtained from the interview that took place 1 week after treatment (fig. 2). The self-rated improvements of health condition as well as subjective expectation toward treatment effectiveness were significantly more positive in the bioreso- nance than in the placebo group.

Comparing bioresonance method (success rate 28.6% after 1 year) with the most effective pharmacological method using varenicline, the results are similar; yet, they vary in the occur-

ence of side effects caused by varenicline, such as nausea, in- somnia, and partly even attempted suicides. (In 2009, even a warning by the Food and Drug Association was issued). Many studies have been conducted on the medication mentioned above. For example, Oncken et al. 2006 [34] documented the following success rates after 1 year of treatment with vareni- cline and bupropion: 23.0% for varenicline, 14.6% for bupro- pion; and 10.3% for placebo, revealing that the 3 treatments differ significantly. These results are in line with findings from a randomized controlled trial by Jorenby et al. [35]. According to the trial of Tonstad et al. [36], the carbon monoxide content indicating physical nicotine dependence was significantly low- er in the varenicline group compared to the placebo group in weeks 13–24 (70.5% vs. 49.6%) as well as in weeks 13–52 (43.6% vs. 36.9%). These results correspond with findings from other studies [37–38]. According to the meta-analysis by Eisenberg et al. [39], on a pharmacological level the most suc- cessful results were obtained with varenicline.

With regard to complementary therapies in smoking cessa- tion, so far no comparable effects are known for any other method. In a recent placebo-controlled study on ear acupunc- ture, former positive results from non-controlled studies could 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- pants’ health condition after treatment was not possible. There- fore, follow-up data was gathered via telephone and assessed by 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 could not be verified by a fully objective measurement.

One participant in the placebo group was unavailable after treatment and thus could not be included in the evaluation. Due to the high number of participants, however, this would not substantially influence the significance of the results.

Six participants in the verum and 14 in the placebo group took antidepressants. These group differences may have influ- enced the results.

The results of this double-blind pilot study verify the effi- cacy of the bioresonance approach in smoking cessation and confirm the practice-related results of Isik [31] that showed a success rate of 48.2% with the bioresonance method 3 months after treatment. Regarding this time period, Jorenby et al. [35] reported a success rate of 43.9% in the varenicline group and 29.8% in the bupropion group. Gonzales et al. [38] document- ed a success rate of 44.0% for varenicline and 29.5% for bu- propion. According to the results of Isik, the success rate of the bioresonance method is similar to the best pharmacological results, also after a 3-month observation period, only without any side effects.

The results of this study have to be scrutinized by large-scale randomized placebo-controlled double-blind studies, especial- ly comparing bioresonance with pharmacological methods.

Conclusion

According to the findings obtained from this study, bioreso- nance therapy is clinically effective in smoking cessation, with- out involving any adverse side effects.

Disclosure Statement

AP, CC, ZK, HI, FE, TC, and ZG have no conflict of interest in rela- tion to this article. MG was a scientific consultant at Med-Tronik GmbH.

 

 

 

 

 

 

Mora 生物能共振醫學生物光子研究文獻

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Human clinical studies with mora devices Dr. Michael Galle

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